Government and Regulations

When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.

This is an “unequivocally positive” step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.

And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.

Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.

Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.

Many public health advocates applaud the surgeon general’s position.

Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.

“We want to put it more in reach,” said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. “It could not have been a better endorsement.”

Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a “rational” response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.

“I’m not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina,” wrote Goodman, an acute-care nurse practitioner, referring to chest pain.

“What, exactly, are we offering to addicts once their condition has been reversed?” she asked, noting that without treatment and therapy programs that help wean people from addiction “the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby.”

Results would likely be limited by naloxone’s price tag.

Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.

But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.

“Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it,” Wen said.

The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.

Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.

Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.

Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.

“There’s clearly some overlap” here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.

But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.

Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.

Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.

“Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes,” said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. “Ten free kits is not going to be enough.”

Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.

But that money is almost dried up. “We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it,” Phillips said.

Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.

Pharmacies assess the hurdles of distribution.

Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.

“This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it],” Hitchens said. “A lot were probably saying, ‘What in the devil is naloxone?’”

Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.

Access, though, is always subject to retail pressures.

“If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves,” said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.

A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.

That supply stream “meets people where they are,” Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.

“Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention,” Raymond said.

He’d like to see the federal government step in to negotiate prices where smaller programs can’t.

The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.

In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.

A Senate bill would authorize $300 million annually to equip first responders with naloxone.

But critics say those approaches still don’t address the underlying problems: cost and funding.

“You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it,” Wen said. “I don’t care which one. My only concern is the health and well-being of our residents.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.

This is an “unequivocally positive” step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.

And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.

Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.

Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.

Many public health advocates applaud the surgeon general’s position.

Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.

“We want to put it more in reach,” said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. “It could not have been a better endorsement.”

Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a “rational” response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.

“I’m not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina,” wrote Goodman, an acute-care nurse practitioner, referring to chest pain.

“What, exactly, are we offering to addicts once their condition has been reversed?” she asked, noting that without treatment and therapy programs that help wean people from addiction “the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby.”

Results would likely be limited by naloxone’s price tag.

Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.

But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.

“Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it,” Wen said.

The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.

Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.

Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.

Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.

“There’s clearly some overlap” here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.

But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.

Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.

Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.

“Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes,” said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. “Ten free kits is not going to be enough.”

Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.

But that money is almost dried up. “We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it,” Phillips said.

Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.

Pharmacies assess the hurdles of distribution.

Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.

“This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it],” Hitchens said. “A lot were probably saying, ‘What in the devil is naloxone?’”

Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.

Access, though, is always subject to retail pressures.

“If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves,” said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.

A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.

That supply stream “meets people where they are,” Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.

“Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention,” Raymond said.

He’d like to see the federal government step in to negotiate prices where smaller programs can’t.

The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.

In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.

A Senate bill would authorize $300 million annually to equip first responders with naloxone.

But critics say those approaches still don’t address the underlying problems: cost and funding.

“You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it,” Wen said. “I don’t care which one. My only concern is the health and well-being of our residents.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

When Surgeon General Jerome Adams issued an advisory calling for more people to carry naloxone — not just people at overdose risk, but also friends and family — experts and advocates were almost giddy.

This is an “unequivocally positive” step forward, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University.

And not necessarily a surprise. Adams, who previously was Indiana’s health commissioner, was recruited to be the nation’s top doctor in part because of his work with then-Gov. Mike Pence, now the vice president. In Indiana, Adams pushed for harm-reduction approaches, which included expanded access to naloxone and the implementation of a needle exchange to combat the state’s much-publicized HIV outbreak, which began in 2015 and was linked to injection drug use.

Others cautioned, though, that his have-naloxone-will-carry recommendation is at best limited in what it can achieve, in part because the drug is relatively expensive.

Kaiser Health News breaks down what the advisory means, experts’ concerns and what policy approaches may be in the pipeline.

Many public health advocates applaud the surgeon general’s position.

Naloxone, which is a drug that can keep drug users alive by reversing opioid overdoses, is viewed by many as the cornerstone of the harm-reduction approach to the epidemic. Experts say people with addiction problems should carry it, and so should their family, friends and acquaintances.

“We want to put it more in reach,” said Traci Green, an associate professor of emergency medicine and community health sciences at Boston University, who has extensively researched the opioid abuse crisis. “It could not have been a better endorsement.”

Others, including Diane Goodman, who penned a recent Medscape commentary reflecting on the advisory, wonder whether this is a “rational” response to the scourge, since opioid addiction is one of many health problems people might encounter in everyday life and for which treatment options are still limited.

“I’m not sure it makes much more sense than any of us carrying a bottle of nitroglycerin to treat patients with end-stage angina,” wrote Goodman, an acute-care nurse practitioner, referring to chest pain.

“What, exactly, are we offering to addicts once their condition has been reversed?” she asked, noting that without treatment and therapy programs that help wean people from addiction “the odds of survival for any length of time remain low, no matter how much reversal medication is kept nearby.”

Results would likely be limited by naloxone’s price tag.

Take Baltimore, which has been hit particularly hard by the opioid epidemic. Its health department already has pushed for more people to carry naloxone.

But the drug’s price is an issue, said Dr. Leana Wen, the city’s health commissioner, and an emergency physician. She suggested that the federal government negotiate directly for a lower price, or give more money to organizations and agencies like hers so they can afford to maintain an adequate supply.

“Every day, people are calling us at the Baltimore City Health Department and requesting naloxone, and I have to tell them I can’t afford for them to have it,” Wen said.

The drug is available in generic form, which can be stored in a vial and injected via a needle, as well as in patented products, such as the nasal spray Narcan, sold by ADAPT Pharmaceuticals, and Kaleo’s Evzio, a talking auto-injector.

Generic naloxone costs $20 to $40 per dose. Narcan, the nasal spray, costs $125 for a two-dose carton, according to ADAPT’s website. A two-pack of Evzio costs close to $4,000, according to GoodRx.

Health departments and first responders qualify for a discounted rate of $75 per carton of Narcan. Kaleo has made Evzio coupons available to consumers, so that some will not have a copay, and it advertises a discount for federal and state agencies.

Skeptics point out that similar methods have been used to build brand loyalty and potentially make a particular product a household name. That’s how Epi-Pen became synonymous with epinephrine for the treatment of anaphylactic shock.

“There’s clearly some overlap” here between the pricing strategies used by naloxone manufacturers and Epi-Pen distributor Mylan, said Richard Evans, co-founder of SSR Health, which tracks the pharmaceutical industry.

But it’s not a perfect comparison. The presence of low-cost generics changes the calculus, he said, as does the different level of demand.

Nonprofit organizations and health care providers keenly feel the pressures of increasing demand and cost.

Experts say price breaks on naloxone are not sufficient to cover the costs on the ground.

“Sixty-four thousand people lost their lives [nationally in 2016] — that’s someone every 12 minutes,” said Justin Phillips, executive director of Overdose Lifeline, an Indianapolis-based nonprofit. “Ten free kits is not going to be enough.”

Phillips said her organization relies on generic naloxone, which is the least expensive formulation. It’s the only feasible option, using dedicated grant money the group received from the state attorney general’s office as part of a program funded by a settlement with pharmaceutical companies.

But that money is almost dried up. “We need to be able to access naloxone — which I’m told is pennies to make — for the pennies it cost to make it,” Phillips said.

Phillips, who worked with Adams when he ran Indiana’s health department, said she has discussed the need for naloxone funding with the surgeon general, but never its price.

Pharmacies assess the hurdles of distribution.

Local pharmacies are key in this chain, but the overdose antidote is new territory for many pharmacists, said Randy Hitchens, the executive vice president of the Indiana Pharmacists Alliance. He said in 2015, when Adams began his push to get naloxone into the hands of drug users and their families, only one or two retail pharmacies carried it.

“This has always been an emergency room drug. Retail pharmacists typically were not used to dealing with [it],” Hitchens said. “A lot were probably saying, ‘What in the devil is naloxone?’”

Today, he estimates 60 to 70 percent of Indiana’s more than 1,100 retail pharmacies carry the drug. Walgreens, the pharmacy chain, has committed to stocking Narcan.

Access, though, is always subject to retail pressures.

“If pharmacies are not seeing a steady stream coming in asking for it, they won’t be incentivized to carry it on their shelves,” said Daniel Raymond, the deputy director of policy and planning for the Harm Reduction Coalition.

A patchwork of other decentralized sources for naloxone exist: syringe-exchange vans, county and state health departments, churches and community centers, all trying to find ways to get overdose medication into the hands of people who need it.

That supply stream “meets people where they are,” Raymond said, but those little programs don’t have the muscle to negotiate discounted prices.

“Individual health programs are trying to navigate the crisis on their own, but when you see … growing demand and limited supply, it’s a role for federal intervention,” Raymond said.

He’d like to see the federal government step in to negotiate prices where smaller programs can’t.

The surgeon general’s message is one part of Washington’s broader response to the epidemic. But even as Congress crafts an opioid epidemic response package, it’s not clear it will tackle these concerns.

In the House of Representatives’ Energy and Commerce Committee, one bill being discussed would require all state Medicaid programs to cover at least one form of naloxone. Currently, not all state Medicaid programs do so.

A Senate bill would authorize $300 million annually to equip first responders with naloxone.

But critics say those approaches still don’t address the underlying problems: cost and funding.

“You can either make naloxone available, at a much discounted price, or we need to have a lot more resources in order to purchase it,” Wen said. “I don’t care which one. My only concern is the health and well-being of our residents.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

After weeks of speculation, President Donald Trump fired VA Secretary David J. Shulkin, MD, on March 28 and proposed White House physician US Navy RADM Ronny L. Jackson, MD, as his replacement. In another unusual move, President Trump did not ask Deputy Secretary of Veterans Affairs Thomas G. Bowman to manage the agency during the confirmation process, but instead asked Robert Leon Wilkie Jr who was serving as the US Department of Defense Undersecretary of Defense for Personnel and Readiness.

While acknowledging that all cabinet members serve at the pleasure of the President, Shulkin placed the blame for his dismissal squarely on other VA political appointees. “There are many political appointees in the VA that believe that we are moving in the wrong direction or weren’t moving fast enough toward privatizing the VA,” Shulkin told NPR in an early morning interview. “I think that it’s essential for national security and for the country that we honor our commitment by having a strong VA. I was not against reforming VA, but I was against privatization.”

Shulkin was clearly prepared and quick to indentify his oponents in the administration. He wrote a New York Times op-ed that was published just hours after his firing. “Successes within the department have intensified the ambitions of people who want to put VA health care in the hands of the private sector,” Dr. Shulkin wrote. “I believe differences in philosophy deserve robust debate, and solutions should be determined based on the merits of the arguments. The advocates within the administration for privatizing VA health services, however, reject this approach. They saw me as an obstacle to privatization who had to be removed. That is because I am convinced that privatization is a political issue aimed at rewarding select people and companies with profits, even if it undermines care for veterans.”

“As I prepare to leave government,” Shulkin concluded, “I am struck by a recurring thought: It should not be this hard to serve your country.”

Although controversy has swirled around Dr. Shulkin since the release of a VA Inspector General report that was highly critical of a trip to Europe, he dismissed the trip as a cause of his dismissal. According to Shulkin, the White House had refused to allow him to defend himself and point out that the trip was for the White House and the VA. “This was the five allies conference, a trip that the VA secretary has participated in for 40 years with major allies,” he told NPR “The single expenditure spent was on a coach airfare for my wife who was officially invited. Everything was pre-approved by our ethics committee. When the Inspector General didn't like the way that my staff had handled the approval, I wrote a check back to the government.”

Despite the controversy, veteran service organizations (VSOs) and congressional leaders have remained supportive of Dr. Shulkin and skeptical of Dr. Jackson. Most of the VSOs were quick to issue statements. “We are grateful for [Dr. Shulkin’s] efforts to steer VA toward sensible, lasting transformation of veterans health care and hope to see those plans continue moving forward,” said Commander Delphine Metcalf-Foster of Disabled American Veterans in a statement. “While we look forward to learning more about the qualifications and views of the new nominee, we are extremely concerned about the existing leadership vacuum in VA.  At a time of critical negotiations over the future of veterans health care reform, VA today has no Secretary, no Under Secretary of Health or Benefits, and the named Acting Secretary has no background in health care and no apparent experience working in or with the Department.”

In his statement, AMVETS Executive Director Joe Chenelly raised a number of issues that are likely to take center stage in the confirmation hearings, asking “is it appropriate for an active-duty military officer to run a federal agency?” and “with an official bio that does not seem to contain any indication that he’s held a command, is the president’s nominee fully prepared to lead such a massive bureaucracy?” Chenelly added, “I am deeply concerned about the nominee. Veterans’ lives depend on this decision, and the Trump administration needs to substantiate that this active-duty Navy officer is qualified to run a $200 billion bureaucracy, the second largest agency in the government.”

After weeks of speculation, President Donald Trump fired VA Secretary David J. Shulkin, MD, on March 28 and proposed White House physician US Navy RADM Ronny L. Jackson, MD, as his replacement. In another unusual move, President Trump did not ask Deputy Secretary of Veterans Affairs Thomas G. Bowman to manage the agency during the confirmation process, but instead asked Robert Leon Wilkie Jr who was serving as the US Department of Defense Undersecretary of Defense for Personnel and Readiness.

While acknowledging that all cabinet members serve at the pleasure of the President, Shulkin placed the blame for his dismissal squarely on other VA political appointees. “There are many political appointees in the VA that believe that we are moving in the wrong direction or weren’t moving fast enough toward privatizing the VA,” Shulkin told NPR in an early morning interview. “I think that it’s essential for national security and for the country that we honor our commitment by having a strong VA. I was not against reforming VA, but I was against privatization.”

Shulkin was clearly prepared and quick to indentify his oponents in the administration. He wrote a New York Times op-ed that was published just hours after his firing. “Successes within the department have intensified the ambitions of people who want to put VA health care in the hands of the private sector,” Dr. Shulkin wrote. “I believe differences in philosophy deserve robust debate, and solutions should be determined based on the merits of the arguments. The advocates within the administration for privatizing VA health services, however, reject this approach. They saw me as an obstacle to privatization who had to be removed. That is because I am convinced that privatization is a political issue aimed at rewarding select people and companies with profits, even if it undermines care for veterans.”

“As I prepare to leave government,” Shulkin concluded, “I am struck by a recurring thought: It should not be this hard to serve your country.”

Although controversy has swirled around Dr. Shulkin since the release of a VA Inspector General report that was highly critical of a trip to Europe, he dismissed the trip as a cause of his dismissal. According to Shulkin, the White House had refused to allow him to defend himself and point out that the trip was for the White House and the VA. “This was the five allies conference, a trip that the VA secretary has participated in for 40 years with major allies,” he told NPR “The single expenditure spent was on a coach airfare for my wife who was officially invited. Everything was pre-approved by our ethics committee. When the Inspector General didn't like the way that my staff had handled the approval, I wrote a check back to the government.”

Despite the controversy, veteran service organizations (VSOs) and congressional leaders have remained supportive of Dr. Shulkin and skeptical of Dr. Jackson. Most of the VSOs were quick to issue statements. “We are grateful for [Dr. Shulkin’s] efforts to steer VA toward sensible, lasting transformation of veterans health care and hope to see those plans continue moving forward,” said Commander Delphine Metcalf-Foster of Disabled American Veterans in a statement. “While we look forward to learning more about the qualifications and views of the new nominee, we are extremely concerned about the existing leadership vacuum in VA.  At a time of critical negotiations over the future of veterans health care reform, VA today has no Secretary, no Under Secretary of Health or Benefits, and the named Acting Secretary has no background in health care and no apparent experience working in or with the Department.”

In his statement, AMVETS Executive Director Joe Chenelly raised a number of issues that are likely to take center stage in the confirmation hearings, asking “is it appropriate for an active-duty military officer to run a federal agency?” and “with an official bio that does not seem to contain any indication that he’s held a command, is the president’s nominee fully prepared to lead such a massive bureaucracy?” Chenelly added, “I am deeply concerned about the nominee. Veterans’ lives depend on this decision, and the Trump administration needs to substantiate that this active-duty Navy officer is qualified to run a $200 billion bureaucracy, the second largest agency in the government.”

After weeks of speculation, President Donald Trump fired VA Secretary David J. Shulkin, MD, on March 28 and proposed White House physician US Navy RADM Ronny L. Jackson, MD, as his replacement. In another unusual move, President Trump did not ask Deputy Secretary of Veterans Affairs Thomas G. Bowman to manage the agency during the confirmation process, but instead asked Robert Leon Wilkie Jr who was serving as the US Department of Defense Undersecretary of Defense for Personnel and Readiness.

While acknowledging that all cabinet members serve at the pleasure of the President, Shulkin placed the blame for his dismissal squarely on other VA political appointees. “There are many political appointees in the VA that believe that we are moving in the wrong direction or weren’t moving fast enough toward privatizing the VA,” Shulkin told NPR in an early morning interview. “I think that it’s essential for national security and for the country that we honor our commitment by having a strong VA. I was not against reforming VA, but I was against privatization.”

Shulkin was clearly prepared and quick to indentify his oponents in the administration. He wrote a New York Times op-ed that was published just hours after his firing. “Successes within the department have intensified the ambitions of people who want to put VA health care in the hands of the private sector,” Dr. Shulkin wrote. “I believe differences in philosophy deserve robust debate, and solutions should be determined based on the merits of the arguments. The advocates within the administration for privatizing VA health services, however, reject this approach. They saw me as an obstacle to privatization who had to be removed. That is because I am convinced that privatization is a political issue aimed at rewarding select people and companies with profits, even if it undermines care for veterans.”

“As I prepare to leave government,” Shulkin concluded, “I am struck by a recurring thought: It should not be this hard to serve your country.”

Although controversy has swirled around Dr. Shulkin since the release of a VA Inspector General report that was highly critical of a trip to Europe, he dismissed the trip as a cause of his dismissal. According to Shulkin, the White House had refused to allow him to defend himself and point out that the trip was for the White House and the VA. “This was the five allies conference, a trip that the VA secretary has participated in for 40 years with major allies,” he told NPR “The single expenditure spent was on a coach airfare for my wife who was officially invited. Everything was pre-approved by our ethics committee. When the Inspector General didn't like the way that my staff had handled the approval, I wrote a check back to the government.”

Despite the controversy, veteran service organizations (VSOs) and congressional leaders have remained supportive of Dr. Shulkin and skeptical of Dr. Jackson. Most of the VSOs were quick to issue statements. “We are grateful for [Dr. Shulkin’s] efforts to steer VA toward sensible, lasting transformation of veterans health care and hope to see those plans continue moving forward,” said Commander Delphine Metcalf-Foster of Disabled American Veterans in a statement. “While we look forward to learning more about the qualifications and views of the new nominee, we are extremely concerned about the existing leadership vacuum in VA.  At a time of critical negotiations over the future of veterans health care reform, VA today has no Secretary, no Under Secretary of Health or Benefits, and the named Acting Secretary has no background in health care and no apparent experience working in or with the Department.”

In his statement, AMVETS Executive Director Joe Chenelly raised a number of issues that are likely to take center stage in the confirmation hearings, asking “is it appropriate for an active-duty military officer to run a federal agency?” and “with an official bio that does not seem to contain any indication that he’s held a command, is the president’s nominee fully prepared to lead such a massive bureaucracy?” Chenelly added, “I am deeply concerned about the nominee. Veterans’ lives depend on this decision, and the Trump administration needs to substantiate that this active-duty Navy officer is qualified to run a $200 billion bureaucracy, the second largest agency in the government.”

As Assistant Deputy Under Secretary of Health Quality, Safety and Value, Shereef Elnahal, MD led VA efforts to improve the quality of care and to find, develop, and expand successful local programs through the Diffusion of Excellence initiative. More recently, he helped to develop new performance metrics for VA facilities and to increase transparency to veterans about wait times and quality. Federal Practitioner recently asked Dr. Elnahal to discuss these initiatives.

Improving the Veteran Experience

Federal Practitioner. Last year, VA launched accesstocare.va.gov to provide the public access to performance, wait time, and other data. What was the rationale for creating the website?

Shereef Elnahal, MD. The rationale, which directly aligns with the top priorities outlined by VA Secretary David J. Shulkin, MD, was simple: If we provide veterans with an easy-to-use tool that lets them see data on wait times and quality, they’ll be able to make informed decisions about where and when they receive their health care.

Secretary Shulkin has underscored the importance of improving the timeliness of VA health care services while simultaneously empowering veterans through transparency of information. This website provides a vital tool for realizing his vision.

Federal Practitioner. What types of data and tools are currently included on the site and what would you like to include in the future?

Dr. Elnahal. Right now, veterans can find information about wait times, quality of care, as well as other veterans’ experiences at local VA facilities. They also can compare quality of care provided by VA medical centers with that of local private hospitals. In addition, we recently added a feature whereby veterans can see if a local VA facility is better, worse, or the same as the regional average wait time of private sector clinics.

For example, if you’re a veteran and want to find out how quickly you can get an appointment with a primary care provider in your area, you simply visit www.accesstocare.va.gov and click the box “How Quickly Can My VA Facility See Me?” You’ll then be directed to a page that asks whether you want to find out about wait times at individual facilities or learn about facilities with same-day access. By clicking the former, you’ll be taken to a screen that includes a map and a few drop-down menus. From there, you can query the system in several ways, including “How soon can I get an appointment at the facility closest to me?” in which case the site will display a list of facilities in your area, with the closest facility listed first, along with wait times. Or you can ask “How soon can I get an appointment at a nearby facility?” in which case, the system will list facilities in your area displayed according to wait time, with the shortest wait time listed first. No other health care system that we know of provides this level of transparency.

Finally, last October, we also added a new feature, “Our Providers,” which provides information on more than 40,000 full-time and part-time VA health care providers. By visiting www.accesstocare.va.gov/ourproviders, veterans and their families can search practitioners by state, VA facility name, occupation, gender, and the service line to which the practitioner is assigned.

Federal Practitioner. What feedback have you received on accesstocare.va.gov from veterans and veterans groups?

Dr. Elnahal. The response has been overwhelmingly positive, both in terms of what veterans and Veterans Service Organizations (VSOs) have told us, and what we’ve seen in the news. For example, I read a story quoting an Arizona Veterans of Foreign Wars senior vice commander who said “That’s the thing about transparency. You can talk about it and promise it, but putting yourself out there online and making it available for everyone to use is a whole other story. That’s being pretty transparent.”¹

I should note, though, that our desire for feedback didn’t end with the site’s launch. We want veterans and VSOs to continue advising us on ways to improve the site. On the website itself, you can find a section that allows you to give feedback, and we encourage veterans and their family members to do so.

Quality of Care

Federal Practitioner. What metrics are you using internally to measure and improve the quality of VA performance and health care?

Dr. Elnahal. We mainly use metrics that are already reported by private sector hospitals and clinics, such as Medicare core metrics, patient experience surveys, and those that are administered by the National Committee for Quality Assurance (NCQA).

Federal Practitioner. How are central office, VISN, or facility leadership using these metrics?

Dr. Elnahal. Each of these levels of management look at their specific purview, identify areas where they are falling behind the rest of the system or the private sector, and focus their resources on improving those specific areas. At the national level, the main focus right now is on those facilities that Secretary Shulkin has identified as “high risk” so that we can make sure they are on a fast path to improvement. We cannot afford to wait on improving these facilities, and Secretary Shulkin has asked us to focus our resources on the areas that need it most. I think it’s also important to note that we’ve been working to create a standard structure for quality (and safety) governance. Through this structure, which includes boards and committees at every level of VHA, we’re supporting front-line improvement teams that focus on quality of care in particular clinical service lines. We’re also leveraging these front-line teams to promote rapid sharing of best practices across the entire enterprise.

Federal Practitioner. How important is employee engagement and employee satisfaction to VA quality improvement?

Dr. Elnahal. Employee engagement and satisfaction are integral to quality improvement and are high priorities at VA. One factor that makes VA especially unique, even among other federal departments and agencies, is that our workforce truly is mission driven. VA employees are typically not paid quite as highly as health care workers in the private sector and are often asked to do jobs that are more difficult. Our veterans need and deserve the highest quality of care, and for service-related conditions, that can be quite complex. The people who choose to work for VA are invested in the mission, and about one-third of them are veterans themselves.

In addition, VA measures employee satisfaction more consistently and robustly than do most other health care institutions. Every year, a survey called the All-Employee Survey is released to every employee in VHA, and detailed questions are asked about how folks are feeling about their work environment, supervisors, you name it. We play close attention to these results across the organization—happier, engaged employees are more likely to provide the best service they can to veterans, which is why we care so much about this issue.

Federal Practitioner. Do you have any insight based on these metrics on the VA’s recent progress in improving access and quality of care?

In a recent analysis of 15 large metropolitan areas, we found that VA facility outpatient access has improved by 6 days on average between 2014 and 2017, while wait times in the private sector increased by 6 days on average. Wait times have improved in 11 of the 15 metropolitan areas. The number of unique patients seen and the volume of encounters nationally increased substantially between FY14 and FY17 for all 4 analyzed specialties: cardiology, dermatology, primary care and orthopedics.

For example, in cardiology the number of unique patients seen increased by 12%, and the volume of encounters increased by 19%. This progress is further illustrated by our improvement in our Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) data. VA has had incremental improvements annually in access according to reported HCAHPS scores for primary care and specialty care appointments, both urgent and routine care. The percentage of patients who believe “I ‘always’ got an appointment for care needed right away/routine care,” has been improving, on average, 1.3% annually since 2014.

In terms of care quality, several reports have been published in recent years that show high levels of performance in standard metrics for quality and patient safety, and in most, VA exceeds the private sector’s performance. VA continues to strive for the highest possible quality of care that we can provide.

Diffusion of Excellence

Federal Practitioner. How has the Diffusion of Excellence (DoE) program grown from its inception?

Dr. Elnahal. Since 2015, when we launched the initiative, the program has grown considerably both in size as well as in the diversity of best practices put forward.

Federal Practitioner. Does this initiative play into the larger efforts to improve transparency and quality of care?

Dr. Elnahal. Absolutely. Every cycle, categories of best practices are aligned seamlessly with the priorities of the moment. For example, suicide prevention and controlling the opioid epidemic were just some of the priorities we focused on this past year, because they are what the organization has been focused on at large. Quality and patient safety—perennial priorities of VHA—are always reflected in our solicitation of best practices.

Federal Practitioner. Can you identify/describe a few successful DoE programs that exemplify VA employees’ commitment to improving quality of care?

Dr. Elnahal. One example that springs to mind is the Home-based Mental Health Evaluation, or HOME, a program that bridges the gap in mental health care recently discharged rural veterans’ experience. In VISN 16, the program reduced psychiatric rehospitalizations by nearly 50% and the average length of a hospital stay by 41% by having staff meet with hospitalized veterans; complete a home visit within 1 week after the patient is discharged; and maintain weekly phone contact until the veteran starts outpatient mental health services.

Another example is a program developed by staff at the North Florida/South Georgia Veterans Health Care System in Gainesville, which helped reduce wait times in the hospital’s cardiology clinic. This best practice encourages physicians to review individual requests for consultations with specialists. They are asked to triage the requests to determine whether a face-to-face encounter is needed, if the request can be handled either at a local outpatient clinic or electronically, or whether the doctor needs more information before deciding what to do. In 1 year, this process reduced wait times in Gainesville’s cardiology clinic by 46%, to about 10 days.

Another Boston VA project is the development of a screening and transfer process for patients who want to be detoxified from substances to which they have become addicted. The facility’s psychosomatic medicine service team uses an algorithm for screenings and transfers that embeds available literature on the subject and a multidisciplinary consensus into an order set for electronic consultations. This results in an evidence-based, multidisciplinary, and technologic approach to the transfer process.

Federal Practitioner. Do you see DoE as a laboratory for quality of care improvement that could expand beyond the VA?

Dr. Elnahal. Absolutely. In fact, I recently coauthored, with Secretary Shulkin and Deputy Under Secretary for Health Carolyn Clancy, a commentary  that provided a how-to for private sector systems to replicate our efforts.² In that commentary, we identified four distinct phases of diffusing best practices across health care systems: Identify promising practices, recruit champions, replicate; and establish consistency, standardize, and sustain.

As Assistant Deputy Under Secretary of Health Quality, Safety and Value, Shereef Elnahal, MD led VA efforts to improve the quality of care and to find, develop, and expand successful local programs through the Diffusion of Excellence initiative. More recently, he helped to develop new performance metrics for VA facilities and to increase transparency to veterans about wait times and quality. Federal Practitioner recently asked Dr. Elnahal to discuss these initiatives.

Improving the Veteran Experience

Federal Practitioner. Last year, VA launched accesstocare.va.gov to provide the public access to performance, wait time, and other data. What was the rationale for creating the website?

Shereef Elnahal, MD. The rationale, which directly aligns with the top priorities outlined by VA Secretary David J. Shulkin, MD, was simple: If we provide veterans with an easy-to-use tool that lets them see data on wait times and quality, they’ll be able to make informed decisions about where and when they receive their health care.

Secretary Shulkin has underscored the importance of improving the timeliness of VA health care services while simultaneously empowering veterans through transparency of information. This website provides a vital tool for realizing his vision.

Federal Practitioner. What types of data and tools are currently included on the site and what would you like to include in the future?

Dr. Elnahal. Right now, veterans can find information about wait times, quality of care, as well as other veterans’ experiences at local VA facilities. They also can compare quality of care provided by VA medical centers with that of local private hospitals. In addition, we recently added a feature whereby veterans can see if a local VA facility is better, worse, or the same as the regional average wait time of private sector clinics.

For example, if you’re a veteran and want to find out how quickly you can get an appointment with a primary care provider in your area, you simply visit www.accesstocare.va.gov and click the box “How Quickly Can My VA Facility See Me?” You’ll then be directed to a page that asks whether you want to find out about wait times at individual facilities or learn about facilities with same-day access. By clicking the former, you’ll be taken to a screen that includes a map and a few drop-down menus. From there, you can query the system in several ways, including “How soon can I get an appointment at the facility closest to me?” in which case the site will display a list of facilities in your area, with the closest facility listed first, along with wait times. Or you can ask “How soon can I get an appointment at a nearby facility?” in which case, the system will list facilities in your area displayed according to wait time, with the shortest wait time listed first. No other health care system that we know of provides this level of transparency.

Finally, last October, we also added a new feature, “Our Providers,” which provides information on more than 40,000 full-time and part-time VA health care providers. By visiting www.accesstocare.va.gov/ourproviders, veterans and their families can search practitioners by state, VA facility name, occupation, gender, and the service line to which the practitioner is assigned.

Federal Practitioner. What feedback have you received on accesstocare.va.gov from veterans and veterans groups?

Dr. Elnahal. The response has been overwhelmingly positive, both in terms of what veterans and Veterans Service Organizations (VSOs) have told us, and what we’ve seen in the news. For example, I read a story quoting an Arizona Veterans of Foreign Wars senior vice commander who said “That’s the thing about transparency. You can talk about it and promise it, but putting yourself out there online and making it available for everyone to use is a whole other story. That’s being pretty transparent.”¹

I should note, though, that our desire for feedback didn’t end with the site’s launch. We want veterans and VSOs to continue advising us on ways to improve the site. On the website itself, you can find a section that allows you to give feedback, and we encourage veterans and their family members to do so.

Quality of Care

Federal Practitioner. What metrics are you using internally to measure and improve the quality of VA performance and health care?

Dr. Elnahal. We mainly use metrics that are already reported by private sector hospitals and clinics, such as Medicare core metrics, patient experience surveys, and those that are administered by the National Committee for Quality Assurance (NCQA).

Federal Practitioner. How are central office, VISN, or facility leadership using these metrics?

Dr. Elnahal. Each of these levels of management look at their specific purview, identify areas where they are falling behind the rest of the system or the private sector, and focus their resources on improving those specific areas. At the national level, the main focus right now is on those facilities that Secretary Shulkin has identified as “high risk” so that we can make sure they are on a fast path to improvement. We cannot afford to wait on improving these facilities, and Secretary Shulkin has asked us to focus our resources on the areas that need it most. I think it’s also important to note that we’ve been working to create a standard structure for quality (and safety) governance. Through this structure, which includes boards and committees at every level of VHA, we’re supporting front-line improvement teams that focus on quality of care in particular clinical service lines. We’re also leveraging these front-line teams to promote rapid sharing of best practices across the entire enterprise.

Federal Practitioner. How important is employee engagement and employee satisfaction to VA quality improvement?

Dr. Elnahal. Employee engagement and satisfaction are integral to quality improvement and are high priorities at VA. One factor that makes VA especially unique, even among other federal departments and agencies, is that our workforce truly is mission driven. VA employees are typically not paid quite as highly as health care workers in the private sector and are often asked to do jobs that are more difficult. Our veterans need and deserve the highest quality of care, and for service-related conditions, that can be quite complex. The people who choose to work for VA are invested in the mission, and about one-third of them are veterans themselves.

In addition, VA measures employee satisfaction more consistently and robustly than do most other health care institutions. Every year, a survey called the All-Employee Survey is released to every employee in VHA, and detailed questions are asked about how folks are feeling about their work environment, supervisors, you name it. We play close attention to these results across the organization—happier, engaged employees are more likely to provide the best service they can to veterans, which is why we care so much about this issue.

Federal Practitioner. Do you have any insight based on these metrics on the VA’s recent progress in improving access and quality of care?

In a recent analysis of 15 large metropolitan areas, we found that VA facility outpatient access has improved by 6 days on average between 2014 and 2017, while wait times in the private sector increased by 6 days on average. Wait times have improved in 11 of the 15 metropolitan areas. The number of unique patients seen and the volume of encounters nationally increased substantially between FY14 and FY17 for all 4 analyzed specialties: cardiology, dermatology, primary care and orthopedics.

For example, in cardiology the number of unique patients seen increased by 12%, and the volume of encounters increased by 19%. This progress is further illustrated by our improvement in our Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) data. VA has had incremental improvements annually in access according to reported HCAHPS scores for primary care and specialty care appointments, both urgent and routine care. The percentage of patients who believe “I ‘always’ got an appointment for care needed right away/routine care,” has been improving, on average, 1.3% annually since 2014.

In terms of care quality, several reports have been published in recent years that show high levels of performance in standard metrics for quality and patient safety, and in most, VA exceeds the private sector’s performance. VA continues to strive for the highest possible quality of care that we can provide.

Diffusion of Excellence

Federal Practitioner. How has the Diffusion of Excellence (DoE) program grown from its inception?

Dr. Elnahal. Since 2015, when we launched the initiative, the program has grown considerably both in size as well as in the diversity of best practices put forward.

Federal Practitioner. Does this initiative play into the larger efforts to improve transparency and quality of care?

Dr. Elnahal. Absolutely. Every cycle, categories of best practices are aligned seamlessly with the priorities of the moment. For example, suicide prevention and controlling the opioid epidemic were just some of the priorities we focused on this past year, because they are what the organization has been focused on at large. Quality and patient safety—perennial priorities of VHA—are always reflected in our solicitation of best practices.

Federal Practitioner. Can you identify/describe a few successful DoE programs that exemplify VA employees’ commitment to improving quality of care?

Dr. Elnahal. One example that springs to mind is the Home-based Mental Health Evaluation, or HOME, a program that bridges the gap in mental health care recently discharged rural veterans’ experience. In VISN 16, the program reduced psychiatric rehospitalizations by nearly 50% and the average length of a hospital stay by 41% by having staff meet with hospitalized veterans; complete a home visit within 1 week after the patient is discharged; and maintain weekly phone contact until the veteran starts outpatient mental health services.

Another example is a program developed by staff at the North Florida/South Georgia Veterans Health Care System in Gainesville, which helped reduce wait times in the hospital’s cardiology clinic. This best practice encourages physicians to review individual requests for consultations with specialists. They are asked to triage the requests to determine whether a face-to-face encounter is needed, if the request can be handled either at a local outpatient clinic or electronically, or whether the doctor needs more information before deciding what to do. In 1 year, this process reduced wait times in Gainesville’s cardiology clinic by 46%, to about 10 days.

Another Boston VA project is the development of a screening and transfer process for patients who want to be detoxified from substances to which they have become addicted. The facility’s psychosomatic medicine service team uses an algorithm for screenings and transfers that embeds available literature on the subject and a multidisciplinary consensus into an order set for electronic consultations. This results in an evidence-based, multidisciplinary, and technologic approach to the transfer process.

Federal Practitioner. Do you see DoE as a laboratory for quality of care improvement that could expand beyond the VA?

Dr. Elnahal. Absolutely. In fact, I recently coauthored, with Secretary Shulkin and Deputy Under Secretary for Health Carolyn Clancy, a commentary  that provided a how-to for private sector systems to replicate our efforts.² In that commentary, we identified four distinct phases of diffusing best practices across health care systems: Identify promising practices, recruit champions, replicate; and establish consistency, standardize, and sustain.

As Assistant Deputy Under Secretary of Health Quality, Safety and Value, Shereef Elnahal, MD led VA efforts to improve the quality of care and to find, develop, and expand successful local programs through the Diffusion of Excellence initiative. More recently, he helped to develop new performance metrics for VA facilities and to increase transparency to veterans about wait times and quality. Federal Practitioner recently asked Dr. Elnahal to discuss these initiatives.

Improving the Veteran Experience

Federal Practitioner. Last year, VA launched accesstocare.va.gov to provide the public access to performance, wait time, and other data. What was the rationale for creating the website?

Shereef Elnahal, MD. The rationale, which directly aligns with the top priorities outlined by VA Secretary David J. Shulkin, MD, was simple: If we provide veterans with an easy-to-use tool that lets them see data on wait times and quality, they’ll be able to make informed decisions about where and when they receive their health care.

Secretary Shulkin has underscored the importance of improving the timeliness of VA health care services while simultaneously empowering veterans through transparency of information. This website provides a vital tool for realizing his vision.

Federal Practitioner. What types of data and tools are currently included on the site and what would you like to include in the future?

Dr. Elnahal. Right now, veterans can find information about wait times, quality of care, as well as other veterans’ experiences at local VA facilities. They also can compare quality of care provided by VA medical centers with that of local private hospitals. In addition, we recently added a feature whereby veterans can see if a local VA facility is better, worse, or the same as the regional average wait time of private sector clinics.

For example, if you’re a veteran and want to find out how quickly you can get an appointment with a primary care provider in your area, you simply visit www.accesstocare.va.gov and click the box “How Quickly Can My VA Facility See Me?” You’ll then be directed to a page that asks whether you want to find out about wait times at individual facilities or learn about facilities with same-day access. By clicking the former, you’ll be taken to a screen that includes a map and a few drop-down menus. From there, you can query the system in several ways, including “How soon can I get an appointment at the facility closest to me?” in which case the site will display a list of facilities in your area, with the closest facility listed first, along with wait times. Or you can ask “How soon can I get an appointment at a nearby facility?” in which case, the system will list facilities in your area displayed according to wait time, with the shortest wait time listed first. No other health care system that we know of provides this level of transparency.

Finally, last October, we also added a new feature, “Our Providers,” which provides information on more than 40,000 full-time and part-time VA health care providers. By visiting www.accesstocare.va.gov/ourproviders, veterans and their families can search practitioners by state, VA facility name, occupation, gender, and the service line to which the practitioner is assigned.

Federal Practitioner. What feedback have you received on accesstocare.va.gov from veterans and veterans groups?

Dr. Elnahal. The response has been overwhelmingly positive, both in terms of what veterans and Veterans Service Organizations (VSOs) have told us, and what we’ve seen in the news. For example, I read a story quoting an Arizona Veterans of Foreign Wars senior vice commander who said “That’s the thing about transparency. You can talk about it and promise it, but putting yourself out there online and making it available for everyone to use is a whole other story. That’s being pretty transparent.”¹

I should note, though, that our desire for feedback didn’t end with the site’s launch. We want veterans and VSOs to continue advising us on ways to improve the site. On the website itself, you can find a section that allows you to give feedback, and we encourage veterans and their family members to do so.

Quality of Care

Federal Practitioner. What metrics are you using internally to measure and improve the quality of VA performance and health care?

Dr. Elnahal. We mainly use metrics that are already reported by private sector hospitals and clinics, such as Medicare core metrics, patient experience surveys, and those that are administered by the National Committee for Quality Assurance (NCQA).

Federal Practitioner. How are central office, VISN, or facility leadership using these metrics?

Dr. Elnahal. Each of these levels of management look at their specific purview, identify areas where they are falling behind the rest of the system or the private sector, and focus their resources on improving those specific areas. At the national level, the main focus right now is on those facilities that Secretary Shulkin has identified as “high risk” so that we can make sure they are on a fast path to improvement. We cannot afford to wait on improving these facilities, and Secretary Shulkin has asked us to focus our resources on the areas that need it most. I think it’s also important to note that we’ve been working to create a standard structure for quality (and safety) governance. Through this structure, which includes boards and committees at every level of VHA, we’re supporting front-line improvement teams that focus on quality of care in particular clinical service lines. We’re also leveraging these front-line teams to promote rapid sharing of best practices across the entire enterprise.

Federal Practitioner. How important is employee engagement and employee satisfaction to VA quality improvement?

Dr. Elnahal. Employee engagement and satisfaction are integral to quality improvement and are high priorities at VA. One factor that makes VA especially unique, even among other federal departments and agencies, is that our workforce truly is mission driven. VA employees are typically not paid quite as highly as health care workers in the private sector and are often asked to do jobs that are more difficult. Our veterans need and deserve the highest quality of care, and for service-related conditions, that can be quite complex. The people who choose to work for VA are invested in the mission, and about one-third of them are veterans themselves.

In addition, VA measures employee satisfaction more consistently and robustly than do most other health care institutions. Every year, a survey called the All-Employee Survey is released to every employee in VHA, and detailed questions are asked about how folks are feeling about their work environment, supervisors, you name it. We play close attention to these results across the organization—happier, engaged employees are more likely to provide the best service they can to veterans, which is why we care so much about this issue.

Federal Practitioner. Do you have any insight based on these metrics on the VA’s recent progress in improving access and quality of care?

In a recent analysis of 15 large metropolitan areas, we found that VA facility outpatient access has improved by 6 days on average between 2014 and 2017, while wait times in the private sector increased by 6 days on average. Wait times have improved in 11 of the 15 metropolitan areas. The number of unique patients seen and the volume of encounters nationally increased substantially between FY14 and FY17 for all 4 analyzed specialties: cardiology, dermatology, primary care and orthopedics.

For example, in cardiology the number of unique patients seen increased by 12%, and the volume of encounters increased by 19%. This progress is further illustrated by our improvement in our Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) data. VA has had incremental improvements annually in access according to reported HCAHPS scores for primary care and specialty care appointments, both urgent and routine care. The percentage of patients who believe “I ‘always’ got an appointment for care needed right away/routine care,” has been improving, on average, 1.3% annually since 2014.

In terms of care quality, several reports have been published in recent years that show high levels of performance in standard metrics for quality and patient safety, and in most, VA exceeds the private sector’s performance. VA continues to strive for the highest possible quality of care that we can provide.

Diffusion of Excellence

Federal Practitioner. How has the Diffusion of Excellence (DoE) program grown from its inception?

Dr. Elnahal. Since 2015, when we launched the initiative, the program has grown considerably both in size as well as in the diversity of best practices put forward.

Federal Practitioner. Does this initiative play into the larger efforts to improve transparency and quality of care?

Dr. Elnahal. Absolutely. Every cycle, categories of best practices are aligned seamlessly with the priorities of the moment. For example, suicide prevention and controlling the opioid epidemic were just some of the priorities we focused on this past year, because they are what the organization has been focused on at large. Quality and patient safety—perennial priorities of VHA—are always reflected in our solicitation of best practices.

Federal Practitioner. Can you identify/describe a few successful DoE programs that exemplify VA employees’ commitment to improving quality of care?

Dr. Elnahal. One example that springs to mind is the Home-based Mental Health Evaluation, or HOME, a program that bridges the gap in mental health care recently discharged rural veterans’ experience. In VISN 16, the program reduced psychiatric rehospitalizations by nearly 50% and the average length of a hospital stay by 41% by having staff meet with hospitalized veterans; complete a home visit within 1 week after the patient is discharged; and maintain weekly phone contact until the veteran starts outpatient mental health services.

Another example is a program developed by staff at the North Florida/South Georgia Veterans Health Care System in Gainesville, which helped reduce wait times in the hospital’s cardiology clinic. This best practice encourages physicians to review individual requests for consultations with specialists. They are asked to triage the requests to determine whether a face-to-face encounter is needed, if the request can be handled either at a local outpatient clinic or electronically, or whether the doctor needs more information before deciding what to do. In 1 year, this process reduced wait times in Gainesville’s cardiology clinic by 46%, to about 10 days.

Another Boston VA project is the development of a screening and transfer process for patients who want to be detoxified from substances to which they have become addicted. The facility’s psychosomatic medicine service team uses an algorithm for screenings and transfers that embeds available literature on the subject and a multidisciplinary consensus into an order set for electronic consultations. This results in an evidence-based, multidisciplinary, and technologic approach to the transfer process.

Federal Practitioner. Do you see DoE as a laboratory for quality of care improvement that could expand beyond the VA?

Dr. Elnahal. Absolutely. In fact, I recently coauthored, with Secretary Shulkin and Deputy Under Secretary for Health Carolyn Clancy, a commentary  that provided a how-to for private sector systems to replicate our efforts.² In that commentary, we identified four distinct phases of diffusing best practices across health care systems: Identify promising practices, recruit champions, replicate; and establish consistency, standardize, and sustain.

Beginning in less than 90 days, new veterans will become eligible for VA mental health care as soon as they leave military service. More than 250,000 service members transition out of the military each year. On Tuesday, the President signed an executive order that gives the DoD, Department of Homeland Security, and VA just 60 days to develop a plan for handling the influx of new patients into the system.

“As service members transition to veteran status, they face higher risk of suicide and mental health difficulties,” said VA Secretary David Shulkin, MD. “During this critical phase, many transitioning service members may not qualify for enrollment in health care. The focus of this executive order is to coordinate federal assets to close that gap.”

How the VA will meet the increased demand remains to be seen. As an executive order, the mandate does not come with additional funds. And in October testimony, Secretary Shulkin admitted that the VA already was having difficulty hiring and training enough mental health care providers to meet existing demand.  

The executive order is focused on the 60% of new veterans who are not immediately eligible for VA health care benefits. According to Secretary Shulkin, in the first year postseparation, often before VA eligibility is determined, these new veterans are especially at risk for suicide. “That 12-month period after you leave service is the highest risk for suicide,” Secretary Shulkin noted. Veterans during that period face almost one and a half to 2 times the risk of suicide in that first 12 months when they leave the service.

The VA outlined 3 approaches that would be implemented to meet the mental health needs for transitioning veterans. Peer counseling will play a particularly important role in the new services. First, the VA will expand its peer community outreach and group session offers and the VA whole health patient-centered care initiative. Currently, the VA Whole Health program is in 18 facilities, but it will be expanded to all facilities. The program focuses on wellness and establishing individual health goals.

In addition, the DoD “Be There Peer Support Call and Outreach Center” services will be expanded. The program will begin to offer peer support for veterans in the year following separation from the uniformed service.

Most consequently, the executive order will expand the DoD Military OneSource, which currently provides free mental health care counseling to active-duty service members and their families. The program will be expanded to include recently transitioned veterans as well. And according to a report in Military Times, Military OneSource care also may be available to the families of new veterans.

Beginning in less than 90 days, new veterans will become eligible for VA mental health care as soon as they leave military service. More than 250,000 service members transition out of the military each year. On Tuesday, the President signed an executive order that gives the DoD, Department of Homeland Security, and VA just 60 days to develop a plan for handling the influx of new patients into the system.

“As service members transition to veteran status, they face higher risk of suicide and mental health difficulties,” said VA Secretary David Shulkin, MD. “During this critical phase, many transitioning service members may not qualify for enrollment in health care. The focus of this executive order is to coordinate federal assets to close that gap.”

How the VA will meet the increased demand remains to be seen. As an executive order, the mandate does not come with additional funds. And in October testimony, Secretary Shulkin admitted that the VA already was having difficulty hiring and training enough mental health care providers to meet existing demand.  

The executive order is focused on the 60% of new veterans who are not immediately eligible for VA health care benefits. According to Secretary Shulkin, in the first year postseparation, often before VA eligibility is determined, these new veterans are especially at risk for suicide. “That 12-month period after you leave service is the highest risk for suicide,” Secretary Shulkin noted. Veterans during that period face almost one and a half to 2 times the risk of suicide in that first 12 months when they leave the service.

The VA outlined 3 approaches that would be implemented to meet the mental health needs for transitioning veterans. Peer counseling will play a particularly important role in the new services. First, the VA will expand its peer community outreach and group session offers and the VA whole health patient-centered care initiative. Currently, the VA Whole Health program is in 18 facilities, but it will be expanded to all facilities. The program focuses on wellness and establishing individual health goals.

In addition, the DoD “Be There Peer Support Call and Outreach Center” services will be expanded. The program will begin to offer peer support for veterans in the year following separation from the uniformed service.

Most consequently, the executive order will expand the DoD Military OneSource, which currently provides free mental health care counseling to active-duty service members and their families. The program will be expanded to include recently transitioned veterans as well. And according to a report in Military Times, Military OneSource care also may be available to the families of new veterans.

Beginning in less than 90 days, new veterans will become eligible for VA mental health care as soon as they leave military service. More than 250,000 service members transition out of the military each year. On Tuesday, the President signed an executive order that gives the DoD, Department of Homeland Security, and VA just 60 days to develop a plan for handling the influx of new patients into the system.

“As service members transition to veteran status, they face higher risk of suicide and mental health difficulties,” said VA Secretary David Shulkin, MD. “During this critical phase, many transitioning service members may not qualify for enrollment in health care. The focus of this executive order is to coordinate federal assets to close that gap.”

How the VA will meet the increased demand remains to be seen. As an executive order, the mandate does not come with additional funds. And in October testimony, Secretary Shulkin admitted that the VA already was having difficulty hiring and training enough mental health care providers to meet existing demand.  

The executive order is focused on the 60% of new veterans who are not immediately eligible for VA health care benefits. According to Secretary Shulkin, in the first year postseparation, often before VA eligibility is determined, these new veterans are especially at risk for suicide. “That 12-month period after you leave service is the highest risk for suicide,” Secretary Shulkin noted. Veterans during that period face almost one and a half to 2 times the risk of suicide in that first 12 months when they leave the service.

The VA outlined 3 approaches that would be implemented to meet the mental health needs for transitioning veterans. Peer counseling will play a particularly important role in the new services. First, the VA will expand its peer community outreach and group session offers and the VA whole health patient-centered care initiative. Currently, the VA Whole Health program is in 18 facilities, but it will be expanded to all facilities. The program focuses on wellness and establishing individual health goals.

In addition, the DoD “Be There Peer Support Call and Outreach Center” services will be expanded. The program will begin to offer peer support for veterans in the year following separation from the uniformed service.

Most consequently, the executive order will expand the DoD Military OneSource, which currently provides free mental health care counseling to active-duty service members and their families. The program will be expanded to include recently transitioned veterans as well. And according to a report in Military Times, Military OneSource care also may be available to the families of new veterans.

After a concerted effort, the VA is now approaching its goal of 100% treatment for patients infected with hepatitis C virus (HCV), VA Secretary David J. Shulkin, MD noted at a speech at the AMSUS Annual Meeting. More than 100,000 veterans have been treated for HCV infection, and 90% have been cured. According to Dr. Shulkin, the VA also has seen significant drops in measures of opioid use and homelessness among veterans. Although the VA is no longer focused on completely ending veteran homelessness, the rate has dropped 50% since 2010, and 3 states (Virginia, Connecticut, and Delaware) have eliminated homelessness completely.

According to Dr. Shulkin, the VA currently is the only health care system that publishes its wait times, quality scores, and disciplinary actions taken against employees. That level of transparency is not only unusual in health care systems, but also unprecedented in the federal government, Dr. Shulkin noted. “I am the only cabinet member that publishes my travel schedule,” Dr. Shulkin told the VA, DoD, and PHS audience.

In addition to promoting current VA progress, Dr. Shulkin also outlined his priorities for the VA moving forward. The priorities included:

1. Greater Choice. Dr. Shulkin maintained that the VA should not only provide more options for veterans seeking health care, but also facilitate their ability to make better health care decisions. Choice for veterans will mean being able to access care both inside and outside the VA system.
2. Modernize the VA. The signature part of VA’s modernization effort has been its decision to adopt the Cerner/GENESIS electronic health record (EHR) system, but it also includes the VA decision to close 1,100 facilities and focus its resources on the remaining facilities. Dr. Shulkin hopes that the combined power of the VA and DoD on a single EHR system will force EHR providers to improve interoperability. In addition, a new program will allow PHS officers to serve in the VA, bringing in much needed public health experience.
3. Improve the Timeliness of Services. Currently, 97% of VA appointments are completed within 30 days, 86% are within a week, and 21% are same day. Improving those metrics will require the VA to “double down on technology,” Dr. Shulkin insisted. The VA now sees 700,000 veterans via telehealth.
4. Focus Resources More Efficiently. The VA can and should be “world class” in areas where it matters most, Dr. Shulkin argued, including areas like prosthetics, traumatic brain injury, posttraumatic stress disorder, and spinal cord injury. Better coordination with the DoD also will help both health care systems to improve efficiency. A “Caregivers Moonshot” initiative also will allow more veterans to remain at home at end of life.
5. Suicide Prevention. While suicide is a public health crisis across the U.S., it is especially acute amongst veterans. According to Dr. Shulkin, reducing veteran suicide will require action both inside and outside the VA. The VA needs to connect with community mental health providers and provide more services to other than honorable discharges.

After a concerted effort, the VA is now approaching its goal of 100% treatment for patients infected with hepatitis C virus (HCV), VA Secretary David J. Shulkin, MD noted at a speech at the AMSUS Annual Meeting. More than 100,000 veterans have been treated for HCV infection, and 90% have been cured. According to Dr. Shulkin, the VA also has seen significant drops in measures of opioid use and homelessness among veterans. Although the VA is no longer focused on completely ending veteran homelessness, the rate has dropped 50% since 2010, and 3 states (Virginia, Connecticut, and Delaware) have eliminated homelessness completely.

According to Dr. Shulkin, the VA currently is the only health care system that publishes its wait times, quality scores, and disciplinary actions taken against employees. That level of transparency is not only unusual in health care systems, but also unprecedented in the federal government, Dr. Shulkin noted. “I am the only cabinet member that publishes my travel schedule,” Dr. Shulkin told the VA, DoD, and PHS audience.

In addition to promoting current VA progress, Dr. Shulkin also outlined his priorities for the VA moving forward. The priorities included:

1. Greater Choice. Dr. Shulkin maintained that the VA should not only provide more options for veterans seeking health care, but also facilitate their ability to make better health care decisions. Choice for veterans will mean being able to access care both inside and outside the VA system.
2. Modernize the VA. The signature part of VA’s modernization effort has been its decision to adopt the Cerner/GENESIS electronic health record (EHR) system, but it also includes the VA decision to close 1,100 facilities and focus its resources on the remaining facilities. Dr. Shulkin hopes that the combined power of the VA and DoD on a single EHR system will force EHR providers to improve interoperability. In addition, a new program will allow PHS officers to serve in the VA, bringing in much needed public health experience.
3. Improve the Timeliness of Services. Currently, 97% of VA appointments are completed within 30 days, 86% are within a week, and 21% are same day. Improving those metrics will require the VA to “double down on technology,” Dr. Shulkin insisted. The VA now sees 700,000 veterans via telehealth.
4. Focus Resources More Efficiently. The VA can and should be “world class” in areas where it matters most, Dr. Shulkin argued, including areas like prosthetics, traumatic brain injury, posttraumatic stress disorder, and spinal cord injury. Better coordination with the DoD also will help both health care systems to improve efficiency. A “Caregivers Moonshot” initiative also will allow more veterans to remain at home at end of life.
5. Suicide Prevention. While suicide is a public health crisis across the U.S., it is especially acute amongst veterans. According to Dr. Shulkin, reducing veteran suicide will require action both inside and outside the VA. The VA needs to connect with community mental health providers and provide more services to other than honorable discharges.

After a concerted effort, the VA is now approaching its goal of 100% treatment for patients infected with hepatitis C virus (HCV), VA Secretary David J. Shulkin, MD noted at a speech at the AMSUS Annual Meeting. More than 100,000 veterans have been treated for HCV infection, and 90% have been cured. According to Dr. Shulkin, the VA also has seen significant drops in measures of opioid use and homelessness among veterans. Although the VA is no longer focused on completely ending veteran homelessness, the rate has dropped 50% since 2010, and 3 states (Virginia, Connecticut, and Delaware) have eliminated homelessness completely.

According to Dr. Shulkin, the VA currently is the only health care system that publishes its wait times, quality scores, and disciplinary actions taken against employees. That level of transparency is not only unusual in health care systems, but also unprecedented in the federal government, Dr. Shulkin noted. “I am the only cabinet member that publishes my travel schedule,” Dr. Shulkin told the VA, DoD, and PHS audience.

In addition to promoting current VA progress, Dr. Shulkin also outlined his priorities for the VA moving forward. The priorities included:

1. Greater Choice. Dr. Shulkin maintained that the VA should not only provide more options for veterans seeking health care, but also facilitate their ability to make better health care decisions. Choice for veterans will mean being able to access care both inside and outside the VA system.
2. Modernize the VA. The signature part of VA’s modernization effort has been its decision to adopt the Cerner/GENESIS electronic health record (EHR) system, but it also includes the VA decision to close 1,100 facilities and focus its resources on the remaining facilities. Dr. Shulkin hopes that the combined power of the VA and DoD on a single EHR system will force EHR providers to improve interoperability. In addition, a new program will allow PHS officers to serve in the VA, bringing in much needed public health experience.
3. Improve the Timeliness of Services. Currently, 97% of VA appointments are completed within 30 days, 86% are within a week, and 21% are same day. Improving those metrics will require the VA to “double down on technology,” Dr. Shulkin insisted. The VA now sees 700,000 veterans via telehealth.
4. Focus Resources More Efficiently. The VA can and should be “world class” in areas where it matters most, Dr. Shulkin argued, including areas like prosthetics, traumatic brain injury, posttraumatic stress disorder, and spinal cord injury. Better coordination with the DoD also will help both health care systems to improve efficiency. A “Caregivers Moonshot” initiative also will allow more veterans to remain at home at end of life.
5. Suicide Prevention. While suicide is a public health crisis across the U.S., it is especially acute amongst veterans. According to Dr. Shulkin, reducing veteran suicide will require action both inside and outside the VA. The VA needs to connect with community mental health providers and provide more services to other than honorable discharges.

The outbreak of Ebola in West Africa in 2014 provided a wake-up call for global health care experts. Responding to the next global health care crisis will require a more coherent and strategic response, and U.S. leadership, to protect both U.S. and global health security. The Ebola crisis “raised consciousness generally that health and security have become more directly linked,” said CAPT Paul Reed, MD, USPHS, interim director of the Center for Global Health Engagement (CGHE) at the Uniformed Services University.

According to CAPT Reed, global health engagement is an essential part of force preparedness and a key part of U.S. dialogue with global partners. The CGHE will host a series of sessions at the upcoming AMSUS meeting on November 28, outside Washington, DC, that will focus on global health strategies, the importance of global health engagement to combat commands, and projects underway to expand global health engagement.

The CGHE mission is to lead, integrate, and bring together thought leadership, research, and advocacy from public health experts, Uniformed Services University faculty, combatant commands, and the Military Health System to national security objectives. The CGHE is focused on developing partnerships to build global capacity and increase resiliency for disaster preparation. In addition, the center is engaged in research studies, including the Measures Of Effectiveness in Defense Engagement and Learning (MODEL) and the Improving Processes and Coordination in Theater (IMPACT) studies.

As the Ebola outbreak made clear, global health threats can impact both military and domestic operations. “There is not distinction between global and domestic health issues,” Dr. Reed told Federal Practitioner. “Global health engagement is a unique aspects of public health. We need to develop a new doctrine. We have to do it collectively and we can't do that in silos. We can't even do it within a federal government silo.”

The outbreak of Ebola in West Africa in 2014 provided a wake-up call for global health care experts. Responding to the next global health care crisis will require a more coherent and strategic response, and U.S. leadership, to protect both U.S. and global health security. The Ebola crisis “raised consciousness generally that health and security have become more directly linked,” said CAPT Paul Reed, MD, USPHS, interim director of the Center for Global Health Engagement (CGHE) at the Uniformed Services University.

According to CAPT Reed, global health engagement is an essential part of force preparedness and a key part of U.S. dialogue with global partners. The CGHE will host a series of sessions at the upcoming AMSUS meeting on November 28, outside Washington, DC, that will focus on global health strategies, the importance of global health engagement to combat commands, and projects underway to expand global health engagement.

The CGHE mission is to lead, integrate, and bring together thought leadership, research, and advocacy from public health experts, Uniformed Services University faculty, combatant commands, and the Military Health System to national security objectives. The CGHE is focused on developing partnerships to build global capacity and increase resiliency for disaster preparation. In addition, the center is engaged in research studies, including the Measures Of Effectiveness in Defense Engagement and Learning (MODEL) and the Improving Processes and Coordination in Theater (IMPACT) studies.

As the Ebola outbreak made clear, global health threats can impact both military and domestic operations. “There is not distinction between global and domestic health issues,” Dr. Reed told Federal Practitioner. “Global health engagement is a unique aspects of public health. We need to develop a new doctrine. We have to do it collectively and we can't do that in silos. We can't even do it within a federal government silo.”

The outbreak of Ebola in West Africa in 2014 provided a wake-up call for global health care experts. Responding to the next global health care crisis will require a more coherent and strategic response, and U.S. leadership, to protect both U.S. and global health security. The Ebola crisis “raised consciousness generally that health and security have become more directly linked,” said CAPT Paul Reed, MD, USPHS, interim director of the Center for Global Health Engagement (CGHE) at the Uniformed Services University.

According to CAPT Reed, global health engagement is an essential part of force preparedness and a key part of U.S. dialogue with global partners. The CGHE will host a series of sessions at the upcoming AMSUS meeting on November 28, outside Washington, DC, that will focus on global health strategies, the importance of global health engagement to combat commands, and projects underway to expand global health engagement.

The CGHE mission is to lead, integrate, and bring together thought leadership, research, and advocacy from public health experts, Uniformed Services University faculty, combatant commands, and the Military Health System to national security objectives. The CGHE is focused on developing partnerships to build global capacity and increase resiliency for disaster preparation. In addition, the center is engaged in research studies, including the Measures Of Effectiveness in Defense Engagement and Learning (MODEL) and the Improving Processes and Coordination in Theater (IMPACT) studies.

As the Ebola outbreak made clear, global health threats can impact both military and domestic operations. “There is not distinction between global and domestic health issues,” Dr. Reed told Federal Practitioner. “Global health engagement is a unique aspects of public health. We need to develop a new doctrine. We have to do it collectively and we can't do that in silos. We can't even do it within a federal government silo.”

From the battlefront to the home front, the face of federal health is changing. Federal Practitioner recently talked with VADM Michael Cowan, MD, executive director of AMSUS, as he prepares for its upcoming 2017 annual meeting. The meeting will focus on the continuation of care from the DoD to VA and PHS.

"When an injury or illness is successfully treated, the responsibility of the health system to that person is not done," VADM Cowan said. "We have seen a revolution in health care, and we are celebrating that revolution. Survival is a wonderful thing, but wouldn't we be cruel if we only saved those people and were done?"

According to VADM Cowan, the meeting will be structured to have frontline and battlefield topics early in the week. Later in the week the focus will turn to providing long-term health care. The meeting will conclude by bringing in patients so that the focus remains patient centered.

In addition to keynote addresses from VA leaders like Secretary David J. Shulkin, MD, and Deputy Under Secretary for Health for Organizational Excellence Carolyn Clancy, MD, the meeting will include presentations on hurricane relief efforts, a keynote address from Surgeon General VADM Jerome M. Adams, MD, MH; and the CDC's new global rapid response team. More information on the conference can be found at amsusmeeting.org.  

From the battlefront to the home front, the face of federal health is changing. Federal Practitioner recently talked with VADM Michael Cowan, MD, executive director of AMSUS, as he prepares for its upcoming 2017 annual meeting. The meeting will focus on the continuation of care from the DoD to VA and PHS.

"When an injury or illness is successfully treated, the responsibility of the health system to that person is not done," VADM Cowan said. "We have seen a revolution in health care, and we are celebrating that revolution. Survival is a wonderful thing, but wouldn't we be cruel if we only saved those people and were done?"

According to VADM Cowan, the meeting will be structured to have frontline and battlefield topics early in the week. Later in the week the focus will turn to providing long-term health care. The meeting will conclude by bringing in patients so that the focus remains patient centered.

In addition to keynote addresses from VA leaders like Secretary David J. Shulkin, MD, and Deputy Under Secretary for Health for Organizational Excellence Carolyn Clancy, MD, the meeting will include presentations on hurricane relief efforts, a keynote address from Surgeon General VADM Jerome M. Adams, MD, MH; and the CDC's new global rapid response team. More information on the conference can be found at amsusmeeting.org.  

From the battlefront to the home front, the face of federal health is changing. Federal Practitioner recently talked with VADM Michael Cowan, MD, executive director of AMSUS, as he prepares for its upcoming 2017 annual meeting. The meeting will focus on the continuation of care from the DoD to VA and PHS.

"When an injury or illness is successfully treated, the responsibility of the health system to that person is not done," VADM Cowan said. "We have seen a revolution in health care, and we are celebrating that revolution. Survival is a wonderful thing, but wouldn't we be cruel if we only saved those people and were done?"

According to VADM Cowan, the meeting will be structured to have frontline and battlefield topics early in the week. Later in the week the focus will turn to providing long-term health care. The meeting will conclude by bringing in patients so that the focus remains patient centered.

In addition to keynote addresses from VA leaders like Secretary David J. Shulkin, MD, and Deputy Under Secretary for Health for Organizational Excellence Carolyn Clancy, MD, the meeting will include presentations on hurricane relief efforts, a keynote address from Surgeon General VADM Jerome M. Adams, MD, MH; and the CDC's new global rapid response team. More information on the conference can be found at amsusmeeting.org.  

Not willing to wait for a pending legislative fix, the VA has proposed a new rule that would allow expanding telehealth offerings across state lines. The Authority of Health Care Providers to Practice Telehealth rule was proposed on October 2, 2017 and comments will remain open through November 1, 2017.

“VA has developed a telehealth program as a modern, beneficiary- and family-centered health care delivery model that leverages information and telecommunication technologies to connect beneficiaries with health care providers, irrespective of the State or location within a State where the health care provider or the beneficiary is physically located at the time the health care is provided,” the rule states. “Telehealth increases the accessibility of VA health care, bringing VA medical services to locations convenient for beneficiaries, including clinics in remote communities and beneficiaries' homes. By providing health care services by telehealth from one State to a beneficiary located in another State or within the same State, whether that beneficiary is located at a VA medical facility or in his or her own home, VA can use its limited health care resources most efficiently.”

The VA has long recognized the importance of telehealth for delivering health care to rural veterans who live far from VAMCs and community-based outpatient clinics. Providing specialty care can be especially challenging, given the dearth of specialists in many rural locations. In addition, many veterans live in a different state than the closest VAMC, creating health care delivery challenges.

The legal standing of telehealth is unclear. Currently, VA requires that health care providers (HCPs) are licensed in the same state as the patient location at time of health care delivery. VA Secretary David J. Shulkin, MD, has called for new legislation clarifying that VA HCPs do have authority to care for patients located in a different state. However, the new rule cites previously granted legislative authority. “In an effort to furnish care to all beneficiaries and use its resources most efficiently,” the rule states, “VA needs to operate its telehealth program with health care providers who will provide services via telehealth to beneficiaries in States in which they are not licensed.”

To date, the rule has received relatively few comments, and none dispute the VA interpretation of its legal authority to change telehealth rules. A few commenters have raised concerns over the quality use of telehealth care, especially for mental health care. Most comments, however, supported the expansion of telehealth to increase access to care for veterans.

House Resolution 2123, the VETS Act of 2017, also contains similar provisions that would streamline interstate telehealth. However, that bill has yet to receive a vote in the House Veterans Affairs committee.

Not willing to wait for a pending legislative fix, the VA has proposed a new rule that would allow expanding telehealth offerings across state lines. The Authority of Health Care Providers to Practice Telehealth rule was proposed on October 2, 2017 and comments will remain open through November 1, 2017.

“VA has developed a telehealth program as a modern, beneficiary- and family-centered health care delivery model that leverages information and telecommunication technologies to connect beneficiaries with health care providers, irrespective of the State or location within a State where the health care provider or the beneficiary is physically located at the time the health care is provided,” the rule states. “Telehealth increases the accessibility of VA health care, bringing VA medical services to locations convenient for beneficiaries, including clinics in remote communities and beneficiaries' homes. By providing health care services by telehealth from one State to a beneficiary located in another State or within the same State, whether that beneficiary is located at a VA medical facility or in his or her own home, VA can use its limited health care resources most efficiently.”

The VA has long recognized the importance of telehealth for delivering health care to rural veterans who live far from VAMCs and community-based outpatient clinics. Providing specialty care can be especially challenging, given the dearth of specialists in many rural locations. In addition, many veterans live in a different state than the closest VAMC, creating health care delivery challenges.

The legal standing of telehealth is unclear. Currently, VA requires that health care providers (HCPs) are licensed in the same state as the patient location at time of health care delivery. VA Secretary David J. Shulkin, MD, has called for new legislation clarifying that VA HCPs do have authority to care for patients located in a different state. However, the new rule cites previously granted legislative authority. “In an effort to furnish care to all beneficiaries and use its resources most efficiently,” the rule states, “VA needs to operate its telehealth program with health care providers who will provide services via telehealth to beneficiaries in States in which they are not licensed.”

To date, the rule has received relatively few comments, and none dispute the VA interpretation of its legal authority to change telehealth rules. A few commenters have raised concerns over the quality use of telehealth care, especially for mental health care. Most comments, however, supported the expansion of telehealth to increase access to care for veterans.

House Resolution 2123, the VETS Act of 2017, also contains similar provisions that would streamline interstate telehealth. However, that bill has yet to receive a vote in the House Veterans Affairs committee.

Not willing to wait for a pending legislative fix, the VA has proposed a new rule that would allow expanding telehealth offerings across state lines. The Authority of Health Care Providers to Practice Telehealth rule was proposed on October 2, 2017 and comments will remain open through November 1, 2017.

“VA has developed a telehealth program as a modern, beneficiary- and family-centered health care delivery model that leverages information and telecommunication technologies to connect beneficiaries with health care providers, irrespective of the State or location within a State where the health care provider or the beneficiary is physically located at the time the health care is provided,” the rule states. “Telehealth increases the accessibility of VA health care, bringing VA medical services to locations convenient for beneficiaries, including clinics in remote communities and beneficiaries' homes. By providing health care services by telehealth from one State to a beneficiary located in another State or within the same State, whether that beneficiary is located at a VA medical facility or in his or her own home, VA can use its limited health care resources most efficiently.”

The VA has long recognized the importance of telehealth for delivering health care to rural veterans who live far from VAMCs and community-based outpatient clinics. Providing specialty care can be especially challenging, given the dearth of specialists in many rural locations. In addition, many veterans live in a different state than the closest VAMC, creating health care delivery challenges.

The legal standing of telehealth is unclear. Currently, VA requires that health care providers (HCPs) are licensed in the same state as the patient location at time of health care delivery. VA Secretary David J. Shulkin, MD, has called for new legislation clarifying that VA HCPs do have authority to care for patients located in a different state. However, the new rule cites previously granted legislative authority. “In an effort to furnish care to all beneficiaries and use its resources most efficiently,” the rule states, “VA needs to operate its telehealth program with health care providers who will provide services via telehealth to beneficiaries in States in which they are not licensed.”

To date, the rule has received relatively few comments, and none dispute the VA interpretation of its legal authority to change telehealth rules. A few commenters have raised concerns over the quality use of telehealth care, especially for mental health care. Most comments, however, supported the expansion of telehealth to increase access to care for veterans.

House Resolution 2123, the VETS Act of 2017, also contains similar provisions that would streamline interstate telehealth. However, that bill has yet to receive a vote in the House Veterans Affairs committee.

Deck: Study finds overall high quality of care but identifies important gaps in assessment and treatment.

Active-duty service members with posttraumatic stress disorder (PTSD) or depression are frequent users of both inpatient and outpatient Military Health System (MHS) care, but there were significant variations in the quality and type of care they received, according to a recent RAND Corporation study. According to the authors, the MHS “performed well in providing initial screening for suicide and substance abuse but needs to improve at providing adequate follow-up to service members with suicide risk.”

The Quality of Care for PTSD and Depression in the Military Health System study is the third in a series of reports on the quality of depression and PTSD care for active-duty service members. The study examined data for 2013-2014 and included 14,654 service members with PTSD and 30,496 with depression; 6,322 service members were in both groups. The goal of the report was to determine whether the service members with PTSD or depression receive evidence-based care and whether there were disparities in care quality by branch of service, geographic region, and other characteristics, such as gender, age, pay grade, race/ethnicity, or deployment history.

Related: New Center of Excellence to Lead Research of “Signature Wounds”

In both the PTSD and depression cohorts, the majority of active-component service members were enlisted soldiers and had 1 or more deployments. A large number of patients were in both the PTSD and depression cohorts. The study noted that more than half of patients in the PTSD cohort had a diagnosis of depression, and more than one-fourth of those in the depression cohort received a PTSD diagnosis during the 12-month observation period.

Service members with PTSD or depression were willing to engage the health system with medians of 40 and 31 visits for PTSD and depression, respectively, during the 1-year observation period. Most of these visits were for unrelated conditions. Importantly, more than half of patients received their care from primary care providers. Social workers, psychiatrists, and clinical psychologists provided care for slightly less than half of the PTSD cohort. These mental health provider groups saw between 33% and 40% of the depression cohort. The majority of patients in both the PTSD and depression cohorts received care for their cohort diagnosis solely at military treatment facilities

Related: Posttraumatic Stress Disorder, Depression, and Other Comorbidities: Clinical and Systems Approaches to Diagnostic Uncertainties

“The high utilization for both medical and psychological conditions combined with the high number of different providers raise questions about the extent of coordination vs fragmentation of care for all the care these service members received,” the study reported. “The high number of psychotherapy visits received by members of these cohorts suggests that the MHS may be more successful than the civilian sector in engaging patients with PTSD or depression in psychosocial interventions.”

The study also highlighted the following important gaps in treatment, assessment, and follow-up:

• Assessment of baseline symptom severity of PTSD for a new treatment episode with the PCL (PTSD Checklist) was not as frequent, though current efforts are under way within the MHS to increase the regular use of the PCL to monitor PTSD patient symptoms.
• Standardized tools were used in less than half of the assessments for depression, suicide risk, and recent substance use and almost never used for assessment of function.
• Appropriate minimal care for patients with suicidal ideation was less than optimal (54%), primarily due to a lack of documentation regarding addressing access to lethal means. A Safety Plan Worksheet has recently been added to the clinical guideline for assessment and management of suicide risk which may improve this performance in the future.
• Most service members with PTSD or depression received at least some psychotherapy, but the MHS could increase delivery of evidence-based psychotherapy.
• Improvements are still needed in rates of outcome monitoring and performance on outcome measures.
• Multiple “statistically significant and clinically meaningful differences” were found in measure scores by service branch, TRICARE region, and service member.

Related: Following the Trajectory of PTSD

Deck: Study finds overall high quality of care but identifies important gaps in assessment and treatment.

Active-duty service members with posttraumatic stress disorder (PTSD) or depression are frequent users of both inpatient and outpatient Military Health System (MHS) care, but there were significant variations in the quality and type of care they received, according to a recent RAND Corporation study. According to the authors, the MHS “performed well in providing initial screening for suicide and substance abuse but needs to improve at providing adequate follow-up to service members with suicide risk.”

The Quality of Care for PTSD and Depression in the Military Health System study is the third in a series of reports on the quality of depression and PTSD care for active-duty service members. The study examined data for 2013-2014 and included 14,654 service members with PTSD and 30,496 with depression; 6,322 service members were in both groups. The goal of the report was to determine whether the service members with PTSD or depression receive evidence-based care and whether there were disparities in care quality by branch of service, geographic region, and other characteristics, such as gender, age, pay grade, race/ethnicity, or deployment history.

Related: New Center of Excellence to Lead Research of “Signature Wounds”

In both the PTSD and depression cohorts, the majority of active-component service members were enlisted soldiers and had 1 or more deployments. A large number of patients were in both the PTSD and depression cohorts. The study noted that more than half of patients in the PTSD cohort had a diagnosis of depression, and more than one-fourth of those in the depression cohort received a PTSD diagnosis during the 12-month observation period.

Service members with PTSD or depression were willing to engage the health system with medians of 40 and 31 visits for PTSD and depression, respectively, during the 1-year observation period. Most of these visits were for unrelated conditions. Importantly, more than half of patients received their care from primary care providers. Social workers, psychiatrists, and clinical psychologists provided care for slightly less than half of the PTSD cohort. These mental health provider groups saw between 33% and 40% of the depression cohort. The majority of patients in both the PTSD and depression cohorts received care for their cohort diagnosis solely at military treatment facilities

Related: Posttraumatic Stress Disorder, Depression, and Other Comorbidities: Clinical and Systems Approaches to Diagnostic Uncertainties

“The high utilization for both medical and psychological conditions combined with the high number of different providers raise questions about the extent of coordination vs fragmentation of care for all the care these service members received,” the study reported. “The high number of psychotherapy visits received by members of these cohorts suggests that the MHS may be more successful than the civilian sector in engaging patients with PTSD or depression in psychosocial interventions.”

The study also highlighted the following important gaps in treatment, assessment, and follow-up:

• Assessment of baseline symptom severity of PTSD for a new treatment episode with the PCL (PTSD Checklist) was not as frequent, though current efforts are under way within the MHS to increase the regular use of the PCL to monitor PTSD patient symptoms.
• Standardized tools were used in less than half of the assessments for depression, suicide risk, and recent substance use and almost never used for assessment of function.
• Appropriate minimal care for patients with suicidal ideation was less than optimal (54%), primarily due to a lack of documentation regarding addressing access to lethal means. A Safety Plan Worksheet has recently been added to the clinical guideline for assessment and management of suicide risk which may improve this performance in the future.
• Most service members with PTSD or depression received at least some psychotherapy, but the MHS could increase delivery of evidence-based psychotherapy.
• Improvements are still needed in rates of outcome monitoring and performance on outcome measures.
• Multiple “statistically significant and clinically meaningful differences” were found in measure scores by service branch, TRICARE region, and service member.

Related: Following the Trajectory of PTSD

Deck: Study finds overall high quality of care but identifies important gaps in assessment and treatment.

Active-duty service members with posttraumatic stress disorder (PTSD) or depression are frequent users of both inpatient and outpatient Military Health System (MHS) care, but there were significant variations in the quality and type of care they received, according to a recent RAND Corporation study. According to the authors, the MHS “performed well in providing initial screening for suicide and substance abuse but needs to improve at providing adequate follow-up to service members with suicide risk.”

The Quality of Care for PTSD and Depression in the Military Health System study is the third in a series of reports on the quality of depression and PTSD care for active-duty service members. The study examined data for 2013-2014 and included 14,654 service members with PTSD and 30,496 with depression; 6,322 service members were in both groups. The goal of the report was to determine whether the service members with PTSD or depression receive evidence-based care and whether there were disparities in care quality by branch of service, geographic region, and other characteristics, such as gender, age, pay grade, race/ethnicity, or deployment history.

Related: New Center of Excellence to Lead Research of “Signature Wounds”

In both the PTSD and depression cohorts, the majority of active-component service members were enlisted soldiers and had 1 or more deployments. A large number of patients were in both the PTSD and depression cohorts. The study noted that more than half of patients in the PTSD cohort had a diagnosis of depression, and more than one-fourth of those in the depression cohort received a PTSD diagnosis during the 12-month observation period.

Service members with PTSD or depression were willing to engage the health system with medians of 40 and 31 visits for PTSD and depression, respectively, during the 1-year observation period. Most of these visits were for unrelated conditions. Importantly, more than half of patients received their care from primary care providers. Social workers, psychiatrists, and clinical psychologists provided care for slightly less than half of the PTSD cohort. These mental health provider groups saw between 33% and 40% of the depression cohort. The majority of patients in both the PTSD and depression cohorts received care for their cohort diagnosis solely at military treatment facilities

Related: Posttraumatic Stress Disorder, Depression, and Other Comorbidities: Clinical and Systems Approaches to Diagnostic Uncertainties

“The high utilization for both medical and psychological conditions combined with the high number of different providers raise questions about the extent of coordination vs fragmentation of care for all the care these service members received,” the study reported. “The high number of psychotherapy visits received by members of these cohorts suggests that the MHS may be more successful than the civilian sector in engaging patients with PTSD or depression in psychosocial interventions.”

The study also highlighted the following important gaps in treatment, assessment, and follow-up:

• Assessment of baseline symptom severity of PTSD for a new treatment episode with the PCL (PTSD Checklist) was not as frequent, though current efforts are under way within the MHS to increase the regular use of the PCL to monitor PTSD patient symptoms.
• Standardized tools were used in less than half of the assessments for depression, suicide risk, and recent substance use and almost never used for assessment of function.
• Appropriate minimal care for patients with suicidal ideation was less than optimal (54%), primarily due to a lack of documentation regarding addressing access to lethal means. A Safety Plan Worksheet has recently been added to the clinical guideline for assessment and management of suicide risk which may improve this performance in the future.
• Most service members with PTSD or depression received at least some psychotherapy, but the MHS could increase delivery of evidence-based psychotherapy.
• Improvements are still needed in rates of outcome monitoring and performance on outcome measures.
• Multiple “statistically significant and clinically meaningful differences” were found in measure scores by service branch, TRICARE region, and service member.

Related: Following the Trajectory of PTSD

The Ebola epidemic of 2014-2016 challenged many federal agencies to find creative ways to help address the vexing problems created by the spread of the disease. There were many factors complicating the response, including the recovery from civil wars in Liberia and Sierra Leone that decimated the physical infrastructure as well as education and other vital services.

The response from the U.S. and the global community took many forms: Not only was there a need for the typical medical care support, but also for basic public health systems to track the spread of disease, provide clean water, and dispose of infectious waste. Because no known preventive vaccines or therapeutics existed for those infected, the recognition of a research component to the response became abundantly clear as the epidemic continued. As a result, the National Institutes of Health (NIH) and the USPHS Commissioned Corps (Corps) serendipitously found themselves allied in a mutually beneficial relationship in the establishment of an Ebola clinical research program in West Africa.

This article describes the events that led to the NIH and Corps participation in the Ebola response, the roles filled by the Corps in supporting the NIH, and the lessons observed from that collaboration. Also presented are considerations regarding preparation of a clinical research response to future outbreaks.

NIH Clinical Research first Response

The 2014-2016 Ebola epidemic in West Africa demonstrated the need for federal agencies to reassess their capacity to respond to global threats to protect the health security of the U.S.¹ The outbreak also challenged the U.S. government to mobilize unique resources that matched the need of this international (and domestic) response.

In 2014, President Barack Obama announced that the U.S. would launch a government response to the Ebola effort. Although a comprehensive research and development program already was in place to establish Ebola virus disease (EVD) countermeasures, no FDA-approved diagnostics, therapeutics, or preventive vaccines were readily available. Fortunately, FDA regulations regarding emergency use authorizations allowed for the use of several EVD diagnostics during this outbreak.² However, the development of drugs and vaccines specific to Ebola had yet to make their way to phase 1 safety studies.

Two vaccine products went into phase 1 studies in the U.S. within months of the declaration of the emergency.^3,4 Additionally, the NIH had organized a collaborative effort between the U.S. government and academic community to identify a research strategy for the evaluation of therapeutics.⁵ Regardless of the state of countermeasures and research proposals, the initial need was for disease control measures and care for Ebola patients. The CDC took the lead in working within the international community to establish an incident management system that could help the impacted countries enact mechanisms to bring the epidemic under control.⁶

As the epidemic progressed, leaders in the Corps and the NIH responded on pathways that eventually would intersect. One of the unfortunate outcomes of the early efforts of improperly protected health care providers was the unintentional transmission of Ebola.⁷ The Corps identified the need to provide high-level care to the health care worker community as one incentive to motivate health care workers to volunteer for hazardous duty inside Ebola treatment units (ETUs).^8,9 Engulfed in the epidemic response, the U.S. government through the National Security Council and secretary of the Department of Health and Human Services (DHHS) evoked its statutory authority to deploy the Corps (42 U.S. Code 204a).

In the first week of October 2014, the Corps sent an advanced echelon team to assess the situation, partner with key host country and international stakeholders, and begin establishment of the U.S. government’s first ever ETU. With logistics, security, and resource support from the DoD and response coordination from the U.S. Agency for International Development, the Corps then deployed the first of four 70-person team rotations to staff the Monrovia Medical Unit (MMU), an ETU specifically dedicated to the treatment of Ebola-infected health care workers. At the time, it was the only ETU specifically dedicated to health care workers in all of Africa. The MMU operated until May 2015 and provided direct patient care for health care workers with Ebola, malaria, and other illnesses.^8,10

In August 2014, representatives from the CDC met with Liberia’s Minister of Health and Social Welfare Walter T. Gwenigale, MD, to discuss the range of available options that could facilitate a better understanding of the prevention and treatment of the disease. This meeting resulted in a letter dated August 22, 2014, from Dr. Gwenigale to then DHHS Sylvia Burwell, requesting a research response. Secretary Burwell responded on October 2, 2014, describing the immediate dispatch of the deputy director for clinical research of the National Institute of Allergy and Infectious Diseases (NIAID) to Liberia to engage in initial discussions with the Liberian minister and other key Liberians involved in the response.

Representatives from the CDC and the commander of the Corps’ Ebola response (and acting deputy surgeon general) were included in those initial meetings, which led to a recognized need for a robust clinical research program of the highest ethical and scientific standards consistent with the expressed requirements of Liberia.¹¹ A second and third trip to Liberia with larger U.S. teams resulted in an agreement signed on November 19, 2014 for the scientific investigation of strategies that tested interventions for treatment, control, and prevention of Ebola.¹²

The agreement led to the establishment of the Partnership for Research on Ebola Virus in Liberia (PREVAIL) to identify research priorities in a collaborative manner between Liberian and American scientists. The first protocol, a vaccine study, was launched in early February 2015.¹² This monumental task involved the support of hundreds of Liberians and dozens of NIH staff who volunteered for rotations to Liberia. Of the 108 volunteers from within the NIH, 18 were PHS officers. 
Shortly after launching the vaccine study, the next priority was initiating the treatment study. This study was delayed primarily due to ZMapp (Mapp Biopharmaceatical, San Diego,CA) production limitations. ZMapp, a monoclonal antibody cocktail, was the first Ebola therapeutic product to be evaluated in a randomized trial.^5,13

During the planning for the study, NIAID staff in Liberia met with Corps staff of the MMU to discuss the logistics associated with implementation of the ZMapp protocol at the MMU. During that meeting, the NIAID deputy director for clinical research expressed interest in obtaining Corps support from outside the NIH to sustain the research effort in West Africa. More specifically, additional pharmacy and laboratory staff were needed to augment NIH research operations. At the time, the MMU commander had recently transitioned from service as the acting surgeon general and was in a unique position to recommend additional Corps resources that could help in the research response.

The February 2015 discussion resulted in the establishment of an NIH/PHS research partnership that continues to exist. This new opportunity was not a significant stretch for the PHS as there was great interest from the Corps for responding to the Ebola crisis. The enthusiasm was consistent with the overall ethos of the Corps, which as a service was composed of highly qualified active-duty, deployable, uniformed, public health professionals who respond to public health crises at home and abroad. To date, 19 Corps officers from outside the NIH have deployed in support of the NIH Ebola clinical research program. An additional 18 Corps officers assigned within the NIH also volunteered for duty in West Africa. Of the 37 Corps officers supporting the NIH clinical research program, 7 served on more than 1 rotation.

Program Expansion

The Ebola clinical research program expanded over time from the initial PREVAIL vaccine study to include studies of therapeutic agents, natural history in Ebola survivors, and an additional vaccine study. The PHS officers have been integral in conducting these studies. The initial study implemented in Liberia, known as PREVAIL I, involved the evaluation of 2 vaccine strategies vs placebo.^12,14 In addition to the NIH-based Corps officers supporting the study, the Readiness and Deployment Operations Group (RedDOG) initiated deployments for an additional 2 pharmacy and 7 laboratory officers to support this study. During the deployment, the pharmacists were asked to extend their reach to Sierra Leone and later to Guinea to help establish PREVAIL II, an evaluation of ZMapp in the treatment of Ebola.¹³ A total of 9 Corps pharmacists, 2 nurses, and 3 physicians deployed to Sierra Leone or Guinea to assist in the PREVAIL II study.

As the epidemic came to an end in Liberia in May 2015, the need for a long-term assessment of Ebola survivors was recognized, resulting in PREVAIL III.¹⁵ Noteworthy in the survivor study was an ophthalmic substudy led by a Corps officer assigned to the National Eye Institute.^16,17 The survivor study also identified that the persistence of the Ebola virus was longer than previously known and that sexual transmission via semen from infected males remained a potential mode of transmission.¹⁸ To address the lingering viral load, a study of an antiviral drug was initiated in Liberia in the summer of 2016, PREVAIL IV.¹⁹

Four Corps pharmacists helped train Liberian pharmacists to establish and sustain this randomized, double-blind, placebo-controlled study. Most recently, Corps pharmacists were deployed to support the initiation of the Partnership for Research on Ebola Vaccines (PREVAC), a collaborative partnership with researchers from Liberia, Guinea, and Sierra Leone with cosponsors from the NIH, Institut national de la santé et de la recherche médicale (Inserm) in France, and the London School of Hygiene and Tropical Medicine in the United Kingdom.²⁰

Deployment Procedures

As previously mentioned, 108 staff (civil service, assigned PHS, and contractors) from within the NIH volunteered for deployment to assist in the clinical research Ebola response. The typical rotation for those volunteers was limited to 3 weeks to minimize the disruption of their normal work assignments. Volunteers were organized into small teams within the Division of Clinical Research were composed of the right mix of physicians, nurses, medical technologists, and pharmacists. The team ensured that staff obtained official government passports, scheduled airline reservations, and received an orientation to the deployment setting as well as to the research studies (Table). Additionally, the team coordinated the voucher submission process for reimbursement of expenses on return from the country. An additional team member was stationed in Liberia to coordinate the housing and transportation arrangements with a local hotel near the U.S. Embassy.

Within a week of the February 2015 initial meeting in Liberia to establish the NIH/PHS collaboration, the NIH deployment team met by phone with the Corps’ RedDOG to discuss initial requirements (eg, number of officers needed, disciplines, time lines, and documentation needed for deployment). These initial discussions resulted in the establishment of more formal processes that evolved over time as the 2 organizations gained experience. Based on the identification of the numbers and types of officers needed, RedDOG used procedures similar to the process for staffing the MMU. A communication went out to the Corps seeking interested officers.

Deployment slots were filled based on the personal availability of the officer and coordination with their immediate supervisor and agency. Officers needed to meet medical clearance requirements and provide current health care provider licensure information. Additional training requirements needed to be completed (eg, U.S. State Department training and good clinical practice [GCP] if not already current). Corps officers also took part in the NIH orientation program for deploying personnel to familiarize them to the situation on the ground in West Africa and the specific clinical research protocols that they would encounter. Given that most of the Corps officers were coming from outside the NIH, the onboarding activities required significant attention to detail as procedures for arranging travel (eg, passport, visa, and airline reservations) and processes for reimbursement of travel/per diem pay differed from more traditional deployments directed through the Corps headquarters.

Commissioned Corps Roles in the Research Response

Whereas the establishment of the research program in Liberia was based primarily on relationships forged over a 2-month period by the NIAID deputy director for clinical research and staff, the extension of the research program into Sierra Leone (March 2015) and Guinea (June 2015) was on a substantially shorter time line. As a result, Corps officers were thrust into roles that immediately employed their leadership and diplomacy skills.

In Sierra Leone and Guinea, the NIAID deputy director for clinical research established initial relationships within the countries. However, Corps officers found themselves in regular interactions with regulators in the Ministry of Health to ensure that applications were complete and import permits for incoming shipments were cleared. Additionally, the research collaboration in Sierra Leone was coordinated through an investigator assigned to a military hospital converted into an ETU. The Corps officers were well suited to maintain and build on that relationship in expanding the protocol to other ETUs throughout Sierra Leone. A site established by the CDC within the Sierra Leone Ministry of Health coordinated ZMapp storage. The Corps officers formed working relationships with the CDC team to establish and improve cold-chain logistics and transportation of the ZMapp to the various ETUs around the country. Corps officers were integral in working with the in-country contract hiring agency. Activities included establishing criteria for clinical research positions, providing input on the interview of respective candidates, and training staff as the team formed. In Sierra Leone, local staff members were hired to work at specific facilities as research coordinators working with the health care delivery teams.

The U.S. team consisted of a physician, nurse research coordinator, and a pharmacist travelling to the sites with a logistics/operations staff member remaining in Freetown.

Fortunately, a Corps nurse on the team had been part of the initial MMU deployment and was trained to work in a special care unit at the NIH for patients with highly contagious infections. This practical experience was essential in the establishment of procedures in a hazardous environment for the administration of the IV ZMapp, monitoring of adverse effects (AEs), provision of medications to mitigate infusion-related reactions, and documentation of those AEs.

The U.S. research team regularly departed Freetown early in the morning 7 days a week with the various supplies needed as they visited up to 4 ETU sites to prepare the ZMapp at the site, await information on any AEs, and collect case report forms (Figures 1 and 2). The ETUs were spread out over a 90-mile radius and could be described as austere platforms for health care delivery.

An additional challenge was dealing with the multinational organizations that staffed the various ETUs. Relief organizations from Italy, the United Kingdom, China, as well as the Sierra Leone military provided the staffing for the 4 ETUs. Regardless of who operated the ETU, the concept of randomization to ZMapp or standard of care required significant tact and diplomacy in communicating the scientific necessity in order to appropriately answer the research question. As Davey and colleagues pointed out, the randomized, controlled trial established the appropriate ethical framework to determine whether the research intervention was associated with harmful effects as there had not been a phase 1 safety study with the drug.¹³

As the summer approached in Sierra Leone, the team worked through challenges in the IV administration of ZMapp as the protein structure of the monoclonal antibody had not previously been subjected to West African environmental extremes. A balance between speed of administration to prevent protein aggregation in the heat as opposed to the risk of infusion reactions from a foreign protein required the team to communicate frequently with, the manufacturer of ZMapp, to establish realistic infusion rate tables. Additionally, as the various deployment teams rotated in and out, procedures for establishing continuity of research operations were enacted and improved on with each rotation. Good documentation practices to adequately collect all required study information (eg, recording AEs, deviations, and signatures on various forms) proved critical to continuity of research operations.

In Guinea, not only was there the new wrinkle of working within a country where the primary language was French, but also a French cosponsor, Inserm. The NIAID clinical director capitalized on the research infrastructure established for a recently completed Inserm study of favipiravir in the treatment of Ebola to extend the ZMapp study to Guinea. Fortunately, many of the Inserm staff were bilingual and readily responded to the NIH training on the requirements of the ZMapp protocol. However, procedures for cold-chain storage and transportation needed to be established. In Guinea, the PHS officers were key in establishing access and temperature monitoring procedures for a secure room inside the U.S. embassy. The issues associated with cold-chain procedures in the infrastructure-limited environments of West Africa are substantial and warrant consideration of a stand-alone paper. Corps officers also took part in weekly country-focused team meetings with embassy staff to describe progress with the ZMapp study.

As the epidemic waned and NIH transitioned to the survivor and viral persistence studies, the operational tempo changed to allow Corps officers to take part in more definitive capacity building efforts. An initial PHS volunteer from the FDA accepted a position within NIAID as a clinical research oversight manager for pharmacy operations. This individual deployed on numerous occasions to the 3 affected West African countries to further establish cold-chain processes for pharmaceuticals and biologics. He also worked with a multidisciplinary team to renovate a clinical research facility in a rural setting in Guinea. In Liberia, he coordinated an effort with other Corps officers to provide educational seminars on clinical research principles and drug-specific topics with the University of Liberia School of Pharmacy.

Challenges

In each instance, the partnership experience was not without a few problems. The match of skills between the officers who wanted to help and those needed for the research program did not always coincide. While the Corps has more than 1,200 pharmacy officers on active duty, only a fraction of those have experience conducting FDA-regulated clinical research.

Communication problems and time pressures were also constant companions to both the Corps and the NIH. The Corps was going through the largest international deployment in its history to staff multiple missions (including the primary MMU mission in Liberia). The addition of the NIH partnership, while consistent with the MMU staffing mission, provided even more work for a very limited resource. Communicating to the many Corps officers who wanted to volunteer and keeping deployment time lines on track were a challenge. Complicating the matter was the addition of stray e-mails from well-intentioned NIH and Corps staff who communicated directly with colleagues to encourage participation, not fully understanding the policies and protocol governing the deployment process.

Time was always an issue as the rotation schedules were relatively short and the number of activities to make an officer deployment ready were numerous. Obtaining official passports and visas was a challenge as that activity required coordination with the U.S. Department of State. Airline schedules changed with little or no notice, complicating deployments and returns. As the NIH added additional research studies for which support was required, time lines for studies to start became difficult to predict with certainty due to factors outside the control of the NIH. Recently, additional security training requirements for government workers traveling abroad were instituted, further complicating the process of deploying an officer.

The Corps officers taking part in this research response (which was not consistent with customary deployments from Corps headquarters) necessarily were volunteers from full-time assignments within DHHS, and as such, required the permission of their supervisory chain to volunteer. Regardless of this limitation, there was widespread support for these additional and specific research deployments. Although the use of short-term rotations was not ideal, in the end, the rotation plans worked, and the NIH was able to fulfill its research mission with the support of the Corps.

Lessons Learned/Preparing for the Future

Many lessons have been learned and continue to be learned throughout this research response and NIH/Corps partnership. Effective and frequent communication between the organization requesting Corps officers and the Corps headquarters is crucial. In the initial deployments, officers were deployed from the FDA with the assumption that they would be familiar with FDA-regulated clinical research. This was not always the case. The NIH and Corps headquarters later collaborated to develop a survey to send to Corps officers that was used to identify specific skill sets needed by officers who would be deploying to conduct clinical research. NIH personnel prescreened survey responses to identify and prioritize officers for deployment consideration by the deployment authority. This process resulted in the selection of officers who generally needed less training and guidance.

Effective training in clinical research principles for deployed officers and other staff needs to be developed and made available to all deploying individuals. All clinical research staff are required to have training on GCP, but most GCP training programs focus primarily on the ethical principles of research as outlined by the Declaration of Helsinki, Nuremberg Code, and other documents. Few GCP training programs present adequate information on the hands-on conduct of clinical research, especially research regulated by the FDA and other government bodies and therefore subject to certain strict requirements. Examples of crucial but often overlooked topics are source document retention, good documentation practices, cold-chain principles, and other issues related to the creation and retention of adequate trial records.²¹

The handoff between returning and deploying officers is crucial. Due to various issues with changing time lines, flights, and administrative processes, it is imperative to plan adequate overlap between returning and deploying officers. Delays in obtaining passports or visas, flight cancellations, and other unforeseen issues may unexpectedly shorten any planned overlap periods. A full workweek is desirable for overlap so that the new officer may experience tasks that occur throughout the week, be introduced to the various team members, and have help if unexpected events occur. A regular staff member should check periodically that proper procedures are being followed, as some information may be missed during each handoff, and consecutive unchecked handoffs could result in large deviations of important procedures. Onboarding and offboarding checklists should be developed and updated regularly to guide the handoff process.

On a larger scale, the respective agencies and other stakeholders involved in planning clinical research for public health emergencies need to be included in regular tabletop training exercises to better understand how to coordinate a response when needed. Additionally, although many of the Corps officers who took part in this deployment served as mentors for others preparing for deployment, establishing a formal roster of experienced officers to support specific roles of this type of response would help serve as a resource center for future deployments. Finally, coordination between any operating division (or agency) and the Corps should be through the established Corps command infrastructure to eliminate miscommunication and complicating deployment processes.²²

Conclusion

The increasing connectedness of this world, as demonstrated by the Ebola epidemic, requires that the HHS engage globally to provide international leadership and technical expertise in science, policy, and programs and work in concert with interagency partners.²³ The missions of the PHS and NIH intersected in a synergistic manner in the research response to the Ebola epidemic of 2014-2016. The PHS Corps mission includes to “protect, promote, and advance the health and safety of the Nation...through rapid and effective response…and advancement of public health science.”²⁴ The Corps mission directly supported the NIH mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.²⁵

The scope and scale of DHHS’s response to the Ebola epidemic was unprecedented. The NIH research program, although successful and an important component, was but a small part in bringing the Ebola crisis to an end. The CDC (including the many Corps officers assigned to that agency) worked successfully with the international community and the host countries to bring the disease under control. The Biological Advanced Research and Development Authority provided expert project management, making vaccines and therapeutics available for research.

The DoD was a partner in the development of countermeasures and phase 1 clinical research programs as well as establishing laboratory facilities in Liberia. The Department of State facilitated the many interactions required for the mobilization of resources into West Africa. The collective efforts of the U.S. government contributed immensely to the protection of U.S. borders and to the successful resolution of the Ebola outbreak of 2014-2016.

The Ebola epidemic of 2014-2016 challenged many federal agencies to find creative ways to help address the vexing problems created by the spread of the disease. There were many factors complicating the response, including the recovery from civil wars in Liberia and Sierra Leone that decimated the physical infrastructure as well as education and other vital services.

The response from the U.S. and the global community took many forms: Not only was there a need for the typical medical care support, but also for basic public health systems to track the spread of disease, provide clean water, and dispose of infectious waste. Because no known preventive vaccines or therapeutics existed for those infected, the recognition of a research component to the response became abundantly clear as the epidemic continued. As a result, the National Institutes of Health (NIH) and the USPHS Commissioned Corps (Corps) serendipitously found themselves allied in a mutually beneficial relationship in the establishment of an Ebola clinical research program in West Africa.

This article describes the events that led to the NIH and Corps participation in the Ebola response, the roles filled by the Corps in supporting the NIH, and the lessons observed from that collaboration. Also presented are considerations regarding preparation of a clinical research response to future outbreaks.

NIH Clinical Research first Response

The 2014-2016 Ebola epidemic in West Africa demonstrated the need for federal agencies to reassess their capacity to respond to global threats to protect the health security of the U.S.¹ The outbreak also challenged the U.S. government to mobilize unique resources that matched the need of this international (and domestic) response.

In 2014, President Barack Obama announced that the U.S. would launch a government response to the Ebola effort. Although a comprehensive research and development program already was in place to establish Ebola virus disease (EVD) countermeasures, no FDA-approved diagnostics, therapeutics, or preventive vaccines were readily available. Fortunately, FDA regulations regarding emergency use authorizations allowed for the use of several EVD diagnostics during this outbreak.² However, the development of drugs and vaccines specific to Ebola had yet to make their way to phase 1 safety studies.

Two vaccine products went into phase 1 studies in the U.S. within months of the declaration of the emergency.^3,4 Additionally, the NIH had organized a collaborative effort between the U.S. government and academic community to identify a research strategy for the evaluation of therapeutics.⁵ Regardless of the state of countermeasures and research proposals, the initial need was for disease control measures and care for Ebola patients. The CDC took the lead in working within the international community to establish an incident management system that could help the impacted countries enact mechanisms to bring the epidemic under control.⁶

As the epidemic progressed, leaders in the Corps and the NIH responded on pathways that eventually would intersect. One of the unfortunate outcomes of the early efforts of improperly protected health care providers was the unintentional transmission of Ebola.⁷ The Corps identified the need to provide high-level care to the health care worker community as one incentive to motivate health care workers to volunteer for hazardous duty inside Ebola treatment units (ETUs).^8,9 Engulfed in the epidemic response, the U.S. government through the National Security Council and secretary of the Department of Health and Human Services (DHHS) evoked its statutory authority to deploy the Corps (42 U.S. Code 204a).

In the first week of October 2014, the Corps sent an advanced echelon team to assess the situation, partner with key host country and international stakeholders, and begin establishment of the U.S. government’s first ever ETU. With logistics, security, and resource support from the DoD and response coordination from the U.S. Agency for International Development, the Corps then deployed the first of four 70-person team rotations to staff the Monrovia Medical Unit (MMU), an ETU specifically dedicated to the treatment of Ebola-infected health care workers. At the time, it was the only ETU specifically dedicated to health care workers in all of Africa. The MMU operated until May 2015 and provided direct patient care for health care workers with Ebola, malaria, and other illnesses.^8,10

In August 2014, representatives from the CDC met with Liberia’s Minister of Health and Social Welfare Walter T. Gwenigale, MD, to discuss the range of available options that could facilitate a better understanding of the prevention and treatment of the disease. This meeting resulted in a letter dated August 22, 2014, from Dr. Gwenigale to then DHHS Sylvia Burwell, requesting a research response. Secretary Burwell responded on October 2, 2014, describing the immediate dispatch of the deputy director for clinical research of the National Institute of Allergy and Infectious Diseases (NIAID) to Liberia to engage in initial discussions with the Liberian minister and other key Liberians involved in the response.

Representatives from the CDC and the commander of the Corps’ Ebola response (and acting deputy surgeon general) were included in those initial meetings, which led to a recognized need for a robust clinical research program of the highest ethical and scientific standards consistent with the expressed requirements of Liberia.¹¹ A second and third trip to Liberia with larger U.S. teams resulted in an agreement signed on November 19, 2014 for the scientific investigation of strategies that tested interventions for treatment, control, and prevention of Ebola.¹²

The agreement led to the establishment of the Partnership for Research on Ebola Virus in Liberia (PREVAIL) to identify research priorities in a collaborative manner between Liberian and American scientists. The first protocol, a vaccine study, was launched in early February 2015.¹² This monumental task involved the support of hundreds of Liberians and dozens of NIH staff who volunteered for rotations to Liberia. Of the 108 volunteers from within the NIH, 18 were PHS officers. 
Shortly after launching the vaccine study, the next priority was initiating the treatment study. This study was delayed primarily due to ZMapp (Mapp Biopharmaceatical, San Diego,CA) production limitations. ZMapp, a monoclonal antibody cocktail, was the first Ebola therapeutic product to be evaluated in a randomized trial.^5,13

During the planning for the study, NIAID staff in Liberia met with Corps staff of the MMU to discuss the logistics associated with implementation of the ZMapp protocol at the MMU. During that meeting, the NIAID deputy director for clinical research expressed interest in obtaining Corps support from outside the NIH to sustain the research effort in West Africa. More specifically, additional pharmacy and laboratory staff were needed to augment NIH research operations. At the time, the MMU commander had recently transitioned from service as the acting surgeon general and was in a unique position to recommend additional Corps resources that could help in the research response.

The February 2015 discussion resulted in the establishment of an NIH/PHS research partnership that continues to exist. This new opportunity was not a significant stretch for the PHS as there was great interest from the Corps for responding to the Ebola crisis. The enthusiasm was consistent with the overall ethos of the Corps, which as a service was composed of highly qualified active-duty, deployable, uniformed, public health professionals who respond to public health crises at home and abroad. To date, 19 Corps officers from outside the NIH have deployed in support of the NIH Ebola clinical research program. An additional 18 Corps officers assigned within the NIH also volunteered for duty in West Africa. Of the 37 Corps officers supporting the NIH clinical research program, 7 served on more than 1 rotation.

Program Expansion

The Ebola clinical research program expanded over time from the initial PREVAIL vaccine study to include studies of therapeutic agents, natural history in Ebola survivors, and an additional vaccine study. The PHS officers have been integral in conducting these studies. The initial study implemented in Liberia, known as PREVAIL I, involved the evaluation of 2 vaccine strategies vs placebo.^12,14 In addition to the NIH-based Corps officers supporting the study, the Readiness and Deployment Operations Group (RedDOG) initiated deployments for an additional 2 pharmacy and 7 laboratory officers to support this study. During the deployment, the pharmacists were asked to extend their reach to Sierra Leone and later to Guinea to help establish PREVAIL II, an evaluation of ZMapp in the treatment of Ebola.¹³ A total of 9 Corps pharmacists, 2 nurses, and 3 physicians deployed to Sierra Leone or Guinea to assist in the PREVAIL II study.

As the epidemic came to an end in Liberia in May 2015, the need for a long-term assessment of Ebola survivors was recognized, resulting in PREVAIL III.¹⁵ Noteworthy in the survivor study was an ophthalmic substudy led by a Corps officer assigned to the National Eye Institute.^16,17 The survivor study also identified that the persistence of the Ebola virus was longer than previously known and that sexual transmission via semen from infected males remained a potential mode of transmission.¹⁸ To address the lingering viral load, a study of an antiviral drug was initiated in Liberia in the summer of 2016, PREVAIL IV.¹⁹

Four Corps pharmacists helped train Liberian pharmacists to establish and sustain this randomized, double-blind, placebo-controlled study. Most recently, Corps pharmacists were deployed to support the initiation of the Partnership for Research on Ebola Vaccines (PREVAC), a collaborative partnership with researchers from Liberia, Guinea, and Sierra Leone with cosponsors from the NIH, Institut national de la santé et de la recherche médicale (Inserm) in France, and the London School of Hygiene and Tropical Medicine in the United Kingdom.²⁰

Deployment Procedures

As previously mentioned, 108 staff (civil service, assigned PHS, and contractors) from within the NIH volunteered for deployment to assist in the clinical research Ebola response. The typical rotation for those volunteers was limited to 3 weeks to minimize the disruption of their normal work assignments. Volunteers were organized into small teams within the Division of Clinical Research were composed of the right mix of physicians, nurses, medical technologists, and pharmacists. The team ensured that staff obtained official government passports, scheduled airline reservations, and received an orientation to the deployment setting as well as to the research studies (Table). Additionally, the team coordinated the voucher submission process for reimbursement of expenses on return from the country. An additional team member was stationed in Liberia to coordinate the housing and transportation arrangements with a local hotel near the U.S. Embassy.

Within a week of the February 2015 initial meeting in Liberia to establish the NIH/PHS collaboration, the NIH deployment team met by phone with the Corps’ RedDOG to discuss initial requirements (eg, number of officers needed, disciplines, time lines, and documentation needed for deployment). These initial discussions resulted in the establishment of more formal processes that evolved over time as the 2 organizations gained experience. Based on the identification of the numbers and types of officers needed, RedDOG used procedures similar to the process for staffing the MMU. A communication went out to the Corps seeking interested officers.

Deployment slots were filled based on the personal availability of the officer and coordination with their immediate supervisor and agency. Officers needed to meet medical clearance requirements and provide current health care provider licensure information. Additional training requirements needed to be completed (eg, U.S. State Department training and good clinical practice [GCP] if not already current). Corps officers also took part in the NIH orientation program for deploying personnel to familiarize them to the situation on the ground in West Africa and the specific clinical research protocols that they would encounter. Given that most of the Corps officers were coming from outside the NIH, the onboarding activities required significant attention to detail as procedures for arranging travel (eg, passport, visa, and airline reservations) and processes for reimbursement of travel/per diem pay differed from more traditional deployments directed through the Corps headquarters.

Commissioned Corps Roles in the Research Response

Whereas the establishment of the research program in Liberia was based primarily on relationships forged over a 2-month period by the NIAID deputy director for clinical research and staff, the extension of the research program into Sierra Leone (March 2015) and Guinea (June 2015) was on a substantially shorter time line. As a result, Corps officers were thrust into roles that immediately employed their leadership and diplomacy skills.

In Sierra Leone and Guinea, the NIAID deputy director for clinical research established initial relationships within the countries. However, Corps officers found themselves in regular interactions with regulators in the Ministry of Health to ensure that applications were complete and import permits for incoming shipments were cleared. Additionally, the research collaboration in Sierra Leone was coordinated through an investigator assigned to a military hospital converted into an ETU. The Corps officers were well suited to maintain and build on that relationship in expanding the protocol to other ETUs throughout Sierra Leone. A site established by the CDC within the Sierra Leone Ministry of Health coordinated ZMapp storage. The Corps officers formed working relationships with the CDC team to establish and improve cold-chain logistics and transportation of the ZMapp to the various ETUs around the country. Corps officers were integral in working with the in-country contract hiring agency. Activities included establishing criteria for clinical research positions, providing input on the interview of respective candidates, and training staff as the team formed. In Sierra Leone, local staff members were hired to work at specific facilities as research coordinators working with the health care delivery teams.

The U.S. team consisted of a physician, nurse research coordinator, and a pharmacist travelling to the sites with a logistics/operations staff member remaining in Freetown.

Fortunately, a Corps nurse on the team had been part of the initial MMU deployment and was trained to work in a special care unit at the NIH for patients with highly contagious infections. This practical experience was essential in the establishment of procedures in a hazardous environment for the administration of the IV ZMapp, monitoring of adverse effects (AEs), provision of medications to mitigate infusion-related reactions, and documentation of those AEs.

The U.S. research team regularly departed Freetown early in the morning 7 days a week with the various supplies needed as they visited up to 4 ETU sites to prepare the ZMapp at the site, await information on any AEs, and collect case report forms (Figures 1 and 2). The ETUs were spread out over a 90-mile radius and could be described as austere platforms for health care delivery.

An additional challenge was dealing with the multinational organizations that staffed the various ETUs. Relief organizations from Italy, the United Kingdom, China, as well as the Sierra Leone military provided the staffing for the 4 ETUs. Regardless of who operated the ETU, the concept of randomization to ZMapp or standard of care required significant tact and diplomacy in communicating the scientific necessity in order to appropriately answer the research question. As Davey and colleagues pointed out, the randomized, controlled trial established the appropriate ethical framework to determine whether the research intervention was associated with harmful effects as there had not been a phase 1 safety study with the drug.¹³

As the summer approached in Sierra Leone, the team worked through challenges in the IV administration of ZMapp as the protein structure of the monoclonal antibody had not previously been subjected to West African environmental extremes. A balance between speed of administration to prevent protein aggregation in the heat as opposed to the risk of infusion reactions from a foreign protein required the team to communicate frequently with, the manufacturer of ZMapp, to establish realistic infusion rate tables. Additionally, as the various deployment teams rotated in and out, procedures for establishing continuity of research operations were enacted and improved on with each rotation. Good documentation practices to adequately collect all required study information (eg, recording AEs, deviations, and signatures on various forms) proved critical to continuity of research operations.

In Guinea, not only was there the new wrinkle of working within a country where the primary language was French, but also a French cosponsor, Inserm. The NIAID clinical director capitalized on the research infrastructure established for a recently completed Inserm study of favipiravir in the treatment of Ebola to extend the ZMapp study to Guinea. Fortunately, many of the Inserm staff were bilingual and readily responded to the NIH training on the requirements of the ZMapp protocol. However, procedures for cold-chain storage and transportation needed to be established. In Guinea, the PHS officers were key in establishing access and temperature monitoring procedures for a secure room inside the U.S. embassy. The issues associated with cold-chain procedures in the infrastructure-limited environments of West Africa are substantial and warrant consideration of a stand-alone paper. Corps officers also took part in weekly country-focused team meetings with embassy staff to describe progress with the ZMapp study.

As the epidemic waned and NIH transitioned to the survivor and viral persistence studies, the operational tempo changed to allow Corps officers to take part in more definitive capacity building efforts. An initial PHS volunteer from the FDA accepted a position within NIAID as a clinical research oversight manager for pharmacy operations. This individual deployed on numerous occasions to the 3 affected West African countries to further establish cold-chain processes for pharmaceuticals and biologics. He also worked with a multidisciplinary team to renovate a clinical research facility in a rural setting in Guinea. In Liberia, he coordinated an effort with other Corps officers to provide educational seminars on clinical research principles and drug-specific topics with the University of Liberia School of Pharmacy.

Challenges

In each instance, the partnership experience was not without a few problems. The match of skills between the officers who wanted to help and those needed for the research program did not always coincide. While the Corps has more than 1,200 pharmacy officers on active duty, only a fraction of those have experience conducting FDA-regulated clinical research.

Communication problems and time pressures were also constant companions to both the Corps and the NIH. The Corps was going through the largest international deployment in its history to staff multiple missions (including the primary MMU mission in Liberia). The addition of the NIH partnership, while consistent with the MMU staffing mission, provided even more work for a very limited resource. Communicating to the many Corps officers who wanted to volunteer and keeping deployment time lines on track were a challenge. Complicating the matter was the addition of stray e-mails from well-intentioned NIH and Corps staff who communicated directly with colleagues to encourage participation, not fully understanding the policies and protocol governing the deployment process.

Time was always an issue as the rotation schedules were relatively short and the number of activities to make an officer deployment ready were numerous. Obtaining official passports and visas was a challenge as that activity required coordination with the U.S. Department of State. Airline schedules changed with little or no notice, complicating deployments and returns. As the NIH added additional research studies for which support was required, time lines for studies to start became difficult to predict with certainty due to factors outside the control of the NIH. Recently, additional security training requirements for government workers traveling abroad were instituted, further complicating the process of deploying an officer.

The Corps officers taking part in this research response (which was not consistent with customary deployments from Corps headquarters) necessarily were volunteers from full-time assignments within DHHS, and as such, required the permission of their supervisory chain to volunteer. Regardless of this limitation, there was widespread support for these additional and specific research deployments. Although the use of short-term rotations was not ideal, in the end, the rotation plans worked, and the NIH was able to fulfill its research mission with the support of the Corps.

Lessons Learned/Preparing for the Future

Many lessons have been learned and continue to be learned throughout this research response and NIH/Corps partnership. Effective and frequent communication between the organization requesting Corps officers and the Corps headquarters is crucial. In the initial deployments, officers were deployed from the FDA with the assumption that they would be familiar with FDA-regulated clinical research. This was not always the case. The NIH and Corps headquarters later collaborated to develop a survey to send to Corps officers that was used to identify specific skill sets needed by officers who would be deploying to conduct clinical research. NIH personnel prescreened survey responses to identify and prioritize officers for deployment consideration by the deployment authority. This process resulted in the selection of officers who generally needed less training and guidance.

Effective training in clinical research principles for deployed officers and other staff needs to be developed and made available to all deploying individuals. All clinical research staff are required to have training on GCP, but most GCP training programs focus primarily on the ethical principles of research as outlined by the Declaration of Helsinki, Nuremberg Code, and other documents. Few GCP training programs present adequate information on the hands-on conduct of clinical research, especially research regulated by the FDA and other government bodies and therefore subject to certain strict requirements. Examples of crucial but often overlooked topics are source document retention, good documentation practices, cold-chain principles, and other issues related to the creation and retention of adequate trial records.²¹

The handoff between returning and deploying officers is crucial. Due to various issues with changing time lines, flights, and administrative processes, it is imperative to plan adequate overlap between returning and deploying officers. Delays in obtaining passports or visas, flight cancellations, and other unforeseen issues may unexpectedly shorten any planned overlap periods. A full workweek is desirable for overlap so that the new officer may experience tasks that occur throughout the week, be introduced to the various team members, and have help if unexpected events occur. A regular staff member should check periodically that proper procedures are being followed, as some information may be missed during each handoff, and consecutive unchecked handoffs could result in large deviations of important procedures. Onboarding and offboarding checklists should be developed and updated regularly to guide the handoff process.

On a larger scale, the respective agencies and other stakeholders involved in planning clinical research for public health emergencies need to be included in regular tabletop training exercises to better understand how to coordinate a response when needed. Additionally, although many of the Corps officers who took part in this deployment served as mentors for others preparing for deployment, establishing a formal roster of experienced officers to support specific roles of this type of response would help serve as a resource center for future deployments. Finally, coordination between any operating division (or agency) and the Corps should be through the established Corps command infrastructure to eliminate miscommunication and complicating deployment processes.²²

Conclusion

The increasing connectedness of this world, as demonstrated by the Ebola epidemic, requires that the HHS engage globally to provide international leadership and technical expertise in science, policy, and programs and work in concert with interagency partners.²³ The missions of the PHS and NIH intersected in a synergistic manner in the research response to the Ebola epidemic of 2014-2016. The PHS Corps mission includes to “protect, promote, and advance the health and safety of the Nation...through rapid and effective response…and advancement of public health science.”²⁴ The Corps mission directly supported the NIH mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.²⁵

The scope and scale of DHHS’s response to the Ebola epidemic was unprecedented. The NIH research program, although successful and an important component, was but a small part in bringing the Ebola crisis to an end. The CDC (including the many Corps officers assigned to that agency) worked successfully with the international community and the host countries to bring the disease under control. The Biological Advanced Research and Development Authority provided expert project management, making vaccines and therapeutics available for research.

The DoD was a partner in the development of countermeasures and phase 1 clinical research programs as well as establishing laboratory facilities in Liberia. The Department of State facilitated the many interactions required for the mobilization of resources into West Africa. The collective efforts of the U.S. government contributed immensely to the protection of U.S. borders and to the successful resolution of the Ebola outbreak of 2014-2016.

The Ebola epidemic of 2014-2016 challenged many federal agencies to find creative ways to help address the vexing problems created by the spread of the disease. There were many factors complicating the response, including the recovery from civil wars in Liberia and Sierra Leone that decimated the physical infrastructure as well as education and other vital services.

The response from the U.S. and the global community took many forms: Not only was there a need for the typical medical care support, but also for basic public health systems to track the spread of disease, provide clean water, and dispose of infectious waste. Because no known preventive vaccines or therapeutics existed for those infected, the recognition of a research component to the response became abundantly clear as the epidemic continued. As a result, the National Institutes of Health (NIH) and the USPHS Commissioned Corps (Corps) serendipitously found themselves allied in a mutually beneficial relationship in the establishment of an Ebola clinical research program in West Africa.

This article describes the events that led to the NIH and Corps participation in the Ebola response, the roles filled by the Corps in supporting the NIH, and the lessons observed from that collaboration. Also presented are considerations regarding preparation of a clinical research response to future outbreaks.

NIH Clinical Research first Response

The 2014-2016 Ebola epidemic in West Africa demonstrated the need for federal agencies to reassess their capacity to respond to global threats to protect the health security of the U.S.¹ The outbreak also challenged the U.S. government to mobilize unique resources that matched the need of this international (and domestic) response.

In 2014, President Barack Obama announced that the U.S. would launch a government response to the Ebola effort. Although a comprehensive research and development program already was in place to establish Ebola virus disease (EVD) countermeasures, no FDA-approved diagnostics, therapeutics, or preventive vaccines were readily available. Fortunately, FDA regulations regarding emergency use authorizations allowed for the use of several EVD diagnostics during this outbreak.² However, the development of drugs and vaccines specific to Ebola had yet to make their way to phase 1 safety studies.

Two vaccine products went into phase 1 studies in the U.S. within months of the declaration of the emergency.^3,4 Additionally, the NIH had organized a collaborative effort between the U.S. government and academic community to identify a research strategy for the evaluation of therapeutics.⁵ Regardless of the state of countermeasures and research proposals, the initial need was for disease control measures and care for Ebola patients. The CDC took the lead in working within the international community to establish an incident management system that could help the impacted countries enact mechanisms to bring the epidemic under control.⁶

As the epidemic progressed, leaders in the Corps and the NIH responded on pathways that eventually would intersect. One of the unfortunate outcomes of the early efforts of improperly protected health care providers was the unintentional transmission of Ebola.⁷ The Corps identified the need to provide high-level care to the health care worker community as one incentive to motivate health care workers to volunteer for hazardous duty inside Ebola treatment units (ETUs).^8,9 Engulfed in the epidemic response, the U.S. government through the National Security Council and secretary of the Department of Health and Human Services (DHHS) evoked its statutory authority to deploy the Corps (42 U.S. Code 204a).

In the first week of October 2014, the Corps sent an advanced echelon team to assess the situation, partner with key host country and international stakeholders, and begin establishment of the U.S. government’s first ever ETU. With logistics, security, and resource support from the DoD and response coordination from the U.S. Agency for International Development, the Corps then deployed the first of four 70-person team rotations to staff the Monrovia Medical Unit (MMU), an ETU specifically dedicated to the treatment of Ebola-infected health care workers. At the time, it was the only ETU specifically dedicated to health care workers in all of Africa. The MMU operated until May 2015 and provided direct patient care for health care workers with Ebola, malaria, and other illnesses.^8,10

In August 2014, representatives from the CDC met with Liberia’s Minister of Health and Social Welfare Walter T. Gwenigale, MD, to discuss the range of available options that could facilitate a better understanding of the prevention and treatment of the disease. This meeting resulted in a letter dated August 22, 2014, from Dr. Gwenigale to then DHHS Sylvia Burwell, requesting a research response. Secretary Burwell responded on October 2, 2014, describing the immediate dispatch of the deputy director for clinical research of the National Institute of Allergy and Infectious Diseases (NIAID) to Liberia to engage in initial discussions with the Liberian minister and other key Liberians involved in the response.

Representatives from the CDC and the commander of the Corps’ Ebola response (and acting deputy surgeon general) were included in those initial meetings, which led to a recognized need for a robust clinical research program of the highest ethical and scientific standards consistent with the expressed requirements of Liberia.¹¹ A second and third trip to Liberia with larger U.S. teams resulted in an agreement signed on November 19, 2014 for the scientific investigation of strategies that tested interventions for treatment, control, and prevention of Ebola.¹²

The agreement led to the establishment of the Partnership for Research on Ebola Virus in Liberia (PREVAIL) to identify research priorities in a collaborative manner between Liberian and American scientists. The first protocol, a vaccine study, was launched in early February 2015.¹² This monumental task involved the support of hundreds of Liberians and dozens of NIH staff who volunteered for rotations to Liberia. Of the 108 volunteers from within the NIH, 18 were PHS officers. 
Shortly after launching the vaccine study, the next priority was initiating the treatment study. This study was delayed primarily due to ZMapp (Mapp Biopharmaceatical, San Diego,CA) production limitations. ZMapp, a monoclonal antibody cocktail, was the first Ebola therapeutic product to be evaluated in a randomized trial.^5,13

During the planning for the study, NIAID staff in Liberia met with Corps staff of the MMU to discuss the logistics associated with implementation of the ZMapp protocol at the MMU. During that meeting, the NIAID deputy director for clinical research expressed interest in obtaining Corps support from outside the NIH to sustain the research effort in West Africa. More specifically, additional pharmacy and laboratory staff were needed to augment NIH research operations. At the time, the MMU commander had recently transitioned from service as the acting surgeon general and was in a unique position to recommend additional Corps resources that could help in the research response.

The February 2015 discussion resulted in the establishment of an NIH/PHS research partnership that continues to exist. This new opportunity was not a significant stretch for the PHS as there was great interest from the Corps for responding to the Ebola crisis. The enthusiasm was consistent with the overall ethos of the Corps, which as a service was composed of highly qualified active-duty, deployable, uniformed, public health professionals who respond to public health crises at home and abroad. To date, 19 Corps officers from outside the NIH have deployed in support of the NIH Ebola clinical research program. An additional 18 Corps officers assigned within the NIH also volunteered for duty in West Africa. Of the 37 Corps officers supporting the NIH clinical research program, 7 served on more than 1 rotation.

Program Expansion

The Ebola clinical research program expanded over time from the initial PREVAIL vaccine study to include studies of therapeutic agents, natural history in Ebola survivors, and an additional vaccine study. The PHS officers have been integral in conducting these studies. The initial study implemented in Liberia, known as PREVAIL I, involved the evaluation of 2 vaccine strategies vs placebo.^12,14 In addition to the NIH-based Corps officers supporting the study, the Readiness and Deployment Operations Group (RedDOG) initiated deployments for an additional 2 pharmacy and 7 laboratory officers to support this study. During the deployment, the pharmacists were asked to extend their reach to Sierra Leone and later to Guinea to help establish PREVAIL II, an evaluation of ZMapp in the treatment of Ebola.¹³ A total of 9 Corps pharmacists, 2 nurses, and 3 physicians deployed to Sierra Leone or Guinea to assist in the PREVAIL II study.

As the epidemic came to an end in Liberia in May 2015, the need for a long-term assessment of Ebola survivors was recognized, resulting in PREVAIL III.¹⁵ Noteworthy in the survivor study was an ophthalmic substudy led by a Corps officer assigned to the National Eye Institute.^16,17 The survivor study also identified that the persistence of the Ebola virus was longer than previously known and that sexual transmission via semen from infected males remained a potential mode of transmission.¹⁸ To address the lingering viral load, a study of an antiviral drug was initiated in Liberia in the summer of 2016, PREVAIL IV.¹⁹

Four Corps pharmacists helped train Liberian pharmacists to establish and sustain this randomized, double-blind, placebo-controlled study. Most recently, Corps pharmacists were deployed to support the initiation of the Partnership for Research on Ebola Vaccines (PREVAC), a collaborative partnership with researchers from Liberia, Guinea, and Sierra Leone with cosponsors from the NIH, Institut national de la santé et de la recherche médicale (Inserm) in France, and the London School of Hygiene and Tropical Medicine in the United Kingdom.²⁰

Deployment Procedures

As previously mentioned, 108 staff (civil service, assigned PHS, and contractors) from within the NIH volunteered for deployment to assist in the clinical research Ebola response. The typical rotation for those volunteers was limited to 3 weeks to minimize the disruption of their normal work assignments. Volunteers were organized into small teams within the Division of Clinical Research were composed of the right mix of physicians, nurses, medical technologists, and pharmacists. The team ensured that staff obtained official government passports, scheduled airline reservations, and received an orientation to the deployment setting as well as to the research studies (Table). Additionally, the team coordinated the voucher submission process for reimbursement of expenses on return from the country. An additional team member was stationed in Liberia to coordinate the housing and transportation arrangements with a local hotel near the U.S. Embassy.

Within a week of the February 2015 initial meeting in Liberia to establish the NIH/PHS collaboration, the NIH deployment team met by phone with the Corps’ RedDOG to discuss initial requirements (eg, number of officers needed, disciplines, time lines, and documentation needed for deployment). These initial discussions resulted in the establishment of more formal processes that evolved over time as the 2 organizations gained experience. Based on the identification of the numbers and types of officers needed, RedDOG used procedures similar to the process for staffing the MMU. A communication went out to the Corps seeking interested officers.

Deployment slots were filled based on the personal availability of the officer and coordination with their immediate supervisor and agency. Officers needed to meet medical clearance requirements and provide current health care provider licensure information. Additional training requirements needed to be completed (eg, U.S. State Department training and good clinical practice [GCP] if not already current). Corps officers also took part in the NIH orientation program for deploying personnel to familiarize them to the situation on the ground in West Africa and the specific clinical research protocols that they would encounter. Given that most of the Corps officers were coming from outside the NIH, the onboarding activities required significant attention to detail as procedures for arranging travel (eg, passport, visa, and airline reservations) and processes for reimbursement of travel/per diem pay differed from more traditional deployments directed through the Corps headquarters.

Commissioned Corps Roles in the Research Response

Whereas the establishment of the research program in Liberia was based primarily on relationships forged over a 2-month period by the NIAID deputy director for clinical research and staff, the extension of the research program into Sierra Leone (March 2015) and Guinea (June 2015) was on a substantially shorter time line. As a result, Corps officers were thrust into roles that immediately employed their leadership and diplomacy skills.

In Sierra Leone and Guinea, the NIAID deputy director for clinical research established initial relationships within the countries. However, Corps officers found themselves in regular interactions with regulators in the Ministry of Health to ensure that applications were complete and import permits for incoming shipments were cleared. Additionally, the research collaboration in Sierra Leone was coordinated through an investigator assigned to a military hospital converted into an ETU. The Corps officers were well suited to maintain and build on that relationship in expanding the protocol to other ETUs throughout Sierra Leone. A site established by the CDC within the Sierra Leone Ministry of Health coordinated ZMapp storage. The Corps officers formed working relationships with the CDC team to establish and improve cold-chain logistics and transportation of the ZMapp to the various ETUs around the country. Corps officers were integral in working with the in-country contract hiring agency. Activities included establishing criteria for clinical research positions, providing input on the interview of respective candidates, and training staff as the team formed. In Sierra Leone, local staff members were hired to work at specific facilities as research coordinators working with the health care delivery teams.

The U.S. team consisted of a physician, nurse research coordinator, and a pharmacist travelling to the sites with a logistics/operations staff member remaining in Freetown.

Fortunately, a Corps nurse on the team had been part of the initial MMU deployment and was trained to work in a special care unit at the NIH for patients with highly contagious infections. This practical experience was essential in the establishment of procedures in a hazardous environment for the administration of the IV ZMapp, monitoring of adverse effects (AEs), provision of medications to mitigate infusion-related reactions, and documentation of those AEs.

The U.S. research team regularly departed Freetown early in the morning 7 days a week with the various supplies needed as they visited up to 4 ETU sites to prepare the ZMapp at the site, await information on any AEs, and collect case report forms (Figures 1 and 2). The ETUs were spread out over a 90-mile radius and could be described as austere platforms for health care delivery.

An additional challenge was dealing with the multinational organizations that staffed the various ETUs. Relief organizations from Italy, the United Kingdom, China, as well as the Sierra Leone military provided the staffing for the 4 ETUs. Regardless of who operated the ETU, the concept of randomization to ZMapp or standard of care required significant tact and diplomacy in communicating the scientific necessity in order to appropriately answer the research question. As Davey and colleagues pointed out, the randomized, controlled trial established the appropriate ethical framework to determine whether the research intervention was associated with harmful effects as there had not been a phase 1 safety study with the drug.¹³

As the summer approached in Sierra Leone, the team worked through challenges in the IV administration of ZMapp as the protein structure of the monoclonal antibody had not previously been subjected to West African environmental extremes. A balance between speed of administration to prevent protein aggregation in the heat as opposed to the risk of infusion reactions from a foreign protein required the team to communicate frequently with, the manufacturer of ZMapp, to establish realistic infusion rate tables. Additionally, as the various deployment teams rotated in and out, procedures for establishing continuity of research operations were enacted and improved on with each rotation. Good documentation practices to adequately collect all required study information (eg, recording AEs, deviations, and signatures on various forms) proved critical to continuity of research operations.

In Guinea, not only was there the new wrinkle of working within a country where the primary language was French, but also a French cosponsor, Inserm. The NIAID clinical director capitalized on the research infrastructure established for a recently completed Inserm study of favipiravir in the treatment of Ebola to extend the ZMapp study to Guinea. Fortunately, many of the Inserm staff were bilingual and readily responded to the NIH training on the requirements of the ZMapp protocol. However, procedures for cold-chain storage and transportation needed to be established. In Guinea, the PHS officers were key in establishing access and temperature monitoring procedures for a secure room inside the U.S. embassy. The issues associated with cold-chain procedures in the infrastructure-limited environments of West Africa are substantial and warrant consideration of a stand-alone paper. Corps officers also took part in weekly country-focused team meetings with embassy staff to describe progress with the ZMapp study.

As the epidemic waned and NIH transitioned to the survivor and viral persistence studies, the operational tempo changed to allow Corps officers to take part in more definitive capacity building efforts. An initial PHS volunteer from the FDA accepted a position within NIAID as a clinical research oversight manager for pharmacy operations. This individual deployed on numerous occasions to the 3 affected West African countries to further establish cold-chain processes for pharmaceuticals and biologics. He also worked with a multidisciplinary team to renovate a clinical research facility in a rural setting in Guinea. In Liberia, he coordinated an effort with other Corps officers to provide educational seminars on clinical research principles and drug-specific topics with the University of Liberia School of Pharmacy.

Challenges

In each instance, the partnership experience was not without a few problems. The match of skills between the officers who wanted to help and those needed for the research program did not always coincide. While the Corps has more than 1,200 pharmacy officers on active duty, only a fraction of those have experience conducting FDA-regulated clinical research.

Communication problems and time pressures were also constant companions to both the Corps and the NIH. The Corps was going through the largest international deployment in its history to staff multiple missions (including the primary MMU mission in Liberia). The addition of the NIH partnership, while consistent with the MMU staffing mission, provided even more work for a very limited resource. Communicating to the many Corps officers who wanted to volunteer and keeping deployment time lines on track were a challenge. Complicating the matter was the addition of stray e-mails from well-intentioned NIH and Corps staff who communicated directly with colleagues to encourage participation, not fully understanding the policies and protocol governing the deployment process.

Time was always an issue as the rotation schedules were relatively short and the number of activities to make an officer deployment ready were numerous. Obtaining official passports and visas was a challenge as that activity required coordination with the U.S. Department of State. Airline schedules changed with little or no notice, complicating deployments and returns. As the NIH added additional research studies for which support was required, time lines for studies to start became difficult to predict with certainty due to factors outside the control of the NIH. Recently, additional security training requirements for government workers traveling abroad were instituted, further complicating the process of deploying an officer.

The Corps officers taking part in this research response (which was not consistent with customary deployments from Corps headquarters) necessarily were volunteers from full-time assignments within DHHS, and as such, required the permission of their supervisory chain to volunteer. Regardless of this limitation, there was widespread support for these additional and specific research deployments. Although the use of short-term rotations was not ideal, in the end, the rotation plans worked, and the NIH was able to fulfill its research mission with the support of the Corps.

Lessons Learned/Preparing for the Future

Many lessons have been learned and continue to be learned throughout this research response and NIH/Corps partnership. Effective and frequent communication between the organization requesting Corps officers and the Corps headquarters is crucial. In the initial deployments, officers were deployed from the FDA with the assumption that they would be familiar with FDA-regulated clinical research. This was not always the case. The NIH and Corps headquarters later collaborated to develop a survey to send to Corps officers that was used to identify specific skill sets needed by officers who would be deploying to conduct clinical research. NIH personnel prescreened survey responses to identify and prioritize officers for deployment consideration by the deployment authority. This process resulted in the selection of officers who generally needed less training and guidance.

Effective training in clinical research principles for deployed officers and other staff needs to be developed and made available to all deploying individuals. All clinical research staff are required to have training on GCP, but most GCP training programs focus primarily on the ethical principles of research as outlined by the Declaration of Helsinki, Nuremberg Code, and other documents. Few GCP training programs present adequate information on the hands-on conduct of clinical research, especially research regulated by the FDA and other government bodies and therefore subject to certain strict requirements. Examples of crucial but often overlooked topics are source document retention, good documentation practices, cold-chain principles, and other issues related to the creation and retention of adequate trial records.²¹

The handoff between returning and deploying officers is crucial. Due to various issues with changing time lines, flights, and administrative processes, it is imperative to plan adequate overlap between returning and deploying officers. Delays in obtaining passports or visas, flight cancellations, and other unforeseen issues may unexpectedly shorten any planned overlap periods. A full workweek is desirable for overlap so that the new officer may experience tasks that occur throughout the week, be introduced to the various team members, and have help if unexpected events occur. A regular staff member should check periodically that proper procedures are being followed, as some information may be missed during each handoff, and consecutive unchecked handoffs could result in large deviations of important procedures. Onboarding and offboarding checklists should be developed and updated regularly to guide the handoff process.

On a larger scale, the respective agencies and other stakeholders involved in planning clinical research for public health emergencies need to be included in regular tabletop training exercises to better understand how to coordinate a response when needed. Additionally, although many of the Corps officers who took part in this deployment served as mentors for others preparing for deployment, establishing a formal roster of experienced officers to support specific roles of this type of response would help serve as a resource center for future deployments. Finally, coordination between any operating division (or agency) and the Corps should be through the established Corps command infrastructure to eliminate miscommunication and complicating deployment processes.²²

Conclusion

The increasing connectedness of this world, as demonstrated by the Ebola epidemic, requires that the HHS engage globally to provide international leadership and technical expertise in science, policy, and programs and work in concert with interagency partners.²³ The missions of the PHS and NIH intersected in a synergistic manner in the research response to the Ebola epidemic of 2014-2016. The PHS Corps mission includes to “protect, promote, and advance the health and safety of the Nation...through rapid and effective response…and advancement of public health science.”²⁴ The Corps mission directly supported the NIH mission to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.²⁵

The scope and scale of DHHS’s response to the Ebola epidemic was unprecedented. The NIH research program, although successful and an important component, was but a small part in bringing the Ebola crisis to an end. The CDC (including the many Corps officers assigned to that agency) worked successfully with the international community and the host countries to bring the disease under control. The Biological Advanced Research and Development Authority provided expert project management, making vaccines and therapeutics available for research.

The DoD was a partner in the development of countermeasures and phase 1 clinical research programs as well as establishing laboratory facilities in Liberia. The Department of State facilitated the many interactions required for the mobilization of resources into West Africa. The collective efforts of the U.S. government contributed immensely to the protection of U.S. borders and to the successful resolution of the Ebola outbreak of 2014-2016.