San Diego VA study testing cannabidiol—a compound derived from cannabis—for PTSD

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Hemp and marijuana both refer to the cannabis sativa plant and its products. Different varieties of the plant, however, can contain different levels of chemical compounds, and that is what distinguishes hemp from marijuana. (Photo: ©iStock/Nastasic)


February 5, 2019
By Mitch Mirkin 
VA Research Communications


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CBD at a glance

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Researchers at the VA San Diego Healthcare System aim to see whether cannabidiol, or CBD—a compound derived from cannabis plants—can help ease PTSD. The study will give CBD as an add-on to prolonged exposure therapy, a proven psychotherapy for PTSD.
The $1.3 million VA-funded study will enroll 136 Veterans, from all service eras.
Dr. Mallory Loflin is leading a VA study in which Veterans with PTSD will receive capsules containing CBD—a compound derived from cannabis—or a lookalike placebo, along with evidence-based psychotherapy. (Photo by Kevin Walsh)
Dr. Mallory Loflin, a research scientist with VA and assistant professor of psychiatry at the University of California, San Diego, is leading the study. Loflin, with VA’s Center of Excellence for Stress and Mental Health, specializes in studying new mental health treatments that target the body’s endocannabinoid system. CBD and related compounds from cannabis bind with receptors—proteins on the surface of cells—that are part of this system.
Loflin says past research suggests that CBD can increase extinction learning in PTSD. This has to do with people “unlearning” unhelpful responses and behaviors they’ve developed in the wake of trauma. This, she says, could boost the speed and effectiveness of prolonged exposure therapy, which helps patients gradually work through their traumatic memories. She says CBD could also ease insomnia and over-arousal. Those types of effects are beneficial on their own, but they could also further boost Veterans’ engagement and retention in treatment.
VA Research Currents interviewed Loflin to learn more about the trial, which plans to start recruiting patients by March 2019.   
It seems there is a lot of confusion and misinformation floating around on the internet about CBD, and cannabis in general. Does that present special challenges for this study?
I certainly get more questions from prospective participants! In particular, folks have a lot of questions about whether it’s legal for them to participate in the study, and whether they could get in trouble with their work. Because I have a Schedule 1 license, under the Controlled Substances Act our participants are 100-percent legally allowed to receive the study drug. The challenge, though, is with the work question. Just because something is legal doesn’t mean that one’s workplace allows it, so we do have to advise them to do their homework to find out if their employer prohibits use of cannabidiol, even in the context of a research study and for medical treatment. That’s obviously something we wouldn’t have to think about with other medication trials. 
“We have a very long way to go to understand the effects of everything in the cannabis plant.”
While there has been legitimate research showing health benefits from CBD, there’s also been hype about how it’s good for virtually anything that ails a person. Is there a concern that this might lead to a stronger-than-usual placebo effect?
Yes, and this isn’t just an issue for CBD either. This is a common problem for cannabinoid research in general. Folks talk about cannabis and cannabinoids being cure-alls for everything from Alzheimer’s to warts, which creates a huge demand on participants to see improvement when they’re in a “cannabinoid research study.” Unfortunately, what we then see is that even folks in the placebo condition in these trials tend to see greater benefit from the inactive treatment than folks would usually see from an active treatment outside the study! This strong placebo effect creates headaches for researchers because it makes it very difficult for our experimental condition (the study drug) to outperform the placebo, increasing the likelihood that the trial will fail. 
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We’ve obviously thought a great deal about this issue and will attempt to measure folks’ expectations about the study drug and attempt to control for that when we analyze the data. Also, I designed this study as an adjunct to psychotherapy because I wanted to test whether the addition of CBD to one of our current frontline treatments for PTSD (prolonged exposure) helps with the process of treatment. But it’s also possible it could impair treatment. 
I’m equally interested in finding out whether taking CBD at the same time as psychotherapy disrupts treatment gains. This is a major question I get from therapists whose patients are self-treating themselves with a cannabinoid during psychotherapy, whether it helps, hurts, or makes no difference. So even if the study “fails” and doesn’t find that CBD outperforms placebo because of too strong of a placebo effect, we should at least be able to see if those in the CBD condition fared worse, which is a very important question. 
Tell me about the CBD product you are using in the study.  
It’s manufactured in a lab to replicate plant-derived CBD. It’s isometrically identical but doesn’t come from cannabis. There was a lot of back and forth on which source to use, but we decided to go with lab-derived for consistency of the drug product. This also helps us test just the effects of CBD alone. Most plant-derived CBD products contain other potentially active compounds that will vary from plant to plant and product type to product type. We could have used plant-derived pure CBD, but at that point it’s just a single molecule. It’s easier to get to that molecule from a synthetic lab-made product than from a plant. 
Would it be correct to use the term “medical marijuana” or “medical cannabis” for this trial?
Neither is technically correct, since our CBD product doesn’t come from cannabis, although I’d argue that the term medical marijuana isn’t precise in any context, since the scientific term for all is cannabis and “marijuana” is really just a colloquial term, and one with quite a racialized history, too.  I guess you’d call our study a “cannabinoid trial.”
Do naturally derived CBD products contain various other compounds, even in very small amounts, that may contribute to the therapeutic effect? By using a synthetic and “pure” CBD product, are you possibly sacrificing some therapeutic benefit and effectiveness?
It’s important to point out that it might not even be CBD that’s responsible for therapeutic effects. It could very well be one of its metabolites [substances that are created when a compound is broken down in the body]. It’s also very likely that a lot of those other compounds in the cannabis plant have therapeutic benefit. However, it’s equally likely that a lot of them also interact with and suppress the effects of CBD, as well. The problem is that we haven’t categorized most of those other compounds in a systematic way, and we know very little about their bioavailability, metabolism, actions, and effects. By studying just one molecule we can at least parse out the direct effect of CBD by itself.  We have a very long way to go to understand the effects of everything in the cannabis plant. 
VA RESEARCH 
TOPIC PAGES
Complementary and Integrative Health
Posttraumatic Stress Disorder (PTSD)
Participants in the trial will receive capsules that contain either CBD or a lookalike placebo. Why use capsules as opposed to other forms of CBD?
It came down to regulatory process more than anything else. Encapsulating a pharmaceutical product is considered standard pharmacy procedures, but mixing it with sesame oil (for sublingual) or another solid (for inhalation) would be changing the formulary. In the eyes of the Food and Drug Administration (FDA), this would then be considered a different drug product, not pure CBD. We would have had to do all kinds of preliminary studies to demonstrate safety with that new “mixture” before obtaining FDA approval to proceed with the study. Since we don’t have enough data yet to know which method of delivery produces the most consistent effect, oral seemed like a good first start. 
What legal and regulatory processes did your team have to go through to do this trial?
First, we applied to VA Clinical Science Research and Development for funding. That application was reviewed by a scientific panel of researchers who scored it based on merit of the study design and potential for impact on Veterans’ health. After receiving notice that the study would be funded, we applied for and received approval from the FDA to test oral CBD as an investigational new drug product for the treatment of PTSD. We also received approval from the California Department of Justice to recruit state residents as participants in a controlled-substance research study. 
I also applied for and was granted a Schedule 1 researcher registration, which required a site visit from the federal Drug Enforcement Administration to ensure that we had appropriate facilities and procedures in place to store and administer the drug. Because we decided to purchase CBD as an active pharmaceutical ingredient and encapsulate it in our pharmacy, we did not need National Institute of Drug Abuse approval, though this would be a typical first step for a cannabis-based study. But we did need to get approvals from federal VA contracting for sourcing the drug product from a chemical manufacturer. 
The trial will enroll 136 Vets. Will that be a large enough sample to enable you to stratify the results based on factors like service era, duration of PTSD, gender, or race? In other words, will you be able to learn which subgroups of Veterans with PTSD can potentially benefit most from CBD?
We’ll certainly investigate whether those factors impacted outcomes as a secondary follow-up to the study, but you’re correct that the sample size isn’t large enough to test this as a primary outcome. 
Is this the first randomized, controlled trial of CBD for PTSD in the U.S. or worldwide? Are there any—even small pilot studies—that show up in the medical literature?
Not at all! Two other cross-over trials that compare different combinations of THC and CBD with placebo for PTSD are underway in British Columbia and Arizona. To my knowledge, though, this is the first cannabinoid trial primarily funded by VA. There is also a double-blind clinical trial preparing to launch at New York University that would test CBD alone as a potential treatment for comorbid PTSD and alcohol use disorder.
CBD at a glance

CBD is short for cannabidiol (pronounced kan-a-bih-die-ole). CBD is one of hundreds of chemical compounds found in cannabis plants. One large group of these compounds is known as cannabinoids. Scientists have identified more than 100 cannabinoids, including CBD.
Besides CBD, another compound found in cannabis is THC, short for tetrahydrocannabinol. THC is “pscychoactive,” meaning it produces a high, a feeling of euphoria. CBD does not have this property.
Studies and anecdotal experience suggest a variety of possible health benefits from cannabinoids such as CBD and THC—for example, easing chronic pain and anxiety—but researchers are still learning exactly which compound produces which effects, and what the risks are.
The terms hemp and marijuana are associated with CBD, and there is much confusion as to their precise definitions. See this blog post from the National Institute on Drug Abuse for an explanation.
What’s important to know is that varieties of the cannabis plant that would be considered marijuana contain far more THC than do varieties that are grown as hemp. According to the 2018 Farm Bill, hemp that is grown legally in the U.S. can contain no more than 0.3 percent of THC.
CBD products can be derived from either “marijuana” or “hemp” varieties of cannabis—or they can be made synthetically in a lab. CBD can be used in various forms, such as oils, sprays, creams, gummies, and capsules.
Although CBD does not produce a high, until recently it was considered a Schedule 1 drug—in all its forms—and was subject to tight regulation. The 2018 Farm Bill loosened restrictions on CBD derived directly from hemp, as part of the bill’s legalizing of commercial production of hemp. However, there are currently no hemp-derived CBD products that meet FDA criteria for research. The synthetic version being used in the VA trial and other forms of CBD being used in research are still classified as Schedule 1 drugs. As such, approvals for the research must be obtained from several agencies, including the Drug Enforcement Administration and the FDA.



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New VA health care rules: Trump overreach or more choice for vets? By: Leo Shane III


A patient walks down a hallway at the Fayetteville Veterans Affairs Medical Center in North Carolina in March 2015. Critics and supporters of plans to expand veterans access to private-sector medical appointments are gearing up for a new round of fights after the release of new draft community care rules this week. (Patrick Semansky/AP)

WASHINGTON — The fight over privatizing Veterans Affairs health care is about to escalate.
On Wednesday, department officials released their first public draft of new rulesregarding which veterans will be eligible for private-sector medical appointments covered by taxpayer funds. The rules amount to a massive expansion of those outside care options, potentially adding more than 1 million more patients to community care programs.
Almost immediately, critics attacked the plan as an overreach by President Donald Trump’s administration to shift patients and funding from the federal veterans medical system to the private sector, in an attempt to undermine government backed health care. House Veterans’ Affairs Committee Chairman Mark Takano, D-Calif., has promised a public hearing on the issue in coming weeks.
“Rather than working to find an equilibrium within the system by building up VA’s ability to deliver high quality care, … today’s announcement places VA on a pathway to privatization and leads Congress to assume the worst,” he said in a statement after the rules release.

New VA plan: Vets facing 30-minute drives, 20-day waits for appointments could get private-sector care instead
The draft standards could massively expand the number of outside medical appointments that taxpayers have to fund.
By: Leo Shane III
But VA officials are calling those reactions nothing more than hyperbolic partisanship, and they said the new rules are designed to give veterans more options, not undermine the existing system.

They also insist that the changes won’t significantly alter how the majority of veterans in America get their care, since many are satisfied with their current care plans. The small percentage who aren’t will now enjoy more choices, with the government picking up the bill.
“Most Americans can already choose the health care providers that they trust, and President (Donald) Trump promised that veterans would be able to do the same,” said VA Secretary Robert Wilkie.


“With VA’s new access standards, the future of the VA health care system will lie in the hands of veterans, exactly where it should be.”
The rules release is the culmination of nearly two years of debate within veterans community over how to balance promised health care with program reforms — and whether Trump supporters have pushed that line too far. Now, the disagreements are likely to get even more attention, as outside groups view the fight as a proxy for broader arguments over whether the president is interested in improving federal agencies or dismantling them.


For today’s VA, it’s the best of times and the worst of times
In the last year, the Department of Veterans Affairs has seen big successes and even bigger controversies.
By: Leo Shane III
** The new rules

Currently, VA community care options are a collection of at least seven separate programs, each with different eligibility and payment rules. The most well-known is the VA Choice program, put in place after the department’s 2014 wait time scandal that forced the resignation of multiple top VA officials, including former Secretary Eric Shinseki.
The Choice program allows veterans who live 40 miles away from a VA medical facility or face a 30-day wait for care there to receive funding for medical appointments in their local community. Those standards have been attacked from both sides of the political aisle, as either too loose or too restrictive.
Last summer, Congress passed (with overwhelming bipartisan support) the VA Mission Act, mandating that department officials consolidate the existing community care programs and come up with new eligibility rules.
Many Democrats who had warned that Trump officials were pushing for too much private-sector funding still went along with the legislation, arguing that reforms were needed regardless of the potential pitfalls.
The draft rules unveiled by Wilkie this week would echo the VA Choice limits but ease them significantly.

For primary care and mental health medical appointments, the department is proposing a 30-minute average drive time standard and a wait-time standard at closer VA facilities of 20 days. For specialty care, the drive-time standard would increase to 60 minutes and the wait-time standard would increase to 28 days.
Drive times would be calculated according to a private-sector program based on Microsoft’s Bing search engine maps.
About 600,000 veterans enrolled in VA health care are eligible for the existing community care programs. The proposed expanded standards will raise that number to between 1.5 million and 2.1 million patients, according to the department.
But VA officials are quick to note that eligibility doesn’t mean guaranteed use. Last year, of all the veterans eligible for the VA Choice program, only about 36 percent used it. Less than 1 percent used those outside care appointments to cover all their medical appointment needs.
Usage of all community care programs dropped about 2 percent from 2016. As a result, VA officials are saying they don’t expect a significant rise even if the expanded rules are put in place.


Vets groups and lawmakers say they’re against it — but what does ‘privatization’ of Veterans Affairs really mean?
The term will command much of the debate at the new VA secretary’s confirmation hearing, but different groups have different definitions.
By: Leo Shane III
** Patients’ choice or bureaucratic attack?
But critics don’t buy that, saying the new rules could easily amount to a rapid expansion of the program.
“My concern is if (the standards) are too broad, it’s going to hollow out the VA, and we’re not going to be able to foot the bill,” said Senate Veterans’ Affairs Committee ranking member Jon Tester, D-Mont.
“A 30-minute drive, if you’re in Scobey, Montana, that seems reasonable. But if you’re in the middle of Chicago caught in traffic, does that work? We need a lot more information.”
VA planners have put a price tag of more than $21 billion over five years on the new standards. But critics have also questioned that, saying it will fall short of actual costs, especially if administration officials push the new options as preferred.
“We are witnessing a deliberate attempt to drain the coffers that feed the VA and to force our veterans into the fragmented and chaotic private sector, a system that is costly, inefficient and unprepared to meet the needs of our veterans,” said National Nurses United Co-president Jean Ross, in a statement.

“Nurses are concerned that veterans returning from combat will find it harder to find specialized care or advocates to help them navigate through the maze of private-sector providers. If we fail to provide for our veterans, we are failing to live up the promise we made when they took the oath to serve.”
The group, along with federal union officials, have warned that years of bad-mouthing VA services combined with loosening eligibility rules for outside care options will lead to worse care for veterans.
Since his presidential campaign, Trump has repeatedly suggested that many veterans face onerous wait times when turning to VA for medical care, showing the need for more outside options.
But earlier this month, a study published in the Journal of the American Medical Association found that in most cases veterans’ waits for appointments with VA clinics are shorter than in the private sector. In 2017, the average wait time for VA doctors was just under 18 days, compared to nearly 30 days for private sector care.
In addition, veterans groups have long argued that private-sector doctors aren’t always prepared to deal with combat injuries like post-traumatic stress and traumatic brain injury. They worry that the push for more outside appointments takes focus away from building up VA services and resources.

“It will not be acceptable to veterans like our members, who use VA health care almost exclusively, to cannibalize the existing system in order to fund the expansion of this new community care program,” said Carl Blake, executive director for Paralyzed Veterans of America.

With deadline looming, lawmakers worry about new VA community care rules
Department officials say they are on track to put new veterans medical rules in place by June, but advocates worry they haven’t seen details so far.
By: Leo Shane III
** What is privatization?
When Takano holds his planned hearing on the new standards, the primary question will become whether tripling the number of veterans eligible for outside care amounts to privatizing VA’s core mission to provide care for veterans.


Wilkie has already argued that it does not. In his statement before Wednesday’s release, he offered an early rebuttal to the privatization claims, arguing that allowing veterans more choices for their care will force VA hospitals to strive for even better service, in turn providing better care to veterans.
“Our medical services must meet our veterans’ needs and reinforce the trust that forms the basis for every interaction with VA,” he said. “We will constantly innovate, upgrade, and pursue ways to serve our nation’s heroes as best we can. Our new access standards are a vital part of this effort.”
But opponents say the new community care program won’t hold outside providers to the same wait-time or quality standards that VA physicians must meet. That puts VA at a disadvantage as they try to explain to veterans why their breadth of experience and associated support resources many outweigh a slightly-shorter car drive for check-ups.

“The standards turn a blind eye to the quality of care veterans would receive in the private sector,” said Russell Lemle, a senior policy analyst at the Veterans Healthcare Policy Institute, a frequent critic of the administration’s VA reform plans.
“These standards will privatize veterans’ health care, plain and simple. They open up the floodgates for veterans to receive vouchers for private sector services. Now for the first time, dollars will follow veterans into the private sector, leaving less money and less staff available for VA facilities.”
Veterans groups have offered a mixed assessment of the rules thus far.
Officials at the Veterans of Foreign Wars, like PVA, expressed serious concerns about the rules as written now. Officials at Disabled American Veterans said they have numerous unanswered questions about “whether sufficient new funding will be provided, without diverting resources from existing VA programs or modernization plans.”
But AMVETS National Executive Director Joe Chenelly praised the initial draft.

“The reality is VA-funded care is being placed in the hands of the veteran, and that is the right thing to do,” he said. “Many of those veterans will choose to go to a VA medical facility, while others want more freedom of choice.”
But Chenelly — along with officials from Wounded Warrior Project and several other organizations — said they still have questions about the implementation, many of which were not explained to key community stakeholders before the Wednesday announcement.
Republicans on the House and Senate Veterans’ Affairs Committee have largely offered support for the community care changes thus far, potentially giving VA support when their officials are summoned before those panels on Capitol Hill in coming weeks.
Under rules laid out the Mission Act, VA officials must finalize the new community care rules by the beginning of March. They’ll go into effect in June, unless lawmakers opt to block them.





About
this
Author
About Leo Shane IIILeo covers Congress, Veterans Affairs and the White House for Military Times. He has covered Washington, D.C. since 2004, focusing on military personnel and veterans policies.

THE TRUMP ADMINISTRATION PROPOSES NEW RULES TO ENCOURAGE VETERANS TO SEEK PRIVATE CARE

The new access standards are the most important step toward reshaping the Department of Veterans Affairs in line with Trump’s vision of enlarging the private sector’s role.ISAAC ARNSDORF12 HOURS AGO When Congress passed a bill last year to transform the Continue reading THE TRUMP ADMINISTRATION PROPOSES NEW RULES TO ENCOURAGE VETERANS TO SEEK PRIVATE CARE

New VA health care rules: Trump overreach or more choice for vets? By: Leo Shane III




A patient walks down a hallway at the Fayetteville Veterans Affairs Medical Center in North Carolina in March 2015. Critics and supporters of plans to expand veterans access to private-sector medical appointments are gearing up for a new round of fights after the release of new draft community care rules this week. (Patrick Semansky/AP)


WASHINGTON — The fight over privatizing Veterans Affairs health care is about to escalate.
On Wednesday, department officials released their first public draft of new rulesregarding which veterans will be eligible for private-sector medical appointments covered by taxpayer funds. The rules amount to a massive expansion of those outside care options, potentially adding more than 1 million more patients to community care programs.
Almost immediately, critics attacked the plan as an overreach by President Donald Trump’s administration to shift patients and funding from the federal veterans medical system to the private sector, in an attempt to undermine government backed health care. House Veterans’ Affairs Committee Chairman Mark Takano, D-Calif., has promised a public hearing on the issue in coming weeks.
“Rather than working to find an equilibrium within the system by building up VA’s ability to deliver high quality care, … today’s announcement places VA on a pathway to privatization and leads Congress to assume the worst,” he said in a statement after the rules release.

New VA plan: Vets facing 30-minute drives, 20-day waits for appointments could get private-sector care instead
The draft standards could massively expand the number of outside medical appointments that taxpayers have to fund.
By: Leo Shane III
But VA officials are calling those reactions nothing more than hyperbolic partisanship, and they said the new rules are designed to give veterans more options, not undermine the existing system.

They also insist that the changes won’t significantly alter how the majority of veterans in America get their care, since many are satisfied with their current care plans. The small percentage who aren’t will now enjoy more choices, with the government picking up the bill.
“Most Americans can already choose the health care providers that they trust, and President (Donald) Trump promised that veterans would be able to do the same,” said VA Secretary Robert Wilkie.


“With VA’s new access standards, the future of the VA health care system will lie in the hands of veterans, exactly where it should be.”
The rules release is the culmination of nearly two years of debate within veterans community over how to balance promised health care with program reforms — and whether Trump supporters have pushed that line too far. Now, the disagreements are likely to get even more attention, as outside groups view the fight as a proxy for broader arguments over whether the president is interested in improving federal agencies or dismantling them.


For today’s VA, it’s the best of times and the worst of times
In the last year, the Department of Veterans Affairs has seen big successes and even bigger controversies.
By: Leo Shane III
** The new rules

Currently, VA community care options are a collection of at least seven separate programs, each with different eligibility and payment rules. The most well-known is the VA Choice program, put in place after the department’s 2014 wait time scandal that forced the resignation of multiple top VA officials, including former Secretary Eric Shinseki.
The Choice program allows veterans who live 40 miles away from a VA medical facility or face a 30-day wait for care there to receive funding for medical appointments in their local community. Those standards have been attacked from both sides of the political aisle, as either too loose or too restrictive.
Last summer, Congress passed (with overwhelming bipartisan support) the VA Mission Act, mandating that department officials consolidate the existing community care programs and come up with new eligibility rules.
Many Democrats who had warned that Trump officials were pushing for too much private-sector funding still went along with the legislation, arguing that reforms were needed regardless of the potential pitfalls.
The draft rules unveiled by Wilkie this week would echo the VA Choice limits but ease them significantly.

For primary care and mental health medical appointments, the department is proposing a 30-minute average drive time standard and a wait-time standard at closer VA facilities of 20 days. For specialty care, the drive-time standard would increase to 60 minutes and the wait-time standard would increase to 28 days.
Drive times would be calculated according to a private-sector program based on Microsoft’s Bing search engine maps.
About 600,000 veterans enrolled in VA health care are eligible for the existing community care programs. The proposed expanded standards will raise that number to between 1.5 million and 2.1 million patients, according to the department.

But VA officials are quick to note that eligibility doesn’t mean guaranteed use. Last year, of all the veterans eligible for the VA Choice program, only about 36 percent used it. Less than 1 percent used those outside care appointments to cover all their medical appointment needs.
Usage of all community care programs dropped about 2 percent from 2016. As a result, VA officials are saying they don’t expect a significant rise even if the expanded rules are put in place.


Vets groups and lawmakers say they’re against it — but what does ‘privatization’ of Veterans Affairs really mean?
The term will command much of the debate at the new VA secretary’s confirmation hearing, but different groups have different definitions.
By: Leo Shane III
** Patients’ choice or bureaucratic attack?
But critics don’t buy that, saying the new rules could easily amount to a rapid expansion of the program.
“My concern is if (the standards) are too broad, it’s going to hollow out the VA, and we’re not going to be able to foot the bill,” said Senate Veterans’ Affairs Committee ranking member Jon Tester, D-Mont.
“A 30-minute drive, if you’re in Scobey, Montana, that seems reasonable. But if you’re in the middle of Chicago caught in traffic, does that work? We need a lot more information.”
VA planners have put a price tag of more than $21 billion over five years on the new standards. But critics have also questioned that, saying it will fall short of actual costs, especially if administration officials push the new options as preferred.
“We are witnessing a deliberate attempt to drain the coffers that feed the VA and to force our veterans into the fragmented and chaotic private sector, a system that is costly, inefficient and unprepared to meet the needs of our veterans,” said National Nurses United Co-president Jean Ross, in a statement.

“Nurses are concerned that veterans returning from combat will find it harder to find specialized care or advocates to help them navigate through the maze of private-sector providers. If we fail to provide for our veterans, we are failing to live up the promise we made when they took the oath to serve.”
The group, along with federal union officials, have warned that years of bad-mouthing VA services combined with loosening eligibility rules for outside care options will lead to worse care for veterans.
Since his presidential campaign, Trump has repeatedly suggested that many veterans face onerous wait times when turning to VA for medical care, showing the need for more outside options.
But earlier this month, a study published in the Journal of the American Medical Association found that in most cases veterans’ waits for appointments with VA clinics are shorter than in the private sector. In 2017, the average wait time for VA doctors was just under 18 days, compared to nearly 30 days for private sector care.
In addition, veterans groups have long argued that private-sector doctors aren’t always prepared to deal with combat injuries like post-traumatic stress and traumatic brain injury. They worry that the push for more outside appointments takes focus away from building up VA services and resources.

“It will not be acceptable to veterans like our members, who use VA health care almost exclusively, to cannibalize the existing system in order to fund the expansion of this new community care program,” said Carl Blake, executive director for Paralyzed Veterans of America.

With deadline looming, lawmakers worry about new VA community care rules
Department officials say they are on track to put new veterans medical rules in place by June, but advocates worry they haven’t seen details so far.
By: Leo Shane III
** What is privatization?
When Takano holds his planned hearing on the new standards, the primary question will become whether tripling the number of veterans eligible for outside care amounts to privatizing VA’s core mission to provide care for veterans.
Wilkie has already argued that it does not. In his statement before Wednesday’s release, he offered an early rebuttal to the privatization claims, arguing that allowing veterans more choices for their care will force VA hospitals to strive for even better service, in turn providing better care to veterans.
“Our medical services must meet our veterans’ needs and reinforce the trust that forms the basis for every interaction with VA,” he said. “We will constantly innovate, upgrade, and pursue ways to serve our nation’s heroes as best we can. Our new access standards are a vital part of this effort.”
But opponents say the new community care program won’t hold outside providers to the same wait-time or quality standards that VA physicians must meet. That puts VA at a disadvantage as they try to explain to veterans why their breadth of experience and associated support resources many outweigh a slightly-shorter car drive for check-ups.

“The standards turn a blind eye to the quality of care veterans would receive in the private sector,” said Russell Lemle, a senior policy analyst at the Veterans Healthcare Policy Institute, a frequent critic of the administration’s VA reform plans.
“These standards will privatize veterans’ health care, plain and simple. They open up the floodgates for veterans to receive vouchers for private sector services. Now for the first time, dollars will follow veterans into the private sector, leaving less money and less staff available for VA facilities.”
Veterans groups have offered a mixed assessment of the rules thus far.
Officials at the Veterans of Foreign Wars, like PVA, expressed serious concerns about the rules as written now. Officials at Disabled American Veterans said they have numerous unanswered questions about “whether sufficient new funding will be provided, without diverting resources from existing VA programs or modernization plans.”
But AMVETS National Executive Director Joe Chenelly praised the initial draft.

“The reality is VA-funded care is being placed in the hands of the veteran, and that is the right thing to do,” he said. “Many of those veterans will choose to go to a VA medical facility, while others want more freedom of choice.”
But Chenelly — along with officials from Wounded Warrior Project and several other organizations — said they still have questions about the implementation, many of which were not explained to key community stakeholders before the Wednesday announcement.
Republicans on the House and Senate Veterans’ Affairs Committee have largely offered support for the community care changes thus far, potentially giving VA support when their officials are summoned before those panels on Capitol Hill in coming weeks.
Under rules laid out the Mission Act, VA officials must finalize the new community care rules by the beginning of March. They’ll go into effect in June, unless lawmakers opt to block them.




181

About
this
Author
About Leo Shane IIILeo covers Congress, Veterans Affairs and the White House for Military Times. He has covered Washington, D.C. since 2004, focusing on military personnel and veterans policies.

Supporters Push for Blue Water Navy Bill After Court Ruling

An A-4 Skyhawk launches from the USS Coral Sea in March 1965, during operations in the South China Sea. Congress may extend VA benefits to "blue water" sailors who served on deep-water warships operating off the Vietnam coast. (US Navy photo)


An A-4 Skyhawk launches from the USS Coral Sea in March 1965, during operations in the South China Sea. Congress may extend VA benefits to “blue water” sailors who served on deep-water warships operating off the Vietnam coast. (US Navy photo)


30 Jan 2019
Military.com | By Richard Sisk
A bipartisan push in Congress on a bill to get Agent Orange benefits for “Blue Water Navy” veterans of Vietnam gained traction Wednesday from a court ruling that went against opposition from the Department of Veterans Affairs.
“I hope they’ve heard it loud and clear at the VA,” Thomas Snee, national executive director of the Fleet Reserve Association, said of the court ruling that could extend Agent Orange benefits and health care to an estimated 90,000 sailors who served off the coast of Vietnam.

Snee, a former master chief who served on the destroyer Vogelgesang off Vietnam, said, “The VA needs to stop pushing back and get to ‘Yes.’ “
In a 9-2 ruling, the U.S. Court of Appeals for the Federal Circuit ruled in favor of 73-year-old Alfred Procopio Jr., who served on the aircraft carrier Intrepid off Vietnam. He had been denied benefits by the VA for lack of scientific evidence that his diabetes and prostate cancer were related to exposure to the toxic defoliant Agent Orange.
In her ruling for the majority supporting Procopio’s claim, Judge Kimberly A. Moore wrote, “We find no merit in the government’s arguments to the contrary.”
John Wells, a lawyer and Navy veteran who argued the case for Procopio, said that “innumerable veterans were denied palliative and potentially lifesaving benefits” in the long struggle for coverage.
In a statement after the ruling, Wells, head of the Military Veterans Advocacy group, said, “The many people who fought this battle alongside us and the veterans whose lives have been forever changed by the VA’s policy are all due thanks and credit.”
The VA has yet to decide whether to appeal the decision or continue to oppose congressional efforts to pass a bill mandating benefits and health care for the Blue Water veterans.
“VA is reviewing this decision and will determine an appropriate response,” a spokesman said.
In his concurring opinion in the Procopio case, Judge Raymond T. Chen wrote that legislation is needed to back up the court’s action.
“Recent debates in Congress, which required consideration of the significant cost of the proposed addition of Blue Water Navy veterans [for Agent Orange benefits], underscores why Congress, rather than the courts, should be the one to revisit our interpretation,” he wrote.
Last year, the House unanimously passed a Blue Water Navy bill, but several Republican senators, citing the costs, blocked a vote in the Senate. A spokesman for Sen. Mike Enzi, R-Wyoming, one of the senators who blocked the vote, said that he was “still reviewing the [court] decision at this time.”
A similar bill was introduced on the House side earlier this month. Rep. Mark Takano, D-California, the new chairman of the House Veterans Affairs Committee, said the court ruling “appears to bring our country one step closer to ensuring that we fulfill our duty to care for veterans affected by exposure to Agent Orange.”
He noted the failure of the bill last year, and said in a statement, “It is time for Congress to right this wrong, redouble our effort to pass H.R. 299 and uphold our responsibility to care for our nation’s veterans.”
Sen. Johnny Isakson, R-Georgia, chairman of the Senate Veterans Affairs Committee, said in a statement that he supported the bill last year “because I believe [Blue Water veterans] should have remained eligible for these benefits as Congress intended.”
“I am pleased to see this recent court decision, and I look forward to working with the VA on its next steps on addressing this,” he said.
Earlier this month during a VA town hall meeting webcast, Paul Lawrence, head of the Veterans Benefits Administration, said the VA still lacks “sufficient evidence” to prove a presumptive link between service off the coast of Vietnam and the illnesses caused by the widespread use of the Agent Orange.
Those who served on the ground or the inland waters of Vietnam currently are eligible for benefits for the “presumptive” link to 14 Agent Orange-related illnesses, but those who served off the coast are not.
“In terms of presumptives, they come with a real requirement of sufficient evidence to indicate it’s warranted,” Lawrence said.
Major veterans organizations hailed the court’s decision and urged Congress to move quickly on legislation for the aging Blue Water veterans.
Veterans of Foreign Wars National Commander B.J. Lawrence said the ruling for Procopio, a life member of VFW Post 6587 in Spring Lake Park, Minnesota, was laudable, but “the VFW isn’t quite ready to celebrate.”
“That’s because the VA can always appeal the ruling and Congress has yet to pass a Blue Water Navy bill,” he said in a statement. “But it is very encouraging to now have a court of law support Blue Water Navy veterans along with the court of public opinion.”
Carl Blake, an Army veteran and executive director of Paralyzed Veterans of America, said the court ruling “resolves a decades-long controversy that has visited a grave injustice” on Blue Water veterans.
“Now our staff around the country will work to ensure that the Blue Water veterans and their families receive their benefits,” he said in a statement.
— Richard Sisk can be reached at Richard.Sisk@Military.com.

New VA plan: Vets facing 30-minute drives, 20-day waits for appointments could get private-sector care instead By: Leo Shane III


Veterans wait outside the Veterans Affairs Puget Sound Medical Center in Seattle on March 30, 2015. Department officials on Wednesday released new proposed standards for veterans seeking care at outside clinics and hospitals, at VA’s expense. (Elaine Thompson/AP)

WASHINGTON — Veterans who live more than 30 minutes from a Veterans Affairs medical clinic or face a wait of more than 20 days for most health care appointments would be eligible for expanded private-sector medical options under new proposed guidelines unveiled by department officials on Wednesday.
The new standards would replace the 40-mile, 30-day guidelines currently in place for most veterans and could dramatically expand the number of outside health care appointments that VA will have to fund in coming years.
Veterans would also be able to receive urgent care outside the VA system in a to-be-established community care network. Those emergency appointments would require a co-payment from the patients, but department accountants would cover the bulk of costs.

With deadline looming, lawmakers worry about new VA community care rules
Department officials say they are on track to put new veterans medical rules in place by June, but advocates worry they haven’t seen details so far.
By: Leo Shane III
In a statement, VA Secretary Robert Wilkie said the new standards — scheduled to be in place by June — are a vital part in ensuring proper health care for veterans well into the future.
“Most Americans can already choose the health care providers that they trust, and President Trump promised that veterans would be able to do the same,” he said. “With VA’s new access standards, the future of the VA health care system will lie in the hands of veterans, exactly where it should be.”

The new access standards were mandated under legislation passed by Congress last summer with bipartisan support.
But congressional Democrats have repeatedly warned that shifting too many VA resources to outside clinics and doctors’ offices could slowly drain away needed resources from the department’s facilities and lead to privatizing VA’s core mission of providing health care for veterans.
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Lawmakers were scheduled to be briefed on the new draft standards on Wednesday afternoon. Capitol Hill staffers and several prominent veterans groups have complained that much of the work in writing the standards in recent months has been done behind the scenes, without sufficient input from the larger veterans community.
VA announces access standards for health care https://t.co/6K5olhdads pic.twitter.com/ZLt6wbw2Q5
— Veterans Affairs (@DeptVetAffairs) January 30, 2019
VA officials have disputed that. On Monday, Wilkie issued a rebuttal even before the new details were out, attacking critics who “will claim falsely and predictably that they represent a first step toward privatizing the department.”
Both Wilkie and previous VA secretaries have said the current community care rules are a patchwork of seven different programs that have separate eligibility regulations, billing policies and reimbursement rates. The consolidated program is designed to simplify and streamline that.
“Strict and confusing qualification criteria like driving distances and proximity to VA facilities that don’t offer needed services will be replaced by eligibility guidelines based on what matters most: the convenience of our veteran customers,” Wilkie said in his Monday statement.

VA officials said the new draft standards are based on “best practices both in government and in the private sector.”
For primary care and mental health medical appointments, the department is proposing a 30-minute average drive time standard and a wait-time standard at closer VA facilities of 20 days.
For specialty care, the drive-time standard would increase to 60-minutes and wait time to 28 days.

TriWest takes over VA community care programs nationwide
The move comes as department officials work to overhaul VA’s outside care programs over the next year.
By: Leo Shane III
VA officials said they expect the new standards to more than triple the number of veterans eligible for outside care. About 8 percent of veterans in the Veterans Health Administration now qualify for the community care programs. The new standards are expected to take that to between 20 and 30 percent.
But officials also are not anticipating a significant rise in new outside appointments, citing a slight decrease in community care usage last year. Initial estimates for the new plan are more than $21 billion over five years.
Those costs have raised significant concerns from critics, especially as fiscal hawks on Capitol Hill have expressed concern about the ever-growing VA budget. Last year, department spending topped $200 billion for the first time.

Officials from the Veterans of Foreign Wars said department officials should have gotten more feedback from advocates about potential problems with the new standards before their release.
“VA is repeating previous mistakes,” said VFW Executive Director Bob Wallace. “Twenty days is just as arbitrary as 30 days, and by simply once again adopting Prime Service Area standards does not serve the best interest of veterans. ”
But officials from Concerned Veterans for America, which has been pushing for the community care overhaul in recent years, praised the new proposed rules as an important step forward for veterans care.
“These standards are simple and straightforward, eliminating much of the confusion created by the Veterans Choice Program and the VA’s other community care programs,” Executive Director Dan Caldwell said in a statement.
“While we would prefer the primary care wait time standard be shorter, these access standards are still a significant step forward in giving veterans more control over their health care and making the VA more veteran-centric.”

Lawmakers are expected to hold hearings on the new proposed rules in coming weeks.



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About Leo Shane III Leo covers Congress, Veterans Affairs and the White House for Military Times. He has covered Washington, D.C. since 2004, focusing on military personnel and veterans policies.

VA’s benefits appeals process will see a dramatic changeover next month

   Jan 22, 2019     FOLLOW US Veterans and Retirement Report   VA’s benefits appeals process will see a dramatic changeover next month  A new process for all appeals of veterans’ benefits cases will go into effect on Feb. 19.  Read Story   Advertisement  Civilian Life 101: Here’s what Continue reading VA’s benefits appeals process will see a dramatic changeover next month

VA Renews Opposition to Agent Orange Benefits for Blue Water Navy Vets

A Vietnam veteran listens as Agent Orange expert and military historian Paul Sutton addresses the group during a town hall meeting held at the New Jersey State council, Vietnam Veterans of America, at VFW Post 809 in Little Ferry, N.J., on Sept. 27, 2015. (Jim Anness/Northjersey.com via AP)

A Vietnam veteran listens as Agent Orange expert and military historian Paul Sutton addresses the group during a town hall meeting held at the New Jersey State council, Vietnam Veterans of America, at VFW Post 809 in Little Ferry, N.J., on Sept. 27, 2015. (Jim Anness/Northjersey.com via AP)
18 Jan 2019
Military.com | By Richard Sisk
The Department of Veterans Affairs shows no signs of backing off opposition to extending Agent Orange health care and benefits to “Blue Water Navy” Vietnam veterans, setting up another major battle this year with veterans groups and overwhelming majorities in the House and Senate.
The VA still lacks “sufficient evidence” to prove a presumptive link between service off the coast of Vietnam and the illnesses caused by the widespread use of the defoliant Agent Orange, Paul Lawrence, the VA’s under secretary and head of the Veterans Benefits Administration, said Thursday.


“In terms of presumptives, they come with a real requirement of sufficient evidence to indicate it’s warranted,” he said in a panel discussion on a VA Town Hall webcast.
Veterans who served on the ground or on the inland waterways of Vietnam are now eligible for Agent Orange health care and benefits. But existing studies do not show definitive causation between the illnesses suffered by the estimated 90,000 Blue Water Navy veterans and the use of Agent Orange, Lawrence said.
“We understand the situation,” he said. “We talked about having more studies in 2019 that would give us more insight into what the causation was and the definitive conclusions behind it.”
He gave no indication of when the studies might be completed.
Blue Water veterans can file a claim, which will be evaluated on a case-by-case basis, Lawrence said, but they “must be supported by science.”
He took a similar position on claims by veterans that they suffered illnesses from the toxic fumes of the burn pits used in Iraq and Afghanistan, saying those claims also must be supported by scientific evidence.
On Monday, the U.S. Supreme Court rejected an appeal by veterans for damages against companies that managed the open-air burn pits.
Last August, Lawrence and VA Secretary Robert Wilkie stunned Congress by announcing their opposition to a bill extending Agent Orange benefits to Blue Water sailors that had overwhelming bipartisan support in the House and Senate.
The bill had passed 382-0 in the House and appeared headed to easy passage in the Senate with the support of Sen. Johnny Isakson, R-Georgia, chairman of the Senate Veterans Affairs Committee.
However, Lawrence, at a Senate Veterans Affairs Committee hearing, said, “It’s difficult to hear from veterans who are ill,” but “there is no conclusive science” from a report by the Institute of Medicine to show a service connection.
Major veterans service organizations (VSOs) disputed Lawrence on the evidence, but the bill failed in December when Sen. Mike Enzi, R-Wyoming, citing the costs, blocked a Senate vote.
The Congressional Budget Office had estimated that about 90,000 sailors could be covered by the bill, which would likely cost about $1.1 billion over 10 years.
Last week, House Democrats reintroduced the “Blue Water Navy” bill, setting up another lengthy battle with the VA on extending Agent Orange benefits.
In a statement, Rep. Mark Takano, D-California, the new chairman of the House Veterans Affairs Committee, said, “We must get to work and finally secure the benefits our Blue Water Navy veterans earned over 40 years ago.”
On Thursday, three VSOs — the Paralyzed Veterans of America, Disabled American Veterans and the Veterans of Foreign Wars — said that passage of the Blue Water Navy bill would be at the top of their legislative agenda for 2019.
“One of our key legislative concerns is ensuring that veterans who were exposed to dangerous toxic chemicals and other environment hazards during their service receive full compensation and other earned benefits,” DAV National Commander Dennis Nixon said in a statement.
— Richard Sisk can be reached at Richard.Sisk@Military.com.

VA Official: No ‘Secret Plan’ to Privatize Health Care Under Mission Act

Dr. Richard Stone, then VA's principal deputy under secretary of health, speaks at a planning summit in March 2016. (Kate Viggiano/Veterans Affairs)



Dr. Richard Stone, then VA’s principal deputy under secretary of health, speaks at a planning summit in March 2016. (Kate Viggiano/Veterans Affairs)
18 Jan 2019
Military.com | By Richard Sisk
The head of the Veterans Health Administration said Thursday that there is no “secret plan” to privatize Department of Veterans Affairs health care under the Mission Act, which expands community-care options and has repeatedly been championed by President Donald Trump.
“There is no such plan,” said Dr. Richard Stone, executive in charge of the VHA and its system of more than 170 medical centers and 1,000 clinics nationwide.


Talk of privatization “creates fear and trepidation among our 341,000 brothers and sisters that call themselves employees of the VHA,” he said. “Let me assure you that if you’re an employee of the VA, there’s no plan to privatize. Your job is safe; stay with us.”
The question of privatization loomed over the Mission Act before and after it was passed last year with the intent of consolidating and streamlining the problem-plagued Choice program.
In signing the Mission Act into law last June, Trump said, “All during the campaign, I’d go out and say, ‘Why can’t they just go see a doctor instead of standing in line for weeks and weeks and weeks?’ Now they can go see a doctor. It’s going to be great.”
Despite continuing problems with access, Stone, a former deputy surgeon general of the Army and recipient of the Combat Action Badge, said that veterans themselves have shown that they prefer the VA to private, or community care.
“We can offer access to health care at unprecedented rates” at the VHA, the nation’s largest health care system, he said.
In calendar year 2018, “we did more than 58 million appointments with veterans. That’s 3.7 million more than four years ago,” Stone said. In addition, the VHA has cut wait times for urgent appointments from 19 days in 2014 to two days last year.
“And we continue to get better,” he said.
Stone made the comments at one of the VA’s periodic webcast Town Halls on issues facing the department.
VA Secretary Robert Wilkie opened the webcast, pointing to recent studies by the Partnership for Public Service and Dartmouth showing that the VA is “one of the best places to work” in government, and also stating that the VHA provides health care that is as good or better than the private sector.
Wilkie listed his priorities going forward as curbing veteran suicides, implementing the Mission Act, and putting in place new electronic health records to make VA and Defense Department systems interoperable.
He said the VA had recently awarded contracts that could be worth $55 billion through 2026 for implementing the Mission Act for VA Regions 1, 2 and 3, covering 36 states, plus Washington, D.C.; Puerto Rico; and the U.S. Virgin Islands.
The contracts went to Optum Public Sector Solutions Inc., the government-services branch of Optum, the health services arm of UnitedHealth Group. Another regional contract is expected to be awarded in April and two more in December, Wilkie said.
— Richard Sisk can be reached at Richard.Sisk@Military.com.
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