VA Pilot Demonstration Update and ACTION CONOPS
What Can Clinics Do to Work with the VA and potentially be reimbursed for TBI/PTSD treatments?
Concept of Operations for
Delivery of HBOT-for-PTSD/TBI and
Update on VA’s HBOT Pilot Demonstration Program
CONTENTS
I. Concept of Operations for ACTION Urging Congress and the VA to expand use of HBOT for TBI/PTSD
- Your Senators and Congressional legislators are your best route to success in becoming part of the growing effort to employ HBOT, with reimbursement, to combat TBI/PTSD/PSC. The “model” is North Dakota where the delegation continues to work tirelessly to expand the program. There is simply no substitute for the effort you have to put in to educate local, state and especially federal legislators about HBOT. These elected officials can pressure the VA leadership to add your site.
- Strengthen your relationships with your local VA. It is highly likely that any expansion of the VA Pilot Demonstration Program will involve clinics that are integrated into working with their local VA. What does that mean? If you are not already on the VA approved vendor list, consider beginning the process to get added to their list.
- Become a Preferred Provider. Call your local VA and let them know you are an HBOT provider and that you would like to work with them to provide on-label and off-label services to veterans.
- Contact VA doctors who are authorized to diagnose and prescribe for use of HBOT for veterans. Invite them to the clinic. Do what you must to ensure that you and your clinic are known quantities.
- Contact the Center for Compassionate Innovation (CCI) [202-461-6969, and below] and speak with the staff conducting the Pilot to learn more about the Program. Become a known quantity to them.
- NOTE: The new legislation does not allocate any dollars to treatment. HBOT is still an off-label Indication that is uninsured. However, the VA will pay for treatment to providers who have contracts for services under the “meaningful use” contract between the VA and you the provider.
Congressional Actions:
- Passage of S.785, the Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019, moves us to the next level of action required of Congress, the VA, the DoD, and the White House.
- Members must be contacted, educated and “encouraged” to demand that DoD, the VA and military medicine in general inform all brain-wounded service members about HBOT, and the availability and locations of treatment centers.
- Congress must ensure the President’s orders are followed, that insured coverage must be made available for HBOT treatment for all service members.
- POCs on Capitol Hill to contact, in addition to your US Senators and Legislators, include:
- Congress can further demand that states be reimbursed for their own Hyperbaric Oxygen Treatments provided to TBI/PTSD veterans in the private or state sector under the Veterans Bureau Act of 1921.
White House Actions:
- $10Million moved immediately to treat 1,000 veterans in clinics outside the VA. That plan, using a current Pilot Demonstration Program in the VA’s Compassionate Care Coalition, is spelled out in more detail below.
- Immediate use of DoD Hyperbaric facilities on Army, Navy, USAF and Marine properties, to treat active duty service members, augmented by private civilian clinics listed at: https://treatnow.org/treatments/treatment-centers/ . There are over 1,150 hospitals across the country with one of more HBOT chambers with only 50% utilization rate that are available to treat today. We can provide a list of those hospitals by state.
- Immediate expansion of the VA Pilot Demonstration Project to fund treatments with HBOT in TreatNOW Coalition clinics and through local and regional hospitals.
- Orders to use Tricare funding to provide insured coverage outside DoD and the VA for HBOT for TBI/PTSD/PCS, where hyperbaric medicine is not practiced for brain wounds within the VA or DoD.
- Clarification of all signed Executive Orders mandating that the multiple epidemics afflicting the military – suicide, mental health, brain wounding – demand that military medicine is obligated under the doctrine of Informed Consent to inform service members about treatments that are safe, effective and available in the private sector.
- Insistence that the recent Executive Order, the Task force/National Roadmap to Empower Veterans and End Suicide, include proponents for Functional Medicine and alternative, non-drug interventions to arrest the suicide epidemic.
- Mandate that the FDA, CMS, CDC, VA and DoD fast-track approval of HBOT for insured coverage under rules that apply in times of epidemics. Justification is the existing nineteen HBOT clinical trials data collected since 2007.
- As with diabetic foot wounds, CMS/Medicare can approve HBOT for TBI under the Medicare Coverage with Evidence Program.
VA Actions:
- Contact the VA’s Center for Compassionate Innovation and insist that the VA expand and accelerate their Pilot Demonstration Project to fund TBI/PTSD/PCS patients using HBOT, with funds under Tricare and a portion of the drug budget. communityengagement@va.gov. The current 5/6 sites should be expanded to dozens more clinics or hospitals that are already safely and effectively treating and healing TBI/PTSD/PCS using donated funds. The Pilot has shown near-total success with nearly 30 patients, using CCI standards.
- Insist that the VA inform all brain-wounded veterans that HBOT treatment is available that is safe, effective and nearly always leads to elimination of suicidal ideation, depression, and use of drugs.
- The VA Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act of 2018, signed into law by the President on June 6, 2018, appropriated $5.2 billion in mandatory funding for the Veterans Choice Program to continue to provide care to Veterans until the new, consolidated Veterans Community Care Program is operational. MISSION Act funds should be utilized to provide HBOT for TBI care, since the VA does not offer HBOT care for brain wounds. There is an extensive network of over 1,150 hospitals across the country with HBOT chambers, trained and qualified medical staff, technicians, and doctors available to treat today.
- Educate the VA’s primary doctor in charge of brain wounds, Dr. Richard A. Stone about HBOT’s mechanisms of action that heal brain wounds. See: https://www.youtube.com/watch?v=AirL26SUq10&feature=youtu.be.
- We must light a fire under the VA’s Center for Compassionate Care Innovation (CCI) and their Demonstration Pilot. Contact CCI within the VA and demand expedited and expanded use of HBOT within the VA. [https://www.va.gov/opa/ pressrel/pressrelease.cfm?id=3978]. The Oklahoma State Center, allied with Muskogee VA, has treated a dozen patients, all successfully. The Travis AFB facility near to the Sacramento VA has treated no patients. San Antonio TX has successfully treated a handful and Tampa FL has treated none. The Fargo ND clinic has successfully treated over 14 and more are in the pipeline. CCI intended to evaluate processes for 200 patients. We have to increase their sense of urgency, along with their outreach and the acceptance of TBI patients. Contact CCI for information about the Demonstration Project at: communityengagement@va.gov CCI Project Leads include Tracy Weistreich (541) 499-5945 Tracy.Weistreich@va.gov and Jamie D. Davis Jamie.Davis5@va.gov .
- Ensure that every Marine with TBI/PTSD/PCS knows to ask for HBOT for TBI/PTSD/PCS. Starting with Marines in the Wounded Warrior Battalion, provide every veteran with information about where HBOT clinics are and offer help in getting insured Tricare, or equivalent, coverage for treatments.
- Help every veteran understand that help is available immediately, irrespective of VA actions. Private sector clinics need to be put in contact with VSOs that will help fund HBOT treatments. See America’s Mighty Warriors and www.treatnow.org and other organizations that are currently helping to heal brain wounds with HBOT and alternative therapies.
- The VA should start immediately contracting with 1150+ across the country local hospitals for access to their HBOT chambers for internal use of HBOT for diabetic foot wounds (DFW), thus avoiding amputations. At a minimum, all DFW patients should be informed that HBOT is FDA-approved for their wounds since 2002 and that HBOT clinics and hospital Wound Care Centers across the country are available to treat those wounds. From 1989 through 2020, it is estimated 199,000 veterans have experienced Lower Limb Amputations (LLA’s), or on average of 6032 LLA’s per year at an estimated surgical total cost of $12.5B. 70.9% of these veterans die within three years. FDA approved HBOT for DFW could potentially lower this cost in half or more while saving as many lives yearly.
- A growing number of medical doctors are diagnosing and prescribing HBOT for their brain wounded: Wounded Warrior Battalion/East, Ft Bragg, Joint Base Sam Houston, Force Recon Marines. Chambers are available on bases across the services that can be employed today to treat brain wounded SpecOps. The private sector cannot and should not be expected to do DoD’s job for free.
- In addition to Suicide Prevention, mental health and TBI/PTSD, drug and substance abuse emergencies, SpecOps has front-line problems that HBOT can address, like High Altitude Mortality Reduction in Combat Casualty Care. Too many casualties die at altitude due to oxygen starvation.
DoD Actions:
- On October 1, 2018 the DEPSECDEF instituted the WARFIGHTER BRAIN HEALTH AND COUNTERING TRAUMATIC BRAIN INJURY Task Force. Dr. Terry Rauch, Acting Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight, was put in charge. DoD needs to be reminded that they can rapidly bring HBOT to bear on the TBI/Suicide/Drug Overdose problem, starting with using their own chambers to treat brain wounds. In parallel, they can insist that the Tricare, Choice/MISSION act insurance covers HBOT-for-TBI, and that all service members with brain wounds are told that a safe, effective and drug-free alternative is available to provide them what the DEPSECDEF articulated: “Our objective always must be to return the warfighter to full health and maximize each member’s quality of life in our military and civilian communities – no matter how long it takes.” Dr. Rauch can be reached at (703) 681-8472 or terry.m.rauch.civ@.mail.mil.
- The Deputy Secretary of Defense Memorandum dated October 1, 2018 on a Comprehensive Strategy and Action Plan for Warfighter Brain Health stipulates on Page 3, “We must standardize our diagnostic and treatment protocols across the spectrum of medical and non-medical care options, to optimize the use of existing therapies, while rapidly translating emerging science into our methods and practice: improving access to care and clinical trial participation for warfighters who have sustained a TBI; and leveraging advanced diagnostic tools, promising breakthrough therapies, and long-term monitoring to fast-forward our ability to identify, care for, and treat those affected”. Simply put, engage with the medical industry and bring about that treatment that has a proven track record of healing TBI.
VSO Actions:
- Ensure all active duty, retired and veteran service members know about HBOT and know that they have a right via “informed consent” to be told about treatments and therapies like HBOT. To the extent possible, that should include VSA providing objective data documenting brain injury.
- Ensure Command is told about on-going pro-bono efforts with HBOT that work to heal brain wounds and restore patients to combat status in most cases.
- Brief Services Commanders and DoD on actions currently underway that continue to demonstrate the safety and efficacy of HBOT to treat and help heal brain wounds.
- Demand that service medical personnel know about worldwide science about HBOT that shows safety, efficacy and cost-effectiveness of using HBOT and alternative therapies.
- Brief all organization personnel on the need to find, inform, and assist brain-wounded service members to get hyperbaric oxygen therapy help ASAP.
- Collaborate with other VSOs to identify, inform, assist and ensure treatment for brain wounds using HBOT before it is too late.
State Legislative Actions:
II. Update on VA’s HBOT Pilot Demonstration Program
- OSU/Tulsa Wound Care Center at Oklahoma State University Medical Center: Twelve patients have completed 40 treatments each, for a total of 480 hours of treatments. They have evaluated and started treatment on 16 patients referred by the VA. Three stopped treatments for various personal reasons. One chose not to pursue treatment following the initial evaluation. One other has never showed up for the scheduled treatments following the initial evaluation. There are five patients that have been recently referred by the VA that are being scheduled for the initial evaluation. The VA has not found any problems with the referral process, and the OSU Wound Care Center and Hyperbaric Unit has been reimbursed for all the HBO treatments provided. The major difficulty, according to the VA is that patients worry about the length of treatment, two months. [Tulsa does not dive twice a day; other clinics will and do.]
- Travis AFB, CA: VA Northern California Health Care System in cooperation with David Grant Medical Center on Travis Air Force Base: A few phone calls, one referral, no treatments completed, no recent activity.
- San Antonio, the South Texas Veterans Health System, in cooperation with Nix Health and San Antonio Military Medical Center, Fort Sam Houston: Four treated successfully, others being assessed for the program.
- Tampa: James A. Haley Veterans’ Hospital and Undersea Oxygen Clinic and Florida Hospital. No referrals, even after several visits by VA staff.
- Fargo, ND: Fargo VA Health Care System and Healing with Hyperbarics, Fargo ND Fourteen complete, six in treatment, pipeline appears to be filling with referrals.
NET NET: 30 successes out of 30 fully treated, no significant complications. But there is no sustained activity. This despite 2 clinics allegedly active for 2.9 years, 2 more at one year, and the 5th after several months.
- One thing was made clear to us at the beginning: this HBOT Pilot is not meant to be scientific research. Rather it is an opportunity for the VA to observe and learn what it can about how logistics surrounding HBOT treatment, and how HBOT is administered. [The logical extension of that line of reasoning is that the VA is learning in preparation for making HBOT available VA-wide. There is no indication of where the VA intends to go with whatever they learn. Nevertheless, it was good to read that data are meant to be recorded in the VA’s Computerized Patient Record System (CPRS).]
- One clinic told us about reimbursement for the Pilot. Under Local Coverage Determination (LCD), Medicare Code G0277 was approximately $80/unit, with each daily treatment 4 units = $320 per dive. Physician Code 99183 was $125. Invoices would be paid out of a Special Allocated Fund at the completion of 40 dives. Another clinic is receiving quite a bit less for each dive.
- It is TreatNOW’s position that there needs to be a defined tactical path forward, especially when there is a treatment protocol that is producing 80-100% positive results. A medium-term approach could transform the VA Pilot Program into an IRB study whereby the data collected under protocol could be published and shared among scientist and the medical profession in addition to the CMS and FDA.
- The question was raised early about the designation “PTSD-only” patients, and whether patients with TBI could get the help. The Protocol from the VA for the Pilot states: “This clinical demonstration project proposes to provide Veterans, with a history of posttraumatic stress disorder (PTSD), with or without a diagnosis of co-occurring traumatic brain injury (TBI), access to hyperbaric oxygen therapy (HBOT).” Our advice is that every veteran with evidence of brain injuries, irrespective of diagnosis, get in front of their mental health provider ASAP and: request a reevaluation for PTSD and/or TBI; and request HBOT treatment. Chances are the VA Health Provider will not have heard about the Pilot Demonstration Project.
- Another question is whether veterans outside the area of the five Pilot Sites are eligible for inclusion at one of the five sites, and whether the VA will pay for expenses like travel, per diem, etc. Here’s one answer we got from within the VA/CCI:
“As I mentioned on the phone, we strongly encourage Veterans who are experiencing suicidal ideation to call the Veterans Crisis Line (800-273-8255, select 1) and to contact their VA mental health provider for acute care.
“I also mentioned this morning that referrals for the HBOT for PTSD initiative are made by VA providers. Veterans who are not enrolled at one of the five facilities participating in the initiative should contact the VA mental health provider where they are enrolled to request a referral. The process is internal to VA and utilizes the Veteran’s VA electronic health record. You can read more about this internal process in VHA Directive 1232(2) Consult Processes and Procedures.
“I would like to emphasize that, if a Veteran is not enrolled at one of the five VA facilities participating in this project, they should contact their VA mental health provider at the VA where they are enrolled to discuss a referral for treatment that is not available at their facility. Contacting the Fargo VA directly when the Veteran is enrolled at a VA facility in Iowa is not the appropriate process. Call the VA mental health provider at the VA where you are enrolled.
“Placing a referral and approval of referrals is determined on an individual basis and depends on a number of factors. These factors are discussed between a Veteran and their VA provider when the Veteran expresses interest in or is recommended by the VA provider to try any treatment modality, including HBOT. Our office is not involved in the referral process or decisions on Veteran’s healthcare or benefits. VA facilities participating in the HBOT for PTSD initiative have established their own protocols for carrying out this initiative.
“Veterans can speak to the VA staff where they are enrolled for more information on their eligibility and benefits. Veterans may seek out care at non-VA facilities at their discretion, however, they may not be reimbursed for expenses they pay out-of-pocket outside of the VA network.
“For additional questions regarding the work we do in the Office of Community Engagement, you are very welcome to visit our website (https://www.va.gov/HEALTHPARTNERSHIPS/) or send an email to CommunityEngagement@va.gov.”
- Another guidance email from within the VA states: “VA cannot refuse treatment for any eligible Veteran. The issue becomes the receiving facility’s willingness to provide this treatment for a Veteran not currently under their care. Eligibility for travel reimbursement for eligible Veterans also plays into the equation. If travel reimbursement eligible, the Veteran will receive this benefit, too.
We leave these decisions up to the referring provider to coordinate with the provider who considers the request, as VA policy dictates. My suggestion is to have the VA … provider reach out to [one of the 5 sites]
If the … provider is willing to make the referral and [one of the 5 sites] is also in agreement and willing to accept the referral, the patient meets all requirements for the demonstration, and the patient agrees to the referral, then it’s possible for a Veteran to be seen at a different facility than that from which s/he currently receives care.
As for the payment of transportation to the referral site, that’s beyond my understanding. I would imagine that would be something that [the 5 sites] should be able to address…. I believe the referral site is generally responsible for travel (although I may be way off base). That’s how mental health residential treatment referrals were handled when they were out of state and I was an active VA clinician.
- To Summarize: Experience to this point tells us several things about the “PTSD-only” Pilot:
- The VA is not marketing HBOT inside the VA, not even at the 5 sites
- In at least one site, we know the VA has not told their PTSD patients about HBOT or the Program. “Informed consent” does not seem to be of any consideration to staff.
- The VA is already alerted to the request we made that veterans outside the 5 site areas [see list below] be allowed to request treatment in one of the 5 sites.
- Independent of the Pilot Program, Clinics that would like to become providers to the VA must become known to their local VA. In some cases, that means getting on a “preferred provider” list. In most cases that means being willing to accept on-label patients and work within the rules laid down by the VA. Suggest you get in touch with your local VA for specifics. And get to know the doctors in the VA who do the diagnoses and referrals. Educate them.
- In the short term, we would appreciate all clinics getting information to your networks about the Pilot and the need for veterans to contact their VA Mental Health Provider with the information provided in this email.
- Legislators at the federal and state levels need to be aware that 100+ private HBOT clinics exist throughout the US. They can and should all be used to deal with the tens of thousands of suffering brain wounded, whether on active duty or veteran/Reserve/National Guard. One of the major complaints about the VA making HBOT available at only 5 clinics is that it is extremely difficult for patients to take up to two months off work to attend treatment.
- Another complaint heard over and over is that veterans worry about losing their disability rating when they get better.
- Bottom line is that there is no VA advocate from within the VA system, either in HQ or at the individual facilities, committed to ensuring all brain wounded veterans are aware of the program, much less advocating for and spurring the patients to seek HBOT treatment. Veterans are simply not being encouraged and assisted to get HBOT.
- With the passage of S.785, the VA will be pressured to increase the number of clinics, and research will commence on the use of HBOT for TBI. You can be part of that plan. Call you national Senators and Congresspeople. Have their staffs come visit to learn more; they are the gate-keepers who can encourage their members to visit and become advocates. They can “encourage” the VA to make your clinic part of the Pilot. Think “squeaking wheel.”
Email to: communityengagement@va.gov