The Veteran Diabetic Foot Ulcer (DFU) Epidemic

Why are Excessive VHA Amputations Being Conducted When Lower Cost Civilian Limb Preservation Programs Utilizing Hyperbaric Oxygen Therapy are so Clinically Successful Saving Limbs and Lives?

‍

‍

 SAVE FEET, SAVE LIMBS, SAVE LIVES       

CARE FOR HIM WHO SHALL HAVE BORNE THE BATTLE

Abraham Lincoln

Article by: By Eric Koleda

The increase in the Worldwide Diabetic Patient population at risk for Lower Limb Amputation (LLA) is growing exponentially. The Diabetic Foot Ulcer (DFU) epidemic increase in US Veteran Diabetes population is due to poor clinical management is at epidemic proportions. Cutting off appendages occurs more often with Veterans than in the civilian Medicare population. The alarming Veteran LLA could be largely mitigated by aggressive vascular intervention, comprehensive wound care plus Hyperbaric Oxygen Therapy (HBOT) but is not.

‍

The Under Secretary of Health for the VHA provided a raw data report in July 2022 to the US Congress. The data from the VHA report is the basis for this article. The full 50-page report was generated based on the VHA data to US Congress and can be located on TreatNOW.org. The estimated 2.2 million VHA diabetic Veterans have a legal, ethical, and moral right to be provided timely information and access to HBOT treatments for their DFUs. Tragically, they are not.

The data from the VHA tells a shocking story about the current DFU epidemic. “More than 796,340 VHA Veterans have died Prematurely from DFU LLAs in 22-years, more than all Veterans Killed in Action (623,982) since the beginning of WW I. The VHA DFU LLA mortality rate is 64-71 percent within 3-years post-LLA surgery as compared to a 74 percent DFU heal rate with timely and aggressive HBOT treatments outside the VHA. The 22-year average annual VHA DFU LLA’s is 36,197 of which 24,433 DFU Veterans die on average post 3-year LLA. The 20-year average annual DFU Veterans NOT receiving HBOT is 93.7 percent which is stunning considering HBOT has been approved by the Center for Medicare and Medicaid Services since 2002, Tricare since 2008 and FDA since 2010. 

‍

Several of the TreatNOW.org national network of clinical based Wound Care and Hyperbaric Oxygen Therapy Services participate in the VA Community Care Provider Network. These civilian Advanced Wound Care and Hyperbaric Medicine Programs have only seen a few family or self-referred Diabetic Veteran’s requesting advanced care in one of the clinic-based Diabetic Limb Salvage Programs.  According to the VHA data from 2002 to 2022, only 548 DFU Veterans on average per year receive HBOT which is 1.5 DFU Veterans per day across the entire U.S. This civilian hospital and or clinic services provide aggressive evaluation, vascular surgical intervention, wound care, and Hyperbaric Oxygen Therapy not available within the VA system. The superior civilian systems provide improved outcome statistics as compared to the VA LLA statistics using CMS Medicare, FDA, Tricare, and VA guidelines.

The VA has not made itself available to meet with local NY VA Community Care Provider representatives to offer DFU Veteran referrals. The VA total Lifetime cost of Diabetic Veteran care, LLA amputations, prosthesis, morbidity, and mortality rates are appalling as compared to the civilian diabetic community. It is estimated the VHA has expended approximately $12.5 billion over the past two decades on Veteran DFU Lower Limb Amputations (LLA). The civilian sector, hospital and clinical track record can offer the VA diabetic Veteran at risk of lower limb amputation superior clinical outcomes, the duration and quality of life, plus a significant reduction in lifetime care costs to the American Taxpayer.

‍

The VHA does not operate or offer HBOT chambers in their 171-national hospital network as shared by Dr. Steven Lieberman, VHA Under Secretary of Health. This requires the VHA to refer patients to outside services. VHA Medical doctors are medically and legally obligated to provide  the doctrine of “Informed Consent” meaning, doctors must inform DFU Veterans HBOT is an approved treatment option for diagnosed Wagner Grade III DFUs and it is a treatment option for you to choose. The doctrine of “Informed Consent” seeks to ensure that doctors: tell patients of their diagnosis; and that those patients understand the nature and purpose of recommended interventions; and, most importantly, that patients are made aware of the burdens, risks, and expected benefits of all options under the Code of Medical Ethics Opinion 2.1.1. Are the VHA medical doctors and administrators informing DFU Veterans they are entitled to receive HBOT treatments outside the VHA and being referred to outside HBOT services on a timely basis? Based on the interviews and the VHA data indicating over 93% of DFU Veterans are not receiving HBOT treatments, it appears they are not informed. 

‍

The lack of informed consent of approved FDA, CMS and Tricare HBOT has put Veterans limbs and life at risk. 

‍

There are over 1,156 hospitals across the U.S. with CMS certified trained staff and hyperbaric oxygen therapy chambers providing advanced DFU care. There are over 200 private clinics offering HBOT. HBOT heals DFU’s if treated timely with aggressive wound care, a limb and LIFE saving treatment. The VHA cannot legally or medically deny Veterans access to HBOT as it is a CMS, FDA and Tricare approved and insurance covered treatment option. Timely access and referral for treatments is essential and Veterans should mandate timely medical referral if denied.” Caregivers should demand timely information, referrals, and treatment within the private medical sector. 

‍

Eric Koleda, a USAF Veteran and National Director for TreatNOW interviewed several DFU Veterans including Hershel Bowling from Indiana. Mr. Koleda asked Hershel and his wife Cindy, “Did the VHA ever mention Hyperbaric Oxygen Therapy treatment was available for your DFU?” They both responded, “What is that?” When Koleda spoke with DFU Vietnam Veteran Jim Divone from NY, he said he received HBOT for his DFU after seeing a Podiatrist outside the VHA and having the treatment paid for by his health insurance outside the VHA network. “The Northport VA never mentioned to me HBOT was an approved treatment modality, it was not offered to me as a treatment option, nor was I made aware it was readily available through the VA Community Care Provider network.” Experience indicates that the estimated 2.2 million diabetic Veterans face a similar neglect. 

‍

Current laws mandate the VHA refer Veterans to Civilian services they cannot offer. The VA Mission Act of 2018 states “The Secretary shall subject to the availability of appropriations, furnish hospital care, medical services and extended care services to a covered Veteran if the Department does not offer the care or services the Veteran requires.” The VA does not offer HBOT chambers in any of their 171 hospitals across the country. Further, it states, “the decision to receive hospital care, medical services, or extended care services under such sub-paragraphs from a health care provider specified in subsection (c) shall be the election of the Veteran.”  Under the Veterans Access, Choice and Accountability Act of 2014, it states, “Requires the Secretary of Veterans Affairs to provide those non-VA medical facilities with information as to whether or not a veteran is covered under a health care plan not administered by the VA.” “Makes such health care plans primarily responsible for paying for the hospital care and medical services provided to veterans for non-service-connected disabilities if such plans cover such care and services.” The average age of DFU LLA Veterans was 66.2 years old making many Veterans covered under the Center for Medicare and Medicaid for HBOT treatments.

‍

The VHA DFU LLA data reflects a substantially higher lifetime costs, morbidity, mortality and a tragic reduction in Veteran length and quality of life. This is below the Medicare civilian population statistical comparators as reflected in the full DFU report. 

‍

A full 74 percent of the high amputation-risk civilian population did not experience lower leg amputation due largely to the timely and aggressive use of HBOT and Wound Care in their Amputation Prevention Clinical Care Plan. Among persons with diabetes, 66.7 percent of lower extremity amputations hospitalizations were paid by Medicare and additional 8.1 percent were paid by Medicaid. Combined, this represents approximately 75 percent of the cost. This is putting a large financial burden on the U.S. taxpayers and the public health system in 2023. Not only are LLAs costly, approximately 74% could be avoided if timely wound care and HBOT treatments were provided.

‍

A single mono-place hyperbaric oxygen chamber is shown in Figure 1. Full 360-degrees vision is maintained, as well as two-way communication with the operator. The chamber is normally pressurized with 100% oxygen. HBOT positively affects the tissue healing process anywhere in the body. The patient breaths 100% oxygen as the body is exposed to increased atmospheric pressure. More oxygen molecules penetrate blood plasma, as much as 10-15 times greater than normal. This super-saturation of oxygen in the body’s tissues promotes new capillary blood vessel growth in the feet and legs as well as other tissues damaged by diabetes, radiation, trauma, or infection begin to heal at an accelerated rate. There are FDA, Tricare, and CMS approved indications which the VA should recognize which are available to Veterans. You may visit FDA.gov, CMS.gov or Tricare.mil for details of coverages.

‍

Approximately 74 percent of DFU patients receiving HBOT for their DFU’s are healed and avoid amputation. With an estimated 75,000 Veteran DFUs diagnosed in the VHA in 2019, the need for Veteran access and referral to HBOT treatment is immediate with an estimated 36,000 Lower Limb Amputations annually. Veterans with a diagnosed Wagner Grade III or higher DFU, who have shown no improvement after 30 days or more of standard treatment, are eligible for HBOT treatments within the VHA medical system through CMS, the Community Care Act and The VA Mission Act of 2018. Diabetic Veterans comprise approximately 49.5% of all amputations in the US (36,000/73,000)  while comprising only 9% of the total US population.

‍

African Americans are 4 times more likely to experience diabetes-related amputation than whites.  Approximately 85% of amputations are the result of a diabetic foot ulcer.  Every year in the United States, about 73,000 amputations of the lower limb not related to trauma are performed on people with diabetes. 

‍

‍

During the 2-year study period, 124,487 Medicare beneficiaries comprised of 71, 286 men [57.3%] and 13,100 rural residents [10.5%] were hospitalized with diabetic foot ulcers (Table 1). A total of 21, 649 individuals (17.4%) identified as Black, 10,158 (8.2%) identified as Hispanic.  An additional 4,155 (3.3%) identified as another race or ethnicity (American Indian, or Alaska Native, Asian or Pacific Islander or unknown race or ethnicity. A total of 28.9% of patients or 35,962 were identified as minorities. The VA healthcare system is the largest integrated healthcare system in the United States, with over 9 million Veterans enrolled. According to the 2022 US census, the majority of Veteran minorities comprised of Hispanic or Latino (16.9%) and African American (11.8%). This equates to 28.7 percent. With an estimated 2.2 million diabetic Veterans, minorities equate to approximately 631,000 at risk of LLAs and post three-year death from complications associated with amputation. 

‍

The research has identified a correlation between the U.S. enslaved population map of 1860, the average annual U.S. Lower Limb Amputations (LLA), the CDC Identified Diabetes Belt map, and the CDC Stroke Death Rate map that overlay one another as shown in Figure 2. Black patients are losing limbs at triple the rate of others. The rate of leg and foot amputations among US adults aged 40 and older with diagnosed diabetes declined by 65 percent between 1996 and 2008. Nontraumatic lower-extremity amputation among adults with diabetes rates declined 43.8 percent between 2000 and 2013.However, the rates for black Americans and Veterans does not appear to have followed this trend. The VHA LLA rates did not decline during the same 1996 to 2013 period, the numbers increased significantly. The TreatNOW DFU report submitted to Congress indicates from 2002 there were 3,951 diabetes amputations per year versus 2021 with 5,846 diabetes amputations per year. This represents a 49% increase in Veteran amputations.

‍

The VA’s Health Services Research & Development (HSR&D) has spent about $12 million to fund research studies related to identifying and reducing disparities in health outcomes between minority and other Veterans since 2014. Using VA data from 2009 and 2014, the study found lower rates of control of hypertension and diabetes among Veterans who were African American, Hispanic, American Indian/Alaska Native, Native Hawaiian and Pacific Islanders compared with White Veterans. A cross-sectional study including 1,162,148 US Veterans found that wait time disparities increased significantly from the pre-COVID-19 period to the COVID-19 period for Black and Hispanic Veterans.  Black Veterans who ask the Department of Veterans Affairs for physical or mental health benefits are less likely to get them than their white counterparts, according to new data compiled by the VA.  The Military Times reported in 2021 “The Department of Veterans Affairs was being sued by two Veterans’ groups for failing to provide data on racial disparities in disability compensation benefits and healthcare services.” According to a statement from the Black Veterans Project plaintiffs Richard Brookshire, who co-founded the Black Veterans Project, seeks to compel transparency and accountability of the VA. On November 30 2022, a law suit filed on behalf of Conley Monk Jr., a 74-year-old former United States Marine Corps member, alleges that the VA’s disability compensation claim determinations systematically discriminated against Black veterans like him from 2001 to 2020, citing VA records from that period.

‍

* The Spread of US Slavery 1790-1860 map, https://lincolnmullen.com/blog/mapping-the-spread-of-american-slavery/

** Average annual Amputation map 2009, https://www.ncbi.nlm.nih.gov/books/NBK567977/figure/ch20.fig16/

***CDC.gov Identified Diabetes Map, https://diabetesed.net/wp-content/uploads/2022/07/Diabetes-Belt-CDC.pdf

****Stroke Death Rate Map, CDC.gov, https://www.cdc.gov/dhdsp/maps/national_maps/stroke_all.htm

‍

On January 20, 2023, a formal complaint was filed by TreatNOW.org with the VA Office Inspector General which stated, “VA is systematically across the entire country denying Diabetic Foot Ulcer Veterans routine access to FDA, CMS, and Tricare approved Hyperbaric Oxygen Therapy (HBOT), resulting in Lower Limb Amputations (LLA) and death for 71% of Veterans 3-years post-surgery. Aggressive clinical and surgical interventions, wound care plus HBOT has helped the civilian CMS has helped resolve 74% of DFUs without LLA's and saves lives. Veterans are not informed of HBOT treatments under the Code of Medical Ethics 2.1.1 or provided routine access under The Mission Act of 2018 for services.” The submittal alleges violations of The VA Mission Act of 2018, the Code of Medical Ethics Opinion 2.1.1 and the Veterans Access, Choice, and Accountability Act of 2014. The VA OIG, responding to a Whistleblower request on February 17, 2023, stated: “The OIG has reviewed your submission and determined the problem can best be addressed by management officials or a program office directly responsible for the issue you describe. To ensure your concerns are addressed please contact the VA Hotline.” The letter was signed “Erin/RP#79, VA OIG Hotline.” US Senate and House Whistleblower reports were electronically filed on February 22, 2023, with the Senate, and March 17, 2023, with the House regarding the same issue. As of this date no responses have been received.

‍

HBOT is an on-label, FDA-approved indication, an industry standard protocol, used worldwide and accepted as effective, insured, and safe for improved healing in DFUs and thus reducing LLAs. Is the current VHA HBOT referral rate of only 6 percent for diabetic Veterans the root cause of the higher amputation rates for the approximate 2.2 million diabetics in the VA system? Are the 2.2 million diabetic Veterans at risk because they are not being informed about approved HBOT treatments? The cost of referring and treating diabetic DFU Veterans with HBOT is a fraction of the overall cost of amputations, hospitalization, aftercare, prescription medications, wheelchair, and prosthetic devices. Saving feet, limbs and lives should not be a debate when the treatment which heals 74 percent of DFUs avoiding LLAs has been approved since 2002. Our Veterans deserve the best care our country can provide, and it appears our Veterans with DFU’s may not be receiving it. 

‍

If you are a diabetic Veteran within the VHA diagnosed with a DFU, you have a legal, medical, and ethical right to timely access of Hyperbaric Oxygen Therapy. The TreatNow.org organization can help DFU Veterans. If you are a diabetic Veteran with a DFU or have had Lower Limb Amputation, we would like to hear from you. You may contact us at TreatNOW.org information line at 571-549-4268.

‍

Peer Review: This article was reviewed by Mr. Glenn Butler, Founder and CEO of Life Support Technologies Group in New York, and Dr. Robert L. Beckman, Ph.D., Co-Founder and Executive Director, TreatNOW

‍