What we are asking for
We, the undersigned, respectfully urge the Department of Veterans Affairs to reconsider Clinical Determination and Indication CDI 00059 and restore Veterans' access to Annular Fibrin Injections (AFI) for chronic discogenic back pain, based on these factors: (1) the experimental designation misapplies evidence from a different procedure while meaningful real-world data supports AFI's safety and effectiveness; (2) CDI 00059 violates Veterans' rights to physician-guided care under Federal law; (3) it creates inequitable access based on personal wealth; and (4) it drives Veterans toward irreversible surgery by eliminating a lower-risk alternative.
Background
On December 1, 2025, the VHA Office of Integrated Veteran Care issued CDI 00059, designating annular fibrin injections as "investigational, experimental, and not medically necessary." This determination blocks Veterans from accessing a minimally invasive spinal treatment that has helped thousands of patients — and it rests on a flawed reading of the evidence, conflicts with Federal law, and fails core ethical obligations.
What is Annular Fibrin Injection (AFI)?
AFI uses fibrin sealant — an FDA-approved substance (Baxter TISSEEL, approved since 1998) in routine surgical use for over 25 years, including in VA-covered laminectomies and fusions — to seal tears in the dural sac. It has also been used to seal the outer ring of the spinal disc, the annulus fibrosus, during discectomy procedures.
The AFI procedure involves a guided diagnostic annulogram to identify tears or leaks in the annulus fibrosus, followed by injection of fibrin sealant to seal the disk and alleviate symptoms. It is a targeted, outpatient procedure that preserves disc anatomy and keeps all future surgical options open. It offers Veterans a meaningful alternative after they have exhausted conservative care such as physical therapy and epidural steroid injections.
Why Clinical Determination and Indication 00059 Must Be Reconsidered
The "experimental" label is based on an inappropriate comparison of studies. The primary evidence the VA cites against AFI — Ju et al. (2022) — does not study AFI at all. It is a post-hoc analysis of the terminated BIOSTAT trial, which injected a different fibrin formulation into the intradiscal space, the nucleus pulposus, not the annulus fibrosus that AFI targets. These are anatomically distinct procedures with different mechanisms. Worse, that analysis drew on a single trial site, where the saline control arm contained only three patients — a sample so small that a single outlier could drive the entire result. A determination of the effectiveness of AFI cannot rest on a study of a different procedure with only 3 control subjects. This type of analysis and conclusion is not scientifically or statistically justified.
The actual AFI evidence is meaningful. The Pauza et al. (2024) registry — the first study of intra-annular fibrin at scale — followed 827 patients with an average of 11.2 years of chronic back pain, most of whom had already failed surgery and other treatments. It showed statistically significant improvement (P<0.001) across scientifically validated outcome measures (ODI, VAS back and leg, EuroQol, PROMIS, NASS satisfaction) at every time point through 36 months, with no serious adverse events. Under the 21st Century Cures Act, this type of real-world registry evidence is a recognized basis for medical decision-making — the same standard already accepted for lumbar fusion, disc arthroplasty, and spinal cord stimulators. Applying a stricter standard to AFI alone, without explanation, is an unexplained inconsistency.
CDI 00059 conflicts Federal Law and VA Policy. When a Veteran and their physician agree that annular fibrin injection is the right treatment, federal law was written to protect that decision. The MISSION Act requires the VA to provide community care when:
"the covered veteran and the covered veteran's referring clinician agree that furnishing care and services through a non-Department entity or provider would be in the best medical interest of the covered veteran based upon criteria developed by the Secretary." — 38 U.S.C. § 1703(d)(1)(E), MISSION Act (Caring for Our Veterans Act of 2018)
Congress also built in a clear limit on how far the VA can go in restricting that care:
"The Secretary shall not limit the types of hospital care, medical services, or extended care services covered veterans may receive under this section if it is in the best medical interest of the veteran to receive such hospital care, medical services, or extended care services, as determined by the veteran and the veteran's health care provider." — 38 U.S.C. § 1703(n)(1), MISSION Act (Caring for Our Veterans Act of 2018)
CDI 00059 conflicts with the second provision. By categorically excluding annular fibrin injection regardless of individual circumstance, it imposes exactly the kind of blanket treatment restriction § 1703(n)(1) was written to prevent — one made by administrative policy before any Veteran or physician is ever heard.
It creates two-tiered healthcare. Veterans with personal resources can still access AFI as a cash-pay procedure. Those who depend on VA coverage — often those who have significant service-connected injuries and are economically vulnerable — cannot. A federally funded system, built to serve those who served, should not amplify the access disparities found in the private market.
Denial is clinically and economically counterproductive. Disc degeneration is progressive. Denying AFI during the early intervention window may permanently eliminate AFI as an option as the condition progresses, leaving Veterans with only lumbar fusion — which is irreversible and carries a 22.7% revision rate at 10 years after surgery and progressive, adjacent-disk degeneration in 25–40% of patients within 10 years — This does not include patients who have undergone fusion and have had incomplete or inadequate pain improvement.
Forcing Veterans past a logical, lower-risk step directly to major surgery significantly increases the costs of both lifetime healthcare and disability compensation. Institutional denials that contradict a physician's recommendation are also associated with care disengagement and worsened outcomes in Veterans.
What We Are Asking For
We acknowledge that no adequate randomized controlled trial of AFI (annular fibrin injection) has yet been conducted. We ask for a responsible, evidence-generating path that has the potential to relieve veterans’ pain and greatly improve their quality of life.
Veterans with chronic discogenic back pain — many carrying service-connected injuries — deserve access to a treatment their physicians recommend that is supported by meaningful evidence. A blanket administrative denial that substitutes bureaucratic judgment for clinical judgment dishonors the covenant between this nation, those who served it, and the healthcare professionals sworn to care for them.