Vagus Nerve Society Position Statement: WISeR Model and VNS for Epilepsy
The Centers for Medicare & Medicaid Innovation (CMMI) has announced the 6-year WISeR (Wasteful and Inappropriate Service Reduction) pilot, which applies AI-driven prior authorization to select “low-value” services in Medicare FFS. Beginning January 2026 in six states (Texas, New Jersey, Washington, Ohio, Arizona and Oklahoma), WISeR will require pre-approval (or retrospective review) for procedures including vagus nerve stimulation (VNS).
The Vagus Nerve Society recognizes CMS’s goal of reducing waste, but we must ensure that essential therapies for refractory epilepsy are not labeled “inappropriate care.” Importantly, CMS’s own coverage policy affirms that VNS is a safe and effective treatment for medically refractory partial-onset seizures.
For many patients with drug-resistant epilepsy, VNS implantation, and ongoing device management is life changing. We therefore take a critical stance on how WISeR could impact these patients.
Patient Access: WISeR would subject VNS to added layers of review. For busy clinicians and epilepsy centers, additional paperwork and uncertain reimbursement timing will distract from patient care. These new requirements will potentially jeopardize patient access to care.
Perverse Incentives: This move establishes dangerous incentives to deny these procedures as contractors are paid on a share of “averted expenditures” and reductions in utilization. VNS patients, especially children or those with severe epilepsy syndromes, cannot afford such setbacks.
Transparency and Oversight: Another major concern is the opacity of WISeR’s algorithms and criteria. CMS has not made public the specific review criteria or evidence thresholds for WISeR decisions. Vendor decision-making remains a black box, providing little to no insight into how prior authorization determinations will be made.
Contradiction to Policy: Finally, the Vagus Nerve Society echoes concerns that WISeR’s expansion of prior authorization contradicts recent policy goals. Medicare’s fee-for-service program has historically not required PA for procedures like VNS, outside specific areas. Leading organizations note that WISeR would dramatically expand prior authorization in traditional Medicare, making efforts to limit unnecessary hurdles.
Together, these issues would make the WISeR model ill-suited for VNS therapy. Evidence-based coverage already exists for VNS (NCD 160.18), meaning additional automated reviews are unnecessary and risk error. The Vagus Nerve Society therefore aligns with other medical groups in opposing the broad application of WISeR’s prior authorization to neuromodulation therapies.
In summary, the Vagus Nerve Society is deeply concerned that the WISeR model, as proposed, will hinder access to a proven epilepsy therapy. We join national organizations in warning that expanding prior authorization in this way “will likely limit beneficiaries’ access to care, increase burden on our already overburdened health care workforce, and create perverse incentives” (delbene.house.gov). Patients with refractory epilepsy rely on timely VNS intervention; imposing Medicare Advantage–style prior authorization in fee-for-service is not justified by evidence and carries real risks to patient safety and quality of life.
Accordingly, we urge CMS to reconsider VNS under WISeR. If the demonstration proceeds, we insist on robust safeguards to ensure no qualified patient is denied necessary treatment. Our position is consistent with that of the AMA and other specialty societies. The Vagus Nerve Society will continue to advocate for policies that protect patient access to VNS therapy and reduce unnecessary administrative burdens on epilepsy care.
