Authorizing Relief

by James Cavuoto, editor

In previous issues of this publication, we’ve highlighted some of the negative impacts on the neurotechnology industry from the new administration in Washington, DC. Many of these have related to funding cuts for critical research and staffing cuts for key government agencies and programs.

But in case these impacts were not enough, neuromodulation vendors now find themselves under the eight ball for reimbursement decisions. In our sister publication BioElectRx Business Report, contributing editor Victor Pikov has highlighted some of the pricing changes that CMS has proposed. Vendors can also expect to face new demands for prior authorization from CMS for a range of procedures, including SCS, PNS, DBS, and VNS implantations.

Earlier this year, CMS unveiled a new program called WISeR, which stands for Wasteful and Inappropriate Service Reduction. The WISeR Model will test a new process on whether enhanced technologies, including artificial intelligence, can expedite the prior authorization processes for select items and services that have been identified as particularly vulnerable to fraud, waste, and abuse, or inappropriate use. Included among these services are most forms of neuromodulation, including SCS, DBS, SNS, and HGNS. The program will be rolled out in six states beginning 2026: New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington. Procedures performed in a doctor’s office appear to be exempt from the new rule.

“CMS is committed to crushing fraud, waste, and abuse, and the WISeR Model will help root out waste in Original Medicare,” said CMS Administrator Dr. Mehmet Oz. “Combining the speed of technology and the experienced clinicians, this new model helps bring Medicare into the 21st century by testing a streamlined prior authorization process, while protecting Medicare beneficiaries from being given unnecessary and often costly procedures.”

The agency contends that waste in healthcare represents up to 25% of healthcare spending in the U.S. Although the roll out will not be nationwide, the announcement triggered a swift reaction from several neurotech vendors and implanters. Joshua Rosenow, director of functional neurosurgery at Northwestern University, was pointed in his criticism. “Why are we going backwards and imposing MORE barriers to patient care?” he posted on LinkedIn. “Moreover, why are we targeting procedures such as DBS for Parkinson’s, VNS for epilepsy as “wasteful”? There has never been an implication that these therapies are being used inappropriately. Do we want to delay or deny care for someone at risk for SUDEP from intractable seizures or for someone whose quality of life is devastated by side effects of medications for PD?”

There was also some consternation in the patient community. One user posted in the Parkinson’s forum on Reddit, “I guess that worm in RFK Jr.’s head is now in charge of CMS. I’m so glad I had my DBS surgery when qualified individuals were running the government agencies.”

We’re all for eliminating waste, fraud, and abuse but it’s alarming that the new program seems to be singling out promising neurotech therapies while ignoring the enormous waste and abuse visited upon our country by the pharmaceutical industry. The opioid epidemic is but one example of how that industry has strained federal budgets. The costs are far beyond the inflated price of the drugs themselves, but include the costs to society for the crime, family turmoil, and homelessness that opioid addiction has caused over the years.

Ironically, pain neuromodulation systems represent a potent opportunity to address this epidemic, and delaying the delivery of alternative pain therapies to patients is not likely to result in cost savings in the long run.