We generate the evidence. We also watch it.
A standing brief on what's moving in interventional pain and neuromodulation evidence — regulatory action, trial results, payer policy, publications — from the team building the registries underneath it. Briefings, not press releases. Written for the people inside the decisions.
The Ambulatory Specialty Model starts January 1. The final participant list is out.
CMS has published the final participant list for the Ambulatory Specialty Model, its mandatory payment model for specialists treating Medicare low back pain and heart failure. Pain management, interventional pain, anesthesiology, neurosurgery, orthopedic surgery, and PM&R clinicians in selected areas can confirm their status on Data.CMS.gov, and the ASM participant portal is open. Part B adjustments start at up to ±9% and widen to ±12% by the fifth year — and the outcomes a practice records in 2027 set what it is paid in 2029.
Function is what gets scored. CMS's CY 2027 fee schedule proposal would measure whether practices run a standardized functional assessment, and would award bonus quality points for reporting patient-reported outcomes on low back pain. The final rule is expected in November. Practices that collect validated PROs before January 1 start the model with a baseline instead of a gap.
Read CMS's ASM participant update ›- Confirm status now. The final list is on Data.CMS.gov. Participation is mandatory for the five performance years, 2027 through 2031.
- A baseline before the first episode. Function and pain measured with validated instruments before treatment, not reconstructed from charts afterward.
- Follow-up on a schedule. 30, 90, and 180-day outcomes captured the same way across every patient, so the practice's score reflects its care, not its paperwork.
What's moving in pain and neuromodulation evidence.
Filter by beat. Every briefing links to its primary source.
CMS proposes a new back-pain function measure for ASM — and bonus points for patient-reported outcomes
The CY 2027 fee schedule proposal would replace ASM's discontinued Functional Status Change measure with a Functional Outcome Assessment measure, add a claims-based lumbar MRI overuse measure, and award up to five extra quality points for voluntary PRO reporting on low back pain. CMS would use that PRO data to build the outcome measures practices are scored on later. The final rule is expected in November.
WISeR's gold card: a 90% approval rate to skip AI-assisted prior auth review
CMS began gold-carding under its WISeR prior authorization model in Washington State on July 6, with the other five model states following quarterly. Providers need at least 10 requests and a 90% affirmation rate, exemptions apply service by service, and status is rechecked every quarter. Nerve stimulator implants and epidural steroid injections are in scope, and early Texas approvals ran at 62% — for pain practices, the documentation behind each request decides who qualifies.
Neuromodulation consolidates: Medtronic–SPR, Boston Scientific–Nalu, Globus–Nevro
Three acquisitions in under a year — $650M for SPR's temporary PNS system, $533M for Nalu, $250M for Nevro. Acquirers are paying for clinical evidence and reimbursement depth as much as for hardware. Medtronic closed the SPR deal July 16. For every other sponsor in the space, the post-market evidence base just became a valuation line item.
CDRH's RWE town hall: what "relevance and reliability" means when FDA reviews a registry
FDA's February 2026 town hall walked industry through the final device RWE guidance and its 60-day transition. The takeaways for post-market registries: document provenance up front, pre-specify the analysis, and expect FDA to review the data source as closely as the result.
Five-year real-world data at NANS 2026: SCS and DRG reduce pain-related healthcare visits
Abbott presented real-world data analyses at NANS 2026 showing sustained reductions in pain-related healthcare utilization for patients on BurstDR™ SCS and DRG stimulation. Utilization is the outcome payers actually price — and the analyses are a template for what a commercial registry can produce.
FDA finalized its real-world evidence guidance for devices. The evidence bar for neuromodulation shifted.
The final guidance supersedes the 2017 framework. FDA no longer requires identifiable, patient-level data in every RWE submission, opening the door to de-identified and aggregate registry data, and every submission now needs a documented relevance and reliability assessment. Provenance, audit trail, and instrument validity are the questions FDA asks first.
A 24-month real-world SCS cohort: 61% pain reduction at 3 months, 43% at 24
Seventy-six patients, five follow-up windows, multilevel modeling across 452 observations. The durability curve — steep early relief that partially regresses by year two — is the shape real-world SCS data keep producing, and the reason follow-up completion past 12 months matters more than the headline number.
361 HCT/P enforcement is reshaping the amniotic and placental playbook
With enforcement discretion long over, real-world evidence infrastructure isn't optional for this category anymore. What sponsors in the space are building, and why a commercial registry is the new pilot study.
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No filler. Sent when something material moves in pain or neuromodulation evidence — we publish when it matters, not on a schedule. Sponsors, clinician-researchers, payers, and the curious. Unsubscribe anytime.
Because we're in the field, not adjacent to it.
Celéri Health is the evidence infrastructure for interventional pain and neuromodulation. We build the registries sponsors run their post-market programs on. We operate the PainRWD™ Science Cloud. We run the EDC, built to 21 CFR Part 11 requirements, that regulatory-grade evidence depends on.
That means when FDA moves, when a sponsor publishes, when a payer rewrites a coverage policy, when a competitor drops new data — we have a position. Not a hot take. A position grounded in what the data actually does.
Regulatory
FDA guidance, CDRH activity, and what each change means for post-market, PMA supplement, and label-expansion evidence.
Trial results
Pivotal and post-market readouts — with attention to the responder definitions and follow-up windows behind the headline number.
Coverage and payer
CMS, commercial, and workers' comp policy — where evidence requirements are heading and what a dossier will need to show.
Biologics
361 HCT/P enforcement, regenerative medicine, and the evidence infrastructure the category now requires.
Publications
What lands in the journals — what a paper establishes, what its methods section concedes, and what it adds to the debate.
Industry
Acquisitions, launches, and reimbursement moves — and what each says about the value of a post-market evidence base.
Celéri Research
Celéri Health's own publications, congress abstracts, and dataset milestones — and why we sequence them the way we do.
Reading the field is one thing. Building the evidence is another.
If a briefing changes what you need to prove, Celéri Health will map that objective to the right evidence track and stand up the infrastructure to get there.
