FDA in Focus
As federal policymakers continue to evaluate how to accelerate patient access to emerging technologies, the Washington Committee has significantly expanded its direct engagement with the U.S. Food and Drug Administration (FDA) and key stakeholders shaping the future of medical innovation. Throughout the quarter, the Committee prioritized a multi-pronged strategy focused on clinical evidence generation, artificial intelligence (AI) integration, physician entrepreneurship, and the modernization of federal regulatory device pathways affecting neurosurgical care.
These efforts culminated in the participation of then-FDA Commissioner Marty Makary, MD, MPH, at the 2026 AANS Annual Scientific Meeting in San Antonio, Texas. Dr. Makary delivered the prestigious Charles L. Plante Lecture and participated in a high-level fireside chat moderated by Washington Committee Chair Alexander A. Khalessi, MD, MBA. The discussion focused on ongoing FDA modernization initiatives, centering on the integration of real-world evidence, adaptive clinical trial models, and real-time data workflows within device development.
A central focus of the dialogue involved the FDA-CMS Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway—an initiative intended to better coordinate FDA approval and Medicare coverage determinations for Breakthrough Devices earlier in the product lifecycle. The Washington Committee has consistently advocated for greater alignment between the FDA and CMS to address the “coverage gap” for neurosurgical technologies, in which prolonged delays between regulatory clearance and Medicare reimbursement determinations slow patient access and stifle physician adoption. Committee leadership actively raised these operational realities in concurrent discussions with both FDA and CMS officials, safeguarding rigorous patient safety standards while streamlining pathways for clinically significant technologies.
Dr. Makary’s participation reflected months of sustained engagement by organized neurosurgery. Beyond the plenary stage, Dr. Makary joined targeted, concurrent meetings with the CNS Executive Committee, the AANS Executive Committee, the Washington Committee, and members of the Drugs and Devices Subcommittee. These sessions allowed neurosurgical leaders to engage directly on regulatory predictability, clinical evidence standards, post-market surveillance, barriers affecting physician innovators, and the expanding footprint of AI in clinical decision-making.
Through the Drugs and Devices Subcommittee, chaired by Joshua M. Rosenow, MD, organized neurosurgery expanded its presence in national policy conversations. The subcommittee advanced neurosurgical perspectives within the FDA’s Office of Neurological and Physical Medicine Devices, participated in Medical Device User Fee Amendments (MDUFA) VI stakeholder consultations, and collaborated with participants in the Total Product Life Cycle Advisory Program to ensure federal regulators grasp the clinical realities of neurosurgical device deployment.
The subcommittee has also accelerated its focus on physician innovation and safety tracking. In May, Subcommittee Vice Chair Paul M. Arnold, MD, and Resident Fellow Faith C. Robertson, MD, organized the highly successful webinar, “Surgeons as Entrepreneurs.” Featuring active neurosurgeon innovators and direct FDA participation, the program examined regulatory pathways, commercialization hurdles, and clinical evidence development.
In parallel, the subcommittee continues to work to mitigate risks to patient safety by strengthening neurosurgeons’ engagement in adverse event reporting. Driven by Laura Stone McGuire, MD, MS, the subcommittee met directly with FDA staff to explore critical technical improvements to the Manufacturer and User Facility Device Experience (MAUDE) database to optimize post-market surveillance and physician reporting systems.
Building the Case Against the Efficiency Adjustment
The Washington Committee is leading a disciplined campaign to challenge the finalized “efficiency adjustment” under the CY 2026 Medicare Physician Fee Schedule (MPFS), which imposes an across-the-board 2.5% reduction to work relative value units (RVUs) for non-time-based codes. This flawed policy relies on economy-wide labor metrics, under the mistaken assumption that technological advancements automatically reduce physicians’ work.
Rejecting broad, generic specialty appeals, the Committee engineered a multi-stage screening framework to isolate high-acuity neurosurgical services where CMS’s premise breaks down clinically. By analyzing RUC activity, utilization data, and procedural intensity, the framework identifies complex services where technology complements, rather than substitutes for, intricate surgical execution.
This evidence-based approach forces a fundamental paradox: CMS cannot validly recognize the distinct intensity of complex neurosurgical procedures — as it does via separate exemptions under the CMMI WISeR model — while simultaneously applying arbitrary, mathematical cuts. The Committee continues to engage CMS, HHS, and congressional stakeholders to secure targeted, data-backed carve-outs that safeguard beneficiary access against mechanisms that threaten to suppress physician adoption and limit patient care.
CMS Opens Door to Physician-Owned Hospital Integration in IPPS Proposed Rule
In June, the AANS and CNS submitted comments on CMS’ FY 2027 Hospital Inpatient Prospective Payment System (IPPS) proposed rule, focusing on two major priorities for neurosurgery: recognition of complex spinal fusion procedures and the future role of physician-owned hospitals in value-based payment models.
The organizations strongly supported CMS’ proposal to establish new Medicare Severity Diagnosis-Related Groups (MSDRGs) for extensive and complex spinal fusion procedures, recognizing that highly complex spinal deformity and reconstruction cases require substantially greater resources than routine spinal fusions. The comments also urged CMS to refine the proposal using clinically grounded definitions of complexity rather than device-specific criteria.
The letter also responded to CMS’ request for information on physician-owned hospitals and participation in the Transforming Episode Accountability Model (TEAM). While supporting opportunities for physician-owned hospitals to voluntarily participate in TEAM, the AANS and CNS cautioned CMS against expanding the model without stronger evaluation methods, reliable risk adjustment, and meaningful performance measures. The comments highlighted concerns regarding CMMI’s historical track record, noting findings from both the Congressional Budget Office and Government Accountability Office showing limited success in translating demonstration models into scalable reforms. The organizations also opposed the immediate inclusion of newly proposed spinal fusion MS-DRGs in TEAM, warning that insufficient historical claims data could expose hospitals treating the most complex patients to inappropriate financial risk.
The inclusion of the RFI follows months of sustained engagement between the Washington Committee and key federal officials in Congress and HHS. Advocacy efforts included direct meetings with CMS and HHS leadership, coalition coordination, policy letters, podcasts, op-eds, and congressional testimony. Earlier this year, Anthony M. DiGiorgio, DO, MHA, highlighted the role of physician-owned hospitals during House Energy and Commerce Committee testimony examining healthcare affordability and provider consolidation. Washington Committee leadership also engaged Administration officials over the past year as part of broader advocacy efforts on physician autonomy, site neutrality, and competition policy.
Spine Societies Push Back on Cervical Fusion Coverage Restrictions
In May, the AANS and CNS joined other leading national spine organizations in issuing a multi-society position statement calling for an end to insurance denials of interbody biomechanical devices used in cervical fusion procedures.
The statement responded to payor policies that continue to classify interbody biomechanical devices (CPT 22853) as experimental or not medically necessary despite more than two decades of routine use in cervical fusion surgery and extensive peer-reviewed evidence supporting their safety and effectiveness. Neurosurgical and spine leaders emphasized that these implants remain a standard component of modern cervical fusion procedures and warned that coverage restrictions may limit patient access to appropriate surgical care.
The effort reflected ongoing collaboration between organized neurosurgery and spine stakeholders to address utilization management and coverage policies that are inconsistent with current standards of care.
CMS Proposes Prior Authorization Reforms for Drugs
In June, the AANS and CNS joined the Alliance of Specialty Medicine in comments responding to CMS’ proposed rule, Interoperability Standards and Prior Authorization for Drugs. The proposal would extend existing interoperability, transparency, and electronic prior authorization requirements to prescription drugs covered by Medicare Advantage and other federally funded payor markets. It builds on CMS’ 2024 prior authorization reforms.
The comments supported CMS’ efforts to modernize prior authorization processes through greater use of electronic data exchange, faster decision-making, and expanded public reporting of prior authorization metrics. At the same time, the Alliance urged CMS to adopt shorter decision timelines, establish meaningful enforcement mechanisms for plans that fail to meet required response deadlines, and improve coordination between medical and pharmacy benefit systems.