The Honorable Mehmet Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
P.O. Box 8010
Baltimore, MD 21244-8010
RE: Medicare Program; Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway
Dear Administrator Oz,
On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), representing more than 4,000 neurosurgeons nationwide, we appreciate the opportunity to submit comments to the Centers for Medicare & Medicaid Services’ (CMS) Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway notice published in the Federal Register on August 11, 2026.
The notice addresses several issues of significant importance to neurosurgical patients and providers. In particular, the AANS and CNS comment on RAPID Pathway eligibility criteria, the participation of devices that have advanced beyond the Investigational Device Exemption (IDE) pre-submission stage, identifying clinical outcomes that are meaningful to Medicare beneficiaries, and evidence development for RAPID National Coverage Determination (NCD).
In summary, the AANS and CNS:
- Support CMS efforts to align RAPID eligibility with participation in the FDA Breakthrough Devices Program and the Total Product Life Cycle Advisory (TAP) Program to ensure evidence generation aligns with regulatory and coverage expectations from the beginning of the product development process;
- Call on CMS to establish a transition pathway for devices beyond the IDE pre-submission stage to be eligible for RAPID;
- Call on CMS to establish a mechanism for Breakthrough Devices supported by appropriately designed Non-Significant Risk (NSR) studies to participate in RAPID;
- Support CMS efforts to identify clinical outcomes that reflect what matters most to Medicare
- beneficiaries, including symptom burden, quality of life, and the ability to maintain independence,
- and that are appropriate for the specific technology under review;
- Encourage CMS to use independent, clinician-led registries when additional postmarket evidence is necessary under Coverage with Evidence Determination (CED);
- Call on CMS to define the process, evidence expectations, and review milestones that would support extension of RAPID coverage when sponsors are generating meaningful evidence toward a permanent Medicare coverage determination; and
- Call on CMS to ensure that implementation of RAPID does not inadvertently delay consideration of other technologies waiting for coverage review through existing NCD pathways.
Click here to view the full Comments on CMS RAPID Coverage Pathway (CMS-3487-NC)
