Comment on CMS-2026-1255-0001

HealthLX submits these comments on the 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (file code CMS-0062-P). HealthLX is a health IT vendor and a founding member of the HL7 Da Vinci Project; we build and operate the FHIR-based APIs and prior authorization workflows that impacted payers rely on under CMS-9115-F, CMS-0057-F, and CMS-4208-F. Our full comments are attached. We support the direction of this rule: extending electronic prior authorization to drugs, adopting FHIR under HIPAA, requiring payers to report API endpoints to a central directory, and aligning standards versioning with the ONC Health IT Certification Program. Our recommendations aim to make these proposals succeed in production, including for the many impacted payers that must comply with limited budgets and technical staff. Key recommendations: - Require the use-case implementation guides (CRD, DTR, PAS) rather than overlapping base FHIR, and scope conformance to the capabilities each API actually uses. - Keep the least-mature components (CDex, FAST Security) recommended rather than required until production-ready, with phased compliance dates. - Build the endpoint directory as a FHIR-enabled registry aligned to the NDH Endpoint Profile; collect discrete, coded authentication details; and extend the initial reporting window to 90 days while easing manual update deadlines. - Retain both NCPDP F&B and RTPB for pharmacy-benefit drugs, and reuse the CRD/DTR/PAS workflow for medical-benefit drugs, using the CRD CoverageInformation signal to route each drug to the correct pathway. - On the HIPAA transaction standards, adopt FHIR only for the prior-authorization-scoped 278 and the narrow eligibility check; retain X12N 270/271 for all other eligibility, with a generous coexistence period rather than rapid deprecation. - Preserve version-transition overlap windows (at least 12 to 18 months) rather than hard cutovers. - Recognize that payers depend on PBMs, vendors, and delegated entities they do not fully control; confirm that compliance may be met through vendors, expect data-holding entities to support the standards, and provide accommodations and low-cost paths for small health plans. - Act on the API-implementation RFI with mandatory, standardized conformance testing (e.g., ONC-recognized Inferno test kits) tied to the ONC Certification Program, because inconsistent conformance, not the absence of standards, is the largest barrier to real-world interoperability. Above all, we encourage CMS to articulate a clear, unifying vision for how this rule fits with CMS-9115-F, CMS-0057-F, CMS-4208-F, the ONC Certification Program, HIPAA Administrative Simplification, TEFCA, and the National Directory of Healthcare Providers & Services, so payers and vendors can invest coherently. Please see the attached letter for full detail. Contact: Will Tesch, CEO, will.tesch@healthlx.com, (877) 539-7741.