Comment on CMS-2026-2344-0002

Dear Administrator Oz: Massive Bio, Inc. appreciates the opportunity to comment on the CY 2027 OPPS/ASC proposed rule. Massive Bio is a U.S.-based health technology company whose artificial intelligence platform performs oncology clinical trial matching and longitudinal patient navigation at national scale. Our platform is listed in the CMS Medicare App Library, is DiMe-certified (having earned the Digital Medicine Society Seal), and operates under an organizational National Provider Identifier through which we furnish and bill Medicare care-management services — including Principal Illness Navigation (PIN), Principal Care Management (PCM), Chronic Care Management (CCM), Remote Therapeutic Monitoring (RTM), and Transitional Care Management (TCM) — for Medicare beneficiaries with cancer. Massive Bio is also a pledgee under two of CMS’s Health Tech Ecosystem early-adopter initiatives: the Conversational AI Assistants pledge, under which we have committed to build patient-facing AI that connects to CMS Aligned Networks or personal health record apps and, with patient consent, delivers personalized support while clearly distinguishing educational content from clinical guidance and routing patients to a health professional when needed; and the Kill the Clipboard pledge, under which we have committed to enable patients to retrieve their health records from CMS Aligned Networks and share them with providers via FHIR bundles, QR codes, and SMART Health Cards/Links, eliminating repetitive manual intake. Our clinical AI has been prospectively validated: our SYNERGY-AI real-world evidence study, presented at ESMO and encompassing 3,804 patients, demonstrated an F1 score of 0.82 for automated trial-eligibility determination, and our publicly announced collaboration with OpenAI converts free-text clinical trial eligibility criteria into structured, machine-readable parameters at scale. We write from the perspective of an organization that has already operationalized, under existing Medicare payment rules and CMS’s own interoperability commitments, many of the capabilities this proposed rule contemplates. We strongly support CMS’s decision to establish a durable payment framework for Software as a Medical Service (SaMS). It is the most consequential step the agency has taken toward rational, technology-neutral payment for algorithmic clinical services. Our comments make one central argument: as currently drafted, the SaMS framework is implicitly organized around image-analysis diagnostics, and CMS should deliberately architect the category — now, in its first full rulemaking cycle — to encompass data-driven clinical decision services built on interoperable oncology data standards, beginning with AI-enabled clinical trial matching built on mCODE (minimal Common Oncology Data Elements). Doing so would give Medicare its first true option-value-based payment model, modernize prior authorization, extend subspecialty-level oncology decision support into rural America, and create the payment bridge to decentralized and just-in-time clinical trials that the agency, the FDA, and ARPA-H have each independently called for.