Comment on CMS-2026-2377-0001
Anonymous AnonymousOpposeBusiness
Summary: The commenter, an RPM vendor, opposes the proposed requirement that all clinical staff furnishing RPM and RTM services must be directly employed by the billing physician practice. They argue the mandate would impose prohibitive costs on small and rural practices, reduce patient access to services, and propose targeted regulatory alternatives to address program integrity concerns without restricting labor-market structures.
The undersigned submits these comments in response to CMS's proposed requirement under CMS-1848-P that all clinical staff furnishing Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) services be directly employed by the billing physician practice. The Commenter is a third-party RPM vendor that supports independent physician practices and nurse practitioner practices in delivering compliant, high-quality RPM services to Medicare beneficiaries. The Commenter expressly supports CMS's program integrity goals and does not oppose enhanced regulatory oversight of the RPM marketplace. The full comment is attached as a PDF upload.
The Commenter respectfully submits that the proposed employment mandate is not calibrated to the program integrity concerns CMS has identified and would cause substantial unintended harm. Small, rural, and underserved practices — including practices serving non-English speaking populations and practices operating with a single staff member — lack the financial and operational capacity to hire, train, and supervise dedicated in-house RPM staff, and will discontinue RPM services entirely if the mandate is finalized, leaving high-risk Medicare beneficiaries without access to daily physiologic monitoring. The Commenter also identifies a material methodological flaw in the OIG audit data underlying the proposed rule: the OIG's inference of service fragmentation from the absence of CPT 99454 claims does not account for patients with sub-threshold device utilization (fewer than 16 reading days), a common and entirely legitimate clinical occurrence that generates no 99454 claim while still supporting a valid 99457 claim.
In lieu of the employment mandate, the Commenter proposes ten specific, targeted regulatory alternatives — including a mandatory physician enrollment order requirement, a Practice-Designated Care Coordinator Model with a 250-patient panel cap, mandatory clinical integration and documentation standards, a domestic workforce requirement, and a vendor registration framework — each of which addresses one or more of CMS's five enumerated concerns at the level of actual clinical behavior, without restricting the labor-market structure of the RPM industry. Proposed regulatory language for each alternative is provided in Appendix A. The Commenter respectfully requests that CMS withdraw the proposed employment requirement and adopt the targeted alternatives described in the attached comment.