The claim that CMS is proposing to “bar payment” for third-party remote patient monitoring is close but imprecise, and the distinction matters for billing compliance. In the Calendar Year (CY) 2027 Medicare Physician Fee Schedule (PFS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) is not proposing to eliminate Medicare payment for remote physiologic monitoring (RPM) or remote therapeutic monitoring (RTM) outright. Instead, CMS proposes that the clinical monitoring component of RPM/RTM — the actual review, interpretation, and patient interaction — may only be billed to Medicare when performed by a direct employee of the billing practitioner or practice, under general supervision. Vendors would still be permitted to supply the underlying technology: devices, software, dashboards, connectivity, and analytics. What the rule targets is outsourcing the clinical service itself to a third-party company that bills through, or on behalf of, the practice.
For research administrators and billing compliance staff working on decentralized and hybrid clinical trials, this is directly relevant: many of the same third-party vendor arrangements CMS is now restricting for routine Medicare billing are structurally similar to the vendor-run remote monitoring programs used in decentralized clinical trial (DCT) designs.
What CMS actually proposed
According to legal analysis of the proposed rule text published alongside industry and law-firm coverage, the CY2027 PFS proposed rule would, if finalized as written:
- Permit Medicare payment for RPM/RTM clinical monitoring services only when furnished by a direct employee of the billing practitioner or practice (staff need not be on-site, but the billing relationship must run through the practice itself, not a contracted third-party vendor).
- Leave vendors free to continue supplying devices, software platforms, dashboards, connectivity, and analytics — the nonclinical infrastructure layer — without restriction.
- Add an established-patient limitation for RTM billing.
- Require an initiating visit at the start of a monitoring episode.
- Require that clinical monitoring be performed under general supervision by the direct-employee standard described above.
In other words, the mechanism is narrower than a blanket payment ban: it is a who-may-bill-and-furnish restriction aimed specifically at outsourced clinical monitoring labor, not a prohibition on RPM/RTM as a covered service or on vendor technology generally.
The OIG findings behind the proposal
CMS ties the proposal to Department of Health and Human Services Office of Inspector General (HHS-OIG) oversight work on RPM billing. Two relevant HHS-OIG evaluations are the ones most frequently cited in coverage of this proposed rule:
- A September 2024 HHS-OIG evaluation found that 43% of Medicare enrollees who received RPM did not receive all three required service components — patient education and device setup, device supply, and monthly treatment management — raising concerns about incomplete or improperly billed episodes of care.
- A follow-up HHS-OIG report, Billing for Remote Patient Monitoring in Medicare (OEI-02-23-00261, released August 2025), found that Medicare RPM payments in 2024 exceeded $500 million — a figure widely reported elsewhere as approximately $536 million — and flagged specific billing patterns warranting program-integrity scrutiny, including practices billing RPM for a high proportion of enrollees with no prior history at the practice, and practices billing for multiple monitoring devices per patient per month.
It is worth being precise about what that dollar figure represents: it is HHS-OIG’s estimate of total Medicare RPM payment volume for 2024, not a quantified finding of fraud or improper payment loss. The report identifies billing patterns that pose program-integrity risk and warrant further oversight — it does not itself label the full $500-536 million as fraudulent. Coverage that shorthands this as a “$536M fraud finding” overstates what HHS-OIG’s report actually concluded, even though the underlying oversight concern (outsourced, loosely supervised clinical monitoring billing) is real and is exactly what the CY2027 proposal responds to.
Timeline: comment period and effective date
The CY2027 PFS proposed rule’s public comment period is scheduled to close September 14, 2026, at 11:59 p.m. ET. Most provisions, including the RPM/RTM direct-employee billing restriction, are proposed to take effect January 1, 2027, pending finalization. As with any CMS proposed rule, provisions can change between the proposed and final rule based on public comment — organizations should treat the mechanics above as the current proposal, not a locked-in final requirement, until CMS issues the CY2027 PFS final rule later in 2026.
Why this matters for decentralized clinical trial billing compliance
This is analysis, not a restatement of CMS guidance — CMS’s proposed rule governs Medicare Part B fee-for-service billing for RPM/RTM CPT codes generally; it is not clinical-trial-specific regulation, and most sponsor-funded remote monitoring technology used purely for research endpoints in a decentralized clinical trial is never billed to Medicare as a separate RPM/RTM service in the first place. The connection research administrators should understand runs through two channels:
- Hybrid and pragmatic trial designs that bill routine care to Medicare. Trials enrolling Medicare beneficiaries that rely on a coverage analysis under the Medicare Clinical Trial Policy (NCD 310.1) sometimes bill RPM/RTM as routine standard-of-care monitoring separately from investigational, sponsor-funded procedures. If a site or sponsor relies on a third-party DCT technology vendor to furnish that routine-care monitoring component, the same direct-employee billing restriction CMS is proposing for ordinary Medicare RPM/RTM billing would apply to it — the trial context does not exempt a claim from the underlying PFS billing rules. Billing compliance teams building or updating a coverage analysis that includes RPM/RTM codes should flag this proposal now and revisit vendor arrangements before the rule is finalized.
- Program-integrity methodology as a template. Independent of whether a given trial’s remote monitoring is billed to Medicare at all, the billing-pattern red flags HHS-OIG used here — concentration of new-patient billing, multiple-device billing per patient per month, incomplete required service components — are a useful internal audit checklist for any organization contracting a third-party vendor to run remote monitoring, connected-device, or wearable-data programs in a decentralized trial, even where the payer is a sponsor rather than Medicare. Commercial payers and study sponsors increasingly track CMS’s coverage and program-integrity posture on RPM/RTM, so vendor contracts and delegation-of-authority documentation for remote monitoring services are worth reviewing against this proposal’s logic even outside strict Medicare billing scenarios.
What to do before the rule is finalized
- Identify any active or planned trials where RPM/RTM CPT codes are billed to Medicare as routine care under an NCD 310.1 coverage analysis, and confirm who actually furnishes the clinical monitoring component — practice-employed staff or a contracted vendor.
- Review third-party remote monitoring vendor agreements to distinguish clearly between technology/infrastructure services (which the proposal leaves untouched) and clinical monitoring labor (which the proposal restricts to direct employees).
- Track the CY2027 PFS proposed rule through the comment period (closing September 14, 2026) and the eventual final rule, since specific provisions — including the RPM/RTM billing restriction — can change before taking effect.
- Loop in institutional billing compliance and coverage-analysis staff early; this is a Medicare Part B fee schedule change, not a clinical-trial-specific rule, so it is easy for research administration teams to miss it if monitoring is limited to trial-specific regulatory trackers.
Sources
- HHS Office of Inspector General, Billing for Remote Patient Monitoring in Medicare, Report No. OEI-02-23-00261 (August 2025) — oig.hhs.gov
- National Law Review, “CMS Proposes to Restrict Outsourced Remote Monitoring Services Under Medicare” — natlawreview.com
- CMS Newsroom, fact sheets for the CY2027 Medicare Physician Fee Schedule proposed rule — cms.gov/newsroom/fact-sheets
For background on how routine-cost billing works alongside investigational procedures, see CASRAI’s guide to Medicare coverage analysis for clinical trials and the dictionary entry on the Medicare Clinical Trial Policy (NCD 310.1). For the broader decentralized-trial operating context this billing question sits inside, see Decentralized Clinical Trials: What They Are, FDA Guidance, and Key Components and Challenges and Risks of Launching a Decentralized Clinical Trial.
