CMS Innovation Center Model: ACCESS (Outcome-Aligned Payments) FDA Pilot: TEMPO (Digital Health Enforcement Discretion)

The CMS ACCESS Model and FDA TEMPO Pilot

Q: Does ACCESS replace RPM/CCM/APCM billing codes?

No. ACCESS introduces an outcomes-aligned payment option in Original Medicare and does not repeal fee-for-service rules like RPM, CCM, or APCM. You must decide which pathway you are operating under for a given patient and keep workflows cleanly separated.

Q: Who is not eligible to participate as an ACCESS organization?

Organizations must be Medicare Part B–enrolled providers or suppliers with an active TIN and a physician Clinical Director. Durable medical equipment and laboratory suppliers are excluded.

Q: Is there cost-sharing for the ACCESS Co-Management Payment?

CMS states there is no beneficiary cost-sharing for the co-management payment and advance consent is not required for that service.

Q: How often can the ACCESS co-management service be billed?

CMS describes the co-management service as billable once every four months per beneficiary per track, with an additional onboarding-related payment the first time it is billed for a beneficiary using a CMS-specified modifier.

Q: Can a TEMPO device be used outside of the ACCESS context?

FDA frames TEMPO as a pilot connected to the ACCESS model and expects enforcement discretion requests to apply when devices are offered to or by ACCESS participants for an intended use to improve patient outcomes. Using a TEMPO device outside that scope is inconsistent with the notice.

What they actually authorize, where practices fail, and what changes operationally starting 2026.

ACCESS creates a Medicare pathway that pays for chronic-condition management based on measured outcomes instead of billed activities, while TEMPO is a narrowly scoped FDA pilot that may allow certain digital health devices to be used within ACCESS under defined enforcement-discretion conditions while real-world performance data is collected.

For practice owners, compliance officers, billing directors, population health leads, and digital-care operators serving Original Medicare.

Last Updated: December 18, 2025

Practical consequence: Less activity-based billing friction does not eliminate compliance; it shifts obligations to enrollment integrity, outcome measurement, quality safeguards, data exchange, and device regulatory posture.

How to use this page: Operational interpretation for planning, workflow design, contracting, and risk management. Not legal advice.

Key effective dates

FDA TEMPO statements of interest begin Jan 2, 2026
FDA follow-up requests expected around Mar 2, 2026
First ACCESS performance period starts Jul 5, 2026

Who this affects

Medicare Part B–enrolled provider/supplier organizations delivering technology-supported chronic care, and digital health manufacturers seeking deployment inside ACCESS.

Scope

Original Medicare beneficiaries in qualifying ACCESS tracks; TEMPO devices intended for clinician-supervised outpatient use in ACCESS.

Section Index / Navigation Map

Key takeaway in one sentence
What ACCESS actually changes (and what it does not)
What TEMPO actually authorizes (and what it does not)
Common failure patterns and the operational mechanics behind them
Why those patterns are non-compliant (auditor logic)
Edge cases and clarifications
Forward-looking changes and known upcoming guidance
Practical implications for practices
Planning checklist
How this fits the bigger CMS and payer trajectory
How FairPath enforces this at scale
FAQs
References

1. Key Takeaway in One Sentence

ACCESS replaces activity-tied fee-for-service incentives with outcome-aligned recurring payments for defined chronic-condition tracks in Original Medicare, while TEMPO may allow limited, clinician-supervised use of certain digital health devices within ACCESS under FDA enforcement discretion--without eliminating the need for rigorous enrollment integrity, quality safeguards, regulatory compliance, and defensible data trails.

2. What ACCESS Actually Changes (and What It Does Not)

The CMS Innovation Center’s ACCESS Model is a voluntary, 10-year national test in Original Medicare that introduces outcome-aligned payments to support technology-enabled care for common chronic conditions. CMS’s premise is that fee-for-service payments tied to specific activities or devices do not match how technology-supported care is delivered, and that an outcomes-based option can expand access.

Nothing about ACCESS repeals existing Medicare billing rules like RPM, CCM, or APCM. ACCESS is an additional pathway that sits alongside fee-for-service, which means the compliance risk shifts toward enrollment integrity, data exchange, safeguards, and outcome measurement--not away from them.

2.1 What ACCESS is, in CMS’s terms

CMS describes ACCESS as testing an outcome-aligned payment approach in Original Medicare beginning July 5, 2026. Payments are recurring and tied to measured outcomes rather than minutes or devices, reflecting CMS’s intent to pay for results instead of enumerated activities.

2.2 ACCESS clinical tracks and qualifying conditions

CMS lists four initial tracks: early cardio-kidney-metabolic (eCKM), cardio-kidney-metabolic (CKM), musculoskeletal (MSK), and behavioral health (BH), each with defined qualifying conditions (e.g., eCKM includes hypertension with dyslipidemia/overweight/prediabetes markers; CKM includes diabetes, CKD, and ASCVD). CMS notes it may consider additional tracks later.

2.3 Who can participate and who can use services

Eligible participants are Medicare Part B–enrolled providers or suppliers (excluding DME and lab suppliers) with an active TIN, compliant licensure/HIPAA/FDA posture (or FDA enforcement discretion), and a physician Clinical Director overseeing quality and compliance. Patients are Original Medicare beneficiaries with qualifying conditions; Medicare Advantage is excluded. CMS may randomly assign a small share of enrollees to a control group.

2.4 What CMS requires operationally beyond payment

CMS will monitor performance, may disenroll organizations that miss quality or safety standards, and will publish risk-adjusted outcomes. ACCESS participants must send electronic updates at initiation, milestones, and completion via HIEs or CMS Aligned Networks; co-managing clinicians can bill a co-management payment when documented review and coordination occur. CMS intends to offer the CMS-sponsored model patient incentive safe harbor so participants can uniformly forego OAP cost-sharing if they choose, with disclosure if they collect it.

3. What TEMPO Actually Authorizes (and What It Does Not)

The FDA’s TEMPO Pilot is explicitly connected to ACCESS and allows certain digital health manufacturers to request enforcement discretion for defined requirements while collecting real-world performance data and pursuing marketing authorization. FDA expects statements of interest beginning January 2, 2026 and plans follow-up information requests around March 2, 2026.

FDA cites enforcement discretion examples such as premarket authorization and investigational device requirements, applied case by case while data are collected.
FDA emphasizes baseline expectations: devices intended to improve outcomes generally must be authorized for that use; TEMPO is a pilot pathway for limited scenarios inside ACCESS.
FDA plans to select up to about 10 manufacturers per clinical use area (aligned to the ACCESS tracks) and focus on devices intended for clinician-supervised outpatient treatment that do not present potential for serious risk.
Participation is not an indication of future authorization decisions; FDA expects participants to collect and share real-world data, maintain records, and move toward marketing submissions on a defined timeline.

4. Common Failure Patterns / Traps

Trap 1: Treating ACCESS as “not billing, therefore not auditable”

Outcome-aligned payments change the audit surface but do not remove it. Enrollment qualification, update transmission, outcome measurement integrity, cost-sharing elections, and co-management documentation remain auditable.

Trap 2: Confusing “technology-supported care” with “device-only care”

A device-plus-data flow without defined clinical management, milestones, and accountability is misaligned with ACCESS’s design and governance expectations.

Trap 3: Assuming TEMPO is a general-purpose FDA bypass

TEMPO is limited enforcement discretion for ACCESS contexts, not a blanket exemption or an alternative to marketing authorization.

Trap 4: Ignoring the clinician-supervised outpatient constraint

Operational models must define supervision, escalation, and interpretation responsibilities for device output; TEMPO assumes clinician-supervised outpatient use.

Trap 5: Breaking cost-sharing rules through inconsistent collection policy

CMS expects a uniform cost-sharing policy and disclosure. Selective waivers or patient-by-patient decisions create avoidable compliance liability.

Trap 6: Co-management billing without the required documentation trail

CMS conditions co-management payment on documented review of ACCESS updates plus a written assessment and coordination action. Treating it as a referral stipend fails under scrutiny.

5. Why This Is Non-Compliant (Auditor Logic)

Enrollment integrity breaks: enrolling patients without qualifying conditions or without proper enrollment pathways converts outcome-based payments into payments for non-qualified populations.
Quality safeguard breaks: lack of clinical director oversight, performance monitoring, or required update transmission at initiation/milestones/completion undermines CMS’s safeguards.
Cost-sharing integrity breaks: collecting or waiving cost-sharing inconsistently with CMS’s uniformity expectation or outside the model patient incentive safe harbor creates inducement and billing risk.
Device regulatory posture breaks: using devices outside FDA authorization or outside TEMPO enforcement discretion, or without required reporting and submission plans, misrepresents the device’s regulatory status.

6. Edge Cases & Clarifications

Is ACCESS available to Medicare Advantage patients? No. ACCESS is tested in Original Medicare; MA is excluded.
Can a patient enroll in more than one ACCESS track? Yes. CMS states people can sign up in multiple tracks from the same or different organizations.
What if a patient is assigned to a control group? CMS notes a small share of enrollees may be randomly assigned to control groups; they retain full access to regular Medicare services.
Do MSK patients get a continuation period? No. MSK focuses on resolving chronic pain during the initial period and does not include an optional follow-on period.
Does TEMPO mean a device is FDA cleared? No. TEMPO allows enforcement discretion in limited contexts; participation does not equal authorization and FDA expects a path toward marketing submission.

7. Forward-Looking Policy Changes

ACCESS begins July 5, 2026 and runs 10 years (through Jun 30, 2036), with applications accepted on a rolling basis through Apr 1, 2033.
Applications submitted by April 1, 2026 are needed for consideration in the first performance period; later applications may start January 1, 2027.
CMS will share the ACCESS Co-Management Payment G-code, modifier, and additional billing guidance in 2026.
FDA TEMPO statements of interest start January 2, 2026; follow-up requests for additional information begin around March 2, 2026.

8. Practical Implications for Practices

Enrollment qualification is the new gatekeeper. Under ACCESS the primary question is whether the patient qualifies for the specific track, not whether minutes or device days were logged.
Build a data trail around outcomes. Payments hinge on measured improvement/control, so baselines, cadences, and attribution logic must be defensible and reproducible.
Implement outbound clinical update workflows. Required initiation, milestone, and completion updates must flow via HIE/CMS Aligned Networks with reliable delivery evidence.
Formalize cost-sharing policy. Choose and document your OAP cost-sharing election and apply it uniformly; prevent ad hoc waivers.
Track TEMPO device posture. Treat TEMPO use as a controlled state with recordkeeping, reporting cadence, and a path to marketing authorization.

9. Planning Checklist

Decide if you are applying as an ACCESS participant, co-managing with one, or contracting as a technology partner; obligations differ.
Implement track-level qualification logic for eCKM, CKM, MSK, and BH with auditable enrollment justification.
Define outcome measures, baselines, and attribution rules per track so calculations can be reproduced from data.
Build a clinical update pipeline (initiation, milestones, completion) with signatures, storage, and delivery proof via HIE/CMS Aligned Networks.
Establish and enforce a uniform OAP cost-sharing policy with disclosure before enrollment.
Gate co-management claims on documented review and action and enforce CMS frequency limits.
Create a registry of TEMPO device status, enforcement-discretion scope, reporting obligations, and marketing submission timelines.

10. How This Fits the Bigger CMS / Payer Trajectory

ACCESS continues CMS’s shift from activity-based payments to outcomes-based models and binds operations to data exchange requirements rather than billing mechanics. CMS’s use of aligned networks, electronic update mandates, and public outcomes directories signal an interoperability-first future where commercial and MA payers can mirror the structure.

Even if a practice never enters ACCESS, the model previews what payers want: measurable outcomes, standardized data interfaces, and audited performance.

11. How FairPath Automates or Enforces This

Track qualification as code: enrollment cannot proceed unless qualifying conditions and baselines meet track requirements, with preserved rationale for audits.
Outcome measurement integrity: outcomes are defined with baselines, windows, and reproducible evidence of control/improvement aligned with OAP intent.
Care-update transmission workflow: initiation, milestone, and completion updates are scheduled, delivered, and retained with status tracking via aligned networks.
Cost-sharing uniformity gates: elections to collect or forego OAP cost-sharing are enforced uniformly with required disclosures.
Co-management billing controls: claims require documented review and action and respect CMS frequency limits and onboarding modifiers.
TEMPO posture tracking: device status, enforcement-discretion scope, reporting cadence, and marketing submission timelines are controlled so operations cannot drift into unbounded use.

12. FAQ

Does ACCESS replace RPM/CCM/APCM billing codes? No. ACCESS is an outcomes-aligned payment option in Original Medicare; you must choose the pathway for each patient and avoid mixing assumptions.
Who is not eligible to participate as an ACCESS organization? CMS excludes DME and lab suppliers; participants must be Medicare Part B–enrolled providers/suppliers with an active TIN and a physician Clinical Director.
Are beneficiaries required to pay Part B cost-sharing for OAPs? CMS intends to permit participants to forego OAP cost-sharing uniformly under the model patient incentive safe harbor; if collecting, disclose expected amounts and apply uniformly.
Is there cost-sharing for the co-management payment? CMS states no cost-sharing applies, and advance consent is not required.
How often can co-management be billed? Once every four months per beneficiary per track, with an onboarding-related additional payment the first time billed using a CMS modifier.
Can a TEMPO device be used outside the ACCESS context? FDA frames TEMPO as an ACCESS-connected pilot; enforcement discretion is expected to apply when devices are offered to or by ACCESS participants for the intended use, not for general distribution.

13. References

CMS: ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model page and Outcome-Aligned Payments framing.
CMS: ACCESS Technical Frequently Asked Questions (tracks/conditions, eligibility, safeguards, cost-sharing, co-management, interoperability, ACO/MIPS interactions).
FDA: TEMPO press announcement (enforcement discretion framing, scope, clinical areas, participant counts).
Federal Register / FDA Notice: Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot (scope, enforcement discretion examples, RWD expectations, selection limits, timelines).
eCFR: 42 CFR 1001.952 (CMS-sponsored model patient incentive safe harbor referenced by CMS).
CMS: Interoperability Framework and CMS Aligned Networks concept (for ACCESS coordination requirements).
Social Security Act 71115A (Innovation Center authority for model testing and evaluation).