For Prospective ACCESS Participants

This checklist helps organizations prepare the technology, reporting, and connected-device components required for an ACCESS application submitted to the Centers for Medicare & Medicaid Services (CMS).

Healthfully provides application-ready technology descriptions, workflows, and evidence to support these requirements.

1. Organizational & Clinical Readiness (Participant Responsibility)

Before submitting an ACCESS application, confirm:

Organization is (or will be) Medicare Part B–enrolled under an active TIN

Applicable state licensure requirements are met

A physician Clinical Director is designated for clinical quality and compliance

Target ACCESS track(s) selected:

Behavioral Health (BH)
Musculoskeletal (MSK)
eCKM / CKM (cardiometabolic)

Clinical workflows align with outcome-based care (not fee-for-service)

2. Patient-Reported Outcome Measures (PROMs)

ACCESS payments are tied to validated patient-reported outcomes.

Before submitting an ACCESS application, confirm:

Required PROMs for selected track(s):

BH: PHQ-9, GAD-7, WHODAS 2.0 (12-item)
MSK: validated pain/function PROM(s)

PROMs are administered:

At baseline
At required follow-up intervals
At care completion (where applicable)

PROM wording, scales, and scoring are not modified

PROM data is timestamped and attributable to the correct patient and care period

Healthfully supports:

Locked-fidelity PROM instruments
Automated cadence and reminders
Scoring, versioning, and audit evidence suitable for CMS review

3. Outcome & Data Reporting to CMS

Your application must describe how required measures will be submitted to CMS.

Confirm that you can state:

Use of standards-based APIs for CMS reporting

Ability to submit:

Patient-level PROM results
Required vitals and/or clinical data (by track)

Reporting approach supports:

Validation
Error handling
Future CMS schema updates

Healthfully supports:

A CMS reporting adapter that assembles and submits required data
Versioned schemas and submission tracking
Operational dashboards for reporting status

4. Care Coordination & PCP / Referring Clinician Updates

ACCESS requires electronic care updates at defined moments.

Confirm that your application describes:

Identification of the patient’s PCP and/or referring clinician

Electronic care updates sent at:

Care initiation
Clinical milestones
Care completion

Use of HIPAA-compliant secure delivery methods (e.g., Direct Secure Messaging, HIE-supported exchange)

Evidence of “reasonable efforts” if delivery is unsuccessful

Healthfully supports:

Standardized ACCESS Care Update templates
Secure electronic delivery (Direct messaging)
Delivery logs and audit trails

5. Device & Vital Sign Strategy (Required for eCKM / CKM; Optional for Others)

If applying for cardiometabolic tracks, your application must address vital sign capture. CMS requires that blood pressure data used for outcome measurement be source-verifiable and transmitted electronically; manual transcription is not considered compliant

Confirm that you can state:

Blood pressure is collected using validated, FDA-cleared devices

BP readings are not manually entered

Measurement data includes:

Timestamp
Device source
Patient attribution

Data transmission is reliable for Medicare populations

Healthfully supports:

FDA-cleared home BP devices through established device and connectivity partners
Cellular-enabled connectivity (no smartphone or Wi-Fi required)
Automatic data transmission
Source and timestamp preservation for reporting
Device manufacturers and FDA clearance remain with the original OEM. Healthfully provides program integration and data orchestration.

6. Privacy, Security, and Compliance

Your application must confirm compliance with applicable requirements.

Confirm that you can document:

HIPAA compliance as a covered entity

Business Associate Agreements with technology vendors

Administrative, technical, and physical safeguards

No conditioning of care on optional data authorizations

Healthfully supports:

HIPAA-compliant platform infrastructure
Business Associate Agreement
Security posture documentation for application support

7. Final Pre-Submission Check

Before submitting your ACCESS application, confirm:

Selected ACCESS track(s) align with technology and device readiness

PROM strategy is fully described and compliant

Care coordination approach meets CMS requirements

Reporting approach references standards-based CMS APIs

Device strategy (if applicable) addresses provenance and reliability

Supporting documentation is internally reviewed and approved

To see track-specific checklists, see

Download
the checklist

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How Healthfully Supports Applicants

Healthfully provides:

Application‑ready technology documentation
Evidence artifacts and workflow documentation
Optional device kits for cardiometabolic tracks
Implementation support after ACCESS acceptance

Healthfully supports ACCESS applications by providing the technology evidence and operational workflows CMS expects so you can focus on delivering outcomes. Healthfully’s role is limited to technology enablement and documentation support; clinical delivery and compliance remain the responsibility of the ACCESS Participant.

Organizations may contact Healthfully to request application-ready technology documentation

Contact Healthfully

Version control notice
‍This page represents the authoritative ACCESS technology and reporting requirements maintained by Healthfully. Downloadable checklists are provided as reference copies only. Applicants should rely on the live webpage and applicable CMS guidance when preparing ACCESS application responses

This checklist and supporting guidance are maintained by Healthfully, a healthcare technology platform that supports organizations participating in the CMS ACCESS Model.

Healthfully is not affiliated with, endorsed by, or acting on behalf of the Centers for Medicare & Medicaid Services

For Prospective ACCESS Participants

1. Organizational & Clinical Readiness (Participant Responsibility)

2. Patient-Reported Outcome Measures (PROMs)

3. Outcome & Data Reporting to CMS

4. Care Coordination & PCP / Referring Clinician Updates

5. Device & Vital Sign Strategy (Required for eCKM / CKM; Optional for Others)

6. Privacy, Security, and Compliance

7. Final Pre-Submission Check

Download the checklist

How Healthfully Supports Applicants

Organizations may contact Healthfully to request application-ready technology documentation

Download
the checklist