ACCESS Application Support Checklist — Technology & Reporting Requirements by Track

Prepared for prospective ACCESS applicants to the Centers for Medicare & Medicaid Services.

1. Behavioral Health (BH) Track

Conditions: Depression, Anxiety

A. Clinical & Outcome Requirements (Applicant must address)

Treats one or more qualifying BH conditions (depression and/or anxiety)

Uses validated outcome measures for symptom improvement

Provides longitudinal, outcome-based care (not encounter-only)

B. Required PROMs (CMS-defined)

PHQ-9 (depression)

GAD-7 (anxiety)

WHODAS 2.0 (12-item) for overall functioning

PROMs collected at:

Baseline
Quarterly intervals
End of care (where applicable)

PROM wording, response scales, and scoring are not modified

Healthfully supports:

Locked-fidelity PHQ-9, GAD-7, WHODAS
Automated cadence and reminders
Scoring, versioning, timestamps, audit logs

C. Care Coordination

Ability to identify PCP and/or referring clinician

Secure electronic care updates sent at:

Enrollment
Clinical milestones
Completion

Updates sent via HIPAA-compliant methods (e.g., Direct Secure Messaging)

Evidence of reasonable delivery efforts retained

Healthfully supports:

ACCESS care-update workflows
Secure delivery + delivery evidence logs

D. CMS reporting adapter

Standards-based API submission approach

Patient-level PROM data submission

Reporting supports validation and resubmission

Healthfully supports:

CMS reporting adapter for PROM submission
Submission tracking and error handling
CMS defines clinical eligibility and outcome thresholds; Healthfully supports the technical capture, validation, and reporting of required data.

2. Musculoskeletal (MSK) Track

Condition: Chronic musculoskeletal pain (>3 months)

A. Clinical & Outcome Requirements

Treats chronic MSK pain

Focus on pain reduction, functional improvement, and interference

Uses validated PROMs to demonstrate improvement

B. Required PROMs

One or more validated MSK PROMs, such as:

Brief Pain Inventory (BPI-SF)
Quick
DASHLEFS
ODI / NDI

PROMs collected:

Baseline
Quarterly
End of care

PROM structure and scoring are not altered

Healthfully supports:

Standardized MSK PROM reporting instruments
Locked instrument fidelity
Automated cadence and scoring
Audit-ready documentation

C. Care Coordination

Secure care updates to PCP/referrer at required moments

Delivery via HIPAA-compliant electronic methods

Documentation of delivery attempts

Healthfully supports:

Standard MSK-specific care update workflows
Direct Secure Messaging + evidence logs

D. CMS Reporting

Submission of PROM-based outcome improvement

Standards-based API reporting

Healthfully supports:

PROM-centric CMS reporting
Longitudinal outcome tracking per care period
CMS defines clinical eligibility and outcome thresholds; Healthfully supports the technical capture, validation, and reporting of required data.

3. Early Cardio-Kidney-Metabolic (eCKM) Track

Conditions: Hypertension ± dyslipidemia, obesity/overweight, prediabetes

A. Clinical & Outcome Requirements

Treats hypertension or qualifying eCKM combinations

Demonstrates improvement or control of:

Blood pressure
Weight / central obesity markers
Lipids and/or HbA1c (as applicable)

B. Vital Signs & Device Requirements (Critical)

Blood pressure collected using validated, FDA-cleared upper-arm BP devices

BP readings are not manually entered

BP data includes:

Timestamp
Device source
Patient attribution

Reliable data capture for Medicare populations

Healthfully Device Kit supports

FDA-cleared home BP devices through established device and connectivity partners
Cellular connectivity (no smartphone/Wi-Fi dependency)
Automatic data transmission
Provenance-preserved ingestion

C. PROMs (Supplemental)

Patient-reported measures used as appropriate to supplement vitals

PROM fidelity maintained

Healthfully supports:

PROM capture alongside vitals
Unified reporting pipeline

D. Care Coordination

Care updates to PCP/referrer at enrollment, milestones, completion

Secure electronic delivery

Documentation of delivery attempts

Healthfully supports:

Cardio-metabolic care update workflows
Delivery + audit logs

E. CMS Reporting

Submission of BP improvement/control data

Standards-based API reporting

Healthfully supports:

Device + PROM reporting adapter
Schema-versioned submissions
CMS defines clinical eligibility and outcome thresholds; Healthfully supports the technical capture, validation, and reporting of required data.

4. Cardio-Kidney-Metabolic (CKM) Track

Conditions: Diabetes, CKD (3a/3b), ASCVD

A. Clinical & Outcome Requirements

Treats hypertension or qualifying eCKM combinations

Demonstrates improvement/control of:

Blood pressure
Weight
Lipids
HbA1c

CKD-specific labs reported where applicable:

eGFR
UACR

B. Device & Data Provenance (Required)

FDA-cleared BP devices

No manual BP entry

Source-verifiable measurements

Reliable data capture for Medicare populations

Healthfully Device Kit supports

Home BP capture with reliable transmission devices through established device and connectivity partners
Provenance metadata retained for reporting

C. Laboratory Data Strategy

Plan for receiving lab results (e.g., EMR, lab interfaces, HIE)

Lab data aligned to CMS reporting windows

Healthfully supports:

Normalization of lab values for CMS reporting (where integrated)
Attribution to care periods

D. Care Coordination

PCP/referrer updates at defined milestones

Secure electronic delivery

Delivery evidence retained

Healthfully supports:

Care‑update workflows
Secure delivery + logs

E. CMS reporting adapter

Submission of vitals, labs, and outcomes via CMS APIs

Ability to support future schema updates

Healthfully supports:

CKM-ready reporting adapter
Submission tracking and error remediation

4. Final Track-Specific Pre-Submission Check

For each ACCESS track selected, confirm:

Required PROMs identified and compliant

Device strategy defined (if applicable)

Care coordination delivery method specified

CMS reporting approach described

Roles and responsibilities are clearly articulated

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the checklist

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Guidance for applicants

Your ACCESS application should demonstrate that outcome measurement, care coordination, and CMS reporting are operational realities—not future plans—and Healthfully provides the enabling technology to support this across each track.

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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

ACCESS Application Support Checklist — Technology & Reporting Requirements by Track

1. Behavioral Health (BH) Track

2. Musculoskeletal (MSK) Track

3. Early Cardio-Kidney-Metabolic (eCKM) Track

4. Cardio-Kidney-Metabolic (CKM) Track

4. Final Track-Specific Pre-Submission Check

Download the checklist

Guidance for applicants

Download
the checklist