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ACCESS Model

Resource Packet

Your Complete Guide to the CMS ACCESS Model

Advancing Chronic Care with Effective, Scalable Solutions

Model Duration: July 5, 2026 – June 30, 2036

Table of Contents

1Eligibility Checklist
2Clinical Tracks Quick Reference
3Timeline & Key Dates
4Outcome-Aligned Payments Explained
5Guide for PCPs & Referring Providers
6Technology & FDA Compliance
1

Eligibility Checklist

Use this checklist to determine if your organization qualifies to participate in the ACCESS Model.

Organization Requirements

Medicare Part B Enrollment — Organization must be enrolled in Medicare Part B as a provider or supplier
Exclusions Check — Organization is NOT a DME, Prosthetics, Orthotics, Supplies supplier or laboratory supplier
Active TIN — Organization has an active Taxpayer Identification Number

Leadership Requirements

Clinical Director — Designated a Medicare-enrolled physician to serve as Clinical Director
Clinical Oversight — Clinical Director will oversee care quality and compliance
Compliance Responsibility — Clinical Director accepts responsibility for regulatory compliance

Compliance Requirements

State Licensure — Organization complies with all applicable state licensure requirements
HIPAA Compliance — Organization is a HIPAA-covered entity with privacy and security policies in place
FDA Compliance — If using digital health tools/devices, organization meets FDA requirements or operates under FDA enforcement discretion

Technical Requirements

API Readiness — Organization can report required measures via CMS-hosted APIs
HIE Integration — Organization can integrate with a Health Information Exchange or similar trusted network
Electronic Updates — Organization can send electronic care plans and updates to referring clinicians
2

Clinical Tracks Quick Reference

ACCESS launched with four clinical tracks addressing common chronic conditions. Five more tracks start April 1, 2027.

Early Cardio-Kidney-Metabolic (eCKM)

Conditions: Hypertension (high blood pressure), OR two or more of: dyslipidemia, obesity/overweight with central obesity marker, prediabetes
Outcomes: Control or minimum improvement in blood pressure, lipids, weight, and HbA1c
Continuation: Yes

Cardio-Kidney-Metabolic (CKM)

Conditions: One or more of: Diabetes mellitus, Chronic kidney disease (Stage 3a or 3b), Atherosclerotic cardiovascular disease
Outcomes: Control or minimum improvement in BP, lipids, weight, HbA1c; submission of eGFR and UACR data
Continuation: Yes

Musculoskeletal (MSK)

Conditions: Chronic musculoskeletal pain (pain lasting more than 3 months)
Outcomes: Minimum improvement in pain intensity, interference, and overall function via validated PROM
Continuation: No

Behavioral Health (BH)

Conditions: Depression, Anxiety, or both
Outcomes: Minimum improvement in PHQ-9 (depression) and/or GAD-7 (anxiety); submission of WHODAS 2.0
Continuation: Yes

Coming April 1, 2027

Announced September 15, 2026. Current participants and applicants do not need to reapply. Outcome measures and payment amounts are not yet published.

Heart Failure · COPD · Substance Use Disorder · Tobacco Cessation · Chronic MSK Pain Follow-On Period

3

Timeline & Key Dates

Model Duration

10 Years: July 5, 2026 – June 30, 2036

Application Timeline

July 5, 2026Model launched — First cohort began (160+ organizations)
September 15, 2026CMS announced five new tracks
October 1, 2026Application deadline for January 2027 start
January 1, 2027Second cohort begins
April 1, 2027New tracks begin: heart failure, COPD, substance use disorder, tobacco cessation, MSK follow-on
Through 2033Rolling admissions continue

Preparation Checklist

Before You Apply

  • Review eligibility requirements
  • Assess organizational readiness
  • Identify clinical track(s)
  • Begin Medicare Part B enrollment

Application to Onboarding

  • Submit application via CMS portal
  • Prepare API reporting infrastructure
  • Establish HIE integration
  • Train staff on outcome measurement
4

Outcome-Aligned Payments Explained

OAPs are a new payment approach that rewards results rather than activities.

Traditional Fee-for-Service

  • • Payment tied to specific activities
  • • Pays for volume of services
  • • Prescriptive service requirements
  • • Activity-based billing

Outcome-Aligned Payments

  • • Payment tied to health outcomes
  • • Pays for results
  • • Flexibility in care delivery
  • • Recurring condition management payments

Example Outcome Targets

ConditionExample Target
HypertensionLower blood pressure by 10 mmHg OR reach guideline target
DiabetesImprove HbA1c by defined amount OR reach control target
DepressionAchieve minimum improvement on PHQ-9 score
Chronic PainDemonstrate improvement in pain intensity and function
5

Guide for PCPs & Referring Providers

ACCESS is designed to complement traditional care, not replace it.

How to Refer Patients

1

Identify Eligible Patients

Patients with Original Medicare who have qualifying conditions in one of the clinical tracks.

2

Review ACCESS Directory

CMS will maintain a public directory with participant outcomes to help patients make informed choices.

3

Make the Referral

Refer patient to appropriate ACCESS organization, or patient can self-enroll directly.

4

Receive Updates

ACCESS organizations must electronically share care plans, progress updates, and completion notifications.

Co-Management Payment

Bill for coordinating care with ACCESS organizations. Document review of patient updates and coordination actions taken.

No beneficiary cost-sharing for co-management payments.

6

Technology & FDA Compliance

Many digital tools used in ACCESS may be subject to FDA oversight.

FDA Compliance Options

Option 1: FDA-Authorized Devices

Device has received FDA clearance (510(k)), approval (PMA), or De Novo authorization.

Option 2: FDA Enforcement Discretion

FDA has stated it does not intend to enforce requirements for certain low-risk devices (e.g., general wellness products).

Option 3: FDA TEMPO Pilot

Coordinated FDA-CMS review pathway for innovative devices. Products reviewed through TEMPO may be well-suited for ACCESS.

Digital Health Tool Checklist

Regulatory

Determined if product meets device definition
Identified FDA regulatory pathway
Confirmed clearance/approval or enforcement discretion

Technical

Can integrate with CMS reporting APIs
Supports HIE data exchange
Uses standard data formats (FHIR)

Quick Reference

Key Contacts

Email: ACCESSModelTeam@cms.hhs.gov

Interest Form: app.innovation.cms.gov/ACCESSLOI

RFA: cms.gov/priorities/innovation/files/access-rfa.pdf

Critical Dates

July 5, 2026: Model launched

October 1, 2026: Next cohort deadline

April 1, 2027: New tracks begin

June 30, 2036: Model ends

The Tracks (April 2027: + Heart Failure, COPD, Substance Use Disorder, Tobacco Cessation, MSK Follow-On)

eCKM
Early Cardio-Kidney-Metabolic
CKM
Cardio-Kidney-Metabolic
MSK
Musculoskeletal
BH
Behavioral Health