CMS Cardiac Contractility Modulation Coverage Policy Updated for 2026 (NCD 383)

The Centers for Medicare & Medicaid Services has modified its National Coverage Determination for Cardiac Contractility Modulation (CCM) in heart failure management, effective March 12, 2026. This update to NCD 383 establishes Coverage with Evidence Development (CED) as the pathway for Medicare reimbursement, meaning coverage is conditional — and the conditions are detailed. If your facility implants or manages CCM devices, your billing and clinical teams need to understand exactly what CMS now requires before a claim hits the payer.

Field	Detail
Payer	CMS (Centers for Medicare & Medicaid Services)
Policy	Cardiac Contractility Modulation (CCM) for Heart Failure (HF)
Policy Code	NCD 383
Change Type	Modified
Effective Date	2026-03-12
Impact Level	High
Specialties Affected	Cardiology, Cardiac Electrophysiology, Cardiac Surgery, Hospital Outpatient Billing, Cardiac Device Clinics
Key Action	Confirm your facility is enrolled in or affiliated with a CMS-approved CED study before implanting or billing for CCM services.

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What Is Cardiac Contractility Modulation and Why This NCD 383 Update Matters

Cardiac Contractility Modulation is a device-based therapy for heart failure that delivers non-excitatory electrical signals to the myocardium to improve cardiac contractility. It targets patients who remain symptomatic despite optimized medical therapy — a population that has limited device-based options, particularly those who don't qualify for cardiac resynchronization therapy (CRT).

The significance of this NCD 383 modification is that CMS has moved CCM into Coverage with Evidence Development (CED) status. CED isn't a blanket denial — it's conditional coverage. Medicare will pay for CCM and related items and services, but only when the treatment is furnished as part of a CMS-approved research study that meets specific scientific and protocol standards. For billing teams, that distinction is everything.

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CMS CCM Coverage Criteria: Who Qualifies Under NCD 383

Patient Eligibility Requirements

Under the updated NCD 383, CMS covers CCM for heart failure management when all of the following patient-level criteria are satisfied:

That GDMT requirement deserves attention in documentation. "At least three months" isn't a checkbox — it means clinical notes, medication records, and the heart team's formal determination need to be in the chart before implantation occurs. If those records aren't there, the claim is at risk.

Who Is Explicitly Excluded from Coverage

CMS has identified three hard exclusions. Patients are not eligible for CCM coverage under NCD 383 if they:

#	Covered Indication Copy
1	Meet any FDA-labeled contraindication for the device
2	Have previously undergone a heart transplant
3	Are under 18 years old

These aren't medical necessity judgment calls — they're categorical exclusions. Any claim submitted for a patient in one of these categories will face denial.

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The CED Study Requirement: What CMS Expects From Participating Sites

This is where NCD 383 gets operationally complex. Coverage doesn't exist outside of a CMS-approved CED study. The CCM implantation and all related items and services must be furnished within the context of that study. There is no "standard" Medicare coverage pathway for CCM independent of CED participation as of the effective date.

What a CMS-Approved CED Study Must Include

CMS has defined the required elements of any approved study protocol. Each approved protocol must incorporate:

Primary outcomes tracked through a minimum of 24 months:

• All-cause mortality
• Heart failure hospitalizations
• Or a composite of both — with each component reported individually

Study design elements:

• An active comparator arm (not placebo or sham)
• A care management plan identifying the clinical team members, their roles, and their responsibilities for follow-up CCM patient management
• Design sufficient to support subgroup analyses across the following strata:

Subgroup Variable	Required Strata
Age	Under 65 / 65–74 / 75 and older
Cardiomyopathy etiology	Ischemic vs. non-ischemic
CRT status	No CRT vs. CRT
LVEF	≥35% vs. <35%
Systolic blood pressure	At or above median vs. below median
Diabetes status	Diabetic vs. non-diabetic
Other demographics	Clinically important factors

These subgroup strata aren't optional. A study protocol that doesn't allow for these analyses won't receive CMS approval — and a facility enrolling patients in a non-approved study won't have a coverage pathway.

AHRQ Scientific Standards Compliance

In addition to the protocol requirements above, CMS requires that all approved CED studies adhere to 17 scientific standards identified by the Agency for Healthcare Research and Quality (AHRQ), as set forth in CMS's Coverage with Evidence Development Guidance Document published August 7, 2024. These standards address:

• Sponsor and investigator qualifications and resources
• Written milestone plans covering enrollment progress, interim reporting, and final results
• ClinicalTrials.gov registration with a complete final protocol — including the statistical analysis plan — delivered to CMS before study initiation
• Scientific rationale and evidence sufficiency to address CMS-identified evidence gaps

The practical implication: your institution's research or compliance team needs to verify that the specific CED study your facility is participating in has been formally approved by CMS and meets all AHRQ criteria. Participation in any CCM study is not automatically equivalent to CED-eligible participation.

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Benefit Categories Under NCD 383

CMS has designated CCM as potentially covered under multiple Medicare benefit categories:

• Outpatient Hospital Services Incident to a Physician's Service
• Physicians' Services
• Prosthetic Devices

CMS notes this may not be an exhaustive list. The "Prosthetic Devices" category is notable — it signals how CMS is classifying the CCM device itself, which has implications for how facilities bill for the device component versus the implantation procedure.

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Affected Codes

The current version of NCD 383 does not list specific CPT or HCPCS codes. CMS has not enumerated procedure codes within the published policy at this time. Billing teams should monitor for any associated Local Coverage Determinations (LCDs), transmittals, or claims processing instructions from their Medicare Administrative Contractor (MAC) that assign codes to CCM services under this NCD.

For reference, this policy has no associated ICD-10-CM diagnosis codes listed in the NCD document itself. Documentation of heart failure diagnosis and GDMT history remains essential for medical necessity support regardless of which codes are ultimately used.

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What Your Billing Team Should Do

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