CMS Leadless Pacemakers Coverage Policy Update (NCD 370): What Billing Teams Need to Know for 2026

The Centers for Medicare & Medicaid Services has modified its National Coverage Determination for leadless pacemakers under NCD 370, with an updated effective date of March 12, 2026. This policy governs Medicare coverage for catheter-delivered, leadless cardiac pacing devices—a technology that eliminates the need for a traditional device pocket and transvenous lead. Billing and revenue cycle teams working with electrophysiology, cardiology, or cardiac surgery practices need to understand exactly how Coverage with Evidence Development (CED) requirements apply before submitting claims.

What CMS Covers Under NCD 370: Leadless Pacemaker Coverage Requirements

Medicare coverage for leadless pacemakers is not unconditional. Under NCD 370, the Centers for Medicare & Medicaid Services covers leadless pacemakers exclusively through Coverage with Evidence Development (CED)—a framework that ties Medicare payment to participation in qualifying clinical research.

CED coverage has been in place since January 18, 2017, and the 2026 modification continues and refines that framework. Coverage is available in two scenarios:

1. FDA-approved studies — Procedures performed as part of an active, FDA-approved investigational study qualify for coverage.
2. Prospective longitudinal studies — Procedures using devices in accordance with their FDA-approved labeling qualify when the device either has an associated ongoing FDA post-approval study, or has already completed an FDA post-approval study.

The distinction matters for billing. A leadless pacemaker implanted outside of a qualifying study structure is not a covered Medicare benefit under this NCD, regardless of medical necessity.

CMS Study Approval Criteria: What Qualifies as a CED Study Under NCD 370

Not every study automatically qualifies. CMS evaluates prospective studies against 13 criteria before approving them for CED purposes. Approved studies are posted to the CMS Coverage with Evidence Development website.

The research questions that every qualifying study must address include:

Key criteria from CMS's 13-point framework include requirements that the study:

If a study does not meet all 13 criteria, procedures performed under it do not qualify for Medicare coverage under NCD 370. Billing for those procedures exposes your practice or facility to denial and potential recoupment risk.

Benefit Categories and Site-of-Service Considerations

NCD 370 applies across multiple Medicare benefit categories:

• Inpatient Hospital Services
• Physicians' Services
• Prosthetic Devices

This multi-category structure means the policy can affect claims billed under Part A (facility/inpatient) and Part B (professional services, prosthetic device allowances) simultaneously. Facilities and professional billers need to coordinate to ensure both sides of the claim reflect compliant CED study enrollment documentation.

Affected Codes

The policy document for NCD 370 (Policy Key: 370-v1) does not list specific CPT or HCPCS codes in this version. CMS has not enumerated procedure codes directly within this NCD as published.

Action required: Contact your Medicare Administrative Contractor (MAC) to confirm the current procedure codes accepted for leadless pacemaker claims under CED coverage. MACs may publish local coverage articles (LCAs) that accompany this NCD and provide code-level billing guidance. Do not assume legacy codes from prior versions are still applicable without MAC confirmation.

Related ICD-10 Diagnosis Codes: The policy does not enumerate specific ICD-10-CM codes. Medical necessity documentation should support the cardiac indication for pacing (e.g., sick sinus syndrome, atrioventricular block) in accordance with the FDA-approved device labeling, but NCD 370 itself does not restrict coverage to a defined diagnosis code list.

What Your Billing Team Should Do