Leadless Pacemakers — NCD 370 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 370 governing leadless pacemaker coverage, with an effective date of January 9, 2026. Here's what billing teams need to know before submitting claims.

CMS leadless pacemaker coverage policy under NCD 370 has been updated. The policy continues Coverage with Evidence Development (CED) requirements, meaning reimbursement hinges on whether the procedure is performed within a qualifying study. This policy does not list specific CPT or HCPCS codes — your team needs to confirm the right codes with your Medicare Administrative Contractor before billing.

Quick-Reference Table

CMS Leadless Pacemaker Coverage Criteria and Medical Necessity Requirements 2026

NCD 370 is the National Coverage Determination governing Medicare coverage of leadless pacemakers. Coverage is not open — it is conditional. CMS covers leadless pacemakers only through Coverage with Evidence Development (CED), which means your procedure must occur inside a qualifying, CMS-approved study.

This isn't a new concept. CED has been the coverage model for leadless pacemakers since January 18, 2017. The 2026 modification updates the policy terms, but the core structure holds: no approved study, no coverage, no reimbursement.

What CMS actually covers under NCD 370:

CMS covers leadless pacemakers in two scenarios. First, the procedure must be performed in an FDA-approved study. Second — and this is the broader pathway — CMS covers leadless pacemakers in prospective longitudinal studies when the device is used within its FDA-approved label, and the device either has an ongoing FDA post-approval study or has already completed one.

Both pathways require the study to be reviewed and approved by CMS. The study must be posted on CMS's CED website to qualify.

Medical necessity under this policy is study-dependent. A physician's order alone does not satisfy medical necessity under NCD 370. The clinical indication must align with the FDA-approved label, and the patient must be enrolled in a qualifying study. If either condition is absent, the claim will not meet medical necessity criteria under this coverage policy.

The benefit categories covered are inpatient hospital services, physicians' services, and prosthetic devices. That's a wide scope — it means facility billing, professional billing, and device billing all fall under NCD 370. If your team bills across any of these categories for a leadless pacemaker procedure, this policy applies to you.

Prior authorization isn't explicitly required by NCD 370 itself. But your Medicare Administrative Contractor may impose prior auth or documentation requirements at the local level. Don't assume national coverage alone clears the claim. Check with your MAC before the procedure date.

CMS Leadless Pacemaker Study Criteria and CED Requirements

This is where the billing complexity lives. CMS won't just accept that a study exists — it evaluates each study against 13 criteria. Your facility needs to confirm the study you're participating in has cleared all 13 before billing under NCD 370.

Here's what CMS looks for. The study must have a principal purpose of testing whether the device improves health outcomes for enrolled Medicare beneficiaries. The rationale must be supported by scientific and medical evidence. The results must not duplicate existing knowledge without justification.

The study design must be methodologically sound. The enrolled subject count must be sufficient to answer the specific research questions defined in the NCD. The sponsor must be capable of completing the study. All 13 criteria appear in the full NCD text — ask your compliance officer to walk through them against your current study before your next billing cycle.

Three research questions must be addressed in every qualifying study's protocol:

1. What are the peri-procedural and post-procedural complications of leadless pacemakers?
2. What are the long-term outcomes of leadless pacemakers?
3. How do patient characteristics — age, gender, comorbidities — affect the use and health effects of leadless pacemakers?

These aren't optional. They must be a fully-described, written part of the study protocol. If the study your facility uses doesn't explicitly address all three, it may not qualify for CED coverage. That creates denial risk on every claim tied to that study.

The real issue here: many billing teams treat CED as a background condition — "someone approved this study, so we're good." That's not enough. You need written confirmation that your specific study is posted on CMS's CED website. Pull that confirmation and keep it in your documentation file. If a claim gets audited, you'll need it.

Coverage Indications at a Glance

CMS Leadless Pacemaker Billing Guidelines and Action Items 2026

The NCD 370 update took effect January 9, 2026. If your team has been billing leadless pacemaker claims, review every open claim and make sure the supporting documentation is airtight.

CPT, HCPCS, and ICD-10 Codes for Leadless Pacemakers Under NCD 370

A Note on Codes Under NCD 370

This policy does not list specific CPT, HCPCS, or ICD-10 codes. That's not unusual for a national coverage determination of this type — NCD 370 defines the coverage conditions, not the billing codes directly.

For leadless pacemaker billing, your team needs to work with your MAC to confirm the correct procedure codes. Historically, leadless pacemaker procedures have been billed under specific CPT codes for transcatheter pacemaker insertion — but those codes must be verified against your MAC's current fee schedule and any local coverage determination your MAC has published.

Do not use codes from older claim examples or assume historical billing patterns still apply. Get written guidance from your MAC. Document that guidance. Keep it with your billing guidelines file for NCD 370.