Artificial Hearts and Related Devices - RETIRED — NCD 246 | CMS Coverage Update

TL;DR: The Centers for Medicare & Medicaid Services modified NCD 246 for artificial hearts and related devices, effective January 9, 2026. The section has been retired and consolidated into NCD 20.9.1. Here's what billing teams need to know.

CMS artificial heart coverage policy has been restructured. NCD 246 in the Medicare NCD Manual is now retired. The Centers for Medicare & Medicaid Services folded all artificial heart and related device coverage rules into NCD 20.9.1, with that consolidation effective December 1, 2020 — though the formal retirement entry in NCD 246 reflects an update issued March 9, 2023. The January 9, 2026 version stamp reflects continued administrative maintenance of this retirement record. This policy does not list specific CPT or HCPCS codes.

Quick-Reference Table

CMS Artificial Heart Coverage Criteria and Medical Necessity Requirements 2026

The real issue here is that NCD 246 no longer governs anything. If your billing team or compliance documentation still references NCD 246 as the authority for artificial heart coverage decisions, you're citing a policy that CMS retired over four years ago.

The operative coverage policy is now NCD 20.9.1. That's where CMS artificial heart coverage criteria live. That's where medical necessity determinations for biventricular replacement devices are grounded. Pull NCD 246 out of any internal billing guidelines, prior authorization checklists, or denial appeal templates and replace it with NCD 20.9.1.

The clinical definition hasn't changed with this retirement. An artificial heart remains a biventricular replacement device. It requires removal of a substantial part of the native heart — both ventricles. The device cannot be removed without a heart transplant. The patient dies without one. That clinical reality shapes everything about how coverage policy applies here, and NCD 20.9.1 carries those criteria forward.

CMS maintains NCD 246 in the NCD Manual as a shell entry. It exists to tell you where the content went. Nothing in NCD 246 itself authorizes or denies coverage anymore. If a claim denial references NCD 246 as justification, or if your prior authorization documentation cites NCD 246, that's a documentation problem worth correcting.

Whether Medicare artificial heart reimbursement is available in a specific case depends entirely on NCD 20.9.1, and potentially on applicable local coverage determinations from the relevant Medicare Administrative Contractor. The MAC has discretion in areas where a national coverage determination doesn't resolve every question — and for a device this clinically complex, those gaps exist.

CMS Artificial Heart Exclusions and Non-Covered Indications

NCD 246 itself contains no exclusions. It contains no coverage criteria. It is a retired policy stub pointing to NCD 20.9.1.

What this section is really about is scope. Artificial hearts — as defined by CMS — are biventricular replacement devices requiring excision of both ventricles. Ventricular assist devices (VADs), which support the native heart rather than replace it, fall under different coverage authority. Don't conflate the two when billing or appealing.

If your team is billing for a left ventricular assist device (LVAD) as destination therapy or bridge to transplant and trying to apply NCD 246 logic, stop. Those devices have their own coverage framework. NCD 246 — and by extension NCD 20.9.1 — addresses full biventricular replacement only.

Coverage Indications at a Glance

CMS Artificial Heart Billing Guidelines and Action Items 2026

1. Remove NCD 246 from every internal reference document before your next claims cycle.

This means billing guidelines, payer policy binders, prior authorization checklists, and denial management protocols. Every instance of "NCD 246" should now read "NCD 20.9.1." This is a find-and-replace task, not a clinical decision — but it has real consequences for claim denial management and audit exposure.

2. Pull NCD 20.9.1 and confirm your team has read the current criteria.

The content from NCD 246 was incorporated into NCD 20.9.1 effective December 1, 2020. If your team hasn't reviewed NCD 20.9.1 since then, there's a gap in your coverage policy knowledge that could be costing you on claims or appeals. Get the current policy in front of your cardiac device billing staff.

3. Audit any open appeals that cite NCD 246.

If you have in-flight claim appeals referencing NCD 246 as coverage authority, update them now. An appeal that cites a retired NCD as justification is a weak appeal. Replace the NCD 246 reference with NCD 20.9.1. This is a quick fix with material upside.

4. Confirm prior authorization requirements with the relevant MAC under NCD 20.9.1.

Artificial heart procedures are low-volume and high-cost. Prior authorization requirements, documentation standards, and medical necessity thresholds may have MAC-level nuance that NCD 20.9.1 doesn't fully resolve. Contact your Medicare Administrative Contractor directly if you're preparing a case. Don't assume the national policy answers every question.

5. Update your payer policy tracking to monitor NCD 20.9.1 going forward.

NCD 246 is retired. It won't change substantively again. NCD 20.9.1 is the live policy. That's what needs to be in your tracking system, your alert subscriptions, and your annual coverage policy review cycle. If you were watching NCD 246 for updates, shift that attention to NCD 20.9.1 now.

6. If your compliance documentation references NCD 246 in a formal compliance plan or billing manual, update it before the next compliance review.

This is low-urgency but worth scheduling. Citing a retired NCD in a formal compliance document creates unnecessary audit risk. Flag it for your compliance officer and get it corrected at the next scheduled update cycle.

CPT, HCPCS, and ICD-10 Codes for Artificial Hearts and Related Devices Under NCD 246

Covered CPT and HCPCS Codes

This policy does not list specific CPT or HCPCS codes. NCD 246 is a retired shell policy. All code-level billing guidance for artificial heart devices is governed by NCD 20.9.1. Check NCD 20.9.1 directly for applicable codes.

Key ICD-10-CM Diagnosis Codes

This policy does not list specific ICD-10-CM codes. Applicable diagnosis codes for artificial heart procedures should be confirmed against NCD 20.9.1 and your MAC's local coverage determinations.

The absence of codes in NCD 246 is not a gap in this post — it's an accurate reflection of what the policy contains. Any source that lists codes under NCD 246 is either citing NCD 20.9.1 content or fabricating. Artificial heart billing starts and ends at NCD 20.9.1 for national Medicare guidance.