CMS NCD 20.9 Artificial Hearts Coverage: What the Retirement of NCD 246 Means for Your Billing Team
CMS has officially retired NCD 246, the standalone National Coverage Determination covering artificial hearts and related devices. The policy content hasn't disappeared—it has been consolidated into NCD 20.9.1, effective December 1, 2020, with this retirement formalized in the NCD Manual revision issued March 9, 2023. If your team is still referencing NCD 246 when billing Medicare claims for biventricular replacement devices, you're working from a defunct policy number that no longer exists as an independent entry.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Artificial Hearts and Related Devices — RETIRED |
| Policy Code | NCD 246 |
| Change Type | Modified (Retirement / Consolidation) |
| Effective Date | 2026-03-12 (policy key updated) |
| Impact Level | Medium |
| Specialties Affected | Cardiothoracic Surgery, Advanced Heart Failure, Cardiac Device Implantation, Hospital Revenue Cycle |
| Key Action | Update all internal policy references from NCD 246 to NCD 20.9.1 and verify current clinical and billing criteria under the consolidated NCD. |
What CMS NCD 246 Covered — And Why It No Longer Exists as a Standalone Policy
Artificial hearts occupy a narrow but clinically significant corner of Medicare coverage. The device at the center of this NCD is a biventricular replacement—meaning both ventricles of the native heart are removed and replaced with a mechanical system. This is not a ventricular assist device (VAD). This is full biventricular replacement, and the clinical stakes are extreme: removing this device is incompatible with life unless the patient undergoes a heart transplant.
Given that clinical reality, CMS has always treated these devices as prosthetic devices under the Medicare benefit category structure—not as durable medical equipment. That classification matters for how claims are constructed, which benefit category applies, and how medical necessity is documented.
NCD 246 previously stood as the independent policy home for artificial heart coverage criteria. CMS folded that content into NCD 20.9.1 effective December 1, 2020. The March 2023 NCD Manual revision (Rev. 11892) completed the administrative process by formally removing the section from the manual entirely. What you're seeing in policy key 246-v8 is the final housekeeping step—confirming the retirement is complete.
CMS Artificial Heart Coverage Under NCD 20.9.1: What Billing Teams Need to Know
Because NCD 246 has been retired in favor of NCD 20.9.1, your operative policy reference for Medicare billing of artificial hearts is now exclusively NCD 20.9.1. Any internal coverage guides, pre-authorization checklists, or payer contract reference documents that cite NCD 246 should be updated immediately.
The Centers for Medicare & Medicaid Services structured this consolidation to reduce fragmentation across related cardiac device policies. NCD 20.9 serves as the parent section for cardiac devices, with NCD 20.9.1 housing the specific coverage criteria that formerly lived in NCD 246.
For billing managers: this is an administrative consolidation, not a coverage restriction or expansion. The clinical criteria governing whether CMS will cover an artificial heart implantation have not been eliminated—they've migrated. Your team needs to be looking in the right place.
Clinical Context: What Makes Artificial Heart Billing High-Stakes
The biventricular replacement device is one of the most clinically complex items in the Medicare fee-for-service billing environment. A few points that directly affect how you document and bill:
Device permanence: Because removal without transplant is lethal, artificial hearts are not implanted as a bridge-to-recovery option in the way some VADs are. The indication—and the documentation supporting it—must reflect the severity and irreversibility of the patient's condition.
Benefit category: CMS classifies artificial hearts under prosthetic devices, not DME. Billing under the wrong benefit category is a common denial driver for high-cost cardiac device claims. Make sure your team is applying the correct benefit category on the claim.
Cross-reference compliance: With NCD 246 retired and all governing language now in NCD 20.9.1, any Medicare Administrative Contractor (MAC) reviews or audits will reference NCD 20.9.1. If your documentation or appeal language cites NCD 246, it won't align with the current NCD Manual—a fixable but avoidable problem.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
The policy data for NCD 246 (policy key 246-v8) does not list specific CPT or HCPCS codes. This is consistent with the retirement status of the policy—code-level billing guidance for artificial hearts now resides in NCD 20.9.1.
No codes are listed under NCD 246. Do not reference NCD 246 as a code source in claims or appeals. For applicable procedure and device codes, consult NCD 20.9.1 directly through the CMS NCD Manual or your MAC's local coverage resources.
There are no ICD-10-CM diagnosis codes, CPT codes, or HCPCS Level II codes enumerated in the NCD 246 retirement policy document.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Update internal policy references within 30 days. Audit any billing guides, payer policy binders, or EHR-based coverage rules that cite NCD 246. Replace every reference with NCD 20.9.1. This includes appeal letter templates, prior authorization request forms, and pre-service review checklists. |
| 2 | Pull and review NCD 20.9.1 in full. Your team needs to confirm the current medical necessity criteria, coverage conditions, and any applicable HCPCS or CPT codes listed under NCD 20.9.1. Do not assume that because NCD 246 had no codes listed, the consolidated NCD is code-free—verify directly. |
| 3 | Audit any pending or recently denied claims that referenced NCD 246. If a claim was submitted or an appeal was filed citing NCD 246 as the coverage authority, review whether the denial or adjudication result may have been affected by the incorrect NCD citation. Resubmit or supplement with the correct NCD 20.9.1 reference if necessary. |
| 4 | Confirm benefit category designation on all future claims. Artificial hearts are billed under the prosthetic devices benefit category. Verify your claim build reflects this—not DME—before submission to avoid preventable denials. |
| 5 | Flag this change for your MAC outreach contacts. If your facility implants artificial hearts or manages post-implant billing, confirm with your regional MAC how they want NCD 20.9.1 cited on claims and in prior authorization requests going forward. |
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