TL;DR: The Centers for Medicare & Medicaid Services modified NCD 110 governing ICD implantable cardioverter defibrillator coverage, effective March 7, 2026. Here's what your billing team needs to know.
CMS ICD coverage policy under NCD 110 Medicare has four distinct coverage indications — each with its own clinical gatekeeping requirements. This policy does not list specific CPT or HCPCS codes in the current published version, but the medical necessity criteria are detailed and strict. Get these criteria wrong on your documentation, and the claim denial risk is high.
| Field | Detail |
|---|---|
| Payer | CMS (Centers for Medicare & Medicaid Services) |
| Policy | Implantable Cardioverter Defibrillators (ICDs) — NCD 110 |
| Policy Code | NCD 110 |
| Change Type | Modified |
| Effective Date | March 7, 2026 |
| Impact Level | High |
| Specialties Affected | Cardiology, Electrophysiology, Cardiac Surgery, Cardiac Rehabilitation |
| Key Action | Audit documentation for shared decision-making requirements before billing ICD implantation for B2, B3, and B4 indications |
CMS Implantable Cardioverter Defibrillator Coverage Criteria and Medical Necessity Requirements 2026
NCD 110 is the National Coverage Determination governing Medicare coverage of implantable cardioverter defibrillators. The Centers for Medicare & Medicaid Services classifies ICDs under the Prosthetic Devices benefit category.
The coverage policy has been effective for services on or after February 15, 2018, and this 2026 modification keeps the four-indication structure intact. What matters for your billing team is understanding which indication applies to each patient — because the documentation requirements differ materially depending on that classification.
Indication B1: Prior History of Sustained VT or Cardiac Arrest from VF
This is the most straightforward indication. CMS covers an ICD when the patient has a personal history of sustained ventricular tachyarrhythmia (VT) or cardiac arrest due to ventricular fibrillation (VF).
The patient must have documented either an episode of sustained VT — spontaneous or induced by an electrophysiology (EP) study — not associated with an acute myocardial infarction and not due to a transient or reversible cause, or a cardiac arrest due to VF, again not due to a transient or reversible cause.
No shared decision-making requirement applies here. That distinction matters for billing. Clean documentation of the qualifying VT or VF episode gets you through medical necessity review.
Indication B2: Prior MI with LVEF ≤ 0.30
CMS covers ICD implantation for patients with a prior myocardial infarction and a measured left ventricular ejection fraction (LVEF) at or below 0.30. Four conditions disqualify a patient from this indication:
| # | Covered Indication |
|---|---|
| 1 | New York Heart Association (NYHA) Class IV heart failure |
| 2 | CABG or PCI with angioplasty and/or stenting within the past three months |
| 3 | MI within the past 40 days |
| 4 | Clinical symptoms or findings that make the patient a candidate for coronary revascularization |
This is where shared decision-making becomes mandatory. Before initial ICD implantation under B2, a formal shared decision-making encounter must occur. It must happen between the patient and a physician under §1861(r)(1) of the Social Security Act, or a qualified non-physician practitioner — meaning a physician assistant, nurse practitioner, or clinical nurse specialist under §1861(aa)(5). The encounter must use an evidence-based decision tool on ICDs. It can happen at a separate visit from the implantation.
Document the shared decision-making encounter in the medical record before you bill. If it's missing, plan for a denial.
Indication B3: Severe Ischemic Dilated Cardiomyopathy, No Prior VT/VF History
CMS covers ICD implantation for patients with severe, ischemic, dilated cardiomyopathy — but no personal history of sustained VT or cardiac arrest from VF — when they meet all of these criteria:
| # | Covered Indication |
|---|---|
| 1 | NYHA Class II or III heart failure |
| 2 | LVEF ≤ 35% |
| 3 | No CABG or PCI within the past three months |
| 4 | No MI within the past 40 days |
| 5 | No clinical findings making them a revascularization candidate |
Shared decision-making using an evidence-based tool is required here too, same standards as B2.
Indication B4: Severe Non-Ischemic Dilated Cardiomyopathy, No Prior VT/VF History
This indication mirrors B3 but applies to non-ischemic cardiomyopathy. The clinical criteria are the same — NYHA Class II or III, LVEF ≤ 35%, same three exclusions — with one additional requirement: the patient must have been on optimal medical therapy for at least three months before ICD implantation.
That three-month optimal medical therapy window is a hard requirement. Document it explicitly. Shared decision-making is mandatory under the same standards as B2 and B3.
CMS ICD Exclusions and Non-Covered Indications
NYHA Class IV heart failure disqualifies patients from B2, B3, and B4 coverage. CMS has drawn a clear line here. A patient in Class IV does not qualify under these indications, regardless of their LVEF.
Recent revascularization is also a bar to coverage under B2, B3, and B4. If the patient had CABG or PCI with angioplasty and/or stenting within the past three months, the ICD is not covered under these indications. Same rule for an MI within the past 40 days.
Clinical candidates for coronary revascularization are excluded from B2, B3, and B4 coverage. If the attending physician finds symptoms or findings suggesting revascularization is appropriate, document why ICD implantation was selected instead — or expect scrutiny on the claim.
Coverage Indications at a Glance
| Indication | Status | Key Clinical Criteria | Shared Decision-Making Required? |
|---|---|---|---|
| B1: Prior sustained VT or cardiac arrest due to VF | Covered | Documented VT (spontaneous or EP-induced) or VF arrest; not associated with acute MI or transient/reversible cause | No |
| B2: Prior MI, LVEF ≤ 0.30 | Covered | LVEF ≤ 0.30; no NYHA Class IV HF; no CABG/PCI in past 3 months; no MI in past 40 days; not a revascularization candidate | Yes — must use evidence-based tool |
| B3: Ischemic dilated cardiomyopathy, no VT/VF history | Covered | NYHA Class II or III; LVEF ≤ 35%; no CABG/PCI in past 3 months; no MI in past 40 days; not a revascularization candidate | Yes — must use evidence-based tool |
| B4: Non-ischemic dilated cardiomyopathy, no VT/VF history | Covered | NYHA Class II or III; LVEF ≤ 35%; ≥ 3 months optimal medical therapy; no CABG/PCI in past 3 months; no MI in past 40 days; not a revascularization candidate | Yes — must use evidence-based tool |
| NYHA Class IV with no VT/VF history | Not Covered | Class IV heart failure disqualifies from B2, B3, B4 | N/A |
| Post-CABG/PCI (within 3 months) with no VT/VF history | Not Covered | Recent revascularization disqualifies from B2, B3, B4 | N/A |
| Post-MI (within 40 days) with no VT/VF history | Not Covered | Recent MI disqualifies from B2, B3, B4 | N/A |
CMS ICD Billing Guidelines and Action Items 2026
This policy has real financial exposure. ICD implantation is a high-cost procedure, and claim denial on documentation grounds is common. Here are the specific steps your team should take before and after the effective date of March 7, 2026.
| # | Action Item |
|---|---|
| 1 | Audit your shared decision-making documentation process now. For every ICD implant billed under B2, B3, or B4, the medical record must show a formal shared decision-making encounter using an evidence-based tool before implantation. If your physicians or advanced practitioners are not consistently documenting this encounter, fix the workflow before billing another claim under these indications. This is not a gray area — CMS's language is explicit. |
| 2 | Confirm that the shared decision-making encounter is documented separately from the implant visit if it occurred at a separate visit. The policy permits this. But "the patient and I discussed the device" buried in an operative note does not satisfy the requirement. The encounter needs to be identifiable and linked to an evidence-based decision tool. |
| 3 | Verify LVEF measurement documentation for B2 and B3/B4 claims. CMS requires a measured LVEF — not estimated, not inferred. Make sure the echocardiogram or imaging report is in the record and that the measured value is ≤ 0.30 (B2) or ≤ 0.35 (B3/B4). A missing or ambiguous LVEF measurement is a direct path to denial. |
| 4 | Check the timing exclusions for every B2, B3, and B4 claim. Build a pre-claim checklist: Was there a CABG or PCI in the past three months? An MI in the past 40 days? Are there signs the patient is a revascularization candidate? If any of these are present, the ICD billing under these indications fails medical necessity on its face. |
| 5 | For B4 claims, document the three-month optimal medical therapy window explicitly. This requirement is unique to non-ischemic cardiomyopathy patients. Your documentation must show what therapy was used, when it started, and that the three-month threshold was met before implantation. Vague language about "medical management" will not hold up to scrutiny. |
| 6 | Confirm the qualifying practitioner type for shared decision-making encounters. CMS limits who can conduct the required encounter — physicians under §1861(r)(1) or qualified non-physician practitioners under §1861(aa)(5), meaning PAs, NPs, and CNSs. A dietitian or a social worker conducting the encounter does not satisfy the requirement, regardless of how thorough the conversation was. |
| 7 | If you're uncertain how this coverage policy applies to your specific patient mix or service setting, loop in your compliance officer before billing. The interaction between NCD 110 and any applicable Local Coverage Determinations from your Medicare Administrative Contractor adds another layer. Your MAC may have issued supplemental guidance — check before the effective date of March 7, 2026. |
| 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 |
CPT, HCPCS, and ICD-10 Codes for ICDs Under NCD 110
The current published version of NCD 110 (policy key 110-v5) does not list specific CPT or HCPCS codes. This is not unusual for older NCDs — CMS often leaves code-level specificity to the Medicare Administrative Contractor layer through Local Coverage Determinations and Local Coverage Articles.
Work with your MAC to confirm which CPT codes for ICD implantation, generator replacement, lead placement, and remote monitoring map to this NCD in your region. Your ICD billing team should be running those claims through the B1–B4 indication framework above regardless of which specific codes are on the claim.
If your MAC has issued an LCD or billing article associated with NCD 110, that document will carry the code-level detail. Check the CMS LCD database or your MAC's website directly. If your billing team isn't already tracking MAC-level policy alongside NCDs, this is a good reminder to build that into your workflow.
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