NCDs vs LCDs: How Medicare Coverage Determinations Work for Device Companies

2026-08-27 · Caduvo Team

Medicare coverage is a two-tier system: binding National Coverage Determinations (NCDs) from CMS, and regional Local Coverage Determinations (LCDs) from MACs. Learn how to search the Medicare Coverage Database and what to do when coverage is absent or restrictive.

A 510(k) clearance gets your device to market. It does not get Medicare to pay for it. Medicare coverage is a separate, opaque process that unfolds across two levels: national and local. This post breaks down how National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) work, who writes them, and how to find the rules that apply to your device.

The Two-Tier Medicare Coverage System

Medicare coverage decisions come in two flavors: national and local. A National Coverage Determination (NCD) is a binding rule issued by CMS. It applies to all Medicare contractors and beneficiaries nationwide. An NCD tells you whether a service or device is covered, under what conditions, and for which populations.

A Local Coverage Determination (LCD) is issued by a Medicare Administrative Contractor (MAC). It applies only within that contractor’s geographic jurisdiction. If no NCD exists, the MAC can decide on its own. If an NCD does exist, an LCD cannot contradict it—but it can add more specific clinical criteria or documentation requirements.

There are currently 7 Part A/B MACs covering the U.S. Each one has its own medical director, its own advisory committee, and its own process for drafting LCDs. That means a device could be covered by Noridian in Jurisdiction F but not by Palmetto in Jurisdiction M.

National Coverage Determinations (NCDs): The Rules Everyone Must Follow

NCDs are the top of the hierarchy. They are developed by CMS’s Coverage and Analysis Group, often at the request of an external stakeholder or through a national coverage analysis (NCA). The process typically takes 6 to 9 months from opening to final decision.

An NCD can result in one of three outcomes:

• National coverage: the service is covered for specific indications.
• Coverage with evidence development (CED): coverage is tied to participation in a clinical study or registry.
• Non-coverage: Medicare will not pay for the service.

Real example: The NCD for implantable cardioverter defibrillators (ICDs) (NCD 20.4) specifies who qualifies based on ejection fraction, NYHA class, and etiology. It also sets strict documentation rules. If your device falls outside those parameters, no MAC can override the NCD to pay for it.

NCDs are relatively rare. CMS issues only a handful each year. Most devices and procedures operate under the LCD system.

Local Coverage Determinations (LCDs): Where MACs Write the Rules

For the vast majority of procedures, CMS has never issued an NCD. That’s where LCDs step in. A MAC drafts an LCD to clarify coverage for a specific service, device, or diagnostic test. The LCD typically includes:

• A list of covered CPT/HCPCS codes and ICD-10 diagnosis codes.
• Patient eligibility criteria (age, clinical history, test results).
• Utilization limits (frequency, quantity).
• Documentation requirements.

Example: Noridian’s LCD for Lower Limb Prostheses (L33787) sets out the exact functional levels, evaluation requirements, and components that must be documented before a prosthetic knee or foot is covered. If you submit a claim without a documented functional level assessment, the claim gets denied—even if the device is FDA-cleared.

LCDs are binding on all providers, suppliers, and claims processors in that MAC’s jurisdiction. They are not optional. A coverage gap can be as damaging as a non-coverage decision.

MACs publish draft LCDs for public comment before finalizing them. This is a window for device companies to submit evidence and shape the final policy. The comment period is typically 45 days.

How to Search the Medicare Coverage Database

The Medicare Coverage Database (MCD) is the single source of truth for both NCDs and LCDs. Here’s how to use it effectively:

1. Go to cms.gov/medicare-coverage-database.
2. Select the “Coverage” tab.
3. Choose “National Coverage Document” or “Local Coverage Document” from the dropdown.
4. Enter a keyword, CPT/HCPCS code, or ICD-10 code. For a device, start with the HCPCS code that describes your product or the procedure it is used in. If you don’t yet have a code, search by the disease state or procedure name.
5. Filter by state, MAC, or document type (draft, active, retired).
6. For LCDs, pay attention to the “MAC Jurisdiction” field. The same LCD may be adopted by multiple MACs through a collaborative process, but always verify the jurisdiction.

Pro tip: Search by the LCD ID if you know it. If you’re monitoring a specific MAC, check the “Draft LCDs” periodically. MACs are required to publish their draft LCDs in the MCD. Missing a draft can mean losing your chance to comment.

If your search returns no NCD and no LCD, coverage is left to the discretion of the MAC. That often means claims are reviewed on a case-by-case basis using Medicare’s “reasonable and necessary” standard. This is a high-risk zone. Without a written policy, providers may be reluctant to adopt the device, and audits can retroactively deny claims.

When Coverage Is Absent or Restrictive: What Device Companies Can Do

A coverage gap or a restrictive LCD is a signal to act, not to wait. Here are the practical options:

• Request a new LCD. You can submit a formal reconsideration request to the MAC. This requires a well-organized evidence package: published clinical studies, HCPCS code assignment, FDA clearance, and cost data. The MAC will review the request and decide whether to open a new LCD.
• Challenge an existing LCD. If an LCD is too narrow or outdated, you can also request a reconsideration. You’ll need to show that the current policy is not supported by evidence or that new evidence warrants a change.
• Pursue an NCD. If coverage varies dangerously across MACs, you can request a national coverage analysis from CMS. This is a heavier lift—expect a 6- to 12-month process and a high bar for evidence. But an NCD can level the field.
• Work through professional societies. Clinical guidelines and society position statements carry weight. Getting a society to endorse coverage criteria can strengthen a reconsideration request.
• If your device has Breakthrough Device Designation, you may qualify for the Transitional Coverage for Emerging Technologies (TCET) pathway, but it’s not automatic. Read more about the real coverage implications in our Breakthrough Device Designation guide.

Do not wait for FDA clearance to start. A coverage strategy takes months. The medical device reimbursement primer walks through the full coding-coverage-payment sequence.

Actionable Takeaways

• Check the Medicare Coverage Database for any NCD or LCD that mentions your target procedure or HCPCS code. If none exists, document the gap.
• Monitor draft LCDs from all 7 MACs at least quarterly. A draft LCD can appear with little warning and reshape your market overnight.
• If coverage is absent, build the evidence package now: 2 to 3 peer-reviewed studies, cost-effectiveness data, and a clear clinical rationale.
• When writing a reconsideration request, address the exact criteria in the LCD. Vague arguments get ignored.
• Tools that track LCDs across MACs save time. Caduvo, for example, maps coverage policies by jurisdiction and alerts you to changes, so you don’t have to search the MCD manually for each MAC.