NCDs vs LCDs: How Medicare Coverage Determinations Work for Device Companies
2026-09-08 · Caduvo Team
Medicare coverage hinges on two layers: National Coverage Determinations (NCDs) that apply nationwide, and Local Coverage Determinations (LCDs) that vary by region. This guide explains the hierarchy, how to search the Medicare Coverage Database, and what device companies can do when coverage is absent or restrictive.
A device can sail through FDA clearance and still sit on a shelf if Medicare won’t pay for it. The gatekeeper isn’t the FDA—it’s a coverage determination. Medicare’s rules are split into two layers: National Coverage Determinations (NCDs) that apply everywhere, and Local Coverage Determinations (LCDs) that vary by region. Knowing which one governs your device, and how to find it, is the difference between a product with a market and a product with a press release.
National vs. Local: Two tiers with different weight
CMS issues NCDs under the Social Security Act. They are binding on all Medicare contractors and apply nationwide. An NCD can decide that a service is “reasonable and necessary” (covered), not reasonable and necessary (non-covered), or covered only under specific conditions—coverage with evidence development. Typically, NCDs address high-cost technologies, controversial procedures, or devices that prompt a national-level question. For example, CMS issued an NCD for implantable cardioverter defibrillators (ICDs) that specifies criteria for primary prevention.
LCDs, by contrast, are written by the 12 Medicare Administrative Contractors (MACs) that process claims for Part A and Part B in their jurisdictions. An LCD may fill in the gaps when no NCD exists, or interpret an NCD for local practice. Because LCDs are regional, a device might be covered in Florida but not in California, or covered with different documentation requirements. The hierarchy is clear: an NCD always preempts an LCD. If an NCD says a service is non-covered, no MAC can override it. But when an NCD is silent, MACs have discretion. For a broader view of how coverage fits into the reimbursement picture, see our medical device reimbursement guide.
Who writes the rules: Meet the Medicare Administrative Contractors
The 12 MACs process Part A and Part B claims for defined geographic jurisdictions. Companies like Noridian, Palmetto GBA, CGS, and NGS each manage a slice of the country. They issue LCDs, adjudicate claims, and handle appeals. A MAC may publish an LCD when it sees variation in local practice, or when clinicians request clarity on a new technology. An LCD typically includes an “Indications and Limitations of Coverage” section and a related billing and coding article. For example, Jurisdiction M (Palmetto GBA) might have an LCD for a specific molecular test that differs from Jurisdiction F (Noridian).
MACs also convene Carrier Advisory Committees and invite public comment on proposed LCDs. If you’re targeting a specific region, you need to know which MAC covers that state and review its final LCDs, proposed LCDs, and any draft policies. The MAC’s own website often lists draft LCDs before they appear in the centralized database.
How to search the Medicare Coverage Database
The Medicare Coverage Database (MCD) is the official source for NCDs and LCDs. Here’s a step-by-step way to use it:
- Go to the Medicare Coverage Database.
- Use the “Advanced Search” to filter by document type, state, MAC, or keyword.
- Select “National Coverage Determination” or “Local Coverage Determination” under Document Type.
- For LCDs, choose a state or MAC jurisdiction from the dropdown. If you don’t know your MAC, CMS provides a state-to-MAC mapping.
- Enter a keyword—a CPT code, a HCPCS code, or a procedure name. (Not sure which codes to search? Start with our guide to HCPCS codes.)
- Review the results: “Final” LCDs are active policies; “Proposed” LCDs may become final; “Draft” LCDs are open for comment.
- Open the document and read the “Indications and Limitations of Coverage” section. That’s where you’ll find the specific clinical criteria.
- Check the “Related Local Coverage Documents” for billing and coding articles that often contain documentation requirements.
Note that the MCD doesn’t always surface the newest draft LCDs from every MAC. For a complete picture, you’ll need to check each MAC’s website separately. Monitoring updates across 12 MACs manually is a heavy lift—that’s where Caduvo’s coverage intelligence can automate the tracking, but here’s how to start manually.
What device companies can do when coverage is absent or restrictive
When there’s no NCD and no LCD, a device is covered at the discretion of the MAC on a case-by-case basis. Providers can submit claims with documentation of medical necessity, but reimbursement is unpredictable. To build a predictable coverage pathway, you have several options:
- Replicate a favorable LCD. If another MAC already covers your device, request a reconsideration from the MAC in your target region. Provide the same clinical evidence, peer-reviewed literature, and a coverage dossier that outlines the rationale.
- Request a revision of a restrictive LCD. If an existing LCD limits coverage to a population that excludes your device, you can engage the MAC’s medical director. Submit a formal reconsideration request with comparative data, cost-effectiveness analyses, and support from professional societies.
- Pursue a national coverage determination. You can petition CMS for an NCD. This is a formal process requiring a full technology assessment. The acceptance rate is low unless the device is high-impact. For devices that received FDA Breakthrough Device Designation, the Transitional Coverage for Emerging Technologies (TCET) pathway can lead to a national coverage determination with evidence development. See our post on breakthrough device designation for details.
- Educate providers and coders. Even without a formal LCD, strong documentation of medical necessity can improve claim approvals. Work with physician champions to develop consistent documentation templates.
In all cases, start by mapping the LCD landscape. Identify every MAC where your target customers are located and read every final and proposed LCD. The absence of a restrictive LCD isn’t the same as a green light—but it’s a starting point.
Actionable takeaways
- Begin with the Medicare Coverage Database: search your device’s CPT or HCPCS codes in every MAC jurisdiction.
- Map LCDs to your early adopter sites to understand local coverage rules and documentation requirements.
- If no coverage exists, build a clinical evidence dossier and engage the MAC’s medical policy team early.
- Monitor the MCD at least quarterly for proposed LCDs that could affect your device.
- For devices with a breakthrough designation, explore the TCET pathway for a possible NCD.