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

2026-08-15 · Caduvo Team

Medicare coverage hinges on a two-tiered system of National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs). This post explains how they work, how to search the Medicare Coverage Database, and what device companies can do when coverage is missing or restrictive.

Your device has FDA clearance. Your HCPCS code is active. But the first Medicare claim for the procedure comes back denied. Reason: no coverage determination. For market-access teams, that moment clarifies a hard truth — regulatory approval and payment are not the same thing. Understanding the difference between National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) is where real reimbursement work begins.

Medicare covers items and services that are “reasonable and necessary.” How that principle gets turned into binding payment rules is through a two-tiered system: NCDs set national policy, and LCDs fill in the gaps at the regional level. If no determination exists, MACs may decide on a claim-by-claim basis, but that’s fragile. For device companies, knowing how to search existing policies and what to do when coverage is absent matters from the day you start mapping market access.

National Coverage Determination: One Rule, All Jurisdictions

A National Coverage Determination (NCD) is a CMS decision that applies to all 50 states, territories, and D.C. It binds every Medicare Administrative Contractor (MAC). If an NCD says a service is not covered, no MAC can override it.

CMS issues NCDs under §1862(a)(1)(A) of the Social Security Act. They can be positive, negative, or with conditions (e.g., Coverage with Evidence Development). As of early 2025, about 380 active NCDs exist. They often address high-cost or controversial technologies: bariatric surgery, artificial discs, continuous glucose monitors.

An NCD typically specifies the patient population, required billing codes (CPT/HCPCS), facility requirements, and the clinical evidence used. For example, NCD 100.3 covers lumbar artificial disc replacement only under a CED study. That means a device company selling an artificial disc must ensure the procedure happens in a CED-approved facility or face non-coverage.

When an NCD exists, it preempts any LCD on the same topic. That hierarchy is absolute.

Local Coverage Determinations: MACs Fill the Gaps

Where no NCD exists, Medicare Administrative Contractors can issue Local Coverage Determinations (LCDs). Twelve A/B MACs process Part A and Part B claims for specific geographic jurisdictions. An LCD applies only within that MAC’s region, so a device could be covered under First Coast in Florida but denied under NGS in Illinois.

LCDs outnumber NCDs and often cover routine items — DME, diagnostic tests, surgical procedures that CMS has never addressed nationally. They frequently link to Local Coverage Articles that detail coding and documentation rules.

The practical challenge for device makers? A patchwork of coverage policies across jurisdictions, requiring engagement with multiple MACs to secure consistent payment. If no NCD or LCD exists, claims are adjudicated individually. That leads to inconsistent results and frequent denials.

How to Search the Medicare Coverage Database

The Medicare Coverage Database (MCD) is the single authoritative source for all NCDs, LCDs, and related articles. Access it at cms.gov/medicare-coverage-database.

To research a specific device or procedure:

1. Click “Advanced Search.”
2. Select “National Coverage Determination” or “Local Coverage Determination” under Document Type.
3. Enter a CPT/HCPCS code, ICD-10 code, or keyword in the search field. Typing the HCPCS code K0553 (continuous glucose monitor) pulls up the NCD and any jurisdiction-specific LCDs.
4. For LCDs, filter by state or MAC jurisdiction under “Geographic Area” — critical when mapping a launch.
5. Check the effective date and revision history. MACs update LCDs regularly.

Manually checking each MAC’s LCDs is tedious. Some teams build trackers from bulk MCD exports, but a missed update can cost months of denied claims. Tools that monitor coverage changes across all jurisdictions for specific codes can cut review time significantly.

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

Your device has no NCD and either no LCD or an unfavorable one. Several paths exist.

1. Engage the MAC medical director. Each MAC has a formal process for requesting a new LCD or reconsidering an existing one. You submit a letter, clinical evidence, and a draft policy. Expect 9-12 months. Start on the MAC’s website to find their specific requirements.

1. Request an NCD reconsideration from CMS. This centralizes the process but is resource-intensive. You must demonstrate that a national policy is needed due to widespread variation in MAC decisions or significant cost/clinical impact. Send the request to CMS’s Coverage and Analysis Group. Review cycles run 6-9 months.

1. Use the Transitional Coverage for Emerging Technologies (TCET) pathway. If your device has FDA Breakthrough Device Designation, TCET provides up to four years of national coverage linked to an evidence development plan. This can solve the absence-of-coverage problem for truly novel devices. Learn more about the designation and its reimbursement implications in our Breakthrough Device Designation post.

1. Support reasonable-and-necessary arguments with evidence. Even without an LCD, you can help providers build cases for individual claims. Supply published studies, society guidelines, and cost-effectiveness data for MAC reviewers. Some MACs offer pre-claim review, though predictability is low.

Actionable Takeaways

• Check the Medicare Coverage Database before commercial planning. Use CPT/HCPCS codes and ICD-10 codes to surface existing NCDs and LCDs.
• If an NCD exists, it controls payment conditions entirely. Understand CED requirements or diagnosis restrictions.
• If no NCD exists, map LCDs across all 12 MAC jurisdictions. Coverage can be a patchwork.
• When coverage is absent, the speediest path is often MAC engagement with clinical evidence — not an immediate NCD request.
• For breakthrough devices, TCET provides a defined coverage bridge. Investigate early whether you qualify.

Medicare coverage isn’t automatic. A methodical MCD search, a clear grasp of the NCD/LCD hierarchy, and a targeted strategy for engaging MACs or CMS can shorten the gap between clearance and first paid claim.