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    LCD and NCD

    Local and National Coverage Determinations from Medicare.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    A National Coverage Determination (NCD) is a Medicare-wide policy on whether and under what conditions an item or service is covered. A Local Coverage Determination (LCD) is issued by a Medicare Administrative Contractor (MAC) for its jurisdiction. NCDs bind all Medicare contractors, while LCDs apply only within a MAC's region, so coverage can differ between states until an NCD exists. Medicare Advantage plans must follow NCDs and LCDs but may add utilization management. Manufacturers can request a new NCD or LCD, or a reconsideration, by submitting supporting evidence.
    What the regulation says
    The Centers for Medicare & Medicaid Services (CMS) establishes National Coverage Determinations (NCDs) to specify the conditions under which a particular medical item or service is covered nationally under Medicare. Local Coverage Determinations (LCDs) are developed by Medicare Administrative Contractors (MACs) to define coverage within their specific geographic jurisdictions, often preceding or complementing NCDs.

    What this means in practice

    Coverage typically begins as LCD policy via one or more MACs; pivotal NCDs (e.g., TAVR, TCAR, TMVR) define the national clinical-evidence and facility/operator standards.

    Examples

    • A MedTech manufacturer developing a new diagnostic imaging device must review existing NCDs and relevant LCDs to understand the evidence required for Medicare coverage and reimbursement.
    • A quality assurance team ensures that product labeling and marketing materials accurately reflect the limitations and conditions of coverage specified in applicable NCDs and LCDs.
    • During clinical trial design, a regulatory professional considers the data requirements outlined in potential NCDs or LCDs to ensure the study generates sufficient evidence for future reimbursement.
    Common pitfalls
    • •Misinterpreting an LCD as a national policy can lead to denied claims in other jurisdictions.
    • •Failing to consider both NCDs and relevant LCDs when determining coverage for a medical device or service can result in incomplete reimbursement strategies.
    • •Assuming that an absence of an NCD means automatic coverage can lead to significant financial losses if an LCD also denies coverage.
    • •Not understanding the specific evidence requirements outlined in an NCD or LCD can lead to insufficient clinical trial design or data collection activities.

    Frequently asked questions

    NCDs and LCDs directly influence market access and reimbursement for MedTech products. Manufacturers must understand these policies to ensure their devices meet coverage criteria and are eligible for payment by Medicare.
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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Official citation replacements checked: . Medicare documents support Medicare coding, coverage or payment context, not every payer policy or CPT editorial procedure. Citation replacement does not change the full term review date.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 2 verified 1 unchecked· last checked 2026-06-20· added official documents checked 2026-11-01
    eCFR·2CMS·1
    1. 1
      42 CFR § 405.1060 : Applicability of NCDs
      Tier 1 Verified
      eCFRecfr.gov
    2. 2
      42 CFR § 405.1062 : Applicability of LCDs
      Tier 1 Verified
      eCFRecfr.gov
    3. 3
      Medicare coverage determination process: national and local decisions
      Tier 2 Unchecked
      CMScms.gov

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