Medicare NCD vs LCD for Medical Devices: Coverage Determination Strategy and Evidence Requirements

Complete guide to Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) for medical device manufacturers — how each process works, evidence requirements, timelines, the new RAPID pathway, Coverage with Evidence Development, MAC jurisdictions, and practical strategies for securing Medicare coverage.

Why Coverage Determinations Determine Device Commercial Success

Medicare coverage is limited to items and services that are "reasonable and necessary" for the diagnosis or treatment of illness or injury, and that fall within a Medicare benefit category. But "reasonable and necessary" is not self-defining — Medicare must interpret this standard for each technology. That interpretation happens through coverage determinations: National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs).

For medical device manufacturers, coverage is the gateway to adoption. Without it, hospitals will not purchase the device, physicians will not use it, and patients will not benefit from it — regardless of FDA approval status. Understanding the differences between NCDs and LCDs, the evidence required for each, and the strategic considerations for choosing between pathways is essential for any reimbursement strategy.

This guide explains both pathways in detail, compares their features, describes the evidence CMS requires, covers recent 2026 policy developments including the new RAPID coverage pathway, and provides a practical framework for building a coverage strategy.

What Is a National Coverage Determination (NCD)?

An NCD is a nationwide policy decision by CMS determining whether a particular medical service, procedure, or technology will be covered under Medicare. Once issued, an NCD applies uniformly across all Medicare Part A and Part B programs nationwide. Medicare Advantage plans must provide at least equivalent coverage, though they may add requirements such as prior authorization.

NCD Authority and Scope

NCDs are made through an evidence-based process with opportunities for public participation, as outlined in the Social Security Act §1862(l) and the August 7, 2013 Federal Register notice (78 FR 48164-69). CMS's Coverage and Analysis Group (CAG) within the Center for Clinical Standards and Quality (CCSQ) is responsible for developing and implementing NCDs.

An NCD can:

Provide full national coverage for a technology
Limit coverage to specific patient populations or clinical scenarios
Require Coverage with Evidence Development (CED), meaning coverage is available only within approved clinical studies or registries
Issue a non-coverage determination

Who Can Request an NCD

Anyone can request an NCD — manufacturers, healthcare providers, patient advocacy organizations, or individual beneficiaries. There is no restriction on who may initiate a request, provided they comply with the formal NCD process. Requests are accepted on a rolling basis and submitted electronically to NCDRequest@cms.hhs.gov.

NCD Process and Timeline

The NCD process generally takes 9 to 12 months and follows six defined phases:

Phase 1 — Request Acceptance: The period between when a stakeholder submits the NCD request and when CMS's CAG accepts it. CMS informs the public by posting a tracking sheet on the CMS coverage webpage.

Phase 2 — Evidence Review Initiation: The period between CAG acceptance and formal initiation of evidence review. CMS may also invite informal public comment during this phase.

Phase 3 — Evidence Review: The statutorily defined period during which CMS conducts its evidence analysis. The proposed NCD decision memo must be published within 6 months of the tracking sheet posting. This extends to 9 months if an external technology assessment or Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting is required.

Phase 4 — Proposed Decision and Public Comment: A 30-day public comment period follows publication of the proposed NCD decision memo.

Phase 5 — Final Decision: CMS has 60 days after the comment period closes to release the final NCD decision memo.

Phase 6 — Implementation: The NCD becomes effective and CMS updates the Medicare Coverage Database and relevant claims processing instructions.

In practice, recent NCD timelines have ranged from 6 months to over 2 years for complex decisions, as CMS does not always publish tracking sheets immediately upon receipt.

What a Complete NCD Request Must Include

A complete, formal NCD request should contain:

A clear description of the item or service for which coverage is sought
The Medicare benefit category under which the item or service would be covered
A detailed clinical and scientific evidence summary, including published literature, clinical trial data, and any relevant technology assessments
FDA authorization status (approval, clearance, or exemption)
Information on how the technology is currently used in clinical practice
Relevant CPT/HCPCS and ICD-10 codes
A statement of the specific coverage determination being requested

What Is a Local Coverage Determination (LCD)?

An LCD is a coverage decision made by a Medicare Administrative Contractor (MAC) that applies within its specific geographic jurisdiction. In the absence of an NCD, MACs have the authority to determine whether an item or service is reasonable and necessary for Medicare beneficiaries in their region.

MAC Structure

There are currently seven A/B MACs, collectively covering 12 Medicare jurisdictions across the United States. Each MAC is responsible for processing claims and developing coverage policy for its assigned jurisdictions. MACs are private healthcare insurers that contract with CMS.

LCD Process and Timeline

The LCD process generally takes 6 to 12 months and follows these steps:

Request Review (60 days): The MAC reviews the request within 60 calendar days and notifies the requestor whether the request is complete or incomplete.

LCD Development: If the request is complete, the MAC begins the development process described in the Medicare Program Integrity Manual (Chapter 13, Section 13.2). The MAC may consult with subject matter experts and the Carrier Advisory Committee (CAC), which provides a formal mechanism for healthcare professionals to inform the evidence used in LCD development.

Proposed LCD Publication: The MAC publishes the proposed LCD on the Medicare Coverage Database (MCD) website. MACs generally have 365 days from publication of the proposed LCD to finalize or retire it.

Public Comment and Open Meeting: A minimum 45-day public comment period follows proposed LCD publication, along with an open public meeting where stakeholders can present their views.

Final LCD Publication: After the comment period, the MAC publishes the final LCD. A minimum 45-day notice period is required before the LCD takes effect.

LCD Reconsideration

Anyone can request reconsideration of an existing LCD. The request must generally demonstrate that new evidence or data supports a change. MACs must consider all LCD reconsideration requests from beneficiaries residing or receiving care in their jurisdiction and providers doing business in their jurisdiction.

NCD vs LCD: Key Differences for Device Manufacturers

Feature	NCD	LCD
Decision maker	CMS (federal level)	MAC (regional contractor)
Geographic scope	Nationwide	MAC jurisdiction only
Timeline	9–12 months (often longer)	6–12 months
Evidence standard	Same "reasonable and necessary" standard	Same standard as NCD
Public process	Federal Register, public comment periods, possible MEDCAC hearing	MAC-led public comment, CAC consultation
Precedent value	Binding nationwide; MA plans must provide equivalent coverage	Applies only within MAC jurisdiction; other MACs may reference but are not bound
Reconsideration	Formal reconsideration follows same process as initial request	Request to the specific MAC
Cost to manufacturer	Higher (broader evidence package, often requiring health economics data)	Lower (focused evidence package for one MAC)
Strategic value	Gold standard — nationwide coverage certainty	Faster path but limited geographic scope

When approximately 80% of Medicare coverage determinations are LCDs

Historically, approximately 80 percent of Medicare coverage determinations have been LCDs rather than NCDs. This means that for most devices, coverage is established regionally through MACs rather than nationally through CMS. A device manufacturer's coverage strategy must account for this reality.

Coverage with Evidence Development (CED)

For technologies where the evidence is promising but not yet definitive, CMS may provide coverage through CED. Under CED, Medicare covers the item or service only when it is furnished in the context of a CMS-approved clinical study or registry. This pathway has been used for several recent device NCDs.

Recent CED Examples (2025–2026)

Cardiac Contractility Modulation (CCM) for Heart Failure: Effective October 28, 2025, CMS covers CCM for heart failure under CED through NCD 20.39. Coverage requires participation in CMS-approved studies supported by AHRQ.
Renal Denervation (RDN) for Uncontrolled Hypertension: Effective October 28, 2025, CMS covers both radiofrequency and ultrasound renal denervation under CED through NCD 20.40. The technology is not covered outside of CMS-approved studies.
Implantable Cardiac Defibrillators (ICDs): NCD 20.4 was updated with ICD-10 diagnosis code corrections in February 2026, with Group 1 and Group 2 diagnosis codes specifying coverage eligibility.

CED Compliance Requirements

CED coverage requires strict adherence to:

Patient selection criteria defined in the NCD
Registry or clinical trial participation
Documentation standards for evidence collection
Data reporting to CMS-approved study sponsors

These services are likely to attract medical review and audit scrutiny, so providers must maintain comprehensive documentation.

The RAPID Coverage Pathway (2026)

On April 23, 2026, CMS and FDA announced the RAPID (Regulatory Alignment for Predictable and Immediate Device) coverage pathway — a significant development for medical device manufacturers.

How RAPID Works

Under the RAPID pathway:

CMS issues a proposed NCD on the same day an eligible device receives FDA market authorization
This triggers the statutorily required 30-day public comment period
Medicare national coverage and payment could be available as soon as two months after market authorization

This represents a dramatic improvement over the traditional NCD timeline, which typically requires 9 to 12 months (and often longer) after FDA authorization.

Eligibility

The RAPID pathway is designed for devices participating in FDA's Breakthrough Device Program. CMS will apply lessons learned from the Transitional Coverage for Emerging Technologies (TCET) Pathway, which has been paused for new candidates as CMS focuses on implementing RAPID.

Strategic Implications

For device manufacturers with FDA Breakthrough Device designation, RAPID fundamentally changes the reimbursement timeline. Companies should:

Engage CMS early during the Breakthrough Device development process
Prepare the evidence package for NCD review in parallel with FDA submissions
Anticipate that coverage decisions will be synchronized with FDA authorization dates

Evidence Requirements for Coverage Determinations

CMS and its MACs use the same evidentiary standards and evidence-based process to evaluate available evidence. CMS divides clinical evidence assessment into three stages:

Stage 1: Quality of Individual Studies

CMS evaluates the internal validity of each study, considering:

Study design (randomized controlled trials carry the most weight)
Sample size and statistical power
Patient selection criteria and representativeness
Blinding and allocation concealment
Completeness of follow-up
Potential for bias

Stage 2: Relevance to the Medicare Population

Even well-designed studies may not directly apply to Medicare beneficiaries. CMS assesses whether:

Study populations include patients aged 65 and older
Comorbidities common in the Medicare population are represented
Outcomes relevant to Medicare beneficiaries (functional status, quality of life, healthcare utilization) are measured
The clinical setting mirrors where Medicare patients receive care

Stage 3: Overarching Conclusions from the Body of Evidence

CMS evaluates the totality of the evidence, considering:

The direction and magnitude of the intervention's risks and benefits
Consistency of findings across studies
Generalizability of results
Whether the evidence supports a conclusion that the technology is "reasonable and necessary"

Hierarchy of Evidence

CMS typically follows a hierarchy of evidence:

Systematic reviews and meta-analyses of high-quality RCTs
Individual high-quality RCTs
Well-designed non-randomized controlled studies
Well-designed cohort or case-control studies
Case series and case reports
Expert opinion and clinical consensus

Manufacturers seeking NCDs should aim to provide evidence at the highest levels of this hierarchy, with particular attention to outcomes that matter to CMS: mortality, morbidity, functional improvement, healthcare utilization, and cost-effectiveness.

Building a Coverage Strategy for Your Medical Device

Strategy 1: Pursue an NCD When You Have Strong Evidence

Pursue an NCD when your device:

Has FDA Breakthrough Device designation (especially with the RAPID pathway)
Is supported by high-quality clinical trial data, including RCTs
Addresses a significant unmet medical need for Medicare beneficiaries
Has no existing NCD or a non-coverage NCD that needs updating
Requires national coverage consistency for adoption

Strategy 2: Start with LCDs for Faster Regional Coverage

Pursue LCDs when:

Evidence is adequate but not yet sufficient for a national determination
You need coverage faster than the NCD timeline allows
Your device addresses a need that varies by region or patient population
You want to build a track record of coverage before pursuing an NCD
Resource constraints make a full NCD application impractical

A common approach is to secure LCDs in one or more MAC jurisdictions, generate real-world evidence from covered patients, and then use that evidence to support an NCD request.

Strategy 3: Leverage CED for Promising Technologies

CED is appropriate when:

Clinical trial data is promising but not yet definitive for the broad Medicare population
Your device requires real-world evidence to demonstrate effectiveness
CMS has signaled that CED is the preferred pathway (as with CCM and RDN)
You can support registry infrastructure or clinical study participation

Strategy 4: Combine Pathways

The most effective coverage strategies often combine multiple pathways:

Obtain initial coverage through LCDs in key jurisdictions
Pursue NTAP for adequate inpatient payment
Request an NCD for national coverage consistency
Accept CED if CMS requires it, while continuing evidence generation
Seek NCD reconsideration once additional evidence becomes available

Recent Coverage Policy Developments Affecting Device Manufacturers

LCD Process Modernization (21st Century Cures Act)

Under the 21st Century Cures Act, CMS streamlined the LCD process with requirements for:

Transparent and public LCD development process
MAC analysis of evidence with published rationale
Relocation of codes and retirement of non-coverage LCDs for Category III CPT codes

Medicare Advantage Coverage Standards

CMS has strengthened requirements for Medicare Advantage plans regarding internal coverage criteria. MA plans must demonstrate that any additional coverage criteria beyond NCD/LCD requirements are based on clinical evidence and explicitly support patient safety. Plans must maintain evidentiary standards without modification for the full coverage year.

NCD 310.1: Clinical Trial Policy

The Clinical Trials NCD (310.1) provides coverage for routine costs of qualifying clinical trials. Device manufacturers conducting clinical investigations should ensure their trials meet the requirements of this NCD to enable Medicare coverage of routine care costs for trial participants.

Skin Substitute LCD Developments

In late December 2025, CMS directed all MACs to withdraw planned LCDs for skin substitute grafts and cellular/tissue-based products for diabetic foot ulcers and venous leg ulcers that were scheduled to become effective January 1, 2026. This reversal illustrates the dynamic nature of LCD policy and the importance of monitoring MAC activity.

Coverage Restrictions and Limitations

Even when coverage is established through an NCD or LCD, restrictions may apply:

Eligible patient populations: Coverage may be limited to specific diagnoses, disease stages, or patient characteristics
Setting of care: Some technologies are covered only in inpatient settings, specialized outpatient clinics, or ambulatory surgery centers
Concurrent treatment requirements: Coverage may require that specific conditions be met before the technology is used alongside other treatments
Off-label use exclusion: Use of a device outside its FDA-approved indication may not be covered
Prior authorization: Medicare Advantage plans may impose prior authorization requirements even when NCD coverage exists

The Medicare Coverage Database (MCD) at CMS.gov is the authoritative source for all NCDs, LCDs, and related coverage articles. Manufacturers should monitor the MCD regularly for new and modified coverage determinations that affect their technologies.

Practical Checklist for Coverage Strategy

24+ months before launch:

Assess whether your device needs NCD, LCD, or both
Engage CMS informally to understand evidentiary expectations
Design clinical trials with CMS evidence requirements in mind
If pursuing Breakthrough Device designation, prepare for RAPID pathway engagement

12–24 months before launch:

Prepare the evidence package for coverage determination request
Identify relevant MAC jurisdictions for potential LCD requests
Align clinical endpoints with both FDA and CMS evidence standards
Consider health economics data to support coverage rationale

6–12 months before launch:

Submit NCD or LCD request
Engage clinical societies and patient advocacy organizations for support
Prepare public comments and stakeholder engagement strategy
Monitor NCD/LCD tracking sheets and public comment periods

At launch and post-launch:

Ensure providers understand coverage requirements and documentation standards
Monitor claims data for coverage denials and patterns
Collect real-world evidence to support coverage expansion
Prepare for NCD/LCD reconsideration if initial determination is unfavorable