Medicare Coverage with Evidence Development (CED) for Medical Devices

Executive Summary: Navigating Coverage Purgatory

For medical device manufacturers, achieving FDA clearance or approval is only the first major milestone on the path to commercial success. The second, and often more challenging, hurdle is securing robust reimbursement. In the United States, the Centers for Medicare & Medicaid Services (CMS) determines whether a technology is "reasonable and necessary" for the Medicare population.

When CMS determines that a promising device lacks the clinical evidence required for unrestricted national coverage, it often employs a policy mechanism known as Coverage with Evidence Development (CED). Under a CED National Coverage Determination (NCD), Medicare will pay for the device and associated procedures only if the beneficiary is enrolled in a CMS-approved clinical study or national registry.

Direct Decision Brief

If you are developing a high-risk, high-cost, or novel medical device, you must understand the strategic implications of entering the CED pathway:

1. The Core Mechanism: CED is not a simple "yes" or "no" coverage decision. It is a highly conditional coverage gate. If your device is placed under CED, you cannot receive Medicare reimbursement for routine clinical use unless the patient, site, and device are enrolled in an active, approved trial or registry.
2. The Graduation Problem: While CED is theoretically designed as a temporary transition phase to allow manufacturers to generate real-world evidence, graduation to unrestricted coverage is extremely rare. Peer-reviewed data shows that graduation typically takes 4 to 12 years, and the vast majority of technologies placed in CED remain there indefinitely.
3. The Evidence Strategy: If your device is a candidate for CED (e.g., in fields like structural heart, neuromodulation, or advanced oncology diagnostics), you must design your clinical development plan to satisfy both FDA's premarket safety/effectiveness requirements and CMS's post-market CED registry requirements.
4. The Registry Burden: Operating under CED requires significant administrative overhead. You must partner with national registries (such as those run by the American College of Cardiology or the Society of Thoracic Surgeons) or run your own multi-center longitudinal studies, ensuring that clinical sites submit rigorous data for every single patient.

What Is Medicare Coverage with Evidence Development (CED)?

Coverage with Evidence Development (CED) is a policy option that allows CMS to provide Medicare coverage for promising clinical items and services that are not yet supported by sufficient evidence to warrant unrestricted national coverage. By conditioning payment on participation in an approved study or registry, CMS seeks to protect Medicare beneficiaries while simultaneously encouraging the generation of high-quality clinical evidence.

Statutory and Legal Foundation

The legal authority for CED is derived from Section 1862(a)(1)(A) and Section 1862(a)(1)(E) of the Social Security Act:

• Section 1862(a)(1)(A): This is the foundational statutory gate, prohibiting Medicare payment for items or services that "are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member."
• Section 1862(a)(1)(E): This section provides the explicit authority for CMS to conduct and pay for clinical research. By linking these two sections, CMS argues that for certain promising technologies, an item or service is "reasonable and necessary" only when provided within a controlled, evidence-generating clinical trial or registry setting that guarantees close patient monitoring and structured data collection.

Historic Milestones and Evolution

CMS first formally operationalized the CED concept in 2005 with the publication of two seminal National Coverage Determinations:

1. Implantable Cardioverter-Defibrillators (ICDs) (NCD Manual Section 20.4): Conditioned coverage on patient enrollment in a national registry to monitor long-term outcomes and safety outside of clinical trial settings.
2. FDG PET for Oncologic Conditions (NCD Manual Section 220.6.17): Restricted payment for positron emission tomography to patients enrolled in the National Oncologic PET Registry (NOPR) to determine if PET scans changed clinical management decisions.

Following these initial applications, CMS and the Agency for Healthcare Research and Quality (AHRQ) issued a formal guidance document in 2006 to establish the criteria for CED studies. Over the next two decades, this policy was refined.

On August 7, 2024, CMS published its latest updated Coverage with Evidence Development Guidance Document, following extensive public feedback and MEDCAC (Medicare Evidence Development & Coverage Advisory Committee) review. The 2024 guidance updated the study-design criteria, emphasized health equity and diversity in trial enrollment, and streamlined the process for utilizing real-world evidence (RWE) generated from national registries.

As of the August 7, 2024 guidance, CMS had:

• Issued 27 NCDs requiring CED since the program's inception.
• Approved more than 120 individual clinical studies and 5 national registries.
• Generated clinical evidence across 14 distinct therapeutic topics.
• Removed the CED requirement for only 3 topics through formal NCD reconsiderations.

That 27-NCD figure is a 2024 baseline, not a ceiling. CMS has continued to expand the mechanism and added at least four new device CED NCDs in 2025 alone — transcatheter tricuspid valve replacement (March 19, 2025), transcatheter edge-to-edge tricuspid repair (July 2, 2025), cardiac contractility modulation for heart failure (October 28, 2025), and renal denervation for uncontrolled hypertension (October 28, 2025) — pushing the active device CED roster higher. These recent additions are mapped in the table below.

Active Medical Device NCDs Requiring CED

The CED mechanism is heavily concentrated in high-cost cardiovascular devices, neurostimulators, and diagnostic imaging. For these product classes, CMS has determined that traditional clinical trials are too small or short-term to prove that the benefits seen in select patient populations translate to the broader, older, and multi-morbid Medicare population.

The following table maps the primary medical device and procedure NCDs that currently require CED, along with their associated registries:

The 2025 Tricuspid, Heart-Failure, and Hypertension Expansion

The four newest device CED NCDs signal where CMS sees the next evidence gaps: structural tricuspid intervention (TTVR and T-TEER, both added in 2025), heart-failure neuromodulation (CCM), and catheter-based hypertension therapy (RDN). For manufacturers in these spaces, the practical implication is that a standard FDA approval does not unlock routine Medicare payment — it unlocks payment only inside a CMS-approved study or registry, with coverage denied for any patient treated outside that protocol. If your launch plan assumed an unrestricted NCD on the strength of a pivotal trial, the 2025 expansions are a reminder that CMS applies its own, broader evidence bar to the multi-morbid Medicare population.

Key Takeaway for Developers

If your technology falls within these therapeutic areas or represents a novel mechanical or bioelectronic intervention, you must assume that CMS will evaluate your national coverage request through the lens of CED. A standard regulatory approval will not prevent CMS from placing the device in "coverage with evidence development" if they believe the pivotal trial population was too narrow.

How a Device Enters and Exits the CED Pathway

The lifecycle of a device under CED is a multi-year regulatory and operational process. Understanding the transition points—from initial NCD request to final graduation—is critical for commercial planning.

                           The Medicare CED Lifecycle
                                       |
    [Pivotal Trial & FDA Approval] -> [CMS NCD Request / Reconsideration]
                                       |
                                       v
    [CMS NCD Decision: Impose CED] -> [Registry Setup & Payment Gate]
                                       |
                                       v
    [Evidence Generation (4-12 Years)] -> [NCD Reopening Request]
                                       |
                                       v
                       ---------------------------------
                       |                               |
              [Graduation to NCD]              [Ceded to MACs (LCD)]

1. The Entry Point: NCD Reconsideration

A device typically enters the CED pathway through the National Coverage Determination (NCD) process. This can occur in two ways:

• Manufacturer Request: A manufacturer requests a national coverage policy for a newly approved device that currently lacks a clear reimbursement pathway.
• CMS Initiative: CMS opens an existing NCD for reconsideration because new clinical data or safety concerns have emerged regarding a class of devices.

During the 9-month NCD review process, CMS evaluates the existing clinical evidence. If the agency concludes that the device shows promise but the evidence is insufficient to support an outright "reasonable and necessary" determination across the entire Medicare population, it issues an NCD decision memo imposing a CED requirement.

2. The Operational Phase: Registry and Study Setup

Once the NCD is finalized, the manufacturer cannot receive Medicare reimbursement until the operational infrastructure of the CED is established:

• Study Protocol Approval: The manufacturer or a professional medical society must submit a detailed study protocol or registry integration plan to CMS.
• AHRQ Review: The Agency for Healthcare Research and Quality (AHRQ) must review and approve the protocol, ensuring it meets the scientific standards outlined in the CMS guidance.
• Site Credentialing: Individual hospitals and clinical sites must register with the approved database and demonstrate that they have the staff and infrastructure to comply with the data collection requirements.

3. The Graduation Point: Exiting CED

To exit the CED pathway and secure unrestricted national coverage, the NCD must be formally reopened and reconsidered. This requires a formal request backed by the accumulated clinical data generated during the CED period. CMS will evaluate the registry or study results to determine if:

1. The technology has demonstrated a clear, long-term clinical benefit in the real-world Medicare population.
2. The safety profile is acceptable outside of highly selected clinical trial centers.
3. The optimal patient selection criteria can be clearly defined.

Based on this review, CMS can:

• Graduate the Device: Update the NCD to provide national, unrestricted coverage for patients meeting specific clinical criteria (removing the registry requirement).
• Cede to Local Discretion: Retire the NCD and allow local Medicare Administrative Contractors (MACs) to make coverage decisions on a case-by-case basis (Local Coverage Determinations, or LCDs).
• Retain or Restrict: Maintain the CED requirement because the data remains inconclusive, or restrict coverage further if safety issues were identified.

The Graduation Problem: Quantifying Coverage Purgatory

The primary critique of the CED pathway by industry groups and medical device innovators is the "graduation problem." Although CMS designed CED to be a temporary mechanism to facilitate timely access while evidence is gathered, in practice, it functions as a long-term barrier.

The Numbers: A USC Schaeffer Center Analysis

A landmark May 2023 analysis by the USC Schaeffer Center for Health Policy and Economics quantified the graduation rates and timelines of technologies placed in CED since 2005. The study analyzed the historical progress of the 27 items and services subjected to CED:

• Unrestricted National Coverage (Graduated): Only 4 out of 27 items had their CED requirement retired with a transition to unrestricted national coverage.
• Ceded to Local Contractors: 2 out of 27 items had their NCD retired, allowing local MACs to determine coverage.
• Indefinite CED (Active): The remaining 21 items remained under the CED requirement, with no set end date.
• The Time Horizon: Among the very few technologies that did successfully graduate or transition, the time elapsed between the initial CED imposition and the final graduation ranged from 4 to 12 years.

For example, FDG PET imaging remained under CED requirements for well over a decade before CMS fully retired the registry conditions, despite accumulating real-world evidence of its clinical utility in oncology staging and management.

Why Graduation is So Slow

Several structural factors explain why devices become trapped in CED:

1. Lack of Sunset Clauses: CMS NCDs do not include automatic expiration dates or "sunset clauses" for CED requirements. The policy remains in effect until a manufacturer or external group submits a formal petition to reopen the NCD.
2. Funding and Administration: Running a national registry is expensive. Professional societies (like the ACC or STS) charge registration fees, and hospitals must dedicate clinical coordinators to enter data. Because the registry infrastructure becomes a self-sustaining entity, there is little administrative incentive to dismantle it.
3. High Bar for Reconsideration: Reopening an NCD requires a substantial body of peer-reviewed publications. For niche devices or smaller manufacturers, funding the long-term clinical studies required to prompt a CMS reconsideration is financially prohibitive.

Study and Registry Requirements: What Manufacturers Must Know

If your device is subject to a CED NCD, you must design your clinical operations to comply with the strict study-design requirements established by CMS and AHRQ. Under the August 7, 2024 guidance, any approved study or registry must satisfy several core scientific principles.

The AHRQ Scientific Standards

For any study or registry to be approved by CMS under a CED National Coverage Determination, it must satisfy the rigorous standards developed in collaboration with the Agency for Healthcare Research and Quality (AHRQ). The August 7, 2024 guidance document consolidates these into several key scientific and design criteria that manufacturers must demonstrate in their study protocols:

1. Clear Therapeutic Objective: The principal purpose of the study must be to test whether the item or service meaningfully improves health outcomes (such as survival, functional status, quality of life, or symptomatic relief) for patients who meet the clinical eligibility criteria.
2. Methodological Appropriateness: The study design must be appropriate to answer the primary research questions. While randomized controlled trials (RCTs) remain the gold standard, CMS permits prospective observational registries and longitudinal studies if they incorporate rigorous confounding control.
3. Institutional Capability: The study must be sponsored and conducted by an organization or network that has the clinical, statistical, and data-management capability to successfully complete the protocol and analyze the results.
4. ClinicalTrials.gov Registration: The study must be registered on the public registry (ClinicalTrials.gov) prior to enrolling the first patient, ensuring transparency in research objectives and endpoints.
5. Public Protocol and Plan: The study protocol, detailed statistical analysis plan, and data collection forms must be written, finalized, and made publicly available before patient enrollment begins.
6. Scientific Rigor and Validity: The study's design, execution, and analysis must meet high standards of scientific validity. This includes pre-specifying endpoints, minimizing dropouts, and performing intent-to-treat analyses where appropriate.
7. Demographic and Clinical Representation: The study population must be representative of the actual Medicare beneficiary population. The protocol must show how the trial will enroll patients who reflect the age, gender, race, ethnicity, and comorbidities of the Medicare population affected by the condition.
8. Control of Confounding Variables: The study must incorporate statistical methods (such as propensity score matching, multivariable regression, or instrumental variables) to control for confounding factors that could skew the comparison between the device and standard therapies.
9. Bias Mitigation: The protocol must include specific mechanisms to minimize observer and investigator bias, such as blinded endpoint adjudication committees or centralized imaging core laboratories.
10. Conflict of Interest Management: The study's design and analysis must minimize potential conflicts of interest. Database management, statistical computations, and manuscript drafting should be overseen by independent academic steering committees or clinical research organizations rather than the device manufacturer alone.
11. Ethical Conduct: The study must be approved by an Institutional Review Board (IRB) and conducted in full compliance with federal regulations governing the protection of human subjects (45 CFR Part 46).
12. Public Dissemination of Results: The sponsors must commit to publishing the study results in a peer-reviewed journal or making them publicly available on a registry site within a reasonable timeframe (typically 12 months) following study completion.
13. Enrollment Diversity and Equity: Under the 2024 updated guidelines, protocols must contain an explicit diversity and inclusion plan. Sponsors must detail how they will remove barriers to enrollment for underrepresented populations, including rural beneficiaries and racial minorities, ensuring the real-world evidence reflects all segments of the Medicare population.

By aligning your clinical trial design with these 13 standards early in the development lifecycle, you can avoid costly protocol revisions when submitting your CED inclusion request. Refer to the peer-reviewed literature, such as the analysis in JAMA Health Forum (PMCID PMC9972405), for historical case studies on how study design deficiencies have delayed CED approvals.

The Role of National Registries

For major device classes (like TAVR or ICDs), CMS utilizes established national registries. This is the most efficient pathway for manufacturers, as the registry infrastructure already exists. For example, the STS/ACC TVT Registry serves as the sole approved data collection mechanism for TAVR. Any hospital performing a TAVR procedure must enter dozens of data fields per patient—including baseline characteristics, procedural details, and follow-up outcomes—into the TVT database. If a hospital fails to enter this data, or if the patient does not meet the registry's inclusion criteria, Medicare will deny payment for the entire procedure, including the hospital stay and the device itself.

Intersection with the FDA-CMS RAPID Coverage Pathway

To address the graduation problem and accelerate access to novel technologies, the federal government has attempted to build bridges between the FDA approval process and CMS coverage.

The latest iteration of this effort is the FDA-CMS RAPID coverage pathway (alongside the proposed Transitional Coverage for Innovative Technology, or TCET, guidelines). Designed primarily for FDA-designated Breakthrough Devices, these programs seek to establish a synchronized review process:

1. Early Engagement: CMS participates in FDA pre-submission meetings for Breakthrough devices, helping the sponsor design a single clinical trial that satisfies both agencies.
2. Transitional Coverage: Upon FDA approval, the device receives immediate transitional Medicare coverage for a period of up to 4 years.
3. Streamlined CED: During this transitional period, the manufacturer generates the additional clinical evidence required by CMS, often utilizing a streamlined CED registry or longitudinal study.

The Critical Distinction for STeP

While the RAPID and TCET pathways represent a major step forward for Breakthrough devices, sponsors of devices in the Safer Technologies Program (STeP) do not have access to these transitional coverage benefits. See our dedicated FDA Safer Technologies Program (STeP) guide for the eligibility and application mechanics.

STeP devices must navigate the traditional, non-synchronized reimbursement pathway. This makes the strategic planning for STeP devices even more critical: you must be prepared to handle the full registry and evidence-generation burden without the benefit of automatic transitional payment.

Frequently Asked Questions (FAQ)

Is CED the same as an NCD or an LCD?

No. An NCD (National Coverage Determination) is a nationwide policy established by CMS regarding whether Medicare will cover a specific item or service. An LCD (Local Coverage Determination) is a policy established by an individual Medicare Administrative Contractor (MAC) for its specific geographic region. CED is a condition or mechanism layered on top of an NCD. It is a specific type of NCD that states, "We will cover this nationwide, but only if the patient is enrolled in an approved registry or study."

Can a device under CED be covered outside of an approved study or registry?

No. If a National Coverage Determination contains a CED requirement, Medicare will not pay for the device or procedure if the patient is not enrolled in the approved trial or registry. Any claims submitted for patients outside the approved study protocol will be denied.

How long does a device typically stay under CED before it graduates?

Based on historical data from the USC Schaeffer Center, the vast majority of devices placed under CED remain there indefinitely. For the very few that have successfully graduated to unrestricted national coverage, the process took between 4 and 12 years of continuous data collection and clinical publications.

Sources

1. Centers for Medicare & Medicaid Services (CMS), "Coverage with Evidence Development", Program Page. Available at: CMS CED Landing Page
2. Centers for Medicare & Medicaid Services (CMS), "Coverage with Evidence Development Guidance Document", Published August 7, 2024. Available at: CMS CED Guidance Document PDF
3. Centers for Medicare & Medicaid Services (CMS), "Medicare Coverage Document - Coverage with Evidence Development (MCDId 27)", Current Reference. Available at: CMS MCDId 27
4. USC Schaeffer Center for Health Policy and Economics, "Medicare's Coverage With Evidence Development: A Barrier to Patient Access and Innovation", White Paper, May 1, 2023. Available at: USC Schaeffer CED Analysis
5. JAMA Health Forum, "CMS Coverage With Evidence Development: Challenges and Opportunities for Improvement", Peer-reviewed analysis. Available at: JAMA Health Forum (PMCID PMC9972405)
6. Centers for Medicare & Medicaid Services (CMS), "Cardiac Contractility Modulation for Heart Failure" (NCD 20.39, effective October 28, 2025). Available at: CMS CCM CED Page
7. Centers for Medicare & Medicaid Services (CMS), "Renal Denervation for Uncontrolled Hypertension" (NCD 20.40, effective October 28, 2025). Available at: CMS RDN CED Page
8. Centers for Medicare & Medicaid Services (CMS), "Transcatheter Tricuspid Valve Replacement (TTVR)" (effective March 19, 2025). Available at: CMS TTVR CED Page
9. Social Security Administration, "Social Security Act Section 1862 [42 U.S.C. 1395y] - Exclusions from Coverage", Legal Reference. Available at: Social Security Act Section 1862