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    v1.0.31
    OpenPayerPolicy UpdatesDurable Medical Equipment (DME)Curative Surgical Implant Coverage | OpenPayer
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    CurrentCurativePolicy CHP-OP-2026-082

    82. DME - Surgical Implants (Durable)

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    Medical-necessity criteria for implantable devices, separately reported implant supplies, durable implant components, and replacement or external components not governed by a device-specific policy.

    Policy Summary
    PayerCurative
    Policy82. DME - Surgical Implants (Durable)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit complete clinical, device-regulatory, least-costly-alternative, HDE, and replacement documentation as applicable.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    4FDA authorization pathways recognized
    4Core general implant criteria
    6Required documentation categories
    5Does-not-meet-criteria scenarios
    4Safety-related review pathways
    18Reference billing codes

    Coverage Criteria

    General implant and implant-supply criteria

    Covered when ALL of the following are met:

    • The associated procedure meets its governing policy, or, for a device furnished on its own, a qualifying diagnosis and a documented functional deficit or disease process that the device addresses are present.
    • The device has FDA authorization and is used within its labeled indication, anatomic site, and age range.FDA authorization: PMA, 510(k), De Novo, or HDE

      Use outside labeling must be supported by peer-reviewed evidence or a specialty-society guideline under the plan's off-label use standards.

    • Where a CMS NCD or LCD addresses the specific device, its clinical criteria are met; where none exists, the applicable specialty-society guideline and FDA labeling govern.
    Policy Summary
    PayerCurative
    Policy82. DME - Surgical Implants (Durable)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit complete clinical, device-regulatory, least-costly-alternative, HDE, and replacement documentation as applicable.
    SourceLink
    On This Page
    Coverage CriteriaMedical Necessity FrameworkReplacement Components and AccessoriesNot CoveredReference CodingProvider Actions and Review RequirementsRequired DocumentationPolicy BackgroundDefinitions
    The device is the least costly option that meets the documented need.

    A specific device may be used when the clinician documents a rationale such as anatomy, prior device failure, compatibility with an existing implant, or a labeled indication available only for that device.

    Humanitarian device exemption devices

    Covered when ALL of the following are met:

    • The member has the rare condition specified in the HDE labeling.HDE-labeled rare condition
    • The implanting facility has institutional review board approval for HDE use, as required by the FDA.

      IRB approval is required.

    • Alternative FDA-approved treatments are unavailable, ineffective, or contraindicated, as documented in the record.

      Document the absence, ineffectiveness, or contraindication of suitable alternatives.

    Replacement components, batteries, and external parts

    Covered when ALL of the following are met:

    • The base implant was covered, or would meet criteria, and continues to provide documented benefit.

    • The replacement is needed because ONE of the following applies:

      • The component is lost.
      • The component is irreparably damaged.
      • The component is at end of life.
      • The component is no longer compatible or supported by the manufacturer.
      • The member's condition has changed.

    Cardiac rhythm devices, including implantable cardioverter-defibrillators, pacemakers, and their leads; neurostimulator electrodes, generators, and components; coronary stent placement; spine bone graft and interbody-device procedures; and breast implants are reviewed under their designated cardiac, neurostimulator, orthopedic, or reconstruction policies rather than this general implant framework.

    A device with no FDA authorization is not covered under this policy's medical-necessity criteria. A Category A IDE device used outside an approved clinical trial is likewise excluded and is subject to the plan's experimental and investigational standards.

    The policy does not cover unproven off-label use outside the labeled anatomic site, indication, or age range when peer-reviewed or specialty-society guideline support is absent. It also excludes a device that duplicates the function of a working implant without documented need for both, and devices supported only by unpublished, manufacturer-generated data.

    A more costly device is not medically necessary when a less costly device meets the documented need, unless the request includes a documented device-specific clinical rationale supporting the higher-cost option.

    A device that duplicates the function of a working implant is not medically necessary when the record does not document why both devices are needed.

    Medical Necessity Framework

    General DME implant criteria

    Implantable devices and separately reported implant supplies are medically necessary when ALL general criteria are met:

    • The associated procedure is covered under its governing policy, or the standalone device addresses a qualifying diagnosis and documented functional deficit or disease process.
    • The device is FDA-authorized and used within labeling or supported under off-label standards.FDA authorization: PMA, 510(k), De Novo, or HDE

      Off-label use must be supported by peer-reviewed evidence or a specialty-society guideline.

    • Applicable device-specific CMS clinical criteria are met; when none exists, specialty-society and FDA criteria govern.
    • The device is the least costly appropriate option unless a documented clinical rationale supports a specific device.

      Facility-billed implants integral to an approved procedure are reviewed with that procedure.

    Replacement components and external parts

    Replacement components are medically necessary when ALL criteria are met:

    • The base implant was covered or would meet criteria and continues to provide documented benefit.

    • The replacement is needed because ONE of the following applies:

      • The component is lost.
      • The component is irreparably damaged.
      • The component is at end of life.
      • The component is no longer compatible or supported by the manufacturer.

    Replacement Components and Accessories

    Implant external components, batteries, and accessories
    Replacement timingEvent-based; no fixed interval specified.
    Covered replacement eventsReplacement may be needed when the component is lost, irreparably damaged, at end of life, or no longer compatible or supported by the manufacturer.
    Additional qualifying eventReplacement may also be needed when the member's condition has changed.

    Not Covered

    The following scenarios do not meet this policy's coverage criteria: investigational or unauthorized devices, including Category A IDE devices used outside approved clinical trials; unproven off-label use without peer-reviewed or specialty-society guideline support; more costly devices without documented device-specific rationale when a less costly option meets the need; duplicative devices when a working implant already provides the function and no need for both is documented; and devices supported only by unpublished manufacturer-generated data. Requests in these circumstances must be referred for physician review rather than denied automatically or by a non-physician reviewer.

    Reference Coding

    Cardiac lead procedures (Policy 83)CPT
    33215Cardiac lead procedures (Policy 83)
    33216Cardiac lead procedures (Policy 83)
    Spinal neurostimulator electrode procedures (Policy 84)CPT
    63650Spinal neurostimulator electrode procedures (Policy 84)
    63655Spinal neurostimulator electrode procedures (Policy 84)
    Miscellaneous surgical supplyHCPCS
    A4649Miscellaneous surgical supply
    L8699Miscellaneous surgical supply
    Device C-codes (pass-through and implant categories)HCPCS
    C1713Device C-codes (pass-through and implant categories)
    C1721Device C-codes (pass-through and implant categories)
    C1722Device C-codes (pass-through and implant categories)
    C1760Device C-codes (pass-through and implant categories)
    C1762Device C-codes (pass-through and implant categories)
    C1763Device C-codes (pass-through and implant categories)
    C1767Device C-codes (pass-through and implant categories)
    C1768Device C-codes (pass-through and implant categories)
    C1776Device C-codes (pass-through and implant categories)
    C1777Device C-codes (pass-through and implant categories)
    1–10 of 17
    1/2
    Injectable bulking agents, ocular, aqueous shunt, and middle-ear implantsHCPCS
    L8603Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8604Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8605Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8606Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8607Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8608Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8609Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8612Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    L8613Injectable bulking agents, ocular, aqueous shunt, and middle-ear implants
    Cochlear external component and small-joint implantsHCPCS
    L8629Cochlear external component and small-joint implants
    L8630Cochlear external component and small-joint implants
    L8631Cochlear external component and small-joint implants
    L8641Cochlear external component and small-joint implants
    L8642Cochlear external component and small-joint implants
    L8658Cochlear external component and small-joint implants
    L8659Cochlear external component and small-joint implants
    Vascular graft and other implantsHCPCS
    L8670Vascular graft and other implants
    L8678Vascular graft and other implants
    Neurostimulator components (Policy 84)HCPCS
    L8679Neurostimulator components (Policy 84)
    L8680Neurostimulator components (Policy 84)
    L8681Neurostimulator components (Policy 84)
    L8682Neurostimulator components (Policy 84)
    L8683Neurostimulator components (Policy 84)
    L8684Neurostimulator components (Policy 84)
    L8685Neurostimulator components (Policy 84)
    L8686Neurostimulator components (Policy 84)
    L8687Neurostimulator components (Policy 84)
    L8688Neurostimulator components (Policy 84)
    1–10 of 11
    1/2
    Auditory osseointegrated deviceHCPCS
    L8690Auditory osseointegrated device

    Provider Actions and Review Requirements

    Prior Authorization

    Procedure Authorization May Cover Facility-Billed Implant

    Implant supplies billed by a facility as part of a procedure follow the procedure's authorization. A separate device authorization is not required when the procedure authorization identifies the device.

    Documentation Required

    Required Clinical and Device Documentation

    The request and medical record should include documentation sufficient to establish the clinical need, device status, and appropriateness of the requested implant.

    • Diagnosis, functional deficit or disease process, and the associated procedure or authorization for it.
    • Device manufacturer, model, and FDA authorization type and number (PMA, 510(k), De Novo, or HDE).
    • Confirmation of labeled use, or evidence supporting off-label use.
    • Least-costly-alternative rationale, or a device-specific reason such as anatomy, compatibility, or prior failure.
    • For HDE devices: IRB approval and documented absence of alternatives.
    • For replacements: the reason, including failure, end of life, recall, or change in condition, and the date of the original implant.
    Denial Risk

    Does Not Meet Medical-Necessity Criteria

    The following circumstances do not meet medical-necessity criteria under this policy. Requests in these circumstances must be referred for physician review and must not be denied by an automated system or non-physician reviewer.

    • A device with no FDA authorization, or a Category A IDE device used outside an approved clinical trial — experimental or investigational.
    • Use outside the labeled anatomic site, indication, or age range without peer-reviewed or guideline support — unproven off-label use.
    • A more costly device when a less costly device meets the documented need and no device-specific rationale is documented — not medically necessary under the least-costly-alternative requirement.
    • A device that duplicates the function of a working implant the member already has, without a documented need for both — duplicative.
    • A device supported only by unpublished, manufacturer-generated data — insufficient evidence and experimental or investigational.
    Denial Risk

    Investigational or Unauthorized Device

    A requested device that is Category A investigational or has no FDA authorization must be routed to physician review under the plan's experimental and investigational standards. Routine patient costs of an approved clinical trial must be covered as required by 42 U.S.C. 300gg-8.

    • A Category A IDE device used outside an approved clinical trial is also subject to physician review.
    • Do not proceed through an automated approval pathway for an unauthorized or investigational device.
    Note

    Physician Review Required for Adverse Determination

    Any adverse determination involving a request that does not meet medical-necessity criteria requires physician review. An automated system or non-physician reviewer may not issue the adverse determination.

    • Route the request to a physician reviewer when the device is experimental or investigational, off-label without supporting evidence, duplicative, unnecessarily costly, or supported only by insufficient evidence.

    Required Documentation

    Documentation Required

    Submit all applicable supporting documentation

    Submit complete documentation appropriate to the request, including clinical need, device-regulatory status, labeled or supported off-label use, least-costly-alternative or device-specific rationale, and applicable HDE or replacement records.

    • Diagnosis, functional deficit or disease process, and associated procedure or authorization
    • Manufacturer, model, and FDA authorization type and number
    • Least-costly-alternative rationale or device-specific reason, such as anatomy, compatibility, or prior failure
    • For HDE devices: IRB approval and documented absence of alternatives
    • For replacements: reason for replacement and date of the original implant

    Policy Background

    The policy distinguishes prosthetic devices from other implantable devices. A prosthetic device replaces all or part of an internal organ, including contiguous tissue, or replaces all or part of the function of a permanently inoperative or malfunctioning internal organ. Other implants are treated as supplies integral to a covered procedure. Coverage therefore depends on the applicable procedure or device criteria, FDA authorization, appropriate labeled or supported use, and selection of the least costly appropriate option.

    Definitions

    Prosthetic device (internal)
    Device typeA device that replaces all or part of an internal body organ.
    Included tissueThe replacement may include contiguous tissue.
    Functional replacementThe device may replace all or part of the function of a permanently inoperative or malfunctioning internal organ.
    FDA authorization
    Premarket approvalPremarket approval (PMA) for the specific device, as shown in FDA device databases.
    Clearance or classification510(k) clearance or De Novo classification for the specific device, as shown in FDA device databases.
    Humanitarian device exemptionHumanitarian device exemption (HDE) for the specific device, as shown in FDA device databases.
    Category A IDE device
    Device statusAn experimental device.
    Risk designationThe absolute risk of the device type has not been established.
    IDE categoryCategory A is the experimental IDE designation.
    Category B IDE device
    Device statusA non-experimental or investigational device.
    Established safety and effectivenessThe device type has already been shown to be safe and effective.
    Primary risk questionIncremental risk is the main question.
    The member's condition has changed.