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    v1.0.31
    OpenPayerPolicy UpdatesProsthetics & OrthoticsRegence Definitive Prostheses Prior Auth | OpenPay…
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    CurrentRegencePolicy M-DME18

    Definitive Lower Limb Prostheses

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    Medical-necessity review and preauthorization for definitive, permanent lower limb prostheses and specified components for Regence Medicare Advantage members; preparatory and microprocessor-controlled prostheses are outside scope.

    Policy Summary
    PayerRegence
    PolicyDefinitive Lower Limb Prostheses
    Policy CodePolicy M-DME18
    Change TypeNo material change
    Effective Date10/01/2026
    Last ReviewAug 1, 2026
    Next Review Date07/01/2027
    Key ActionObtain preauthorization for definitive, permanent prostheses and submit the applicable specific HCPCS code.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Definitive onlyProsthesis type addressed
    RequiredPreauthorization

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    2
    Scope exclusions
    45Covered HCPCS codes
    9Documentation categories

    Definitive Lower Limb Prosthesis Coverage

    Definitive Prosthesis Scope

    This policy addresses medical necessity criteria for definitive lower limb prostheses only. Preauthorization is required only for definitive (permanent) prostheses.

    Definitive prosthesis scope

    • A prosthesis is a fabricated substitute for a missing body part. Lower limb prostheses may include prosthetic feet, ankles, knees, and socket insertions and suspensions.
    • A definitive prosthesis is provided after the surgical wound has healed and the residual limb has matured.
    • This policy applies only to definitive lower limb prostheses and the codes noted in this policy.
    • Unlisted codes should not be used when there is a specific applicable code; see the Coding Note.
    • If the requested replacement is not addressed in LCD L33787 and Article A52496, refer to Durable Medical Equipment, Prosthetic and Orthotic Replacements, Duplicates, Repairs, and Upgrades to Existing Equipment MDME75.

    This policy does not address preparatory prostheses, which may be considered medically necessary.

    This policy does not address microprocessor-controlled prostheses.

    Medicare and member Evidence of Coverage documents exclude services or procedures considered investigational or experimental, cosmetic, or not medically reasonable and necessary. Services or items that are excluded or non-covered may result in member financial responsibility; providers are encouraged to inform members in advance. A member, appointed representative, or treating provider may request coverage before services are rendered through a pre-service organization determination.

    Services or items considered not medically reasonable and necessary under Title XVIII of the Social Security Act, §1862(a)(1)(A), are excluded from coverage.

    Applicable HCPCS Codes

    Covered HCPCS CodesHCPCSCovered
    L5000Partial foot, shoe insert with longitudinal arch, toe filler.
    L5010Partial foot, molded socket, ankle height, with toe filler.
    L5020Partial foot, molded socket, tibial tubercle height, with toe filler.
    L5050Ankle, Symes, molded socket, SACH foot.
    L5060Ankle, Symes, metal frame, molded leather socket, articulated ankle/foot (SACH).
    L5100Below knee (BK), molded socket, shin, SACH foot.
    L5105Below knee (BK), plastic socket, joints and thigh lacer, SACH foot.
    L5150Knee disarticulation (or through knee), molded socket, external knee joints, shin, SACH foot.
    L5160Knee disarticulation (or through knee), molded socket, bent knee configuration, external knee joints, shin, SACH foot.
    L5200Above knee (AK), molded socket, single axis constant friction knee, shin, SACH foot.
    1–10 of 45
    1/5
    CodingHCPCS
    L5726Addition, exoskeletal knee-shin system, single axis, external joints, fluid swing phase control.
    L5728Addition, exoskeletal knee-shin system, single axis, fluid swing and stance phase control.
    L5780Addition, exoskeletal knee-shin system, single axis, pneumatic/hydra pneumatic swing phase control.
    L5783Addition to lower extremity, user adjustable, mechanical, residual limb volume management system.
    L5810Addition, endoskeletal knee-shin system, single axis, manual lock.
    L5811Addition, endoskeletal knee-shin system, single axis, manual lock, ultra-light material.
    L5812Addition, endoskeletal knee-shin system, single axis, friction swing and stance phase control (safety knee).
    L5814Addition, endoskeletal knee-shin system, polycentric, hydraulic swing phase control, mechanical stance phase lock.
    L5816Addition, endoskeletal knee-shin system, polycentric, mechanical stance phase lock.
    L5818Addition, endoskeletal knee-shin system, polycentric, friction swing and stance phase control.
    1–10 of 33
    1/4

    Authorization, Documentation, and Billing Requirements

    Prior Authorization

    Preauthorization Required for Definitive Prostheses

    Preauthorization is required for definitive (permanent) lower limb prostheses before services are rendered. This policy addresses medical necessity for definitive prostheses and applies to the codes identified in the policy.

    Documentation Required

    Complete Supporting Documentation

    Submit complete clinical and functional records for review. Missing documentation may affect the review and decision outcome.

    • History and physical/chart notes, including prior prosthetic use
    • Current condition, residual-limb status, and other relevant medical problems
    • Current functional capabilities and expected functional potential, including an explanation for any difference
    • Functional level and desire to ambulate

    Lower Limb Prosthesis Overview

    A prosthesis is a fabricated substitute for a missing body part. Lower limb prostheses may include prosthetic feet, ankles, knees, socket insertions, and suspension components. A definitive prosthesis is generally provided after the surgical wound has healed and the residual limb has matured.

    Key Terms

    Prosthesis
    DefinitionA fabricated substitute for a missing body part.
    Definitive prosthesis
    DefinitionA permanent lower limb prosthesis provided after the surgical wound has healed and the residual limb has matured.
    Policy Summary
    PayerRegence
    PolicyDefinitive Lower Limb Prostheses
    Policy CodePolicy M-DME18
    Change TypeNo material change
    Effective Date10/01/2026
    Last ReviewAug 1, 2026
    Next Review Date07/01/2027
    Key ActionObtain preauthorization for definitive, permanent prostheses and submit the applicable specific HCPCS code.
    SourceLink
    On This Page
    Definitive Lower Limb Prosthesis CoverageApplicable HCPCS CodesAuthorization, Documentation, and Billing RequirementsLower Limb Prosthesis OverviewKey Terms
  1. Physician's order, if applicable
  2. Date of service the prosthesis or component was provided
  3. For replacement items: comparative limb measurements, when applicable, or the specific physiological change necessitating replacement
  4. Warranty information and a repair-versus-replacement analysis, including the cost to repair compared with the cost to replace
  5. Documentation Required

    Product Identification Required

    Identify the product being requested or supplied so the item can be accurately reviewed and billed.

    • Manufacturer name
    • Model number
    • For components, make/model and serial number, if applicable
    Documentation Required

    Replacement Documentation

    For replacement items, document objective evidence supporting the replacement rather than relying on a replacement request alone.

    • Comparative limb measurements, if applicable
    • Specific physiological change that necessitates replacement
    Documentation Required

    Bilateral Amputee Assessment

    For bilateral amputees, document the patient's actual current functional status and expected potential. Do not rely strictly on functional-level classifications when assessing medical necessity.

    • Describe current functional capabilities and any relevant differences between current status and expected potential
    Billing Rule

    Use the Applicable Specific HCPCS Code

    Report all items with the applicable specific HCPCS code. Do not use an unlisted code when a specific descriptive code is available; inappropriate unlisted coding or failure to use a specific code may result in an inaccurate review.

    • The health plan defers to the Medicare Pricing, Data Analysis, and Coding (PDAC) contractor (Palmetto GBA) for proper code assignment of most items
    • Use an unlisted code, such as HCPCS E1399, only when no appropriate descriptive code exists
    Denial Risk

    Incomplete Supporting Documentation May Affect the Decision

    Incomplete clinical, functional, product, or replacement documentation may prevent the plan from confirming that policy criteria are met and could affect the review and decision outcome.

    • Ensure all requested records are submitted before review, including clinical history, functional assessment, product identifiers, and replacement justification
    Denial Risk

    Excluded or Noncovered Services

    Investigational or experimental, cosmetic, or otherwise not medically reasonable and necessary services or items may be excluded from coverage under the member's Evidence of Coverage or applicable Medicare requirements. Providers should inform members in advance when they may be financially responsible for non-covered services.

    • The member Evidence of Coverage and applicable CMS policies take precedence in the event of a conflict
    • A member, appointed representative, or treating provider may request a pre-service organization determination before services are rendered