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This is a new policy published on 7/28/2020. It will be effective on 8/29/2020 or later.
  
Horizon BCBSNJ
Uniform Medical Policy ManualSection:D M E
Policy Number:051
Effective Date: 08/29/2020
Original Policy Date:07/28/2020
Last Review Date:
Date Published to Web: 07/28/2020
Subject:
UCB-Type Berkeley Shell Custom-Made Foot Orthotic

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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The UCBL foot orthotic was developed out of the research and academic efforts at the University of California Berkley Biomechanics Laboratory (UCBL). The critical research into the biomechanical functions of the foot and ankle, specifically the talocrural and subtalar joints, fostered the development of a brace that could stabilize deficits in these areas. (1, 2) The UCBL foot insert was developed to stabilize the foot within the shoe and to maintain stability during movement and ambulation. (3, 4) The ankle joint axis naturally deviates downward from the medial to lateral aspects of the foot. A deviation in the orientation of this axis or an anatomical deformation can have serious consequences to the functional stability of the foot and ankle. These include pain, ambulatory dysfunction, balance control and appearance. Take for example, a valgus or varus abnormality of the foot. This can lead to over pronation or supination of the foot, respectively, and cause significant morbidity and long term sequelae. A function of the UCBL is to help maintain the vertical alignment of the tibia down through to the calcaneus. Hence, this is the nature of the UCBL being a functional orthotic. The purpose and intent of the UCBL is a clear example of form meeting function. This function is what defines the material composition and structure of a true UCBL foot orthotic. Although the fabrication technology has changed over the decades, the key components remain the same. (4, 5, 6, 7, 8)

Policy:
[INFORMATIONAL NOTE: The New Jersey Orthotic and Prosthetic Appliances Mandate, P.L.2007, c.345 (effective April 12, 2008) requires health benefit plans to provide coverage for expenses incurred in obtaining an orthotic or prosthetic appliance if the appliance is obtained from a licensed orthotist, prosthetist, or any certified pedorthist as determined to be medically necessary by the covered person's physician.

An "orthotic appliance" is defined in N.J.S.A. 45:12B-3, as a brace or support but does not include fabric elastic supports, corsets, arch supports, trusses, elastic hose, canes, crutches, cervical collars, dental appliances or other similar devices carried in stock and sold by drug stores, department stores, corset shops or surgical supply facilities.]


I. The UCB-type (L3000) foot orthotic is considered medically necessary when ALL of the following criteria are met:
    A. It is prescribed by a qualified and licensed healthcare provider.
    B. It is prescribed as part of a treatment plan for a qualifying condition (e.g., flexible pes planus, plantar fasciitis, heel spurs, etc.).
    C. There has been an adequate trial of conservative treatment for 2-4 weeks or documentation of failure and/or a contraindication to conservative treatment before orthotics are dispensed. Conservative treatments include physical therapy, a home exercise plan, oral medications (i.e., NSAIDS, acetaminophen), weight loss, a prefabricated orthotic and other non-invasive treatments.
    D. The orthotic dispensed meets ALL of the following characteristics for a UCBL foot orthotic:
      1. It is a functional orthotic. It is posted in the forefoot either intrinsically or extrinsically.
      2. It is custom fabricated and fitted. It is fabricated from a three dimensional model of the patient’s foot (i.e., mold or scan).
      3. The core structure is composed with a material of adequate strength to control flexible deformities of the foot and maintain the hindfoot in neutral position. Additional accommodative padding may be needed to maintain stability and comfort.
      4. The heel cup is of adequate depth to encompass the calcaneus. A minimum of 10 mm heel cup depth would be required.*

      (*) Please note that heel cup depth would more commonly be between 15 mm to 40 mm depending on the anatomy of the patient. The deep heel cup is essential for the maintenance of hindfoot control as described above.

II. The following properties do not meet the criteria for a UCBL foot orthotic, and thus it would not be considered medically necessary:
    A. Any over the counter or off the shelf orthotic that is not custom fitted or fabricated to the individual needs of the patient and their anatomy.
    B. Any orthotic of a soft material or material that does not have the strength to provide control of the foot. This applies to the core material only and does not include the padding for pressure points or underlying arch support.
    C. A modified foot orthosis (MFO) that does not have all the characteristics of a UCBL as listed in policy statement I.D. above. Recent data has shown that the flexibility of the MFO insole and its walls are not able to maintain stability when compared to a UCBL. (9)
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
UCB-Type Berkeley Shell Custom-Made Foot Orthotic
University of California Berkeley Biomechanics Laboratory (UCBL) Functional Foot Orthotic
UCBL (University of California Berkeley Biomechanics Laboratory) Functional Foot Orthotic
Berkeley Shell Foot Insert
Foot Insert, Removable, Molded to Patient Model, UCB Type, Berkeley Shell
Foot Orthotic, UCB-Type, Berkeley Shell
Shoe Insert, UCB-Type, Berkeley Shell

References:
1. Close, J.R. and V.T. Inman: The Action of the Ankle Joint. Prosthetic Devices Research Project, Institute of Engineering Research, University of California, Berkeley, Ser. 11, Issue 22. Berkeley, The Project, April 1952.

2. Close, J.R. and V.T. Inman: The Action of the Subtalar Joint. Prosthetic Devices Research Project, Institute of Engineering Research, University of California, Berkeley, Ser . 11, Issue 24. Berkeley, The Project, May 1953.

3. Henderson, W.H. and L.W. Lamoreux: The Orthotic Prescription Derived from a Concept of Basic Orthotic Functions. Biomechanics Laboratory, University of California, San Francisco and Berkeley, Technical Memorandum. San Francisco, The Laboratory, October 1966.

4. Henderson, W.H. and J.W. Campbell: UC-BL Shoe Insert: Casting and Fabrication. Biomechanics Laboratory, University of California, San Francisco and Berkeley, Technical Report 53. San Francisco, The Laboratory, August 1967.

5. Quigley, M.J.: The Present Use of the UCBL Foot Orthosis Orthotics and Prosthetics, Vol. 28, No. 4, December 1974:59-63.

6. Gould N: Footwear: Shoes and shoe modifications. In Jahss MH (ed): Disorders of the Foot and Ankle: Medical and Surgical Management, Ed 2, Vol 3. Philadelphia, WB Saunders, 1991, pp 73-88.

7. Wapner, K.L. Conservative treatment of the foot. In: Surgery of the Foot and Ankle. St Louis, MO: CV Mosby, 1999:115–130.

8. Elattar, O., Smith, T., Ferguson, A., Farber, D., and Wapner, K.: Uses of Braces and Orthotics for Conservative Management of Foot and Ankle Disorders, Foot & Ankle Orthopaedics, Vol. 3, July 2018.

9. Payehdar1, S., Saeedi, H., Ahmadi, A., Kamali, M., Mohammadi, M. and Abdollah, V.: Comparing the immediate effects of UCBL and modified foot orthoses on postural sway in people with flexible flatfoot, Prosthetics and Orthotics International, Vol. 40(1), 2016:117 –122.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

    HCPCS
      L3000

    * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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    Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

    The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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