HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
O-24-015
Topic:
Ankle-Foot/Knee-Ankle-Foot Orthosis
Section:
Orthotic & Prosthetic Devices
Effective Date:
September 2, 2024
Issued Date:
September 2, 2024
Last Revision Date:
July 2024
Annual Review:
July 2024
 
 

An orthosis is an orthopedic appliance or apparatus used to support, align, prevent, or correct deformities or to improve function of movable parts of the body. Ankle-Foot Orthosis (AFO’s) and Knee-Ankle-Foot Orthosis (KAFO’s) are designed to control knee and ankle motion.

The purpose of a brace is to support a weak or deformed body member or to restrict or eliminate motion in a diseased or injured part of the body.

Policy Position

For an item to be considered for coverage under the brace benefit category, it must be a rigid or semi-rigid device which is used for the purpose of supporting a weak or deformed body extremity or restricting or eliminating motion in a diseased or injured part of the body.  It must provide support and counterforce (i.e., a force in a defined direction of a magnitude at least as great as a rigid or semi-rigid support) on the limb or body part that it is being used to brace. 

Elastic support garments do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices and are non-covered.

An orthosis can be classified as either prefabricated (off-the-shelf or custom fitted) or custom-fabricated. Items that do not meet the definition of a brace are non-covered.


AFO or KAFO Non-Ambulatory/Minimally Ambulatory

Treatment with a static or dynamic positioning AFO may be considered medically necessary for ONE or more of the following conditions:

  • Plantar fascitis; or
  • When ALL of the following conditions are met:
    • Plantar flexion contracture of the ankle with dorsiflexion on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture); and
    • Reasonable expectation of the ability to correct the contracture; and
    • Contracture is interfering or expected to interfere significantly with the individual’s functional abilities; and
    • Used as a component of a therapy program; this includes active stretching of the involved muscles and/or tendons.

If a static or dynamic positioning AFO is used for the treatment of a plantar flexion contracture, the pre-treatment passive range of motion must be measured with a goniometer and documented in the medical record.  There must be documentation of an appropriate stretching program carried out by professional staff or caregiver.

If a static or dynamic positioning AFO is considered medically necessary, a replacement interface is considered medically necessary as long as the individual continues to meet indications and other coverage rules for the splint.  Coverage of a replacement interface is limited to a maximum of one (1) per six (6) months.  Additional interfaces will be denied as not medically necessary.

An AFO or KAFO may be considered medically necessary for the following indications:

  • To assist with standing or transferring if an individual has a documented medical reason(s) to provide stabilization to prevent further or new tissue injury; or
  • To correct, maintain, or prevent worsening of the knee or knee and ankle contractures in patients with severe neurologic or musculoskeletal conditions.

AFO or KAFO Ambulatory

 An AFO may be considered medically necessary for ambulatory individuals with weakness or deformity of the foot and ankle, who require stabilization for medical reasons (including required support for  standing transfers), and have the potential to benefit functionally.

 A KAFO may be considered medically necessary for ambulatory individuals for whom an ankle-foot orthosis is considered medically necessary and additional knee stability is required.

An AFO or KAFO that is custom-fabricated may be considered medically necessary for ambulatory individuals when the basic coverage criteria listed above and ONE of the following criteria are met:

  • The individual could not be fitted with a prefabricated AFO; or
  • The condition necessitating the orthosis is expected to be permanent or of longstanding duration (more than six (6) months);  or
  • There is a need to control the knee, ankle or foot in more than one (1) plane; or
  • The  individual has a documented neurological, circulatory, or orthopedic status that requires custom fabricating over a model to prevent tissue injury; or
  • The individual has a healing fracture which lacks normal anatomical integrity or anthropometric proportions.

If a custom fabricated orthosis is provided but ALL of the coverage criteria above including the additional criteria for a custom fabricated orthosis are not met, the custom fabricated orthosis will be denied as not medically necessary.

Concentric adjustable torsion style mechanisms used to assist knee joint extension may be considered medically necessary for individuals who require knee extension assist in the absence of any co-existing joint contracture.

Concentric adjustable torsion style mechanisms used to assist ankle joint plantarflexion or dorsiflexion may be considered medically necessary for individuals who require ankle plantar or dorsiflexion assist in the absence of any co-existing joint contracture.

Concentric adjustable torsion style mechanisms may be considered medically necessary when used for the treatment of contractures, regardless of any co-existing condition(s). 

Replacement of a complete orthosis or component of an orthosis due to loss, significant change in the individual’s condition, or irreparable accidental damage may be considered medically necessary if the device is still medically necessary.  The reason for the replacement must be documented in the supplier’s record. Replacements not meeting criteria will be considered not medically necessary.

If the specific AFO or KAFO criteria are not met, the orthosis will be considered not medically necessary.

A4467

A9283

A9285

E1810

E1815

L1900

L1902

L1904

L1906

L1907

L1910

L1920

L1930

L1932

L1940

L1945

L1950

L1951

L1960

L1970

L1971

L1980

L1990

L2000

L2005

L2010

L2020

L2030

L2034

L2035

L2036

L2037

L2038

L2106

L2108

L2112

L2114

L2116

L2126

L2128

L2132

L2134

L2136

L2180

L2182

L2184

L2186

L2188

L2190

L2192

L2200

L2210

L2220

L2230

L2232

L2240

L2250

L2260

L2265

L2270

L2275

L2280

L2300

L2310

L2320

L2330

L2335

L2340

L2350

L2360

L2370

L2375

L2380

L2385

L2387

L2390

L2395

L2397

L2405

L2415

L2425

L2430

L2492

L2500

L2510

L2520

L2525

L2526

L2530

L2540

L2550

L2750

L2755

L2760

L2768

L2780

L2785

L2795

L2800

L2810

L2820

L2830

L2840

L2850

L2861

L2999

L4002

L4010

L4020

L4030

L4040

L4045

L4050

L4055

L4060

L4070

L4080

L4090

L4100

L4110

L4130

L4205

L4210

L4350

L4360

L4361

L4370

L4386

L4387

L4392

L4394

L4396

L4397

L4398

L4631

 

 

 

 

 




The following conditions will be considered not medically necessary:

  • Static AFO and replacement interface for individuals with:
    • A fixed contracture; or
    • Foot drop without an ankle flexion contracture; or
  • A component of a static AFO that is used to address positioning of the knee or hip; or
  • A foot drop splint/recumbent positioning device or replacement interface including the following:
    • For non-ambulatory individuals with foot drop due to other more appropriate treatment modalities; or
    • When used solely for the prevention or treatment of a pressure ulcer as it does not meet the definition of a brace to support weak or deformed body parts or to restrict or eliminate motion.
  • Additions to AFO or KAFO’s when a base othosis or the addition is not medically necessary.

The following conditions are considered non-covered:

  • A static AFO and replacement interface when it is used solely for the prevention or treatment of a heel pressure ulcer as it does not meet the definition of a brace to support weak or deformed body parts or to restrict or eliminate motion; or
  • A foot pressure off-loading/supportive device because it does not support a weak or deformed body member or restrict or eliminate motion in a diseased or injured part of the body; or
  • Socks used in conjunction with orthoses; or
  • Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out.

A4467

A9283

A9285

E1810

E1815

L1900

L1902

L1904

L1906

L1907

L1910

L1920

L1930

L1932

L1940

L1945

L1950

L1951

L1960

L1970

L1971

L1980

L1990

L2000

L2005

L2010

L2020

L2030

L2034

L2035

L2036

L2037

L2038

L2106

L2108

L2112

L2114

L2116

L2126

L2128

L2132

L2134

L2136

L2180

L2182

L2184

L2186

L2188

L2190

L2192

L2200

L2210

L2220

L2230

L2232

L2240

L2250

L2260

L2265

L2270

L2275

L2280

L2300

L2310

L2320

L2330

L2335

L2340

L2350

L2360

L2370

L2375

L2380

L2385

L2387

L2390

L2395

L2397

L2405

L2415

L2425

L2430

L2492

L2500

L2510

L2520

L2525

L2526

L2530

L2540

L2550

L2750

L2755

L2760

L2768

L2780

L2785

L2795

L2800

L2810

L2820

L2830

L2840

L2850

L2861

L2999

L4002

L4010

L4020

L4030

L4040

L4045

L4050

L4055

L4060

L4070

L4080

L4090

L4100

L4110

L4130

L4205

L4210

L4350

L4360

L4361

L4370

L4386

L4387

L4392

L4394

L4396

L4397

L4398

L4631

 

 

 

 

 




Microprocessor Controlled KAF/KAFO

 

Microprocessor controlled KAF/KAFO are considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

L2006

 

         



Related Policies

Refer to Medical Policy O-8, Braces and Supports, for additional information.

Refer to Medical Policy E-15, Diabetic Services and Supplies, for additional information.

 


Covered Diagnosis Codes for Procedure Codes L4392, L4396 and L4397

M24.571

M24.572

M24.574

M24.575

 M72.2

 

 


Covered Diagnosis Codes for Procedure code L4631

A52.16

E08.610

E09.610

E10.610

E11.610

E13.610

M14.671

M14.672

M14.69

M62.471

M62.472

 

 

 



Place of Service: Outpatient

AFO/KAFO is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.