HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
O-32-013
Topic:
Lower Limb Prostheses
Section:
Orthotic & Prosthetic Devices
Effective Date:
April 1, 2024
Issued Date:
April 1, 2024
Last Revision Date:
March 2024
Annual Review:
November 2022
 
 

Lower limb prosthesis is an artificial device that replaces all or a part of the missing extremity. The application of an appropriate prosthesis is designed to regain or maintain function of the limb, and depends on the functional level of the amputee and the expected functional rehabilitation potential.

The microprocessor-controlled prosthetic knee is designed for lower limb amputees and congenital lack of limb. It is equipped with a sensor that controls the hydraulic that adjusts the swing and stability of the knee based on the position of the foot to permit a more natural walking pattern at varying speeds.

Policy Position

Immediate Prostheses

Lower limb prostheses, immediate, may be considered medically necessary for a new or revised amputation when ALL of the following criteria are met:

  • The individual has a lower extremity amputation; and
  • The immediate prosthesis is provided after surgery, while the surgical incision is still healing; and
  • The individual is motivated to ambulate using the prosthesis; and
  • The prosthesis is prescribed by an eligible professional provider (i.e., physician with training and expertise in the functional evaluation of individuals with amputations) and fitted/made by an orthotist or prosthetist.

 

Lower limb prostheses, immediate, are complete and all-inclusive; therefore, additional components, add-ons, upgrades, test sockets, or substitutions of components, etc., are considered not medically necessary.

Immediate lower limb prostheses, not meeting the criteria as indicated in this policy are considered not medically necessary.

L5400

L5410

L5420

L5430

L5450

L5460

L5500

L5505

 

 

 

 

 

 




Preparatory Prostheses

Lower limb prostheses, preparatory, may be considered medically necessary for a new or revised amputation when ALL of the following criteria are met:

  • The individual has had an above or below knee amputation; and
  • The preparatory prosthesis is provided to an individual starting a rehabilitation program; and
  • The preparatory prosthesis is provided after the surgical incision has healed; and
  • The individual is motivated to ambulate using the prosthesis; and
  • The preparatory prosthesis is prescribed by an eligible professional provider (i.e., physician with training and expertise in the functional evaluation of individuals with amputations) and fitted/made by an orthotist or prosthetist.

Lower limb prostheses, preparatory, are complete and all-inclusive; therefore, additional components, add-ons, upgrades, adjustments, modifications, or substitutions of components, etc., are considered not medically necessary.

 

Preparatory lower limb prostheses, not meeting the criteria as indicated in this policy are considered not medically necessary.

L5510

L5520

L5530

L5535

L5540

L5560

L5570

L5580

L5585

L5590

L5595

L5600

 

 




Definitive Prostheses

Lower limb prostheses, definitive- initial, may be considered medically necessary when ALL of the following criteria are met: 

·         The individual has had an above or below knee amputation; and

·         The definitive prosthesis is provided to an individual who will be participating in a rehabilitation program appropriate for the individual’s expected functional level; and

·         The definitive prosthesis is provided after the surgical incision is stable (healed); and

·         The definitive prosthesis is provided after the residual limb has matured; and

·         The individual is motivated to ambulate using the prosthesis; and

·         The individual is cognitively capable of using the prosthesis to ambulate effectively at the determined functional level [one (1) – four (4)]; and

·         The individual has sufficient neuromuscular control to effectively and appropriately make use of the definitive prosthesis at the determined functional level [one (1) – four (4)]; and

·         The individual has sufficient cardio-pulmonary capacity to effectively use the definitive prosthesis at the determined functional level [one (1) – four (4)]; and

·         The individual has had an in-person medical evaluation with the ordering physician to establish their overall functional capabilities,

o    NOTE: The ordering physician may delegate this assessment to a licensed/certified medical professional (LCMP) defined as a physical therapist (PT) or occupational therapist (OT), or physician with training and expertise in the functional evaluation of individuals with amputations; and

·      This specialty evaluation must:

o    Evaluate and document the individual’s over-all health status taking into consideration factors related to the amputation and prosthesis use as well the effect of co-morbidities on potential function ; and

o    The evaluation must include a complete physical examination including an objective neuromuscular evaluation, cardio-pulmonary capacity evaluation and cognitive evaluation; and

o    Determine a global activity level as described by the functional level modifiers:

 § Levels zero (0) – four (4) (see Table Attachment); and

·      The individual has had an in-person evaluation by the prosthetist to evaluate prosthetic needs consistent with the overall functional capabilities identified by the medical examination; and

·      The individual is able to ambulate using the device at or above the identified functional level.

Definitive lower limb prostheses, not meeting the criteria as indicated in this policy are considered not medically necessary.

L5050

L5060

L5100

L5105

L5150

L5160

L5200

L5210

L5220

L5230

L5250

L5270

L5280

L5301

L5312

L5321

L5331

L5341

 

 

 




Sockets and Socket Inserts

One (1) socket per individual definitive prosthesis may be considered medically necessary when the prosthesis meets above criteria.

Two (2) test (diagnostic) sockets for an individual definitive prosthesis may be considered medically necessary when the prosthesis meets above criteria.

No more than two (2) of the same socket inserts per individual prosthesis at the same time may be considered medically necessary.

One (1) custom fabricated socket insert may be considered medically necessary when the prosthesis meets the above criteria and the ALL of the following:

  • Non-custom socket inserts are unable to provide an adequate interface between the residual limb and socket; and
  • A different type of non-custom insert will not compensate for the irregular contours of the limb.

Socket replacements for a definitive prosthesis may be considered medically necessary when the prosthesis meets the above criteria, and EITHER of the following:

  • There are changes in the residual limb that cannot be accommodated though the use of socket inserts and/or liners and/or stump stockings, and/or modifications to the existing socket;  or
  • When the existing socket is irreparable due to damage or wear.

Sockets and socket inserts for lower limb prostheses, not meeting the criteria as indicated in this policy are considered not medically necessary.

L5618

L5620

L5622

L5624

L5626

L5628

L5630

L5632

L5634

L5636

L5638

L5639

L5640

L5642

L5643

L5644

L5645

L5646

L5647

L5648

L5649

L5650

L5651

L5652

L5653

L5654

L5655

L5656

L5658

L5661

L5665

L5673

L5679

L5681

L5683

L5700

L5701

L5702

L5703

 

 

 




Suspension Systems

Mechanical

Mechanical suspension systems including, belts, sleeves, straps, socket design features, and pin-locking mechanisms may be considered medically necessary when the prosthesis meets the above criteria, and the individual’s functional level is one (1) - four (4).

Suction

Passive suction systems may be considered medically necessary when the prosthesis meets above criteria, and the individual’s functional level is one (1) – four (4).

Vacuum Suspension System

Vacuum suspension systems (e.g., vacuum-assisted socket system [VASS™]) may be considered medically necessary to control residual limb volume when there is contraindication to or failure of other socket-suspension systems (e.g., mechanical, passive suction) to adequately secure the limb to the prosthesis; and the individual’s functional level is three (3) - four (4).  

 

Suspension systems for lower limb prostheses, not meeting the criteria as indicated in this policy are considered not medically necessary.

L5647

L5652

L5666

L5670

L5671

L5672

L5781

L5782

L7700

 

 

 

 

 




Feet and Ankles

One (1) foot/ankle may be considered medically necessary when a definitive prosthesis meets the above criteria, and the foot/ankle is appropriate for the individual’s functional level [one (1) – four (4)] as indicated below:

  • An external-keel solid ankle cushion heel (SACH) foot or single-axis ankle/foot may be considered medically necessary for individuals whose functional level is one (1) or above; or
  • A flexible-keel foot or multi-axial ankle/foot may be considered medically necessary for individuals whose functional level is two (2) or above; or
  • An energy-storing foot, dynamic response with multi-axial ankle, flex-foot system, flex-walk system or equal, or shank system with vertical loading pylon may be considered medically necessary for individuals whose functional level is three (3) or above; or
  • An axial rotation unit may be considered medically necessary for individuals whose functional level is two (2) or above; or
  • A partial foot prosthesis may be considered medically necessary for individuals whose functional level is one (1) or above.

L5000

L5010

L5020

L5970

L5972

L5974

L5976

L5978

L5979

L5980

L5981

L5982

L5984

L5986

L5987

 

 

 

 

 

 




Knees

Prosthetic knees may be considered medically necessary, when a definitive prosthesis meets the above criteria, and the type is based upon the functional needs of the individual as indicated below:

  • A fluid, pneumatic or electronic knee may be considered medically necessary for individuals whose functional level is three (3) or above.
  • A single axis constant friction knee and other basic knee systems may be considered medically necessary for individuals whose functional level is one (1) or above.

Prosthetic knee for a lower limb prosthesis, not meeting the criteria as indicated in this policy is considered not medically necessary.

Quick change self-aligning units are considered not medically necessary.

L5615

L5610

L5611

L5613

L5614

L5616

L5710

L5711

L5712

L5714

L5716

L5617

L5718

L5722

L5724

L5726

L5728

L5780

L5810

L5811

L5812

L5814

L5816

L5818

L5822

L5824

L5826

L5830

L5840

 

 

 

 

 

 




Hips

A pneumatic or hydraulic polycentric hip joint may be considered medically necessary when a definitive prosthesis meets the above criteria, and for individuals whose functional level is three (3) or above.

A pneumatic or hydraulic polycentric hip joint for a lower limb prostheses, not meeting the criteria as indicated in this policy is considered not medically necessary.

L5961

 

 

 

 

 

 




Additional Criteria

Lower limb prostheses, not meeting the criteria as indicated in this policy is considered not medically necessary.

 All parts of a lower limb prosthesis are considered not medically necessary when any related part is considered not medically necessary.

Lower limb prosthesis is considered not medically necessary for an individual that is at functional level zero (0).

Duplication or upgrade of a functional prosthesis is considered not medically necessary.

Additions/components that are not required for the effective use of the device, or do not serve a functional purpose are considered not medically necessary.

Additions provided for cosmetic reasons are considered not medically necessary.

Prosthetic devices or additions/components not required for participation in normal activities of daily living, including those that are chiefly for convenience, for participation in recreational activities, or that otherwise exceed the medical needs of the amputee (e.g., back-up prosthetic devices, waterproof leg prosthesis [e.g., Water Leg, used for showering, swimming] are considered not medically necessary.

Prosthetic donning sleeve is considered not medically necessary.

Protective outer surface covering systems are considered not medically necessary.

L5962

L5964

L5966

L5999

L7600

 

 




Additions/Accessories

Additions/Accessories may be considered medically necessary when a definitive prosthesis meets the above criteria, and supporting documentation indicates that they aid in, or are essential to, the effective use of the artificial limb, and are appropriate for the individual’s functional level [one (1) – four (4)].

Additions/Accessories not meeting the criteria as indicated in this policy are considered not medically necessary.

L5610

L5611

L5613

L5614

L5615

L5616

L5617

L5618

L5620

L5622

L5624

L5626

L5628

L5629

L5630

L5631

L5632

L5634

L5636

L5637

L5638

L5639

L5640

L5642

L5643

L5644

L5645

L5646

L5647

L5648

L5649

L5650

L5651

L5652

L5653

L5654

L5655

L5656

L5658

L5661

L5665

L5666

L5668

L5670

L5671

L5672

L5673

L5676

L5677

L5678

L5679

L5680

L5681

L5682

L5683

L5684

L5685

L5686

L5688

L5690

L5692

L5694

L5695

L5696

L5697

L5698

L5699

L5710

L5711

L5712

L5714

L5716

L5718

L5722

L5724

L5726

L5728

L5780

L5781

L5782

L5783

L5785

L5790

L5795

L5810

L5811

L5812

L5814

L5816

L5818

L5822

L5824

L5826

L5828

L5830

L5840

L5841

L5845

L5848

L5850

L5855

L5910

L5920

L5925

L5926

L5930

L5940

L5950

L5960

L5961

L5962

L5964

L5966

L5968

L5970

L5971

L5972

L5974

L5975

L5976

L5978

L5979

L5980

L5981

L5982

L5984

L5985

L5986

L5987

L5988

L5990

L5991

L5999

L8400

L8410

L8417

L8420

L8430

L8440

L8460

L8470

L8480

 

 

 

 

 




Repairs/Replacements

All necessary fitting, adjustments, modifications, replacements, etc., made during the 90 days after provision of a prosthesis are considered inherent to the prosthesis.

Lower limb prostheses replacement during the reasonable useful lifetime (usually based on the manufacturer's recommendation or FDA-approved labeling) may be considered medically necessary when supporting documentation indicates that the item is lost or irreparably damaged (i.e., fire, flood, etc.).

Lower limb prostheses replacement after the reasonable useful lifetime (usually based on the manufacturer's recommendation or FDA-approved labeling) may be considered medically necessary for at least ONE of the following when supporting documentation indicates:

  • There is a change in the physiological condition of the individual, and the prosthesis is considered medically necessary; or
  • There is irreparable wear of the device or a part of the device, and the prosthesis is considered medically necessary; or
  • The condition of the device, or part of the device, requires repairs and the cost of such repairs would be greater than 60% of the cost of a replacement device or the part being replaced, and the prosthesis is considered medically necessary.

Lower limb prostheses repairs may be considered medically necessary for EITHER of the following when supporting documentation indicates they are:

  • Required to make the prosthesis functional; or
  • In keeping with the manufacturer’s maintenance recommendations: or
  • Adjustments are required due to wear and tear.

Repairs/Replacements not meeting the criteria as indicated in this policy are considered not medically necessary.

L5700

L5701

L5702

L5703

L5704

L5705

L5706

L5707

L7510

L7520

 

 

 

 




Pediatric Lower Limb Prostheses

Pediatric lower limb prostheses may be considered medically necessary for congenital and acquired pediatric limb deficiencies.

Considerations for pediatric lower limb prostheses include:

  • Infants who are born with a missing or partial limb, or children who lose a limb through injury or amputation, should be evaluated by a prosthetist as soon as possible.
  • It is appropriate for infants and very young children to be fit with a passive prosthesis right away so that the prosthetic limb is incorporated into their developing body image.
  • A child is eligible for prosthetics when they are able to stand on their own (approximately 9-12 months of age).
  • Components must be evaluated for age-appropriateness, considering comfort, weight, durability, and function.
  • A new socket and other prosthetic modifications are required at least once a year for children between the ages of birth to 18 years to allow for normal growth and development.
  • Follow-up with a multidisciplinary approach is recommended.

Pediatric lower limb prostheses, not meeting the criteria as indicated in this policy is considered not medically necessary. 

L5700

L5701

L5702

L5703

L5704

L5705

L5706

L5707

L7510

L7520

 

 

 

 



Microprocessor-Controlled Lower Limb Prosthesis

Microprocessor-controlled knee may be considered medically necessary when the following criteria are met:

  • Individual’s functional level is three (3) or above, as indicated by modifier K3 or K4; and  
  • There is a demonstrated need for long-distance ambulation at variable rates (use of the limb in the home or for basic community ambulation is not sufficient to justify provision of the computerized limb over standard limb applications); or
  • There is a demonstrated patient need for regular ambulation on uneven terrain or for regular use on stairs (use of the limb for limited stair climbing in the home or employment environment is not sufficient evidence for prescription of this device over standard prosthetic application); and
  • Physical ability includes adequate cardiovascular and pulmonary reserve, for ambulation at faster than normal walking speed; and
  • Individual demonstrates adequate cognitive ability to master use and care requirements for the technology; and
  • The patient’s medical record must provide clear documentation of the patient’s history, current condition, and expected functional ability to support the need for the technologic or design feature of the microprocessor-controlled knee (This information must be retained in the physician’s or prosthetist’s files, and be available upon request.).

Microprocessor-controlled knee not meeting the criteria as indicated in this policy is considered not medically necessary.

L5828

L5845

L5848

L5856

L5857

L5858

L5859

L5920

L5930

L5950

L5999

 

 

 




Microprocessor-controlled ankle/foot prosthesis may be considered medically necessary when the individual’s functional level is three (3) or above, as indicated by modifier K3 or K4.

Microprocessor-controlled ankle/foot prosthesis not meeting the criteria as indicated in this policy is considered not medically necessary.

L5973

L5976

L5979

L5980

L5981

L5987

 




Powered and Programmable Flexion/Extension Assist-Control Prosthetic Knees

Powered and programmable endoskeletal knee-shin system with flexion-extension assist (addition to lower extremity) may be considered medically necessary when ALL of the following criteria are met:

  • The individual has a microprocessor (swing and stance phase type) controlled (electronic) knee; and
  • Individual’s functional level is three (3), as indicated by modifier K3 (the device is not intended for high impact activity, sports, excessive loading or heavy duty use); and
  • Weight is between 110 lbs and 275 lbs; and
  • Has a documented comorbidity of the spine and/or sound limb affecting hip extension and/or quadriceps function that impairs K-3 level function with the use of a microprocessor-controlled knee alone; and
  • Is able to make use of a product that requires daily charging; and
  • Is able to understand and respond to error alerts and alarms indicating problems with the function of the unit.

Powered endoskeletal knee-shin system with flexion-extension assist not meeting the criteria as indicated in this policy is considered not medically necessary.

 

L5856

L5859

 

 

 

 

 




Power-Assist Ankle-Foot Prosthetic Systems

Powered ankle or foot prostheses 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.

L5969

 

 

 

 

 

 




Related Policies

Refer to Medical Policy O-5 Powered Exoskeletal Robotic Systems for additional information.


Q72.811

Q72.812

Q72.813

Q72.819

Q72.891

Q72.892

Q72.893

Q72.899

S88.011A

S88.011D

S88.011S

S88.012A

S88.012D

S88.012S

S88.019A

S88.019D

S88.019S

S88.021A

S88.021D

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S88.022D

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S98.022A

S98.022D

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S98.029A

S98.029D

S98.029S

S98.111A

S98.111D

S98.111S

S98.112A

S98.112D

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S98.119A

S98.119D

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S98.131A

S98.131D

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S98.132A

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S98.139A

S98.139D

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S98.141A

S98.141D

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S98.142A

S98.142D

S98.142S

S98.149A

S98.149D

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S98.211A

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S98.212A

S98.212D

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S98.219A

S98.219D

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S98.221A

S98.221D

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S98.222A

S98.222D

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S98.311A

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S98.319A

S98.319D

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S98.321A

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S98.322A

S98.322D

S98.322S

S98.329A

S98.329D

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S98.912D

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S98.919A

S98.919D

S98.919S

S98.921A

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S98.921S

S98.922A

S98.922D

S98.922S

S98.929A

S98.929D

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Z89.9

Z89.411

Z89.412

Z89.419

Z89.421

Z89.422

Z89.429

Z89.431

Z89.432

Z89.439

Z89.441

Z89.442

Z89.449

Z89.511

Z89.512

Z89.519

Z89.521

Z89.522

Z89.529

Z89.611

Z89.612

Z89.619

Z89.621

Z89.622

Z89.629

 



Place of Service: Inpatient/Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Lower limb prostheses 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



Links






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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.





    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.