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Date Printed: August 18, 2017: 07:51 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-L0000-05

Original Effective Date: 07/15/99

Reviewed: 04/28/11

Revised: 11/01/15

Subject: Prosthetics

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

For the purposes of this guideline, prosthetics are appliances or devices used as artificial substitutes to replace absent or non-functioning parts of the human body. A prosthetic can be surgically implanted (surgical prostheses) or worn as an anatomic supplement (non-surgical prostheses).

POSITION STATEMENT:

Prosthetic devices are covered services, according to the member’s individual contract benefit.

The following prosthetic devices and prosthetic-related services meet the definition of medical necessity:

Surgical Prostheses, which are covered under surgery benefits:

- a diagnosis of angina pectoris is indicated;
- the patient is refractory to medical therapy; AND
- the patient is unable or refuses to have coronary bypass surgery following coronary angiography studies;
- (Reimbursement for this device is included in the basic allowance for the implantation procedure.

- prostate cancer;
- diabetes mellitus;
- peripheral neuropathy;
- medical endocrine causes of impotence;
- arteriosclerosis/postoperative bilateral sympathectomy;
- spinal cord injury;
- pelvic-perineal injury;
- post-prostatectomy;
- post-priapism;
- epispadias; AND
- exstrophy.

Non-Surgical Prostheses, which are covered under DME benefits:

The following prosthetic appliances are not eligible for coverage and are typically considered contract exclusions, according to the individual’s BCBSF contract benefits:

Breast Prostheses

Breast prostheses (L8000-L8032, L8039) meet the definition of medical necessity for individuals who have had a mastectomy.

An external prosthesis garment with mastectomy form (L8015) meets the definition of medical necessity when used in the postoperative period prior to permanent breast prosthesis or as an alternative to a mastectomy bra and breast prosthesis.

A custom breast prosthesis (L8035) provided in place of a prefabricated silicone breast prosthesis (L8030, L8031), does not meet the definition of medical necessity and is generally considered a contract exclusion.

Mastectomy sleeves (L8010) do not meet the definition of medical necessity and are generally considered a contract exclusion.

Lower Limb Prostheses

Lower limb prostheses meet the definition of medical necessity when the individual demonstrates specific functional levels as defined by CMS:

The medical record must document the individual’s current functional capabilities and expected functional potential, including an explanation for any existing difference. It is recognized within the functional classification hierarchy that bilateral amputees often cannot be strictly bound by functional level classifications.

When an initial below the knee prosthesis (L5500) or preparatory below the knee prosthesis (L5510 – L5530, or L5540) is provided, prosthetic substitutions and/or additional components are covered according to the functional level assessment except for the following codes: L5629, L5638, L5639, L5646, L5647, L5704, L5785, L5962, L5980, which would be considered incidental to the base prosthesis.

When an above the knee prosthesis (L5505) or above the knee preparatory prosthesis (L5560 – L5580, L5590-L5600) is provided, prosthetic substitutions and/or additional components are covered according to the functional level assessment except for the following codes: L5610, L5631, L5640, L5642, L5644, L5648, L5705, L5706, L5964, L5980, L5710 – L5780, L5790-L5795, which would be considered incidental to the base prosthesis.

When an above the knee prosthesis (L5585) is provided, prosthetic substitutions and/or additional components are covered according to the functional level assessment except for the following codes: L5624, L5631, L5648, L5651, L5652, L5705, L5706, L5964, L5966, which would be considered incidental to the base prosthesis.

If the individual’s potential functional level is 0, prostheses do not meet the definition of medical necessity according to the above level criteria.

Vacuum-Assisted Socket Systems (e.g., Otto Bock VASS™ system) (L5781, L5782) do not meet the definition of medical necessity as the published literature is insufficient to determine the device’s effectiveness for maintaining limb volume.

Feet

Foot prostheses meet the definition of medical necessity when the following criteria are met:

User-adjustable heel height features (L5990) do not meet the definition of medical necessity and are generally a contract exclusion.

Knees

Knee prostheses meet the definition of medical necessity when the following criteria are met:

Ankles

Axial rotation units (L5982 – L5986) meet the definition of medical necessity for individuals whose functional level is 2 or above.

Sockets

A test (diagnostic) socket for an immediate prosthesis or early-fitted prostheses (L5400 – L5460) does not meet the definition of medical necessity for an immediate prosthesis or early-fitted prostheses (L5400 – L5460).

Socket replacements meet the definition of medical necessity if there is adequate documentation of functional or physiological need. Situations when socket replacements may meet the definition of medical necessity include, but are not limited to the following:

Additions, Modifications, Replacements, Repairs

Components and/or additions to the prosthesis may meet the definition of medical necessity based on the individual’s functional ability and expected functional potential as defined by the prosthetist and the ordering physician.

Additional documentation supporting medical necessity must accompany claims submitted for prosthetic components and/or additions.

Additions or modifications do not meet the definition of medical necessity if the related prosthesis is not covered.

Replacement of a prosthetic device is eligible for coverage provided the need for replacement is documented by the attending physician and is due to a change in patient's condition, loss, or irreparable damage as a result of normal wear and tear.

Deluxe/convenience items

Deluxe prosthetic devices do not meet the definition of medical necessity and are not eligible for coverage.

BILLING/CODING INFORMATION:

Prosthetic devices may be described using the HCPCS Level II code range L5000 – L9999. Modifier –LT or –RT should be appended to the appropriate code describing the prosthetic device.

Repairs of prosthetic devices are to be coded by adding modifier –RP to the applicable procedure code for the device.

Adhesive used to attach a breast prosthesis to the chest wall should be reported using A4280.

NOTE: Coverage of some prosthetics may be addressed individually in separate policies (e.g., cochlear implants, intra-ocular lenses, peripheral nerve stimulators) and are listed below in the section entitled RELATED GUIDELINES.

REIMBURSEMENT INFORMATION:

Reimbursement for the following is included in the allowance for the covered prosthetic device:

Test (diagnostic) sockets (L5618 – L5628) for an individual prosthesis are limited to two (2) in a lifetime unless there is documentation in the medical record that justifies the need for additional test sockets.

Socket inserts are limited to two (2) of the same socket insert (L5654 – L5665, L5673, L5679, L5681, L5683) per individual prosthesis at the same time, in a lifetime, unless there is documentation in the medical record that justifies the need for replacement socket inserts.

Reimbursement for stump socks (L8420, L8430, L8435, L8470, L8480, or L8485) is limited to twelve (12) socks purchased within a twelve (12) month period unless documented as to medical necessity for Medical Review.

The following information may be required documentation to support medical necessity: Physician history and physical, treatment plan, treatment notes including documentation of symptoms, behavioral or pharmacologic interventions, and prior test stimulation (if applicable).

Documentation Table

LOINC Codes

LOINC
Time Frame
Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician Initial Assessment

18736-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physical therapy initial assessment

18735-1

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Treatment Plan, Plan of Treatment

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determinations (NCDs) were reviewed on the last guideline reviewed date: Prosthetic Shoe (280.10) and Diagnosis and Treatment of Impotence (230.4) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: External Breast Prostheses (L11554), Facial Prostheses (L11556), and Lower Limb Prostheses (L11442) located at cgsmedicare.com.

DEFINITIONS:

Convenience items: any object/device that increases physical comfort without serving a medically necessary purpose. Although they may be associated with secondary medical uses, the principal or primary use of a convenience item is usually not medical. Additional or duplicate items used for the same purpose, but not at the same time, are considered convenience. (BCBSF DME MCG)

Comfort (personal) items: items that do not contribute meaningfully to the treatment of an illness or injury or the functioning of a malformed body part. (CMS)

Custodial services: serves to assist an individual in their activities of daily living (e.g., walking, bathing, dressing, feeding, getting in and out of bed, using the toilet, supervision of medication that can be self-administered, and preparation of meals); personal care not requiring continuing attention of trained medical or paramedical personnel. (CMS)

Deluxe items: items with features that enhance basic equipment/devices (i.e., electrical or mechanical features) (BCBSF DME MCG)

RELATED GUIDELINES:

Cochlear Implants, 02-69000-03
Lower Limb Microprocessor-Controlled Prosthetics, 09-L0000-06

Myoelectric Upper Extremity Prostheses, 09-L0000-07

Prosthetic Eyes and Lens Implants, 09-V0000-01

Reconstructive Surgery and Cosmetic Surgery, 02-12000-01

Speech Generating Devices (e.g., Dynavox), 09-E0000-51

Speech Therapy, 01-92506-01

OTHER:

None applicable.

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy 1.04.01 – Prosthetics (04/16/04).
  2. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Prosthetic Shoe, Publication 100-3, Section 280.10). 05/89.
  3. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Carrier Determination (LCD) for External Breast Prostheses (L11554). Revised 03/01/08.
  4. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Carrier Determination (LCD) for Facial Prostheses (L11556). Revised 03/01/08.
  5. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Carrier Determination (LCD) for Lower Limb Prostheses (L11442). Revised 01/01/09.
  6. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Carrier Determination Policy Article A25528 for Lower Limb Prosthetics (effective 10/08).
  7. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Carrier Determination Policy Article A20209 for External Breast Prostheses (effective 06/07).
  8. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Carrier Determination Policy Article A25513 for Facial Prostheses (effective 07/09).
  9. McKesson InterQual 2009; Above Knee Prosthetics, Below Knee Prosthetics.
  10. Medicare Benefit Policy Manual, Chapter 15 Covered Medical and Other Health Services, Section 120-Prosthetic Devices (12/18/09).
  11. Medicare Carriers Manual (MCM 2100.4; 2130; 2130.D; 2133; 2323).
  12. Medicare Claims Processing Manual, Chapter 20 Prosthetics and Orthotics, (09/26/08).
  13. Orthocare Innovations (Smart Pyramid TM) website. Accessed 04/14/11.
  14. Otto Bock Harmony Vacuum-Assisted Socket System, Otto Bock HealthCare; Minneapolis, MN. Website accessed 04/14/11.
  15. Washington State Department of Labor and Industries. Office of Medical Director. Health Technology Assessment Brief. Otto Bock Harmony Vacuum Assisted Socket System (VASS). Updated 2003 Apr 3. Accessed 04/14/11

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/28/11.

GUIDELINE UPDATE INFORMATION:

07/15/99

Reformatted, revised Medical Coverage Guideline

12/30/99

HCPCS update

01/01/00

Revised to include additional coding

09/15/01

Revised to include additional covered indications and procedure codes

04/15/02

Cross-reference added for vacuum tumescence / constriction penile prosthetic devices

09/15/03

Reviewed; no change in coverage

01/01/04

Annual HCPCS coding update

07/15/04

Added cross-reference to new MCG for Speech Generating Devices.

09/15/05

Scheduled review; no changes in coverage statement.

08/15/07

Scheduled review; removed references to cochlear implants and intra-ocular lens implants that are addressed in separate guidelines; added facial prostheses to listed covered prosthetics; reformatted guideline; updated references.

06/15/09

Scheduled review; no change in position statement; references updated.

01/01/10

Annual HCPCS coding update: revised descriptor for 52282.

04/15/10

Revisions consisting of addition of reimbursement information for additions, components, modifications, deluxe items, and specific types of prosthetics; update definitions section; update references.

05/15/11

Revisions consisting of adding information regarding tuning devices and vacuum-assisted socket systems (L5781, L5782); references updated.

09/15/11

Revision to add cross-reference regarding SpeechEasy® devices; formatting changes.

01/15/13

Revision to add coding for breast prostheses.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 references deleted.

Date Printed: August 18, 2017: 07:51 PM