L11525-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Therapeutic Shoes for Persons with Diabetes

(L11525)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number 18003

Contractor Type DME MAC

Jurisdiction J - G

LCD Information

Document Information

LCD ID Number L11525

LCD Title Therapeutic Shoes for Persons with Diabetes

Contractor's Determination Number TSD

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2012 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Primary Geographic Jurisdiction

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico South Carolina Tennessee Texas Virginia Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993

Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/05/2011

Revision Ending Date

CMS National Coverage Policy

Medicare Benefit Policy Manual (IOM 100-02), Chapter 15, Section 140 Indications and Limitations of Coverage and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

The statutory coverage criteria for therapeutic shoes including the requirement for an order are specified in the related Policy Article.

Separate inserts may be covered and dispensed independently of diabetic shoes if the supplier of the shoes verifies in writing that the patient has appropriate footwear into which the insert can be placed. This footwear must meet the definitions found in this policy for depth shoes or custom-molded shoes.

A custom molded shoe (A5501) is covered when the patient has a foot deformity that cannot be accommodated by a depth shoe. The nature and severity of the deformity must be well documented in the supplier's records and available upon request. If a custom molded shoe is provided but the medical record does not document why that item is medically necessary, it will be denied as not reasonable and necessary.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service

GY - Item or service statutorily excluded or does not meet the definition of any Medicare benefit KX - Requirements specified in the medical policy have been met

LT - Left Side RT - Right Side

HCPCS CODES:

FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OF OFF- A5500 THE-SHELF DEPTH-INLAY SHOE MANUFACTURED TO ACCOMMODATE MULTI- DENSITY INSERT(S), PER

SHOE

A5501 FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OF SHOE MOLDED FROM CAST(S) OF PATIENT’S FOOT (CUSTOM MOLDED SHOE), PER SHOE

A5503 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE OR CUSTOM-MOLDED SHOE WITH ROLLER OR RIGID ROCKER BOTTOM, PER SHOE

A5504 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE OR CUSTOM-MOLDED SHOE WITH WEDGE(S), PER SHOE

A5505 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE OR CUSTOM-MOLDED SHOE WITH METATARSAL BAR, PER SHOE

A5506 FOR DIABETICS ONLY, MODIFICATION (INCLUDING FITTING) OF OFF-THE-SHELF DEPTH-INLAY SHOE OR CUSTOM-MOLDED SHOE WITH OFF-SET HEEL(S), PER SHOE

A5507 FOR DIABETICS ONLY, NOT OTHERWISE SPECIFIED MODIFICATION (INCLUDING FITTING) OF OFF-THE- SHELF DEPTH-INLAY SHOE OR CUSTOM-MOLDED SHOE, PER SHOE

A5508 FOR DIABETICS ONLY, DELUXE FEATURE OF OFF-THE-SHELF DEPTH-INLAY SHOE OR CUSTOM-MOLDED SHOE, PER SHOE

A5510 FOR DIABETICS ONLY, DIRECT FORMED, COMPRESSION MOLDED TO PATIENT’S FOOT WITHOUT EXTERNAL HEAT SOURCE, MULTIPLE-DENSITY INSERT(S) PREFABRICATED, PER SHOE

FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, DIRECT FORMED, MOLDED TO FOOT AFTER

A5512 EXTERNAL HEAT SOURCE OF 230 DEGREES FAHRENHEIT OR HIGHER, TOTAL CONTACT WITH PATIENT’S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 1/4 INCH MATERIAL OF SHORE A 35 DUROMETER OR

3/16 INCH MATERIAL OF SHORE A 40 DUROMETER (OR HIGHER), PREFABRICATED, EACH

FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, CUSTOM MOLDED FROM MODEL OF PATIENT’S FOOT, A5513 TOTAL CONTACT WITH PATIENT’S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 3/16 INCH

MATERIAL OF SHORE A 35 DUROMETER OR HIGHER), INCLUDES ARCH FILLER AND OTHER SHAPING

MATERIAL, CUSTOM FABRICATED, EACH

ICD-9 Codes that Support Medical Necessity

For ICD-9 codes relating to statutory coverage, see Policy Article.

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the prescribing physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

If the prescribing physician is the supplier, a separate order is not required, but the item provided must be clearly noted in the patient's record.

A new order is not required for the replacement of an insert or modification within one year of the order on file. However, the supplier's records should document the reason for the replacement. A new order is required for the replacement of any shoe. A new order is also required for the replacement of an insert or modification more than one year from the most recent order on file. The detailed written order must be signed on or after the date of the visit with the Prescribing Physician (see related Policy Article for information about the visit with the Prescribing Physician).

The supplier must obtain a signed statement from the physician who is managing the patient’s systemic diabetes condition (i.e., the certifying physician) specifying that the patient has diabetes mellitus, has one of conditions 2a

-2f listed in the related Policy Article, is being treated under a comprehensive plan of care for his/her diabetes,

and needs diabetic shoes. The certifying physician must be an M.D. or D.O and may not be a podiatrist, physician assistant, nurse practitioner, or clinical nurse specialist. The "Statement of Certifying Physician for Therapeutic Shoes" form (see LCD Attachments section below) is recommended. Whatever form is used must contain all of the elements contained on the recommended form attached to this LCD. This statement must be completed, signed, and dated by the certifying physician. A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file.

There must be information in the medical records of the certifying physician that:

a. Documents management of the patient’s diabetes; and

b. Documents detailed information about the condition (2a-2f listed in the related Policy Article) that qualifies the patient for coverage.

The Certification Statement by itself does not meet this requirement for documentation in the medical records. The in-person evaluation of the patient by the supplier at the time of selecting the items that will be provided

(refer to related Policy Article, Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include at least the following:

1. An examination of the patient’s feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.

2. For all shoes, taking measurements of the patient’s feet.

3. For custom molded shoes (A5501) and inserts (A5513), taking impressions, making casts, or obtaining CAD-CAM images of the patient’s fee that will be used in creating positive models of the feet.

The in-person evaluation of the patient by the supplier at the time of delivery (refer to related Policy Article, Non- Medical Necessity Coverage and Payment Rules, criterion 5) must be conducted with the patient wearing the shoes and inserts and must document that the shoes/inserts/modifications fit properly.

The ICD-9 code that justifies the need for these items must be included on the claim.

KX AND GY MODIFIERS:

Suppliers must add a KX modifier to codes for shoes, inserts, and modification only if criteria 1-5 in the Non- Medical Necessity Coverage and Payment Rules section of the related Policy Article have been met. This documentation must be available upon request. The Statement of Certifying Physician form is not sufficient to meet this requirement.

If criteria 1-5 in the Non-Medical Necessity Coverage and Payment Rules section of the related Policy Article have not been met, the GY modifier must be added to each code.

If a KX or GY modifier is not included on the claim line, it will be rejected as missing information.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices

Utilization Guidelines Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision Advisory Committee Meeting Notes

Start Date of Comment Period 05/01/1993

End Date of Comment Period 06/14/1993

Start Date of Notice Period 07/01/1993

Revision History Number 010

Revision History Explanation Revision Effective Date: 02/04/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Denial statements for custom fabricated shoes DOCUMENTATION REQUIREMENTS:

Added: Statement about timing of detailed written order. (Effective 1/1/2011)

Added: Clarification about documentation that must be in the certifying physician’s records. Added: Documentation required at the time of selecting the shoes/inserts. (Effective 7/1/2010) Added: Documentation required at the time of delivery. (Effective 7/1/2010)

Revised: Criteria for use of the KX and GY modifiers

Revision Effective Date: 08/01/2009 CMS NATIONAL COVERAGE POLICY:

Added: Benefit Policy Manual reference

HCPCS CODES AND MODIFIERS:

Added: GY

DOCUMENTATION REQUIREMENTS:

Revised: Instructions for certification statement to indicate that it be completed by the certifying physician. Revised: Instructions concerning KX modifier to refer to the Policy Article.

Clarified: Information documenting that KX modifier requirements have been met be in the records of the certifying physician.

Added: Instructions for use of GY modifier.

03/01/2008 - In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 07/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Moved: Requirement for an order to the Policy Article.

Moved: Statement about coverage of modifications to the Policy Article. Removed: DMERC references.

DOCUMENTATION REQUIREMENTS:

Removed: DMERC references.

06/01/2007 - In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006 (March publication) HCPCS CODES AND MODIFIERS:

Added: A5512 and A5513

Deleted: K0628 and K0629

Revision Effective Date: 01/01/2006 LMRP converted to LCD and Policy Article DOCUMENTATION REQUIREMENTS:

Removed the requirement for additional documentation to be submitted with the claim. Removed the requirement for a narrative description to be included on a claim with code A5507. Removed claim form completion reference for the CMS-1500 form or the electronic equivalent.

Revision Effective Date: 04/01/2004 HCPCS CODES AND MODIFIERS:

Added: K0628 and K0629 Deleted: A5509 and A5511

CODING GUIDELINES:

Added definitions for codes K0628 and K0629

Revision Effective Date: 04/01/2003 POLICY TITLE:

Retitled policy to reflect current American Diabetes Association nomenclature. HCPCS CODES AND MODIFIERS:

Added: EY

INDICATIONS AND LIMITATIONS OF COVERAGE:

Added standard language concerning coverage of items without an order.

Clarified the term “calendar year” to mean the period from January through December. DOCUMENTATION REQUIREMENTS:

Added standard language concerning use of the EY modifier for items without an order.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

04/01/2002 – Crosswalked HCPCS code A5502 to A5509, A5510 and A5511. Added non-coverage statement for A5510. Updated ICD-9 code range for diabetes mellitus in Coverage and Payment Rules section. Added RT and LT modifiers. Replaced ZX with KX modifier. Clarified that code A5507 can be used for repairs to diabetic shoes. Clarified that the certifying physician may not be a podiatrist.

12/01/2000 – Revised Statement of Certifying Physician for Therapeutic Shoes form adding “Circle all that apply” for all questions and statement that person signing the form must be an M.D. or D.O.

03/01/1998 – Removed HCPCS L3649, added HCPCS K0401. Added definitions for certifying physician, prescribing physician, and supplier in the Definitions section.

04/01/1995 – Revised definition of ZX modifier in Documentation section.

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Reason for Change Maintenance (annual review with new changes, formatting, etc.)