LCD/NCD Portal

L11525 THERAPEUTIC SHOES FOR PERSONS WITH DIABETES

 

Region IV

DME

Jurisdiction C

08/05/2011

 

 

• For any item to be covered by Medicare, it must

o be eligible for a defined Medicare benefit category

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

o Meet all other applicable Medicare statutory and regulatory requirements.

o 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.

o 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.

o The nature and severity of the deformity must be well documented in the supplier's records and available upon request.

o 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:

 

A5500 FOR DIABETICS ONLY, FITTING (INCLUDING FOLLOW-UP), CUSTOM PREPARATION AND SUPPLY OF OFF-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

A5512 FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, DIRECT FORMED, MOLDED TO FOOT AFTER 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

A5513 FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, CUSTOM MOLDED FROM MODEL OF PATIENT’S FOOT, 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

 

 

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."

o It is expected that the patient's medical records will reflect the need for the care provided.

o 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.

o 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.

o 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.

o However, the supplier's records should document the reason for the replacement.

o A new order is required for the replacement of any shoe.

o 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.

o 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.

o 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.

o The "Statement of Certifying Physician for Therapeutic Shoes" form (see LCD Attachments section below) is recommended.

o Whatever form is used must contain all of the elements contained on the recommended form attached to this LCD.

o This statement must be completed, signed, and dated by the certifying physician.

o 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:

o Documents management of the patient’s diabetes; and

o 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:

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

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

• 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.

o 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.

 

 

Sources of Information and Basis for Decision

 

A37065 - Therapeutic Shoes for Persons with Diabetes - Policy Article - Effective July 2010

 

Statement of Certifying Physician for Therapeutic Shoes

 

 

Local Coverage Determination (LCD) for Therapeutic Shoes for Persons with Diabetes (L11525)