Documentation Checklist: Required Documentation in Supplier's File

Therapeutic Shoes for Persons with Diabetes
DOCUMENTATION CHECKLIST
Required Documentation in Suppliers File*
Documentation of a Dispensing Order (preliminary written or verbal order)
that contains:
Description of the item
Name of the beneficiary
Name of the physician
Date of the order

Physician signature (for written orders) or supplier
signature (for verbal orders)
NOTE: Only required if the items are dispensed prior to obtaining the detailed written order.
Detailed Written Order That Contains:

Beneficiarys name
List of all separately billable items ordered
Quantity to be dispensed (for inserts)
The treating physicians signature
The date the treating physician signed the order (must be personally entered
by physician)
The date of the order
Physicians signature on the written order meets CMS Signature Requirements
http://www.cgsmedicare.com/jc/pubs/news/2010/0410/cope12069.html
Order was obtained prior to submitting the claim to Medicare.
The order is dated on or after a documented beneficiary visit with the prescribing physician.
Changes/corrections to the order have been initialed/signed and dated.
NOTE: If the prescribing physician is the supplier, a separate order is not required, but the items
provided must be clearly noted in the patients record.
Direct Delivery
Beneficiarys name
Delivery address
Quantity delivered
Detailed description of item(s)
Brand
Signature of person accepting delivery
Relationship to beneficiary
Delivery date
Signed and dated Certifying Physician Statement (physician managing the beneficiarys
systemic diabetes condition) that specifies the beneficiary meets ALL the criteria listed below:
Has diabetes
Has one of the following conditions

Previous amputation of the other foot, or part of either foot, or

History of previous foot ulceration of either foot, or
History of pre-ulcerative calluses of either foot, or
Peripheral neuropathy with evidence of callus formation of either foot, or
Foot deformity of either foot, or
Poor circulation in either foot
Is being treated under a comprehensive plan of care for his/her diabetes, and needs
diabetic shoes.
Page 1
Originated January 18, 2011.
Revised January 25, 2016.
2016 Copyright, CGS Administrators, LLC.
Signature on the Certifying Physician Statement meets CMS Signature Requirements

Certifying Physician is an M.D. (Medical Doctor) or D.O. (Doctor of Osteopathy)
Clinical evaluation documenting the management of the patients diabetes
Evaluation was performed by the Certifying Physician;
Visit occurred within 6 months prior to delivery (if DOS is on or after 01/01/11); and
Signature meets CMS Signature Requirements
Clinical evaluation documenting that the beneficiary met one or more of criteria a f listed
above
Evaluation was either personally performed by the certifying physician OR the certifying
physician obtained documentation from another clinician, reviewed the information and
indicated agreement with the information by initialing and dating the record;
Evaluation was performed and/or reviewed by the Certifying Physician prior to completion
of the Statement of Certifying Physician;
Visit to document the qualifying foot condition occurred within 6 months prior to delivery
(if DOS is on or after 01/01/11); and
Signature meets CMS Signature Requirements
Supplier in-person evaluation conducted prior to or at the time of selection of items includes
at least the following:
An examination of the beneficiarys feet with a description of the abnormalities that will
need to be accommodated by the shoes/inserts/modifications;
Measurements of the patients feet; and
For custom molded shoes and inserts, information regarding taking impressions, making
casts, or obtaining CAD-CAM images of the patients feet that will be used in creating
positive models of the feet.
In-person visit, at the time of delivery, which assesses the fit of the shoes and inserts with the
beneficiary wearing them
Verification that the supplier disclosed Supplier Standards to the beneficiary
Claims for Custom Molded Shoes (A5501)
Suppliers evaluation documents all of the following:
Patient has a foot deformity that cannot be accommodated by a depth shoe;
The nature and severity of the deformity is described in detail; and
Visit included taking impressions, making casts, or obtaining CAD CAM images of the
patients feet in order to create positive models of the feet.
Claims for Custom Molded Inserts (A5513)
PDAC website lists the insert as HCPCS code A5513 or the supplier has the
following documentation:
List of materials that were use; and
A description of the custom fabrication process.
Reminders
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Suppliers should not submit claims to the DME MAC prior to obtaining a valid written order.
Items billed to the DME MAC before a signed and dated order has been received must be
submitted with an EY modifier added to each affected HCPCS code.
yy
Suppliers must add a KX modifier to codes for shoes, inserts, and modification only if
coverage criteria have been met. This documentation must be available upon request. The
Statement of Certifying Physician form is not sufficient to meet this requirement.
yy
If all coverage criteria have not been met, the GY modifier must be added to each code.
Page 2 2016 Copyright, CGS Administrators, LLC.
January 25, 2016.
yy
If a KX or GY modifier is not included on the claim line, it will be rejected as missing
information.
yy
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.
yy
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.
yy
A new order is not required for the replacement of an insert or modification within one year
of the order on file. However, the suppliers records should document the reason for the
replacement.
yy
A new order is required for the replacement of any shoe.
Additional Information References on the Web

yy
TSD Resources http://www.cgsmedicare.com/jc/coverage/mr/TSD_Resources.html
yy
Supplier Documentation Requirements http://www.cgsmedicare.com/jc/pubs/pdf/Chpt3.pdf
yy
Local Coverage Determinations (LCDs) and Policy Articles
http://www.cgsmedicare.com/jc/coverage/LCDinfo.html
NOTE: It is expected that the patients medical records will reflect the need for the care
provided. These records are not routinely submitted to the DME MAC but must be available
upon request. Therefore, while it is not a requirement, it is a recommendation that suppliers
obtain and review the appropriate medical records and maintain a copy in the beneficiarys file.
DISCLAIMER
This document was prepared as an educational tool and is not intended to grant rights or impose
obligations. This checklist may contain references or links to statutes, regulations, or other policy materials.
The information provided is only intended to be a general summary. It is not intended to take the place of
either written law or regulations. Suppliers are encouraged to consult the DME MAC Jurisdiction C Supplier
Manual and the Local Coverage Determination/Policy Article for full and accurate details concerning
policies and regulations.
Page 3 2016 Copyright, CGS Administrators, LLC.
January 25, 2016.

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Therapeutic Shoes for Persons with Diabetes

Date of the order

Previous amputation of the other foot, or part of either foot, or

Therapeutic Shoes for Persons with Diabetes

Signature on the Certifying Physician Statement meets CMS Signature Requirements

Page 2 2016 Copyright, CGS Administrators, LLC.

January 25, 2016.

Therapeutic Shoes for Persons with Diabetes

Additional Information References on the Web

Page 3 2016 Copyright, CGS Administrators, LLC.

January 25, 2016.

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