September 2, 2010
Therapeutic Shoes – Policy Revision/ Documentation Requirements
A revision of the Therapeutic Shoes Policy Article (PA) has been released. In addition, the following revision to the Documentation Requirements section of the LCD is being made. It will be incorporated in a subsequent revision of the Therapeutic Shoes LCD.
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. For claims with dates of service on or after January 1, 2011, 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 and must be received by the supplier prior to claim submission. A new Certification Statement is required for a shoe, insert or modification provided more than one year after the most recent Certification Statement on file.
There must be information in the medical records of the certifying physician that:
- Documents management of the patient's diabetes; and
- 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:
- An examination of the patient's feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.
- 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.
These revisions address two main areas:
- In-person fitting and delivery. This requirement is included in the DMEPOS Quality Standards published in October 2008. This policy revision incorporates information that was published in an article in May 2010.
- Certification statement. The Medicare statute – Social Security Act, Title XVIII, Section 1861(s)(12) – states that the physician who is managing the individual's diabetic condition must (1) document that the patient has one of several specified conditions that predispose the patient to diabetic ulcers of the feet and (2) certify that the individual needs therapeutic shoes and inserts under a comprehensive plan of care related to their diabetes. The DME MACs have received a number of questions relating to the timing and sequencing of visits and other activities related to this requirement. The policy revision clarifies these requirements.
The statute, national policy, and LCD/PA identify three entities involved in the provision of therapeutic shoes: Certifying Physician, Prescribing Physician, and Supplier. Definitions of these entities are found in the Therapeutic Shoes Policy Article. The following table summarizes the sequence and timing of the various steps required for the coverage of therapeutic shoes and inserts.
Note: The information contained in this article is only a summary of requirements. For complete information, you must review the entire LCD and Policy Article at http://www.cms.gov/mcd/search.asp?from2=search.asp&
|Activity||Responsibile Person||Requirements 1|
|1||Visit to document diabetes management 2||Certifying MD/DO||Within 6 months prior to delivery|
|2||Visit to document qualifying foot condition 2||Certifying MD/DO, other MD/DO, DPM, PA, NP, CNS||Within 6 months prior to delivery|
|3||Completing Certification Statement||Certifying MD/DO||After visit(s) to document diabetes management and qualifying foot condition2
After Certifying Physician reviews and signs report of visit documenting qualifying foot condition by other MD/DO, DPM, PA, NP, CNS – if applicable3
Prior to initial provision of shoes and inserts
For subsequent provision of shoes and inserts, required if delivery is more than 1 year after most recent Certification Statement
|4||Providing dispensing order to supplier4||Prescribing physician||After visit with Prescribing physician
|5||Signing detailed written order||Prescribing physician||After visit with Prescribing physician|
|7||Delivery visit||Supplier||After selection visit
After receiving dispensing order or detailed written order
|8||Submitting claims||Supplier||After delivery
After receiving detailed written order
After receiving Certification Statement
- If the table states that one event needs to occur "before" or "after" another event, both could occur on the same date if that sequence was followed
- Effective for dates of service on/after 1/1/2011
- Applicable if qualifying foot condition is not documented on visit with Certifying Physician
- Separate dispensing order not needed if detailed written order received by supplier prior to delivery