• Within 3 months prior to delivery
• Signed on or after visit(s) to document diabetes management and foot condition

• After delivery
• After receiving SWO
• After receiving certification statement

• To meet criterion 2, certifying physician (MD/DO, NP/PA practicing "incident to", NP part of PCF Demonstration Project) must either:
  • Personally document one or more of criteria 2a-2f in medical record if they have performed foot exam and prescribed shoes; or
  • MD/DO - Obtain, initial, date/sign (prior to or on same day as signing certification statement) and indicate agreement (I agree) with information from medical records of an exam and order from a podiatrist, other MD or D.O., physician assistant, nurse practitioner, or clinical nurse specialist, practicing independently, that documents one of more of criteria 2a-2f. It is not specific as to where agreement exists but must be included on actual medical record
  • NP/PA practicing "incident to" - Documents in medical record, then certifying physician signs, dates and indicates agreement. Completes certification statement. Certifying physician co-signs
  • NP part of PCF Demonstration Project - Documents in medical record and completes certification statement
• Some foot deformity examples include bunions and hammertoes but are not limited to these

• Certifying physician is not required to document a foot exam and/or need for diabetic shoes in his/her medical record when they are NOT prescribing physician. If provider who prescribed shoes has documented one or more of conditions 2A-2F and certifying physician has dated/initialed and indicated agreement with those records prior to signing Certification Statement, criteria 2 will be met. Records are not required to match if Certifying Physician has agreed with records of provider who prescribed shoes and performed foot exam
• When suppliers are reviewing physician's medical records for a comprehensive plan of care, physician must have documented in those notes what is occurring with beneficiary's diabetes and how are they managing their diabetes. This will be different for every beneficiary and their condition. May include adjusting medications/monitoring their diet/exercise regimen/reviewing their blood sugar logs or getting labs like A1C
• A provider other than the certifying physician can provide order for shoes and do foot exam but MD/DO or NP/PA as certifying physician must be treating beneficiary for their diabetic condition. The beneficiary must be seen within six months prior to delivery of shoes. This requirement is the same whether suppliers are in a rural area or not

• When custom molded inserts are provided by suppliers, suppliers must conduct and document taking impressions, making casts, or obtaining CAD-CAM images of feet. This must be conducted each year beneficiary is receiving shoes. For all shoes, taking measurements of the beneficiary’s feet is also required each year

• To meet criterion five, at time of in-person delivery to beneficiary of items selected, supplier must conduct an objective assessment of fit of shoe and inserts and document results. This is to verify that shoes/inserts properly fit beneficiary. A beneficiary's subjective statements regarding fit as sole documentation of in-person delivery does not meet this criterion. Some examples of what would be in "fitting" chart note for an objective assessment will include quantifying data. There should be objective information about what fitter observed. E.g., foot box fits properly, length and width are appropriate, beneficiary walked a few steps and there was no rubbing, etc. It is not a requirement that beneficiary ambulate while wearing shoes

Medicare has limited coverage provisions for shoes, inserts, and shoe modifications used by beneficiaries. In order to be eligible for coverage, such items must qualify in either:

1. the benefit category for therapeutic shoes provisioned in the treatment of a diabetes-related condition(s) or
2. the benefit category for leg braces (to which the shoes and related items would be considered for coverage as integral components of the leg brace).

• The Centers for Medicare & Medicaid Services (CMS) has recently provided guidance to the DME MACs about the delegation of certifying physician (MD or DO) comprehensive management of diabetes responsibilities to nurse practitioners (NP) and physician assistants (PA) prescribing therapeutic shoes and inserts for persons with diabetes. This clarification is specific to NPs and PAs who are practicing under the supervision of an MD or DO (i.e., "incident to") and does not extend to NPs who practice independently (i.e., bill under their own NPI).
• Services and Supplies Furnished Incident to a Physician's/NPP's Professional Service CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 60

• CMS is exercising its authority under the Primary Care First (PCF) model to waive Section 1861(s)(12) of the Act and the implementing regulations at 42 CFR 410.12 to allow nurse practitioners to certify that an order for diabetic shoes is required according to Section 1861(s)(12). Additional information, including the PCF Participant list and the Participating Regions and Payer Partners, are at the bottom of the PCF model page.

• Suppliers must bill each item on two separate claim lines using the RT and LT modifiers and 1 UOS on each claim line. Claim lines for HCPCS codes requiring use of the RT and LT modifiers, billed without the RT and/or LT modifiers or with the RTLT on a single claim line, will be rejected as incorrect coding