Article - Therapeutic Shoes for Persons with Diabetes - Policy Article (A52501)

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor 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. Information provided in this policy article relates to determinations other than those based on Social Security Act 1862(a)(1)(A) provisions (i.e. reasonable and necessary).Therapeutic Shoes and inserts are covered under the Therapeutic Shoes for Individuals with Diabetes benefit (Social Security Act 1861(s)(12)). In order for a beneficiarys equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.For an item addressed in this policy to be covered by Medicare, aStandard WrittenOrder (SWO)must be communicated to the supplier prior to claim submission. If the supplier bills for an item without first receiving the SWO, the item will be denied as statutorilynoncovered.The Certifying Physician is defined as a doctor of medicine (M.D.) or a doctor of osteopathy (D.O.) who is responsible for diagnosing and treating the beneficiarys diabetic systemic condition through a comprehensive plan of care. The certifying physician may not be a podiatrist or clinical nurse specialist. Consequent to the M.D. or D.O. restriction, a nurse practitioner (NP) and a physician assistant (PA) may not serve in the role of the certifying physician, unless practicing incident to the supervising physicians authority, as described below.NPs or PAs providing ancillary services as auxiliary personnel could meet the incident to requirements in their provision of therapeutic shoes to beneficiaries with diabetes if all of the following criteria are met:The supervising physician has documented in the medical record that the patient is diabetic and has been, and continues to provide, the patient follow-up under a comprehensive management program of that condition; and,The NP or PA certifies that the provision of the therapeutic shoes is part of the comprehensive treatment plan being provided to the patient; and,The supervising physician must review and verify (sign and date) all of the NP or PA notes in the medical record pertaining to the provision of the therapeutic shoes, acknowledging their agreement with the actions of the NP or PA.In states where the NP may practice independently, the NPs employment situation would require compliance with Medicare incident to rules in order to serve as the certifying physician. Please refer to the applicable A/B MAC for further information.The Prescribing Practitioner is the person who actually writes the order for the therapeutic shoe, modifications and inserts. This practitioner must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing practitioner may be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribing practitioner may be the supplier (i.e., the one who furnishes the footwear).The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary and that bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Practitioner may be the supplier. The Certifying Physician may only be the supplier if the certifying physician is practicing in a defined rural area or a defined health professional shortage area.Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all of the following criteria are met:The beneficiary has diabetes mellitus (Reference diagnosis code section below); andThe certifying physician has documented in the beneficiary's medical record one or more of the following conditions:Previous amputation of the other foot, or part of either foot, orHistory of previous foot ulceration of either foot, orHistory of pre-ulcerative calluses of either foot, orPeripheral neuropathy with evidence of callus formation of either foot, orFoot deformity of either foot, orPoor circulation in either foot; andThe certifying physician has certified that indications (1) and (2) are met and that he/she is treating the beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs diabetic shoes. For claims with dates of service on or after 01/01/2011, the certifying physician must:Have an in-person visit with the beneficiary during which diabetes management is addressed within 6 months prior to delivery of the shoes/inserts; andSign the certification statement (refer to the Policy Specific Documentation Requirements section below) on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the beneficiary. (Refer to the Policy Specific Documentation Requirements section below.)At the time of in-person delivery to the beneficiary of the items selected, thesuppliermust conduct an objective assessment of the fit of the shoe and inserts and document the results. A beneficiarys subjective statements regarding fit as the sole documentation of the in-person delivery does not meet this criterion.If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied as noncovered. When codes are billed without a KX modifier (see Policy Specific Documentation Requirements section below), they will be denied as noncovered.In order to meet criterion 2, the certifying physician must either:Personally document one or more of criteria a  f in the medical record of an in-person visit within 6 months prior to delivery of the shoes/inserts and prior to or on the same day as signing the certification statement; orObtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of an in-person visit with a podiatrist, other M.D or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that is within 6 months prior to delivery of the shoes/inserts, and that documents one of more of criteria a  f.The requirement that the in-person visit(s) be within 6 months prior to delivery of the shoes/inserts is effective for claims with dates of service on or after 1/1/2011.Note: The certification statement is not sufficient to meet the requirement for documentation in the medical record.Depending on the items ordered, both the evaluation and delivery could occur on the same day if the supplier had both a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the items that meet the beneficiarys needs. Both components of the visit (criteria 4 and 5 above) must be clearly documented.For claims with dates of service on or after 1/1/2011, there must be an in-person visit with the prescribing practitioner within 6 months prior to delivery of the shoes/inserts.For beneficiaries meeting the coverage criteria, coverage is limited to one of the following within one calendar year (January  December):One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2 additional pairs of inserts (A5512, A5513, or A5514); orOne pair of depth shoes (A5500) and 3 pairs of inserts (A5512, A5513, or A5514) (not including the non-customized removable inserts provided with such shoes).A modification of a custom molded or depth shoe may be covered as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications: rigid rocker bottoms (A5503), roller bottoms (A5503), wedges (A5504), metatarsal bars (A5505), or offset heels (A5506). Other modifications to diabetic shoes (A5507) include, but are not limited to flared heels.Quantities of shoes, inserts, and/or modifications greater than those listed above will be denied as noncovered.Items represented by code A5510 reflect compression molding to the beneficiary's foot over time through the heat and pressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contact at the time of dispensing, they do not meet the requirements of the benefit category and will be denied as noncovered.Inserts used in noncovered shoes are noncovered.Deluxe features of diabetic shoes (A5508) will be denied as noncovered.There is no separate payment for the fitting of the shoes, inserts or modifications or for the certification of need or prescription of the footwear. Claims for unrelated evaluation and management services provided by the practitioner are processed by the local carrier.Shoes are also covered if they are an integral part of a covered leg brace. However, different codes are used for footwear provided under this benefit. See the medical policy on Orthopedic Footwear for details.REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is availablehere.Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.POLICY SPECIFIC DOCUMENTATION REQUIREMENTSIn addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.An order for each item billed must be signed and dated by the prescribing practitioner, 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 practitioner is the supplier, a separate order is not required, but the item provided must be clearly noted in the beneficiary'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. TheSWO must be signed on or after the date of the visit with the Prescribing Practitioner.The supplier must obtain a signed statement from the practitioner who is personally managing the beneficiarys systemic diabetes condition (i.e., the certifying physician) specifying that the beneficiary has diabetes mellitus, has one of conditions 2a-2f above, 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 or clinical nurse specialist. An NP or PA may not serve in the role of the certifying physician, unless practicing incident to the supervising physicians authority.The "Statement of Certifying Physician for Therapeutic Shoes" form (see related LCD Attachments section) is recommended. Whatever form is used must contain all of the elements contained on the recommended form attached to the related LCD. This statement must be completed, signed, and dated by the certifying physician. If an NP or PA is practicing incident to a supervising physician, the NP or PA completes, signs, and dates the statement; however, the supervising physician (M.D. or D.O.) must review and verify (sign and date), acknowledging agreement with the NP or PA. 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:Documents management of the beneficiarys diabetes; andDocuments detailed information about the condition (2a-2f listed above) that qualifies the beneficiary for coverage.The Certification Statement by itself does not meet this requirement for documentation in the medical records.The in-person evaluation of the beneficiary by the supplier at the time of selecting the items that will be provided (refer to Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include 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.For all shoes, taking measurements of the beneficiarys feet.For custom molded shoes (A5501) and inserts (A5513 and A5514), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiarys feet that will be used in creating positive models of the feet.