DME MAC Joint Publication
Medicare provides coverage for therapeutic shoes and related inserts for beneficiaries with diabetes. Custom molded inserts are billed using HCPCS code 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]. Inserts billed with A5513 must be made in compliance with criteria specified in the code narrative described above, the coding guidelines section of the LCD related Policy Article, and the DMEPOS Quality Standards. Suppliers of these inserts must assure themselves that the products provided meet the requirements for classification as A5513 before billing this HCPCS code.
The HCPCS code narrative passage, "…CUSTOM MOLDED FROM MODEL OF PATIENT'S FOOT…", requires that a physical model of the beneficiary's foot must be produced and that the insert be individually molded to the physical model. Some manufacturers do not produce an actual physical model of the individual beneficiary's foot. Instead, a CAD-CAM system creates an electronic positive model derived from specific patient measurements, i.e. a "virtual model", or use a library of generic models to fabricate an insert. Inserts produced using these or similar techniques must not be coded as A5513 for Medicare billing.
The Medicare Benefit Policy Manual (Internet Only Manual 100-2) chapter 15, §140 describes the benefit requirements associated with therapeutic shoes. It describes a covered insert. The section says, in relevant part:
- 3. Inserts - Inserts are total contact, multiple density, removable inlays that are directly molded to the patient's foot or a model of the patient's foot and that are made of a suitable material with regard to the patient's condition. [Emphasis added]
The Therapeutic Shoes for Persons with Diabetes LCD related Policy Article coding guidelines section says:
- Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a model of the beneficiary's foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length, or toe shape. [Emphasis added]
The DMEPOS Quality Standards Appendix C (42 CFR 424.57) defines custom fabrication for these items and requires that custom fabricated inserts be made to a physical model of the individual beneficiary's foot. Appendix C says, in relevant part:
1. Custom Fabricated: A custom fabricated item is one that is individually made for a specific Patient. No other patient would be able to use this item…
- Molded-to-Patient-Model: A particular type of custom fabricated device in which either:
- An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; or
- A digital image of the patient's body part is made using Computer-Aided Design-Computer-Aided Manufacturing (CAD-CAM) software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient. [Emphasis added]
These standards are not met by:
- Electronic (virtual) beneficiary models created within CAD-CAM systems which in turn are used to directly fabricate the insert; or,
- Generic models which are used to create a nonspecific insert for later modification to individual beneficiary specifications.
Therapeutic shoe inserts produced from virtual or generic models must be billed to Medicare using HCPCS code A9270 [NON-COVERED ITEM OR SERVICE].
Refer to the Therapeutic Shoes for Persons with Diabetes LCD and related Policy Article for additional information about coverage, coding, and documentation.
CMS has given labs that produce direct milled diabetic inserts until May 31st, 2018 to comply with the current quality standards of producing diabetic inserts using a positive model of the patients foot. Furthermore CMS has implemented the determination project which is requiring all labs who manufacture A5513 diabetic inserts to send in their custom diabetic inserts to be recoded prior to June 1st, 2018. All current PDAC letters prior will be rescinded effective May 31st, 2018.
APMA and AOPA have joined together and have given comments to CMS to allow for Direct Milling of the A5513 diabetic inserts using a digital model. Dia-Foot expects that decision to come in the next few months as labs will have to prepare to make the inserts using a positive model of the foot.
Dia-Foot currently manufacturers the A5513 inserts using a positive model of the foot. Dia-Foot will be offering direct milled inserts and scanners if CMS reverses their decision.
Update November 2 by CMS
CMS is proposing to update the Quality Standards to allow for direct milled diabetic inserts using a digital model of the foot. CMS plans to make their final decision by January 1st, 2018.
Update November 28th by CMS
CMS held an open forum conference call on November 28th at 2 pm. They went over the A5513 diabetic inserts. They are proposing to change the current Quality Standards and allow for fabrication of direct milled inserts using a digital model of the foot. The wrinkle to this is that a modifier will have to used when dispensing these inserts vs. dispensing a positive model diabetic inserts. CMS is proposing a fee of $38.67 per direct milled insert and $43.09 for a positive model insert. This represents a 11.4% decline ($26.52 less for the 3 pairs) for the supplier if a direct milled insert is dispensed. CMS sited that a positive model insert requires higher overhead to produce vs. a direct milled insert thus the price difference. I am sure the powers to be will argue that both inserts should be billed the same and under the same CPT code of A5513. CMS will have their final decision prior to January 1st, 2018.