CMS Finalizes Revised DMEPOS Quality Standards

On January 9, 2018, CMS published its final changes to the DMEPOS Quality Standards, specifically the standards that address the definition of the term “molded to patient model” as it relates to the provision of custom fabricated diabetic inserts.

CMS made only one small change to the definitions it included in its November 2, 2017 proposed rule that included direct milled, custom fabricated diabetic inserts made using a digital or virtual model of the patient’s foot in the proposed definition of the term “molded to patient model.” There was no change in the proposed language in the final changes to the DMEPOS Quality Standards. CMS did include the use of a foam box impression as an acceptable means of creating an impression of the patient’s foot for use in the creation of a positive model of the patient’s foot.

While AOPA is generally pleased with the changes to the DMEPOS Quality Standards, it remains concerned regarding CMS’ indication that direct milled, custom fabricated inserts will be reimbursed at a significantly lower rate (14% lower) than inserts made from a physical model of the patients foot that are currently described by HCPCS code A5513. In its response to AOPA’s and other’s comments regarding this issue, CMS stated that, “The first step CMS must take is to finalize the DMEPOS Quality Standards. Once that step is completed, CMS can assess what needs to be done in order to implement any changes to the quality standards.”

Obviously, the failure of CMS to address concerns over different reimbursement rates for direct milled diabetic inserts that are essentially identical in structure and function to inserts molded over a positive model of the patient’s foot can be seen as disappointing, but on the other hand, if CMS were locked in to the idea of the suggested 14% decrease for scanned devices, they could have easily closed the door, but they didn’t. AOPA believes we made some inroads with our arguments: (1) that FDA, not CMS has authority as to manufacturing processes; (2) that very significant harm could arise for compromised diabetic patients if there are any new impediment to receiving proper shoes/inserts; and (3) that provisions in CMS’ own Claims Processing Manual do not afford CMS the authority to reduce (or increase) prices when exploding a code into two similar codes; so in that respect, we are cautiously optimistic. AOPA will continue to address this issue with high ranking CMS officials to ensure that patients continue to have access to the highest quality, most clinically appropriate care.

The final revisions to the DMEPOS Quality Standards as well as a summary of comments received by CMS, and their responses may be viewed on the CMS website.

Read the comments AOPA submitted to CMS on diabetic shoes inserts and quality standards.

Questions regarding this issue may be directed to Joe McTernan at or Devon Bernard at