SADMERC Coding Verification for Diabetic Inserts
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SADMERC Coding Verification for Diabetic Inserts

PFA continues to receive requests for clarification regarding the SADMERC (now PDAC) coding verification requirement, which became effective July 1, 2006, for diabetic inserts A5512 and A5513.  Following is information provided by Doran Edwards, M.D., medical director of the SADMERC:

All A5512 devices must be coded by the SADMERC.  The coding verification process is carried out by the manufacturer of the A5512 device. SADMERC must verify that the thickness and durometer readings are within the parameters required for billing with that code. (11/06)

How "Manufacturer” Is Defined

For the A5513 code, SADMERC requires all manufacturers to submit samples of the base material, pictures and narrative description of the manufacturing process, and a completed Coding Verification Application.  For the purposes of this code, a "manufacturer” is considered to be any entity that creates inserts that meet the definition of custom fabricated (molded to patient model) and then sells, ships, dispenses, or otherwise delivers the end product to someone other than the end user (the patient).  Whether the product is renamed or not by the supplier who provides it to the patient, every one of those types of devices must be code-verified by the SADMERC.

For practitioners who custom-fabricate inserts for use only by the patient (the end user) – with no intervening steps or suppliers -- SADMERC only requires that they use materials and methods of construction that meet the minimum standards of thickness, durometer measurement, and manufacturing technique.

Code verification by the SADMERC is optional at this time.  Should abuse or fraud be detected in significant portions of the industry, these requirements may change.  In all instances, the supplier is responsible to ensure that the items provided Medicare beneficiaries are safe and effective and meet the descriptions in the HCPCS code language.  Incorrect coding may result in penalties or prosecution depending on the severity of the infraction.  If any practitioner is unsure of the accuracy of the coding for the devices they provide, a formal Coding Verification Review may be requested. (10/06)

To view the latest Product Classification List for HCPCS codes, utilize the DMECS search tool at

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