The current policy on Therapeutics Shoes states that for claims with dates of service on or after July 1, 2006, the only products that may be billed to the DMERCs using codes A5512 and A5513 are those for which a Coding Verification Review has been made by the SADMERC and subsequently published in the Product Classification List on the SADMERC web site. That policy as it applies to A5513 is being revised.
Diabetic inserts coded as A5512 and A5513 must meet the material thickness and durometer scale hardness measures outlined in the HCPCS codes. All inserts to be billed as A5512 must be coded by the SADMERC and on the Classification List. Items not on the Product Classification List must be billed with code A9270 and will be denied as noncovered. Samples of the products must be submitted with the Coding Verification Application. Applications are available on the SADMERC website at www.palmettogba.com.
For inserts to be billed as A5513 only manufacturers are required to submit applications and samples for code verification. For Medicare purposes, 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). The SADMERC requires all manufacturers to submit a sample of each base layer material, pictures and narrative description of the manufacturing process, and a completed Coding Verification Application. Suppliers who provide the manufactured product to the patient (whether renamed or relabeled or not) must have a copy of the original SADMERC Coding Verification Letter approving that device as A5513 from the manufacturer on file and available to the PSC upon request. For claims with dates of service on or after July 1, 2006, if a supplier dispenses a manufactured custom fabricated insert and doesn't have a copy of the letter, code A9270 must be used and the insert will be denied as noncovered.
For practitioners who create custom fabricated inserts from raw materials for dispensing directly to the end user (the patient) with no intervening steps or handlers, the SADMERC only requires that they use materials and methods of construction that meet the minimum standards of thickness, durometer measurement, and manufacturing technique as defined for the code. In all instances, the supplier is responsible to ensure that the items provided to 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. For individual practitioners, code verification by the SADMERC is optional at this time. However if the practitioner is unsure of the accuracy of the coding for the devices provided, a formal Coding Verification Review may be requested.
Published by Palmetto GBA as the SADMERC, June 2006. Republished by Noridian as the PDAC, August 2008. Republished by Palmetto GBA as the PDAC, January 2019.