Current Pedorthics September-October 2017 - Vol.49, Issue 5 - Page 53

INDUSTRYNEWS CMS Launches Redetermination Project Regarding A5513 Process 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… a. Molded-to-Patient-Model: A particular type of custom fabricated device in which either: i. 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 ii. 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: 2. Electronic (virtual) beneficiary models created within CAD-CAM systems which in turn are used to directly fabricate the insert; or, 3. Generic models which are used to create a nonspecific insert for later modification to individual beneficiary specifications. Reduced to what is germane to the discussion, this language indicates that a CAD-CAM system that is utilized to actually create the shell of the orthoses directly produces a device that does not qualify to be billed under A5513. The CAD-CAM equipment would have to be used to create a positive mold of the foot, and then the device would have to be fabricated over that positive. Based on this Joint Publication, CMS then launched what they are referring to as the A5513 Product Coding Redetermination Project. This project allows suppliers (pedorthists) to continue to bill orthoses made from products that have been submitted to the CMS Pricing, Data Analysis and Coding (PDAC) contractor by their manufacturer, which appear on the "PFA will be utilizing the platform of the seats we hold on the CMS Regional Councils to try to force the LCD to be reexamined..." list [2] (click here) to bill for reimbursement under A5513 until May 31, 2018. In the meantime, all manufacturers holding a current PDAC approval letter must resubmit their product for review. Part of the review process will involve examining the manufacturing process utilized to create the custom insert to verify that the device is, in fact, direct molded or molded to a physical model. PFA disagrees with the notion that an insert made from what CMS is referring to as a “virtual” model of the patient’s foot is inherently less accurate and less appropriate than one produced over a positive model. If we look at the traditional method of manufacture, the foot is cast in some fashion, essentially “transferring” the contours of the plantar surface to the negative. The negative is then used to transfer the contours to a positive cast. That positive is then used to transfer the Current Pedorthics September/October 2017 51