According to the biotech industry on the 26th, the American Medical Association (AMA) revised the “Category III” items within the CPT codes starting this month.
CPT is a medical procedure coding system that records tests, surgeries, and procedures performed by U.S. healthcare institutions and medical professionals using standardized numbers. It is classified into Categories I, II, and III based on the nature of the procedure. While the AMA revises the entire CPT code set once a year, Category III updates are released semiannually in January and July.
If a procedure falls under Category I, which covers basic medical procedures, hospitals can use the CPT code to report treatment details to insurance companies and bill for the associated costs. Category II consists of optional codes designed to measure the performance and quality of medical services; they are used to track whether physicians have properly followed clinical guidelines and performed necessary tests on patients.
The Category III codes released this time are temporary codes assigned to new medical technologies that have not yet become established as standard medical procedures. Before formal insurance reimbursement rates are assigned within five years, if the medical procedure is utilized in U.S. healthcare settings and meets clinical evidence and regulatory requirements, it may be converted to a Category I code following an application and review process.
The newly added Category III codes include: △1030T–1035T (patient-specific digital 3D modeling); △1044T–1049T (harvesting and transplantation of autologous skin structures); and △1050T–1053T (subcutaneous monitoring for heart failure exacerbation). Starting next January, separate codes (1092T–1094T) will also apply to medical procedures involving the implantation of acellular scaffolds into areas of knee cartilage defects.
Accordingly, Rokit Healthcare announced that U.S. medical institutions can now officially document clinical trials and treatment processes utilizing the company’s artificial intelligence (AI) organ regeneration platform. However, a review of the original text of the code revisions released by the AMA reveals that it is unclear whether these codes can be directly applied to Rokit Healthcare’s technology.
Codes 1044T–1049T, pertaining to skin regeneration, cover medical procedures in which a patient’s full-thickness skin (epidermis to dermis) is harvested to create and apply an autologous heterotopic skin graft. Code 1044T specifies the harvesting of full-thickness skin, while codes 1046T–1049T respectively define the application of such grafts to the trunk, extremities, face, hands, and feet.
Rokit America’s procedure differs. According to the securities registration statement submitted by Rokit America to the U.S. Securities and Exchange Commission (SEC), its diabetic foot regeneration platform involves harvesting adipose tissue from the patient’s abdomen and micro-processing it to create an autologous bio-ink. It then uses a 3D bioprinter to print a regenerative patch tailored to the shape of the affected area and applies it to the wound. In other words, it differs from the core requirements of the codes in that it harvests fat rather than skin and uses fat-tissue-based patches instead of full-thickness skin grafts.
Digital 3D modeling is also more closely aligned with the business models of other domestic companies. Sections 1030T–1035T define medical procedures that process medical images captured via CT or MRI—in the standard DICOM (Digital Imaging and Communications in Medicine) format—into patient-specific digital 3D models and create surgical simulations.
In contrast, Rokit Healthcare’s artificial intelligence (AI) wound recognition application, “AiD Regen,” uses depth-sensing technology to scan wounds and convert them into real-time 3D models. Simply put, it scans a wound, converts it into a 3D model, and then transfers that data to a bioprinter. In other words, it is not a specialized task involving the precise conversion of DICOM medical images for use by medical staff in surgical planning, simulation, or computational analysis; rather, it is closer to an intermediate process designed to quickly and automatically print a patch that precisely fits the wound.
Mr. A, who has experience in U.S. biotech regulatory affairs, stated, “CPT codes are not automatically assigned to specific products; instead, each medical procedure is reviewed individually to determine whether it meets the detailed requirements specified by the code.” He added, “While Category III is a provisional code with a relatively lower approval threshold than Category I, there have been numerous cases until recently where applications were put on hold or withdrawn during AMA review due to failure to meet the requirements.”
CoreLineSoft and Medical IP are cited as potential domestic beneficiaries of the 3D modeling codes. CoreLineSoft’s 3D medical imaging modeling software, “AVIEW Modeler,” segments the necessary areas from CT and MRI medical images to create 3D data and converts this into files suitable for 3D printing. Since it converts DICOM medical images into 3D models and printing data, it aligns with subcategories such as 1030T–1035T. It has also secured relevant certifications from the U.S. Food and Drug Administration (FDA), as well as in South Korea, Europe, Japan, and Australia.
Medical IP’s medical image analysis software, “MEDIP Pro,” is another product that uses artificial intelligence (AI) to automatically segment CT and MRI images in DICOM format, rendering organs and lesions as 3D models. It supports various file formats, including DICOM, OBJ, STL, 3MF, and VTK, and can be used for surgical planning, simulation, and precision 3D printing. It has also secured FDA and European CE certifications.
Of course, the establishment of the relevant Category III designation does not necessarily mean that the product’s use in U.S. healthcare settings will surge or that sales will immediately follow. In particular, CPT Category III is a temporary code that does not guarantee insurance coverage or reimbursement rates. Furthermore, for the product to be used in U.S. healthcare settings, separate procedures—such as adoption by local hospitals—are required in addition to FDA approval.
