Documentation and Reimbursement for 3D Printed Anatomic Models and Guides





Introduction


In the American healthcare system, standardized documentation is critical to ensure accurate medical billing and coding for appropriate reimbursement. An encounter for radiology services starts with a test order from a referring physician which includes the patient’s signs/symptoms or a reason for performing the test. Once the imaging exam is performed, information about the exam and the diagnosis including the International Classification of Diseases-10 codes must be recorded. Next, providers or certified medical coders assign current procedural terminology (CPT) codes that denote procedures and services. Finally, payers will review these claims and render healthcare reimbursement. This chapter will discuss proper documentation for three-dimensional (3D) printed anatomic models and guides, CPT codes for 3D printing, and current efforts to demonstrate widespread use of 3D printing in medicine.


Documentation


Medical record


The multiple steps of care including history, orders, vital signs, medications, lab, imaging and testing results, consultations, biopsies, procedures, clinical outcomes, and care plans are documented in the current comprehensive medical record which is largely in an electronic format. Most importantly, this record serves as the patient’s clinical history for all care providers in order for them to give the patient optimal care. Information is also included in the medical record to describe the effort that goes into a patient’s care such as which type of healthcare workers are involved, the amount of time spent, and the materials and techniques used.


Documentation of 3D printed anatomic models is largely reflective of documentation for other medical services. It starts with an electronic order which lists the important information to know for planning. This includes patient name, medical record number, ordering physician and contact number, indication or diagnosis, anatomic structures to include, date needed by, sidedness, and whether imaging has been performed yet. Additional questions on mirror imaging, need for guides, material, and color preferences are also helpful. For the best understanding of what is needed, it is important to talk directly to the ordering physician before starting.


Data storage organization


Secure backed up large capacity computer storage is needed to keep each patient’s imaging data, segmentation, and computer-aided design (CAD) files, photos, and any videos which are created from the files. Other patient-specific information such as quality assurance measures can also be kept in these files. This information can be organized and listed by the patient’s name and clinic number similar to filing in a classic medical record ( Fig. 8.1 ).




Fig. 8.1


Example of possible patient file organization for the various data files used during the creation of 3D printed anatomic models. The images are representative of the content of each file. These folders reflect the steps of the process. In addition, files can include information on the specific DICOM data used, type of segmentation and CAD software, number of structures segmented, printing technologies and materials used, post-processing techniques, and details regarding the QA process.


Dictation


A formal dictation is placed in the medical record to document the creation of the model. The dictation can be organized in any number of ways depending on each institution’s dictation guidelines and software. Completing the dictation can be easier if it is created with as many pick lists as possible to choose options from. Most dictation software has some type of pick list options. A dictation format similar to that used in interventional radiology procedures could be considered as it has a similar organization of history and indication, findings, procedural technique, and final impression. The dictation report can begin with a short history and specific indication for the model. This would include the basic information from the request form including general anatomic structure, side, type and date of imaging used, contrast used, and laterality as needed.


The procedural technique would go through the multiple steps of model and guide creation which would make up the largest part of the dictation. This would include segmentation and CAD processing details including the design time with the level of staff that completed these and specific details including how many and which anatomic structures are in the model. The dictation would also include the type of 3D printing technology, specific printer, and type of materials and colors used to create the model. Postprocessing procedures including cleaning and curing time would also be part of the technique. How and where guides are sterilized should be documented. Quality control measures done to check accuracy of the model and guides can also be noted.


The final impression would be a short synopsis of what type of model was created and for what use. Additional information could include date of model delivery, to whom it was delivered, and what department they are in. Color photos of the final model may be placed both with the dictation and in the imaging section of the medical record.


The extensive and detailed information in the dictation reflects the work, skill, and effort put into creating the models. These data are invaluable and are used for patient care, quality improvement, and to potentially include in research studies and registries. Importantly, components of the clinical and technical documentation are used to determine the appropriate level of reimbursement for services rendered by both government and private healthcare insurers.


Reimbursement


Current procedural terminology codes


In medicine, one of the major hurdles to development of 3D printed anatomic models and guides has been a lack of reimbursement. Obtaining reimbursement for a new service through governments and private insurance is a multiyear process which takes significant organization as well as institutional support and patience. It is about a 2- to 3-year process at best to go from CPT code application to inclusion in the Medicare Fee Schedule. Medical centers creating models for clinical care need to be able to absorb the cost of the models before they are able to create enough to demonstrate the models’ efficacy. Development funding at many medical centers has been able to help bridge the gap between the cost of creating 3D printed models and insurance reimbursement.


In the United States (US), medical reimbursement is a complex process. It is overall based on the assumption that it is paying for physician or healthcare provider work and the resources used for medical services and procedures. Each of these services and procedures is itemized and has a specific code and reimbursement attached to them. The Healthcare Common Procedure Coding System (HCPCS), maintained by the Centers for Medicare and Medicaid Services (CMS), is ultimately in charge of developing, reviewing, and updating these codes. HCPCS is divided into two levels. HCPCS level I codes consist of the CPT codes which are set and published by the American Medical Association (AMA), whereas HCPCS level II codes use the HCPCS alphanumeric code and generally include nonphysician products, supplies, and services not included in CPT. CPT codes are currently accepted as the standard for healthcare providers throughout the US to report medical procedures and services.


CPT codes were first established by the AMA in 1966 and were used to help set standard terms and descriptors to document medical procedures. They were not initially associated with reimbursement. Over the next decades, the CPT codes were updated regularly and became more detailed. As the CPT system evolved, it became the national coding system for healthcare provider services and procedures in 2000. The CPT codes are regularly reviewed and updated by the CPT Editorial Panel which meets three times a year. The panel is made up of 17 members including healthcare and insurance providers, hospitals, and CMS. They are supported by the CPT Advisory Committee, a large group made up of multiple major medical societies and organizations representing healthcare providers, and act as a resource for the CPT Editorial Panel. There are high standards for requirements of confidentiality and disclosure of any conflict of interest for the panel.


There are currently three CPT code categories: Category I, II, and III. Category I CPT codes are established medical services and have met the requirements of wide clinical use and documented efficacy. Category I CPT codes use the familiar five-digit codes for healthcare provider services. For example, the code 74177 is used for computed tomography (CT) of the abdomen and pelvis with contrast, and the code 74178 is used for CT of the abdomen and pelvis, with and without contrast. Category I codes are billable for reimbursement.


Category II codes are supplemental tracking codes for reporting quality performance measures that reflect good clinical care. The reporting of Category II codes is optional, and these codes are not used in place of Category I codes. Category II codes contain five characters—the first four are numerical, followed by an alphabetical fifth character, the letter “F.” These codes are not associated with any relative value units (RVUs); therefore, they are billed with a $0 billable charge amount. Although not reimbursed, the use of Category II codes is expanding as the emphasis on quality care grows.


Category III CPT codes were established in 2001 and are used for data collection for emerging technologies that are not yet mature and do not yet meet Category I criteria. They need to show medical specialty support, peer-reviewed literature showing growth, and ongoing clinical studies to evaluate their efficacy. When approved, they are assigned a four-digit code followed by the letter “T” as an identifier. The Category III codes are used to demonstrate how widespread their use is and for data collection in investigational protocols. They are only voluntarily reimbursable and RVUs are not assigned to them. Under HIPAA, Category III codes, though, are accepted by all healthcare payers. Local payments may be sought from local insurance carriers or through local Medicare contractors. Category III codes are temporary and can only be used for 5 years. After that time, they sunset if not converted into Category I codes. A 5-year extension for Category III codes may be obtained if approved by the CPT Editorial panel. ,


Establishment of CPT codes for 3D printed anatomic models and guides


In the spring of 2018, the American College of Radiology (ACR) CPT Advisory Team, after many months of work and with consultation with the Radiological Society of North America (RSNA) 3D Printing Special Interest Group, submitted a Category III CPT code application to the CPT Editorial Panel of the AMA for 3D printed anatomic models and guides. A Category III code was thought to be the most appropriate because 3D printing of anatomic models represents a relatively new technology with developing use in patient care. The Category III application outlined the extensive process of creating anatomic models using imaging data including physician effort and the multiple technical inputs of performing image segmentation, creating CAD files, 3D printing the files, and post-processing the printed models. The application also included multiple peer-review medical articles supporting the clinical value of the models and guides and documentation of use of the models for patient care in multiple medical centers in the US.


The codes requested were based on the number of anatomic components included in the model. This approach seemed to best reflect the complexity and work needed to create the model. It was recognized that 3D printing and associated technologies such as segmentation software are a dynamic changing landscape and that over time, things would evolve and the work effort and technical input may well change. The submitted codes were the best effort to gather information on the technology as it stood at that point of time. This situation was a good fit for the exploratory Category III code category and would not constrain using a different measure of work and cost for a subsequent Category I application.


The CPT Editorial Panel reviewed the application over the summer of 2018 and requested input from the CPT Advisory Committee which is a group made up of multiple medical societies. In September 2018, the application was reviewed by the full CPT Editorial Panel at an open AMA CPT meeting in Boston. The ACR CPT Advisory Team formally presented the application and answered questions from the panel. The panel voted in private and the results were announced in late October that the four Category III codes for 3D printing of anatomic models and guides were approved ( Table 8.1 ). The codes became available for submission for billing use for services provided as of July 1, 2019.



Table 8.1

List of the four Category III CPT codes for 3D printed anatomic models and guides.



















CPT Code Code Description
0559T Anatomic model 3D printed from image dataset(s); first individually prepared and processed component of an anatomic structure
0560T Each additional individually prepared and processed component of an anatomic structure (list separately in addition to code for primary procedure) (use 0560T in conjunction with 0559T)
0561T Anatomic guide 3D printed and designed from image dataset(s); first anatomic guide
0562T Each additional anatomic guide (list separately in addition to code for primary procedure) (use 0562T in conjunction with 0561T)

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May 29, 2021 | Posted by in GENERAL RADIOLOGY | Comments Off on Documentation and Reimbursement for 3D Printed Anatomic Models and Guides
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