On November 1st, 2018, it was announced that the American Medical Association (AMA) CPT® Editorial Panel accepted a Category III CPT code proposal led by the American College of Radiology (ACR) for 3D printed anatomic models and surgical guides. The new Category III CPT codes will be effective on July 1, 2019.”  More specifically, four temporary Category III CPT codes 055T, 0560T, 0561T, 0562T were accepted. “Codes 0559T, 0560T represent the production of 3D-printed models of individually prepared and processed components of structures of anatomy. These individual components of structures of anatomy include, but are not limited to, bones, arteries, veins, nerves, ureters, muscles, tendons and ligaments, joints, visceral organs, and the brain. The 3D-printed anatomical models can be printed in unique colors and/or materials. Codes 0561T, 0562T represents the production of 3D-printed cutting or drilling guides (i.e. surgical guides) using individualized imaging data. 3D printed guides are cutting or drilling tools used during surgery and are 3D printed so that they precisely fit an individual patient’s anatomy to guide the surgery…” 
To many insiders on the manner, this was a celebratory moment after months of lobbying and organizational efforts primarily by RSNA SIG group and SME. This article aims to explain the relevance of CPT codes with getting paid in doing work with 3D printed anatomical modeling and surgical guides in the U.S.
Getting paid for work that is done that is beneficial to patients, straightforward, right? For many who have worked in the space for many years, many of the amazing 3D anatomical models were underpaid work because of the reimbursement path. Having a Category III code is a good start.
What is the CPT code?
CPT (Current Procedural Terminology) codes are a set of code published and maintained by American Medical Association. All the codes are also copyrighted by AMA.  The CPT codes offer a system to doctors across the U.S. a uniform, accurate, and efficient process to communicating about and reporting on medical services or procedures performed for more than 5 decades. It is widely accepted by both the public and private sectors.
What are Category I and Category III CPT codes?
Category I codes represent services that are widely performed, have FDA approval or clearance (if needed) and are supported by a sufficient level of evidence published in the peer-reviewed literature. It is a “permanent” code in the CPT code book published yearly. An example of Category I codes is “cataract surgery. On the other hands, Category III codes represent services using new and emerging technologies (such as 3D-printed anatomical models for presurgical planning), and were created to allow for data collection for new procedures or services and to limit the use of established Category I code for new technologies that are now described by existing codes. Category III differ from Category I codes in that they may not be yet widely adopted by healthcare providers and do not require FDA approval, nor need to meet a certain level of supporting evidence. These codes are considered “temporary”, which means if they are not converted into Category I status (by wider adoption and well-documented clinical evidence) in five years, they will be archived. [5-7]
What is the relationship among Category I, Category III CPT codes, and reimbursements?
Technically speaking, there is no published statement between CPT codes and reimbursement from payors (Medicare, insurance companies, etc.) Even having a billing code like CPT Category I code does not guarantee that payers will provide payment for the procedure. When a new procedure billing code is established, insurers base coverage decisions on a myriad of factors, including independent health technology assessments (which evaluate all available technical and scientific evidence supporting the intervention), peer-reviewed published clinical data, real-world evidence of clinical efficacy (outside a clinical trial environment), and practice guidelines published by relevant professional societies. Often, Category I CPT code is tied with Medicare reimbursement. Private payers (i.e. insurance companies) reimbursements are variable but typically follow the trend of Medicare.  In the past, many payors simply exclude any reimbursement to Category III procedures/services, often limiting the wider adoption of emerging technologies. However, there is a trend from the payor side to cover Category III code even before Category I code, largely depending on the willingness among physicians to embrace the new technology.  That is, physicians are critical players in making 3D printed anatomical models eventually Category I code status.
Who are the other major players in getting reimbursed?
Nonetheless, physicians are not the only important players on this path. The other major players are :
- Patients are often important drivers of adopting emerging technologies. Along with patient advocacy groups, they can be powerful forces that influence physicians’ treatment choices, practice guidelines, research funding, and government policies. For example, an organization OpHeart is a nonprofit organization that was founded by the mother of a patient who benefited from using 3D printing to treat her congenital heart disease. It is actively promoting the more widespread use of the procedure and also is at the heart of a large multi-center clinical trial focusing on the efficacy of the procedure.
- Healthcare organizations like hospitals and clinics must be willing to try new procedures and devices, despite potential burdens it may thrust upon their clinical and administrative staff. A great example is the 3D printing initiative at the Mayo Clinic. It not only has a large clinical staff supporting this initiative in their daily practices, it also organizes regular CME conferences to promote and educate other physicians and organizations about the technology.
- Professional medical societies must be open to updating their guidelines to include new and innovative products once sufficient clinical evidence has been provided, as this is a huge driver in securing coverage from payers. Clearly, the American College of Radiology is behind the current Category III CPT code success.
- Payors (e.g. Medicare, insurance companies) need to work with companies and organizations to provide fair and equitable coverage for innovative products.
- Coding agencies such as CMS and AMA must be willing to work with other stakeholders to create or amend existing codes when necessary to efficiently support the adoption of new, beneficial technologies.
At the end of the day, the complex path for a new procedure like 3D printed anatomical models to be fully and fairly reimbursed is ultimately determined by whether the procedure can be widely adopted by clinicians and if payors are willing to cover. In a simpler term, is there a “product-market fit”? We have five years to see.
About the Author:
Jenny Chen, M.D.
Jenny Chen MD, is currently the Founder and CEO of 3DHEALS, a company focusing on education and industrial research in the space of bioprinting, regenerative medicine, healthcare applications using 3D printing. She is trained as a neuroradiologist, Dr. Chen holds degrees in both medicine and radiology from the David Geffen School of Medicine at UCLA and completed fellowship training in neuroradiology at Harvard Medical School. She currently serves as Adjunct Clinical Faculty in neuroradiology at Stanford University Medical Center. With a focus on health technology, Dr. Chen also serves as a startup Mentor to IndieBio EU and French Tech Hub, tech accelerators that help IT and life science companies launch and expand their product offerings, identify customers, and manage operations. Her interests lie in the applications of emerging technologies (especially in the field of 3D printing and bioprinting), automated biology, and has a vision of decentralized and personalized healthcare delivery system for our near future.
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