In 2016, when I co-authored the first edition of ” A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery“, focusing on a systematic thinking process to address these questions by evaluating components of operational management with Michelle Gabriel. However, selling a book is not going to accelerate adaption, instead, I decided to publish this book as a regularly updated online version of 3DHEALS Guide in five digestible parts, focusing on and adding new information from field experts from all over the world to provide a foundation to any early adapters.

The first time I learned about 3D printing (a.k.a. additive manufacturing ) for pre-surgical planning was in 2012 during RSNA (Radiological Society of North America) in Chicago. As a small box containing pieces of a 3D-printed heart from a pediatric patient was passed around the conference room, I could tell that the room stopped breathing. For me, it was a sensational moment as a radiologist and as a healthcare provider. Having a patient’s disease in three-dimension in my hands was unimaginable. I immediately wanted to learn more about the technology and how I, as a radiologist, could use it to help my clinical colleagues. However, to me, the road to implementation was not simple and almost obscure.  The barrier to entry for such technology seems to require one to be a combination of a designer, a mechanical engineer, and a software developer, and lastly a healthcare provider. 

Not giving up, I started organizing meetings focusing on learning and discussing healthcare 3D printing solutions in San Francisco called 3DHEALS, hoping to create a community composed of various disciplines to start to have more practical conversations to accelerate the adaptation of the technology.

Michelle and I met at an after-work healthcare technology conference, and we instantly hit it off because of our complementary knowledge and interest in healthcare, operational management, 3D printing, and engineering. We are both fascinated with the complex process of integrating promising technologies into healthcare. On top of that, Michelle’s background in both operations management and material science and engineering, and mine in medicine and education add unique perspectives to this book. 

That said, we both are fully aware of our limitations in various aspects of the subject of 3D printed surgical planning and do not proclaim to be field experts. This post serves as part 7 of this Guide series to thank individuals and companies for their insights and relationship with us and publication reference. Since our Guides are regularly updated and our conversations with our ecosystem never stop, this page will be updated whenever our guides are updated when appropriate.

Now On Demand:

1. Introduction:  What is operational management?
2. Technical Background
3. Strategic Issues
4. Tactical Issues
5. Financial Issues       
6. Financial Worksheet         
7. Acknowledgments/References

Acknowledgements: 

We would like to give special thanks and acknowledgment to the following individuals: 

• Dr. Parit Patel (Assistant professor of plastic and reconstructive surgery at Loyola Medicine)
• Dr. Elliot Brown (Assistant professor of radiology and biomedical imaging at Yale University)
• Dr. Jose Morey (Medical scientist with IBM Watson project, adjunct professor of radiology and biomedical imaging at the University of Virginia)
• Mr. Glen Jett from Sutter Health for providing valuable financial insights.
• Dr. Justin Ryan (Arizona State University Post-Doctoral Researcher, Phoenix Children’s Hospital Research Scientist) for providing valuable feedbacks and research on 3D printing for pediatric congenital heart cases.

• Dr. Justin Ryan
• Mr. Shannon Walter (Stanford School of Medicine, Manager of 3D and Quantitative Imaging Laboratory)
• Mr. Chris Letrong (Stanford School of Medicine, 3D Technologist)
• Dr. Ben Taragin (Children Hospital at Montefiore, Director of Pediatric Radiology)
• Dr. Joaquim M. Farinhas (Neuroradiology, Montefiore Medical Center)
• Materialse Inc. 
• Whitecloud Inc. 
• Stanford School of Medicine

References:

1. Columbus L. 2015 roundup of 3D printing market forecasts and estimates. http://www.forbes.com/sites/louiscolumbus/2015/03/31/2015-roundup-of-3d-printing-market-forecasts-and-estimates/. Published March 31, 2015.
2. Chen HJ, Gabriel M. Healthcare 3D printing in academia. 3D https://3dheals.com/healthcare-3d-printing-in-academia/. Published October 1, 2015.
3. Friedman T, Michalski M, Goodman TR, Elliot Brown. 3D printing from diagnostic images: a radiologist’s primer with an emphasis on musculoskeletal imaging—putting the 3D printing of pathology into the hands of every physician. Skeletal Radiology, 1–15. http://doi.org/10.1007/s00256-015-2282-6. Published November 23, 2015.
4. Koleilat I, Jaeggli M, Ewing JA, et al. Interobserver variability in physician-modified endograft planning by comparison with a three-dimensional printed aortic model. Journal of Vascular Surgery, 1–8. http://doi.org/10.1016/j.jvs.2015.09.044. Published June 17, 2015.
5. Vaquerizo B, Theriault-Lauzier P, Piazza N. Percutaneous Transcatheter Mitral Valve Replacement: Patient-specific Three-dimensional Computer-based Heart Model and Prototyping. Revista Española De Cardiología (English Edition), 1–9. http://doi.org/10.1016/j.rec.2015.08.005.
6. Giannopoulos AA, Chepelev L, Sheikh A, et al. 3D printed ventricular septal defect patch: a primer for the 2015 Radiological Society of North America (RSNA) hands-on course in 3D printing. 3D Printing in Medicine, 1–20. http://doi.org/10.1186/s41205-015-0002-4.
7. Cai T, Rybicki FJ, Giannopoulos AA, et al. The residual STL volume as a metric to evaluate accuracy and reproducibility of anatomic models for 3D printing: application in the validation of 3D-printable models of maxillofacial bone from reduced radiation dose CT images. 3D Printing in Medicine, 1–9. http://doi.org/10.1186/s41205-015-0003-3.
8. Rybicki FJ. 3D Printing in Medicine: an introductory message from the Editor-in-Chief. 3D Printing in Medicine, 1–1. http://doi.org/10.1186/s41205-015-0001-5.
9. VanKoevering KK, Morrison RJ, Prabhu SP, et al. Antenatal Three-Dimensional Printing of Aberrant Facial Anatomy. Pediatrics, 136(5), e1382–e1385. http://doi.org/10.1542/peds.2015-1062.
10. Dickinson KJ, Matsumoto J, Cassivi SD, et al. Individualizing Management of Complex Esophageal Pathology Using Three-Dimensional Printed Models. The Annals of Thoracic Surgery, 100(2), 692–697. http://doi.org/10.1016/j.athoracsur.2015.03.115.
11. Itagaki MW. Using 3D printed models for planning and guidance during endovascular intervention: a technical advance. Diagnostic and Interventional Radiology, 21(4), 338–341. http://doi.org/10.5152/dir.2015.14469.
12. Tai BL, Wang AC, Joseph JR, et al. A physical simulator for endoscopic endonasal drilling techniques: technical note. Journal of Neurosurgery, 1–6. http://doi.org/10.3171/2015.3.JNS1552.
13. Weinstock P, Prabhu SP, Flynn K, et al. Optimizing cerebrovascular surgical and endovascular procedures in children via personalized 3D printing. Journal of Neurosurgery: Pediatrics, 1–6. http://doi.org/10.3171/2015.3.PEDS14677.
14. Grant GT, Liacouras P, Santiago GF, et al. Restoration of the donor face after facial allotransplantation: digital manufacturing techniques. Annals of Plastic Surgery. 2014:72(6), 720–724. http://doi.org/10.1097/SAP.0000000000000189.
15. Huotilainen E, Paloheimo M, Salmi M, et al. Imaging requirements for medical applications of additive manufacturing. Acta Radiologica. 2014:55(1), 78–85. http://doi.org/10.1177/0284185113494198.
16. Huotilainen E, Jaanimets R., Valášek J, et al. Inaccuracies in additive manufactured medical skull models caused by the DICOM to STL conversion process Journal of Cranio-Maxillofacial Surgery. 2014:42(5), e259–e265. http://doi.org/10.1016/j.jcms.2013.10.001.
17. Lethaus B, Poort L, Böckmann R, et al. Additive manufacturing for microvascular reconstruction of the mandible in 20 patients. Journal of Cranio-Maxillofacial Surgery. 2012:40(1), 43–46. http://doi.org/10.1016/j.jcms.2011.01.007.
18. Li Y, Jiang Y, Ye B, et al. Treatment of Dentofacial Deformities Secondary to Osteochondroma of the Mandibular Condyle Using Virtual Surgical Planning and 3-Dimensional Printed Surgical Templates. Journal of Oral Maxillofacial Surgery. 2015:1–20. http://doi.org/10.1016/j.joms.2015.06.169.
19. Mazzoni S, Bianchi A, Schiariti G, et al. Computer-Aided Design and Computer-Aided Manufacturing Cutting Guides and Customized Titanium Plates Are Useful in Upper Maxilla Waferless Repositioning. Journal of Oral Maxillofacial Surgery. 2015:73(4), 701–707. http://doi.org/10.1016/j.joms.2014.10.028.
20. Ogden KM, Aslan C, Ordway N, et al. Factors Affecting Dimensional Accuracy of 3-D Printed Anatomical Structures Derived from CT Data. Journal of Digital Imaging. 2015. http://doi.org/10.1007/s10278-015-9803-7.
21. Pinto JM, Arrieta C, Andia ME, et al. Sensitivity analysis of geometric errors in additive manufacturing medical models. Medical Engineering and Physics. 2015:37(3), 328–334. http://doi.org/10.1016/j.medengphy.2015.01.009.
22. Ryan JR, Chen T, Nakaji P, et al. Ventriculostomy simulation using patient-specific ventricular anatomy, 3D printing and hydrogel casting. World Neurosurgery. 1–7. http://doi.org/10.1016/j.wneu.2015.06.016.
23. Wang JQ, Zhao CP, Sun X, et al. Printed three-dimensional anatomic templates for virtual preoperative planning before reconstruction of old pelvic injuries: initial results. Chinese Medical Journal. 2015:128(4), 477–6. http://doi.org/10.4103/0366-6999.151088.
24. Watson RA. A low-cost surgical application of additive fabrication. Journal of Surgical Education. 2014:71(1), 14–17. http://doi.org/10.1016/j.jsurg.2013.10.012.
25. Werner H, Santos JRL, Fontes R, et al. Additive manufacturing models of fetuses built from three-dimensional ultrasound, magnetic resonance imaging and computed tomography scan data. Ultrasound in Obstetrics and Gynecology. 2010:36(3), 355–361. http://doi.org/10.1002/uog.7619.
26. Wong KC, Kumta SM, Geel NV, et al. One-step reconstruction with a 3D-printed, biomechanically evaluated custom implant after complex pelvic tumor resection. Computer Aided Surgery: Official Journal of the International Society for Computer Aided Surgery. 2015:20(1), 14–23. http://doi.org/10.3109/10929088.2015.1076039.
27. Mendez B, Chiodo MV, and Patel PA. Customized “in-office” three-dimensional printing for virtual surgical planning in craniofacial surgery. The Journal of Craniofacial Surgery. 2015:26(5):1584-6. http://doi.org/10.1097/SCS.0000000000001768.
28. Peasah SK, McKay NL, Harman JS, et al. Medicare non-payment of hospital-acquired infections: infection rates three years post implementation. Medicaid & Medicare Research Review. 2013:3(3). https://www.cms.gov/mmrr/Downloads/MMRR2013_003_03_a08.pdf.
29. Willis DR. How to decide whether to buy new medical equipment. American Academy of Family Physicians. 2004. http://www.aafp.org/fpm/2004/0300/p53.html.
30. Rybicki F. Medical 3D printing for the radiologist. Radiographics. 2015:35(7):1965-88. http://www.ncbi.nlm.nih.gov/pubmed/26562233.
31. Small T, Krebs V, Molloy R, et al. Comparison of acetabular shell position using patient specific instruments vs. standard surgical instruments: a randomized clinical trial. The Journal of Arthroplasty. 2014:29(5): 1030–1037. http://dx.doi.org/10.1016/j.arth.2013.10.006.
32. Frakes DH, Ryan JR, Almefty KK, et al. Cerebral aneurysm clipping surgery simulation using patient-specific 3d printing and silicone casting. World Neurosurgery. 2016:88,175-181. http://www.worldneurosurgery.org/article/S1878-8750(16)00112-1/abstract.
33. Sher D. New study confirms 3d printing market to grow to $17 billion by 2020. 3D Printing Industry. 2015. http://3dprintingindustry.com/2015/08/24/new-study-confirms-3d-printing-market-grow-17-billion-2020/.
34. Zaleski A. Here’s why 2016 could be 3D printing’s breakout year. Fortune. 2015. http://fortune.com/2015/12/30/2016-consumer-3d-printing/.
35. Sher D. Many 3d printing patents are expiring soon: heres a round up & overview of them. 3D Printing Industry. 2015. http://3dprintingindustry.com/2013/12/29/many-3d-printing-patents-expiring-soon-heres-round-overview/.
36. Earls A, and Baya V. The road ahead for 3-D printers. PwC. 2014. http://www.pwc.com/us/en/technology-forecast/2014/3d-printing/features/future-3d-printing.html.
37. After explosion, US Department of Labor’s OSHA cites 3-D printing firm for exposing workers to combustible metal powder, electrical hazards: Powderpart Inc. faces $64,400 in penalties. S. Department of Labor: Occupational Safety & Health Administration. 2014. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=NEWS_RELEASES&p_id=26019.
38. Azimi P, Zhao D, Pouzet C, et al. Emissions of ultrafine particles and volatile organic compounds from commercially available desktop three-dimensional printers with multiple filaments. ACS Publication. 2016. http://pubs.acs.org/doi/full/10.1021/acs.est.5b04983.
39. 3d printing safety. Carnegie Mellon University. http://www.cmu.edu/ehs/fact-sheets/3D-Printing-Safety.pdf.
40. Columbus L. 2015 roundup of 3d printing market forecasts and estimates. Forbes. 2015. http://www.forbes.com/sites/louiscolumbus/2015/03/31/2015-roundup-of-3d-printing-market-forecasts-and-estimates/.
41. We cant wait: Obama administration announces new public-private partnership to support consortium of businesses, universities, and community colleges from Ohio, West Virginia and Pennsylvania co-invest with federal government in a manufacturing innovation institute. The White House. 2012. https://www.whitehouse.gov/the-press-office/2012/08/16/we-can-t-wait-obama-administration-announces-new-public-private-partners.
42. Standard Terminology for Additive Manufacturing – General Principles-Terminology (ASTM) ISO/ASTM 52900:2015(E)
43. Gross BC, Erkal JL, Lockwood SY, et al. Evaluation of 3d printing and its potential impact on Biotechnology and the chemical sciences. Analytical Chemistry. 2014:86, 3240-3253. http://pubs.acs.org/doi/ipdf/10.1021/ac403397r.
44. 3d printers and 3d printing: technologies, processes and techniques. Sculpteo. https://www.sculpteo.com/en/3d-printing/3d-printing-technologies/.
45. Davies CT, Baird LM, Jacobson MD, et al. 3d printing of medical devices: when a novel technology meets traditional legal principles. Reed Smith. 2015. https://www.reedsmith.com/3d-printing-of-medical-devices–when-a-novel-technology-meets-traditional-legal-principles-09-09-2015/.
46. Leinauer M. FDA regulations (or lack thereof) of 3d printed medical devices. Ice Miller Legal Counsel. 2015. http://www.icemiller.com/ice-on-fire-insights/publications/fda-regulations-%28or-lack-thereof%29-of-3d-printed-me/.
47. Espalin D, Perez M, Medina F, et al. Sterilization of FDA-manufactured parts. Stratasys. http://web.stratasys.com/rs/objet/images/SSYS-WP-Sterilization-FDM-01-14%20FINAL.pdf.
48. CPT process – how a code becomes a code. American Medical Association. http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt/cpt-process-faq/code-becomes-cpt.page.
49. Gholipour A, Estroff JA, Sahin M, et al. A posteriori estimation of isotropic high-resolution volumetric MRI from orthogonal thick-slice scans. Warfield Departments of Radiology and Neurology, Childrens Hospital Boston, and Harvard Medical School. 2010:13(0 2): 109–116.
50. Ejaz F, Ryan J, Henriksen M1, David Frakes, et al. Color-coded patient-specific physical models of congenital heart disease. Rapid Prototyping Journal. 2013. http://ipalab.fulton.asu.edu/wp-content/JournalPubs/RPJ_2013.pdf.
51. Matsumoto JS, Morris JM, Foley TA, et al. Three-dimensional physical modeling: applications and experience at Mayo Clinic. RadioGraphics. 2015:35(7), 1989-2006. http://doi.org/10.1148/rg.2015140260.
52. Clinical Trials. https://clinicaltrials.gov/.
53. Johnson S. Erlanger inks deal with 3D-printer startup to print models of patients’ organs. Times Free Press. 2015. http://www.timesfreepress.com/news/local/story/2015/oct/12/model-surgery-local-tech-startsays-3-d-mockup/330008/.
54. Grunewald SJ. Can 3d digital models be patented? Federal courts to make key decision this summer. com. 2015. http://3dprint.com/104501/federal-court-3d-model-patent/.
55. Laser melting (LM). Additively. https://www.additively.com/en/learn-about/laser-melting.
56. Layer thickness in 3D printing: an additive manufacturing basic. Sculpteo. https://www.sculpteo.com/en/glossary/layer-thickness-definition/.
57. Hospital value-based purchasing. Centers for Medicare & Medicaid Services. 2015: https://www.cms.gov/Medicare/Quality-initiatives-patient-assessment-instruments/hospital-value-based-purchasing/index.html.
58. M Cotteleer, et al. The 3D Opportunity Primer: the Basics of Additive Manufacturing. Deloitte University Press. March 6, 2014. http://dupress.com/articles/the-3d-opportunity-primer-the-basics-of-additive-manufacturing/?id=2el:3dp:dupmooc:eng:dup:mmddyy:novoed
59. Technical Considerations of Additive Manufacture Medical Device: Draft Guidance for Industry and Food and Drug Administration Staff. 2016. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

Related Articles:

3DHEALS Guides (Collective) – This is where we dive deep into subjects that you will find helpful for your projects and career.

3DEALS Expert Corner (Collective) – This is where we invite field experts to write their perspectives in a first-person narrative. To write for this column, please email: info@3dheals.com

3DHEALS From Academia (Collective) – This section features recent, relevant, close to commercialization academic publications in the space of healthcare 3D printing, 3D bioprinting, and related emerging technologies.

The post 3D Printing in Hospitals (Guide): Acknowledgement, References appeared first on 3DHeals.

Want to write a piece for 3DHEALS Expert Corner? Email us: info@3dheals.com

As the world is becoming more aware of the potential impact of 3D printing in medical/surgical workflow, tissue engineering, new products and procedures (and the startups behind them) based on additive manufacturing are surfacing. The bigger question to innovators, healthcare payors, and startup founders beyond the initial excitement of making things work: Is there enough long-term sustainable value of this new product, procedure, or startup?

Pricing of the said medical devices will be the single most important determining factor of this question. [1]

To a MedTech startup founder, in 3D printing or not, this question is even more existential as it will be the single most important factor to a company’s valuation.  This becomes even more significant in light of the expensive process to bring either 510(k) or PMA medical device from concept to market, a reportedly 31 million dollars for 510(k) device, and 94 million dollars for PMA device, with FDA related cost up to 80 percent of the total cost. [2]

Therefore, a lot of skin in the game.

Intuitively, pricing too high will result in poor adoption, and pricing too low will make little financial incentives to long term survival of the procedure or startup.

However, pricing of a new medical device (and related procedure) is getting progressively complex because of several reasons:

1. Comparable devices may not exist to set standards for new devices based on emerging technologies.
2. Complex U.S. healthcare systems with several different and often co-existing reimbursement pathways. (Remember DRG, CPT code, RVU, HCAHPS?)
3. Opaque reimbursement process involving individual negotiations between device companies and payors. One study even shows that the price difference of the same implantable device can vary up to twice. [Figure 1][5]
4. Pricing is complex anyways regardless. The many factors contributing to the final price require careful evaluation starting from product development, clinical trial, manufacturing, market research, to salesforce development.
5. All of the above are constantly changing. [4]

Having a pricing strategy expert may help, but it will be costly. While we don’t have quick answers, have deep knowledge about the following elements of your product could help you with your own pricing strategy:

1. Know your products:

• What kind of product is your medical device? (May check multiple boxes here) [3]
  • Is it capital equipment (e.g. 3D scanner, CAD/CAM system)?
  • Consumables (e.g. 3D printed Implants, stents)?
  • Services (e.g. 3D printing service bureau)?
  • Software (e.g. 3D printing-related CAD software)
• Does it meet unmet needs? For example, one unique benefit of 3D printing is mass customization, hence its ability to scale production of personalized devices. Another example is surgical planning tools, when a surgeon can significantly reduce intra-operative time with 3D printed patient-specific guides and anatomical models than other methods.
• How much does it cost to produce? This will include the cost of materials, infrastructure, and labor over time.

2. Know Your Comparables/Competitors

• Are there other products to market earlier than yours? (e.g. other spinal cages via conventional or even 3D printing process)
• How does your product compare to these in terms of production cost, clinical outcome, user adoption?  
• Is there an existing code for reimbursement? Whatever is covering your competitor’s device can also cover yours. The pricing point will depend on the existing amount a provider receives for performing a procedure using the competitor/comparable device.

3. Payor Economics

• Who will pay for this new device? This could be hospitals, payors, surgeons, practice owners, or even patients.
• Is the incremental cost of the product to the payer balanced by the risk-adjusted NPV (Net Present Value) of the longer-term savings that the use of the product engenders? For example, decreased readmission or device replacement rate due to the more successful hip implant using 3D printed surgical guide.

4. Patient Economics

• Is there a better outcome for the patient that’s quantifiable? If so, how do you price that benefit in? For example, QALYs (quality-adjusted life years) for the patients can be included in pricing.
• There is a growing trend of outcome-based pricing strategies. [4]

5. Provider Economics

• Does it decrease Hassel factors? A Hassel factor is anything that prevents us from doing our work efficiently and effectively. Examples of Hassel factors include inefficient processes, bad policies, outdated procedures, lack of tools, and etc.  [6] For example, prosthetists can now skip several steps to produce prosthetics with the help of direct 3D scanning of a patient’s residual limb for a quick perfect fit. Another example is frequently seen in dentistry, for example, the now more widespread use of Cerec CNC machine to produce a dental crown in office save time and money for both the dentists and the patients.  The improved functionality and efficiency should be priced in.
• Does the product increase brand building for the provider (e.g. doctors, dentist, hospitals)? For example, it is now common that many U.S. Children Hospitals now have established 3D printing purpose because it is perceived as a higher standard of care in a specialty hospital with complicated cases. Large academic medical centers also invest more in 3D printing because it builds their brands as technologically advanced and is going along a trend towards more personalized and safer healthcare delivery system.

Bottom line, pricing is difficult but critical. It requires not only a deep understanding of the product/procedure but also where it stands in a complex value system and how payors, users, patients receive the new technology.

References:

1. Five Ways to Price your New MedTech Product
2. Medtech Price Strategies: Who Is Going to Pay for It?
3. Medical Device Pricing Strategy (Slides)
4. Pricing in the Medical Device Industry
5. An Overview of the Medical Device Industry
6. Hassel Factor Index

Related Articles:

Healthcare 3D Printing Clinical Trials

Cardiac 3D Printing: The Heart of the Matter

3D Printing Has Come of Age But How Safe Are the Devices Going Into Our Mouth?

Generative Design and 3D Printing

The post Pricing Strategies for 3D Printing Related Medical Devices appeared first on 3DHeals.

On November 1^st, 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.” [1] 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…”  [2]

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. [3] 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. [7] 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. [6] 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 [6]:

• 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.

Final Word:

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.

References:

1.     New ACR-Sponsored CPT Codes Approved by the AMA

2.     CPT Category III Codes Long Descriptor.

3.     Everything you need to get started in medical billing & coding – Intro to CPT code

4.     CPT Mission and purpose

5.     Understanding CPT codes for Physician Reimbursement

6.     Category III CPT codes: Coming of age in new healthcare environment

7.     From “Approved” to “Covered” – What Medical Device Companies Need to Know

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.

 Want to write a piece for 3DHEALS Expert Corner? Email us: info@3dheals.com

Related Articles:

Idea to Implementation: Revenue Strategies for 3D Printing for Pre-surgical Planning

Idea to Implementation: Reimbursement, the Elephant in the Room

Three Key Takeaways from RAPID 2019 for Healthcare 3D Printing

Interview: Doris Canen, 3D Printing Tax Law Expert

The post Category III CPT Codes: Reimbursements for 3D Printed Anatomical Models and Surgical Guides appeared first on 3DHeals.

Hui Jenny Chen, MD and Michelle Gabriel, MS, MBA
(This blog is adapted from our A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery)

Healthcare is a highly regulated industry. Understanding local healthcare market and reimbursement strategy is essential to the survival and growth of any new medical technology. In order to be eventually viable financially, most U.S. 3D printing service providers need to answer two questions:

How is the service paid now?

There is currently no established stand-alone reimbursement process for pre-surgical planning 3D printing service. Occasionally, services provided by established 3D printing companies such as 3DSystems/Medical Modeling (Denver, U.S.A.) can get paid indirectly by their contracts with a medical device company, who bills third-party payers for the cost of the medical device which includes 3D printing services.

For example, craniofacial reconstruction surgeons will use the pre-surgical planning 3D printed models and/or cutting guide made by Medical Modeling, Inc. (3DSystems, Denver, U.S.A.), who has a contract with Stryker. Stryker bundles 3D printing services under a single medical device fee, and the hospital bills third-party payers for it. (Figure 1)

Figure 1. An example of current 3D printing reimbursement process (arrows represent direction of payment)

The result of such bundled billing is a lack of cost transparency. As the interest in 3D printing for surgical planning grows, however, more providers are now willing to pay out-of-pocket either at full price or at a negotiated price with 3D printing companies directly for similar services, bypassing any third-party (Figure 2). There is a trend towards more existing commercial 3D printing service providers venturing into the pre-surgical 3D printing arena. For example, Anatomics (St Kilda, Australia), 3D Ops (Tennessee, USA), and Whiteclouds (Utah, USA).

Figure 2. An example of future 3D printing reimbursement process (arrows represent direction of payment)

Additionally, a growing number of larger healthcare organizations and academic hospitals, such as the Harvard hospitals, Mayo Clinic, and Cleveland Clinic have dedicated significant internal research and development grants to develop in-house 3D printing centers. However, payers currently do not reimburse expenses for 3D printing at all if performed “in-house” or “in-office”. Thus, currently, 3D printing service appears to add costs to the overhead of health care facilities. Some have suggested potential cost savings for the hospital to provide 3D printing service as part of the surgical care, but these remain to be anecdotal [27].

How will the service be paid in the future?

For either “in house” and “outsourced” 3D printing services to be paid consistently, future work must be done to a have a procedural terminology (CPT) code created and the associated professional and facility fee assigned. The reimbursement for the physician and hospital services would then need to be negotiated with payers, insurance groups and the Centers for Medicare and Medicaid Services (CMS). [27] To achieve such “code-able” status by the AMA (American Medical Association) [48], the procedure must be officially recognized as part of patient care, which has demonstrated sufficient clinical evidence that the procedure improves patient outcomes.

Although many recent papers have documented significant improvements associated with multiple outcome metrics including reducing operating time and surgical accuracy [13], the results are still too early and too little to convince the payers. Another added challenge also includes lack of an advocacy entity for this purpose. However, this will likely change as the field matures.

https://3dheals.com/idea-to-implementation-in-house-vs-outsourced-3d-printing-for-surgical-applications/

The post Idea to Implementation: Reimbursement, the Elephant in the Room appeared first on 3DHeals.

As the organizers of 3DHEALS events, it may surprise people that we could never accurately predict the outcome of 3DHEALS conferences. That includes what the speakers will discuss, what kind of audience we will attract, and what kind of new connections will be made.
Since its inception, 3DHEALS events have pleasantly surprised us in many ways every time.  The community we have attracted is small, intimate, but also powerful and capable. That is probably the most constant thing we can predict.
For our August 3DHEALS legal conference, we had the pleasure of listening to the most original presentations on legal issues related to healthcare 3D printing, from IP/Patent concerns (Erik Birkeneder from NixonPeabody), to medical device liability (Colleen Davies from ReedSmith), to new digital security software development for healthcare 3D printing (Stephan Thomas from Identify3D).   The Q&A session moderated by past FDA fellow Dr. Mirza was as stimulating as the presentations, as the audience was composed of the usual mixed of intellects with backgrounds ranging from healthcare consultants, legal, journalist, engineering, environment risk scientist, healthcare providers, and beyond.
Our readers can watch the recordings of the conference on YouTube soon.
 
 

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August – Edgeinterns , Francis Kong and Megan McLeod

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

The post 3DHEALS EVENT RECAP: Legal Landscape of Healthcare 3D Printing – Knowing the Unknown appeared first on 3DHeals.

Infographics: Legal Landscape of Healthcare 3D Printing Innovations

Healthcare industry is notoriously highly regulated. The legal issues surrounding healthcare 3D printing technologies are not only complex but often completely unknown to both the scientific and the entrepreneur communities. As the healthcare 3D printing community grows exponentially, even the legal experts themselves are sometimes struggling to keep up with new problems facing with the rapidly growing field and innovations. Come and join us at 3DHEALS August event focusing on some of the most interesting legal topics surrounding healthcare 3D Printing.

The post Infographics: Legal Landscape of Healthcare 3D Printing Innovations appeared first on 3DHeals.