164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 Id. Firemen’s Ins. Co. of Washington, D.C. v.

Kline & Son Cement Repair, Inc., 474 F. Supp. 2d 779, 792-94 (E.D.

Va. 2007). Karishma Paroha, June 2, 2014, 3-D Printed Products, Product Liability And Insurance Implications, http://www.kennedyslaw.com/article/3dprintedproducts/. Stuart Collins, Allianz, The universe in 3D, http://www.agcs.allianz.com/insights/expert-risk-articles/the-universe-in-3d/ Reimbursement refers to coding, coverage, and payment – all three components are needed for reimbursement. Michael Sanchez, M.A., Medical Device Reimbursement presented at St. Thomas University, Design and Manufacturing in the Medical Device Industry Course, December 3, 2012. CMS, private insurers, analysts, and venture capitalists should also be part of these early discussions, so that all parties are on the same page for this new and increasingly growing technology. Gail L.

Daubert, et al., Food and Drug Law and Regulation 944 (David Adams, et al., eds. 3d ed.) Id. Payors will ask, for example, is the 3D printed device better than a traditionally manufactured device and will the 3D printed device have the same longevity as its traditionally manufactured counterpart? If the answer is no to either of these questions, then the payor will not understand the benefit derived from the 3D printed device, as opposed to a traditionally manufactured device, which likely has a long-standing clinical history. See section 510(k) of the Food, Drug and Cosmetic Act (21 U.S.

Code § 360) Tiffini Diage, MPH, Planning for Successful Medical Device Reimbursement: So Your Device is Cleared, Now What? NAMSA See Aetna Stereolithography Policy Decision No. 0613, located at: http://www.aetna.com/cpb/medical/data/600_699/0613.html Tiffini Diage, MPH, Planning for Successful Medical Device Reimbursement: So Your Device is Cleared, Now What? NAMSA See id. Gail L. Daubert, et al., Food and Drug Law and Regulation 944 (David Adams, et al., eds.

3d ed.) See Prospective Payment Systems (“PPS”), located at cms.gov/Medicare/Medicare-fee-for-service-Payment (“Medicare payment to facilities is based on prospective payment systems in which payment is made based on a predetermined, fixed amount.”). Payment for a particular service is then derived based on the code reported on the claim form and the classification system of that service (for example, diagnosis-related groups for inpatient services; ambulatory payment classification for hospital outpatient services). Thus, if a new service is billed with an existing code and the new service and technology (e.g., 3D printed implant) is more expensive, the payment to the hospital will not reflect added costs.

On the other hand, if the 3D printed implant is less expensive than the current implant, and surgery and other care is similar and an existing code is reported, the hospital may be satisfied with the PPS payment. Medicare payment to physicians is based on a fee schedule that looks at the (1) physician work, (2) practice expense and (3) professional liability insurance costs associated with furnishing a service. Each of these three components is assigned relative value units (“RVUs”) and then adjusted for geographical cost differences and site of service. The total adjusted RVUs are multiplied by the annual conversion factor, which is a dollar amount to determine the Medicare-allowed payment to a particular physician for a specific service.

Gail L. Daubert, et al., Food and Drug Law and Regulation 960-61 (David Adams, et al., eds. 3d ed.) Although there are several major coding systems, CPT codes are the system most likely to play a role with 3D printed medical devices. There are three categories of CPT codes: • Category I: procedures that are consistent with contemporary medical practice and are widely performed • Category II: supplementary tracking codes that can be used for performance measures • Category III: temporary codes for emerging technology, services and procedures See http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billinginsurance/cpt/applying-cpt-codes.page If existing CPT codes are used, payors may still not approve 3D printed devices if they are more costly, over traditional manufactured devices, without any proven benefit. Gail L.

Daubert, et al., Food and Drug Law and Regulation 955-56 (David Adams, et al., eds. 3d ed.) Gail L. Daubert, et al., Food and Drug Law and Regulation 960-61 (David Adams, et al., eds.

3d ed.). See generally Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule & Other Revisions to Part B for CY 2014, 78 Fed. Reg.

74,229 (Dec. 10, 2013) (final update to the 2014 Medicare physician fee schedule). See Tiffini Diage, MPH, Planning for Successful Medical Device Reimbursement: So Your Device is Cleared, Now What? NAMSA Endnotes 39 .