Wright Medical Group N.V. today announced that the Centers for Medicare & Medicaid Services (CMS) published an update to the reimbursement calculation used to determine the transitional pass-through payment for the device category applicable to AUGMENT Regenerative Solutions, including AUGMENT Bone Graft and AUGMENT Injectable, originally implemented on Jan. 1. Based on this update, when hindfoot and ankle fusions are performed in the hospital outpatient and ambulatory surgical center settings of care, the facility will be paid for the incremental cost of AUGMENT, thereby facilitating Medicare beneficiary access to the advantages of AUGMENT by removing an economic barrier.
 
This update is made retroactive to Jan. 1, and the existing transitional device pass-through code (C1734) may be used to bill for AUGMENT for hindfoot and ankle fusion procedures when used in treatment of Medicare beneficiaries enrolled in Medicare Part B under the traditional Medicare program.
 
Robert Palmisano, president and CEO of Wright, commented, “The update to the transitional pass-through payment in the outpatient setting will help ensure healthcare providers have access to AUGMENT Regenerative Solutions, which offer a clear patient benefit by eliminating the complications of the additional surgery required to harvest autograft that can result in site-specific complications and/or prolonged harvest site pain in some patients.  Wright has been dedicated to advancing the standard of care for hindfoot and ankle fusion, and we are proud that the Centers for Medicare & Medicaid Services, the country's largest payer for health care, recognizes the importance of our AUGMENT technology to its beneficiaries.”
 
Dr. Gregory C. Berlet of the Orthopedic Foot and Ankle Center in Westerville, Ohio, stated, “This transitional pass-through payment is monumental for my hindfoot and ankle arthritis patients who require a fusion procedure.  AUGMENT is already proven to offer clear patient benefit by enabling a healing rate and safety profile non-inferior to autogenous bone graft. Based upon the data showing more consistent fusion outcomes in patients aged 65 and older as compared to autograft, and the approval of the transitional pass through payment, I can now use AUGMENT in outpatient facilities for these patients as the economic concerns have been resolved.”
 
Transitional pass-through payments are intended to facilitate Medicare beneficiary access to the advantages of new and innovative devices by allowing for adequate payment for these new devices while the necessary cost data is collected to incorporate the costs for these devices into the procedure Ambulatory Payment Classifications rate. After rigorous vetting, the CMS concluded that AUGMENT is of great clinical utility in the outpatient setting and approved Wright’s application for transitional pass-through payment, which became effective Jan. 1, 2020.  This marked the first orthopedic implant to secure pass-through payment approval in over a decade,¹ unlocking access to benefits for patients, physicians and facilities, including:
 

• AUGMENT improves patient outcomes by eliminating chronic pain associated with the autograft harvest site, which was found to be clinically significant at 52 weeks in 8.8 percent of patients and 5.2 percent of patients at an average follow-up of nine years.^2,3
• AUGMENT was found to provide two times the odds ratio for fusion success on CT compared to autograft in patients 65 years of age or older.⁴
• AUGMENT eliminates medically significant surgical complications associated with the autograft harvest from a second surgical site, which were found to occur in 8.9 percent (15/167) of patients in the AUGMENT clinical trials.^2,5,6

References 
¹ Search of www.cms.gov conducted 6/29/2020.
² DiGiovanni CW, Lin SS, Baumhauer JF, et al. Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): an alternative to autogenous bone graft. J Bone Joint Surg Am. 2013;95(13):1184-1192.
³ Baumhauer JF, Glazebrook M, Younger A, et al. Long-term Autograft Harvest Site Pain After Ankle and Hindfoot Arthrodesis [published online ahead of print, 2020 May 20]. Foot Ankle Int.    2020;1071100720920846.
⁴ Berlet G, Baumhauer J, Glazebrook M, et al. Impact of Patient Age and Graft Type on Fusion Following Ankle and Hindfoot Arthrodesis. 2020 AAOS Annual Meeting.
⁵ Daniels TR, Younger A, Penner MJ, et al. Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a β-TCP-Collagen Matrix. Foot Ankle
    Int. 2015;36(7):739-748.
⁶ Daniels TR, Anderson J, Swords MP, et al. Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an
    Alternative to Autograft. Foot Ankle Int. 2019;40(9):1068-1078.