WMGI Wright Medical Group NV

Wright Medical Group N.V. (NASDAQ: WMGI) 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 January 1, 2020.  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 January 1, 2020, 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 chief executive officer 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 January 1, 2020.  This marked the first orthopedic implant to secure pass-through payment approval in over a decade1, 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% of patients and 5.2% of patients at an average follow-up of 9 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% (15/167) of patients in the AUGMENT clinical trials.2,5,6

For additional AUGMENT Regenerative Solutions reimbursement support tools and information, visit www.wright.com/Reimbursement. 

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products.  The company is committed to delivering innovative, value-added solutions improving quality of life for patients worldwide and is a recognized leader of surgical solutions for the upper extremity (shoulder, elbow, wrist and hand), lower extremity (foot and ankle) and biologics markets, three of the fastest growing segments in orthopedics.  For more information about Wright, visit www.wright.com.

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.

Cautionary Note Regarding Forward-Looking Statements   

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by words such as “believe,” “expect,” “estimate,” “predict,” “target,” “potential,” “likely,” “continue,” “ongoing,” “could,” “should,” “intend,” “may,” “might,” “plan,” “seek,” “anticipate,” “project” and similar expressions, as well as variations or negatives of these words. Forward-looking statements in this release include, without limitation, statements regarding the performance and market acceptance of the Company’s products, the pricing of the Company’s products, and the timing of and ability to obtain reimbursement of procedures utilizing the Company’s products. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Applicable risks and uncertainties include, among others, physician acceptance, endorsement, and use of Company products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims; product recalls; the effects of industry, economic or political conditions outside of the Company’s control; competitor activities; and other risks and uncertainties detailed from time to time in documents filed with the Securities and Exchange Commission (the “SEC”) by the Company, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to the Company, and the Company assumes no obligation to update any forward-looking statements. 

Investors & Media: 

Julie D. Dewey                                                                                                         Sr. Vice President, Chief Communications OfficerWright Medical Group N.V.(901) 290-5817julie.dewey@wright.com