Wright Medical Group N.V. Announces Update to Medicare Transitional Device Pass-Through Payment for AUGMENT® Regenerative Solutions
Transitional Pass-Through Payment Reimburses Hospital Outpatient and
Facilitates Medicare Beneficiary Access to AUGMENT by Removing Economic Barrier
This update is made retroactive to
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
- 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.
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.
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
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
Investors & Media:
Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Source: Wright Medical Group N.V.