'I• INTEGRA II LI MIT UNCE RTAINTY w June 13, 2017 VIA ELECTRONIC DELIVERY Ms. Seema Verma Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1677-P P.O. Box 8011 Baltimore, MD 21244-1850 Re: CMS-1677-P: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates Dear Administrator Verma: On behalf oflntegra LifeSciences Corporation (Integra LifeSciences), I write to provide comments on one aspect of the above-captioned proposed rule - the reassignment of six total ankle replacement (TAR) procedure codes to Medicare Severity-Diagnosis Related Group (MS-DRG) 469, regardless of whether major complications or comorbidities (MCC) are reported, for fiscal year (FY) 2018, and the related retitling of MS-DRGs 469 and 470. Integra LifeSciences supports the proposed reassignment of the six TAR procedure codes to MS-DRG 469 and the related retitling ofMS-DRGs 469 and 470 and asks that the Centers for Medicare & Medicaid Services (CMS) finalize these proposals. Background Integra LifeSciences is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in extremity reconstruction, neurosurgery, general surgery, and soft tissue repair. Headquartered in Plainsboro, New Jersey, Integra LifeSciences markets the Cadence® Total Ankle System and the Saito Talaris® Total Ankle Prosthesis. These products are designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis. Available in a variety of sizes and design configurations intended for both primary surgery and revision surgery applications, both the Cadence® Total Ankle System and the Saito Talaris® Total Ankle Prosthesis are designed to reduce pain, restore alignment, and allow for movement at the replaced joint. Integra • 311 Enterprise Drive, Plamsboro, NJ 08536 609-275-0500 • 8oo-654··2873 tol l free • 609--275-5363 fax • integ ralife.com 'I• INTEGRA II UMI r UNCERfA!NTY Discussion Integra LifeSciences strongly supports CMS' s FY20 18 proposals to reassign certain total ankle replacement (TAR) procedure codes to MS-DRG 469, whether an MCC is reported or not, and to retitle MS-DRGs 469 and 470. 1 Presently, TAR procedures are assigned to either MS-DRG 469 (Major Joint Replacement or Reattachment of Lower Extremity with major complications or comorbidities (MCC)) or MS-DRG 470 (Major Joint Replacement or Reattachment of Lower Extremity without MCC).2 These two MS-DRGs are distinguished only by the presence or absence of MCC. Pursuant to an analysis ofFY2016 claims data, CMS found significant clinical and cost variances among total hip replacement, total knee replacement, and TAR procedures.3 In this analysis, CMS focused on six TAR procedure codesOSRFOJ9; OSRFOJA; OSRFOJZ; OSRGOJ9; OSRGOJA; and OSRGOJZ. It found that the average cost of these TAR cases exceeds the average cost of all procedures assigned to MS-DRG 470- resulting in underpayment for TAR procedures assigned to MS-DRG 470. Therefore, for FY2018, CMS proposes to assign all TAR procedures, whether or not MCC is reported, to MS-DRG 469, and to retitle MS-DRGs 469 and 470 as follows. 4 MS-DRG469 Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with MCC or Total Ankle Replacement. MS-DRG470 Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity without MCC. Integra LifeSciences urges CMS to finalize its proposal to reassign the identified TAR procedure codes from MS-DRG 470 to MS-DRG 469 whether or not MCC are present. We agree with CMS that it is clinically appropriate to reassign these TAR procedures from MS-DRG 470 to MS-DRG 469, and that TAR procedures require more resources than other cases assigned to MS-DRG 4 70. As the manufacturer of aT AR system, we agree that TAR "is a complicated surgery that involves the replacement of the damaged parts of the three bones that comprise the ankle joint, as compared to the two 81 Fed. Reg. 19796, 19829-30 (Apr. 28, 2017). !d. 3 !d. at 19830. 4 !d. 1 2 2 l~J INTEGRA LIMIT UNCERTAINTY bones in hip and knee replacement procedures." 5 After removal of the damaged ankle, the surgeon must insert the replacement ankle in an anatomically narrow location of the body and bones to recreate the ankle joint. Further, as part of the procedure, the surgeon must also address the tightness of the calf muscle and Achilles tendon, and in some cases perform an additional lengthening procedure to improve the patient's range of motion. These procedures are further complicated when performed on the Medicare population which comprises a large proportion of the patient mix. In addition, Integra LifeSciences agrees with CMS's proposal to retitle MS-DRGs 469 and 470 for enhanced clarity in light ofthe proposed TAR procedure codes reassignments. It will be helpful to avoid any confusion with regard to the whether MSDRG 469 is appropriate for the TAR procedures whether MCC is reported or not. Because the proposed retitling avoids such confusion, we recommend that CMS finalize this proposal too. Lastly, Integra LifeSciences supports CMS' s continued policy of reviewing requests for MS-DRG assignments, undertaking claims analyses to evaluate such requests, and to propose appropriate MS-DRG reassignment when required such as in the case ofTAR procedures. * * * * * * Thank you for considering Integra LifeSciences's comments and recommendations. For the reasons discussed above, we support CMS ' s FY2018 proposals to reassign the identified TAR procedure codes for to MS-DRG 469 and to retitle MS-DRGs 469 and 470. We respectfully request that these proposals be finalized for FY20 18. If you have any questions, do not hesitate to call Donna Cartwright at 609936-2265 or email her at donna.cartwright@integralife.com at your convenience. Sincerely, ._}L-"""' <- iv {fJ ·7 . JosephRolley Vice President, Reimbursement & Market Access 5 !d. at 19829. 3 'I "'. •