SUBMITTED ELECTRONICALLY

May 26, 2017
Ms. Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Attention: CMS-1677-P
7500 Security Boulevard
Baltimore, MD 21244-1850
RE: Medicare IPPS Proposed Rule for FY 2018 (CMS-1677-P) –Total Ankle Replacement
Provisions
Dear Ms. Verma:
Wright Medical Technology, Inc. (Wright) appreciates this opportunity to submit comments regarding the
Centers for Medicare & Medicaid Services’ (CMS) proposed Medicare hospital inpatient prospective
payment system (IPPS) rule for fiscal year (FY) 2018 (“Proposed Rule”). As discussed in greater detail
below, our comments address the need to modify the Medicare severity diagnosis-related group (MSDRG) assignments for Primary and Revision total ankle replacement (TAR) procedures.
Wright is a focused, specialty orthopaedic company that provides extremity and biologic solutions that
enable clinicians to alleviate pain and restore their patients’ lifestyles. We are a recognized leader of
surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and
ankle) and biologics (synthetic and tissue-based bone graft substitute materials) markets. Wright is
committed to finding and delivering the best possible solutions to patients, providers, and Medicare.
Wright fully supports CMS’s proposal to establish more equitable payment for Primary TAR
procedures by assigning all Primary TAR procedures to MS-DRG 469, even when there is no MCC
reported, in the final FY 2018 IPPS rule. We also request that CMS continue to examine claims data
and MS-DRG assignments to ensure that Medicare beneficiaries have continued access to Revision of
TAR procedures.
Our recommendations are discussed in greater detail below.

I.

MS-DRG Assignment for Primary TAR Procedures

Primary TAR procedures currently are assigned to MS-DRGs 469 and 470 (Major Joint Replacement or
Reattachment of Lower Extremity with and without MCC, respectively), to which total hip arthroplasty
(THA) and total knee arthroplasty (TKA) are also assigned, despite significant clinical and cost
differences among these procedures. This has resulted in significant IPPS underpayment for Primary
TAR procedures. While Primary TAR is a much more complex and costly procedure than THA or TKA,
Wright has long been concerned that TAR procedures are “lost” within the current MS-DRG assignment
because total knee/hip replacement procedures are among the highest-volume Medicare procedures. We
therefore previously requested that CMS assign these procedures to MS-DRGs that provide more accurate
payment.

 Wright Medical Technology, Inc.

Comments on FY 2018 IPPS Proposed Rule
Page 2 of 7`

In the Proposed Rule, CMS presents data demonstrating the extent of the current underpayment for
Primary TAR cases, particularly when they track to MS-DRG 470 – which currently represent the
overwhelming majority of Medicare TAR cases:
Total Ankle Replacements Procedures
MS-DRG
MS-DRG 469– All cases
MS-DRG 469– Cases reporting
TAR procedure codes
MS-DRG 470– All cases
MS-DRG 470– Cases reporting
TAR procedure codes

Number of
Cases

Average
Length of Stay

Average
Costs

25,778

6.7

$22,139

31

4.6

$23,828

461,553

2.7

$14,751

2,114

1.9

$20,862

TAR
Shortfall
-$1,689

-$6,111

CMS’s data indicate that the 2,114 TAR cases in MS-DRG 470 had average costs that were more than
40% higher ($6,111) than the average costs of all cases in MS-DRG 470 (specifically $20,862 for
Primary TAR cases compared to $14,751 for all cases). Within MS-DRG 469, the Primary TAR cases
have average costs that are $1,689 more than all cases.
In light of this stark cost-to-payment disparity, CMS proposes to reassign the following Primary TAR
procedure codes from MS-DRG 470 to MS-DRG 469, even if there is no MCC reported:







0SRF0J9 (Replacement of right ankle joint with synthetic substitute, cemented, open approach);
0SRF0JA (Replacement of right ankle joint with synthetic substitute, uncemented, open approach);
0SRF0JZ (Replacement of right ankle joint with synthetic substitute, open approach);
0SRG0J9 (Replacement of left ankle joint with synthetic substitute, cemented, open approach);
0SRG0JA (Replacement of left ankle joint with synthetic substitute, uncemented, open approach);
and
0SRG0JZ (Replacement of left ankle joint with synthetic substitute, open approach).

While the average costs of the Primary TAR procedures in MS-DRG 470 are somewhat lower than the
average costs for all cases in MS-DRG 469 ($20,862 versus $22,139), CMS importantly points out that
“the average costs are much closer to the average costs of TAR procedure cases in MS-DRG 470.” In
addition to cost considerations, CMS’s clinical advisors agreed that that it is clinically appropriate to
reassign all TAR procedure cases from MS-DRG 470 to MS-DRG 469, even when there is no MCC
reported.
CMS also proposes to change the titles of MS-DRGs 469 and 470 to account for the reassignments, as
follows:



MS-DRG 469: “Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity with
MCC or Total Ankle Replacement”
MS-DRG 470: “Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity
without MCC.”

 Wright Medical Technology, Inc.

Comments on FY 2018 IPPS Proposed Rule
Page 3 of 7`

Wright strongly supports CMS’s proposal, and strongly commends CMS for its thoughtful
consideration of how to address the current payment inequity for Primary TAR procedures. We
agree with CMS’s assessment that cost data demonstrate that average hospital costs for Primary TAR
cases are significantly higher than THA and TKA cases, particularly within MS-DRG 470. It is simply
not sustainable for hospitals to be dramatically undercompensated for the costs of furnishing Primary
TAR surgery. As the number of Primary TAR cases steadily increases, correcting payment disparities
will only become more critical to ensuring Medicare beneficiary access to TAR as a safe and effective
alternative to arthrodesis of the ankle when medically appropriate, and prescribed by their surgeon.
It is also very much appreciated that CMS’s clinical advisors evaluated and recognized Primary TAR as a
much more complicated surgery compared to other lower extremity joint replacement procedures. We
agree with this assessment. TAR procedures replace the damaged parts of the three bones that make up
the ankle joint, the smallest weight-bearing joint in the body. TAR procedures require specialized
surgical skills, different operative technique and operating room resources, and a complexity of implant
device design, engineering, manufacture and functional specifications vastly different than used in THA
and TKA procedures. Wright applauds CMS’s advisors for confirming that it is clinically appropriate for
CMS to reassign all of the TAR procedure cases from MS-DRG 470 to MS-DRG 469, even when there is
no MCC reported.
CMS’s proposal would remedy a historical cost-to-payment disparity, and thus enable hospitals to
continue offering Primary TAR surgery to Medicare beneficiaries as an economically sustainable, and
clinically viable, alternative to ankle fusion when medically appropriate. Wright therefore urges CMS
to adopt its proposal to assign all Primary TAR procedures to MS-DRG 469, even when there is no
MCC reported, in the final FY 2018 IPPS rule.

II.

Revision of TAR Procedures

Wright also appreciates CMS’s consideration of the MS-DRG assignment for Revision of TAR
procedures in light of newly-available ICD-10 data. These procedures currently are assigned to MSDRGs 515, 516, and 517 (Other Musculoskeletal System and Connective Tissue O.R. Procedures with
MCC, with CC and without CC/MCC, respectively).
As we have previously noted to CMS, the current MS-DRG assignments for Revision of TAR procedures
are based on the previous ICD-9 code -- 81.59 (Revision of joint replacement of lower extremity, not
elsewhere classified). This unspecified code included toe and foot joint revision procedures in addition to
Revision of TAR. Although CMS cost files have shown higher costs for MS-DRG 515, 516, and 517
cases reporting ICD-9 code 81.59, CMS could not previously determine which of these cases were
revision of TAR cases due to the use of an unspecified code.
The ICD-10-PCS structure established a much more granular coding framework for Revision of TAR
procedures. Unfortunately, however, it appears that the MS-DRG assignment logic has not fully and
accurately captured all of the correct codes and code combinations under the new ICD-10-PCS
framework. A certified coding expert with RHIA, CCS, and ICD-10-Trainer credentials engaged by
Wright Medical has determined that only two of the “Revision of TAR codes” examined by CMS in the
Proposed Rule actually are applicable to Revision of TAR procedures without removal of primary
components based on the indications for use and surgical technique. The expert also identified 10
additional ICD-10-PCS codes that are applicable to Revision of TAR procedures depending upon the
combination of procedures reported.

 Wright Medical Technology, Inc.

Comments on FY 2018 IPPS Proposed Rule
Page 4 of 7`

Specifically, the Proposed Rule includes an analysis of the following revision of synthetic substitute ICD10 codes:



0SWG0JZ-0SWGXJZ Revision of synthetic substitute in left ankle joint
[by approach; includes codes 0SWG0JZ, 0SWG3JZ, 0SWG4JZ, 0SWGXJZ]
0SWF0JZ-0SWFXJZ Revision of synthetic substitute in right ankle joint
[by approach; includes codes 0SWF0JZ, 0SWF3JZ, 0SWF4JZ, 0SWFXJZ]

However, only two of these codes involve revision of joint, but without removal / replacement of any
components: 0SWG0JZ 0SWF0JZ (Revision of Synthetic Substitute in Left/Right Ankle Joint, Open
Approach, respectively). The other six ICD-10-PCS codes are for percutaneous and external approaches,
both of which are not applicable to Revision of TAR procedures. Revision of TAR procedures can
only be performed as an open procedure. An open approach is necessary for a surgeon to access the joint,
surgically remove and replace failed components, and conduct any necessary surgical preparation of the
native bone for proper seating of Revision of TAR implant components.
Furthermore, there are additional ICD-10-PCS codes that hospitals may be using in combination to report
TAR revision procedures depending on the extent of the revision and materials used. Thus, an additional
10 ICD-10-PCS codes, which were not identified in the Proposed Rule, should be analyzed:




0SPG0JZ 0SPF0JZ (Removal of Synthetic Substitute from Left/Right Ankle Joint, Open
Approach)
0SUG0JZ 0SUF0JZ (Supplement of Left/Right Ankle Joint with Synthetic Substitute, Open
Approach)
0SRF0J9 0SRG0J9 0SRF0JA 0SRG0JA 0SRF0JZ 0SRG0JZ (Replacement of Left/Right
ankle joint with synthetic substitute, cemented, uncemented or not specified, open approach).

Table 1 lists the full range of ICD-10-PCS codes for Revision of TAR, based on research by a certified
coding expert, in accordance with the surgical technique for Revision of TAR. The American Hospital
Association Coding Clinic1 and the ICD-10-PCS Reference Manual2 confirm that the additional codes
referenced in Table 1 should be billed in combinations to accurately identify the removal and revision
with replacement of primary implanted TAR components, using the open surgical approach, in certain
surgical scenarios.

1
2

ICD-10-CM/PCS Coding Clinic, fourth quarter, 2016 pages 110-112.
ICD-10-PCS Reference Manual, page 73.

 Wright Medical Technology, Inc.

Comments on FY 2018 IPPS Proposed Rule
Page 5 of 7`

Table 1: ICD-10-PCS Codes that Correctly Identify Revision of TAR Procedures

Revision of TAR
Procedure

ICD-10
Code

ICD-10-PCS Description

Revision of TAR with
Structural Components
Intact

0SWG0JZ

Revision of Synthetic Substitute in Left Ankle Joint, Open Approach

0SWF0JZ

Revision of Synthetic Substitute in Right Ankle Joint, Open
Approach

Revision of TAR with
Polyethylene Liner
Replacement

0SPG0JZ

Removal of Synthetic Substitute from Left Ankle Joint, Open
Approach

0SPF0JZ

Removal of Synthetic Substitute from Right Ankle Joint, Open
Approach

0SUG0JZ

Supplement Left Ankle Joint with Synthetic Substitute, Open
Approach

0SUF0JZ

Supplement Right Ankle Joint with Synthetic Substitute, Open
Approach

0SPG0JZ

Removal of Synthetic Substitute from Left Ankle Joint, Open
Approach

0SPF0JZ

Removal of Synthetic Substitute from Right Ankle Joint, Open
Approach

0SRF0J9

Replacement of Right ankle joint with synthetic substitute, cemented,
open approach

0SRG0J9

Replacement of Left ankle joint with synthetic substitute, cemented,
open approach

0SRF0JA

Replacement of Right ankle joint with synthetic substitute,
uncemented, open approach

0SRG0JA

Replacement of Left ankle joint with synthetic substitute,
uncemented, open approach

0SRF0JZ

Replacement of Right ankle joint with synthetic substitute, open
approach

0SRG0JZ

Replacement of Left ankle joint with synthetic substitute, open
approach

Revision of TAR with
Primary Structural
Components
Exchanged

Note that the Proposed Rule indicates that there were only six Revision of TAR cases in the December
2016 update of the FY 2016 MedPAR file. While Revision of TAR procedure utilization should be
expected to be much lower than Primary TAR procedure utilization, the omission of multiple ICD-10PCS codes that may be used in tandem to report Revision of TAR procedures is likely responsible for the
relative lack of cases in the CMS analysis. We are concerned that relying on only a subset of revision of
TAR cases made it impossible to adequately and properly assess the actual utilization and cost-topayment ratio for Revision of TAR among all the multiply body segment revision joint arthroplasty
procedures that collectively map to MS-DRGs 515, 516 or 517.

 Wright Medical Technology, Inc.

Comments on FY 2018 IPPS Proposed Rule
Page 6 of 7`

Furthermore, the average cost data presented on these six claims ($7,423 - $11,400) significantly
understates the costs to hospitals in furnishing Revision of TAR procedures, which we expect would have
a very similar cost-to-payment ratio to that of Primary TAR implants. Thus the reliability of the Revision
of TAR data presented in the Proposed Rule is questionable and most likely a result of:
1. The range of codes included in the analysis (inclusion of six inapplicable ICD-10-PCS codes
and omission of ICD-10-PCS codes that may be reported in combination, as set forth in Table 1);
2. Inaccurate or incomplete coding and/or reporting of costs by hospitals, which also could
involve hospitals not consistently reporting ICD-10-PCS codes for Revision of TAR cases; and/or
3. Incorrect trimming of the data in a way that understated Revision of TAR cases.
In fact, an analysis of the FY 2016 MedPAR proposed rule file conducted by an expert OPPS data analyst
identified an additional 67 Revision of TAR removal and replacement code pairs that incorrectly tracked
to MS-DRG 469, primary hip and knee joint replacement. These cases had a standardized cost of
$20,535 – almost double the costs CMS otherwise attributes to Revision of TAR cases in the
proposed rule.
We therefore request that CMS continue to examine the utilization and cost data in the MedPAR
file in your next analysis, applying the full complement of ICD-10-PCS codes identified in Table 1
that may be used to report Revision of TAR procedures. That is, this updated data inquiry should
include both “stand alone” Revision of TAR ICD-10-PCS codes (0SWG0JZ and 0SWF0JZ) and cases in
which two removal/supplement/replacement codes are billed in tandem, per Coding Clinic and ICD-10PCS Reference manual requirements. This expanded analysis is necessary to correctly and properly
identify Revision of TAR procedures and all related costs and cost differentiation for Revision of TAR
procedures for purposes of accurate MS-DRG assignment.
Furthermore, Wright encourages CMS to draft a Medicare Learning Network (MLN) Matters educational
article for Part A providers and Medicare Administrative Contractors (MACs) to ensure that all parties are
consistently coding Revision of TAR procedures on the UB-04 (CMS-1450 claim form). It is also critical
that MACs process and pay for Revision of TAR procedures based on the complete list of Revision ICD10-PCS codes identified in Table 1, and not based on the incomplete ICD-10-PCS codes identified in the
Proposed Rule.
Finally, we request that CMS continue to review hospital billing and coding data for Revision of TAR
procedures using the full complement of ICD-10-PCS codes identified in Table 1. An increasing number
of claims for Revision of TAR procedures will certainly become identifiable in the future as patients and
implants naturally age into a need for revision surgery, as has been observed across all surgical joint
replacement procedures. CMS should proactively monitor and take all necessary steps to prevent
Medicare underpayment from imposing an inadvertent barrier to patient access to medically-necessary
Revision of TAR procedures.

*****

Wright appreciates the consideration of our comments on ways to ensure that Medicare beneficiaries
continue to have access to Primary TAR procedures, and Revision of TAR procedures. We respectfully

 Wright Medical Technology, Inc.

Comments on FY 2018 IPPS Proposed Rule
Page 7 of 7`

request that you address these recommendations in developing the FY 2018 IPPS final rule. If you have
any questions, please do not hesitate to contact me.
Sincerely,

Erik Harris
Senior Director, Global Reimbursement & Market Access
Wright Medical Technology, Inc.
erik.harris@wright.com
(615) 779-4174 Cell