LCD Reference Article Response To Comments Article

Response to Comments: Total Joint Arthroplasty

A60399

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
CGS Administrators, LLC	MAC - Part A	15101 - MAC A	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part B	15102 - MAC B	J - 15	Kentucky
CGS Administrators, LLC	MAC - Part A	15201 - MAC A	J - 15	Ohio
CGS Administrators, LLC	MAC - Part B	15202 - MAC B	J - 15	Ohio

Article Information

General Information

Article ID
A60399

Article Title
Response to Comments: Total Joint Arthroplasty

Article Type
Response to Comments

Original Effective Date
01/29/2026

Retirement Date
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Article Text

This article is response to comments during the open comment period for L40232. CGS received comments from one stakeholder which are addressed in this article.

Response To Comments

Number	Comment	Response
1	On behalf of Stryker, I am submitting comments for your consideration in response to CGS’ proposed draft policy *Total Joint Arthroplasty DL40232*. Stryker is an interested party to this draft LCD as we are the manufacturer of the Mako robotic arm, which is included in this proposed policy. The Mako System is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicompartmental knee replacement and/or patellofemoral replacement (PKA); Total Knee Arthroplasty (TKA); and Total Hip Arthroplasty (THA). This robotic platform has been utilized in over 2 Mil procedures globally and approximately 20% of US hospital facilities have and are utilizing the MAKO System to perform knee and hip arthroplasty procedures. We respectfully request that CGS Medicare eliminate CPT® codes 20985, 0054T, 0055T and HCPCS code S2900 from this proposed LCD. We believe this medical policy should focus solely on the primary surgical interventions based on the medical necessity of the patient and not include ancillary platforms to assist with surgeon technique. Surgical technique should be at the discretion of the operating surgeon, based on their clinical decision-making to ensure optimal patient clinical outcomes. Literature was submitted with the comments.	Thank you for your comments (1-8) and submitted literature. This literature was not initially included because: The Banger et al (2021) was included in several systematic reviews and already considered in the analysis. The Loke systematic review was not published until after the LCD was proposed. When higher quality study designs, such as systematic reviews and RCTs, are available retrospective reviews with inherit low quality are typically not considered unless they provide additional insight on a specific cohort. Cost analysis and review papers are not considered. The submitted literature has been added to the LCD but does not change the coverage decision. The literature does not demonstrate a difference between conventional and robotic assistance for long term outcomes. While the retrospective reports highlight a trend towards improved post-operative pain and function in the short term this is based on low quality evidence and must be balanced against the associated risk with increased operative time. The findings are also not consistent in the literature as some reports do not demonstrate these trends
2	CGS Medicare's proposed determination has not differentiated between the two modalities of Computer Assisted Navigation and Robotic Assisted Surgery despite these being distinct technologies with differentiate mechanisms of action, clinical applications, and evidence bases. If CGS develops a coverage position, each modality should be evaluated individually leveraging the specific literature documenting clinical outcomes for each unique device.	The LCD distinguishes these modalities and the literature for CAN and robotic assistance are separated into two separate sections within the LCD. Analysis of the literature was conducted for CAN and robotic assistance separately. The section title was removed to ensure clarity on this approach
3	The proposed LCD has considered Robotic Assisted modalities as a homogeneous category overlooking the variability in design, functionality, and clinical performance among different platforms. The LCD states that "Robotic Assistance is intended to assist with bone resection soft-tissue assessment and implant positioning using software defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. This is supported by very low-quality evidence.” This references a systematic review related to only one specific robotic system, ROSA. There are multiple robotic systems for total joint replacement, and they are not designed equally. Results of one system cannot be attributed to another. The following systematic review and meta-analysis comparing MAKO robotic-assisted compared to conventional total hip arthroplasty for hip osteoarthritis indicated MAKO robotic-arm-assisted THA significantly improves Forgotten Joint Scores, Oxford Hip Scores and reproducibility in implant positioning without compromising on surgical duration and complication rates. (Loke et al. Journal of Orthopedic Surgery and Research (2025) 20:466 https://doi.org/10.1186/s13018-025-05866-1). Furthermore, Vermue et al. reviewed available literature on robotic-systems in TKA and stated, “…the current evidence regarding each robotic system is diverse in quantity and quality. Each system has its own specificities and must be assessed for its own value…"	Each device does not have a separate CPT code and the code descriptor applies to category of devices not individual manufacturers. The LCD is consistent in this approach. Some of the literature addresses devices individually while other papers provide assessments of multiple devices within the body of evidence. We believe the individual provider must consider the specificities as well as their training and comfort when selecting devices to be used.
4	The proposed LCD cites "A nationwide database study was conducted to evaluate the difference between robotic and non-robotic TKA on peri and postoperative complications and opioid consumption. The authors reported lower revision rates, manipulation under anesthesia, systemic complications and opioid consumption for postoperative pain management in the robotic arm. This study is limited by retrospective design, data limited to a single robotic platform, high risk of confounding and risk of selection bias specifically in regard to opioid data, short term follow up which limits the understanding of complications beyond 90 days to 1 year, variations in patient selection with potentially higher risk patients in the non-robotic group resulting in low-quality evidence. This study is also limited by focusing on data limited to a single robotic platform." As stated, we advise that each robotic system be considered separately based on the merits of its supporting clinical data. In contrast to source 57 cited above, the following example for the Mako technology: Bhimani et al. reviewed 140 consecutive patients for six-week Mako RA-TKA and 127 consecutive patients undergoing manual TKA with minimum six-week follow-up. Patients undergoing RA-TKA had significantly lower pain scores at rest and with activity at two and six-weeks. The RA-TKA group required an average of 3.2 mg less morphine equivalents per day relative to the conventional. At six weeks, 70.7% of patients in the RA-TKA group were free of opioid use compared to the 57.0% in the manual TKA group.	See comment #3. The Bhimani study has been added to LCD. This report is limited by retrospective design without control of variables which may have impacted on the results and cannot be considered to establish causation. While the study states consecutive enrollment the lack of availability of robotic instrumentation introduced potential bias. Additionally, the study cannot address missing outcome date and is limited to short-term follow-up resulting in low confidence in the evidence.
5	Reference #59 (Wu et al) of the policy cites an article that is a review of robotic assisted revisions. The patients in this article represents off-label use of the technology and should not be considered as rationale for this coverage decision.	This study was a systematic review conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The LCD considers primary and revisions in the scope and therefore the paper remains part of the LCD.
6	Policy Reference #64 (Zhang et al) only includes data through 2020. Additionally, your conclusion in the rationale for determination rests on an assessment of literature which does not appropriately distinguish between different technologies and robotic systems and their specific benefits and outcomes. We recommend CGS considers more current system specific research be considered such as, Chen Z, Bonutti PM, Barsoum WK, Mont MA, Bains SS, Jacofsky DJ. Technology Review: CT Scan-Guided, 3-Dimensional, Robotic-Arm Assisted Lower Extremity Arthroplasty. Surg Technol Int. 2022 May 19;40:297-308. The purpose of this systematic was to clearly and concisely summarize the good-to-high quality studies focusing on CT scan-based, 3-dimensional robotically assisted unicompartmental knee arthroplasty, total knee arthroplasty, and total hip. A total of 63 of 63 good-to-excellent methodology score studies were positive for this technology, including 11 that demonstrated decreased pain and/or opioid use when compared to traditional arthroplasty techniques. The summary results of these high-quality, peer-reviewed published studies demonstrated multiple advantages of this CT scan-based robotic-arm assisted platform for lower extremity arthroplasty. Furthermore, the proposed LCD omitted several publications that cite specific clinical benefits of the Mako robotic arm assisted procedures including improved clinical and patient reported outcomes. A) Marchand et al. compared 210 patients receiving RA-TKAs performed by a single surgeon with 210 manual TKAs completed by the same surgeon immediately preceding implementation robotic-arm assisted technology. The postoperative total WOMAC and mean physical function scores were significantly better for the CT based cohort than the manual cohort. B) Bendich et al compared 1,770 RA-THA, 3,155 Navigated THA and 8,877 Manual-THA procedures from a large single institution. The odds of a re-operation for dislocation were 0.3 (i.e. ≈1/3rd) for RA-THA compared to M-THA. This was statistically significant. C) Shaw and colleagues conducted a registry-based study comparing dislocation rates and related revisions between 523 Robotic Arm assisted (RA-THA) and 1724 manual (M-THA) cases. The rate of dislocation was approximately a quarter in RA-THA group compared to the M-THA (0.6% vs. 2.5%). All cases of unstable RA-THA were successfully treated conservatively, whereas 46% of unstable M-THA were revised for recurrent instability. D) Blyth and colleagues conducted a randomized controlled trial compared manual Partial Knee Arthroplasty patient (M-PKA) with Robotic Arm Assisted Partial Knee Arthroplasty (RA-PKA) patients. The trial analyzed the American Knee Society Score (AKSS), Oxford Knee Score (OKS), Forgotten Joint Score, Pain visual analogue scale, analgesic use, patient satisfaction, complications relating to surgery, 90-day pain diaries and the requirement for revision surgery. Robotic arm-assisted surgery resulted in improved early pain scores and early function scores in some patient reported outcomes measures. Continued from comment 7 the Proposed LCD omitted several publications that cite specific clinical benefits of the Mako robotic arm assisted procedures including improved clinical and patient reported outcomes. Banger et al conducted a 5-year follow-up of 104 of the same original 130 randomized controlled trial participants (80%). Both M-PKA and RA-PKA reported successful results over all outcomes. At five years, there was a lower reintervention rate in the robotic arm assisted group with 0% requiring further surgery compared with six (9%) of the manual group requiring additional surgical intervention.	Literature search criteria have been added to the LCD for clarity. The LCD considered literature for the past 10 years. All submitted literature that met the search criteria was added to the LCD including the papers cited above except Chen’s technology review, which was not submitted or accessible, but since this was not original research would be considered as a review paper and therefore not eligible
7	Another important consideration is implementation of this proposed LCD would create disparities in the delivery of care for the Medicare patient populations in Kentucky and Ohio as this policy change is incongruent with access to care in other Medicare Jurisdictions	CGS Administrators cannot comment on coverage for other Medicare Administrative Contractors. CGS has conducted case by case reviews of claims for the Category III codes 0554T or 0555T and given lack of evidence have not covered these services reducing the impact to J15 providers.
8	CGS took into consideration a limited subset of the available evidence and did not distinguish between different technologies and robotic systems when deeming these modalities non-medically necessary. To maintain consistency with coverage policies in other jurisdictions, the LCD for Total Joint Arthroplasty should focus on establishing guidelines for patient selection, indications for treatment, revision and replacement criteria, and medical necessity for the primary surgical intervention. Ancillary modalities, such as surgical navigation and robotic assistance, should not be included in the scope of this policy. To ensure equitable access for Medicare beneficiaries in Ohio and Kentucky, Stryker requests that CPT codes 20985, 0054T, 0055T, and HCPCS S2900 be removed from the proposed LCD.	See comments #1-7.

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Associated Documents

Related Local Coverage Documents
LCDs
L40232 - Total Joint Arthroplasty (Future)

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Updated On	Effective Dates	Status
01/22/2026	01/29/2026 - N/A	Currently in Effect	You are here

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Contents

Response to Comments: Total Joint Arthroplasty

Document Note

Note History

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Response To Comments

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