Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

1. Background: Process for Valuing New, Revised, and Potentially Misvalued Codes

Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as outlined in section II.C. of this final rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comments about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values and typically made any appropriate adjustments and finalized those values.

In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and re-proposed values for those codes in the CY 2017 PFS proposed rule. We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values.

As part of our obligation to establish RVUs for the PFS, we thoroughly review and consider available information including recommendations and supporting information from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the Federal Government as part of our process for establishing valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we proposed those values as recommended. Additionally, we continually engage with interested parties, including the RUC, regarding our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. 2. Methodology for Establishing Work RVUs a. Background

For each code identified in this section, we conduct a review that includes the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted

by specialty societies as part of the formal RUC process.

Components that we use in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We use the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilize an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. Section 1848(c)(1)(A) of the Act specifically defines the work component as the resources that reflect time and intensity in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refine the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.

Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the non-facility setting.

We have developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an E/M service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least \1/3\ of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.

Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long- established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.

Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.

The following paragraphs discuss our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist, we also include a summary of interested party reactions to our approach. We noted that many commenters and interested parties have expressed concern over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we used to make the adjustments is derived from their survey process. We note that we are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.

We observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we adjusted work RVUs to account for significant changes in time, we started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old-time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.

In so doing, rather than ignoring the RUC-recommended value, we used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC- recommended value. If we believe that such changes in time are already accounted for in the RUC's recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options.

We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the

service, then we generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.

Several interested parties, including the RUC, have expressed general objections to our use of these methodologies and suggested that our actions in adjusting the recommended work RVUs are inappropriate; other interested parties have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we employed to identify potential values that reconcile the RUC-recommended work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time.

We received several comments regarding our methodologies for work valuation in response to the CY 2026 PFS proposed rule (90 FR 32593 through 32597) and the following is a summary of the comments we received and our responses.

Comment: Several commenters disagreed with CMS' reference to older work time sources and stated that their use led to the proposal of work RVUs based on flawed assumptions. Commenters stated that codes with “CMS/Other” or “Harvard” work time sources, used in the original valuation of certain older services, were not surveyed, and therefore, were not resource based. Commenters also stated that it was invalid to draw comparisons between the current work times and work RVUs of these services to the newly surveyed work time and work RVUs as recommended by the RUC.

Response: We agree that it is important to use the recent data available regarding work times and note that when many years have passed since work time has been measured, significant discrepancies can occur. However, we also believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The work times currently associated with codes play a very important role in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had been routinely overestimated, this would undermine the relativity of the work RVUs on the PFS in general, in light of the fact that codes are often valued based on comparisons to other codes with similar work times. Such an assumption would also undermine the validity of the allocation of indirect PE RVUs to physician specialties across the PFS.

Instead, we believe that it is crucial that the code valuation process take place with the understanding that the existing work times that have been used in PFS ratesetting are accurate. We recognize that adjusting work RVUs for changes in time is not always a straightforward process and that the intensity associated with changes in time is not necessarily always linear, which is why we apply various methodologies to identify several potential work values for individual codes. However, we reiterate that we believe it would be irresponsible to ignore changes in time based on the best data available, and that we are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. For additional information regarding the use of old work time values that were established many years ago and have not since been reviewed in our methodology, we refer readers to our discussion of the subject in the CY 2017 PFS final rule (81 FR 80273 through 80274).

Comment: Several commenters disagreed with the use of time ratio methodologies for work valuation. Commenters stated that this use of time ratios is not a valid methodology for valuation of physician services. Commenters stated that treating all components of physician time (preservice, intraservice, postservice and post-operative visits) as having identical intensity is incorrect and inconsistently applying it to only certain services under review creates inherent payment disparities in a payment system, which is based on relative valuation. Commenters stated that in many scenarios, CMS selects an arbitrary combination of inputs to apply rather than seeking a valid clinically relevant relationship that would preserve relativity. Commenters suggested that CMS determine the work valuation for each code based not only on surveyed work times, but also the intensity and complexity of the service and relativity to other similar services, rather than basing the work value entirely on time. Commenters recommended that CMS embrace the clinical input from practicing physicians when valid surveys were conducted and provide a clinical rationale when proposing crosswalks for valuation of services.

Response: We disagree and continue to believe that the use of time ratios is one of several appropriate methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values recommended by the RUC and other commenters do not account for survey information that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. In accordance with the statute, we believe that changes in time and intensity must be accounted for when developing work RVUs. When our review of recommended values reveals that changes in time are not accounted for in a RUC- recommended work RVU, the obligation to account for that change when establishing proposed and final work RVUs remains.

We recognize that it would not be appropriate to develop work RVUs solely based on time, given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual procedures. We clarify that we do not treat all components of physician time as having identical intensity. If we were to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and this would not be accurate, as indicated by the many services that share the same time values but have different work RVUs. For example, among the codes reviewed in this CY 2026 PFS final rule, the following all share the same intraservice and total work time of 20 minutes: CPT codes 55715 (Biopsy, prostate, each additional, MRI- ultrasound fusion or in-bore CT- or MRI-guided), 92973 (Percutaneous transluminal coronary thrombectomy aspiration mechanical), 93571 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography), 98980 (Remote therapeutic monitoring treatment management services,

physician or other qualified health care professional time in a calendar month requiring at least 1 real-time interactive communication with the patient or caregiver during the calendar month, first 20 minutes), and 99457 (Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring 1 real-time interactive communication with the patient/caregiver during the calendar month; first 20 minutes). However, these codes had very different proposed work RVUs of 1.05, 1.75, 1.80, 0.62, and 0.61, respectively. These examples demonstrate that we do not value services purely based on work time; instead, we incorporate time as one of multiple different factors in our review process. Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key references or similar codes) to validate these RVUs. For more details on our methodology for developing work RVUs, we direct readers to the discussion in the CY 2017 PFS final rule (81 FR 80272 through 80277).

We do not believe that our review process is arbitrary in nature. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). Regarding the commenter's concerns regarding clinically relevant relationships, we emphasize that we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, we do not agree that codes must share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk.

In response to comments, in the CY 2019 PFS final rule (83 FR 59515), we clarified that terms “reference services”, “key reference services”, and “crosswalks” as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purpose of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate feedback from interested parties, we stated that we would seek to limit the use of the term, “crosswalk,” to those cases where we made a comparison to a CPT code with the identical work RVU (83 FR 59515). We noted that we also occasionally make use of a “bracket” for code valuation. A “bracket” refers to when a work RVU falls between the values of two CPT codes, one at a higher work RVU and one at a lower work RVU.

We look forward to continuing to engage with interested parties and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and we will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes. Table A-E12 contains a list of codes and descriptors for which we proposed work RVUs for CY 2026; this includes all codes for which we received RUC recommendations by February 10, 2025. The finalized work RVUs, work time and other payment information for all CY 2026 payable codes are available on the CMS website under downloads for the CY 2026 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/index.html). b. Efficiency Adjustment (1) Background

We have historically relied on survey data provided by the American Medical Association (AMA)/Specialty Society Relative Value Scale (RVS) Update Committee (referred to as the RUC) to estimate practitioner time, work intensity, and practice expense for the purpose of establishing RVUs for the codes used for payment under the PFS. As described in section II.C. of this final rule, CMS regularly revalues codes as part of its potentially misvalued codes initiative, as required by section 1848(c)(2)(K) of the Act, using RUC survey data that shows clinicians' estimates of how long a particular service takes to complete. In the CY 2025 PFS final rule, we summarized public comments that we had received expressing concerns with using RUC data as a source of valuation and identifying a need for empirical data in the context of valuing advanced primary care management services (89 FR 97898). In response to these comments, we indicated that we were open to alternative recommendations for how to price these and other services, and that we would consider all options presented to us with a preference for information with empirical evidence behind it. We also reminded commenters that we do not exclusively rely on RUC recommendations and can receive data and recommendations from other outside sources as well.

In the CY 2026 proposed rule (90 FR 32399 through 32400) we discussed the challenges experienced with survey data. The limits of survey data are in part based on the nature of the surveys. There have been longstanding concerns about the use of surveys that have low response rates, low total number of responses, and a large range in responses, all of which may undermine the accuracy of recommendations relying on survey data.\35\ For example, a Government Accountability Office (GAO) Report found that the median number of responses to surveys administered by the RUC for payment year 2015 was 52, the median response rate was only 2.2 percent, and 23 of the 231 surveys had under 30 respondents. Another study conducted compared operative times in the National Surgical Quality Improvement Project to RUC survey times, adjusted for patient variables, and found a wide variation in the median RVU per hour ratio for 11 surgical specialties, with the highest specialties overreporting (via RUC values) by 27 and 23 minutes per case. All surgical specialties showed overreporting in RUC survey times compared to operative times. This resulted in high RVU per hour payments for surgeons in those specialties.\36\

\35\ https://www.gao.gov/products/gao-15-434.

\36\ Uppal, S., Barber, E.L., Reynolds, R.K., Rice, L.W., & Spencer, R.J. 2019. Discrepancies created by surgeon self-reported operative time and its impact on procedure relative value units (RVUs) and reimbursement. Gynecologic Oncology, 154, 14. https://doi.org/10.1016/j.ygyno.2019.04.039.

We stated that with such low response rates, we are concerned that those practitioners who respond to the RUC surveys may be fundamentally different than those clinicians who do not respond to the surveys. Widely read journals, such as the Journal for the American Medical Association, specify that for submitting authors, “survey studies should have sufficient response rates (generally greater than or equal to 60 percent), and appropriate characterization of non-responders to ensure that nonresponse bias does not threaten the validity of the findings.” \37\ The GAO report noted that the RUC has undertaken steps to mitigate the effects of possible biases; however, the report goes on to describe the potential conflicts of interest survey respondents may have, as those that serve Medicare beneficiaries would benefit from an increase in the relative values for the services they perform.\38\ Another component of these surveys is the selection of another service code that is similar to the service in question. Since there are so many procedure, radiology, and diagnostic test codes, the selection of a high-valued service for potential comparisons, either by the specialty society administering the survey, or by respondents, could further bias results. Additionally, RUC surveys contain clinical vignettes, and expert reviewers have raised concerns that these clinical vignettes are not typical and thus may lead to biased recommendations that usually overinflate time spent on the service.\39\ And as detailed in section II.B. of this final rule, we further articulate the particular challenges of using the recently completed PPI survey data, including the quality of the data, sampling variation, and lack of comparability to previous survey data--similar challenges that we have experienced over time with surveys estimating the time and work intensity of individual services, used to establish the work RVUs. We stated that CMS has historically had to rely on survey data due to a lack of other more reliable sources of information, but in recent years many new methods to identify empiric inputs used in valuation have been developed.\40\

\37\ Journal of the American Medical Association, Instructions for Authors. Available from: https://jamanetwork.com/journals/jama/pages/instructions-for-authors.

\38\ https://www.gao.gov/products/gao-15-434.

\39\ Zuckerman, S., K. Merrell, R. Berenson, et al. 2016. Collecting empirical physician time data: Piloting an approach for validating work relative value units. Report prepared for the Centers for Medicare & Medicaid Services. Washington, DC: The Urban Institute. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Collecting-Empirical-Physician-Time-Data-Urban-Report.pdf.

\40\ National Academies for Sciences, Engineering, and Math. Improving Primary Care Valuation Processes to Inform the Physician Fee Schedule. Available from: https://nap.nationalacademies.org/catalog/29069/improving-primary-care-valuation-processes-to-inform-the-physician-fee-schedule.

We noted that in the CY 2024 PFS proposed rule (88 FR 78975 through 78982), we requested comments on how we may evaluate E/M services more regularly and comprehensively. We raised specific questions for commenters to consider, including whether the methods used by the RUC and CMS were appropriate to accurately value E/M and other HCPCS codes, and we requested that commenters provide specific recommendations on improving data collection and making better evidence-based and more accurate payments for E/M and other services. In response, as we summarized in the CY 2024 PFS final rule (88 FR 78977), commenters stated that the methods used do not lead to accurate valuation and that the problems lie with the nature of E/M services and the PFS's budget neutrality adjustment. They stated that the resources used in furnishing the work portion of E/M services are primarily a function of the time the clinician spends with the patient and, therefore, are not amenable to efficiency gains and that the valuation process is not responsive to efficiency gains, leading to passive devaluation of E/M services under the constraints of budget neutrality. At the time, we responded that we recognized that there are opportunities to improve how all services are valued and better account for resource variation for different types of care under the PFS.

We explained that for several years, we have been concerned about not accounting for the efficiencies gained in work RVUs for non-time- based services. Non-time-based codes, such as codes describing procedures, radiology services, and diagnostic tests, should become more efficient as they become more common, professionals gain more experience, technology is improved, and other operational improvements (including but not limited to enhancements in procedural workflows) are implemented. We highlighted, however, that there are often many years between a code's introduction and revaluation within the RUC process, with only a few hundred out of the more than 9,000 codes paid under the PFS considered for revaluation annually by the RUC. While there is significant variability in how often codes are reviewed by the RUC, on average, CMS estimates that there are 25.49 years since a code valuation has been reviewed by the RUC (this includes 5382 out of 9970 codes which were never reviewed). We stated that when we exclude from the average those codes that have never been reviewed, the average is 17.69 years since the last review of a code by the RUC. We noted that these numbers weight each code equally and the PFS itself is heavily weighted by utilization towards a much smaller number of often utilized codes.

Furthermore, even when a code is reviewed by the RUC, 2 to 3 years usually pass between when the survey data was collected and its use by CMS in setting rates becomes effective. We stated that in the intervening years without revaluation, we are most likely overvaluing codes by not accounting for these efficiencies gained in the valuation of work RVUs for non-time-based services. And even when recommendations have been submitted by the RUC to CMS as potentially misvalued codes from 2009 to 2025, the RUC only recommended a decrease in the physician time and resources for the codes 39 percent of the time.\41\

\41\ American Medical Association. “AMA/Specialty Society RVS Update Committee: An Overview of the RUC Process.” Available from: https://www.ama-assn.org/system/files/ruc-update-booklet.pdf.

In the CY 2026 proposed rule (90 FR 32401) we explained how studies have demonstrated that CMS continues to overvalue non-time-based services. In a pilot project for CMS conducted by the Urban Institute in 2016,\42\ which compared data obtained from electronic health records and direct observation, the ratios of fee schedule time to empirical time were often inflated, with the largest discrepancies in imaging and other test interpretations. In the study, the median ratio of PFS time to empiric intraservice physician time for CT and MRI scans was 2.13, for noninvasive cardiac testing was 4.00, and for mammography was 1.67. Another study compared estimated procedure time from anesthesia claims and the PFS time, and found that the mean estimated procedure time was 27 percent lower than the time used for PFS valuation.\43\

Expert reviewers have attributed some of the discrepancies to automation and personnel substitution that has become prevalent in the time between when CMS adopted many codes and when those codes are revalued.\44\ We noted that MedPAC, in their 2018 recommendations to Congress, recommended three options to offset these historic distortions, including passive devaluation: (1) an automatic reduction to the prices of new services and services with high growth rates; (2) an extension of the annual numeric target for CMS to reduce the prices of overpriced services; and (3) an across-the-board reduction to all fee schedule services other than ambulatory E&M services.\45\ For reasons, as further described below in this section, we proposed a modified version of MedPAC's third option for procedures, radiology, and diagnostic tests.

\42\ Zuckerman, S., K. Merrell, R. Berenson, et al. 2016. Collecting empirical physician time data: Piloting an approach for validating work relative value units. Report prepared for the Centers for Medicare & Medicaid Services. Washington, DC: The Urban Institute. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Collecting-Empirical-Physician-Time-Data-Urban-Report.pdf.

\43\ Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. “Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialties.” JAMA Surg. 2022 May 1;157(5):e220099. doi: 10.1001/jamasurg.2022.0099.

\44\ Zuckerman et al, 2016.

\45\ MedPAC Report to Congress, 2018. Chapter 3: Rebalancing Medicare's Physician Fee Schedule Toward Ambulatory Evaluation and Management Services.” Available from: https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/jun18_ch3_medpacreport_sec.pdf.

We stated that section 1848(c)(2)(B)(ii)(I) of the Act provides that the Secretary shall, to the extent he determines to be necessary, adjust the number of RVUs to take into account changes in medical practice. We explained that we believe that many of the efficiency gains that historically may not have been fully reflected in the valuation of work RVUs for non-time-based services represent or have been caused by changes in medical practice. Therefore, to take into account changes in medical practice and better reflect the resources involved in furnishing services paid under the PFS, we proposed to establish an efficiency adjustment to the work RVUs, as well as corresponding updates to the intraservice portion of physician time inputs for non-time-based services. We explained that our initial proposed approach was designed to be conservative in nature, as we are concerned about making too many changes at once to the current methodology. We noted that we may, in the future, consider making additional corresponding updates to the direct PE inputs for clinical labor and equipment costs. Our proposal was based on our assumption that both the intraservice portion of physician time and the work intensity (including mental effort, technical effort, physical effort, and risk of patient complications) would decrease as the practitioner develops expertise in performing the specific service. As expertise develops, learning leads to enhanced familiarity with the various aspects of a service, variations in the anatomy of each patient, and confidence in the practitioner's own ability to handle unexpected challenges that arise.

For example, one cross-specialty observational study found that increased surgical experience was associated with significant reductions in operative time for coronary artery bypass grafting, total knee replacement, and bilateral reduction mammoplasty.\46\ While this expertise in part develops as a practitioner accumulates years of experience following the culmination of training, it also accumulates across the entire health system with the creation of a new procedure or service that practitioners must grow accustomed to. We further noted that changes in medical practice such as enhancements in operational workflows and technology advancements after the introduction of a new procedure or service can further reduce the risk associated with the service and increase efficiencies. When a new surgical technique is introduced, operational workflows and procedures are based on previous experience with a similar service, which may not directly translate to the new procedure. We explained that these workflows generally evolve over time as experience grows, and tend to result in improvements, which make the service more efficient. This is consistent with systematic reviews demonstrating that with increased case volume and years of expertise, surgeons demonstrate decreased risk of poor outcomes.\47\ We provided examples of other studies have found that with increased experience performing new procedures, clinicians demonstrate increased operational efficiency and decreased time. For example, one systematic review found that for clinicians newly introduced to robotic thoracic surgery, a reduction in operating time based on the increasing number of cases performed.\48\ Another study concluded that for robotic thoracic procedures, the hourly productivity increase for experienced and proficient surgeons ranged from 11.4 work relative value units/hour (+26 percent) for lobectomy to 17.0 work relative value units/hour (+50 percent) for segmentectomy.\49\ We stated that these changes in practitioner experience, operational workflows, and new technologies in totality represent large-scale, system-wide changes in medical practice as described in section 1848(c)(2)(B)(ii)(I) of the Act that may not have been previously accounted for in the valuation of non-time-based codes. Given the relative infrequency of service revaluation under the PFS and the limitations of reliance on survey data, we are concerned that the RVUs we have established for codes paid under the PFS may not reflect these efficiencies accrued as practitioners gain experience, operational workflows improve, and new technology is adopted.

\46\ Maruthappu, Mahiben, Antoine Duclos, Stuart Lipsitz, Dennis Orgill, Matthew Carty. “Surgical Learning Curves and Operational Efficiency: A Cross-Specialty Observational Study.” BMJ Open. 2015 Mar 13;5(3):e006679.

\47\ https://pubmed.ncbi.nlm.nih.gov/25072442/.

\48\ Power, Alexandra, Desmond D'Souza, Susan Moffatt-Bruce, Robert Merritt, Peter Kneuertz. “Defining the Learning Curve of Robotic Thoracic Surgery: What Does it Take? Surg Endosc. 2019 Dec;33(12):3880-3888. doi: 10.1007/s00464-019-07035-y. Epub 2019 Aug 2.

\49\ https://pubmed.ncbi.nlm.nih.gov/37562675/.

(2) Methodology for the Efficiency Adjustment

In the CY 2026 PFS proposed rule (90 FR 32401 through 32403) we described our proposed methodology to calculate the efficiency adjustment. We proposed using the Medicare Economic Index (MEI) productivity adjustment. The MEI is a measure of inflation faced by physicians with respect to their practice costs and general wage levels, and includes inputs used in furnishing physicians' services such as physician's own time, non-physician employees' compensation, rents, medical equipment, and more. Every year, the CMS Office of the Actuary (OACT) subtracts the MEI productivity adjustment from the MEI percent change moving average to calculate the final MEI update. The MEI productivity adjustment used for the final MEI update reflects the most recent historical estimate of the 10-year moving average growth of private nonfarm business total factor productivity, as calculated by the Bureau of Labor Statistics.\50\ Every year, the productivity adjustment for the final MEI update is calculated by OACT based on historical data. For example, in 2026 the productivity adjustment for the final MEI update will reflect historical data through 2024. OACT incorporates a 10-year moving average to minimize yearly fluctuations in productivity associated with normal business cycles. We stated that the productivity adjustment to be applied to the proposed MEI percent change moving average for CY 2026 was listed in Table A-E1 (0.8 percent) of the CY 2026 PFS

proposed rule, and it will be updated for the final rule based on the most up to date data. We explained that the MEI productivity adjustment is substantively similar to the productivity adjustment required for the hospital inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) at sections 1886(b)(3)(B)(xi)(II) and 1833(t)(3)(F)(i) of the Act, respectively. The main difference is that the MEI productivity adjustment reflects historical data at the time of the CY update and the OPPS and IPPS productivity adjustments reflect a forecast to correspond to the FY update.

\50\ 87 FR 69709.

For CY 2026, we proposed to apply the efficiency adjustment using a look-back period of 5 years. We considered a couple initial look-back periods. We explained that despite the efforts to update valuation, many codes have never been revalued, and even for codes that have been revalued, there is, on average, more than 17 years since revaluation recommendations submitted by the RUC. Thus, using a look-back period of 17 years would help to account for the average amount of time that has elapsed since the last revaluation. However, using a look-back period of 17 years may be imprecise because, even when a code has been reviewed by the RUC, historic reliance on survey data may have skewed results and not properly accounted for efficiencies in the physician time and work RVU. Therefore, we also proposed to apply the efficiency adjustment to the codes that the RUC and CMS have reviewed within the look-back period of 5 years, including codes being proposed for revaluation this year, as many of the challenges discussed previously in this section, namely reliance on survey data, still apply. We realized that adjusting for the efficiencies gained would be a change in our payment methodology, and so as an initial conservative approach, we proposed a look-back of 5 years. We stated that this represents our intended cadence for updating the efficiency adjustment (3 years), plus an additional 2 years, since it has historically taken about 2 years to make changes to PFS valuation after we receive new recommendations from the RUC.

We recognized that over time, there may be variation in the efficiencies accrued service-by-service (for example, the previously cited research has identified that efficiencies have been gained more in minor procedures and radiology services than in major inpatient procedures). But because PFS intraservice time is higher than empirical intraservice time on average for studied non-time-based services,51 52 we stated that we believe applying the efficiency adjustment to non-time-based services more broadly, instead of applying it only to certain services that may be more likely to accrue efficiency gains, may help to improve the overall accuracy of our valuation of these services under the PFS. We further stated that a look-back period of 5 years is not intended to account for the full magnitude of previously unaccounted for efficiency gains in services paid under the PFS, and that we may consider making refinements to the efficiency adjustment in future rulemaking to better account for these gains. To implement this efficiency adjustment, we proposed to decrease the work RVUs and make corresponding changes to the intraservice physician time for codes describing non-time-based services by a factor equal to the MEI productivity adjustment, equivalent to if this factor had been applied every year over the past 5 years. [GRAPHIC] [TIFF OMITTED] TR05NO25.015

In the CY 2026 PFS proposed rule we used the proposed methodology described above, and included Table A-E2, which outlined examples of two different CPT codes that would be subject to the proposed efficiency adjustment. We noted that Table A-E2 was intended only as an illustrative example.

\51\ Zuckerman et al, 2016.

\52\ Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. “Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialties.” JAMA Surg. 2022 May 1;157(5):e220099. doi: 10.1001/jamasurg.2022.0099.

In the CY 2026 PFS proposed rule (90 FR 32402) we explained that this methodology yielded a proposed efficiency adjustment of 2.5 percent, which would be a downward (negative) adjustment for certain codes, for CY 2026. Given the 5-year look back period, the formula summed all productivity adjustments included in the final MEI updates from CY 2022-CY 2026. We noted that the CY 2026 productivity adjustment will be updated for the CY 2026 final rule to reflect more recent historical data from the Bureau of Labor Statistics.

[GRAPHIC] [TIFF OMITTED] TR05NO25.016

We solicited comments on the initial look-back period and the use of the MEI productivity adjustment percentage values for calculation of the efficiency adjustment for 2026. We sought comments on whether adjustments should be made in future rulemaking to also adjust the direct PE inputs for clinical labor and equipment time that correspond with the physician time inputs.

In the CY 2026 PFS proposed rule (90 FR 32403) we stated that if the proposed methodology to calculate the efficiency adjustment was finalized for CY 2026, we proposed to apply the efficiency adjustment to the intraservice portion of physician time and work RVUs every 3 years. We stated that this timing would imply that the next efficiency adjustment after CY 2026 would be calculated and applied in CY 2029 PFS rulemaking, reflecting efficiency gains measured from 2027 through 2029. We also proposed to update and apply the proposed efficiency adjustment with a cadence of every 3 years to align with the other updates under the PFS, including updates to the Geographic Practice Cost Index (GPCI) and Malpractice (MP) RVUs, and explained that this would allow for streamlining so that interested parties can expect updates on a similar timeframe. We also sought comments as to whether or not efficiencies stop accruing for services after a predefined number of years.

In addition, we proposed applying this efficiency adjustment to non-time-based services that we expect to accrue efficiencies over time. We proposed to apply the adjustment to all codes except time- based codes, including but not limited to, E/M visits, care management services, behavioral health services, services on the CMS telehealth list, and maternity codes with a global period of MMM. This adjustment would apply to all codes that are assigned a procedure status of A (active), B (bundled), C (contractor/carrier priced code), I (not valid for Medicare purposes), N (noncovered service by Medicare), R (restricted coverage), and T (injections), and are not otherwise excluded. Included code families represent the procedures, diagnostic tests, and radiology services that CMS expects to accrue efficiencies over time as changes in medical practice occur, including changes in clinician expertise, workflows, and technology. We sought comments on the codes expected to accrue efficiencies over time. The full descriptions of these indicators can be found in the Medicare Claims Processing Manual, Chapter 23 at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c23.pdf. Additionally, we noted that a list of the codes we proposed to apply this adjustment to could be found under the Downloads section posted with the proposed rule at https://www.cms.gov/medicare/payment/fee-schedules/physician/federal-regulation-notices.

Finally, in the CY 2026 PFS proposed rule we explained that we understand that accruing efficiencies do not apply equally to all services, and that efficiencies gained over time may often apply more to services that take less time to perform. We further explained that efficiencies gained in services that could be performed many times per day such as cataract extractions, skin biopsies, and CT scans, allow the practitioner to perform more of those services in a given day. We sought comments on whether and how we should consider additional efficiencies for services that require less time to perform. Additionally, we sought comments on whether the introduction of new artificial intelligence has or will lead to otherwise unaccounted for efficiencies gained in specific services.

We also proposed that the public may submit nominations via the “Potentially Misvalued Codes” process, as described in section II.C. of this final rule, so going forward, if they believe the efficiency adjustment will lead to inaccurate physician time and work RVUs for a particular code. We stated that nominations submitted should include supporting information. For the reasons discussed previously in this section, we also proposed that CMS will place greater emphasis on “empiric” supporting information for the codes nominated, to avoid the limitations of using survey data. We provided proposed examples of empiric data may include electronic health record logs, operating room logs, and time-motion data and should be robust enough to achieve a high degree of assuredness as to accuracy and be inclusive of multiple types of practices (for example, inclusive of academic, health centers, and private practices wherever possible). We solicited comments on what kinds of data CMS should consider as valid, reliable, empiric information for this purpose.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters stated that they believe we do not have the authority to apply an efficiency adjustment to non-time-based services, and that doing so would require a statutory change. The commenters stated that the application of the efficiency adjustment across all physician work RVUs is inconsistent with the approach envisioned by section 1848(c)(2) of the Act. The commenters stated that while section 1848(c)(2) of the Act may allow for extrapolation in some circumstances, such as where data is not available, this would not be the case with the physician work RVUs that have been evaluated by the RUC on an ongoing basis. The commenters stated that reference to “such units” at section 1848(c)(2)(B)(ii)(I) of the Act appears to be to section 1848(c)(2)(B)(i) of the Act that states “relative values established under this paragraph for all physicians' services.” The commenters stated that the implication of the statute is that the adjustments consider the individual circumstances of a procedure and not be applied across the board. A few commenters also stated that the efficiency adjustment proposal departs from the resource-based methodology that they state the Congress established for the PFS. A few commenters also stated the proposed efficiency adjustment undermines congressional intent to provide an increase in payment for physicians servicing Medicare beneficiaries.

Response: As stated in the CY 2026 PFS proposed rule (90 FR 32401),

section 1848(c)(2)(B)(ii)(I) of the Act provides that the Secretary shall, to the extent he determines to be necessary, adjust the number of RVUs to take into account changes in medical practice. We believe that many of the efficiency gains that historically may not have been fully reflected in the valuation of work RVUs for non-time-based services represent or have been caused by changes in medical practice. To take into account changes in medical practice and better reflect resources involved in furnishing services paid under the PFS, we believe that our proposal to establish an efficiency adjustment to the work RVUs, as well as corresponding updates to the intraservice portion of physician time inputs for non-time-based services, is appropriate.

Comment: We received many comments regarding the efficiency adjustment proposal. Concerns expressed by the commenters include:

That the proposed efficiency adjustment proposal does not account for the complexities of individual procedures or the varying efficiencies across different specialties. The commenters stated that applying a uniform reduction could undermine the financial stability of practices, especially in rural and underserved areas where access to care is already limited. They state the proposed reduction could lead to reduced patient access to essential services, particularly in specialties facing workforce shortages. The commenters state the proposed efficiency adjustment prioritizes speed over quality of care and puts patients' safety at risk.

That the proposal lacks transparency as to the data and methodology used to justify the efficiency adjustment. The commenters stated the proposal is arbitrary and capricious under section 5 U.S.C. 706(2)(A) of the Administrative Procedure Act (APA).

That CMS should adopt a more targeted approach to incorporate efficiency gains within specific services or code families.

That CMS should finalize a policy that will benefit all specialties and not just those that frequently bill time-based codes.

That certain specialties have limited use of physician extenders. While some specialties gain efficiencies through the use of physician extenders, such as nurse practitioners and physician assistants, others are unable to leverage these physician extenders, thus limiting their potential for efficiency gains.

Why certain specialties and code families (for example, E/ M, behavioral health, care management, maternity, telehealth) are exempt, and that clear justification for the exemptions were not provided.

A letter published by the Journal of the American College of Surgeons \53\ indicated that for inpatient only procedures, surgical times are not declining, rather procedures had longer or similar operative times. Therefore, surgical and procedural services are not becoming more efficient over time, and in some cases, are becoming less efficient. Another study showed that in Q2 2025, “productivity is up 12% for physicians and 11% for advanced practice providers compared to two years ago.” \54\

\53\ Childers, Christopher P MD, Ph.D.; Foe, Lauren M MPH; Mujumdar, Vinita JD; Mabry, Charles D. MD, FACS; Selzer, Don J MD, MS, FACS; Senkowski, Christopher K MD, FACS; Ko, Clifford Y MD, MS, MSHS, FACS, FASCRS; Tsai, Thomas C MD, MPH, FACS, Journal of the American College of Surgeons, Longitudinal Trends in Efficiency and Complexity of Surgical Procedures: Analysis of 1.7 Million Operations Between 2019 and 2023, Aug. 13, 2025. https://journals.lww.com/journalacs/abstract/9900/longitudinal_trends_in_efficiency_and_complexity.1369.aspx.

\54\ https://medcitynews.com/2025/09/physician-healthcare-medicare-payment-reimbursement/.

Technology can, at times, increase the amount of physician time and cognitive skill required to perform a service. For example, a few commenters specifically mentioned that reading CT scans and MRIs today requires reviewing more images than it did in past years. Commenters stated CMS' assumption does not consider factors such as increases in care complexity, patient acuity, staff salaries, AI- generated insights, and the electronic health record (“EHR”) systems that require the same or more resources than in the past.

Adjusting physician work RVUs and intraservice time for all non-time-based codes, while exempting commonly performed services that are often used as key reference services, will cause disruption in the processes to update the Resource-Based Relative Value Scale (RBRVS) and ensure appropriate relativity of new and revised codes, and there would be rank-order anomalies within and across code families.

Response: We appreciate the commenters for their responses and appreciate the additional information. We understand the concerns raised by the commenters about the broad application of the proposed efficiency adjustment and the potential impact on specific specialties, patient access and care quality, particularly in rural and underserved areas. However, existing processes to account for efficiencies have been insufficient, as we described in the proposed rule (90 FR 32399 through 32403). Even when codes are revalued, it is based on survey data, with the corresponding shortcomings that we have articulated. In the CY 2026 PFS proposed rule (90 FR 32402), we recognized that while efficiencies may accrue more in some services compared to others, the fact that PFS intraservice time is higher than empirical intraservice time on average for studied non-time-based services,55 56 means that applying the efficiency adjustment will more accurately reflect empiric data compared to not doing so.

\55\ Zuckerman, Stephen, Katie Merrell, Robert Berenson, Susan Mitchell, Divvy Upadhyay, Rebecca Lewis. “Collecting Empirical Physician Time Data: Piloting an Approach for Validating Work Relative Value Units.” Dec 14, 2016. Available from: https://www.urban.org/research/publication/collecting-empirical-physician-time-data-piloting-approach-validating-work-relative-value-units.

\56\ Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. “Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialties.” JAMA Surg. 2022 May 1;157(5):e220099. doi: 10.1001/jamasurg.2022.0099.

In response to commenters concerned about technological advances in imaging and their impact on physician intraservice time, we note that imaging and other test interpretations have some of the highest mean empirical time to PFS intraservice time ratios of the services studied.\57\ We appreciate that changes in technology may have varying impacts on different services, and welcome empiric data from commenters for future rulemaking.

\57\ Zuckerman, Stephen, Katie Merrell, Robert Berenson, Susan Mitchell, Divvy Upadhyay, Rebecca Lewis. “Collecting Empirical Physician Time Data: Piloting an Approach for Validating Work Relative Value Units.” Dec 14, 2016. Available from: https://www.urban.org/research/publication/collecting-empirical-physician-time-data-piloting-approach-validating-work-relative-value-units.

In response to commenters' references to the published letter from the Journal of American College of Surgeons, we reviewed the letter \58\ and note that while operative times increased for approximately 51 percent of CPT codes evaluated, they remained the same for approximately 38 percent of CPT codes

and declined for approximately 11 percent. Furthermore, the stated increase in operative time given in the letter is 3.1 percent. We note that this information was published in a research letter, and therefore, we are not privy to the detailed methods used by the authors. However, we point commenters to a recent review of PFS intraservice times and times observed in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), and estimates derived from Medicare anesthesia claims which indicates that NSQIP median operative and anesthesia times are on average, 16 to 17 percent lower than PFS intraservice times.\59\

\58\ Childers, Christopher P MD, Ph.D.; Foe, Lauren M MPH; Mujumdar, Vinita JD; Mabry, Charles D. MD, FACS; Selzer, Don J MD, MS, FACS; Senkowski, Christopher K MD, FACS; Ko, Clifford Y MD, MS, MSHS, FACS, FASCRS; Tsai, Thomas C MD, MPH, FACS, Journal of the American College of Surgeons, Longitudinal Trends in Efficiency and Complexity of Surgical Procedures: Analysis of 1.7 Million Operations Between 2019 and 2023, Aug. 13, 2025. https://journals.lww.com/journalacs/abstract/9900/longitudinal_trends_in_efficiency_and_complexity.1369.aspx.

\59\ Reid, Rachel O., Yu, Anthony, Hussey, Peter S., Hero, Joachim O., Klig, Cameron, Crespin, Daniel J., Swabe, Gretchen, Burgette, Lane F. “Surgical Procedure Time Comparisons, Comparing Physician Fee Schedule Intraservice Times with Real-World Times as Observed in National Surgical Quality Improvement Program Intraoperative Times and Anesthesia Claims, https://www.rand.org/pubs/research_reports/RRA3470-1.html.

Additionally, we have seen that even after a change in valuation (such as a decrease in PFS time), the PFS intraservice time still is above empirically-observed time.\60\ This is why, as we articulated in the proposed rule, we had discussed that CMS would preferentially consider empiric information submitted by interested parties, if they believe the efficiency adjustment led to incorrect valuation of the service. We believe that robust empiric data is important to avoid some of the shortcomings of survey data in accounting for efficiencies over time. We believe the efficiency adjustment will promote interested parties to submit more precise empiric data, which means that there will still be changes on a service-by-service basis, even if the efficiency adjustment itself affects all non-time-based services. As we proposed, interested parties can submit their requests as part of the Potentially Misvalued Codes initiative, as described in section II.C. of this final rule. We look forward to continued engagement with the public on this topic and are interested in information that could assist us in potentially refining this policy through future rulemaking.

\60\ Reid, Rachel O., Yu, Anthony, Hussey, Peter S., Hero, Joachim O., Klig, Cameron, Crespin, Daniel J., Swabe, Gretchen, Burgette, Lane F. “Surgical Procedure Time Comparisons, Comparing Physician Fee Schedule Intraservice Times with Real-World Times as Observed in National Surgical Quality Improvement Program Intraoperative Times and Anesthesia Claims, https://www.rand.org/pubs/research_reports/RRA3470-1.html.

Comment: Several commenters state that the RUC process already accounts for efficiency and applying an efficiency adjustment to codes recently reviewed would be redundant. The commenters stated that CMS should exempt newly established codes, codes established in recent years, or codes that have been recently reevaluated by the RUC.

Response: We understand and appreciate the RUC for providing recommendations to CMS over the years. For many years, we did not have other sources of data to inform valuation of service paid under the PFS, and the RUC recommendations derived from surveys have been particularly important in the revaluation of services. However, studies have demonstrated that CMS continues to overvalue non-time-based services, with PFS time greater than mean procedure time by more than 20 percent,\61\ which is in part due to the lack of both regular revaluing of all codes, and the nature of the survey data that has been the foundation of many of the RUC recommendations. The survey data used in RUC recommendations often have low response rates (as low as the single digits, even when publications for research usually require a response rate of at least 60, and appropriate characterization of non- responders to ensure that nonresponse bias does not threaten the validity of the findings \62\), the survey data is based on clinical vignettes that have raised concerns for bias.\63\ This leads to the RUC Relativity Assessment Workgroup's Potentially Misvalued Services Project recommending the valuation of approximately 40 percent of identified services be decreased.\64\ And even after a revaluation in the PFS, recent data demonstrates that PFS time still is higher than actual intraservice time.\65\ This is why, to better recognize efficiencies gained, we proposed an efficiency adjustment. We welcome interested parties to submit empiric data that is robust in nature related to certain services, if they believe it is not correct to assume that efficiencies are gained over time, and we will consider whether or not reevaluation is needed as part of the Potentially Misvalued Codes initiative.

\61\ Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. “Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialties.” JAMA Surg. 2022 May 1;157(5):e220099. doi: 10.1001/jamasurg.2022.0099.

\62\ Journal of the American Medical Association, Instructions for Authors. Available from: https://jamanetwork.com/journals/jama/pages/instructions-for-authors.

\63\ Zuckerman, Stephen, Katie Merrell, Robert Berenson, Susan Mitchell, Divvy Upadhyay, Rebecca Lewis. “Collecting Empirical Physician Time Data: Piloting an Approach for Validating Work Relative Value Units.” Dec 14, 2016. Available from: https://www.urban.org/research/publication/collecting-empirical-physician-time-data-piloting-approach-validating-work-relative-value-units.

\64\ American Medical Association. “AMA/Specialty Society RVS Update Committee: An Overview of the RUC Process.” Available from: https://www.ama-assn.org/system/files/ruc-update-booklet.pdf.

\65\ Reid, Rachel O., Yu, Anthony, Hussey, Peter S., Hero, Joachim O., Klig, Cameron, Crespin, Daniel J., Swabe, Gretchen, Burgette, Lane F. “Surgical Procedure Time Comparisons, Comparing Physician Fee Schedule Intraservice Times with Real-World Times as Observed in National Surgical Quality Improvement Program Intraoperative Times and Anesthesia Claims, https://www.rand.org/pubs/research_reports/RRA3470-1.html.

Additionally, we are persuaded by the commenters' feedback that it would not be appropriate to apply the efficiency adjustment to new services, given that practitioners would not be able to accrue efficiencies for services that are new in the first year. Therefore, we are exempting codes new for CY 2026 from the efficiency adjustment for CY 2026.

Comment: Several commenters provided feedback on the exemption of E/M visits from the efficiency adjustment. Several commenters were in support of exempting E/M visits from the efficiency adjustment. A commenter stated that the current RVU evaluation process unduly favors non-E/M services, due to a variety of factors, including methodological and accuracy issues with the RUC surveys. Another commenter stated that while some E/M codes may be chosen based on time or medical decision making, they all heavily depend on time spent with the patient and thus are not amenable to efficiencies that otherwise apply to procedural or technology-oriented services. Since any given E/M code may be selected based on time, they are akin to other time-based services and thus properly excluded from the efficiency adjustment proposed by CMS. Conversely, a commenter stated that the proposed policy penalizes specialties with low time-based E/M utilization while benefiting specialties that predominantly bill time-based E/M services. The commenter continued to state that if finalized as proposed, the policy could create significant relativity distortions across the PFS.

Several commenters highlighted that CMS has made several increases to E/M work RVU values in recent years but did not make corresponding increases to the E/M components of global surgical packages. The commenters stated that this discrepancy has led to a loss of relativity within the fee schedule and undervalues global surgical packages. A few commenters stated the efficiency adjustment decreases the work value of bundled E/M visits, creating a

discrepancy in payment between standalone and bundled E/M visits. They recommended CMS correct this inequity to maintain the relativity of code values.

Response: We appreciate the feedback and support from commenters. Based on section 1848(c)(2)(C)(i) of the Act, which requires the Secretary to determine a number of work relative value units for the service or group of services based on the relative resources incorporating physician time and intensity required in furnishing the service, including global surgical services, we continue to believe standalone E/M services should be exempt from the efficiency adjustment as detailed in the CY 2026 PFS proposed rule (90 FR 32593 through 32597). We also wish to clarify that the E/M visits are exempt from the efficiency adjustment, regardless of whether the E/M visit is billed based on time or medical decision making.

Comment: Several commenters stated that CMS should forego the efficiency adjustment, as intraservice times are increasing because patient's conditions are becoming more complex, stating that as the average age of patients increases, patient body mass index (BMI) rises, and the number of chronic conditions patients are diagnosed with increases.

Response: Over the last decade, we have updated PFS payment policies as appropriate and remain committed to improving how Medicare payment recognizes the resources involved in furnishing covered services. As a part of the CY 2014 PFS final rule, we recognized care management as a critical service contributing to better health outcomes for individuals (78 FR 74414 through 74427). Since then, we have implemented coding and payment for many care management services to better recognize the resources involved in furnishing medically necessary care management activities that generally are performed outside the context of a face-to-face, in-person visit, most often by the billing practitioner's clinical staff on behalf of patients with complex health care needs, including transitional care management in the CY 2013 PFS final rule (77 FR 68979); non-complex and complex chronic care management (CCM) in the CY 2015, 2017, and 2019 PFS final rules (78 FR 74414, 83 FR 58577, and 81 FR 80244); and principal care management (PCM) in the CY 2020 PFS final rule (84 FR 62962). The CCM and PCM code families now include five sets of codes which are reported monthly on a timed basis, each set with a base code of 20 to 60 minutes and an add-on code for each additional 30 minutes. The code sets vary by the degree of complexity of patient conditions (that is, non-complex and complex CCM for multiple chronic conditions or PCM for a single high-risk condition), and whether the number of minutes spent by clinical staff or the physician or non-physician practitioner (NPP) is used to meet time thresholds for billing. We remind commenters of these services which are available for care management and coordination, to support beneficiaries with a variety of complex health needs. Furthermore, we will continue to engage with interested parties on this topic and are interested in information that could assist us in estimating physician intraservice time for covered services.

Comment: Several commenters indicated that despite our stated intention to exclude time-based services from the efficiency adjustment, we included several time-based services including physical medicine and rehabilitation services and remote therapeutic monitoring (RTM) on the list of services which we proposed to apply this adjustment.

A commenter stated that telehealth services are excluded from the adjustment, but some telehealth codes are on the impacted efficiency adjustment list.

Additionally, several commenters stated that diagnostic, prophylactic, or therapeutic intravenous infusions, such as chemotherapy, should not be subject to the efficiency adjustment, as the infusion rates are recommended on the required FDA labeling, and therefore cannot be made more efficient, or delivered at a faster rate.

Several commenters requested exclusions of:

Certain specialties, non-time-based codes, and/or services (for example, specialties with workforce shortages, annual wellness visits (AWVs), bariatric surgery codes, cataract codes, etc.).

Services where efficiencies would compromise patient safety.

Codes for services valued through crosswalk rather than RUC surveys.

Software-based services, such as Artificial Intelligence- enabled Coronary Plaque Analysis (AI-CPA) and Fractional Flow Reserve derived from Computed Tomography, as they do not yield efficiency gains with increased use.

Response: We appreciate the commenters' diligence in reviewing the list of services to which we proposed to apply the efficiency adjustment. We agree with the commenters that time-based services and services on the CMS telehealth list should be included in the list of codes exempt from the efficiency adjustment list. We have removed the time-based physical medicine and rehabilitation services and RTM services and services on the CMS telehealth list from the list of codes to which the efficiency adjustment will apply. Additionally, we appreciate the information provided by the commenters with regard to FDA labeling for diagnostic, prophylactic, or therapeutic intravenous infusions. We are removing time-based, drug administration codes from the list of codes to which the efficiency adjustment will apply in CY 2026. We continue to believe that applying the efficiency adjustment to non-time-based services more broadly, instead of applying it only to certain services, will help to improve the overall accuracy of our valuation of these services under the +PFS. Given our commitment to refining the efficiency adjustment over time, we look forward to continued engagement with the public on future rulemaking for these services. We welcome any empirical data regarding physician intraservice work time for PFS services that commenters are able to submit to us. Interested parties can submit their request as part of the Potentially Misvalued Codes initiative, as described in section II.C. of this final rule.

Comment: A commenter requested a hold harness policy for rural and safety net providers.

Response: We appreciate the commenter's feedback and may consider this for future rulemaking.

Comment: Several commenters requested that CMS conduct a more targeted review of specific codes rather than applying a broad application. Some commenters requested that CMS apply the efficiency adjustment to only a subset of codes, that is, older codes that have not been revalued for 17-25 years, exempting codes that take less time to perform, focusing on high volume codes, etc. Several commenters supported the efficiency adjustment, and some of these commenters urge careful consideration of its implementation to avoid unintended consequences. Several commenters recommend delaying implementation to conduct specialty specific reviews, or to phase in implementation (that is, over 3 years) to give organizations time to adjust to changes in revenue. Some commenters stated CMS should use a shorter lookback period, while other commenters stated CMS should use a longer lookback period, such as a 10 year lookback period.

Response: We appreciate the commenter's feedback on the efficiency adjustment proposal. As stated in proposed rule, the efficiency adjustment

proposal reflects a conservative approach based on studies of overvaluation, which is why we are using a conservative 5-year lookback period. While we acknowledge the suggestions to delay or phase in implementation and to conduct specialty-specific reviews, we continue to believe the proposal is an appropriate balance between timely policy implementation and the need for future refinement. We are committed to continue engaging with the public and will continue to consider public feedback on the efficiency adjustment policy, as we may need to make refinements and would address through future rulemaking accordingly.

Comment: Many commenters also provided recommendations for CMS to consider assisting with more accurate valuation of codes including:

Bundling related services into broader payment packages, stating that CMS could decrease the administrative burden associated with frequent code-specific revaluations, allowing greater focus and in turn accuracy. Consolidating codes in this manner would streamline data collection, code review, and payment adjustments, and better align the PFS with established practices in other Medicare payment systems.

Establishing a Technical Advisory Panel to discuss and advise on service packages, service valuation including the appropriate collection and use of empirical data, code level estimates of physician intraservice time, cadence for updates, and potential efficiency adjustments while considering the potential impact on physicians, beneficiaries, and the Trust Fund.

Consider implementing a modifier or HCPCS G-code for surgical complexity so that surgeons will be able to identify the cases that are more complex, which would more directly and appropriately address CMS' interest in isolating the services that are truly more efficient.

Also, the commenters recommended CMS work with medical professionals to develop time and motion studies for high volume procedures to determine if there are or have been any efficiency gains over time. The commenters believe empirical data is needed to support this policy, such as data points that may be captured by analyzing EHR data.

Response: We appreciate the commenters for their feedback and may consider these suggestions for future rulemaking.

Comment: Several commenters stated that CMS should not make corresponding adjustments to direct PE input for clinical labor or equipment because these costs have only increased. They also suggest that CMS consult with interested parties and seek input from the RUC.

A few commenters recommended making corresponding updates to the inputs for clinical labor and equipment costs and to factor all those changes into CMS' indirect PE methodology, where appropriate. The commenters stated that not making these changes creates a distortion in which CMS is not fully accounting for the efficiencies garnered over time as technology advances, workflows improve, and expertise develops. The commenters continued to state that procedures that become more efficient, for example, also reduce clinical labor time and costs and equipment costs (for example, since the equipment is being used for less time).

Response: We appreciate the comments submitted by the public and may consider these suggestions for possible future rulemaking.

Comment: Several commenters stated that they were unable to replicate the productivity adjustments that are used to derive the proposed efficiency adjustment. They state that these productivity adjustments for 2022 to 2026 are not listed in either of the CMS online tables related to the MEI or in information available from the U.S. Bureau of Labor Statistics (BLS). A few commenters requested that CMS supplement the values posted in Table A-E1 of the CY 2026 PFS proposed rule (90 FR 32593) with a brief narrative describing the calculation methodology, any year-over-year rounding conventions, and the precise source data (for example, Bureau of Labor Statistics series) used for each input in a separate file to be posted to the CMS web page.

Response: Total factor productivity (TFP), as measured by the U.S. Bureau of Labor Statistics (BLS), captures the portion of economic growth that cannot be explained solely by increases in labor and capital inputs. Instead, it reflects improvements in efficiency, technology, organizational practices, and other factors that enhance how inputs are combined to produce output. Unlike labor productivity, which only looks at output per hour worked, TFP accounts for multiple inputs, including labor (adjusted for composition), capital, and intermediate goods, using cost-share weights to build combined input indexes. Because it represents a residual, TFP is sensitive to measurement quality but is widely viewed as an indicator of innovation and long-term potential growth.

BLS TFP data are revised on a regular basis to incorporate updated source data, methodological improvements, and benchmarking adjustments. Because TFP relies on inputs from other agencies, such as Gross Domestic Product and capital data from the Bureau of Economic Analysis and labor data from Census surveys and the Current Population Survey, revisions to those underlying sources flow into BLS TFP estimates. In addition, changes in methodology, such as the 2022 update to labor composition measurement, can lead to historical revisions. Typically, BLS issues annual revisions for TFP in the private business, private nonfarm business, and manufacturing sectors, as well as for detailed industries to reflect any methodological changes and to incorporate more recent data.

BLS typically publishes TFP data on an annual schedule, with an initial preliminary release followed by revised (final) estimates once more complete source data is available.

As stated in the CY 2026 PFS proposed rule (90 FR 32593), the productivity adjustments used in the proposed efficiency adjustment are based on the BLS TFP data for the private nonfarm business sector. Preliminary TFP estimates for the private nonfarm business sector are typically released in March for the prior year. For example, 2024 preliminary TFP data were released in March 2025. These estimates rely on the most up to date but still incomplete data from the Bureau of Economic Analysis (BEA), Census, and other sources. Final (revised) TFP estimates are usually incorporated in the fall release cycle (often around November to December), when more complete national accounts and input data are available. At this point, BLS re-estimates the TFP measures for the most recent year and may also revise prior years.

Table A-E3 lists the BLS TFP release dates for the years 2020 to 2024 for both the preliminary publication and the later revision (“final”) date when BLS issued a formal revision.

[GRAPHIC] [TIFF OMITTED] TR05NO25.017

The preliminary TFP estimates do not remain as a separate, permanent data set. When BLS releases revised (or “final”) estimates later in the year, the new numbers overwrite the preliminary figures in the public data tables. The archived TFP data can be obtained from the archived TFP news releases at https://www.bls.gov/bls/news-release/home.htm#tfp.

To determine the productivity adjustment, we use the annual index levels for total factor productivity from 1987 to the latest year of data published by BLS at the three decimal level of precision. We then calculate the 10-year moving average of the annual index levels to derive the 10-year average TFP index level, unrounded. Next, we calculate the growth rate of the current year to the prior year of the 10-year average index levels to derive the 10-year moving average growth. Finally, this value is rounded to 1 decimal place to arrive at the final applicable productivity adjustment. Questions related to the methodology for how TFP is calculated should be directed to the Bureau of Labor Statistics--Office of Productivity and Technology (OPT), https://www.bls.gov/productivity.

We acknowledge commenters' concerns that the MEI update and productivity adjustment have not been published separately in the recent CY PFS regulations on a consistent basis since it is not used to calculate PFS payment rates, with the exception of the telehealth originating site facility fee; however, the relevant information is available by reference to the FQHC market basket update, which is based on the latest historical data at the time of the publication of the final rule. The “Actual Regulation Market Basket Updates (ZIP)” link in the downloads section of the following cms.gov web page contains a spreadsheet that details the productivity adjustment applied for each FQHC market basket update: https://www.cms.gov/data-research/statistics-trends-and-reports/medicare-program-rates-statistics/market-basket-data. The productivity adjustment in the FQHC market basket for the corresponding period would match that of the MEI and is consistent with the information provided in the proposed rule.

We highlight that the productivity adjustment applicable to the CY 2026 MEI and FQHC market basket updates is finalized to be 0.8 percentage point, the same as was proposed. The productivity adjustment corresponding to the payment update for CY 2026 incorporates the Bureau of Labor Statistics' total factor productivity estimates through 2024, published on March 21, 2025. This adjustment is determined by calculating the 10-year moving average of changes in annual economy- wide, private nonfarm business total factor productivity.

Table A-E4 presents the efficiency adjustment of 2.5 percent, which is derived from the cumulative productivity adjustments finalized in each PFS final rule from CY 2022 through CY 2026. Additionally, we provide a comparison of the estimated productivity adjustment based on the latest revised TFP data available from BLS at the time of this CY 2026 PFS final rule. [GRAPHIC] [TIFF OMITTED] TR05NO25.018

While there are updated percentages based on revised BLS TFP data at the time of drafting this final rule, as indicated in Table A-E4, we note that our proposed approach was designed to be conservative in nature, as we are concerned about making too many changes at once to the current methodology. Therefore, as we discuss

in the summary for this section, we are finalizing the proposed efficiency adjustment of 2.5 percent for CY 2026.

Comment: Several commenters stated that it is unreasonable for CMS to apply the efficiency adjustment, essentially a productivity adjustment, to reduce PFS payments when there is no corresponding market basket or inflationary adjustment to increase PFS payments annually. The commenters observed that, unlike other Medicare FFS payment systems where a market basket percentage increase is calculated and then reduced by a productivity adjustment to determine the final payment rate update, CMS is proposing to apply a type of productivity adjustment to decrease payment for the PFS without the associated yearly payment increase of a market basket. The commenters suggested that CMS should work with Congress to make sure there is a permanent change to the PFS to ensure that there is a mechanism to account for annual input price inflation, such as the MEI update. Several commenters requested that CMS provide additional clarification surrounding why the agency believes that this measure of overall productivity growth across the economy is an adequate proxy for service-level efficiency gains within the Medicare program and stated their belief that it is unreasonable to extrapolate changes in physician productivity from estimates of nonfarm business productivity across the entire economy. Additionally, a commenter supported the use of the MEI productivity adjustment as a basis for the efficiency adjustment, stating that it is a good approximation of physician- specific multifactor productivity.

Response: We appreciate the comments regarding using the MEI productivity adjustment to calculate the efficiency adjustment. We acknowledge that, unlike other Medicare payment systems where annual payment updates are based on a market basket increase that is then adjusted for productivity, the PFS does not include an automatic mechanism to account for inflationary input cost growth.

However, we continue to believe that the productivity adjustments used in the proposed efficiency adjustment, based on the BLS TFP data for the private nonfarm business sector, is a reasonable and appropriate proxy for productivity improvements that can be expected over time in the provision of physician services. While we recognize that the data reflects productivity growth in the broader nonfarm business sector, it is the widely accepted and consistently measured estimate of economy-wide productivity gains used to adjust the FFS annual market basket updates as required by section 3401 of the Affordable Care Act (ACA), These legislatively mandated payment adjustments have been used across most FFS Medicare payment systems since 2012.

We appreciate commenters' suggestions that CMS work with Congress to explore statutory changes that would allow for a more comprehensive update framework under the PFS, including mechanisms to account for annual input price inflation. While CMS does not have the authority to make such changes unilaterally, we understand the importance of these concerns and will continue to consider commenter's suggestions as we continue to make refinements to this policy through future rulemaking.

We also note that at a commenter supported the use of the MEI productivity adjustment, stating that it represents a reasonable approximation of physician-specific multifactor productivity. We continue to believe that the MEI productivity adjustment provides a useful and analytically supported approach to account for efficiency gains and ensure consistency with broader Medicare payment policy. We continue to welcome, review and consider the public's feedback on this issue and will evaluate whether refinements or alternative approaches may be appropriate in future rulemaking.

Comment: We received several comments regarding the cadence of the efficiency adjustment proposal. Several commenters also requested that CMS clarify its decision to continually apply the efficiency adjustment every 3 years. A few commenters stated that anything more than a one- time adjustment is unwarranted. Other commenters described that efficiencies cannot continue to be gained year-over-year and that at some point, there is a maximum efficiency that can be realized, and going beyond that point will compromise patient care. A commenter stated that the efficiency adjustment is different from the GPCI and MP updates, in contrast to those updates, which have occurred every 3 years for decades with finite and consistent impact on affected services, the efficiency adjustment has the potential to be substantially disruptive to the fee schedule every year it is implemented. The commenter recommended CMS to defer subsequent efficiency adjustments until the impact on Medicare patient care can be appropriately evaluated to ensure that it is not harmful. A commenter stated that technological adoption is rarely linear and believes 3 years is insufficient to determine that innovation and efficiency have been embedded across an entire procedure or service. The commenter recommended CMS extend the adjustment period beyond 3 years to provide adequate time to assess the impacts of innovative technologies on their workflows and care delivery. Another commenter stated implementing a consistent 2.5 percent reduction every 3 years indefinitely risks causing ongoing cuts to payments for certain services, without clear evidence that further efficiencies are actually achievable. Another commenter stated that CMS did not specify an endpoint for the efficiency reduction. The commenter continued to state that as proposed, CMS would, theoretically, continue to apply the efficiency adjustment until such time that the intraservice time is zero.

Response: We appreciate the commenters for their thoughtful input. We acknowledge the concern that efficiencies may not accrue indefinitely and that overly repeated application of the efficiency adjustment could have cumulative effects over time. As such, we will continue to monitor the impact of the efficiency adjustment. While we proposed a 3-year cadence, we may revisit the frequency and consider establishing a sunset provision or other refinements in future rulemaking.

After consideration of public comments, for CY 2026 we are finalizing to establish an efficiency adjustment to the work RVUs, as well as corresponding updates to the intraservice portion of physician time inputs for non-time-based services, with refinements. We will apply the efficiency adjustment to the intraservice portion of physician time and work RVUs every 3 years. To calculate the efficiency adjustment, we are finalizing the use of the MEI productivity adjustment over a 5-year look back period from CY 2022 to CY 2026. We note, as displayed in Table A-E4, using more recent historical data from the BLS yielded an efficiency adjustment of 3.6 percent. As we discussed in the CY 2026 PFS proposed rule (90 FR xxx), our approach in applying an efficiency adjustment is to take into account changes in medical practice and to better reflect resources involved, and it is designed to be conservative in nature, as we are concerned about making too many changes at once to the current methodology. Therefore, we are finalizing the proposed efficiency adjustment of 2.5 percent. We are exempting additional codes, specifically time-based codes, services on the CMS

telehealth list, and new codes for CY 2026, as reflected in the Codes Subject to Efficiency Adjustment file. This file can be found in the public use files for CY 2026; the file is available on the CMS website under downloads for the CY 2026 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. 3. Methodology for the Direct PE Inputs To Develop PE RVUs a. Background

On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or non-facility direct PE inputs and refine the inputs accordingly.

Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table A-E13 details our refinements of the RUC's direct PE recommendations at the code-specific level. In section II.B. of this final rule, Determination of Practice Expense Relative Value Units (PE RVUs), we address certain refinements that will be common across codes. Refinements to particular codes are addressed in the portions of that section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. In this final rule, we also note that many of the refinements listed in Table A-E13 result in changes under the $0.35 threshold and would be unlikely to result in a change to the RVUs.

We note that the direct PE inputs for CY 2026 are displayed in the CY 2026 direct PE input files, available on the CMS website under the downloads for the CY 2026 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been used in developing the CY 2026 PE RVUs as displayed in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates). b. Common Refinements (1) Changes in Work Time

Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies. (2) Equipment Time

Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.

In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time will also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also noted that we believe these same assumptions will apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question will be available if the room is not being occupied by a particular patient. For additional information, in that rule we referred readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639). (3) Standard Tasks and Minutes for Clinical Labor Tasks

In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The

RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

We refer readers to section II.B. of this final rule, Determination of Practice Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks. (4) Recommended Items That Are Not Direct PE Inputs

In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs. (5) New Supply and Equipment Items

The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2026 we received invoices for several new supply and equipment items. Tables A-E13 and A-E14 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this final rule, Determination of Practice Expense Relative Value Units, we encourage interested parties to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encourage interested parties to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.

We remind interested parties that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables A-E13 and A-E14 also include the number of invoices received and the number of non-facility allowed services for procedures that use these equipment items. We provide the non- facility allowed services so that interested parties will note the impact the particular price may have on PE relativity, as well as to identify items that are used frequently, since we believe that interested parties are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs, and we encourage interested parties to provide additional invoices so that we may identify and use accurate prices in the development of PE RVUs.

In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we may use existing items as proxies for the newly recommended items. In other cases, we include the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so. (6) Service Period Clinical Labor Time in the Facility Setting

Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address code-specific refinements to clinical labor in the individual code sections. (7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap

We note that the list of services for the upcoming calendar year that are subject to the MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services; and the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap; are displayed in the public use files for the PFS proposed and final rules for each year. The public use files for CY 2026 are available on the CMS website under downloads for the CY 2026 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more information regarding the history of the MPPR policy, we referred readers to the CY 2014 PFS final rule with comment period (78 FR 74261 through 74263).

Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171, enacted on February 8, 2006) amended section 1848(b)(4) of the Act to require that, for imaging services, if--(i) The TC (including the TC portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The Medicare OPD fee schedule amount established under the prospective payment system (PPS) for HOPD services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under section 1833(t)(2)(D) of the Act, the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor under the PFS, for the fee schedule amount for such TC for such year. As required by section 1848(b)(4)(A) of the Act, for imaging services furnished on or after January 1, 2007, we cap the TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient Prospective Payment System (OPPS) payment amount for the service (prior to geographic adjustment). We then apply the PFS geographic adjustment to the capped payment amount. Section

1848(b)(4)(B) of the Act defines imaging services as “imaging and computer-assisted imaging services, including X-ray, ultrasound (including echocardiography), nuclear medicine (including PET), magnetic resonance imaging (MRI), computed tomography (CT), and fluoroscopy, but excluding diagnostic and screening mammography.” For more information regarding the history of the cap on the TC of the PFS payment amount under the DRA (the “OPPS cap”), we referred readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662).

For CY 2026, we identified new and revised codes to determine which services meet the definition of “imaging services” as defined at section 1848(b)(4)(B) of the Act for purposes of this cap. Beginning for CY 2026, we proposed to include the following services on the list of codes to which the OPPS cap applies: CPT codes 0598T (Real-time fluorescence wound imaging with clinical darkness, to identify location of bacterial wound pathogens and measure wound size, per session; first anatomic site (that is, lower extremity, right leg), 0599T (Real-time fluorescence wound imaging with clinical darkness, to identify location of bacterial wound pathogens and measure wound size, per session; each additional anatomic site (that is, upper extremity, left leg) (List separately in addition to code for primary procedure)), 0944T (3D contour simulation of target liver lesion(s) and margin(s) for image- guided percutaneous microwave ablation), 0946T (Orthopedic implant movement analysis using paired computed tomography (CT) examination of the target structure, including data acquisition, data preparation and transmission, interpretation and report (including CT scan of the joint or extremity performed with paired views)), 0961T (Shortwave infrared radiation imaging, surgical pathology specimen, to assist gross examination for lymph node localization in fibroadipose tissue, per specimen (List separately in addition to code for primary procedure)), 0972T (Assistive algorithmic classification of burn healing (i.e., healing or nonhealing) by noninvasive multispectral imaging, including system set-up and acquisition, selection, and transmission of images, with automated generation of report), 0984T (Intravascular imaging of extracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; initial vessel (List separately in addition to code for primary procedure)), 0985T (Intravascular imaging of extracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; each additional vessel (List separately in addition to code for primary procedure)), 0986T (Intravascular imaging of intracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; initial vessel (List separately in addition to code for primary procedure)), 0987T (Intravascular imaging of intracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; each additional vessel (List separately in addition to code for primary procedure)), 70471 (Computed tomographic angiography (CTA), head and neck, with contrast material(s), including noncontrast images, when performed, and image postprocessing), 70472 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed with concurrent CT or CT angiography of the same anatomy (List separately in addition to code for primary procedure)), 70473 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed without concurrent CT or CT angiography of the same anatomy), and 77X09 (Surface radiation therapy; superficial or orthovoltage, image guidance, ultrasound for placement of radiation therapy fields for treatment of cutaneous tumors, per course of treatment (List separately in addition to the code for primary procedure)). We believe that these codes meet the definition of imaging services under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap.

We appreciate commenters' feedback regarding CPT codes 92227 (Imaging of retina for detection or monitoring of disease; with remote clinical staff review and report, unilateral or bilateral), 92228 (Imaging of retina for detection or monitoring of disease; with remote physician or other qualified health care professional interpretation and report, unilateral or bilateral), and 92229 (Imaging of retina for detection or monitoring of disease; point-of-care autonomous analysis and report, unilateral or bilateral), and may consider adding this code to the OPPS cap list for future rulemaking, however as we did not make a specific proposal regarding this service, we consider these comments out of scope for this rule but we appreciate the additional information and may consider it for future rulemaking. We did not receive public comments on the proposed additions to the OPPS cap list for CY 2026. We are finalizing the addition of the services listed above to the list of codes to which the OPPS cap applies, as proposed. 4. Valuation of Specific Codes for CY 2026 (1) Tympanostomy (CPT Code 0583T)

In the CY 2025 PFS final rule (89 FR 97745 through 97746), we reviewed Category III CPT code 0583T (Tympanostomy (requiring insertion of ventilating tube), using an automated tube delivery system, iontophoresis local anesthesia) as potentially misvalued. We considered whether to establish national payment for CPT code 0583T, which is used to report tympanostomy using the TULA system, or whether to create a device-agnostic G-code which could be used to report tympanostomies using the TULA or other devices. We stated that CPT code 69433 (Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia) may serve as a sufficient base code, adequately describing most of the surgeon's work and facility resources. In response to comments supporting the latter approach, we established separate payment for HCPCS code G0561 (Tympanostomy with local or topical anesthesia and insertion of a ventilating tube when performed with tympanostomy tube delivery device, unilateral (List separately in addition to 69433) (Do not use in conjunction with 0583T)) to be billed with CPT code 69433 in order to describe the additional resource costs associated with using the innovative tympanostomy tube delivery devices and/or systems falling under emerging technology and services categories and finalized contractor pricing for CY 2025.

We have received input from interested parties expressing gratitude for the creation of HCPCS code G0561 but also continuing to request that CMS establish national pricing for CPT code 0583T. In response, we sought comments on whether to nationally price both codes, and what inputs for physician work, time, and direct

practice expense would most accurately capture the resource costs associated with performing both procedures. For example, in response to a similar request for comment in CY 2025 PFS rulemaking, commenters recommended a direct crosswalk to the values associated with CPT code 31295 (Nasal/sinus endoscopy, surgical, with dilation (e.g., balloon dilation); maxillary sinus ostium, transnasal or via canine fossa) which they stated was similar to CPT code 0583T with respect to the intensity and invasiveness of the procedure, preparation time for the procedure, and total time to complete the surgery. We sought comments on whether interested parties continue to believe CPT code 31295 would be an accurate comparison or whether there are other services that CMS should consider.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: The RUC indicated that CPT codes 0583T, 69433, and HCPCS code G0561 will be placed on the next level of interest for review.

Response: We acknowledge and appreciate the AMA for the RUC's placement of CPT code 0583T, 69433, and HCPCS code G0561 on their next level of interest for review list and look forward to their input, as well as input from the initial submitters of CPT code 0583T and all other interested parties.

Comment: Many commenters supported national pricing for CPT code 0583T. These commenters stated that national pricing will improve patient access to the procedure and align with time and resources involved, ensuring accurate payment for practitioners performing this procedure in the office setting. Commenters also supported a crosswalk to CPT code 31295 to describe the resources associated with the innovative tympanostomy tube delivery devices and/or systems described by CPT code 0583T, stating that the physician work, time, and direct PE inputs reflected in CPT code 31295 are similar to those of 0583T.

Response: We appreciate the commenters for their feedback.

Comment: A few commenters did not support national pricing for HCPCS code G0561. These commenters recommended waiting until more data and clinical experience become available to support national pricing. Other commenters supported national pricing for HCPCS code G0561 and requested different payment rates for CPT code 0583T and HCPCS code G0561.

Response: We agree with commenters that it may be beneficial to collect more data on the use of HCPCS code G0561 prior to proposing national pricing. Therefore, we are finalizing to maintain contractor pricing for HCPCS code G0561. Regarding pricing for CPT code 0583T, we are persuaded by the comments that stated that the physician work, time, and direct PE inputs reflected in CPT code 31295 are similar to those of 0583T, therefore, we are finalizing a crosswalk to the input values associated with CPT code 31295 for CPT code 0583T for CY 2026. (2) Temporary Female Intraurethral Valve-Pump (CPT Codes 0596T and 0597T)

For the CY 2025 PFS final rule (89 FR 97710), we reviewed CPT codes 0596T (Temporary female intraurethral valve-pump (that is, voiding prosthesis); initial insertion, including urethral measurement) and 0597T (Temporary female intraurethral valve-pump (that is, voiding prosthesis); initial insertion, replacement) as potentially misvalued. We added pricing for 3 new supplies related to these services: (1) inFlow Measuring Device, (2) inflow Valve Pump Device, and (3) inFlow Activator Kit. The RUC reviewed and surveyed these codes as potentially misvalued for the January 2025 meeting and stated that they would flag for the RAW in 3 years.

We proposed the RUC-recommended work RVU of 2.43 for CPT code 0596T and the RUC-recommended work RVU of 1.05 for CPT code 0597T.

We proposed the RUC-recommended direct PE inputs for both CPT codes without refinement.

We did not receive any public comments on this policy, and therefore, we are finalizing as proposed. (3) Skin Cell Suspension Autograft

Comment: We received comments that requested CMS clarify policies related to CPT codes 15011, 15012, 15013, 15014, 15015, 15016, 15017, and 15018. The commenters recommended that CMS establish national pricing for these services.

Response: At this time, our concerns expressed in the CY 2025 PFS final rule (89 FR 97774 through 97776) have not been resolved regarding these services. We continue to have concerns about the service times, segmentation of the coding, and billing patterns of the add-on codes based on the vignettes. We continue to believe contractor pricing is appropriate for these services and look forward to reviewing these codes again after reconsideration of the coding structure and re-survey is complete. Additionally, we did not propose to nationally price these services in the CY 2026 PFS proposed rule (90 FR 32593), so those changes cannot be finalized. We encourage interested parties to work with the MACs to develop the crosswalks for these services while they continue to be contractor priced. (4) Limb Lengthening-Shortening--Femur (CPT Codes 27465, 27466, 27468, and 27458)

The CPT Editorial Panel created a new Category I code, CPT code 27458 (Osteotomy(ies), femur, unilateral, with insertion of an externally controlled intramedullary lengthening device, including iliotibial band release when performed, imaging, alignment assessments, computations of adjustment schedules, and management of the intramedullary lengthening device) in May 2024. This code describes femur lengthening using the insertion of an externally controlled intramedullary lengthening device, including imaging. CPT code 27458 and the other codes within this code family, including CPT codes 27465 (Osteoplasty, femur; shortening (excluding 64876), 27466 (Osteoplasty, femur; lengthening), and 27468 (Osteoplasty, femur; combined, lengthening and shortening with femoral segment transfer), were surveyed during the September 2024 RUC Meeting.

We proposed the RUC-recommended work RVUs of 26.65, 21.13, and 22.65 for CPT codes 27458, 27465, and 27466, respectively. We also proposed the direct PE inputs for CPT codes 27458, 27465, and 27466 without refinement.

However, for CPT code 27468, we disagreed with the RUC's recommendation to contractor price this code. We believe CPT code 27468 is valued appropriately and should not be paid under contractor pricing based on the results of ten surveys. We instead proposed to maintain the current work RVU and direct PE inputs for CPT code 27468 for CY 2026.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter, the AMA, stated at the May 2025 CPT Editorial Panel meeting, CPT code 27468 was deleted for CY 2026 due to the specialty request due to low volume. This was reflected in the CY 2026 RUC resource files submitted to CMS in May 2025. Therefore, the RUC recommended the deletion of CPT code 27468 from Addendum B as the code will not exist in 2026. The same commenter was in support of our proposal of the RUC recommended values for CPT codes 27458, 27465, and 27466.

Response: We appreciate the commenter for their feedback and for the additional information regarding CPT 27468.

After consideration of public comments, we are finalizing our proposed values for CPT codes 27458, 27465, and 27466. For CPT code 27468, we are finalizing the deletion of this code as it will no longer exist in 2026. (5) Limb Lengthening-Shortening--Tibia (CPT Codes 27715 and 27713)

The CPT Editorial Panel created a new Category I code, CPT code 27713, (Osteotomy(ies), tibia, including fibula when performed, unilateral, with insertion of an externally controlled intramedullary lengthening device, including imaging, alignment assessments, computations of adjustment schedules, and management of the intramedullary lengthening device) in May 2024. This code describes tibia lengthening using the insertion of an externally controlled intramedullary lengthening device, including imaging. CPT codes 27713 and 27715 (Osteoplasty, tibia and fibula, lengthening or shortening) were surveyed for the September 2024 RUC Meeting.

We proposed the RUC-recommended work RVU of 28.00 for CPT code 27713 and the work RVU of 22.50 for CPT 27715. We also proposed the direct PE inputs for CPT codes 27713 and 27715 without refinement.

We did not receive public comments on this proposal, and therefore, we are finalizing as proposed. (6) Arthrodesis Great Toe (CPT Codes 28750 and 28755)

At the April 2024 Relativity Assessment Workgroup (RAW), the RAW identified CPT code 28750 (Arthrodesis, great toe; metatarsophalangeal joint) on the “different performing specialty from survey screen,” where the top specialty performing over 50 percent of the Medicare claims did not survey the service or the top two specialties did not survey the service. The RAW noted that when this service was last valued in 1995, podiatry, which now performs over half of the volume for this service, was not involved in the survey. CPT code 28755 (Arthrodesis, great toe; interphalangeal joint) which was valued by the Harvard Studies and never surveyed by the RUC, was added as part of the code family. CPT codes 28750 and 28755, were surveyed at the January 2025 AMA RUC meeting.

We proposed the RUC-recommended work RVU of 8.75 for CPT code 28750.

We disagreed with the RUC-recommended work RVU of 7.50 for CPT code 28755 and we instead proposed a work RVU of 6.76. The RUC-recommended valuation would place it above the median range when compared to other 90-day global codes with similar work times and the current time and work values. We proposed a work RVU of 6.76 for CPT code 28755 based on a direct crosswalk to CPT code 28122 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (for example, osteomyelitis or bossing); tarsal or metatarsal bone, except talus or calcaneus). CPT code 28122 shares the same intraservice work time of 45 minutes as compared with CPT code 28755, it has a very similar total time (230 minutes as compared with 234 minutes), and both of these codes also contain four postoperative office visits in their global periods. We are supporting this proposed work RVU of 6.76 with the total time ratio for CPT code 28755, which calculates at a work RVU of 6.64 (the total time is increasing from 172 minutes to 234 minutes for an increase of 36 percent, which results in a work RVU of 6.64 when multiplied with the current work RVU of 4.88 for CPT code 28755). Our proposed work RVU of 6.76 is further supported by a pair of other 90- day global codes with similar work time values, with a lower bracket of CPT code 26785 (Open treatment of interphalangeal joint dislocation, includes internal fixation, when performed, single) at a work RVU of 6.60 and an upper bracket of CPT code 56620 (Vulvectomy simple; partial) at an RVU of 7.53.

We proposed the RUC-recommended direct PE inputs for all of the codes in this family.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Commenters generally agreed with CMS' proposal of the RUC- recommended work and direct PE inputs for CPT code 28750.

Response: We appreciate the commenters for taking the time to submit comments. After reviewing the comments, we are finalizing the proposed work RVU and direct PE inputs for CPT code 28750.

Comment: A few commenters disagreed with CMS' proposal to lower the work RVU to 6.64 for CPT code 28755. The commenters stated that the Harvard study under which CPT code 28755 was previously valued did not include podiatrists and was reviewed by only nine general orthopedic surgeons. Additionally, the Harvard study did not survey pre- or post- service work or time and instead estimated time based on an algorithm. Additionally, no positioning time was assigned, and post-operative work was underestimated based on this methodology.

Commenters disagreed with the selected crosswalk code, CPT code 28122, stating that the code under review is more intense and requires more work than the selected crosswalk code and has more time, work, effort, and risk involved. Commenters suggested CMS to finalize the RUC-recommended work RVU of 7.50 for CPT code 28755.

Response: We appreciate the commenters for their suggestions. We agree with the case made by commenters that CPT code 28755 is more difficult to perform than CPT code 28122 because CPT code 28755 involves smaller bones. In addition, the RUC-recommended value is supported by a search of similarly timed codes, with the value of 7.50 landing between the mid and upper third of values.

After consideration of public comments, we are not finalizing our proposed work RVU of 6.76 for CPT code 28755 and we are instead finalizing the RUC-recommended work RVU of 7.50. We are finalizing the RUC-recommended direct PE inputs for all of the codes in this family. (7) Closure Left Atrial Appendage With Endocardial Implant (CPT Code 33340)

The Relativity Assessment Workgroup (RAW) reviewed CPT code 33340 (Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation) in 2023 as part of the new technology/service screen. Around that same time, specialty societies asserted that this service was undergoing rapid change. Therefore, the RAW recommended specialty societies conduct a survey for the April 2024 RUC meeting.

We proposed the RUC-recommended work RVU of 10.25 for CPT code 33340. We also proposed the RUC-recommended direct PE inputs for CPT code 33340 without refinement.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters opposed the CMS proposal of the RUC- recommended work RVU of 10.25 for CPT code 33340 because these

commenters believe that the decrease in work RVU from 14.00 to 10.25 was too drastic and could impact beneficiaries' access to these services. A few commenters also disagreed with the comparison to CPT code 49614, stating that it was an inappropriate choice for a valuation crosswalk.

Response: While we understand commenters' concerns, we believe that the RUC-recommended work RVU and direct PE inputs for CPT code of 33340 are appropriate choices for valuation. When CPT code 33340 was surveyed, the intraservice time decreased from 90 minutes to 70 minutes (about 28 percent) while the total time decreased from 183 minutes to 165 minutes (about 11 percent). Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to- one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We believe that CPT code 49614 is an accurate crosswalk for work valuation as it has comparable intraservice time to CPT code 33340 (75 minutes against 70 minutes) and the two codes share the identical total time of 165 minutes.

After consideration of the public comments, we are finalizing our proposed work RVUs and direct PE inputs for CPT code 33340. (8) Thoracic Branch Endograft Services (CPT Codes 33880, 33881, 33883, 33886, 33882, and 35602)

At the September 2024 CPT Editorial Panel meeting, CPT approved endovascular repair of thoracic aortic aneurysms (TEVAR) coding changes. CPT deleted three codes describing the procedure and replaced them with two new codes and four revised codes in the TEVAR family. These revisions update the TEVAR code family to more accurately describe the current practice and current coding standards. The new codes are CPT code 33882 (Endovascular repair of the thoracic aorta by deployment of a branched endograft multipiece system involving an aorto-aortic tube device with a fenestration for the left subclavian artery stentgraft(s) and all aortic tube endograft extension(s) placed from the level of the left common carotid artery to the celiac artery, including preprocedure sizing and device selection, all target zone angioplasty, all nonselective catheterization(s) and left subclavian artery selective catheterization(s), all associated radiological supervision and interpretation), CPT code 35602 (Bypass graft, with other than vein; carotid-contralateral carotid), CPT code 33880 (Endovascular repair of descending thoracic aorta (eg, aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin, radiological supervision and interpretation), CPT code 33881 (by deployment of an aorto-aortic tube endograft not involving coverage of the left subclavian artery origin and all endograft extension(s) placed from the level of the left subclavian carotid artery to the celiac artery), CPT code 33883 (Proximal extension prosthesis(s) not involving coverage of the left subclavian artery origin, delayed placement after endovascular repair of the thoracic aorta, including preprocedure sizing and device selection, nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed), and CPT code 33886 (Distal extension prosthesis(s) from the level of the left subclavian artery to the celiac artery, delayed placement after endovascular repair of descending thoracic aorta, including preprocedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation). The new codes in this code family were surveyed at the January 2025 AMA RUC meeting.

The RUC surveyed this code family and there were overall decreases in the work times. The RUC-recommended work RVUs do not appear to fully account for these decreases. Although we do not believe that changes in work time as reflected in survey values must equate to a one-to-one or linear change in the valuation of work RVUs, we believe that since the two components of work are time and intensity, decreases in the surveyed work time should typically be reflected in decreases to the work RVU.

We reviewed the RUC recommendations and found them to be high, relative to other codes with the same or similar times. Based on a search of similarly timed codes in the RUC database, the RUC- recommended values exceed the work RVUs for five of the six codes.

We disagree with the RUC recommended work RVU of 30.00 for CPT code 33880 and instead we proposed a work RVU of 27.00. This valuation was higher than nearly all of the other 90-day global codes with similar time values. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with an intraservice time of 120 minutes and similar total time around 546 minutes. We instead proposed a direct crosswalk to CPT code 32672 (Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non-bullous) for lung volume reduction (LVRS), unilateral includes any pleural procedure, when performed) at the previously mentioned work RVU of 27.00. CPT code 32672 shares the same intraservice work time of 120 minutes as compared with CPT code 33880, it has a similar total time (567 minutes as compared with 546 minutes), and both of these codes each have two postoperative office visits in their global periods. We are supporting this proposed work RVU of 27.00 with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 43820 (Gastrojejunostomy; without vagotomy) at a work RVU of 22.53 and an upper bracket of CPT code 34702 (Endovascular repair of infrarenal aorta by deployment of an aorto- aortic tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the aortic bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion, when performed (for example, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)) with a work RVU of 36.00.

We disagree with the RUC recommended work RVU of 26.75 for CPT code 33881 and we instead proposed a work RVU of 22.53. The RUC's recommended work RVUs do not match the surveyed drops in work time (from 200 minutes to 110 minutes for CPT code 33881) and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 43820 has a slightly higher intraservice work time of 120 minutes as compared with CPT code 33881 which has 110 minutes, it has a very similar total time (545 minutes as compared with 506 minutes), and three postoperative office visits as compared to CPT code 33881 which has two postoperative office visits in the global period. We are supporting this proposed work RVU of 22.53 with a pair of other 90-day global

codes with similar work time values, with a lower bracket of CPT code 34707 at a work RVU of 22.28 and an upper bracket of CPT code 43880 at an RVU of 27.18.

We disagree with the RUC recommended work RVU of 39.00 for CPT code 33882 and we instead proposed a work RVU of 35.00. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 180 minutes and similar total time around 621 minutes. We proposed a work RVU of 35.00 for CPT code 33882 based on a direct crosswalk to CPT code 33390 (Valvuloplasty, aortic valve, open, with cardiopulmonary bypass; simple (ie, valvotomy, debridement, debulking, and/or simple commissural resuspension)). There were several recently reviewed codes in the RUC database search that have the exact same intraservice time with higher total times and a lower work RVU. CPT code 33390 shares the same intraservice work time of 180 minutes as compared with CPT code 33880, it has a very similar total time (621 minutes as compared with 622 minutes), and both of these codes also contain two postoperative office visits in their global periods. We are supporting this proposed work RVU with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 33647 (Repair of atrial septal defect and ventricular septal defect, with direct or patch closure) at a work RVU of 33.00 and an upper bracket of CPT code 35216 (Repair blood vessel, direct; intrathoracic, without bypass) at an RVU of 35.00.

We disagree with the RUC recommended work RVU of 24.25 for CPT code 33883 and we instead proposed a work RVU of 19.91. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. We proposed a work RVU of 19.91 for CPT code 33883 based on a direct crosswalk to CPT code 44320 (Colostomy or skin level cecostomy).

The RUC-recommended work RVUs do not match the surveyed drops in work time (from 120 minutes to 90 minutes) for CPT code 33883 and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 44320 shares the same intraservice work time of 90 minutes as compared with CPT code 33883, it has a slightly higher total time (507 minutes as compared with 486 minutes), and three postoperative office visits as compared to two post operative office visits for CPT code 33883 in the global period. We are supporting this proposed work RVU of 19.91 with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 33267 (Exclusion of left atrial appendage, open, any method (for example, excision, isolation via stapling, oversewing, ligation, plication, clip)) at a work RVU of 18.50 and an upper bracket of CPT code 43611 (Excision, local; malignant tumor of stomach) at an RVU of 20.38.

We disagree with the RUC recommended work RVU of 23.50 for CPT code 33886 and we instead proposed a work RVU of 19.91. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. We proposed a work RVU of 19.91 for CPT code 33886 based on a direct crosswalk to CPT code 44320. The RUC-recommended work RVUs do not match the surveyed drops in work time (from 100 minutes to 90 minutes) for CPT code 33886 and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 44320 shares the same intraservice work time of 90 minutes as compared with CPT codes 33886, it has a slightly higher total time (507 minutes as compared with 486 minutes), and three postoperative office visits as compared to two post operative office visits for CPT code 33886 in the global period. We are supporting this proposed work RVU of 19.91 with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 33267 at a work RVU of 18.50 and an upper bracket of CPT code 43611 at an RVU of 20.38.

We disagree with the RUC recommended work RVU of 27.40 for CPT code 35602and we instead proposed a work RVU of 23.53. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 150 minutes and similar total time around 486 minutes. Furthermore, we note that there was a decrease in the intraservice time by 23 minutes and the intraservice time ratio for this code suggests that the RUC - recommendation is too high. We proposed a work RVU of 23.53 for CPT code 35602based on a direct crosswalk to CPT code 32669 (Thoracoscopy, surgical; with removal of a single lung segment (segmentectomy)). We note that CPT code 35602was also valued by the RUC using a crosswalk code to maintain relativity within the family.

The RUC's recommended work RVUs do not reflect surveyed drops in work time (from 173 minutes to 150 minutes) for CPT code 35602and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 32669 shares the same intraservice work time of 150 minutes as compared with CPT code 35602, it has a slightly higher total time (502 minutes as compared with 486 minutes), and both of these codes also contain two postoperative office visits in their global periods. We are supporting this proposed work RVU of 23.53 with a pair of other 090-day global codes with similar work time values, with a lower bracket of CPT code 22612 (Arthrodesis, posterior or posterolateral technique, single interspace; lumbar (with lateral transverse technique, when performed)) at a work RVU of 23.53 and an upper bracket of CPT code 35666 (Bypass graft, with other than vein; femoral-anterior tibial, posterior tibial, or peroneal artery) at an RVU of 23.66.

We proposed the RUC-recommended direct PE inputs for all the codes in this family.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Commenters generally agreed with the CMS proposal of the RUC-recommended direct PE inputs for CPT codes 33880, 33881, 33883, 33886, 33882 and 35602 without refinement.

Response: We appreciate the commenters' support for the CMS proposal of the RUC-recommended direct PE inputs for CPT codes 33880, 33881, 33883, 33886, 33882 and 35602 without refinement.

Comment: Several commenters stated that there appeared to be an issue regarding the correct valuation of CPT codes 33880, 33881, 33883 and 33886 resulting from a mathematical error in the utilization crosswalk. The commenters stated that CMS double-counted the utilization for the new codes, most likely due to a misinterpretation attributable to the text in the RUC's utilization crosswalk recommendations stating, “Bundled into 33880” instead of “Savings” (bundled into 33880). The commenters stated that there was a discrepancy of 25,176 work RVUs included in the CMS utilization assumptions compared to what the RUC originally submitted and suggested CMS to correct the mathematical error on which the current work RVUs for CPT codes 33880, 33881, 33883 and 33886 are based.

Response: We appreciate the feedback from the commenters on the utilization crosswalk involving these codes. After reviewing the subject, we agree that there was an unintended technical error involving the utilization crosswalk for CPT codes 33880, 33881, 33883 and 33886 due to a misinterpretation of how the RUC made its recommendations. We are therefore finalizing a correction to this technical error in this final rule.

Comment: A few commenters disagreed with CMS' proposed direct crosswalks and work RVU recommendations for all six codes in this family. Commenters requested the need for CMS to adjust the work RVUs for the Thoracic Endovascular Aortic Repair (TEVAR) code family to reflect the complexity and intensity of these procedures. The commenters expressed that these procedures incorporate significant pre- service planning, intraoperative complexity, and extensive post- operative care that were not fully captured in the original code set or existing comparators. Additionally, the commenters stated that bundling radiographic supervision and interpretation with selective catheter codes into the primary TEVAR codes, along with the deletion of bypass codes, simplifies coding but increases procedure complexity. Commenters agreed with CMS that the two components of work are time and intensity, and decreases in the surveyed work time should typically be reflected in decreases to the work RVU, however, a commenter stated that with TEVAR, the intensity has increased substantially, which they believe should result in less reduction in the work RVU.

Response: We appreciate the commenters for their comments. We continue to believe that the RUC-recommended work RVUs do not appear to fully account for the overall decrease in the work times. We continue to believe that the proposed values for the work RVUs for all of the codes in this code family are accurate. The comparator codes selected account for intensity as well as time required for this service; we note, for example, that the intensity of each code in the family is increasing over its current value at our proposed work valuations.

Comment: Several commenters disagreed with CMS' proposed direct crosswalks and work RVU recommendations, stating that they do not accurately reflect the work and intensity required, especially given the risks such as paralysis and strokes associated with TEVAR. The commenters suggested that CMS finalize the RUC-recommended work RVUs that are based on robust survey data and detailed clinical vignettes, reflecting modern practice and the elevated risks involved which were not present when the codes were initially valued.

Another commenter expressed concerns about the proposed work RVUs for the revised and new CPT codes within the TEVAR procedures. The commenter noted that TEVAR procedures have grown in complexity and risk profile since their initial FDA approval in 2005, and the recent approval of thoracic branch endoprosthesis (TBE) in 2022 has expanded the range of treatable aortic pathology. The commenter maintained that time alone does not fully capture the complexity and intensity of TEVAR procedures and urges CMS to finalize the RUC recommendations to ensure accurate valuation of these life-saving procedures. Another commenter noted with the improvement of device technology, a broader range of patients are treated with TEVAR.

Response: We appreciate the commenters for their comments. We understand the concerns raised by commenters stating that the new six- code family for TEVAR was developed to align with current clinical practices and CPT coding standards. We appreciate that the new procedures incorporate significant pre-service planning, intraoperative complexity, and extensive post-operative care that were not fully captured in the original codes. While we appreciate the recommendations presented by the commenters as it pertains to the work RVUs, several recommendations rely more on the relativity among the subspecialty. We continue to believe that looking at the relativity across the fee schedule allows for better relativity between codes.

Comment: A few commenters noted that TEVAR codes appropriately support automatic co-surgeon involvement due to the inherent complexity and intensity of these interventions and pointed out in contrast, all the crosswalk codes identified necessitate additional documentation to justify co-surgeon involvement. Commenters felt this supported increased intensity and thus a higher work RVU.

Response: With regard to the commenter's concerns regarding clinically relevant relationships, we emphasize that we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, we do not agree that codes must share the same specialty to serve as an appropriate crosswalk.

We continue to believe that our proposed valuations, based on the crosswalks selected, more accurately value these codes since they do not result in the sizable increases in intensity as recommended by the RUC. We maintained relativity between the codes in this family with similarly timed codes.

Comment: Several commenters disagreed with the proposed work RVU of 27.00 for CPT code 33880 and stated that CMS should finalize the RUC- recommended work RVU of 30.00. Commenters stated that the CMS direct crosswalk valuation based on CPT code 32672 relies too heavily on decreases of intraservice time and does not accurately account for the overall measured intensity required to perform this service. Commenters stated that CPT code 33880 requires more than 100 minutes of pre- service evaluation time which includes extensive imaging review and advanced 3D planning due to risks which are not present in any other surgery. Commenters stated that the intensity of the service was reflected in the RUC's recommended valuation and pointed to the two key reference codes from the RUC survey for support.

Response: We disagree with the commenters and continue to believe that our proposed work RVU of 27.00 for CPT code 33880 is a more accurate valuation. As we stated in the proposed rule, the RUC's recommended work RVU of 30.00 was higher than nearly all of the other 90-day global codes with similar time values and would not maintain relativity with other 90-day global period codes with an intraservice time of 120 minutes and similar total time around 546 minutes. The surveyed intraservice time for CPT code 33880 is decreasing from 225 minutes to 120 minutes (47 percent) while the work RVU is would only decrease from the current 34.58 to 30.00 (13 percent) if we were to finalize the RUC's recommended value. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to- one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We believe that it is more accurate to propose a work RVU of 27.00 to capture these decreases in surveyed intraservice time; we also note that our proposed valuation maintains the current intensity for CPT code 33880 instead of resulting in a significant

increase as under the RUC's recommended value.

Comment: Several commenters disagreed with the proposed work RVU of 22.53 for CPT code 33881 and stated that CMS should finalize the RUC- recommended work RVU of 26.75. Commenters stated that the CMS direct crosswalk valuation based on CPT code 43820 relies too heavily on decreases of intraservice time and does not accurately account for the overall measured intensity required to perform this service. Commenters stated that the proposed valuation did not reflect the intensity of a procedure with risks of permanent paralysis and anterior or posterior circulation strokes; commenters also pointed to the two key reference codes from the RUC survey for support.

Response: We disagree with the commenters and continue to believe that our proposed work RVU of 22.53 for CPT code 33881 is a more accurate valuation. As we stated in the proposed rule, the surveyed intraservice time for CPT code 33881 is decreasing from 200 minutes to 110 minutes (45 percent) while the work RVU is would only decrease from the current 29.58 to 26.75 (10 percent) if we were to finalize the RUC's recommended value. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We believe that it is more accurate to propose a work RVU of 22.53 to capture these decreases in surveyed intraservice time for CPT code 33881.

Comment: Several commenters disagreed with the proposed work RVU of 35.00 for CPT code 33882 and stated that CMS should finalize the RUC- recommended work RVU of 39.00. Commenters stated that the CMS direct crosswalk valuation based on CPT code 33390 relies too heavily on decreases of intraservice time and does not accurately account for the overall measured intensity required to perform this service. Commenters stated that the proposed valuation did not reflect the intensity/ complexity of the procedure that requires fenestration alignment and selective catheterization of the subclavian artery, which reflects both the technical sophistication and elevated risk of spinal cord ischemia requiring surgeon-led monitoring. Commenters also pointed to the two key reference codes from the RUC survey for support.

Response: We disagree with the commenters and continue to believe that our proposed work RVU of 35.00 for CPT code 33882 is a more accurate valuation. As we stated in the proposed rule, we found that the RUC-recommended work RVU of 39.00 does not maintain relativity with other 90-day global period codes with the same intraservice time of 180 minutes and similar total time around 621 minutes. We also note that if we were to finalize the RUC's recommended work RVU, CPT code 33882 would be assigned an intensity significantly higher than the rest of this code family. While we agree with the commenters that all of these procedures carry significant patient risks, which is reflected in high intensity values for all of them, we do not agree that CPT code 33882 should have an anomalously high intensity relative to the other Thoracic Branch Endograft Services procedures. By proposing a work RVU of 35.00, our proposed intensity for CPT code 33882 maintains relativity with the rest of its code family.

Comment: Several commenters disagreed with the proposed work RVU of 19.91 for CPT code 33883 and stated that CMS should finalize the RUC- recommended work RVU of 24.25. Commenters stated that the CMS direct crosswalk valuation based on CPT code 44320 relies too heavily on decreases of intraservice time and does not accurately account for the overall measured intensity required to perform this service. Commenters stated that although the intraservice time was the same between CMS' crosswalk code and the surveyed code, CPT code 44320 has very low intensity/complexity comparatively whereas CPT code 33883 is an extension endograft, so the risk of spinal cord ischemia and coverage of the subclavian is similar or even more than CPT code 33881. Commenters also pointed to the two key reference codes from the RUC survey for support.

Response: We disagree with the commenters and continue to believe that our proposed work RVU of 19.91 for CPT code 33883 is a more accurate valuation. As we stated in the proposed rule, we found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. The surveyed intraservice time for CPT code 33883 is decreasing from 120 minutes to 90 minutes (-25 percent) while the work RVU would increase from the current 21.09 to 24.25 (+15 percent) if we were to finalize the RUC's recommended value. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs, not increases. We believe that it is more accurate to propose a work RVU of 19.91 to capture these decreases in surveyed intraservice time for CPT code 33883.

Comment: Several commenters disagreed with the proposed work RVU of 19.91 for CPT code 33886 and stated that CMS should finalize the RUC- recommended work RVU of 23.50. Commenters stated that the CMS direct crosswalk valuation based on CPT code 44320 relies too heavily on decreases of intraservice time and does not accurately account for the overall measured intensity required to perform this service. Commenters stated that although the intraservice time was the same between CMS' crosswalk code and the surveyed code, CPT code 44320 has very low intensity/complexity comparatively whereas CPT code 33886 is an extension endograft, so the risk of spinal cord ischemia and coverage of the artery of Adamkiewicz was highest for the service. Commenters stated that using a colostomy code as a comparator is inappropriate and noted that endovascular major aortic surgery should not be compared with straightforward intra-abdominal procedures; commenters also pointed to the two key reference codes from the RUC survey for support.

Response: We disagree with the commenters and continue to believe that our proposed work RVU of 19.91 for CPT code 33886 is a more accurate valuation. As we stated in the proposed rule, we found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. The surveyed intraservice time for CPT code 33886 is decreasing from 100 minutes to 90 minutes (-10 percent) while the work RVU would increase from the current 18.09 to 23.50 (+30 percent) if we were to finalize the RUC's recommended value. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs, not increases. We believe that it is more accurate to propose a work RVU of 19.91 to capture these

decreases in surveyed intraservice time for CPT code 33886.

We also disagree with the commenters that the use of CPT code 44320 as a valuation crosswalk was inappropriate. We continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, we do not agree that codes must share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk.

Comment: Several commenters disagreed with the proposed work RVU of 23.53 for CPT code 35602 and stated that CMS should finalize the RUC- recommended work RVU of 27.40. Commenters stated that the direct crosswalk valuation based on CPT code 32669 does not accurately account for the overall measured intensity required to perform this service; commenters also pointed to the two key reference codes from the RUC survey for support.

Response: As we stated in the proposed rule, we found that the RUC- recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 150 minutes and similar total time around 486 minutes. Our proposed work RVU of 23.53 for CPT code 35602 maintains similar intensity to the predecessor CPT code (33891) as well as the rest of this code family which suggests that it is a more accurate valuation.

After consideration of the public comments, we continue to believe that the proposed valuation accurately reflects the typical work involved in furnishing Thoracic Branch Endograft services. Therefore, for CY 2026, we are finalizing our proposed work RVUs and direct PE inputs for CPT codes 33880, 33881, 33883, 33886, 33882 and 35602. (9) Lower Extremity Revascularization (CPT Codes 37254, 37255, 37256, 37257, 37258, 37259, 37260, 37261, 37262, 37263, 37264, 37265, 37266, 37267, 37268, 37269, 37270, 37271, 37272, 37273, 37274, 37275, 37276, 37277, 37278, 37279, 37280, 37281, 37282, 37283, 37284, 37285, 37286, 37287, 37288, 37289, 37290, 37291, 37292, 37293, 37294, 37295, 37296, 37297, 37298, and 37299)

In October 2018, three CPT codes (37225, 37227, and 37229) were flagged by the Relativity Assessment Workgroup for high-cost supplies review, leading to a series of significant changes in the lower extremity revascularization (LER) code family. After multiple reviews and discussions between 2018 and 2024, the CPT Editorial Panel ultimately created four new subsections and 46 new codes to replace the existing 16 codes (CPT codes 37220-37235) for LER services. According to the RUC, this comprehensive update was driven by technological advances, changes in practice settings, and the need to better differentiate between a stenosis (that is, a straightforward lesion) and an occlusion (that is, a complex lesion) procedures. These codes were surveyed for the September 2024 RUC meeting and recommendations submitted to CMS for consideration in the CY 2026 PFS final rule. See Table A-E5 for a summary of the codes, and their long descriptors.

According to the RUC, not all codes received a full survey from participants. Eleven selected core codes had complete survey responses from all respondents, while the remaining 35 codes underwent an abbreviated survey process. The 35 abbreviated survey codes were split into two groups and survey respondents only received one of those two groups along with the 11 core codes. There were two notable changes made to the abbreviated survey. First, survey respondents were provided with one of the anchor codes as a comparator instead of using a reference service list; second, survey respondents were only asked one question per abbreviated code in the intensity/complexity section. Therefore, respondents did not complete all elements of the abbreviated survey, as some elements were pre-populated. We note that this method could potentially introduce inaccuracies and bias in the survey outcomes.

For CY 2026, we proposed the RUC-recommended work RVUs for all 46 CPT codes. However, we have concerns about the survey data, specifically regarding the small sample size and large variations in responses. We encouraged commenters to submit additional data for our consideration in determining the valuation of work and direct PE inputs for these CPT codes. Table A-E5 also shows the proposed work RVUs for the 46 CPT codes: [GRAPHIC] [TIFF OMITTED] TR05NO25.019

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We proposed the RUC-recommended PE inputs for all 46 CPT codes, with several revisions to address discrepancies found in the documentation. Regarding the drug-coated balloon (SD382), which is priced at $2,343.33, the RUC recommendations show inconsistent quantity allocations across different code sets. The RUC documentation specifies two units for the initial vessel and one unit for additional vessels in CPT codes 37263-37266 and 37271-37274. However, for CPT codes 37267- 37268 and 37275-37276, only one unit is listed for the initial vessel. Furthermore, CPT codes 37269-37270 and 37277-37279 have no quantity values specified at all. To address these inconsistencies, we propose updating the initial vessel quantities to one unit of the SD382 drug- coated balloon for CPT codes 37263, 37265, 37271, and 37273, while maintaining one unit for additional vessels.

The RUC recommends a quantity of two for supply code SD379 (drug eluting stent, tibial) for four CPT codes in the tibial and peroneal vascular territory, CPT codes 37286, 37287, 37294, and 37295. The RUC- recommended quantity exceeds the number of units of supply code SD266 (stent, self-expanding 2-5 mm XPERT (Abbott)) currently used in CPT code 37230, 37234, 37231, and 37235, respectively. We proposed to reduce the quantity from two to one for supply code SD379 (drug eluting stent, tibial) in each of the four CPT codes 37286, 37287, 37294, and 37295.

For this code family, the RUC recommended 34 minutes of equipment time for the Professional PACS Workstation (ED053). We believe this recommendation contains an unintended technical error regarding the equipment time. Therefore, we proposed using the standard equipment formula for the professional PACS workstation, which calculates equipment minutes as the sum of intraservice work time plus half of the preservice work time.

While we proposed the listed refinements above, we sought comments on whether we should create G-codes to describe the use of high-cost supplies. Alternatively, we sought comments on whether we could use the Hospital Outpatient Prospective Payment System (OPPS) mean unit cost data (MUC) to accurately price these services and their supplies based on how these supplies are paid for in the hospital setting. We sought comments on whether there is additional information we should consider in establishing proposed payments for these services.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: We received many comments on our proposal to update the initial vessel quantities to one unit of the SD382 drug-coated balloon for CPT codes 37263, 37265, 37271, and 37273. Some commenters stated that CPT codes 37263, 37265, 37271 and 37273 would typically require two drug-coated balloons, whereas their corresponding add-on codes (37264, 37266, 37272 and 37274) would typically only require one drug- coated balloon for each additional vessel. For CPT codes 37263, 37265, 37271, and 37273, the commenters stated that the RUC recommendation of two drug-coated balloons was necessary because drug-coated balloons can only deliver their therapeutic payload to one area during a single inflation according to FDA instructions, and these procedures involve treating long segments of arterial disease in the superficial femoral/ popliteal region that typically require coverage by two separate balloons. However, regarding CPT codes 37267, 37268, 37275, and 37276, commenters stated that only one unit is appropriate for the initial vessel. Commenters noted that these codes are most often reported for procedures involving the common femoral artery or the profunda femoris artery segment of the femoropopliteal region, which are shorter vessels with shorter disease segments that can be effectively treated with a single drug-coated balloon. Regarding CPT codes 37269, 37270, 37277, and 37278, commenters stated that covered stents are typically used in these procedures, making drug-coated balloons unnecessary since the treated segments are covered by fabric-coated stents. For CPT code 37279, commenters stated that the practice expense inputs are limited to the additional work associated with Intravascular Lithotripsy, which is performed in addition to the base codes of the family. Therefore, additional drug-coated balloons were not included in this portion of the code family as they are already accounted for in the appropriate base codes.

Response: We appreciate the commenters for the additional information provided. After consideration of the public comments, we agree that the direct PE inputs for CPT codes 37263, 37265, 37271, and 37273 should include two drug-coated balloons (SD382) per code, as we are persuaded by commenters that two balloons are typically required due to the length of disease in the superficial femoral and popliteal segments.

Comment: We received comments supporting the RUC's recommended quantity of two units for drug eluting stent, tibial (SD379) in the tibial segment complex CPT codes 37286, 37287, 37294, and 37295. Commenters stated that these procedures typically require two drug- eluding stents each, whereas tibial segment straightforward taking place in CPT codes 37284 and 37285 only require one drug-eluding stent each. Commenters stated that the length of the vessel is the same between

a straightforward and a complex lesion for CPT codes 37284-37287, but that for tibial interventions, surgeons are typically working with stents that are 38mm long. Commenters stated that complex lesions are typically quite long and as such it is most typical to use 2 stents in the tibial segment for the complex lesions described by CPT codes 37286-37287 and 37294-37295. Some commenters stated that closer to 4 stents would be appropriate for these two codes whereas other commenters stated that in some cases 4 or 5 stents would be required in the tibial segment.

Other commenters stated that since the time that the previous code set was valued, the stents included in that coding's PE supply costs (the self expanding 2-5 mm stent described by supply code SD266) have been removed from the market and are no longer used, which is why the RUC recommended the use of the SD379 tibial stent. Commenters stated that the complex CPT codes (37286, 37287, 37294 and 37295) represent the minority of tibial interventions and that it will be much more likely for tibial interventions to not require stent placement. Commenters concluded that many more of the treatments will be simple stenoses (straightforward lesions) and if stent placement is performed it will only require a single drug eluting stent in most cases.

Response: We appreciate the commenters for the additional information provided. After consideration of the public comments, we were convinced that the use of a second tibial stent would be typical for CPT codes 37286-37287 and 37294-37295. We are therefore finalizing the RUC-recommended two units for the drug eluting stent, tibial (SD379) supply for CPT codes 37286, 37287, 37294 and 37295.

Comment: The commenters recommended CMS to adopt a clinically grounded, evidence-based definition of “complex lesions” within the new LER code set, aligned with clinical literature and professional society guidelines, to ensure accurate coding and payment. According to a commenter, the clinical literature and established professional society guidelines characterize complex lesions in LER as involving one or more of the following features: lesion length greater than 15 cm, moderate to severe arterial calcification, chronic total occlusions (CTOs), in-stent restenosis, prior failed endovascular intervention, involvement of the popliteal artery (particularly P2/P3 segments), multilevel or multivessel disease, and single-vessel runoff.

Response: We appreciate the commenters for the additional information provided. We encourage them to work with the CPT Editorial Panel to develop a clinically grounded, evidence-based definition of “complex lesions” within the new LER code set, consistent with clinical literature and professional society guidelines.

Comment: Many commenters encouraged CMS to establish G-codes for high-cost supplies as it could improve billing accuracy and ensure appropriate reimbursement for expensive medical devices and supplies used in patient care. Commenters also stated that, if CMS intends to utilize Outpatient Prospective Payment System (OPPS) cost data to establish pricing for services and supplies within the PFS the agency should provide a comprehensive and detailed methodological proposal through future rulemaking.

Response: We appreciate the commenters for their feedback regarding the LER code set. We believe that the OPPS cost data might be a useful source of information and will consider it for future rulemaking. We are open to feedback from interested parties.

Comment: Several commenters thanked CMS for creating a new supply pack for the angiography services (SA142) associated with this code family. However, commenters stated that the SA142 supply pack was not assigned to the applicable codes in the LER family (CPT codes 37254, 37256, 37258, 37260, 37263, 37265, 37267, 37269, 37271, 37273, 37275, 37277, 37280, 37282, 37284, 37286, 37288, 37290, 37292, 37294, 37296, and 37298). Commenters provided a list of 20 supply components that together constituted the SA142 supply pack and requested that CMS remove these supply inputs from the LER code family, to be replaced by the SA142 supply pack.

Response: The direct PE inputs recommended by the RUC for this code family listed all of the individual components for the SA142 supply pack separately, rather than bundling them into a supply pack, and at the time it was not clear what supply components constituted the SA142 pack. However, in light of the additional information provided by the commenters, we will remove the supply items that make up the SA142 supply pack from the associated LER codes and replace them with the SA142 pack as requested.

In reviewing the information provided by commenters, we also noticed that the supply components of the SA142 pack as listed by commenters differed from the supply inputs contained within the LER codes in a few places. Specifically, the codes only contained one sterile basin (SJ079) instead of two, they only contained one plastic towel clamp (SD208) instead of four, and they did not contain a lidocaine control syringe (listed under SC051) at all. Since these supplies were not recommended as typical for the LER codes, we have removed them from the SA142 supply pack and updated its pricing to $62.26. With these changes, the price of the SA142 supply pack now matches the sum of its components, as well as matching the price of the supply components removed from the LER codes. Therefore, there is no change in the direct costs of the associated codes due to the replacement of the individual supplies with the SA142 pack. The contents of the SA142 supply pack are listed in this section for reference:

[GRAPHIC] [TIFF OMITTED] TR05NO25.026

After consideration of public comments, we are finalizing the proposed work RVUs and direct PE inputs for the codes in the LER family, with the previously mentioned increase to two drug-coated balloon (SD382) supplies for CPT codes 37263, 37265, 37271, and 37273 as well as two drug eluting tibial stent (SD379) supplies for CPT codes 37286, 37287, 37294 and 37295. Lastly, we are also finalizing the inclusion of a new supply pack for angiography services (SA142) as previously described. (10) Irreversible Electroporation of Tumors (CPT Codes 47384 and 55877)

At the September 2024 CPT Editorial Panel Meeting, two new CPT codes were created for reporting percutaneous irreversible electroporation ablation of one or more tumors: CPT codes 47384 (Ablation, irreversible electroporation, liver, 1 or more tumors, including imaging guidance, percutaneous) and 55877 (Ablation, irreversible electroporation, prostate, 1 or more tumors, including imaging guidance, percutaneous). These new CPT codes were surveyed at the January 2025 AMA RUC meeting. For CY 2026, we are proposing the RUC-recommended work RVUs of 9.41 for CPT code 47384 and 13.50 for CPT code 55877.

We proposed the following refinements to the direct PE inputs for CPT code 47384. We disagreed with the RUC recommendation to use the standard 90-day global pre-service clinical labor times in the facility setting for CPT code 47384 since this is a 0-day global procedure. We did not agree that it would serve the interests of relativity to use the 90-day global clinical labor standard times for a 0-day global service. Therefore, we proposed the standard 000/010 global day extensive pre-service clinical labor times in the facility setting, resulting in the following changes: the minutes associated with CA002 (Coordinate pre-surgery services (including test results)) are reduced from 20 minutes to 10 minutes; the minutes associated with CA003 (Schedule space and equipment in facility) are reduced from 8 minutes to 5 minutes; the minutes associated with CA004 (Provide pre-service education/obtain consent) are reduced from 20 minutes to 7 minutes; and the minutes associated with CA005 (Complete pre-procedure phone calls and prescription) are reduced from 7 minutes to 3 minutes.

We proposed the RUC-recommended direct PE inputs for CPT code 55877 without refinement.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposed work RVU and direct PE inputs for this code family.

Response: We appreciate the commenters for their support.

Comment: Some commenters stated that the level of clinical staff work required for irreversible electroporation is extensive and recommended CMS accept the times in the RUC recommended pre-service package. The reference code selected to assist in establishing direct PE inputs was CPT

code 33361 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach), which is also a 0-day global code. Commenters stated that it serves as an example for the pre-service clinical staff time package, which encompasses the comprehensive use of clinical staff in a facility setting. Commenters also stated that they believe the level of clinical staff work required for irreversible electroporation is extensive and therefore suggested CMS to accept the standard 90-day global pre-service clinical labor times in the facility setting for CPT code 47384.

Response: After reviewing the comments, we remain unconvinced that the information provided would support the need for the standard 90-day global pre-service clinical labor times in the facility setting for CPT code 47384 since this is a 0-day global procedure. We continue to believe that the standard 000/010 global day pre-service clinical labor times in the facility setting is appropriate, and that the recommended standard 90-day global pre-service clinical labor times in the facility setting for CPT code 47384 would not be typical for the procedure. Therefore, we are finalizing the standard 000/010 global day pre- service clinical labor times for CPT code 47384, as proposed.

After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Irreversible Electroporation of Tumors family as proposed. (11) Endoscopic Sleeve Gastroplasty (CPT Code 43889)

In September 2024, CPT approved the addition of a new code to report transoral gastric restrictive procedures using an endosurgical approach. CPT code 43889 (Gastric restrictive procedure, transoral, endoscopic sleeve gastroplasty (ESG), including argon plasma coagulation, when performed) was surveyed for the January 2025 RUC meeting.

The RUC-recommended a direct crosswalk to CPT 36832 (Revision, open, arteriovenous fistula; without thrombectomy, autogenous or nonautogenous dialysis graft (separate procedure)) with a work RVU of 13.50. During the RUC prefacilitation meeting, 1 unit of CPT code 99232 (Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and a moderate level of medical decision making) was removed from the postoperative period, and 20 minutes of work time was added into the immediate post-service time. The RUC also revised the global period of CPT code 43889 to reduce the work and time value of CPT code 99238 (Hospital inpatient or observation discharge day management; 30 minutes or less on the date of the encounter) to half of the original value. We believe the RUC partially applied the 23-hr policy when it applied the policy to the immediate postservice time but not to the work RVU. The 23-hour policy established in the CY 2011 PFS final rule (75 FR 73226) applies to services that are typically performed in the outpatient setting and require a hospital stay of less than 24 hours. We discussed in the CY 2011 PFS final rule that we believe the value of these codes should not reflect work that is typically associated with an inpatient service. We believe the 23-hour policy in its entirety should be applied to CPT code 43889, which includes the work RVUs along with the immediate post service time. Following the valuation methodology we established for the 23-hour policy in the CY 2011 PFS final rule (75 FR 73226), we proposed a work RVU of 12.56 for CPT code 43889. The steps are as follows:

Step (1): The RUC appropriately reduced the hospital discharge day management service included in the global period from 1 to 0.5; therefore, we will skip this step.

Step (2): 13.50 - 1.39 ** = 12.11

Step (3): 12.11 + (20 minutes x 0.0224) *** = 12.56 RVUs

* Value associated with \1/2\ hospital day discharge management service.

** Value associated with an inpatient hospital visit, CPT code 99232.

*** Value associated with the reallocated intraservice time multiplied by the postservice intensity of the 23-hour stay code.

We proposed the RUC-recommended direct PE inputs for CPT code 43889 without refinement.

We proposed a work RVU of 12.56 for CPT code 43889 based on application of the 23-hour policy. We received several comments on our proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters supported the RUC recommended work RVU and stated that the crosswalk value is most appropriate. Commenters noted that the RUC recommendation was based on a crosswalk to CPT code 36832, which does not contain any inpatient hospital visits. Therefore, the need for a visit to be removed is negated, as the underlying crosswalked reference code also does not include inpatient hospital visits. Other commenters recommended that CMS consider using the RUC survey data instead of the crosswalk recommendation in determining the appropriate valuation. A few commenters stated that should CMS decide not to use the survey and base the value on the RUC-recommended crosswalk, CMS should not apply the 23-hour policy since the crosswalk CPT code 36832 already had the 23-hour policy applied. Overall, these commenters were concerned that adjusting the work RVU for CPT code 36832 would increase costs and lead to access issues for beneficiaries.

Response: We appreciate the information provided by commenters. We understand that the inpatient hospital visit was removed from the code valuation and therefore not reflected in the resulting work RVU. We continue to believe the value of these codes should not reflect work that is typically associated with an inpatient service and that the 23- hour policy should be applied in its entirety including the work RVUs along with the immediate post service time.

After reviewing the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 43889 as proposed. (12) Transurethral Robotic-Assisted Resection of Prostate (CPT Codes 52500, 52601, 52630, 52648, 52649, and 52597)

In May 2024, the CPT Editorial Panel created a new CPT code to report transurethral robotic-assisted waterjet resection of the prostate, including ultrasound guidance: CPT code 52597 (Transurethral robotic-assisted waterjet resection of prostate, including intraoperative planning, ultrasound guidance, control of postoperative bleeding, complete, including vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy, when performed). CPT code 52597 was surveyed for the September 2024 RUC meeting along with the existing codes in this code family: CPT code 52500 (Transurethral resection of bladder neck (separate procedure)), CPT code 52601 (Transurethral electrosurgical resection of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)), CPT code 52630 (Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)), CPT code

52648 (Laser vaporization of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)), and CPT code 52649 (Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)). For CY 2026, the RUC recommended a work RVU of 6.00 for CPT code 52500, a work RVU of 10.25 for CPT code 52597, a work RVU of 10.00 for CPT code 52601, a work RVU of 6.55 for CPT code 52630, a work RVU of 10.05 for CPT code 52648, and a work RVU of 14.56 for CPT code 52649.

We proposed the RUC-recommended work RVU of 6.00 for CPT code 52500, the work RVU of 10.25 for CPT code 52597, the work RVU of 10.00 for CPT code 52601, the work RVU of 6.55 for CPT code 52630, and the work RVU of 10.05 for CPT code 52648.

We note that the RUC will be placing CPT code 52597 on the New Technology/New Services list and CPT code 52597 will be re-reviewed by the RUC in 3 years to ensure correct valuation, patient population, and utilization assumptions. Also, we received external input suggesting the RVU for CPT code 52597 should be higher than the RUC recommendation of 10.25 and that an RVU of 14.56 (same as the RUC recommendation for CPT code 52649) would be more appropriate. However, given the survey times and comparisons to similarly timed codes with similar intensity, an RVU of 14.56 for CPT code 52597 would not be accurate. The RUC's valuation for CPT code 52597 is typical for a procedure code with the same work time values (that is, 60 minutes intraservice time and 234 minutes of total time). With all of these considerations, we believe that proposing a work RVU of 10.25 for CPT code 52597 maintains relativity with the other CPT codes in this family.

For CPT code 52649, we disagree with the RUC-recommended work RVU of 14.56 and we are proposing an RVU of 13.00 instead, based on a crosswalk to CPT code 53500 (Urethrolysis, transvaginal, secondary, open, including cystourethroscopy (for example, postsurgical obstruction, scarring)). We believe the RUC-recommended work RVU of 14.56 is too high and should be lowered due to the decrease in intraservice time of 30 minutes (from 120 minutes to 90 minutes), and the decrease in total time by 16 minutes (from 279 minutes to 263 minutes). An RVU of 13.00 for CPT code 52649 is supported by the range of CPT code 64912 (Nerve repair; with nerve allograft, each nerve, first strand (cable)) with an RVU of 12.00, the same intraservice time and 272 minutes of total time, and by CPT code 15730 (Midface flap (that is, zygomaticofacial flap) with preservation of vascular pedicle(s)) with an RVU of 13.50, the same intraservice time and 255.5 minutes of total time.

We proposed the RUC-recommended direct PE inputs for CPT codes 52500, 52597, 52601, 52630, and 52649 without refinement. For CPT code 52648, we proposed to remove the 6 minutes of clinical labor time for CA021 (Perform procedures/services--NOT directly related to physician work time). Therefore, the equipment time reported under EF031 (table, power) has also been reduced by 6 minutes (from 95 minutes to 89 minutes) to reflect the removal of clinical labor activity CA021 from CPT code 52648. We note that CPT code 52648 is performed in the facility setting only and the standard is 0 minutes for CA021 in the facility. Also, supply item SL036 (cup, biopsy-specimen sterile 4oz) was reported as a non-facility PE input for CPT code 52648. Since CPT code 52648 is only performed in the facility setting, we believe inclusion of supply item SD036 as a non-facility PE input was unintentional and therefore proposed to remove it.

Comment: Many commenters disagreed with the proposed work RVU of 10.25 for CPT code 52601. Commenters stated that CPT code 52601 has been the standard of surgical management for benign prostatic hyperplasia (BPH) and that the typical operative time for the procedure has not changed and it demands continuous mental focus, physical effort, and advanced technical skill. Commenters stated that the proposed work RVU constituted a reduction of nearly 25 percent in payment and represented a serious miscalculation in the intensity and complexity of performing the service. Commenters stated that a reduction in payment risked disincentivizing urologists from providing these services, could pressure physicians to alter treatment recommendations, and undermined quality care for patients. Commenters recommended CMS to maintain the current work RVU of 13.16 for CPT code 52601 and to increase the work RVU of all other codes in the family by 31.6 percent (13.16 divided by 10.00) to provide fair and equitable compensation for the broad range of BPH treatments that urologists deliver.

Response: We disagree with the commenters and continue to believe that the proposed work RVU of 10.00, based on the RUC recommendation, remains the most accurate valuation for CPT code 52601. The surveyed intraservice work time for CPT code 52601 is decreasing from 75 minutes to 60 minutes, and although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. Given this reduction in surveyed work time, we do not believe that it would be appropriate to maintain the current work RVU of 13.16 for CPT code 52601; it is therefore not the case that the typical operative type for the procedure is unchanged as many commenters suggested. Similarly, we do not agree that it would be accurate or maintain relativity to increase the work RVU of all other codes in this family by 31 percent which would result in anomalously high intensity values. We also note that the proposed work RVU of 10.00 brings the intensity of CPT code 52601 into alignment with the rest of this code family, as well as into alignment with many other 90-day global services elsewhere on the PFS.

Comment: Several commenters disagreed with the proposed work RVU of 13.00 for CPT code 52649 based on a crosswalk to CPT code 53500. Commenters stated that the 30-minute decrease in intraservice time from when this code was last surveyed in 2010 is the result of the diffusion of skilled surgeons performing this procedure nationally, and the increase in the size of the typical prostate being treated with laser enucleation has led to a significant increase in procedural intensity. A commenter stated that the reduction in time likely reflects advancements in technology and surgeon efficiency starting at month 1 of follow-up and remained improved for the entire follow-up period, rather than diminished work intensity. Commenters stated that CPT code 52649 should not be crosswalked to CPT code 53500, as CPT code 52649 is much more intense and complex to perform since it requires careful preservation of the prostatic capsule and bladder neck to prevent the formation of recto-urethral fistulae and bladder neck injury resulting in significant patient morbidity. Commenters stated that visualization is typically far superior when performing

CPT code 53500 compared to CPT code 52649, and that there is no component of tissue morcellation with a rotational sharp-bladed device at all in CPT code 53500. Commenters requested that CMS finalize the RUC's recommended work RVU of 14.56 for CPT code 52649.

Response: We disagree with the commenters and continue to believe that the proposed work RVU of 13.00 is the most accurate valuation for CPT code 52649. The surveyed intraservice work time for CPT code 52649 is decreasing from 120 minutes to 90 minutes, and although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. Given this reduction in surveyed work time, we do not believe that it would be appropriate to maintain the current work RVU of 14.56 for CPT code 52649, which would result in a significant increase in intensity and place the code out of alignment with the rest of its family.

We also disagree with the commenters that CPT code 53500 is an inappropriate choice for a crosswalk code at the proposed work RVU of 13.00. CPT code 53500 is a transvaginal urethrolysis procedure including cystourethroscopy, with the same intraservice time of 90 minutes and a slightly longer total time (289 minutes as compared with 263 minutes) than CPT code 52649. CPT code 53500 typically requires sutures to close its transvaginal incision and carries risk of complications such as bleeding and urethral or bladder injury; we disagree that this procedure constitutes significantly less intensity as the commenters suggested. Furthermore, we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, we do not agree that codes must share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk. As such, we continue to believe that CPT code 53500 is an appropriate choice to use as a valuation crosswalk for CPT code 52649.

Comment: A commenter stated that CPT code 52649 should have a work RVU more aligned with the work RVU of CPT code 55867 at 19.53. The commenter stated that this valuation would appropriately reflect its technical complexity, equivalent anatomical outcomes to CPT code 55867, and alignment with cross-specialty benchmarks like knee arthroplasty (CPT code 27447), while accounting for the procedure's high skill demands, precision in endoscopic enucleation, and proven long-term efficacy in symptom relief and durability. The commenter also requested that CMS not increase the work valuation for CPT codes 52441 and 52442 which would penalize value and durability and encourage use of an index service that offloads costs into future episodes.

Response: As we stated previously in this section, we continue to believe that the proposed work RVU of 13.00 is the most accurate valuation for CPT code 52649. CPT code 55867 was also reviewed in this same CY 2026 PFS final rule, with a surveyed intraservice time of 180 minutes and a total time of 372 minutes. These work times are substantially longer than the intraservice time (90 minutes) and total time (263 minutes) of CPT code 52649; since the two components of work are time and intensity, and CPT code 55867 has double the intraservice work time, this accounts for the difference in the proposed work RVUs (13.00 and 19.53) of these two codes. Assigning a work RVU of 19.53 to CPT code 52649 would not be typical for this service and would create a rank order anomaly in terms of intensity. As for CPT codes 52441 and 52442, we did not make any proposals associated with them in this rule.

Comment: A commenter disagreed with the proposed work RVU of 10.25 for CPT code 52597 and requested a work RVU of 13.00 or 14.00 instead. The commenter stated that they were providing a new, robust empiric source of information based on an independent survey that yielded 163 responses with broad geographic representation from 33 jurisdictions. The commenter stated that the work RVUs aligned very closely between the 2024 targeted AMA RUC survey respondents and the independent 2025 real world attestation survey across the full spectrum of percentiles, with 25th percentile work RVUs of 13.00 and 14.00 respectively. The commenter also stated that additional empiric information from the clinical literature highlights the similarities in the duration and intensity of physician work between CPT code 52597 and laser enucleation of the prostate, which is typically performed with a Holmium laser (HoLEP), and coded as CPT code 52649. The commenter stated that these clinical similarities suggested that CPT code 52597 should be valued similarly to CPT code 52649 at a work RVU around 13.00 and not similarly to CPT code 53854 (Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy) at a work RVU of 5.93.

Response: We appreciate the submission of this additional survey data by the commenter. However, we disagree with the commenters and continue to believe that the proposed work RVU of 10.25, based on the RUC recommendation, remains the most accurate valuation for CPT code 52597. The RUC has a long history of using a mixture of targeted and random survey respondents for their survey process, as the targeted survey respondents who have personal experience with the procedure in question tend to overestimate its intensity. Our intention in seeking additional information is not to privilege once source over the other. Prioritizing the results of a targeted survey over the data from the data generated by random respondents would not be methodologically appropriate and could lead to inaccurate valuations.

We also have serious concerns about the specific independent survey data submitted by the commenter regarding CPT code 52597. It appears that this survey did not investigate the work times associated with CPT code 52597 and instead questioned the respondents what work RVU their hospital had paid them for performing the procedure. This is a reversal of our methodology for work valuation, in which the work RVU is derived based on both surveyed time data and the intensity of furnishing the service itself. Although we appreciate that the commenter attempted to achieve a broad geographic representation, we also have concerns that this survey methodology overlooks potential geographic variations in payment as well as potential payment markups applied by hospitals.

We continue to believe that the proposed work RVU of 10.25 remains the most accurate valuation for CPT code 52597. Assigning a work RVU of 13.00 or 14.00 for CPT code 52597 as requested by the commenter would create a rank order anomaly within the rest of the code family, as CPT code 52597 would have roughly double the intensity of its peer codes. We do not believe that this would be typical for the procedure and therefore continue to believe that the proposed valuation of 10.25 is most accurate.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter stated that they were concerned that updating the price of the cystoscopy visit supply

pack (SA058) from $113.70 to $37.63 would cause drastic decreases in payment for physicians performing cystoscopy services in the office setting. The commenter stated that even though CMS finalized a 4-year phased transition of the SA058 pricing to soften the impact, the cut remains severe and that CMS should ensure the updated supply pack and equipment times accurately reflect true office costs.

Response: We agree with the commenter on the importance of ensuring accuracy in the pricing of supplies and supply packs. This is why we finalized an update to the pricing of the SA058 supply pack in the CY 2025 final rule to ensure that the price of the full pack matched the price of its individual components. We also finalized the use of a 4- year transition to allow practitioners to adjust to the updated pricing of these supplies (89 FR 97727). We remain open to the submission of additional data regarding the pricing of the SA058 supply pack from interested parties.

Comment: Several commenters agreed with our direct PE refinements to CPT code 52648.

Response: We appreciate the support for our proposals from the commenters.

After consideration of the comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Transurethral Robotic- assisted Resection of Prostate family as proposed. (13) Cystourethroscopy (CPT Code 52443)

At the September 2024 CPT Editorial Panel Meeting, CPT code 0619T (Cystourethroscopy with transurethral anterior prostate commissurotomy and drug delivery, including transrectal ultrasound and fluoroscopy, when performed) was deleted and replaced with CPT code 52443, which describes an endoscopic procedure for the management of benign prostatic enlargement that entails using both a non-medication-coated and a medication-coated balloon to open the prostatic urethra. CPT code 52443 (Cystourethroscopy with initial transurethral anterior prostate commissurotomy with a non-drug-coated balloon catheter followed by therapeutic drug delivery into the prostate by a drug-coated balloon catheter, including transrectal ultrasound and fluoroscopy, when performed) was surveyed at the January 2025 AMA RUC meeting.

We proposed the RUC-recommended work RVU of 3.62 for CPT code 52443. For direct PE, we proposed to refine the clinical labor associated with clinical activity CA023 (Monitor patient following procedure/service, no multitasking) to 0 minutes for CPT code 52443. We note that the RUC-recommended a direct crosswalk of most clinical labor times for CPT code 52443 based on reference CPT code 52441 (Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant), however, the PE Summary of Recommendations for CPT code 52443 only describes patient monitoring activities done while multi-tasking and does not describe any no- multitasking (1:1) patient monitoring time (clinical activity code CA023) like it was described in the PE SOR for CPT code 52441, reviewed for CY 2020 PFS rulemaking. We therefore proposed to remove this clinical labor time.

We also disagreed with the RUC-recommended 40 minutes for the clinical labor associated with clinical activity CA025 (Clean scope) and proposed to refine CA025 to the standard 30 minutes for a flexible scope. We would like to note that, while the PE SOR for CPT code 52443 did not justify non-standard times for clinical activities CA016 (Prepare, set-up and start IV, initial positioning and monitoring of patient) and CA017 (Sedate/apply anesthesia) of 2 minutes, we did not propose to refine these clinical activity times because there was a robust explanation of these non-standard times in the PE SOR for CPT code 52441, which is a clinically similar endoscopy code requiring positioning and anesthetic activities that warrant the non-standard times for CPT codes 52441 and 52443.

For medical supplies, we proposed to remove the SM022 (sanitizing cloth-wipe (patient)) supply because there are five of these cloth wipes included in the SA058 supply (pack, urology cystoscopy visit).

For equipment times, we proposed to refine the time for the ES031 (scope video system (monitor, processor, digital capture, cart, printer, LED light)) and ES018 (fiberscope, flexible, cystoscopy) equipment items to account for the clinical labor times that should be included in the standard scope systems and scope equipment formulas. We disagree with the RUC-recommended 64 minutes for ES031 and ES018, and we proposed to refine ES031 to 52 minutes and ES018 to 79 minutes in accordance with our standard equipment time formulas for scopes and scope video systems. We proposed all other direct PE inputs for CPT code 52443.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Commenters supported our proposal of the RUC recommended work RVU for CPT code 52443 and the non-standard clinical activity times of 5 minutes for CA016 and CA017, compared to the standard time of 2 minutes.

Response: We appreciate the commenters for their support.

Comment: Many commenters disagreed with our proposed work RVU of 3.62 for CPT code 52443. The commenters claimed that the proposed 3.62 work RVU did not accurately reflect the complexity, time, and expertise required to perform this procedure safely and effectively. Commenters noted that compared to other minimally invasive BPH treatments, balloon dilation requires careful patient selection and precise execution during and immediately after the procedure. For example, the physician must perform a transrectal ultrasound before the procedure to measure the length of the prostate. Commenters claimed that without fair and adequate compensation, many urologists may not be able to provide this treatment option to patients who stand to benefit. Some commenters recommended changing the work RVU to 6.84, which they said better aligns with experience performing the Urolift procedure described by CPT code 52441 and should be used as a direct crosswalk. Other commenters referenced the American Urological Association's (AUA) recommendation of 4.50 work RVUs as a better reflection of the work associated with CPT code 52443. Another commenter disagreed with the work RVU crosswalk from CPT code 52443 to CPT code 52441, stating that it should not have been included on the RSL (reference service list) because the valuation of CPT code 52441 is too low.

Response: We appreciate the commenters for their feedback. However, we continue to believe that our proposed work RVU of 3.62, based on the RUC recommendation, remains the most accurate valuation for CPT code 52443. We received a wide range of possible work RVUs for CPT code 52443. Some commenters recommended work RVUs of 4.50 to as high as 8.50. The majority of commenters recommended work RVUs at or above 7.44, which is more than double the RUC's recommended value, higher than the RUC survey's 75th percentile value, and would break relativity with an anomalously high intensity value. We note that procedures with 30 minutes of intraservice time typically are not

valued at a work RVU of 7.44 or higher, and the cystourethroscopy procedure described by CPT code 52443 does not contain the kind of life-threatening patient morbidities which would warrant an outlier intensity valuation.

We wish to clarify for the commenter who claimed that CPT code 52441 should not have been included on the RUC survey for CPT code 52443 that RUC survey respondents did not have to match CPT code 52443 with CPT code 52441; they had the option to match CPT code 52443 to a code with a higher value, if warranted. It is also important to note that the RSL does not dictate what value comes out of the survey or what value gets recommended to CMS, its purpose is to serve as a tool for the individuals filling out the surveys. We remind commenters that CMS has no involvement with the choice of RSL codes or the administration of the RUC's surveys.

Comment: Commenters disagreed with the CMS proposal to refine the clinical labor associated with clinical activity CA023 (Monitor patient following procedure/service, no multitasking) from 5 minutes to 0 minutes. Commenters stated that like the reference code, CPT code 52441, CPT code 52443 is a cystoscopic procedure for the treatment of benign prostatic enlargement. The commenters claimed the typical patient needs to be closely monitored for bleeding, uncontrolled pain and other post-procedural complications in the immediate post-service period when performed in the non-facility setting. Commenters stated that due to the invasive nature of the procedure, typical patients will also need to have their vital signs closely monitored post-service. The commenters recommended 5 additional minutes of non-multi-tasking time to allow clinical staff to best monitor the typically elderly patient having an invasive non-facility procedure to open the prostate.

Response: We appreciate the additional information provided by the commenters regarding the clinical activities associated with CA023. We agree with the commenter that 5 minutes would be more appropriate to closely monitor for bleeding, uncontrolled pain and other post- procedural complications, therefore, we are finalizing the RUC- recommended 5 minutes for CA023 for CPT code 52443.

Comment: Commenters disagreed with the CMS proposal to refine clinical activity CA025 (Clean scope) from the RUC-recommended 40 minutes to the CMS standard of 30 minutes for a flexible scope. They stated that two scopes are used during this procedure, including a two scopes are a transrectal ultrasound probe, therefore the 10 additional minutes was needed for CA025 to clean the second scope, . The commenters stated that the extra 10 minutes is directly tied to the second scope used.

Response: After reviewing the comments, we appreciate the additional information provided about the second scope to support the need for 10 minutes beyond the standard 30 minutes for CA025 for CPT code 52443, and note that 10 minutes of CA025 conforms with our standard cleaning time for a rigid scope, such as a transrectal ultrasound probe. Therefore, we are finalizing 40 minutes total of clinical activity time for CA025 for CPT code 52443 to account for the 30 minutes to clean ES018 and 10 minutes to clean the transrectal ultrasound probe. Upon initial review of the PE SOR and RUC-recommended PE inputs, we note that a second scope was not included in the direct PE for CPT code 52443. Given the additional information provided by the commenter, we assume that EQ250 (ultrasound unit, portable) was used as a substitution because there is not a specific equipment code for a transrectal ultrasound probe (rather than recommending a new equipment type for this code only), therefore, we are finalizing 59 minutes for EQ250 instead of the RUC-recommended 64 minutes to conform with the standard scope equipment formula, which includes the 10 minutes of CA025 attributable to cleaning that rigid scope. We are also finalizing the proposed equipment time of 79 minutes for ES018, which includes the 30 minutes of CA025 attributable to cleaning that flexible scope.

Comment: Commenters disagreed with the removal of the SM021 (sanitizing cloth-wipe (patient)) supply, which they stated was appropriate for this input. They clarified that SM022 refers to sanitizing wipes for surfaces and equipment, noting that four wipes are included to wipe down all surfaces involved in the delivery of patient care, including patient beds, equipment tables, and ultrasound equipment at the conclusion of the procedure. An additional SM021 sanitizing cloth-wipe (patient) is included instead of the five patient wipes included in the standard cystoscopy pack due to the requirement for this procedure to also place a transrectal ultrasound probe. Notably, the additional wipe is utilized to clean the perirectal area, which is not typically required in standard cystoscopy.

Response: We appreciate the additional information provided by the commenters. In response to public comments, we are not finalizing our proposed refinement and instead are finalizing the RUC-recommended inclusion of a single SM021 supply, due to the use of the transrectal ultrasound probe which requires an additional cloth wipe for the patient.

Comment: Commenters disagreed with the scope video system (ES031) equipment time refinement from 64 minutes to 52 minutes and requested that CMS finalize the RUC recommendation of 64 minutes, which they stated was the appropriate value for this input. They also disagreed with the CMS proposal to refine the equipment times for the flexible cystoscopy fiberscope (ES018) from 64 minutes to 79 minutes for CPT code 52443. A commenter recommended 64 minutes of equipment time for both ES031 and ES018.

Response: After reviewing the comments, we are still not convinced that the information provided would support the need for equipment time to increase from a standard equipment time of 52 minutes to 64 minutes for ES031. Also, based on standard scope equipment time for ES018, we continue to believe that 79 minutes is appropriate, and that the recommended 64 minutes would not be typical for the procedure. The equipment time requested by the commenters was based on the RUC recommendations for this code family, which improperly applied the default equipment time formula by including all of the clinical labor associated with tasks that take place in the preservice portion of the service period. We instead proposed to apply our standard equipment time formula for scopes (ES018) and scope video systems (ES031), which we note resulted in a decrease for the ES031 equipment but an increase for the ES018 equipment. Therefore, for CPT code 52443, we are finalizing our proposed equipment time refinement of 52 minutes for ES031 and equipment time refinement of 79 minutes for ES018.

After consideration of the public comments, we are finalizing the RUC-recommended work RVU and direct PE inputs for CPT code 52443 as proposed with the following exceptions where we are finalizing the following RUC recommended direct PE inputs: 5 minutes for CA023 and the inclusion of a single SM021 supply. (14) Prostate Biopsy Services (CPT Codes 55705, 55706, 55707, 55708, 55709, 55710, 55711, 55712, 55713, 55714, 55715, and 76872)

At the April 2022 Relativity Assessment Workgroup (RAW), prostate biopsy services were reviewed and

identified as services performed by the same physician on the same date of service 75 percent of the time or more. As a result of that review, the RAW requested action plans for September 2022 to determine if specific code bundling solutions should occur for CPT codes 55700 (Biopsy, prostate; needle or punch, single or multiple, any approach) and CPT code 76872 (Ultrasound, transrectal;). The RAW referred that issue to the CPT Editorial Panel for revision of descriptors and for clarity in reporting CPT code 55700 with CPT code 76872. At the May 2024 CPT Editorial Panel meeting, CPT deleted existing CPT code 55700, revised CPT codes 55705 (Biopsy, prostate; any approach, non-imaging- guided) and 76872 and added 9 new codes that clarify reporting for prostate biopsies and the imaging procedures that accompany them.

CPT codes 55705, 55706 (Biopsies, prostate, needle, transperineal, stereotactic template guided saturation sampling, including imaging guidance), 55707 (Biopsy, prostate, transrectal, ultrasound-guided (ie, sextant), ultrasound-localized), 55708 (Biopsy, prostate, transrectal, ultrasound-guided (ie, sextant) with MRI-fusion guidance), 55709 (Biopsy, prostate, transperineal, ultrasound-guided (ie, sextant), ultrasound-localized), 55710 (Biopsy, prostate, transperineal, ultrasound-guided (ie, sextant) with MRI-fusion guidance), 55711 (Biopsy, prostate, transrectal, MRI-ultrasound-fusion guided, targeted lesion(s) only), 55712 (Biopsy, prostate, transperineal, MRI- ultrasound-fusion guided, targeted lesion(s) only, first targeted lesion), 55713 (Biopsy, prostate, in-bore CT- or MRI-guided (ie, sextant), with biopsy of additional targeted lesion(s), first targeted lesion), 55714 (Biopsy, prostate, in-bore CT- or MRI-guided targeted lesion(s) only, first targeted lesion), and 55715 (Biopsy, prostate, each additional, MRI-ultrasound fusion or in-bore CT- or MRI-guided targeted lesion (List separately in addition to code for primary procedure)), and 76872 were surveyed at the September 2024 RUC meeting.

We proposed the RUC-recommended work RVUs for all twelve CPT codes in this family. We proposed a work RVU of 1.93 for CPT code 55705, a work RVU of 4.27 for CPT code 55706, a work RVU of 2.63 for CPT code 55707, a work RVU of 3.39 for CPT code 55708, a work RVU of 3.23 for CPT code 55709, a work RVU of 3.81 for CPT code 55710, a work RVU of 2.61 for CPT code 55711, a work RVU of 3.10 for CPT code 55712, a work RVU of 4.00 for CPT code 55713, a work RVU of 3.62 for CPT code 55714, a work RVU of 1.05 for CPT code 55715, and a work RVU of 0.67 for CPT code 76872.

We proposed the RUC-recommended direct PE inputs for all of the codes in this family.

We received public comments on prostate biopsy services. The following is a summary of the comments we received and our responses.

Comment: The commenters supported our proposed values for prostate biopsy services and stated that CMS' changes recognized the added complexity and equipment involved in modern prostate cancer diagnosis. Commenters recommended that CMS monitor the use and outcomes of these new procedures and be ready to make refinements.

Response: We appreciate the comments and after consideration of public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Prostate Biopsy Services family as proposed. (15) Laparoscopic Prostatectomy (CPT Codes 55840, 55842, 55845, 55866, 55867, 55868, and 55869)

In April 2023, the RUC's Relativity Assessment Workgroup identified CPT codes 38571 (Laparoscopy, surgical; with bilateral total pelvic lymphadenectomy) and 55866 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed) as typically reported together 75 percent or more based on 2021 Medicare claims data and referred them to the CPT Editorial Panel to possibly develop a code bundling solution. In May 2024, the CPT Editorial Panel created two new codes to report laparoscopic prostatectomy with lymph node biopsy(ies) (limited pelvic lymphadenectomy) and with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes, respectively: CPT code 55868 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed; with lymph node biopsy(ies) (limited pelvic lymphadenectomy) and 55869 ((Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes). These new codes were surveyed along with the rest of the family, CPT code 55840 (Prostatectomy, retropubic radical, with or without nerve sparing), 55842 (Prostatectomy, retropubic radical, with or without nerve sparing; with lymph:node biopsy(s) (limited pelvic lymphadenectomy)), 55845 (Prostatectomy, retropubic radical, with or without nerve sparing; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes), 55866 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed), and 55867 (Laparoscopy, surgical prostatectomy, simple subtotal (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy), includes robotic assistance, when performed) at the September 2024 RUC meeting.

We proposed the RUC's recommended work RVU for five of the six codes in the Laparoscopic Prostatectomy family. We proposed a work RVU of 21.36 for CPT code 55840, a work RVU of 21.36 for CPT code 55842, a work RVU of 25.18 for CPT code 55845, a work RVU of 22.46 for CPT code 55866, a work RVU of 22.46 for CPT code 55868, and a work RVU of 19.53 for CPT code 55867.

We disagree with the RUC's recommended work RVU of 29.35 for CPT code 55869 and we are instead proposing a work RVU of 27.41 based on a crosswalk to CPT code 50543 (Laparoscopy, surgical; partial nephrectomy). The RUC's recommended work RVU of 29.35 is based on a crosswalk to CPT code 27059 (Radical resection of tumor (for example, sarcoma), soft tissue of pelvis and hip area; 5 cm or greater). However, CPT code 27059 is a procedure typically performed on an inpatient basis, with nearly 200 minutes of additional total time higher than the surveyed work time for CPT code 55869 (608 minutes as compared with 434 minutes), due to the inclusion of five inpatient office visits in its global period. CPT code 55869 will typically be performed on an outpatient basis and does not contain any inpatient office visits in its global period, which leads us to believe that CPT code 27059 is not the most accurate choice of CPT code for a valuation crosswalk.

Instead, we believe that it is more accurate to propose a work RVU of 27.41 for CPT code 55869 based on the crosswalk to CPT code 50543. This crosswalk code is another type of surgical laparoscopy which more closely matches the intraservice work time (240 minutes against 230 minutes) and total work time (557 minutes against 434 minutes) of CPT code 55869. We also note that the intensity of CPT code 55869 is anomalously high in relation to the rest of this code family at the RUC's recommended work RVU of 29.35, roughly 30-40 percent higher

than any of its peer codes. While we agree that CPT code 55869 should have the highest intensity amongst this group of codes, we believe that our proposed work RVU of 27.41 reflects a more accurate intensity relative to the rest of the family.

For the direct PE inputs, we proposed to correct what appears to be an error in the recommendations for CPT code 55867. The RUC-recommended 106 minutes of clinical labor time for the CA039 (Post-operative visits (total time)) activity based on two Level 4 office visits included in the global period for CPT code 55867. However, this CPT code instead contains one Level 3 and one Level 4 office visit which sum to 89 minutes of clinical labor time, not 106 minutes. We proposed to make this correction to the CA039 clinical labor time for CPT code 55867, which also carries over to the equipment time for the power table (EF031) and the surgical light (EF014). We proposed the direct PE inputs as recommended by the RUC in all other cases for this code family.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters disagreed with the proposed work RVU of 27.41 for CPT code 55869 and stated that CMS should instead finalize the RUC-recommended work RVU of 29.35. Commenters stated that CPT code 55869 is significantly more intense than the other services in this code family and the RUC proposed value accurately accounted for this. Commenters stated that the complete extended bilateral pelvic lymph node dissection described by CPT code 55869 adds significant technical complexity and explains the increase in intraservice time for this procedure compared to CPT code 55868. Commenters stated that CPT code 55869 involves not only removal of an organ (prostatectomy) but it also involves a comprehensive lymph node dissection. Commenters also stated that the typical patient population for CPT code 55869 have more advanced prostate cancer compared to patients undergoing other procedures in this code family. Commenters acknowledged that there is a relative dearth of potential crosswalk codes to match CPT code 55869 but still maintained that the RUC's selection of CPT code 27059 was a better crosswalk choice at a work RVU of 29.35.

Response: We disagree with the commenters and continue to believe that our proposed work RVU of 27.41, based on a crosswalk to CPT code 50543, is the most accurate valuation for this service. As we noted in the proposed rule, the RUC-recommended crosswalk (CPT code 27059) has nearly 200 minutes of additional total time higher than the surveyed work time for CPT code 55869 (608 minutes as compared with 434 minutes). This crosswalk code is also a radical resection of a tumor, which is less of a clinical match than our choice of CPT 50543 (another type of surgical laparoscopy). While we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another, and that codes do not necessarily need to share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk, we believe that our choice of crosswalk code is a better match both in terms of total time and clinical similarity. We also continue to believe that the intensity of CPT code 55869 is anomalously high in relation to the rest of this code family at the RUC's recommended work RVU of 29.35. While we agree that CPT code 55869 should have the highest intensity amongst this group of codes, we do not agree that the intensity should be roughly 30 to 40 percent higher than any of its peer codes. At our proposed work RVU of 27.41, the intensity of CPT code 55869 is approximately 15 to 20 percent more intense than the other codes in the family which we believe more accurately captures the relationship between these procedures.

Comment: Several commenters concurred with the technical corrections proposed to the direct PE inputs for CPT code 55867 and stated that they appreciated the proposal of the direct practice expense inputs in all other cases for this code family.

Response: We appreciate the support from the commenters for our proposals.

After consideration of the comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Laparoscopic Prostatectomy family as proposed. (16) Endovascular Therapy With Imaging (CPT Codes 61624, 61626, 75894, and 75898)

In April 2022, the Relativity Assessment Workgroup (RAW) requested action plans to evaluate potential code bundling solutions for the following code pairs: CPT code 61624 (Transcatheter permanent occlusion or embolization [for example, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation], percutaneous, any method; central nervous system [intracranial, spinal cord]) and CPT code 75894 (Transcatheter therapy, embolization, any method, radiological supervision and interpretation), CPT code 61624 and CPT code 75898 (Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis), CPT code 61626 (Transcatheter permanent occlusion or embolization [that is., for tumor destruction, to achieve hemostasis, to occlude a vascular malformation], percutaneous, any method; non- central nervous system, head or neck [extracranial, brachiocephalic branch]) and CPT code 75894, and CPT code 61626 and CPT code 75898. The RUC reviewed these codes during the April 2024 RUC meeting. For CY 2026, the RUC-recommended a work RVU of 20.00 for CPT code 61624, an RVU of 15.31 for CPT code 61626, an RVU of 2.25 for CPT code 75894, and an RVU of 1.85 for CPT code 75898.

We proposed the RUC-recommended work RVU of 2.25 for CPT code 75894 and work RVU of 1.85 for CPT code 75898. However, we have concerns about the survey data due to the significant variations in both work values and intraservice times reported by respondents. These variations can suggest that the proposed RVU values at the 25th percentile may not accurately reflect the actual work involved in performing these services. As a result, we sought public comments regarding the proposed work RVUs for CPT codes 75894 and 75898.

We disagree with the RUC-recommended work RVUs for CPT codes 61624 and 61626. For CPT code 61624, we proposed a work RVU of 17.06 instead of the RUC-recommended 20.00. This proposal is based on a crosswalk to CPT code 49622 (Repair of parastomal hernia, any approach (that is, open, laparoscopic, robotic), initial or recurrent, including implantation of mesh or other prosthesis, when performed; incarcerated or strangulated). This crosswalk is supported by a range of CPT code 33224 (Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator)) with a work RVU of 9.04, 135 minutes intraservice time and 204 minutes total time, and CPT code 93590 (Percutaneous transcatheter closure of paravalvular leak; initial occlusion device, mitral valve.) with a work RVU of 21.70, 135 minutes intraservice time and 223 minutes total time. The intraservice time for CPT code 61624 decreased from 232 to 150 minutes, reducing by 82 minutes, and the total

time decreased from 362 to 246 minutes, reducing by 116 minutes, which supports a lower RVU. The lower work RVU proposal of 17.06 reflects the significant decreases in both intraservice time and total time for CPT code 61624.

For CPT code 61626, we proposed a work RVU of 13.46 instead of the RUC-recommended work RVU of 15.31. This proposal is based on a crosswalk to CPT code 49594 (Repair of anterior abdominal hernia[s] [that is, epigastric, incisional, ventral, umbilical, spigelian], any approach [that is, open, laparoscopic, robotic], initial, including implantation of mesh or other prosthesis when performed, total length of defect[s]; 3 cm to 10 cm, incarcerated or strangulated). This crosswalk is supported by a range of CPT code 55881 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation) with a work RVU of 9.80, 120 minutes intraservice time and 202 minutes total time, and CPT code 93580 (Percutaneous transcatheter closure of congenital interatrial communication (that is, Fontan fenestration, atrial septal defect) with implant) with a work RVU of 17.97, 120 minutes intraservice time and 210 minutes total time. The intraservice time for CPT code 61626 decreased by 53 minutes, and the total time decreased by 90 minutes, which supports a lower RVU. The lower work RVU proposal of 13.46 reflects the significant decreases in both intraservice time and total time for CPT code 61626.

We also proposed the RUC-recommended direct PE inputs for CPT codes 61624, 75894, and 75898 without refinement. However, we disagree with a few RUC-recommended direct PE inputs for CPT code 61626. We proposed to refine the clinical staff time for the CA011 activity 'Provide education/obtain consent' to the standard of 2 minutes for CPT code 61626. Since no rationale was provided in the PE Summary of Recommendations for extending clinical staff time beyond the standard 2 minutes for the CA011 activity, we believe 2 minutes is more appropriate than the RUC-recommended 5 minutes. We also proposed to change the medical supply quantity of the SD172 (guidewire, cerebral (Bentson)) supply from 1 to 0 because CPT code 61626 describes non- central nervous system procedures, while SD172 is a cerebral guidewire; thus, we believe this supply is not typically used in this service.

Additionally, regarding the clinical labor associated with CA024 (Clean room/equipment by clinical staff), we believe that the RUC's recommendation of 3 minutes for CA024 was not properly accounted for in one of the equipment time formula inputs. Therefore, we proposed an increase of 3 minutes to the equipment time for the angiography room (EL011), which increases from 124 to 127 minutes for this code to incorporate this missing time associated with the CA024 activity. Lastly, for CPT code 61626, the equipment time for the professional PACS workstation (ED053) should be half of the physician preservice time plus the full physician intraservice time. We believe this was an unintended error, and we proposed 152 minutes after rounding up from 151.5 minutes.

Although we proposed the direct PE inputs for CPT codes 75894 and 75898 without refinement, we have concerns over one of the RUC- recommended direct PE inputs, CA021 (Perform procedure/service--NOT directly related to physician work time) as the involvement of additional vascular interventional technologists remains unclear. According to the RUC recommendation, CPT codes 61624 and 61626 should not be reported in conjunction with CPT codes 75894 and 75898. And the RUC's recommendation of 60 minutes of clinical labor time for CPT code 75894 and 45 minutes for CPT code 75898 associated with the CA021 activity did not include an adequate explanation for these activities when CPT codes 75894 and 75898 are performed in the absence of CPT codes 61624 and 61626. Thus, we proposed the direct PE inputs as recommended by the RUC; however, due to the concerns mentioned above, we sought public comments regarding the recommended CA021 clinical labor time of 60 minutes for CPT code 75894 and 45 minutes for CPT code 75898, specifically what intraservice clinical labor time would be typical for these procedures.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters disagreed with the CMS proposed work RVU of 17.06 for CPT code 61624 and stated that CMS should instead finalize the RUC-recommended work RVU of 20.00. Commenters stated that the RUC's recommendation of the survey median work RVU of 20.00 more accurately described the physician work involved in furnishing this service, as CMS proposed a lower work RVU of 17.06 based on a crosswalk to CPT code 49622. Commenters noted that CPT code 49622 is not an appropriate crosswalk for CPT code 61624 because these two procedures are fundamentally different. Commenters emphasized that CPT code 61624 involves precise catheter-based embolization of cranial or spinal arteries and requires substantially greater physician work, specialized equipment, and highly trained neurointerventional nurses and technologists with expertise in radiation safety and neuro-monitoring. The commenters further noted that the procedure carries higher malpractice risk due to potential severe and permanent neurological injury. In contrast, CPT code 49622 is a straightforward intra- abdominal procedure of lower complexity that relies on standard operating room equipment and does not require similarly specialized staffs. They commenters stated that crosswalking CPT code 61624 to CPT code 49622 significantly undervalues the physician work, practice expense, and malpractice expense of this complex neurointerventional procedure. A commenter also noted that the survey value for CPT code 61624 is supported by its similarity in intensity to CPT code 61635, which involves vessel stenosis requiring stenting and has an intraservice time of 150 minutes and a total work RVU of 24.28. Many commenters recommended CMS to finalize the RUC-recommended work RVU of 20.00 for CPT code 61624, stating that this value more accurately reflects the physician work and intensity of this complex intracranial procedure.

Response: We appreciate the commenters for the additional information, and we agree with the commenters that crosswalking CPT code 61624 to CPT code 49622 undervalues the physician work, practice expense, and malpractice expense of this complex neurointerventional procedure. Therefore, we are finalizing a work RVU of 20.00 for CPT code 61624.

Comment: Several commenters also disagreed with the CMS proposed work RVU of 13.46 for CPT code 61626 and stated that CMS should instead finalize the RUC-recommended work RVU of 15.31. Commenters stated that the RUC's recommendation of the survey median work RVU of 15.31 more accurately described the physician work involved in furnishing this service. CMS proposed a lower work RVU of 13.46 based on a crosswalk to CPT code 49594 and commenters disagreed with this proposed work RVU; commenters stated that CMS' proposed crosswalk of CPT code 61626 to CPT code 49594 was inappropriate because the work of CPT code 61626 is much more intense than the proposed crosswalk of CPT code

49594. Specifically, commenters stated that CPT code 61626 is a complex neurointerventional embolization involving delicate head and neck vessels, requiring advanced angiographic imaging, microcatheter navigation, and management of catastrophic neurological complication risks, while CPT code 49594 is a standard hernia repair using standard operating room (OR) equipment and has minimal imaging needs. They also stated that CMS relied on inaccurate time estimates rather than the robust physician survey that supports a higher work RVU; therefore, commenters recommended CMS adopt the surveyed valuation and finalize a work RVU of 15.31.

Response: We appreciate the commenters for the additional information they provided. After consideration of public comments, we agree that CPT code 61626, which involves highly specialized neurovascular procedures performed under advanced imaging, entails substantially greater complexity and professional liability than CPT code 49597. The two procedures differ fundamentally in anatomy, technique, resource requirements, physician work, and risk. Thus, the RUC-recommended work RVU of 15.31 is appropriate and we are finalizing this work RVU for CPT code 61626.

Comment: Regarding CPT codes 75894 and 75898, commenters noted that these services were not surveyed in the Harvard Study and had never been reviewed by the RUC or CMS. Instead, the assigned times were input by CMS over 30 years ago at the inception of the RBRVS using an unknown methodology and, therefore, were not valid for relative comparison to the current survey or to other codes. Commenters emphasized that the current survey provides the most valid and accurate data appropriately capturing the work involved and suggested CMS finalize the recommended values of 2.25 for CPT code 75894 and 1.85 for CPT code 75898.

Response: We appreciate the commenters for the additional information they provided. With regards to codes with older time values, we agree that it is important to use the most recent data available regarding time, and we note that when many years have passed between time is measured, significant discrepancies can occur. However, we also believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The times currently associated with codes play a very important element in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had routinely been overestimated, this would undermine the relativity of the work RVUs on the PFS in general, given the process under which codes are often valued by comparisons to codes with similar times and it undermine the validity of the allocation of indirect PE RVUs to physician specialties across the PFS. Instead, we believe that it is crucial that the code valuation process take place with the understanding that the existing work times, used in the PFS ratesetting processes, are accurate. We recognize that adjusting work RVUs for changes in time is not always a straightforward process and that the intensity associated with changes in time is not necessarily always linear, which is why we apply various methodologies to identify several potential work values for individual codes. However, we want to reiterate that we believe it would be irresponsible to ignore changes in time based on the best data available and that we are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. For additional information regarding the use of old work time values in our methodology, we refer readers to our discussion of the subject in the CY 2017 final rule (81 FR 80273 through 80274).

After consideration of public comments, we continue to agree with the commenters that the RUC-recommended values at the 25th percentile accurately reflect the work involved in performing these services. We proposed the work RVU for both CPT code 75894 and CPT code 75898 at the RUC's recommended values, and we are finalizing as such for both codes.

Comment: Several commenters supported CMS' proposal of the recommended direct PE inputs for CPT codes 61624, 75894, and 75898. In addition, a commenter agreed with CMS' correction of the equipment formula inputs by adjusting 3 minutes to the equipment time for the angiography room (EL011), and agreed that the equipment time for the professional PACS workstation (ED053) should be half of the physician preservice time plus the full physician intraservice time leading to 152 minutes.

Response: We appreciate the support of our proposed policies from the commenters.

Comment: For CPT code 61626, commenters emphasized that 5 minutes of clinical staff time for the CA011 activity “Provide education/ obtain consent” was necessary, explaining that informed consent for CPT code 61626 requires detailed discussion of complex anatomy, high- risk complications, and procedure-specific considerations, making it far more time-intensive than the standard 2 minutes. On the other hand, another commenter agreed that clinical staff time for the CA011 code should be 2 minutes.

Response: We appreciate the commenters for their feedback. After reviewing the additional information received during the comment period, we agree with commenters that obtaining informed consent for neurovascular embolization procedures of the head and neck (CPT code 61626) requires additional time beyond the standard allocation. As commenters stated, these procedures involve comprehensive discussions of complex anatomy, serious potential risks including stroke, hemorrhage, and cranial nerve injuries, as well as high-stakes clinical conditions that necessitate thorough patient education. Therefore, we are finalizing the RUC-recommended 5 minutes of clinical labor time for the CA011 task for CPT code 61626; we note that this also increases most of the finalized equipment times by an additional 3 minutes.

Comment: Several commenters disagreed with the proposed deletion of the SD172 guidewire, cerebral (Bentson) supply in CPT code 61626. Commenters stated that the SD172 supply should be retained for patient safety, however if CMS insisted on its removal, then it should be replaced with an additional SD089 (guidewire, hydrophobic) supply.

Response: We disagree with the commenters and continue to believe that use of the SD172 guidewire would not be typical for CPT code 61626. Commenters did not explain why the use of a cerebral guidewire would be typical for a non-central nervous system procedure. However, due to the patient safety concerns identified by the commenters, we will add an additional SD089 guidewire to the direct PE inputs for CPT code 61626. This raises the total quantity of SD089 guidewires to two since CPT code 61626 already included one in its direct PE inputs.

Comment: For CPT codes 75894 and 75898, commenters provided additional information regarding CA021 (Perform procedure/service--NOT directly related to physician work time). They stated that the vascular interventional technologist works closely with the

physician to ensure appropriate imaging, adequate contrast to identify and review vessel details, and proper documentation of images. Commenters explained that technologists assist with imaging, supplies, and other tasks not directly associated with physician work time. The RUC stated that the recommended clinical staff times were supported by the RUC process, compelling evidence, and valid survey data for both codes. Commenters believe that the RUC-recommended times of 60 minutes for 75894 and 45 minutes for 75898 for CA021 were appropriate.

Response: We appreciate the additional information provided by the commenters regarding these clinical labor times. We proposed the RUC- recommended direct PE inputs for CPT codes 75894 and 75898, and we agree with commenters that the typical time for clinical activity CA021 (Perform procedure/service--NOT directly related to physician work time) is 60 minutes for CPT code 75894 and 45 minutes for CPT code 75898.

After consideration of the comments, we are finalizing the RUC- recommended work RVUs of 20.00 for CPT code 61624 and 15.31 for CPT code 61626, as well as work RVUs of 2.25 for CPT code 75894 and 1.85 for CPT code 75898. For CPT code 61626, we are finalizing a 5-minute allocation for clinical activity CA011 (providing education/obtaining consent). We are also finalizing the removal of supply item SD172 while adding an additional SD089 supply for CPT code 61626. Finally, we are finalizing the proposed direct practice expense inputs for CPT codes 75894 and 75898, including 60 and 45 minutes of CA021 clinical staff time, respectively. (17) Guided High Intensity Focused Ultrasound (CPT Code 61715)

In September 2023, the CPT Editorial Panel created a new Category I code to describe magnetic resonance image guided high intensity focused ultrasound (MRgFUS) intracranial ablation for treatment of a severe central tremor that is recalcitrant to other medical treatments for CY 2025 to replace the existing Category III code.

For CY 2025, we finalized the implementation of CPT code 61715 (Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation of target, intracranial, including stereotactic navigation and frame placement, when performed) as a global-only code with direct PE inputs in the facility setting only, as recommended by the RUC. After implementation, an interested party raised concerns about the lack of non-facility pricing for the new CPT code 61715, which would result in an untenable non-facility payment equal to the established facility payment. The interested party expressed concerns about access to the service in the non-facility setting given the facility payment rate and provided information about the appropriateness of the service in the non-facility setting and the payments set by the MACs for the predecessor code. The interested party stated that the predecessor code, CPT code 0398T, was paid $9,750 in the non-facility setting by one MAC, and for CY 2025, CPT code 61715 is paid at $1,180 in the non-facility setting due to being set equal to the facility payment, absent established non-facility PE RVUs. In an effort to temporarily resolve this issue for CY 2025, we implemented PC/TC splits for CPT code 61715, with contractor-pricing for the global and technical components, which would restore MAC discretion in pricing this service, including in the non-facility setting.

For CY 2026, we are seeking comments on non-facility pricing of this service to address the issue permanently. When considering potential crosswalk or reference codes for proposed direct PE inputs in the non-facility setting, we found all codes in the CPT code 615XX, 616XX, 617XX, and 618XX series are only valued in the facility setting and therefore were not tenable crosswalk codes for the non-facility direct PE. Additionally, there are MRI-guidance ultrasound ablation Category III codes that could be commensurate for non-facility direct PE, such as CPT code 0071T (Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue), and the previous predecessor code of CPT code 61715, CPT code 0398T, but they are/were contractor-priced under the PFS and do not have direct PE inputs for consideration.

We considered the prostate tissue MRI-guided ultrasound ablation codes, CPT codes 55881 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation) and 55882 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducer for delivery of thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed) as possible references because they are valued in the non-facility setting, but they include very high-cost disposable supplies and equipment that are specific to the CPT codes including SA136 (TULSA-PRO Disposable Kit) and EQ410 (TULSA-PRO TDC Cart), as well as some other direct PE inputs that may not be typical for CPT code 61715.

We also considered partial crosswalks of CPT codes for portions of CPT code 61715, such as CPT codes 77372 (Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based), 61800 (Application of stereotactic headframe for stereotactic radiosurgery (List separately in addition to code for primary procedure)), 61736 (Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; single trajectory for 1 simple lesion), and 61796 (Stereotactic radiosurgery (particle beam, gamma ray, or linear accelerator); 1 simple cranial lesion), but these codes have similar challenges related to the facility-only pricing and/or direct PE inputs that would not be applicable to or typical for CPT code 61715.

Given these challenges, we sought comments on appropriate non- facility direct PE inputs (clinical labor, disposable supplies, and medical equipment), and/or appropriate crosswalk codes for non-facility direct PE inputs for CPT code 61715. We would also consider a non- facility direct PE RVU crosswalk (in lieu of establishing specific non- facility direct PE inputs) for CPT code 61715 if that PE RVU could be substantiated by commenters. We note that we would not consider the MACs' established payment for the predecessor CPT code 0398T, particularly outlier payment rates, as substantiation for a PE RVU crosswalk for CPT code 61715 because there was significant variation among the MACs' payment for CPT code 0398T, some of which did not establish payment in the non-facility. Additionally, the established MAC payments do not differentiate between work, PE, and malpractice, making it difficult to establish a reasonable PE RVU for CPT code 61715 based on MAC payment alone. We received a second letter from an interested party stating that the previous non-facility payment rate for CPT code 0398T was $9,750, but we note that this payment rate is a significant outlier payment based on the reported range of payments from the MACs in April 2022. The range of reported payments in the facility setting reported by the MACs in April 2022 for

CPT code 0398T was $440.50 to $20,842.19, and $1,554.58 to $2,036.75 when the highest and lowest outliers were removed. Of note, when the outliers were removed from the range, the established payment by the MACs for CPT code 0398T are commensurate with the established national facility pricing of $1,180 for CPT code 61715. In April 2022, only one MAC reported an established non-facility payment of $2,036.75, therefore, we are unable to substantiate the interested parties' statement about a non-facility payment of $9,750 and sought comments on any additional information about the established MAC payments for CPT code 0398T that we could use to consider non-facility pricing for CPT code 61715.The second interested party requested contractor-pricing for CPT code 61715 for CY 2026. We note that, in an effort to temporarily resolve this issue for CY 2025, we implemented the PC/TC splits for CPT code 61715, with contractor-pricing for the global and technical components, to restore MAC discretion when it came to pricing this service. Therefore, for CY 2026, we sought comments on national pricing options in the non-facility setting to address it permanently. We also sought comments in the form of clinical evidence to support the appropriateness of this service in the non-facility setting and the appropriateness of the established PC/TC split for CPT code 61715.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Many commenters stated that the proposed reduction in malpractice RVUs from 7.54 to 1.31 for CPT code 61715 represented a dramatic decrease of more than $200 per procedure without clear justification. Commenters stated that this procedure is a complex, high-liability procedure involving stereotactic targeting within the brain under MRI guidance and that a drastic reduction underestimated the real-world malpractice risk physicians assume. The commenters suggested that CMS to maintain the 2025 malpractice RVUs until sufficient claims data and longer-term safety profiles became available to inform any downward adjustment.

Response: The proposed reduction to the MP RVU for CPT code 61715 was an unanticipated byproduct of the introduction of PC/TC splits that took place during CY 2025. CPT code 61715 was previously valued as a global service without professional and technical component splits; when we introduced these splits, we maintained the current RVUs (including the MP RVU) for the professional component even though it no longer included the technical component portion. When we calculated the proposed CY 2026 valuation for the professional component of CPT code 61715, the MP RVU underwent a significant decrease as the specialties in the claims data reporting only the professional service were different from the specialties that had been reporting the prior global version of the code. This decrease was also magnified as CPT code 61715 is a low volume service where small shifts in the specialty reporting can have an outsized effect on valuation.

To minimize these shifts in the allocation of indirect PE and MP RVUs, we therefore believe it would be more accurate to assign an expected specialty as part of our low volume services list as detailed in section II.B of this final rule. We are finalizing the addition of CPT code 61715 to this list with an expected specialty assignment of Neurosurgery, the most commonly reported specialty for its predecessor CPT code 0398T. We believe that this assignment will result in a more accurate and most stable MP RVU valuation for CPT code 61715.

Comment: Many commenters supported the establishment of non- facility PE RVUs for CPT code 61715 but did not offer specific information about the typical direct PE inputs or appropriate crosswalk codes that we could consider to establish PE RVUs in the non-facility setting. Many commenters expressed concern with non-facility pricing for this service, and stated that the service is not typically performed in the non-facility setting and should only be performed in a tertiary care hospital. Another commenter suggested that we should wait to address payment for CPT code 61715 until the AMA RUC is scheduled to review this code again in 2027. A commenter stated that, based on a detailed simulation of the PE inputs involved with CPT code 61715 in the non-facility setting, the PE RVU should be calculated at 606.74. The commenter stated that this calculation was based on 210 minutes of registered nurse (RN) labor and 240 minutes of MRI technologist labor, along with a series of additional supply and equipment items in addition to the ones that CMS had finalized in CY 2025 rulemaking. The commenter stated that if CMS declined to adopt this PE RVU, the commenter instead recommended that CMS set non-facility PE RVU for CPT code 61715 via a crosswalk to CPT code 27278 or CPT code 37277.

Response: We appreciate the commenters' feedback regarding non- facility PE RVUs for CPT code 61715. We welcome opportunities to discuss establishing non-facility pricing for this code but remind interested parties that more information is needed regarding typical direct PE inputs and/or more information about appropriate crosswalk codes to price CPT code 61715 in the non-facility setting. We disagree with the commenter that the direct PE inputs and recommended PE RVUs requested by the commenter would be typical for CPT code 61715. The commenter's valuation for this procedure would result in the highest PE RVU on the entire PFS, at approximately $21,000 after applying the proposed conversion factor, while the two suggested crosswalk codes would have a valuation around $13,000. We stated in the proposed rule that a requested $9,750 payment from an interested party appeared to be a major outlier for this service, and the range of reported payments in the facility setting reported by the MACs in April 2022 for predecessor CPT code 0398T was $1,554.58 to $2,036.75 when the highest and lowest outliers were removed. We remind interested parties that valuation under the PFS is based on the typical case which does not support valuations in this range for CPT code 61715.

Comment: Many commenters stated that the proposed efficiency adjustment should not be applied to CPT code 61715, as this code only received its initial valuation in 2025, and standard CMS practice has been to allow 3 years of real-world data before reassessing efficiency gains.

Response: We appreciate the feedback on the proposed efficiency adjustment; we note for the commenters that our discussion of the efficiency adjustment can be found above in section II.E.2.b.

After consideration of the comments, we did not receive enough information about typical non-facility direct PE inputs or reasonable crosswalk codes to finalize non-facility pricing for CPT code 61715 for CY 2026, therefore we are finalizing to maintain the facility pricing and coding structure for CPT code 61715 as proposed. We are also finalizing the addition of this code to the low volume services list with an expected specialty assignment of Neurosurgery as detailed above. We welcome opportunities to discuss establishing non-facility pricing, but remind interested parties that valuation under the PFS is based on the typical case.

(18) Percutaneous Interlaminar Lumbar Decompression (CPT Codes 62330 and 62331)

In September 2024, CPT created two new Category I codes to replace existing Category III code 0275T. CPT codes 62330 (Decompression, percutaneous, with partial removal of the ligamentum flavum, including laminotomy for access, epidurography, and imaging guidance (i.e., CT or fluoroscopy), bilateral; one insterspace, lumbar) and 61XX1 (Decompression, percutaneous, with partial removal of the ligamentum flavum, including laminotomy for access, epidurography, and imaging guidance (i.e., CT or fluoroscopy), bilateral; additional interspace(s), lumbar (List separately in addition to code for primary procedure) were surveyed for the January 2025 RUC meeting. CPT code 62287 (Decompression percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle-based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar) was not surveyed as part of the code family due to low utilization (approximately 100 claims in 2023 per the RUC). Specialty societies stated that a code change application requesting the deletion of CPT code 62287 will take place for the 2026 CPT cycle.

We proposed the RUC-recommended work RVUs for both CPT code 62330 (8.00) and CPT code 62331 (4.25) without refinement. We also proposed the RUC-recommended direct PE inputs without refinement for both CPT code 62330 and 62331.

We received comments on our proposals for this code family. The following is a summary of the comments we received and our responses.

Comment: Commenters were generally supportive of CMS' proposal of the RUC-recommended work RVUs and direct PE inputs for CPT codes 62330 and 62331. A commenter requested that CMS restore the RVUs for CPT code 62287, stating they believe it was inadvertently removed. Another commenter also encouraged CMS to ensure that the Medicare practitioner community is aware of the availability of these new codes by including them in the annual MLN Matters educational article containing a summary of the final PFS rule.

Response: We appreciate the commenters for their comments. Regarding the comment pertaining to CPT code 62287, we note that we have addressed this as a technical correction under the PE section of this final rule.

After consideration of the public comments, we are finalizing the work RVU values for the Percutaneous Interlaminar Lumbar Decompression code family (CPT codes 62330 and 62331) as proposed. We are also finalizing the direct PE inputs for CPT codes 62330 and 62331 as proposed. (19) Percutaneous Decompression of Median Nerve (CPT Code 64728)

In September 2024, the CPT Editorial Panel created a new CPT code to report percutaneous decompression of the median nerve at the carpal tunnel using ultrasound guidance and a balloon dilation device while transecting the transcarpal ligament: CPT code 64728 (Decompression; median nerve at the carpal tunnel, percutaneous, with intracarpal tunnel balloon dilation, including ultrasound guidance). For CY 2026, the RUC-recommended a work RVU of 2.70 for CPT code 64728.

We proposed the RUC-recommended work RVU of 2.70 for CPT code 64728. We would like to note that CPT code 64728 is a new technology procedure, previously reported with an unlisted code, and we received external input suggesting the RVU should be 6.00, which is much higher than the RUC recommendation. However, a review of similarly timed procedures does not support an RVU greater than the RUC recommendation of 2.70. The RUC's valuation for CPT code 64728 is very typical for a procedure code with the same work time values (that is, 20 minutes intraservice time and 57 minutes of total time) and has a typical intensity for this kind of procedure.

We proposed the RUC-recommended direct PE inputs for CPT code 64728 without refinement.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters agreed with CMS' proposal of the RUC- recommended work RVU and direct PE inputs for CPT code 64728.

Response: We appreciate the support for our proposals from the commenters.

Comment: Several commenters stated that the payment associated with the proposed work RVU of 2.70 for CPT code 64728 would not adequately reimburse practitioners for the time, effort, complexity, and expertise that go into providing this service. Commenters stated that given the profound impact ultrasound guided CTR procedures has on patients, it is crucial to maintain patient access to this minimally invasive approach that gives patients long-term relief, while allowing them to return to their daily activities due to the lack of a need for general or regional anesthesia and minimal recovery time. Commenters stated that this minimally invasive approach does not mean that the procedure itself is low effort and requested that the payment rate for CPT code 64728 be increased to c reflect the time, complexity and intensity of the work involved in performing this procedure.

Response: We appreciate the additional feedback from the commenters, many of whom described their firsthand experience with this procedure. However, we did not receive additional data from these commenters to indicate that CPT code 64728 typically requires additional time or intensity beyond what was provided by the RUC recommendations. As we noted in the proposed rule, a review of similarly timed procedures does not support a work RVU greater than the RUC recommendation of 2.70 and the RUC's valuation for CPT code 64728 is very typical for a procedure code with the same work time values. Therefore, we continue to believe that the proposed work RVU of 2.70 remains the most accurate valuation for CPT code 64728.

Comment: Several commenters stated that the RUC-recommended work RVU was unreliable because it was based in significant part on input from survey respondents with no experience performing this procedure, which skewed the credible survey responses from physicians with substantial real-world experience. Commenters stated that this resulted in a work RVU recommendation that was based on the incorrect assumption that a minimally invasive procedure takes less time and is less intensive to perform, which is not true and is the exact opposite of the situation for CPT code 64728. Commenters stated that using data from survey respondents with no experience performing CPT code 64728 skewed the data and led the RUC to select CPT code 51102 (Aspiration of bladder, with insertion of suprapubic catheter) for its valuation crosswalk, which was highly problematic because CPT code 51102 lacks critical elements of the survey procedure. Commenters stated that this was an inaccurate comparison for many reasons, including entirely different anatomy, risks, skills, and time required, but most foundationally, because continuous imaging is an integral part of CPT code 64728 and which is not an element of CPT code 51102.

Response: We disagree with the commenters and continue to believe

that the RUC's recommended work RVU of 2.70 is the most accurate valuation for CPT code 64728. The RUC has a long history of using a mixture of targeted and random survey respondents for their survey process, as the targeted survey respondents who have personal experience with the procedure in question tend to overestimate its intensity. Our intention in seeking additional information is not to privilege once source over the other. Prioritizing the results of a targeted survey over the data generated by random respondents would not be methodologically appropriate and could lead to inaccurate valuations.

We also believe that the RUC's use of CPT code 51102 for a valuation crosswalk was an accurate choice for CPT code 64728. CPT code 51102 shares the same intraservice work time of 20 minutes and a highly similar total work time (60 minutes against 57 minutes) when compared with CPT code 64728. While the procedures have significant clinical differences, we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, we do not agree that codes must share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk. Since the two components of work are time and intensity, and these two codes share highly similar work times along with comparable intensity, we believe that CPT code 51102 is an accurate choice for use as a valuation crosswalk.

Comment: Several commenters pointed to additional data sources separate from the RUC survey conducted for CPT code 64728. Commenters stated that there was additional randomized controlled trial data from the Walter Reed Medical Center which reported a mean intraservice time of 32.2 minutes as compared with 20 minutes from the RUC survey. In addition, commenters stated that an independent physician survey of CPT code 64728 was performed by a third party following the AMA RUC meeting in January 2025. Commenters stated that this independent survey had a robust response rate of 63 percent% with a median intraservice time of 25 minutes and a median total time of 65 minutes. Commenters stated that these times were similar to the targeted respondents from the RUC survey and stated that the participating physicians from the independent survey recommended a work RVU of 6.00 for CPT code 64728. An additional commenter stated that the work RVU for this code should be comparable to CPT codes 64721 at 4.85 or CPT code 29848 at 6.23.

Response: We appreciate the submission of these additional sources of data by the commenters. However, as stated above, we disagree with the commenters and continue to believe that the proposed work RVU of 2.70 remains the most accurate valuation for CPT code 64728. While we are intrigued by the use of randomized controlled trial data from institutions such as the Walter Reed Medical Center, we are skeptical that a mean intraservice time of 32 minutes is typical for CPT code 64728. This value would be higher than the 75th percentile results of the RUC survey, in both the random and targeted categories, as well as higher than the median intraservice time of the independent survey at 25 minutes. The patient population at Walter Reed may not be typical of the broader Medicare community which could explain this disparity in surveyed work time, we would be interested in additional information from interested parties as to the generalizability of data from Walter Reed to the Medicare population. As for the independent survey, we believe that its surveyed times are broadly comparable to the RUC's recommended times, with a finding of 25 minutes of intraservice time (against 20 minutes from the RUC) and 65 minutes of total time (against 57 minutes from the RUC). We believe that this additional data reinforces the notion that CPT code 64728 typically takes approximately 20-25 minutes of intraservice time and 60-65 minutes of total time to be performed. We greatly appreciate having this additional data source and we believe that these additional survey times support and reinforce the time values from the RUC's survey.

Regardless of whether we were to finalize 20 minutes or 25 minutes as the intraservice time for CPT code 64728, in neither case would the work RVU of 6.00 requested by the commenters be an accurate representation of the work associated with performing this procedure. As we noted in the proposed rule, a review of similarly timed procedures does not support a work RVU greater than the RUC recommendation of 2.70 and the RUC's valuation for CPT code 64728 is very typical for a procedure code with the same work time values. Assigning a work RVU of 6.00 would result in an anomalously high intensity for CPT code 64728 as compared to other services on the fee schedule. This valuation would create a major rank order anomaly and would not maintain relativity with other services on the PFS. Similarly, the suggested comparator codes from the commenter (CPT codes 64721 and 29848) are not appropriate choices for valuation crosswalks as they have greatly differing work time values. CPT code 64721 has 171 total minutes of total time while CPT code 29848 has 179 minutes of total time; by comparison, CPT code 64728 has 57 minutes of total time in the RUC survey and 65 minutes of total time in the independent survey. Since we are tasked by the statute with valuing work based on time and intensity, we do not believe it would be accurate to value CPT code 64728 comparably to other codes with so much greater work time.

We believe that the availability of these kinds of additional data sources can be a great asset in determining the valuation of service. We also believe that the specific case of CPT code 64728 highlights the importance of collecting data as part of a wider family of related codes, which allows for the assessment of relativity between related services. We want to emphasize that although we do not privilege the RUC's recommendations over other data sources, the requested work RVUs from the independent survey do not maintain relativity with other related services on the PFS, which is why we believe that the RUC's recommended work RVU of 2.70 is more accurate in this case. We welcome the submission of additional data regarding the work RVU and work time of CPT code 64728 for use in potential future rulemaking.

Comment: Several commenters stated that the proposed MP RVU for CPT code 64728 was extremely low and out of line with the malpractice expense for other carpal tunnel release procedures. Commenters stated that all three approaches--open, endoscopic, and ultrasound guided-- require avoiding injury to the same nerves and nerve branches adjacent to the transverse carpal ligament and involve the same risks. Commenters stated that the MP RVU for CPT code 64728 should be comparable to the MP RVUs for CPT codes 64721 and 29848, and recommended CMS to increase the MP RVU for 64728 to 1.25.

Response: We can clarify for the commenters that our valuation methodology does not attach a specific MP RVU to specific codes in the way that we propose and finalize work RVUs. MP RVUs are instead derived annually based on a formula that primarily utilizes the code's work RVU and the risk factors associated with the specialties that bill the code in the

claims data; for more information on the MP RVU methodology, we direct interested parties to Section II.M, Determination of Malpractice Relative Value Units (RVUs). In the specific case of CPT code 64728, this code has a significantly lower proposed work RVU (2.70) as compared with CPT codes 64721 (4.85) and 29848 (6.23), along with significantly lower total work time as detailed above, which explains why its proposed MP RVU was lower.

After consideration of the comments, we are finalizing the work RVU and direct PE inputs for CPT code 64728 as proposed. (20) Baroreflex Activation Therapy (CPT Codes 64654, 64655, 64656, 64657, 64658, 64659, 93145, and 93146)

Baroreflex activation therapy (BAT) treats heart failure symptoms and resistant hypertension by electrically stimulating carotid baroreceptors within the carotid artery. The BAT modulation system received FDA approval in August 2019, and the CPT Editorial Panel approved conversion from a Category III code set to a Category I code set at the September 2024 CPT Panel meeting through the creation of the following CPT codes: 64654 (Initial open implantation of baroreflex activation therapy (BAT) modulation system, including lead placement onto the carotid sinus, lead tunnelling, connection to a pulse generator placed in a distant subcutaneous pocket (that is, total system), and intraoperative interrogation and programming), 64655 (Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; lead only), 64656 (Revision or replacement of baroreflex activation therapy (BAT) modulation system, with intraoperative interrogation and programming; pulse generator only), 64657 (Removal of baroreflex activation therapy (BAT) modulation system; total system, including lead and pulse generator), 64658 (Removal of baroreflex activation therapy (BAT) modulation system; total system, including lead and pulse generator; lead only), 64659 (Removal of baroreflex activation therapy (BAT) modulation system; total system, including lead and pulse generator; pulse generator only), 93146 (Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (for example, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); with programming, including optimization of tolerated therapeutic level setting), and 93145 (Interrogation device evaluation (in person), carotid sinus baroreflex activation therapy (BAT) modulation system including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (for example, battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day); without programming). This code family describes the implantation, replacement, revision, removal and interrogation/programming of a BAT modulation system and was surveyed for the January 2025 RUC meeting.

We proposed the RUC's recommended work RVU for seven of the eight codes in the Baroreflex Activation Therapy family. We are proposing a work RVU of 11.00 for CPT code 64654, a work RVU of 11.30 for CPT code 64655, a work RVU of 8.01 for CPT code 64656, a work RVU of 12.13 for CPT code 64657, a work RVU of 8.95 for CPT code 64658, a work RVU of 8.23 for CPT code 64659, and a work RVU of 0.90 for CPT code 93146.

We disagree with the RUC's recommended work RVU of 0.79 for CPT code 93145 and we instead proposed a work RVU of 0.65 based on a crosswalk to CPT code 93279 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; single lead pacemaker system or leadless pacemaker system in one cardiac chamber), which was the top reference code from the survey. We believe that it is more accurate to base the work valuation for CPT code 93145 on this crosswalk to CPT code 93279 due to the close clinical similarity between the two procedures (both of them cardiac device evaluations) which share the same intraservice work time of 10 minutes and the same total work time of 22 minutes.

The RUC recommended the survey 25th percentile work RVU of 0.79 for CPT code 93145, stating that CPT code 93145 has a higher estimated intensity and complexity than the two key reference services (including CPT code 93279). However, we do not agree that CPT code 93145 should be valued at a higher work RVU based on the intensity for a clinically similar device evaluation code like CPT code 93279. The RUC's recommended work RVU of 0.79 results in an intensity for CPT code 93145 which is close to 40 percent higher than the intensity for peer CPT code 93146. We do not believe that this results in an accurate valuation for the two new codes given that CPT code 93145 describes cases where the BAT device is working properly and does not require adjustment, whereas CPT code 93146 describes cases where the BAT device is working properly but requires additional device programming. We believe that CPT code 93146 should have the higher intensity given the additional device programming required in this code to achieve optimal therapeutic levels for the BAT device. Therefore, we proposed a work RVU of 0.65 for CPT code 93145, which we believe reflects more accurate relativity between CPT code 93145 and CPT code 93146.

We proposed the direct PE inputs as recommended by the RUC for CPT codes 64654-64659. For CPT codes 93145 and 93146, we disagree with the RUC- recommended use of the RN (L051A) clinical labor type. These kinds of device evaluation procedures typically do not make use of RN clinical labor; for example, reference codes 93279 and 93281, which were used as a model for the direct PE inputs of these two new codes, both use a combination of the RN/LPN/MTA blend (L037D) and Medical/ Technical Assistant (L026A) clinical labor types. Therefore, we proposed to refine the clinical labor for CPT codes 93145 and 93146 from RN (L051A) to the RN/LPN/MTA blend (L037D); we proposed that the numerical values for each clinical labor input will remain the same, with only the staff type changing from L051A to L037D. We proposed the rest of the RUC-recommended PE inputs without refinement.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters stated that they appreciated CMS proposing the RUC-recommended work RVU and direct practice expense recommendations for CPT codes 64654, 64655, 64656, 64657, 64658 and 64659.

Response: We appreciate the support for our proposals from the commenters.

Comment: Several commenters disagreed with the proposed work RVU of 0.65 for CPT code 93145 and stated that CMS should instead finalize a work RVU of 0.79 based on the RUC recommendation. Commenters stated that the proposed work RVU of 0.65

relies too heavily on the comparison of measured intensity/complexity between CPT codes 93145 and 93146 and does not accurately account for the survey results. Commenters stated that a direct crosswalk to CPT code 93279 is inappropriate as CPT code 93145 is a new service for patients with chronic heart failure that was placed on the RUC's New Technology list to be re-reviewed in 3 years to ensure correct valuation, patient population and utilization assumptions. Commenters stated that CPT code 93145 has a higher estimated intensity/complexity than both key reference services and that the RUC recommended work RVU of 0.79 maintains relativity within this code family and across other similar codes.

Response: We disagree with the commenters and continue to believe that the proposed work RVU of 0.65 is a more accurate choice for CPT code 93145. We remind commenters that we are tasked by the statute with valuing work based on time and intensity; therefore, we believe that it is entirely appropriate to compare CPT codes 93145 and 93146 based on their respective intensities. Commenters did not explain why CPT code 93145 should be valued close to 40 percent higher than the intensity for peer CPT code 93146 despite being the version of the procedure that does not require additional device programming; we believe that this provides strong evidence that the RUC's recommended work RVU of 0.79 is overvalued. We also note for commenters that we are not ignoring the survey results, as the survey for CPT code 93145 resulted in identical time values as compared with the top reference code, CPT code 93279. Given their identical time values and clinically similar nature of both being device evaluation procedures, we believe that it is more accurate to value CPT codes 93145 and 93279 at the same work RVU of 0.65. We also note that this valuation assigns the same intensity to CPT codes 93145 and 93146, as opposed to the RUC recommendation that anomalously assigns CPT code 93145 significantly higher intensity.

Comment: Several commenters disagreed with the proposal to refine the clinical labor for CPT codes 93145 and 93146 from RN (L051A) to the RN/LPN/MTA blend (L037D). Commenters stated that CPT codes 93145 and 93146 must be performed by registered nurses (RNs) with specialized expertise in advanced heart failure management as the patients receiving BAT are not typical device patients. Commenters stated that evaluating and managing these patients during BAT device interrogation or programming requires a deep understanding of hemodynamics, pharmacology, and device interactions, which are all skills that are well beyond the scope of licensed practical nurses (LPNs) or medical technician assistants (MTAs). Commenters stated that the reprogramming and assessment during BAT follow-up visits are a complex and high-risk process, and it is not uncommon for patients to develop presyncope or syncope while settings are titrated. Commenters stated that the role of clinical staff under CPT codes 93279 and 93281 is fundamentally different and there is minimal independent clinical assessment or medical decision-making required; the difference in skill, responsibility, and clinical risk is dramatic. The commenters recommended CMS to finalize the original RUC recommendation that included the L051A RN clinical labor time for CPT codes 93145 and 93146.

Response: Based on the additional information provided by the commenters, we agree that there is a difference in the technical skill required for the clinical labor in CPT codes 93145 and 93146 as compared with CPT codes 93279 and 93281, and that the use of the RN clinical labor type would be typical for these procedures. We are therefore not finalizing our proposed refinement to convert the clinical labor for CPT codes 93145 and 93146 from RN (L051A) to the RN/ LPN/MTA blend (L037D) and will instead finalize the RUC-recommended RN clinical labor type for all of their clinical labor tasks.

After consideration of the comments, we are finalizing the work RVUs for all of the codes in the Baroreflex Activation Therapy family as proposed. We are also finalizing the direct PE inputs as proposed, with the exception of the change in clinical labor type for CPT codes 93145 and 93146 described above. (21) Percutaneous Electrical Nerve Field Stimulation (CPT Code 64567)

In September 2024, the CPT Editorial Panel created a new CPT code to report percutaneous electrical nerve field stimulation of cranial nerves: CPT code 64567 (Percutaneous electrical nerve field stimulation, cranial nerves, without implantation). For CY 2026, the RUC-recommended a work RVU of 1.50 for CPT code 64567.

We proposed the RUC-recommended work RVU of 1.50 for CPT code 64567, and the RUC-recommended direct PE inputs without refinement.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter stated that they appreciated the CMS proposal of the RUC recommendations for the work RVU, work time, and direct PE inputs for CPT code 64567.

Response: We appreciate the support for our proposals from the commenter.

After consideration of the comments, we are finalizing the work RVU and direct PE inputs for CPT code 64567 as proposed. (22) Laminotomy--Repair of Disc Defect (CPT Code 63032)

In September 2024, the CPT Editorial Panel created a new add-on code to report the repair of an annular defect by implantation of a bone anchored annular closure device after a laminotomy (hemilaminectomy): CPT code 63032 (Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc; with repair of annular defect by implantation of bone anchored annular closure device, including all imaging guidance, 1 interspace, lumbar (List separately in addition to code for primary procedure)). CPT codes 63030 (Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc; 1 interspace, lumbar) and 63035 (Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc; each additional interspace, cervical or lumbar (List separately in addition to code for primary procedure)) were identified as codes in the same family as CPT code 63032, but were recently surveyed in 2022 and discussed in the CY 2023 PFS final rule (87 FR 69495 through 64999). The specialty societies stated that the work for these procedures is unchanged and distinct from the work of the new code, and therefore only surveyed CPT code 63032.

For CY 2026, we proposed the RUC-recommended work RVU of 2.50 for CPT code 63032. There are no direct PE inputs for CPT code 63032.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: A commenter recommended that CMS increase the proposed malpractice RVU for CPT code 63032 to 2.19 as opposed to the proposed 0.78. The commenter

described the clinical tasks performed in CPT code 63032, involving the implantation of a novel FDA PMA-approved bone-anchored annular closure implant following a laminectomy/discectomy. The commenter stated that considering the additional risk not associated with the primary code (CPT code 63030), which does not involve the implantation of a permanent annular closure implant, the MP RVU should be increased for CPT code 63032.

Response: We would like to clarify that our valuation methodology does not attach a specific MP RVU to specific codes in the way that we propose and finalize work RVUs. MP RVUs are instead derived annually based on a formula that primarily utilizes the code's work RVU and the risk factors associated with the specialties that bill the code in the claims data; for more information on the MP RVU methodology, we direct interested parties to section II.M, Determination of Malpractice Relative Value Units (RVUs). In the specific case of CPT code 63032, this code has a significantly lower work RVU (2.50 compared to 12.00) and total work time (21 minutes compared to 305 minutes) as compared with CPT code 63030 which explains why its MP RVU is lower than the base code that it is billed with.

After consideration of the comments, we are finalizing the work RVU of 2.50 for CPT code 63032 as proposed. We proposed and we are finalizing no direct PE inputs for this code. (23) Cerebral Perfusion & CT Angiography-Head & Neck (CPT Codes 70496, 70498, 70471, 70472, and 70473).

In May 2024, the CPT Editorial Panel created three new codes for cerebral perfusion and CT angiography of the head and neck: CPT code 70471 (Computed tomographic angiography (CTA), head and neck, with contrast material(s), including noncontrast images, when performed, and image postprocessing), CPT code 70472 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed with concurrent CT or CT angiography of the same anatomy (List separately in addition to code for primary procedure)), and 70473 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed without concurrent CT or CT angiography of the same anatomy). Codes 70471, 70472, and 70473 were surveyed for the September 2024 RUC meeting, along with the existing standalone codes for CTA head and CTA neck in this code family: CPT code 70496 (Computed tomographic angiography, head, with contrast material(s), including noncontrast images, if performed, and image postprocessing) and CPT code 70498 (Computed tomographic angiography, neck, with contrast material(s), including noncontrast images, if performed, and image postprocessing).

We proposed the RUC-recommended work RVU of 2.50 for CPT code 70471, the work RVU of 0.77 for CPT code 70472, the work RVU of 1.00 for CPT code 70473, and the work RVU of 1.75 for both CPT codes 70496 and 70498.

We proposed the RUC-recommended direct PE inputs for CPT codes 70471, 70472, 70473, 70496, and 70498 without refinement.

We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters stated that they agreed with the proposal of the RUC-recommended work RVUs and direct PE inputs for the codes in this family.

Response: We appreciate the support for our proposals from the commenters.

After consideration of the comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Cerebral Perfusion & CT Angiography-Head & Neck family as proposed. (24) Coronary Atherosclerotic Plaque Assessment (CPT Code 75577)

In September 2024, the CPT Editorial Panel created new Category I CPT code 75577 (Quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease, derived from augmentative software analysis of the data set from a coronary computed tomographic angiography, with interpretation and report by a physician or other qualified health care professional) and deleted the four existing Category III CPT codes associated with coronary atherosclerotic plaque assessment.

We proposed the RUC-recommended work RVU of 0.85 for CPT code 75577. For the direct PE inputs, these recommendations also include a new supply item, Plaque Characterization Analysis Software, that lists a per-patient fee of $1500 for the plaque data analysis summary generated by the vendor. This RUC-recommended supply item accounts for the overwhelming majority of this CPT code's PE valuation. We continue to have concerns that software analysis fees are not well accounted for in our direct PE methodology, as discussed for CPT code 75580 (Noninvasive estimate of coronary fractional flow reserve (FFR) derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified health care professional) in our CY 2024 final rule (88 FR 78901); however, we recognize that the analysis represents a significant part of the resource costs associated with this procedure.

Similar to our previously finalized policy for CPT code 75580, we are therefore proposing to identify a crosswalk code for CPT code 75577 based on the OPPS assignment for the current coding under which this service is paid, Category III CPT code 0625T (Automated quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease, using data from coronary computed tomographic angiography; computerized analysis of data from coronary computed tomographic angiography). We proposed to crosswalk the PE RVU for CPT code 75577 to the PE RVU for CPT code 77373 (Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions), which is a PE-only code with no work RVU and which closely approximates the OPPS assignment previously employed by Category III CPT code 0625T. As we have previously stated in rulemaking, we believe that crosswalking the PE RVU for CPT code 75577 to a code with similar resource costs (CPT code 77373) allows CMS to recognize that practitioners are incurring resource costs for the purchase and ongoing use of the software employed in CPT code 75577, which would not typically be considered direct PE under our current methodology (86 FR 65038 and 65039).

We received public comments on coronary atherosclerotic plaque assessment services. The following is a summary of the comments we received and our responses.

Comment: Commenters supported the proposed work RVU and use of a valuation crosswalk to CPT code 77373 to determine the PE RVU for CPT code 75577. Commenters also requested that this CPT code be excluded from the proposed efficiency adjustment policy.

Response: We appreciate the commenters for their support. We acknowledge commenters' request to exclude CPT code 75577 from our proposed efficiency adjustment policy and we refer readers to that discussion

in the valuation of specific codes section in this rule for more information regarding CPT codes excluded from the efficiency adjustment policy.

Comment: A commenter expressed concern regarding the new supply item, Plaque Characterization Analysis Software, that lists a per- patient fee of $1500 for the plaque data analysis summary generated by the vendor. They stated that this is a high-cost supply item and expressed concerns that a crosswalk is an ad hoc approach that could lead to instability if it is changed in future years.

Response: We acknowledge the commenter's broader policy concerns regarding the supply-item, Plaque Characterization Analysis Software, and we refer readers to the comment solicitation regarding high-cost supply items contained within the discussion for the Lower Extremity Revascularization code family for additional information on this topic, as well as our prior discussion in the CY 2011 PFS final rule with comment period (75 FR 73251) where we discuss broader challenges regarding our ability to price high cost disposable items.

After consideration of the comments, we are finalizing our policies for CPT code 75577 as proposed. (25) Use of the Relationship Between OPPS APC Relative Weights To Establish PE RVUs for Radiation Oncology Treatment Delivery (CPT Codes 77387, 77402, 77407, 77412, and 77417), Superficial Radiation Treatment (CPT Codes 77X05, 77X07, 77X08, and 77X09), and Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and 77525)