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

We typically establish two separate PE RVUs for services that can be furnished in either a non-facility setting, such as a physician's office, or a facility setting, such as a hospital. The non-facility PE RVUs reflects all the direct and indirect practice expenses involved in furnishing a particular service when the entire service is furnished in a non-facility setting. The facility PE RVUs reflects the direct and indirect practice expenses associated with furnishing a particular service in a setting such as a hospital, where those facilities incur a portion of the costs and receive a separate Medicare payment for the service. The types of costs covered by the facility fee are comparable to the PE costs incurred by physicians in non-facility settings, namely direct and indirect costs. For certain services, such as radiation treatment delivery services, the coding itself reflects differing types of resources associated with furnishing the service--from coding describing the technical aspects of the treatment delivery only, which do not include any physician work, to codes that describe both the physician work, and the technical resources associated with that work. The former services are valued through information on the direct practice expenses, whereas the latter are valued through the resource costs associated with the physician work and any applicable direct practice expenses.

When services are furnished in the facility setting, such as a Hospital Outpatient Department (HOPD) or an Ambulatory Surgical Center (ASC), the total combined Medicare payment (made to the facility and the professional) typically exceeds the Medicare payment made for the same service when furnished in the physician office or other non- facility setting. This payment difference is largely based on differences in statutory provisions that specify how payment amounts are determined under the PFS and under facility payment systems, like the Hospital Outpatient Prospective Payment System (OPPS). CMS has received feedback from interested parties that the difference reflects the greater costs that facilities incur than those incurred by practitioners furnishing services in offices and other non-facility settings. For example, interested parties have indicated that hospitals incur higher overhead costs because they maintain the capability to furnish services 24 hours a day and 7 days per week, generally furnish services to higher acuity patients than those who receive services in physicians' offices, and have additional legal obligations such as complying with the Emergency Medical Treatment and Labor Act (EMTALA). Additionally, hospitals incur expenses to meet conditions of participation and ASCs incur expenses to meet conditions for coverage in order to participate in Medicare; many of these conditions are not applicable in non-facility settings.

While we receive recommendations from the RUC that include information on resource costs, this information relies heavily on the voluntary submission of information by individuals furnishing the service. Furthermore, in the case of certain direct costs, such as the price of high-cost disposable supplies and expensive capital equipment, even voluntary information has been very difficult to obtain or validate. Such incomplete, small sample, potentially biased or inaccurate resource input costs may distort our valuation of the non- facility PE RVUs used in calculating PFS payment rates for individual services. As MedPAC noted in their comment to the CY 2011 PFS proposed rule, “using price information voluntarily submitted by specialty societies, individual practitioners, suppliers, and product developers may not result in objective and accurate prices because each group has a financial stake in the process”. We have repeatedly stated, such as in the CY 2018 final rule, that “we do not believe that very small numbers of voluntarily submitted invoices are likely to reflect typical resource costs and create the potential for overestimation of supply and equipment costs” (82 FR 52998). In addition to the difficulty we face in obtaining accurate information about some of the direct PE inputs, the data used in the PFS PE methodology can often be outdated. Although we received updated PPI survey information from the AMA, we did not propose to utilize this new data in our practice expense methodology due to concerns we identified in section II.B. of this final rule. We refer readers there for further discussion.

Under the PFS, we strive to maintain relativity in a variety of ways. For example, we typically review the work RVUs, physician time, and direct PE inputs for all codes within families of codes. We also routinely compare work RVUs across services with similar clinical characteristics, global periods, etc. For direct PE inputs, we routinely make standardized assumptions regarding the typical involvement of clinical staff or use of medical equipment based on the kind of service being furnished.

However, we also recognize that the utility of using the exact same methodologies to establish and maintain appropriate relativity under the PFS can be especially limited for services that are difficult to compare to other PFS services. Radiation treatment delivery services are a clear example of this dynamic. Generally, the PFS practice expense methodology serves the purpose of using direct cost and professional work data to assign relative value units to services. In establishing non-facility PE RVUs, these settings include physician offices for a range of kinds of care and specialties as well as independent clinics/suppliers. However, the costs for furnishing radiation treatment delivery services in non-facility settings (that is, freestanding radiation therapy centers) include capital-intensive and specialized resources that are difficult to compare to the kinds of resources involved in furnishing most other kinds of services in other non-facility settings. For example, the sum of the current

prices for the equipment inputs used in the PE calculations for radiation treatment delivery services (that is, $3,000,966 for ER089 (IMRT accelerator) and $773,104 for ER056 (radiation treatment vault)) is well over twice the price of the next most expensive piece of equipment ($1,559,013 for EL008 (room, MR) used in furnishing other types of services in other non-facility settings. Furthermore, other inputs for capital equipment over $1 million are utilized in a wide array of services for multiple specialties, while the equipment inputs for radiation treatment delivery services are more specialized in that they are used in a small number of services and predominantly in radiation oncology. We have long had difficulty understanding how best to characterize the costs associated with architectural infrastructure needs prompted by the use of linear accelerators. In the CY 2016 PFS final rule (80 FR 70953), we stated that we believe at least some portions of the costs associated with the radiation treatment vault construction are indirect PE under the established methodology. We most recently noted this difficulty in CY 2021 PFS rulemaking when addressing our inability to use the recommended direct PE inputs for proton beam therapy services (85 FR 84625). We described difficulty using invoices provided, given that they did not separately identify the direct PE inputs (that is, cost of the equipment) from that of the infrastructure needs surrounding the equipment. For the CY 2016 PFS final rule (80 FR 70954), technical PFS rate setting concerns related to how costs were allocated to different codes based on presumptions about costs of image guidance, prompted CMS to maintain the HCPCS G- codes under the PFS in use for reporting radiation treatment delivery services instead of newly introduced CPT codes. (These HCPCS G codes, which mirrored the coding structure prior to the newly introduced CPT codes, were developed for CY 2015 PFS rulemaking to allow CMS to include the changes to radiation treatment delivery services in the CY 2016 PFS proposed rule). At that time, CMS adopted the new CPT codes for use under the OPPS, where payment calculations did not suffer from the same problems. Since that time, outpatient radiation therapy services have been reported to Medicare using two different sets of HCPCS codes, depending on whether the services are provided in a HOPD or in a non-facility setting paid under the PFS.

For CY 2026, the CPT Editorial Panel has again revised the codes describing radiation treatment delivery services. This presents an opportunity both to consider adopting CPT codes under the PFS and to re-examine how to best assign relative value units to radiation treatment delivery and superficial radiation treatment delivery services under the PFS. If we were to utilize the RUC-recommended direct PE inputs and new RUC PE survey data to value the new, newly payable, and revised codes in these code families, valuation, and ultimately payment, for these services would be subject to the additional volatility associated with small sample surveys, the unique dynamic of capital-intensive costs, and voluntarily submitted invoice data.

We considered the RUC recommended PE inputs for the new, and revised codes listed above in the context of the concerns we outlined above. Specifically, we considered how PE is allocated for under the standard methodologies and noted that radiation treatment delivery and superficial radiation treatment services require long-term capital and infrastructure investments more like facility costs than most other services paid under the PFS. Therefore, we have determined that identifying an alternative data source that is more routinely updated and standardized would improve the accuracy of valuation for these services.

One alternative data source that we have examined is the use of OPPS cost data to develop PE RVUs. Under section 1848(c)(2)(N) of the Act, we have authority to establish or adjust PE RVUs using cost, charge, or other data from suppliers or providers of services. Under contract with CMS, RAND Corporation (“RAND”) examined the feasibility of using OPPS cost data in developing PE RVUs.66 67 RAND noted that “if OPPS-based costs were used to construct total PE RVUs, the valuation process would also be streamlined by using a single data source, thereby eliminating the valuation complexities posed by having separate direct and indirect cost RVU pools.” RAND identified a number of methodological issues that would need to be resolved to utilize OPPS cost data for all PFS services but found that the potential benefits justified investments to further develop this option. RAND noted that using OPPS data “might not be appropriate for the entirety of services in the MPFS and the advisability of using OPPS data should be evaluated by categories of costs and/or services.” Considering that the resources involved in furnishing radiation treatment delivery and superficial radiation treatment delivery services seem to be primarily driven by capital costs that aren't as likely to vary greatly between facilities like hospitals and free standing centers, and because the billing codes for the services (both old and new) are already stratified into professional and technical services, these services have obvious characteristics that make use of OPPS data particularly appropriate. Additionally, the use of routinely updated, auditable, and standardized cost data from hospital cost reports that is currently used in setting rates under the OPPS offers the possibility of long- term stable rates that many interested parties have long sought and that may be helpful in maintaining access to care for capital-intensive services. Consequently, we believe that using OPPS data in setting the relative rates for these kinds of services represents the best source for improved valuation of practice expense in free-standing radiation centers.

\66\ Burgette, Lane F., Jodi L. Liu, Benjamin M. Miller, Barbara O. Wynn, Stephanie Dellva, Rosalie Malsberger, Katie Merrell, et al. “Practice Expense Methodology and Data Collection Research and Analysis.” RAND Corporation, April 11, 2018. https://www.rand.org/pubs/research_reports/RR2166.html.

\67\ Burgette, Lane F., Joachim O. Hero, Jodi L. Liu, Catherine C. Cohen, Barbara O. Wynn, Katie Merrell, et al. Practice Expense Data Collection and Methodology.” RAND Corporation, November 1, 2021. https://www.rand.org/pubs/research_reports/RRA1181-1.html.

We have long noted that data obtained from hospital cost reports is regularly updated, auditable, and required to adhere to national standards for reporting. For example, in the CY 2015 PFS final rule (79 FR 67569), we noted that “routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid reflection of “relative” resources and could be useful to supplement the resource cost information developed under our usual methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year”.

Under OPPS, services are grouped based on clinical characteristics and resource costs into Ambulatory Payment Classifications (APCs). The OPPS methodology utilizes charges from claims data and cost-to-charge ratios developed from cost report data to establish the geometric mean costs for each APC. APC payments are in turn based on the geometric mean costs associated with the services within the APC.

While the costs involved in furnishing technical services in the facility setting could generally be expected to be greater than or equal to those of providing the same service in the non-facility setting, we believe that the relationship of the costs of services within a code family under the PFS would likely mirror the relationship of those costs of services under the OPPS. (The Ambulatory Surgical Center (ASC) fee schedule, which relies on OPPS relative weights multiplied by an ASC conversion factor, is an example of using the same underlying data to establish relative values in two payment systems while continuing to recognize differences in cost structure between settings). For example, if “service A” is twice as costly under the OPPS as “service B”, it is reasonable to assume that the resource costs of “service A” are twice as costly as “service B” under the PFS. We would expect that the relationship between the resources involved in furnishing services within the same code family under the OPPS would be similar under the PFS. Given that the APC is the payment unit under the OPPS, we believe that applying the relationship of the APC relative weights to the codes within the Radiation Oncology Treatment Delivery and Superficial Radiation Treatment code families is the most accurate and transparent mechanism to translate the relationship of the cost data under the OPPS to the PFS. This approach would help to mitigate volatility in relativity among services that would be attributable to small sample surveys, voluntarily submitted invoice data, or PE allocation methodologies that are not designed primarily for capital-intensive costs in architecture and medical equipment as costly as linear accelerators. Therefore, we proposed to use this relationship between the relative weights of the OPPS APCs to which the codes in these families are assigned to value the PE portion of the Radiation Oncology Treatment Delivery and Superficial Radiation Treatment code families. We proposed to use the CY 2026 proposed OPPS APC relative weights and to update these in the final rule based on the updated OPPS APC relative weights. The OPPS APC relative weights can be found in “Addendum B” under “OPPS Addenda” under the most recent proposed or final rule listed at https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices.

We also proposed to value the MP RVUs for the Radiation Oncology Treatment Delivery and Superficial Radiation Treatment code families with our usual methodology for PE-only services.

While we believe that the relationship between services within the Radiation Oncology Treatment Delivery and Superficial Radiation Treatment code families are well approximated by the relationship between those services under the OPPS, we recognize that the RVUs for these groups of services must reflect the resources involved in furnishing services relative to other services paid under the PFS. As such, the proposed PE RVUs for the Radiation Oncology Treatment Delivery and Superficial Radiation Treatment code families, which are based on the relationship of the relative weights of the OPPS APCs to which these codes are assigned, were calculated using the portion of total PE and MP RVUs accounted for by the volume and PE RVUs of these families as they existed in CY 2025. In other words, we calculated the RVUs for these codes so that the overall PE and MP RVUs for these services represent the same share of total PE and MP RVUs in CY 2025 and CY 2026.

Under the PE methodology, the allocation of indirect PE for a given family of services impacts the allocation of indirect PE for other services furnished by the specialties that furnish that family of services (“relevant specialties”). This results from specialty- specific calculations that occur in steps 12 through 15, described in section II.B. of this final rule, that are impacted by the size of the pool of indirect allocators (that is, work RVUs and direct costs) for each specialty. Since the codes in these families have historically contained direct PE inputs and have historically been allocated indirect PE RVUs using the usual methodology, the proposed PE RVUs for CY 2026 have been calculated in a manner that maintains the same effect on the indirect allocation for other services had the PE RVUs been calculated under the usual methodology. In other words, in calculating the proposed PE RVUs for CY 2026, we approximated the direct costs for these services and allocated indirect PE RVUs per the standard methodology to both arrive at PE RVUs based on the proposal described above and also maintain relativity with the PE RVUs across the fee schedule. We have included those approximate direct costs in the downloads section of our website to facilitate transparency. We note that the direct PE input public use file does not include these proxy inputs since they only serve the purpose of stabilizing the PE allocated to other services. We sought comments on this aspect of the methodology in particular, especially given our interest in transparency in rate setting.

We believe that this proposal will improve the accuracy of the relative values established for these services and prevent reliance on irregularly updated information for establishing and maintaining payment for these services under the PFS. Additionally, we believe that the alignment of coding, underlying cost data and billing units between settings paid under the PFS and OPPS will have additional salutary effects, especially in price transparency for patients and payers.

We sought comments on our proposal to use the relative relationship between the proposed OPPS APC relative weights to establish the PE RVUs for these code families.

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

Comment: Many commenters supported our proposal, stating that utilizing OPPS data will facilitate long-term payment stability, mitigate payment volatility and is better suited for capital-intensive radiation oncology services, noting that the current PE methodology was not designed for expensive equipment like linear accelerators.

Other commenters opposed our proposal. Some commenters were fundamentally opposed to using OPPS data for PFS rate-setting, stating that hospital charge data lacks the granularity of physician practice costs and stating the approach violates Balanced Budget Act of 1997 (BBA) requirements for cost accounting principles. A commenter emphasized that the current methodology's “bottom-up” granular approach is preferable to hospital “averaging” systems. Commenters questioned whether hospital cost data accurately reflects physician practice costs given concerns about charge compression, which occurs when hospitals a lower markup to relatively high cost items and a higher markup to relatively lower cost items. Commenters stated that these hospital charging practices may undervalue high-cost services. Commenters also expressed concern that hospitals may not be accurately accounting for Intensity modulated radiation treatment delivery(IMRT) costs, with some requesting that hospitals directly allocate radiation oncology equipment costs to appropriate cost centers. Some commenters stated that APC groupings result in a loss of granularity due to the averaging of multiple unrelated procedures.

Response: We appreciate commenters support for our proposal. We agree that the use of OPPS APC relative weights to establish the relative relationship of PE RVUs for radiation treatment delivery services is more suited for capital-intensive services. We disagree with commenters who stated that CMS does not have the authority to utilize OPPS data in PFS ratesetting. Under section 1848(c)(2)(N) of the Act, we have authority to establish or adjust PE RVUs using cost, charge, or other data from suppliers or providers of services. We acknowledge commenters' concerns about charge compression and the averaging nature of the OPPS payment system. However, we believe the relationship between the APC relative weights reasonably approximates the relationship between the resource costs required to furnish these services under the PFS.

Comment: Many commenters expressed concerns about payment reduction impacts, citing estimated reductions ranging from 9 percent to 52.5 percent for various combinations of services. Some commenters stated that the economic and policy implications of these proposed changes extend far beyond immediate payment adjustments, with significant market consolidation risks including financial strain that may force more independent practices into hospital systems. Commenters stated that reduced payments could result in migration to hospital outpatient departments, resulting in reduced competition and increased Medicare expenditures. Commenters expressed concern that reduced payments could potentially limit adoption of advanced treatment technologies, risk compromising access to IMRT and other advanced modalities, and result in workforce instability that could affect treatment quality and safety.

Response: As we described in the proposed rule, we calculated the RVUs for these codes so that the overall PE and MP RVUs for these services represent the same share of total PE and MP RVUs in CY 2025 and CY 2026. Therefore, while the RVUs for certain combinations of services may differ between CY 2025 and CY 2026, in aggregate, the total PE and MP RVUs for these services were calculated to be similar.

Comment: Some commenters requested that CMS delay implementation to allow more robust data collection from freestanding practices. These commenters suggested this data could include practice-specific surveys to gather more comprehensive cost data from freestanding centers, better capture actual equipment usage and depreciation, and more accurately assess indirect practice expenses.

Response: Because we believe that using the OPPS data in setting the relative rates for these kinds of services represents the best source for improved valuation, we do not believe it is prudent to delay implementation of this proposal. However, we remain open to additional information, such as that cited by commenters, that could help us inform future proposals that address these services.

Comment: Some commenters expressed concern that image guidance costs will no longer be recognized. A commenter expressed concern that not all RVUs were redistributed from deleted codes.

Response: As we stated in the proposed rule, the valuation of the PE RVUs for the newly valued CPT codes includes a redistribution of the PE RVUs from the newly bundled services to the other services in that family. Therefore, while image guidance costs will not be separately payable, the payment for the treatment delivery services includes the resource costs associated with furnishing the image guidance services. Regarding the concern that not all RVUs were redistributed from deleted codes, we are confirming that we are including the volume for all of these services in calculating the share of PE and MP RVUs that these services represented in CY 2025.

Comment: Several commenters stated that CMS did not demonstrate what the PE RVUs would have been had it applied the standard PE methodology using the RUC's recommended direct PE inputs. Commenters stated that without this comparison, interested parties could not meaningfully assess the impact of CMS' proposal to base PE RVUs on OPPS-derived relative cost data which undermined transparency in policymaking.

Response: We acknowledge the concerns of the commenters and agree that additional information regarding alternatives considered would have assisted in providing opportunities for feedback from interested parties. However, due to the concerns that we outlined in the proposed rule, we believe that the volatility associated with small sample surveys, the unique dynamic of capital-intensive costs, and voluntarily submitted invoice data all contributed to making these services unusually difficult to value through our traditional PE methodology. The coding for these services has also proven to be problematic over the past decade, which previously led to the creation of 17 HCPCS G- codes as discussed below. Any discussion of alternatives considered would have required also publishing valuations for the maintenance of the G-code set, since maintaining these codes would have represented the continuation of current policy. Therefore, we chose to focus on our proposed valuation based on the use of OPPS cost data due to our stated belief that it would be methodologically more accurate for these services. Given the long-standing problems associated with using bottom-up input recommendations for these kinds of services, the inherent alternative to our proposal, of course, would be to maintain the existing set of G-codes and inputs for use under the PFS for CY 2026.

Comment: A commenter recommended that once utilization data becomes available, CMS use the geometric mean of each CPT code rather than APC payment rates to establish the relativity of the PE RVUs.

Response: We may consider this commenter's request in future rulemaking.

At the September 2024 CPT Editorial Panel meeting, the Panel approved the revision of CPT codes 77402, 77407 and 77412 to establish a technique-agnostic family of codes and bundle imaging into the three CPT codes, and the deletion of CPT codes 77385, 77386 and 77014. The related guidelines and tables were all updated to reflect the consolidated services for radiation oncology treatment delivery. These services were subsequently reviewed by the RUC and a valuation recommendation was submitted to CMS for inclusion in CY 2026 rulemaking. Please see Table A-E7 for the current and CY 2026 code descriptors (where applicable) for the CPT codes in this family.

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Although these CPT codes were established for CY 2015, CMS has not used them for payment under the PFS. In October 2013, the CPT Editorial Panel created CPT codes 77402, 77407, 77412, 77385, 77386 and 77387, which were reviewed at the January 2014 RUC meeting for CY 2015. Previously, radiation treatment delivery had been reported with 17 CPT codes. CMS identified concerns with the packaging of Image-guided Radiation Therapy (IGRT) into some of the delivery codes in the family and not others. As a result, CMS created 17 HCPCS G-codes, to mirror the existing codes (at the time), maintained CPT code 77014, and established values that linked directly to the existing values/inputs for the PFS. Table A-E8 includes the HCPCS G-codes and their long descriptors.

[GRAPHIC] [TIFF OMITTED] TR05NO25.028

Over the past several years, the Radiation Oncology community met with CMS and CMMI to address the concerns identified by CMS in the 2015 code set as well as the possibility of creating an episode-based alternative payment approach for radiation therapy services. The G- codes were identified in a Relativity Assessment Workgroup (RAW) screen (CMS/Other source with 2019 estimated Medicare utilization over 20,000). The RAW did not agree with the specialty societies' request to maintain the current valuation because the inputs for these services were last reviewed in 2014, CMS did not accept the RUC recommendations, and the inputs may not represent the services as they are currently performed. As a result, the CPT Editorial Panel reviewed the radiation oncology delivery treatment family at the September 2024 CPT meeting and established a technique-agnostic family of codes and bundled imaging into all three services. The Panel approved the revision of CPT codes 77402, 77407 and 77412 and the deletion of 77385, 77386 and 77014. The specialty societies have also requested that CMS delete the related G-codes, G6001 through G6017. As stated previously, we have not recognized the radiation treatment delivery CPT codes for payment under PFS and have instead used the G-codes to describe these services, based primarily on concerns related to how the conventional practice expense methodology applies to these services. For CY 2026, we are proposing to delete the 17 G-codes and recognize the newly revised CPT codes for payment under the PFS, in conjunction with our proposal to utilize OPPS cost data to establish PE RVUs, as previously described.

We proposed the RUC-recommended work RVU of 0.70 for the single code in the family that has a physician work component, CPT code 77387.

We proposed to utilize the relationship between the proposed OPPS APC relative weights for APCs 5621, 5622, and 5623 to inform the valuation of PE-only CPT codes 77402, 77407, and 77412 when paid under the PFS. As described above, we believe that the relationship between the OPPS APC relative weights more accurately reflects the relative resource costs associated with furnishing these services.

To facilitate the use of the relationship of the OPPS APC relative weights to establish PE RVUs for radiation treatment delivery services, we believe it is important to standardize the billing units and bundling rules between the settings. That is, services in this code family that describe technical costs and are not separately payable under the OPPS will not be separately

payable under the PFS, because the associated costs are incorporated into the costs for separately paid codes. As a result, the proposed PE RVUs for the services in this code family, which are developed based on the relationship of the APC relative weights to which services in this family are assigned, include a redistribution of the PE RVUs from the newly bundled services to the other services in that family, as described in this section.

In an effort to align the relationship between the PFS payment for this code family with the OPPS payment, we are proposing to assign Procedure Status “B” to the technical component of CPT code 77387 to maintain consistency with OPPS payment for this code, which is packaged into payment for the treatment delivery codes, CPT codes 77402, 77407, and 77412, and therefore is not separately payable under the OPPS. As described in section II.B. of this final rule, typically, when services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. In the case of CPT code 77387, we proposed that the PE and total RVU for the global service will equal the PE and total RVU for the professional component only because the technical component is not separately payable under the PFS since the relative resources are included in the valuation of another code (treatment delivery). We proposed to display CPT code 77387 in Addendum B with the professional and technical components, where the technical component has non-payable Procedure Status “B,” as well as the global service equal to the payable professional component, We also sought comment on strategies to mitigate billing confusion that could result from this relatively novel circumstance where the technical component of a service is bundled but the professional component is separately reported. Specifically, we are seeking comments on whether displaying the global service equal to the professional component is problematic, and if it would be preferable to eliminate the global code and display only the professional and technical components in Addendum B.

Similarly, for PE-only CPT code 77417 (Therapeutic radiology port image(s)), we are proposing to assign Procedure Status “B” to align with OPPS payment for this code, which is packaged into payment for the treatment delivery codes, CPT codes 77402, 77407, and 77412 and therefore would not be separately reportable under the PFS. Similarly, it is packaged under the OPPS.

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 requesting that CMS change the APC assignment for CPT codes 77407 and 77412.

Response: We consider comments regarding APC assignments to be outside the scope of this final rule. We refer commenters to the CY 2026 OPPS final rule for responses to comments regarding APC assignment.

Comment: Many commenters disagreed with the proposed utilization crosswalk for CPT codes 77407 and 77412. Commenters stated that although CMS estimated that CPT codes 77407 and 77412 will represent 50 percent and 45 percent of billed charges respectively, commenters anticipated that CPT code 77407 will be billed at a much higher frequency and CPT code 77412 at a lower frequency. A commenter stated that if use of CPT code 77412 is limited to cases involving breath-hold or gating technology, the commenter anticipated that it would constitute approximately 15 percent of billed charges instead of the proposed 45 percent, and the Medicare program will pay substantially more for radiation treatment than intended.

Response: We appreciate the commenters input on the proposed utilization crosswalk. It is important that the utilization crosswalks be as well-founded as possible in order to value the services appropriately. We We also recognize that in many cases, it is difficult to ascertain how services furnished in the past would be most accurately reported using a future code set. We have reviewed the disparate information and recommendations presented by relevant specialty groups and experts as reflected in public comments and through the AMA RUC recommendations, and are finalizing a modified crosswalk that specifically adjusts downward the estimated portion that 77412 would be reported compared to 77407 based on commenters' who represent those who provide care in the non-facility setting. Specifically, we are modifying the utilization crosswalk to crosswalk 35 percent of the utilization to CPT code 77412 and 55 percent of the utilization to CPT code 77407.

Comment: Some commenters described congressional action to remove radiation oncology services from the PFS entirely. Other comments requested site-neutral adjustments to ensure equivalent payment across settings.

Response: As commenters are aware, we do not have the statutory authority to remove radiation oncology services from the PFS entirely. The statutory authorities and formulas that govern the PFS and OPPS, especially for annual updates, are unique. At this time, we do not believe that the accuracy of PFS payment is necessarily improved by ensuring equivalent payment across settings . However, we remain open to additional data that could help us as we develop further policies with respect to these services.

Comment: Some commenters recommended displaying only the professional component for CPT code 77387 to avoid billing confusion. A commenter requested that CMS update the Medicare Claims Processing Manual to include language explaining that CPT codes 77387-26 should be reported regardless of the place of service, when performed. Another commenter stated that it is confusing to allow the professional component of CPT code 77387 to be billed with the treatment delivery codes, since the code description states, “including imaging guidance, when performed”.

Response: We appreciate the commenters' response to our request for strategies to mitigate billing confusion. We do not believe that a change to billing guidance is needed at this time, especially given the lack of consensus regarding the best approach to this novel circumstance. Because the RVUs assigned to CPT 77387-26 and 77386 billed globally will be the same, any initial confusion as to which of these codes should be reported will not have an impact on payment. In the alternative, if we were to eliminate use of one or the other of these billing mechanisms in advance, then any entity not conforming to our envisioned approach would be unable to receive payment. Once a consensus approach to reporting these services under this construct emerges, we anticipate updating the guidance. We refer the commenter to the CPT Editorial Panel for additional information regarding the decision to allow billing CPT code 77387 with the treatment delivery codes.

After consideration of comments received, we are finalizing our proposal to utilize the relationship between the proposed OPPS APC relative weights for APCs 5621, 5622, and 5623 to inform the valuation of PE-only CPT codes 77402, 77407, and 77412, with the additional refinement to the utilization crosswalk described earlier in this section.

Superficial radiation therapy is currently provided using CPT code 77401 (Radiation treatment delivery, superficial and/or ortho voltage, per day) in conjunction with CPT code 77280 (Therapeutic radiology simulation-aided field setting; simple) and HCPCS code G6001 (Ultrasonic guidance for placement of radiation therapy fields).

In October 2020, HCPCS code G6001 was identified by the RAW via the CMS/Other Medicare utilization over 20,000 screen. In January 2021, the RUC recommended referring G6001 to CPT to develop new code(s) that reflect the different process of care between the two specialties (dermatology and radiation oncology). After a 2-year delay to allow time for re-review, the CPT Editorial Panel created four codes and a new subsection to report surface radiation therapy in September 2024. These codes will replace CPT code 77401 and HCPCS code G6001 which were scheduled for deletion by the CPT Editorial Panel and recommended for deletion by CMS, respectively. This code family was surveyed for the January 2025 RUC meeting.

The new codes are as follows:

77X05: Surface radiation therapy; superficial or orthovoltage, treatment planning and simulation-aided field setting.

77X07: Surface radiation therapy, superficial, delivery,

77X08: Surface radiation therapy, orthovoltage, delivery, 150-500 kV, per fraction.

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 proposed the RUC-recommended work RVU for the two codes in the family that have a work RVU. We proposed a work RVU of 0.77 for CPT code 77X05 and a work RVU of 0.30 for CPT code 77X09.

Similar to our approach for the radiation oncology treatment delivery codes discussed above, we believe that using the relationship between the relative weights of the OPPS APCs to which codes in this family are assigned likely more accurately reflect the actual costs of these services compared to use of direct PE input and PE allocation methodologies. Therefore, similar to our proposal for radiation treatment delivery services, we proposed to use this relationship to establish the RVUs for the PE portion of these services.

We proposed to utilize the relationship between the proposed OPPS APC assignments for APCs 5621 and 5732 to inform the valuation of PE- only CPT codes 77X07 ((Surface radiation therapy, superficial, delivery, 150-500 kV, per fraction), and for the technical component of CPT code 77X05 (Surface radiation therapy; superficial or orthovoltage, treatment planning and simulation-aided field setting) when paid under the PFS.

In an effort to align the relationship between the PFS payment for this code family with the relationship of the OPPS information used to develop the RVUs, we proposed to assign Procedure Status “B” to the technical component of CPT code 77X09 to align with OPPS of this code whose costs are packaged into payment for the treatment delivery CPT codes 77X07 and 77X08. We are proposing to display CPT code 77X09 in Addendum B with the professional and technical components, where the technical component is non-payable Procedure Status “B,” as well as the global service equal to the payable professional component, but are seeking comment on strategies to mitigate possible billing confusion that could result from this relatively novel circumstance where the technical component of a service is bundled but the professional component is separately reported. Specifically, we sought comments on whether displaying the global service equal to the professional component is problematic, and if it would be preferable to eliminate the global service and display the professional and technical components only in Addendum B.

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

Comment: Several commenters supported the proposal of the RUC- recommended work RVUs for CPT codes 77X05 and 77X09. Commenters stated their appreciation that CMS was proposing to delete the 17 HCPCS G codes (G6001-G6017) and recognize the newly revised CPT codes for payment under the PFS.

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

Comment: Several commenters disagreed with the proposed work RVUs for CPT codes 77X05 and 77X09 stating that the proposed work valuations did not accurately capture the actual workflow or resource intensity associated with these SRT services. Commenters stated that planning and simulation are not a one-time event and that ultrasound imaging is performed at every fraction to verify depth, confirm margins, monitor treatment response and repopulation, and guide adjustments. Commenters also stated that by limiting both planning and imaging to “per course” and assigning minimal work RVUs with no payable technical component for ultrasound, the proposed structure undervalued the time, clinical judgment, and specialized equipment required for SRT. Commenters recommended CMS revalue these services with direct input from SRT interested parties so that payment policy aligns with real- world clinical practice.

Response: While we appreciate the feedback from the commenters, we continue to believe that our proposed work RVUs for CPT codes 77X05 and 77X09, based on the RUC recommendations, are accurate. The proposed work RVU of 0.77 for CPT code 77X05 was based on a RUC crosswalk to CPT code 95991 (Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) or brain (intraventricular), includes electronic analysis of pump, when performed; requiring skill of a physician or other qualified health care professional) which shares nearly-identical time values and has an intensity value which would be typical for radiation therapy. CPT code 77X09 was valued based on the 25th percentile from the RUC survey and has a work RVU that falls in the median range of other add-on services with roughly 10 minutes of intraservice and total time on the PFS. In both cases, we believe that the proposed work RVUs accurately capture the work and intensity of these services.

We also note that while the technical component for ultrasound guidance is not separately payable, it is bundled into the valuation for 77X05 and 77X09. Specifically, we redistributed the PE RVUs that were previously assigned to the G codes describing ultrasound guidance into the valuation for the other codes in the SRT code family.

Comment: Several commenters disagreed with the proposal to utilize the relationship between the payment rates for APCs 5621 and 5732 to inform the valuation of PE-only CPT codes 77X07 and 77X08, and for the technical component of CPT code 77X05. Commenters stated that SRT services are overwhelmingly performed by

dermatologists in office-based settings and that the shielding requirements and equipment required to furnish SRT differ significantly from other modalities of radiation therapy and treatment delivery. Commenters stated that capital-intensive resources attributable to other radiation services are not applicable to office-based SRT and therefore the relative weights of the OPPS APCs for for CPT codes 77X05, 77X07, and 77X09 are irrelevant to the PE costs associated with performing these services; commenters stated that the RUC's recommended direct PE inputs more accurately measure typical costs for providing care in the office setting than do nonexistent OPPS data.

Response: We acknowledge these concerns from the commenters, as SRT services are infrequently provided in the hospital setting. However, the PFS claims data indicates that there is a minority of SRT services that do take place in the hospital setting, approximately 2 percent of the overall total.. As we stated in the proposed rule, we believe that using the relationship between the relative weights of the OPPS APCs to which codes in this family are assigned more accurately reflect the actual costs of these services compared to use of the direct PE inputs as recommended by the RUC and CMS' PE allocation methodologies. We reiterate that we calculated the RVUs for these codes so that the overall PE and MP RVUs for these services represent the same share of total PE and MP RVUs in CY 2025 and CY 2026. Therefore, while the RVUs for certain combinations of services may differ between CY 2025 and CY 2026, in aggregate, the total PE and MP RVUs for these services were calculated to be similar.

Comment: Many commenters disagreed with the use of PE associated with ultrasound image guidance being bundled into the CPT code 77X07 through the use of the OPPS crosswalk. Commenters stated that not all SRT machines are equipped with ultrasound capabilities and even when radiation devices include an integrated ultrasound wand, ultrasound is not necessarily performed with each fraction of radiation delivery. Commenters stated that CMS has proposed PE RVUs for CPT code 77X07 that incorporated the cost of ultrasound, resulting in payment regardless of whether ultrasound is actually furnished. Commenters cited two peer- reviewed studies that found no demonstrated clinical benefit of using ultrasound guidance for superficial radiation treatment,\68\ and stated that ultrasound is not medically necessary for the treatment of superficial skin cancers and is widely considered low-value care. Commenters cited two peer-reviewed studies that found no demonstrated clinical benefit of using ultrasound guidance for superficial radiation treatment,69 70 and stated that ultrasound is not medically necessary for the treatment of superficial skin cancers and is widely considered low-value care. Commenters also stated that the National Comprehensive Cancer Network (NCCN) Guidelines states that “The use of IGRT for other types of radiotherapy to treat skin cancer is considered unnecessary.” Commenters stated that this would provide payment for a service that five of the MACs have proposed to exclude from coverage, citing a lack of medical necessity. Commenters stated that this could lead to inconsistencies between coverage and payment policy as well as increase the potential for billing confusion among physicians. Other commenters cited studies supporting the efficacy of IGSRT.71 72 73 74

\68\ Gronbeck, C., et al. (2025). Image guidance contributes substantial cost and rarely informs dosimetry management in superficial radiotherapy: A national Medicare analysis. Journal of the American Academy of Dermatology, 93 (3), 795-797.

\69\ Gronbeck, C., et al. (2025). Image guidance contributes substantial cost and rarely informs dosimetry management in superficial radiotherapy: A national Medicare analysis. Journal of the American Academy of Dermatology, 93 (3), 795-797.

\70\ Gronbeck, Christian, et al. (2024) Volume and distribution of radiotherapy performed by dermatologists from 2016 to 2021: A national Medicare trend analysis. Journal of the American Academy of Dermatology, 91(2), 341-344.

\71\ Yu, L, et al (2021). The Treatment of Non-Melanoma Skin Cancer with Image-Guided Superficial Radiation Therapy: An Analysis of 2917 Invasive and In Situ Keratinocytic Carcinoma Lesions. Oncology and Therapy, 9(1), 153-166.

\72\ Tran, A et al. (2023). Analysis of image-guided superficial radiation therapy (IGSRT) on the treatment of early-stage non- melanoma skin cancer (NMSC) in the outpatient dermatology setting. Journal of Cancer Research and Clinical Oncology, 149(9), 6283-6291.

\73\ McClure, E.M., et al. (2023). Image-guided superficial radiation therapy has superior 2-year recurrence probability to Mohs micrographic surgery. Clinical and Translational Radiation Oncology, 43.

\74\ Yu, L et al. (2022). Local control comparison of early- stage non-melanoma skin Cancer (NMSC) treated by superficial radiotherapy (SRT) and external beam radiotherapy (XRT) with and without dermal image guidance: a meta-analysis. Discover Oncology, 13(1):129.

Response: While we appreciate the concern from the commenters, we believe that one of the advantages of bundling in the payment for ultrasound guidance, consistent with the OPPS, would eliminate financial incentives to provide ultrasound guidance where it may be of questionable value. As we stated earlier in this section, services in this code family that describe technical costs and are not separately payable under the OPPS will not be separately payable under the PFS, because the associated costs are incorporated into the costs for separately paid codes. We will assign the procedure status of “B” to the CPT code describing ultrasound guidance; this will mean that the use of ultrasound guidance will not vary the payment made under the PFS.

Comment: Some commenters disagreed with the coding revision to collapse image-guided superficial radiation therapy (IGSRT), superficial radiation therapy (SRT), and electronic brachytherapy into one “surface radiation” code family, stating that this misrepresents how these services are delivered. The commenters stated that combining these services obscures differences in personnel, workflow, and outcomes, and will lead to undervaluation of IGSRT. Commenters suggested that CMS adopt a series of G-codes describing IGSRT.

Response: We do not agree with commenters that the CPT code set reflects an inappropriate grouping of services, and we do not see a Medicare program need to develop G-codes in order to reflect the variations described by commenters.

Comment: Many commenters disagreed with the coding revisions to CPT code 77X09 which would restrict its billing to a single use per treatment course. Commenters stated that under these billing restrictions, patients face a higher risk of recurrence from underdosing (leading to recurrence) or avoidable toxicity from overdosing. Commenters stated that the proposed coding change would particularly harm rural and underserved patients and force many dermatology practices to discontinue offering SRT services.

Response: The coding revisions to CPT code 77X09 described by the commenters were adopted by the CPT Editorial Panel as part of its revision of superficial radiation services. We direct concerns over the “per course of treatment” aspect of CPT code 77X09's code descriptor to the CPT Editorial Panel for additional explanation. We believe that on balance, the new coding set represents an improvement from the current coding, much as we believe that the use of OPPS cost data for these services will be more accurate than other valuation methodologies, and that the alternative to using CPT's coding would be to maintain the current set of G-codes. We remind the commenters that CMS does not have the authority to change the code descriptors for CPT

codes, and we believe that the SRT codes were designed to function together as a group which would not warrant creating a separate G code with a modified code descriptor to replace CPT code 77X09.

For the comments that this coding revision would harm rural and underserved patients, we do not agree. Since ultrasound guidance is bundled into the valuation for CPT code 77X09, the valuation reflects the resource costs associated with furnishing the ultrasound guidance.

Comment: Commenters expressed concern about a gap in the new coding structure and coding instructions. Specifically, commenters stated that the new coding will create barriers to well-established use of orthovoltage radiation treatment for non-malignant musculoskeletal disorders.

Response: We remind commenters that, in cases where a service is not described by an existing CPT code, unlisted codes may be reported.

Comment: Some commenters stated that CMS failed to provide a transparent and comprehensive analysis supporting its proposed PE RVUs for SRT services. The commenters stated that CMS should publish the PE RVUs that would result under the standard PE methodology alongside the OPPS-derived PE RVUs.

Response: We note that an alternative to our proposal to value the new CPT codes would be to establish G-codes to maintain the pre- existing coding and valuation. We have previously taken this approach with regard to certain radiation therapy services.

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PFS payment amounts for proton beam treatment delivery services are currently determined by local Medicare Administrative Contractors (MACs). As discussed in CY 2021 rulemaking (85 FR 84625 through 84626), we have not previously established RVUs for these services due to the unique nature of the equipment costs associated with these services compared to other capital costs addressed by our usual PE methodology. Given the proposals described above to

establish RVUs for the new and revised CPT codes for Radiation Oncology and Superficial Radiation Treatment Delivery Services, we sought comments on whether we should adopt a similar approach to establish RVUs for proton beam treatment delivery services. We note that these services are assigned to APCs 5623 and 5625 under the OPPS with established Medicare payment rates (unlike the contractor pricing in place for these services under the PFS). We specifically seek comments on how we may establish national pricing and total RVUs for these services to maintain relativity within the PFS. For example, would using the overall ratio between OPPS and PFS payment for radiation oncology treatment services to establish initial year RVUs for proton beam treatment delivery services accurately reflect the relative resources involved in furnishing the services? Alternatively, would it be more appropriate to consider the overall difference between the OPPS and Medicare payment as currently determined by the MACs for these services, or are there other alternative methods we should consider? We welcome comments on this topic.

Comment: We received many thoughtful comments in response to this comment solicitation.

Response: We appreciate the commenters for their feedback and will consider it as part of future rulemaking. (26) Combination COVID-19 Vaccine Administration (CPT Codes 90480 and 90481)

In September 2024, the CPT Editorial Panel created a new add-on code, 90481 (each additional component administered (List separately in addition to code for primary procedure)), to report when each additional non-COVID vaccine component is administered with the COVID- 19 vaccine. CPT code 90480 (Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SAR CoV2) (coronavirus disease [COVID19]) vaccine; first or only component of each vaccine administered) was revised as part of this family of services.

We received RUC recommendations for CPT code 90480 that affirmed the September 2023 work and PE RUC recommendations. We previously established CPT code 90480 with a procedure status of “X” on the PFS, and the code is therefore not payable under the PFS. Payment for this CPT code is also addressed under previously finalized policies associated with the emergency use authorization declaration. We refer readers back to the CY 2025 PFS final rule (89 FR 97710) for more information on this previously finalized policy.

We also received RUC recommendations for add-on CPT code 90481. The RUC recommendations for this CPT code do not include work or PE inputs as the recommendations suggest that the work and PE is already included in the administration base code and this add-on code is intended for tracking purposes of the second vaccine.

We proposed to maintain procedure status “X” for CPT code 90480 and assign procedure status “X” to CPT code 90481.

We received public comments on combination COVID vaccine administration services. The following is a summary of the comments we received and our responses.

Comment: Commenters supported our proposal to maintain procedure status “X” for CPT code 90480 and assign procedure status “X” to new CPT code 90481.

Response: We appreciate the commenters for their support.

Comment: Some commenters stated that they have concerns with combination COVID vaccines being procedure status “X” on the PFS as they believe it could create confusion with payment should combination COVID vaccines become available to the market in the future and there are no administration codes. Commenters were also concerned with inadequate payment for the counseling portion of vaccine administration and requested that CMS create a G code for vaccine administration of combination COVID vaccines.

Response: We acknowledge commenters' concerns and appreciate feedback regarding broader COVID vaccine payment policy. We did not propose any policy changes for preventative vaccine administration for the CY 2026 PFS final rule, and we therefore consider those topics out of scope for the purposes of this discussion. We also acknowledge commenters' request for a HCPCs G code for combination covid vaccine administration. We remind commenters that CPT code 90481 is meant to be a tracking code only, so we do not believe the creation of a HCPCs G code for administration would be appropriate at this time.

Comment: Several commenters requested that CMS publish the RUC- recommended work RVU of 0.25 and PE and MP RVUs for CPT code 90480 in Addendum B on a display basis so other payors could utilize these relative values.

Response: We agree with commenters' request to display RVUs for CPT code 90480 and will update Addendum B to reflect the RVUs for this service for display purposes only. We will publish the RVUs for its add-on CPT code 90481 as well, should any exist, also for display purposes only.

After consideration of the public comments, we are finalizing as proposed. (27) Immunization Counseling (CPT Codes 90482, 90483, and 90484)

In May 2024, the CPT Editorial Panel created three new time-based CPT codes 90482, 90483, and 90484 to report vaccine counseling performed where a vaccine is not administered. CPT code 90482 (Immunization counseling by physician or other qualified health care professional when immunization(s) is not administered by provider on the same date of service; 3 minutes up to 10 minutes), CPT code 90483 (Immunization counseling by physician or other qualified health care professional when immunization(s) is not administered by provider on the same date of service; greater than 10 minutes up to 20 minutes) and CPT code 90484 (Immunization counseling by physician or other qualified health care professional when immunization(s) is not administered by provider on the same date of service; greater than 20 minutes). These services were surveyed and reviewed at the September 2024 RUC meeting.

In 2022, CMS created six new HCPCS codes so that Medicaid providers could bill for stand-alone vaccine counseling, “State Health Official Letter #22-002 “Medicaid and CHIP Coverage of Standalone Vaccine Counseling”.\75\ The six HCPCS codes are:

\75\ https://www.medicaid.gov/state-resource-center/downloads/stnd-vacc-cou-spec-hcpcs-codes.pdf.

G0310 (Immunization counseling by a physician or other qualified health care professional when the vaccine(s) is not administered on the same date of service, 5 to 15 mins time. (This code is used for Medicaid billing purposes.))

G0311 (Immunization counseling by a physician or other qualified health care professional when the vaccine(s) is not administered on the same date of service, 16-30 mins time. (This code is used for Medicaid billing purposes.))

G0312 (Immunization counseling by a physician or other qualified health care professional when the vaccine(s) is not administered on the same date of service for ages under 21, 5 to 15 mins

time. (This code is used for Medicaid billing purposes.))

G0313 Immunization counseling by a physician or other qualified health care professional when the vaccine(s) is not administered on the same date of service for ages under 21, 16-30 mins time. (This code is used for Medicaid billing purposes.)

G0314 Immunization counseling by a physician or other qualified health care professional for COVID-19, ages under 21, 16-30 mins time. (This code is used for the Medicaid Early and Periodic Screening, Diagnostic, and Treatment Benefit (EPSDT.)

G0315 Immunization counseling by a physician or other qualified health care professional for COVID-19, ages under 21, 5-15 mins time. (This code is used for the Medicaid Early and Periodic Screening, Diagnostic, and Treatment Benefit (EPSDT.)

The RUC requested that CMS delete HCPCS codes G0310-G0313, and replace them with the new CPT codes 90482, 90483, and 90484. However, we proposed to assign status indicator (“I”) to each of these three services, as not valid for Medicare purposes. Medicare uses other coding for reporting of, and payment for immunization counseling. We are not proposing any work RVUs or PE RVUs for any of the three new CPT codes.

Comment: We received many comments requesting that CMS make CPT codes 90482, 90483, and 90484 payable under the PFS, or at least provide details on what other CPT codes are available to report these services.

Response: As we stated in the proposed rule, (90 FR 32593 through 32597) Medicare uses other coding for reporting of and payment for immunization counseling. Under the PFS practitioners may report and receive payment for immunization counseling where an immunization is not administered under evaluation and management visits (E/M) coding. Practitioners may select the level of E/M visit based on the visit's level of medical decision making or report these visits based on time as appropriate.

Comment: Several commenters requested that CMS publish the RUC- recommended work RVUs and PE and MP RVUs for CPT codes 90482, 90483, and 90484 in Addendum B on a display basis so other payors could utilize these relative values.

Response: We agree with commenters' request to display RVUs for CPT codes 90482, 90483, and 90484 and will update Addendum B to reflect the RVUs for this service for display purposes only. After reviewing all the other public comments we are finalizing as proposed. (28) Colon Motility Services (CPT Codes 91124 and 91125)

In April 2023, the Relativity Assessment Workgroup (RAW) identified CPT codes 91120 and 91122 as reported together 75 percent of the time or more based on 2021 Medicare claims data. The RUC noted that these services are reported together 95 percent of the time and recommended that the specialty societies work with the CPT Editorial Panel to develop a code bundling solution. In May 2024, the CPT Editorial Panel created two new codes, CPT code 91124 (Rectal sensation, tone, and compliance study (for example, barostat)) and CPT code 91125 (Anorectal manometry, with rectal sensation and rectal balloon expulsion test, when performed) to describe these services to replace CPT codes 91120 and 91122. The two new codes were surveyed for the September 2024 RUC meeting.

For CY 2026, the RUC-recommended a work RVU of 3.05 for CPT code 91124 and 2.70 for CPT code 91125. We are proposing these RUC recommendations without refinement.

For the direct PE inputs, we disagreed with the RUC-recommended 17 minutes of clinical labor associated with CA013 (Prepare room, equipment and supplies) for CPT code 91125. We proposed a time of 2 minutes for CA013, which is the standard time for this PE input. We proposed the RUC recommendation of 17 minutes of clinical labor time for CA013 for CPT code 91124 to account for a previous input of 15 minutes to calibrate equipment in similar codes. We recognize it is not typical to have different values for the same clinical labor activity across a code family, and we welcome comments as to the appropriateness of these refinements.

We disagreed with the RUC-recommended 30 minutes of clinical labor associated with CA024 (Clean room/equipment by clinical staff) for CPT 91124 as we stated that we believed this is unnecessarily long and does not match similar services. We proposed a CA024 time of 10 minutes for both codes (CPT 91124 and 91125) based off reference CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)).

We also proposed to refine the SM015 supply (Enzymatic detergent) to a quantity of 4 ounces for both codes, to match similar inputs for similar services. We sought comment on the appropriateness of this refinement, as we do not believe that 120 ounces of the SM015 supply would be typical or necessary given that no HCPCS code on the entire PFS uses more than 8 ounces of this supply.

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

Comment: Several commenters were generally supportive of our proposal of the RUC-recommended work RVU of 3.05 for CPT code 91124 and 2.70 for CPT code 91125.

Response: We appreciate the commenters for their support, and we are finalizing our proposed work RVUs for CPT code 91124 and 91125.

Comment: Several commenters disagreed with the PE refinement from 17 minutes to 2 minutes for the CA013 clinical labor time for CPT code 91125. The commenters noted that CMS may have missed the supporting materials in the PE summary of recommendations (SOR). Commenters noted that 17 minutes of clinical labor time is recommended for both codes to prepare and calibrate the equipment and to test the catheter to ensure there is no leakage; commenters stated that this was true for both CPT codes 91124 and 91125. For CPT code 91124, commenters listed out four specific activities associated with this clinical labor time, and for CPT code 91125, commenters listed out the nine specific activities required to adequately prepare the room, equipment, and supplies.

Response: We appreciate the commenters for providing clarification and delineating the steps that are necessary to prepare the room, equipment, and supplies. After consideration of public comments, and a re-review of the PE SOR, we were persuaded by commenters that 17 minutes would be appropriate for this direct PE input. We are therefore finalizing 17 minutes of CA013 clinical labor time for CPT code 91125.

Comment: For the CA024 clinical labor time (clean room/equipment by clinical staff), commenters disagreed with the proposed direct PE refinements for CPT codes 91124 and 91125. Commenters clarified that the catheter used in both procedures is flexible, not rigid and that flexible scopes typically require more time for cleaning than rigid scopes. A commenter suggested CMS to finalize the direct PE inputs for CPT codes 91124 and 91125 as recommended by the RUC. A commenter disagreed specifically with the reduction of clinical labor time associated with cleaning the room, equipment and supplies, as well as the proposed amount of cleaner. The

commenter suggested finalizing 30 minutes of cleaning time for consistency with cleaning standards for flexible scopes. The commenter also suggested a crosswalk to the direct PE inputs for CPT code 45378 (Colonoscopy, flexible; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure)). Additionally, the commenter pointed out an inconsistency in CMS' recommendations for room and equipment preparation time for CPT codes 91124 and 91125, requesting CMS review supporting materials.

Response: We appreciate the clarification provided by commenters regarding the cleaning time associated with these procedures. However, we continue to believe that 30 minutes of CA024 clinical labor time would not be typical for these procedures. The standard cleaning time for a rigid scope is 10 minutes and the standard time for a flexible scope is 30 minutes; however, CPT codes 91124 and 91125 include catheters, not scopes. While these two codes do contain an SD216 balloon catheter among their direct PE inputs, we do not typically assign 30 minutes of CA024 cleaning time for cleaning the catheter; instead, our standard time for catheter cleaning is 3 minutes. We agree that CPT codes 91124 and 91125 require more time than the standard value for the cleaning tasks associated with the CA024 clinical labor activity, which is why we proposed 10 minutes for this task. When evaluating the crosswalk code (CPT code 45378) suggested by commenters, we also noted that this code had only 3 minutes of CA024 cleaning time, which did not support the requested increase in cleaning time. Therefore, we continue to believe that our proposed 10 minutes of CA024 clinical labor time is accurate for these two codes, and we are finalizing as proposed. We did not see sufficient rationale provided to support a change in valuation at this time, however, we welcome additional information regarding this supply.

Comment: A few commenters also requested CMS to restore the (enzymatic detergent) supply to 120 ounces, based on the vendor's cleaning instructions.

Response: We disagree with commenters that 120 ounces would be appropriate based on the vendor instructions. Among the approximately 70 other codes on the PFS that use the SM015 supply, the typical quantity in use is 4 ounces and no codes use more than 8 ounces. We do not agree that 120 ounces of this product would be typically required for routine cleaning activities. However, we will increase the SM015 supply input for this code from 4 to 8 ounces to match the highest supply quantity amongst codes currently paid under the PFS (CPT codes 30300 and 30560) to reflect the concerns of the commenters.

After consideration of public comments, we are finalizing the work RVUs and direct PE inputs for CPT codes 91124 and 91125 as proposed, with the modification to the CA017 clinical labor time for CPT code 91125 and the modification to the SM015 supply quantity, as previously detailed. (29) Dark Adaptation Diagnostic and Screening Services (CPT Codes 92284 and 92288)

In 2023, specialty societies prepared and submitted a Category I Code Change Application to the CPT Editorial Panel to create CPT code 92288 (Screening dark adaptation measurement (for example, rod recovery intercept time), with interpretation and report), which describes the screening test for retinal and optic nerve disease. This code was created to differentiate between diagnostic dark adaptation testing and screening testing that has possibly been reported under CPT code 92284 (Diagnostic dark adaptation examination (for example, rod and cone sensitivities, rod-cone breakpoint), with interpretation and report). The CPT Editorial Panel also added a parenthetical to CPT code 92284, to describe how the diagnostic dark adaptation test is conducted to identify patients with macular degeneration or inherited retinal diseases when they have symptomatic visual loss without any identifiable cause or clinical examination.

CPT code 92288 describes a screening service that has not been determined to be a preventive service under Section 1861 of the Social Security Act and as such is not covered under Medicare. We are proposing to assign status indicator (“N”) to this service, as a non- covered service. We will list the RUC-recommended RVUs for display purposes only.

In the CY 2023 PFS final rule we finalized a work RVU of 0.00 for CPT code 92284 as proposed (87 FR 69513). The RUC had surveyed this procedure in 2021, reviewed the survey results for the procedure and recommended 1 minute of pre-service time, 3 minutes of intraservice time, 1 minute of immediate post-service time, totaling 5 minutes, all of which reduced the surveyed times. The RUC also recommended a work RVU of 0.14. We disagreed with the RUC-recommended work RVU of 0.14 for CPT code 92284. We found that the recommended work RVU did not adequately reflect reductions in physician time, since the diagnostic screening is usually completed during an E/M visit and largely consists of interpreting machine generated results.

For this latest review of CPT code 92284 for CY 2026, we disagree with the RUC-recommended work RVU of 0.32 and proposed a work RVU of 0.29 for CPT code 92284 based on a crosswalk to code CPT 92132 (Computerized ophthalmic diagnostic imaging (e.g., optical coherence tomography [OCT]), anterior segment, with interpretation and report, unilateral or bilateral), for which we finalized 0.29 work RVU in the CY 2025 PFS. Our proposed work RVU was also supported by reference to CPT code 71110 (Radiologic examination, ribs, bilateral; 3 views), with a work RVU of 0.29. Both codes have intraservice work times of 6 minutes and total times of 8 minutes. While the intraservice work time of both reference codes is 1 minute less than the RUC-recommended median survey time for CPT code 92284, they each have 1 minute for pre- service and post-service times. We believe it is more appropriate to use these reference codes than the RUC-recommended cross walk to CPT 92282 (Imaging of retina for detection or monitoring of disease; with remote physician or other qualified health care professional interpretation and report, unilateral or bilateral) with a work value of 0.32 RVU because we believe the RUC-recommended intraservice work time and work RVU are overstated relative to the current intraservice work time and work RVU for CPT code 92284. Additionally, we also searched for crosswalks to CPT codes with the same intraservice time and a range of similar pre-and post-service times and found that the recommended work RVU of 0.32 fell near the top of this range, which would not maintain relativity of the work values among the identified CPT codes.

We proposed the RUC-recommended direct PE inputs for CPT code 92284 without refinement.

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

Comment: Some commenters opposed the CMS proposed work RVU of 0.29 for CPT code 92284. These comments recommended that CMS revisit the proposal and finalize the RUC-recommended work RVU of 0.32 for CPT code 92284. Commenters maintained that the CMS proposed work RVU of 0.29 does not accurately account for the necessary time and overall measured intensity/complexity arising from increased medical decision-making

related to the advanced analysis to interpret the test results. Several commenters requested that CMS publish the RUC-recommended work RVUs and PE and MP RVUs for CPT code 92288 in Addendum B on a display basis so other payors could utilize these relative values.

Response: We appreciate the commenters for their comments. We continue to believe it is more appropriate to use our proposed work RVU of 0.29 for CPT code 92284 than the RUC-recommended crosswalk to CPT 92282 with a work value of 0.32 RVU. As we stated in the proposed rule, when we searched for other CPT codes with similar time values to CPT code 92284, the RUC's recommended work RVU fell near the top of this range which would not maintain relativity of the work values among the identified CPT codes. We do not believe that the diagnostic dark adaptation examination service being performed in CPT code 92284 would typically have high enough intensity to warrant the RUC's recommended work RVU.

After consideration of these comments, we are finalizing the work RVU and direct PE inputs for CPT code 92284 as proposed, along with finalizing the proposed non-covered status indicator for CPT code 92288. We agree with commenters' request to display RVUs for CPT code 92288; however, we note that the proposed rule already displayed RVUs for this service in Addendum B. We will continue to display these RVUs for the final rule and in future rulemaking. (30) Coronary Therapeutic Services and Procedures (CPT Codes 92920, 92924, 92928, 92933, 92937, 92941, 92943, 92973, 92930, 92945, 93571, and 93572)

In the CY 2013 PFS final rule (77 FR 69063 through 69064), we reviewed 13 new codes to describe percutaneous coronary intervention (PCI) services and assigned bundled status to all the add-on codes for the additional branches off the major coronary arteries because we believed that separately paying for branch-level stents may encourage increased placement of stents. To bundle the work of each new add-on code into its respective base code, we used the RUC-recommended utilization crosswalk to determine what percentage of the base code utilization would be billed with the add-on code, and added that percentage of the RUC-recommended work RVU and physician time for the add-on code to the RUC-recommended work RVU and physician time of the base code.

In September 2022, the CPT Editorial Panel created one new Category I CPT code for percutaneous coronary lithotripsy. The new add-on CPT code 92972 (Percutaneous transluminal coronary lithotripsy) was reviewed by the RUC on an interim basis for CY 2024 while the entire PCI code family was referred to the CPT Editorial Panel for restructuring. Subsequently, the code family was revised at the February 2024 CPT Editorial Panel meeting, including the deletion of the bundled add-on codes, and surveyed for the April 2024 RUC meeting.

The following is a list of the CPT codes and their long descriptors: CPT codes 92920 (Percutaneous transluminal coronary angioplasty, single major coronary artery and/or its branch(es)), 92924 (Percutaneous transluminal coronary atherectomy, with coronary angioplasty when performed, single major coronary artery and/or its branch(es)), 92928 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed, single major coronary artery and/or its branch(es); one lesion involving one or more coronary segments), 92933 (Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed, single major coronary artery and/ or its branch(es)), 92937 (Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed, single vessel major coronary artery and/its branches), 92941 (Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, any combination of intracoronary stent, atherectomy and angioplasty, including aspiration thrombectomy when performed, single major coronary artery and/or its branches or single bypass graft and/or its subtended branches), 92943 (Percutaneous transluminal revascularization of chronic total occlusion, single coronary artery, coronary artery branch, or coronary artery bypass graft, and/or subtended major coronary artery branches of the bypass graft any combination of intracoronary stent, atherectomy and angioplasty; antegrade approach), 92973 (Percutaneous transluminal coronary thrombectomy aspiration mechanical (List separately in addition to code for primary procedure)), 92930 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed, single major coronary artery and/or its branch(es); two or more distinct coronary lesions with two or more coronary stents deployed in two or more coronary segments, or a bifurcation lesion requiring angioplasty and/or stenting in both the main artery and the side branch), 92945 (Percutaneous transluminal revascularization of chronic total occlusion, single coronary artery, coronary artery branch, or coronary artery bypass graft, and/or subtended major coronary artery branches of the bypass graft any combination of intracoronary stent, atherectomy and angioplasty; combined antegrade and retrograde approaches), 93571 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress, when performed; initial vessel (List separately in addition to code for primary procedure)), and 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress, when performed; each additional vessel (List separately in addition to code for primary procedure)). We proposed the RUC-recommended work RVU for all twelve codes in the family. We proposed a work RVU of 8.35 for CPT code 92920, a work RVU of 10.13 for CPT code 92924, a work RVU of 10.00 for CPT code 92928, a work RVU of 11.94 for CPT code 92933, a work RVU of 11.30 for CPT code 92937, a work RVU of 12.72 for CPT code 92941, a work RVU of 13.69 for CPT code 92943, a work RVU of 1.75 for CPT code 92973, a work RVU of 12.00 for CPT code 92930, a work RVU of 15.00 for CPT code 92945, a work RVU of 1.80 for CPT code 93571, and a work RVU of 1.44 for CPT code 93572.

However, we note these work RVUs as recommended by the RUC set new upper ranges for multiple codes in the RUC Database. For example, the proposed work RVU of 12.00 for CPT code 92930 sets a new upper range on RUC Database searches for 000-day global codes with an intraservice time of 75 minutes, with a previous maximum value of 10.25 work RVUs for CPT code 49614 (Repair of anterior abdominal hernia(s) (that is, epigastric, incisional, ventral, umbilical, spigelian), any approach (that is, open, laparoscopic, robotic), recurrent, including implantation of mesh or other prosthesis when performed, total length of defect(s); less than 3 cm, incarcerated or strangulated), with the same

intraservice time and 165 minutes of total time. Similarly, we shared in the RUC's difficulties finding major surgical procedures with the 000-day global period with similar times to use as potential reference or bracket codes.

The RUC did not recommend, and we did not propose any direct PE inputs for these facility-based services.

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 and supported the CMS proposal of the RUC-recommended work RVUs for all 12 codes in the family. A commenter also requested CMS exclude these codes from the proposed efficiency adjustment as these codes were just revalued and contained several new codes.

Response: We appreciate the support for our proposed valuations from the commenters; our discussion of the efficiency adjustment can be found in section II.E.2.b of this final rule.

After consideration of the comments, we are finalizing the work RVUs for all 12 codes in the Coronary Therapeutic Services and Procedures family as proposed. We did not propose, and we are not finalizing any direct PE inputs for these codes. (31) RSV Monoclonal Antibody Administration (CPT Codes 96380 and 96381)

In September 2023, CPT created two Category I codes, 96380 (Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection, with counseling by physician or other qualified health care professional) and 96381 ((Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection) to report administration of respiratory syncytial virus (RSV), monoclonal antibody and seasonal dose, with and without counseling. These codes were effective October 6, 2023 for immediate use. At the time, the RUC did an immediate review of these codes and issued interim recommendations to CMS. The RUC reviewed these codes again at the April 2024 RUC meeting.

We proposed the RUC-recommended work RVU of 0.28 for CPT code 96380 and 0.17 for CPT code 96381. We proposed 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: Several commenters supported the proposed RUC-recommended work and PE inputs for RSV monoclonal antibody administration services. Commenters recommended that CMS engage in ongoing monitoring of payment adequacy as more data is gathered on this service over time. Commenters requested that CMS publish the RUC-recommended work RVUs and PE and MP RVUs for CPT code 96380 and CPT code 96381 in Addendum B on a display basis so other payors could utilize these relative values.

Response: We appreciate the commenters for their support. We agree with commenters' request to display RVUs for CPT code 96380 and 96381; however, we note that the proposed rule already displayed RVUs for these services in Addendum B as both codes have an active status code. We will continue to display these RVUs for the final rule and in future rulemaking.

After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for CPT codes 96380 and 96381 as proposed. (32) Remote Monitoring (CPT Codes 98975, 98976, 98977, 98978, 98980, 98981, 98984, 98985, 98986, 98979, 99091, 99453, 99454, 99457, 99458, 99473, 99474, 99445, and 99470)

In September 2024, the Current Procedural Terminology (CPT) Editorial Panel added one code and made code revisions to report remote physiologic monitoring (RPM) device supply for 2 to 15 days and 16-30 days within a 30-day period to report RPM parameters; created one new code and code revisions to report RPM treatment management services for the first 10 minutes, first 20 minutes, and each additional 20 minutes thereafter; added three remote therapeutic monitoring (RTM) device supply codes to report respiratory, musculoskeletal and cognitive behavioral therapy for 2 to 15 days and 16 to 30 days within a 30-day period; created one new code and made code revisions to report RTM treatment management services for the first 10 minutes, first 20 minutes, and each additional 20 minutes thereafter; and revised remote monitoring guidelines.

Remote physiologic monitoring (RPM) represents the remote monitoring of parameters such as weight, blood pressure, and pulse oximetry to monitor a patient's condition and inform their management. The remote physiologic monitoring code set currently includes CPT codes 99453, 99454, 99091, 99457, 99458, 99473, and 99474 (code descriptors can be found in Table A-E10). For CY 2026, the CPT Editorial Panel created two new RPM codes to describe RPM services that describe less than 16 days of data transmission per 30-day period and less than 20 minutes of interactive communication per month: CPT codes 99445 and 99470. The CPT Editorial Panel also made edits to specify the minimum days of data transmission per 30-day period for CPT code 99454 (new code descriptors and revised code descriptors can be found in Table A- E11). None of the RPM codes (CPT codes 99091, 99474, 99470, 99457, and 99458) met the minimum survey requirements established by the RUC for the January 2025 RUC meeting. As a result, the RUC-recommended that CPT codes 99091, 99474, 99470, 99457, and 99458 be resurveyed after 1 year of utilization data is available for this CPT 2026 code structure. All RPM codes are expected to be reviewed at the January 2028 RUC meeting.

Remote therapeutic monitoring (RTM) represents the monitoring of adherence to at-home therapeutic interventions. RTM can be provided for a variety of conditions, and there are distinct device supply codes that have been created for three types of therapeutic monitoring: respiratory system, cognitive behavioral therapy, and musculoskeletal system monitoring. The remote therapeutic monitoring code set currently includes CPT codes 98975, 98976, 98977, 98978, 98980, and 98981 (code descriptors can be found in Table A-E10). For CY 2026, the CPT Editorial Panel created four new RTM codes to describe RTM services that describe less than 16 days of data transmission per 30-day period and less than 20 minutes of interactive communication per month: CPT codes 98984, 98985, and 98979. The CPT Editorial Panel also made edits to specify the minimum days of data transmission per 30-day period for CPT codes 98976, 98977, and 98978 (new code descriptors and revised code descriptors can be found in Table A-E11). All of the codes in the RTM family are considered new technology (CPT codes 98975, 98984, 98976, 98985, 98977, 98979, 98979, 98980, and 98981) and will be placed on the New Technology list to be reviewed after 3 years of data are available (April 2030).

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

Comment: Several commenters overwhelmingly supported the creation and adoption of CPT codes describing 2 to15 days of monitoring and the first 10 minutes of treatment management services. Commenters stated that these services could be valuable for beneficiaries with acute conditions or are more stable in their treatment. Some commenters did not support the creation of these codes, as they believe that more days of monitoring could deliver greater clinical value and that these codes may increase the potential for inappropriate billing practices.

Response: We appreciate the commenters for their support in our proposal to adopt the new CPT codes. While we understand the concerns presented by commenters who were apprehensive about the adoption of these new codes, we would like to emphasize that services paid under the Physician Fee Schedule, including the new remote monitoring codes, must be reasonable and necessary for the diagnosis and treatment of illness or injury. We continue to believe that the new remote monitoring CPT codes may be reasonable and necessary for some beneficiaries who require remote monitoring services.

Comment: Many commenters did not support any of our proposals for valuation that were lower than the RUC recommendations, and many commenters believe that RTM and RPM are generally undervalued.

Response: We appreciate the commenters for this information. We will consider additional refinements in future rulemaking.

Comment: Several commenters requested clarification around the coding structure of the new CPT codes, specifically around the base and add-on code structure.

Response: We would like to offer further clarification on the coding structure of the new remote monitoring codes. The 2 to 15 day codes (99445, 98984, 98985, and 98986) and 16 to 30 day codes (99454, 98976, 98977, 98978) are not additive and are not a base and add-on code structure. Billing practitioners would only bill for one of those codes for the appropriate number of days of data transmission per 30 days. In addition, the treatment management services describing the first 10 minutes (99470 and 98979) and first 20 minutes (99457 and 98980) of service are also not additive. Billing practitioners would choose the most appropriate code for the time spent that calendar month. In instances where more than 20 minutes of treatment management is needed after either 99457 or 98980 is billed, 99458 or 98981 can be used. Please refer to the CPT codebook for additional information on the structure of these CPT codes.

Comment: Commenters noted that they found Table A-E11 in the proposed rule unclear.

Response: We would like to clarify to commenters that Table A-E11 was intended to display the long descriptors for the Remote Therapeutic and Remote Physiologic Monitoring code families. It was not meant to encompass all edits that were made to the CPT codebook language. We will be adopting all descriptors, guidelines, prefatory language, and parenthetical changes made to the Remote Monitoring section of the 2026 edition of the CPT codebook. Please refer to the CPT codebook for additional information.

Comment: Several commenters requested a variety of changes to the requirements for RPM and RTM, including allowing both new and established patients to receive RPM services, allowing RPM and RTM to be billed concurrently, allowing payment for multiple devices, and allowing billing during the global period. Commenters requested that additional data collection be required for billing (including greater specificity about the types of data that can be collected), implementing duration limits, and adding additional technology and EHR requirements. Commenters also requested changes to the coding for RPM and RTM, including revising code descriptors to align all codes to account for calendar months as opposed to 30-days, creating condition- agnostic RTM coding, creating additional RTM coding for other conditions, and creating coding specific to Software as a Service (SaaS) or AI-generated analysis instead of just provider analysis.

Response: We appreciate the commenters for this information and will consider for future rulemaking. We would also like to refer interested parties to the CY 2024 PFS final rule (88 FR 78882 through 78883), where some of this information was clarified.

Comment: Several commenters requested that we allow additional billing practitioners and clinical staff to furnish remote monitoring services, such as pharmacists, registered dieticians, and athletic trainers.

Response: We appreciate the commenters for their input. As these practitioners do not have the appropriate benefit category to furnish these services, we lack the statutory authority to expand the benefit categories for billing practitioners.

Comment: Several commenters requested that we eliminate geographic adjustments or develop a national price floor for remote monitoring services, as technology costs are fixed and do not vary geographically like labor or practice expense.

Response: Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure relative cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, practice expense (PE), and malpractice (MP)). The PE GPCIs are designed to measure the relative cost difference in the mix of goods and services comprising PEs (not including MP expenses) among the PFS localities as compared to the national average of these costs and are comprised of four component indices (employee wages; purchased services; office rent; and equipment, supplies and other miscellaneous expenses). For the medical equipment, supplies, and miscellaneous expenses component, we believe there is a national market for these items such that there is not significant geographic variation in costs. Therefore, the equipment, supplies and other miscellaneous expense cost index component of the PE GPCI is given a value of 1.000 for each PFS locality.

Comment: Several commenters requested that we update practice expense inputs for remote physiologic and remote therapeutic monitoring to account for software such as a medical device, hardware, and additional technology inputs as direct PE. Commenters recommended CMS make revisions to PE inputs to account for both the device and the supporting infrastructure, software (including Software as a Service (SaaS), or other technology inputs.

Response: We appreciate the commenters for this information and we will consider input and recommendations to update practice expense inputs for future rulemaking. Please see section I(1)(b) of this rule for additional discussion of software as a service.

Comment: Several commenters requested clarification on whether time spent providing audio-only communication with the patient/caregiver (for example, telephone calls) could count towards the time counted for the interactive communication portion of CPT codes 98979, 98980, 98981, 99470, 99457, and 99458. Commenters also requested that we clarify that technological communications, such as secure messaging, asynchronous chat, automated bi-directional messaging, and AI prompts, count towards time for the interactive communication portion of CPT codes 98979, 98980, 98981, 99470, 99457, and 99458. Commenters requested that documented in-clinic discussions meet the interactive communication requirement.

Response: We are clarifying that we are adopting the CPT language around this requirement. The CPT code book states that CPT Codes 98979, 98980, 98981, 99470, 99457, and 99458 “require a live, interactive communication with the patient/caregiver. The interactive communication contributes to the total time, but it does not need to represent the entire cumulative reported time of the treatment management service.” We are not specifying further exclusions for the types of communications that can be had with the patient/caregiver, so long as they meet the CPT specifications. For in-clinic discussions, no time or effort should be counted more than once toward the required time for any services.

Comment: A few commenters requested clarification regarding new RTM CPT codes and the “sometimes therapy” designation.

Response: We note that the new RTM codes 98979, 98984 and 98985 will be designated as “sometimes therapy” codes since they are based on RTM codes we designated as sometimes therapy in the CY 2022 PFS final rule. The “sometimes” therapy designation means that the services can be billed outside a therapy plan of care (POC) by a physician and certain NPPs, when appropriate; and always require a POC therapy modifier when furnished by a physical therapist (PT) or occupational therapist (OT), or by a therapy assistant under the PT's or OT's supervision, or speech-language pathologist. When

furnished by a physical therapist assistant (PTA) or occupational therapy assistant (OTA), RTM codes generally also require the CQ or CO modifier, respectively, in addition to the POC therapy modifier (GP or GO) when the threshold established via the de minimis or 10 percent standard is met or exceeded for the statutorily required payment adjustment that applies to therapy services provided in whole or in part by PTAs and OTAs. The de minimis standard policy including how to determine when the CQ/CO modifiers are applied including an RTM billing example is found on the Therapy Services website in a document titled: Billing Examples Using CQ/CO Modifiers for Services Furnished In Whole or In Part by PTAs and OTAs at: https://www.cms.gov/medicare/coding-billing/therapy-services/billing-examples-using-cq/co-modifiers-services-furnished-whole-or-part-ptas-and-otas.

For the RTM codes designated as sometimes therapy, we are clarifying our policy about the appropriate use of the CQ/CO modifiers for services of PTAs and OTAs apply to the new RTM code 98979. However, the CQ/CO are not applicable to the RTM device codes 98984 and 98985 as they are based on the exiting codes 98976 and 98977. We previously clarified this CQ/CO modifier RTM device code policy for codes 98976 and 98977 in the CY 2022 PFS final rule (86 FR 65116 and 65176) and provided an educational article (MM12446) with the release of Transmittal R11118CP (Change Request 12446) in addition to the above document link on the Therapy Services web page. The related policy for the new and revised RTM codes will also be available after the CY 2026 PFS final rule is issued via a Transmittal for the CY 2026 Annual Update of Therapy Codes.

Comment: A commenter requested that CMS default to State law as it relates to who can assist therapists in the provision of RTM services.

Response: While we appreciate the commenters' concern regarding the shortage of therapy professionals, we remind readers that Medicare regulatory requirements allow for coverage and payment of outpatient occupational and physical therapy services in Sec. Sec. 410.59(a) and 410.60(a), respectively, only if they are furnished by OTs and their supervised OTAs or by PTs and their supervised PTAs to meet the requirements in 42 CFR part 484.

For CPT code 99091, we disagree with the RUC's recommendation of 0.70 work RVUs and proposed to maintain the current work RVU of 1.10 and the corresponding physician time inputs. This code, as well as the other RPM codes, did not meet the minimum survey requirements established by the RUC for the January 2025 RUC meeting. The RPM coding will be resurveyed after 1 year of utilization data is available for this 2026 CPT code structure, and we look forward to reviewing the additional data at that time to refine the valuation for this code more accurately. The RUC did not recommend it, and we did not propose any direct PE inputs for CPT code 99091.

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

Comment: Several commenters were generally supportive of our proposal to maintain the work RVU and the corresponding physician time inputs for CPT code 99091.

Response: We appreciate the commenters for their support. After consideration of public comments, we are finalizing as proposed.

For CPT code 99470, we disagreed with the RUC's recommendation of 0.39 work RVUs and proposed a work RVU of 0.31, with 10 minutes or intraservice/total time. We disagreed with the recommended value and proposed a work RVU of 0.31 for CPT code 99470 based on the total time ratio between the 20 minutes of total time assigned to CPT code 99457 and the 10 minutes of total time assigned to CPT code 99470. This ratio equals 50 percent, and 50 percent of the current work RVU of 0.61 rounds to a work RVU of 0.31. Although we do not believe that the decrease in time described in the code descriptor must equate to a one- to-one or linear decrease in the valuation of work RVUs, since the two components of work are time and intensity, significant reductions in time for codes with equivalent intensity should generally be reflected in decreases to work RVUs. In the case of CPT code 99470, we believe it would be more accurate to propose the total time ratio at a work RVU of 0.31 to account for these decreases in work time compared to CPT code 99457. We also proposed using this time ratio with the current PE inputs for CPT code 99457 for clinical staff time. We proposed 5 minutes of CA021 intraservice clinical labor time and 15 minutes of CA037 post-service clinical labor time for CPT code 99470.

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

Comment: Commenters had mixed views on our proposed refinements to CPT code 99470. While some commenters supported our proposal, many commenters did not support the proposal based on the time ratio compared to CPT code 99457, as the RPM platform and staffing expense is fixed and does not decrease based on minutes of treatment management services provided. Many commenters requested that CMS finalize the RUC recommendations or align all the direct PE inputs with CPT code 99457.

Response: We continue to believe that since the two components of work are time and intensity, significant reductions in time for codes with equivalent intensity should generally be reflected in decreases to work RVUs. Although commenters pointed out that RPM platform and staffing expenses are fixed, there are no RPM platform-related inputs in CPT codes 99457 or 99470. The only PE input for these codes are clinical staff time, which does change based on the minutes of treatment management services provided.

After consideration of public comments, we are finalizing as proposed.

For CPT code 99457, we disagreed with the RUC's recommendation of 0.45 work RVUs and proposed to maintain the current work RVU of 0.61, the current work time of 20 minutes, and the current direct PE inputs. This code, as well as the other RPM codes, did not meet the minimum survey requirements established by the RUC for the January 2025 RUC meeting. RPM coding will be resurveyed after 1 year of utilization data is available for this 2026 CPT code structure, and we look forward to reviewing the additional data at that time to refine the valuation for this code more accurately. For CPT code 99458, we disagreed with the RUC's recommended direct PE inputs and proposed to maintain the current inputs. We proposed the RUC-recommended work RVU of 0.61 for CPT code 99458, as this work RVU was reviewed by the RUC and resulted in no recommended changes for CY 2026. Our proposal to maintain current work RVUs and PE inputs was due to the lack of survey data supporting changes to these codes' valuation, as none of the RPM codes met the minimum survey requirements established by the RUC for the January 2025 RUC meeting. We also believe it is important to maintain relativity between

RPM and RTM codes describing equivalent amounts of treatment management time and effort.

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

Comment: Commenters supported the CMS proposal not to propose the RUC recommendation and maintain the current valuation for CPT code 99457. Commenters supported the proposed work RVU of 0.61 for CPT code 99458, as this work RVU was reviewed by the RUC and resulted in no recommended changes for CY 2026. A few commenters requested that CMS require 16 to 30 days of data (CPT code 99454) to be collected to bill for additional treatment management services (CPT code 99458).

Response: We appreciate the commenters for their support for our proposal for CPT codes 99457 and 99458. While we understand that additional treatment management time may be less common for beneficiaries with fewer days of data collection, we do not believe it is necessary at this time to restrict treatment management services based on days of data collection. We will monitor these concerns by monitoring claims data and may address them in future rulemaking if needed.

After consideration of public comments, we are finalizing as proposed.

For CPT code 99474, we proposed the RUC-recommended work RVU of 0.18 and direct PE inputs without refinement, as this code was reviewed by the RUC and resulted in no recommended changes for CY 2026.

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

Comment: Several commenters supported CMS' proposals for CPT code 99474.

Response: We appreciate the commenters for their support.

After consideration of public comments, we are finalizing as proposed.

For CPT code 99473, which is a PE-only code, we proposed the RUC- recommended direct PE inputs without refinement, as this code was reviewed by the RUC and resulted in no recommended changes for CY 2026.

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

Comment: Commenters supported CMS' proposals for CPT code 99473.

Response: We appreciate the commenters for their support.

After consideration of public comments, we are finalizing as proposed.

For CPT code 99453, which is a PE-only code, we proposed 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 supported CMS' proposals for CPT code 99453. Commenters also requested clarification that CMS will adopt parenthetical changes for this code, specifically the requirement that this service now requires 2 days of monitoring in a 30-day period for reporting, as opposed to 16.

Response: We appreciate the commenters for their support. We will be adopting all descriptors, guidelines, prefatory language, and parenthetical changes made to the Remote Monitoring section of the 2026 edition of the CPT codebook, including for CPT code 99453.

After consideration of public comments, we are finalizing as proposed.

For the PE-only CPT codes 99445 and 99454, the RUC's recommendations included a “digital remote physiologic monitoring device app,” which is a per-click vendor fee that has not traditionally been included as a form of direct PE. We understand that as these technologies evolve, the issues involving the use of software and other forms of digital tools become more difficult to account for accurately in our standard PE methodology. We acknowledge that for CPT codes 99445 and 99454, the overall payment rate is driven by practice expense supply and equipment inputs rather than physician work or clinical staff time We have concerns with the RUC-recommended PE inputs for device supply and equipment, as these inputs are difficult to accurately account for due to lack of substantive invoices and other types of supportive data. As MedPAC noted in their comment to the CY 2011 PFS proposed rule, “using price information voluntarily submitted by specialty societies, individual practitioners, suppliers, and product developers may not result in objective and accurate prices because each group has a financial stake in the process”. We have repeatedly stated, such as in the CY 2018 final rule, that “we do not believe that very small numbers of voluntarily submitted invoices are likely to reflect typical resource costs and create the potential for overestimation of supply and equipment costs” (82 FR 52998). Given our concerns with the RUC-recommended direct PE inputs and our inability to verify the pricing for these inputs, we believe that using Hospital Outpatient Prospective Payment System (OPPS) cost data to value CPT codes 99445 and 99454 may more accurately reflect the actual costs of these technologies. We assume the costs incurred in furnishing these PE-only codes would be the same across settings of care (physician office and hospital outpatient), since these codes do not have any physician work and only account for PE associated with device supply and data transmission. Under section 1848(c)(2)(N) of the Act, we have authority to establish or adjust PE RVUs using cost, charge, or other data from suppliers or providers of services. We proposed to use OPPS cost data to establish the valuation for the practice expense portion of Remote Physiologic Monitoring CPT codes 99445 and 99454. We believe that the OPPS cost data is more accurate than the direct PE inputs recommended by the RUC. OPPS practice expense data obtained from cost reports is regularly updated, auditable, and required to adhere to national standards for reporting. For example, in the CY 2015 PFS final rule (79 FR 67569), we noted that “routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid reflection of “relative” resources and could be useful to supplement the resource cost information developed under our current methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year.” We proposed to utilize the OPPS total geometric mean cost for CPT code 99454 to inform the valuation of CPT codes 99445 and 99454 when paid under the PFS. We proposed to calculate this value by dividing the OPPS Geometric Mean Cost (GMC) for CPT code 99454, which is represented in a dollar amount, by the estimated CY 2026 PFS conversion factor (CF), which represents the dollar value of an RVU, in order to convert the GMC dollar amount into RVUs. The resulting value will be the PE RVU for CPT codes 99445 and 99454. We proposed the same valuation for both CPT codes 99445 and 99454 since the device is supplied to the beneficiary for the full 30-day period, regardless of the number of days that data is transmitted.

We received public comments on these proposals. The following is a

summary of the comments we received and our responses.

Comment: Several commenters had mixed support for CMS' proposal for the same valuation for CPT codes 99445 and 99454. The commenters who supported the proposal stated that this would reduce administrative burden and the risk of coding confusion. Some commenters supported the reasoning that the device is supplied to the beneficiary for the full 30-day period, regardless of the number of days that data is transmitted. We received confirmation of this information from practitioners who furnish RPM services and vendors who supply RPM devices, stating that this aligns the actual technology costs, as these costs are tied to the number of patients receiving these services in a given 30-day period, not the number of days of data collected in those 30 days. The commenters who supported this proposal stated that the proposed valuation more accurately represents the reality of practice expense for these services. Commenters who did not support this proposal stated that a lower valuation for CPT code 99445 would pay for the actual use of the equipment and allow CMS to further ensure program integrity by accurately tracking spending. These commenters also believe that a lower valuation for CPT code 99445 would also incentivize more days of data collection, which would provide more value when determining a plan of care and reward adherence.

Response: We appreciate the commenters for this feedback on our proposal. With the additional information provided by commenters, we continue to believe that practice expense costs for these services remain the same, regardless of the number of days of data collected. We will continue to look into OPPS hospital cost reporting data and may consider changes for future rulemaking.

Comment: Several commenters appreciated the proposal to utilize OPPS data due to PE inputs that have not traditionally been included as a form of direct PE. Many commenters requested additional clarification and additional information on why CMS believes this data is more accurate. The commenters requested that CMS provide detailed data on how PE RVU inputs were derived from OPPS claims. Some commenters did not support the proposal to utilize OPPS data to value these services, as there are different statutory frameworks for payment under OPPS and PFS. Other commenters who did not support the proposal suggested that CMS value these services based on supplier invoices, not OPPS data.

Response: We appreciate the commenters for their support of our proposal to use OPPS data. As we stated in the proposed rule, we have authority to establish or adjust PE RVUs using cost, charge, or other data from suppliers or providers of services. Although the use of invoice data may be beneficial when valuing certain services, exclusively using invoices for the valuation of these PE-only services may not result in objective and accurate prices because each interested party that submits invoices has a financial stake in the process. By using OPPS practice expense data, we have built in guardrails since the data obtained from cost reports is regularly updated, auditable, and required to adhere to national standards for reporting.

Comment: Many commenters did not believe that the use of OPPS data was appropriate for these services when paid under the PFS, as the PE costs incurred in furnishing these services may not be the same across physician office and hospital outpatient settings of care. Commenters were concerned that the correlation between OPPS costs and physician costs has not been established. Also, the commenters stated that physician offices operate on less favorable economies of scale than hospital outpatient departments, and using OPPS data assumes hospital- level infrastructure, purchasing power, and cost-sharing that do not equate to those of physician offices. Commenters cautioned against direct reliance on OPPS data for PE valuation without adjustments, as hospital outpatient departments and physician offices operate under different cost structures and suggested an adjusted PE methodology for physicians and private practices as compared to larger health systems and corporations. Commenters also suggested that CMS incorporate site- neutral adjustment factors when using OPPS data to establish PE relativity. Commenters were concerned that directly transferring costs data between payment systems could potentially lead to inaccurate valuations and that using hospital cost data may lead to overpayments. Other commenters were concerned that hospital cost reports represent bundled purchasing arrangements that do not capture specific device costs, which may not be available to physician offices.

However, some commenters believe that the input costs incurred in furnishing PE-only device supply codes are the same across settings of care.

Response: We continue to believe that the costs incurred in furnishing these PE-only codes would be the same across settings of care (physician office and hospital outpatient), since these codes do not have any physician work and only account for PE associated with device supply and data transmission. We welcome additional forms of data to assist us in refining PE methodology for future rulemaking.

Comment: Many commenters noted difficulty understanding CMS' proposal to use OPPS cost data to value CPT codes 99445 and 99454. Many commenters pointed out that the payment rates for CPT codes 99453 and 99454 under the OPPS differ drastically from the proposed PFS payment rates.

Response: Under the OPPS, we calculate a geometric mean cost for HCPCS codes paid under the OPPS. HCPCS codes are assigned to APCs using clinical criteria and geometric mean cost data. While we proposed to value the PE-only device supply codes using the OPPS cost data, we proposed the RUC-recommended direct PE inputs for CPT code 99453. We consider comments related to the OPPS payment rate for CPT code 99453 to be out of the scope of the proposed rule. Regarding the differing payment amounts for CPT code 99454 under the PFS and OPPS, we note that given that the APC payment rates are calculated using a system of averages, the geometric mean cost for HCPCS codes will often differ from the geometric mean cost for all services assigned to the APC. Differences in the payment systems explain the 20 percent difference in the proposed payment rate for CPT code 99454 under the PFS and the OPPS, since the PFS is using GMC to inform the valuation of CPT code 99454.

Comment: Several commenters requested more information about how the use of OPPS data will be updated over time and how the use of OPPS data will impact reimbursement. Commenters requested that, if finalized, CMS utilize OPPS data as an interim measure until updating the PE methodology to account for inputs associated with technology and digital platforms, such as subscription, data storage, and cybersecurity costs. Commenters also requested that CMS utilize the 2026 GMC for remote monitoring services, as finalized in the CY 2026 OPPS. Commenters requested that, if use of the 2026 GMC is finalized, this value remains static until the PE methodology is updated and does not get updated based on subsequent GMC changes.

Response: We appreciate the commenters for their input on this issue. We believe that it would be appropriate to utilize the most up- to-date cost data by using the CY 2026

GMC values in our calculations for CPT codes 99445 and 99454. We agree with commenters that the use of OPPS data, where appropriate, is a potential solution to a much larger challenge within the current PE methodology. We are interested in feedback and additional data from interested parties that could assist us in improving PE inputs and methodology for services that are primarily valued through technology costs for future rulemaking.

After consideration of public comments, we are finalizing calculating this value by dividing the CY 2026 OPPS Geometric Mean Cost (GMC) for CPT code 99454, which is represented in a dollar amount, by the CY 2026 non-qualifying APM PFS conversion factor (CF), which represents the dollar value of an RVU, to convert the GMC dollar amount into RVUs. The resulting value will be our finalized PE RVU for CPT codes 99445 and 99454.