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 compensation for this specialized role. According to the nominator, the current Medicare payment rate for CPT code 36514 in the non-facility setting fails to adequately account for direct PE costs. First, based on fourth quarter 2024 U.S. sales data, the nominator 24 Chhibber V and King KE. Management of the therapeutic apheresis patient (Chapter 12). In: Apheresis: Principles and Practice, 3rd Edition. Bethesda, MD: AABB Press, 2010. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32383 requested updating the CMS Equipment File price for the cell separator system equipment code (EQ084) from $81,656.40 to $93,321.35, reflecting current market conditions. According to the nominator, the current rate of 0.5 for equipment code EQ084 implies that facilities perform 426 procedures per year per device; however, data from major hospitals, including the three largest-volume hospitals in the U.S., demonstrates that facilities average only 181 procedures per year per device, edures per year per device; however, data from major hospitals, including the three largest-volume hospitals in the U.S., demonstrates that facilities average only 181 procedures per year per device, suggesting a more accurate utilization rate of 0.21. This discrepancy can significantly impact on the calculated costs and subsequent payment rates for equipment code EQ084. After reviewing the nominator’s submission, we do not believe that we have enough information to evaluate whether CPT code 36514 is potentially misvalued, and thus we are not proposing the code as potentially misvalued at this time. To assist us in further considering whether CPT code 36514 is potentially misvalued, we are seeking information on the direct practice expense inputs, particularly regarding the clinical labor code L056A and equipment code EQ084. Specifically, we seek comments on whether to establish a new therapeutic apheresis nurse clinical labor code in the non-facility setting. Also, we seek invoices and other associated information that could be used to update to the cell separator system equipment code EQ084 to reflect current market costs. We do not believe an update to the equipment utilization d other associated information that could be used to update to the cell separator system equipment code EQ084 to reflect current market costs. We do not believe an update to the equipment utilization rate is necessary. We disagree with the nominator that an equipment utilization rate of 21 percent would be typical for the cell separator system. As we stated previously, we currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act. As we discussed in the CY 2021 PFS final rule, it would distort relativity to assign a utilization rate of 21 percent for the cell separator system equipment, as this would have the same effect as doubling the overall price of the equipment (85 FR 84629). (7) Remote interrogation device evaluation (CPT code 93296). An interested party nominated CPT code 93296 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system, leadless pacemaker system, or implantable defibrillator system, remote data acquisition(s), receipt of transmiss evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system, leadless pacemaker system, or implantable defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results) as potentially misvalued, because the service has experienced substantial changes in PE. The nominator emphasized that the current direct practice expense inputs do not accurately represent either the current standard of care or the actual resources required to provide the service, necessitating an urgent review of the code’s resource input valuations. CPT code 93296 is a technical component-only code describing remote monitoring of cardiac devices over 90 days. The nominator stated that this service enables healthcare providers to remotely evaluate implanted cardiac defibrillators and pacemakers, review device data, communicate with patients, and share findings with physicians. The monitoring helps prevent emergencies and reduces hospitalizations through early intervention and timely device adjustments. According to the nominator, the code’s direct costs, last reviewed by RUC in 2016 and implemented in 2018, no ies and reduces hospitalizations through early intervention and timely device adjustments. According to the nominator, the code’s direct costs, last reviewed by RUC in 2016 and implemented in 2018, no longer reflect current service delivery requirements because technological advancements and expanded monitoring protocols have significantly increased service complexity and resource requirements. According to the nominator, the service delivery for CPT code 93296 has evolved significantly, requiring enhanced organizational infrastructure and specialized clinical expertise. Modern service delivery involves complex data management, with each transmission requiring 32 distinct tasks 25 for complete patient care. The 25 Aileen M. Ferrick et al,. 2023 HRS/EHRA/ APHRS/LAHRS Expert Consensus Statement on increased service complexity stems from advanced technology requirements, expanded patient monitoring needs, and more frequent device interrogation, shifting from quarterly to more regular intervals. These changes have created a notable disparity between current resource costs and existing valuations, necessitating updated mechanisms for data management and prioritization. According to the rvals. These changes have created a notable disparity between current resource costs and existing valuations, necessitating updated mechanisms for data management and prioritization. According to the nominator, the direct cost inputs for clinical labor and equipment do not reflect the current direct costs required to furnish the services. The nominator stated that the total direct cost of $25.84 (including clinical labor and equipment) exceeds the CY 2025 national non-facility PFS payment rate of $19.41. They stated that the current valuations do not reflect modern clinical staffing needs and equipment requirements for this pacemaker interrogation system service, despite similar updates being approved for comparable diagnostic services. To assess resource requirements, the nominator conducted an independent study among IDTFs, using standardized data collection and a volume-weighted analysis of 2023 service data. The nominator claimed that their findings demonstrate a significant disparity between current valuations and actual service delivery costs, supporting the need for comprehensive input review. The study of IDTFs conducted by the nominator revealed that CPT code 93296 require ity between current valuations and actual service delivery costs, supporting the need for comprehensive input review. The study of IDTFs conducted by the nominator revealed that CPT code 93296 requires 83.66 minutes of non- physician clinical labor time, significantly more than CMS’ current value of 28 minutes. This time encompasses eleven distinct tasks, from patient enrollment to quality assurance, with the most time-intensive activities being data review and analysis (25.25 minutes) and unscheduled alert management (21.84 minutes). Practical Management of the Remote Device Clinic (2023), http://www.hrsonline.org/guideance/ clinical-resources/2023-hrsehraaphrslahrs-expert- consensus-statement-practical-management- remote-device-clinic?gad_source=1&gclid= Cj0KCQiAkoe9BhDYARIsAH85cDOusU- vRRcEnwoXzUmN2COkX0_DiRVHuOM8cYMf8r iBNXW-KrFagnAaAs5NEALw_wcB. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32384 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Furthermore, the nominator stated that while the valuation for 0033 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32384 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Furthermore, the nominator stated that while the valuation for CPT code 93296 is currently based on electrodiagnostic technologists (L037A) at $0.44 per minute, the service is typically performed by cardiovascular technicians (L038B), who receive $0.60 per minute. Thus, the nominator believes that updating both the time and clinical staff classification is needed for accurate service valuation and consistency with other implantable device monitoring services. Finally, the nominator requested two updates to the equipment costs for CPT code 93296. First, they recommended adjusting the equipment usage time to align with the updated clinical labor time for remote interrogation device evaluation. Second, they recommended changing the assigned equipment code from ‘‘pacemaker interrogation, system’’ (EQ320) priced at $123,250 to ‘‘pacemaker follow-up system’’ (EQ198) priced at $279,453. We note that no invoices were submitted to support these prices. The nominator believes that these changes would align the equipment valuation with actual costs and match ’ (EQ198) priced at $279,453. We note that no invoices were submitted to support these prices. The nominator believes that these changes would align the equipment valuation with actual costs and match similar CMS-approved device monitoring services. Overall, the nominator stated that a review of CPT code 93296 current inputs reveals significant undervaluation in several key areas. According to the nominator, the existing resource costs for clinical labor times, labor types, and equipment costs do not adequately reflect the current service requirements. Based on the submitted information, however, we are not currently proposing to nominate this code as potentially misvalued. We request that the nominator submit a complete report detailing associated direct practice expense input assessment data to enable us to more fully consider whether the code is potentially misvalued. Additionally, we welcome comments, including any analysis or studies from the broader medical community, including the RUC, regarding whether this service has experienced substantial changes in practice expenses since its last review. (8) Fine Needle Aspiration (FNA) (CPT codes 10021, 10004, 10005, 10006) An intere he RUC, regarding whether this service has experienced substantial changes in practice expenses since its last review. (8) Fine Needle Aspiration (FNA) (CPT codes 10021, 10004, 10005, 10006) An interested party requested that CMS reconsider CPT codes 10021 (Fine needle aspiration biopsy, without imaging guidance; first lesion), 10004 (Fine needle aspiration biopsy, without imaging guidance; each additional lesion), 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and 10006 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion) for nomination as potentially misvalued, citing significant undervaluation since 2019. The nominator submitted a request to CMS for the reevaluation of these codes, stating that the payment changes have created a concerning cascade of negative consequences impacting the care of patients with thyroid nodules and cancer. Specifically, the nominator questions the fundamental basis of CMS’ 2019 work RVU reductions for FNA procedures. While the RUC recommended work RVUs of 1.20 for CPT code 10021 and 1.63 for CPT code 10005, CMS instead implemented lower values of 1.03 and 1.46, respectively. The no U reductions for FNA procedures. While the RUC recommended work RVUs of 1.20 for CPT code 10021 and 1.63 for CPT code 10005, CMS instead implemented lower values of 1.03 and 1.46, respectively. The nominator strongly disagreed with CMS’ methodology, particularly its comparison to CPT code 36440 (neonatal blood transfusion). The nominator argued that this crosswalk comparison is inappropriate because the neonatal procedure represents a fundamentally different type of service with distinct work intensity levels, requires different expertise, is rarely billed to Medicare, and serves an entirely different patient population than FNA procedures. The nominator further emphasized that when the work RVU for CPT code 10005 was reduced by 10.5 percent VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32386 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Pro 035 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32386 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules We suggested that interested parties may best engage with the MACs on these issues by appropriately reporting cost data in the MAC requested format. We also recognized that we should maintain consistency in pricing these services that are more indicative of changes in costs that occur yearly. In this proposed rule, we are seeking comments on whether we should assign national pricing under the PFS for PXR transportation services; specifically, for HCPCS code R0070 (Transportation of portable x-ray equipment and personnel to home or nursing home, per trip to facility or location, one patient seen) and HCPCS code R0075 (Transportation of portable x-ray equipment and personnel to home or nursing home, per trip to facility or location, more than one patient seen). We believe that national pricing would be conducive to ensuring consistency in payment rates across localities and also create payment stability for these services. To nationally price HCPCS codes R0070 and R0075, we c tional pricing would be conducive to ensuring consistency in payment rates across localities and also create payment stability for these services. To nationally price HCPCS codes R0070 and R0075, we could use reference codes that have only PE values and no work RVUs because these codes describe only the transportation services associated with PXR. Since these codes are currently paid using contractor pricing, we could also analyze the average MAC payment for them to inform national pricing. For example, we observed that HCPCS code R0070 was priced between $215 to 230 per service while HCPCS code R0075 was priced between $80 to 90 per service. Using these valuations could help to inform us of potential crosswalk codes in order to maintain consistency with the rates currently being paid. By converting the dollar payment for HCPCS codes R0070 and R0075 from Medicare Part B claims data into RVUs through the usage of our current conversion factor under the PFS, we identified potential crosswalk codes. For HCPCS code R0070, we could use a crosswalk to CPT code 93243 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; sc walk codes. For HCPCS code R0070, we could use a crosswalk to CPT code 93243 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report), which has a total national non-facility payment rate of $226.43 for CY 2025, and for HCPCS code R0075, we could use a crosswalk to CPT code 92582 (Conditioning play audiometry), which has a total national non-facility payment rate of $86.69 for CY 2025. We welcome comments from the public on whether we should consider national pricing for HCPCS codes R0070 and R0075, as well as whether these potential crosswalk codes would appropriately value these services, and any other factors we should consider. (11) Cryoablation Therapy To Treat Postoperative Pain An interested party requested we establish a code to describe the additional intraoperative time required by the surgeon to perform adjunctive cryoablation therapy for postoperative pain management. According to the interested party, intraoperative cryoablation therapy is performed as a supplemental procedure alongside primary surgical procedures to provide postoperative pain relief for up to 60 days. The th the interested party, intraoperative cryoablation therapy is performed as a supplemental procedure alongside primary surgical procedures to provide postoperative pain relief for up to 60 days. The therapy works by freezing nerves near the surgical site without causing permanent damage, temporarily blocking pain signals during the patient’s recovery period. The interested party stated that this procedure requires an additional 20–30 minutes of intraoperative time for the surgeon beyond the primary surgical procedure. The interested party referenced clinical evidence highlighting the use of intraoperative cryoablation to reduce the need for opioids in postsurgical patients, as well as recent guideline recommendations.28 29 Currently, there is no specific code to account for the additional physician work associated with intraoperative cryoablation therapy. According to the nomination letter, we included the Cryo Nerve Block Therapy (CryoNB) on the list of devices eligible for temporary additional payments under the Non- Opioids Prevent Addiction in the Nation (NOPAIN) Act 30 in the CY 2025 OPPS final rule (89 FR 94353 through 94354). However, the interested party stated barriers stil dditional payments under the Non- Opioids Prevent Addiction in the Nation (NOPAIN) Act 30 in the CY 2025 OPPS final rule (89 FR 94353 through 94354). However, the interested party stated barriers still exist for physician adoption mainly because there is currently no code to account for the 20– 30 additional minutes of physician work associated with the intraoperative administration and delivery of cryoablation therapy. Also, the interested party stated that many practitioners incorrectly interpret Medicare’s anesthesia rules as prohibiting payment for extra 28 Miller DL, Hutchins J, Ferguson MA, Barhoush Y, Achter E, Kuckelman JP. Intercostal Nerve Cryoablation During Lobectomy for Postsurgical Pain: A Safe and Cost-Effective Intervention. Pain Ther. 2025 Feb;14(1):317–328. doi: 10.1007/s40122– 024–00694–3. 29 Dunning J, Burdett C, Child A, Davies C, Eastwood D, Goodacre T, Haecker FM, Kendall S, Kolvekar S, MacMahon L, Marven S, Murray S, Naidu B, Pandya B, Redmond K, Coonar A. The pectus care guidelines: best practice consensus guidelines from the joint specialist societies SCTS/ MF/CWIG/BOA/BAPS for the treatment of patients with pectus abnormalities. Eur J Cardiothorac Surg. 2 ectus care guidelines: best practice consensus guidelines from the joint specialist societies SCTS/ MF/CWIG/BOA/BAPS for the treatment of patients with pectus abnormalities. Eur J Cardiothorac Surg. 2024 66(1):ezae166. 30 CY 2025 OPPS Final Rule, 89 Fed. Reg. 93912, 94354 (Nov. 27, 2024) (CMS specifically affirmed that ‘‘the CryoNB System meets the statutory requirements and should be paid separately under this provision.’’) professional services when the same surgeon provides ancillary cryoablation therapy.31 According to the nominator, while CMS typically do not allow separate payments for anesthesia services when the same physician performs both the surgical procedure and anesthesia, this limitation does not apply to cryoablation therapy for postoperative pain management.32 However, according to the interested party, ongoing confusion regarding this policy’s application creates an unnecessary barrier to cryoablation procedures that could reduce or replace opioid use for Medicare beneficiaries. The interested party stated that establishment of a G-code for physician work associated with intraoperative cryoablation therapy for postoperative pain would facilitate greater access for eficiaries. The interested party stated that establishment of a G-code for physician work associated with intraoperative cryoablation therapy for postoperative pain would facilitate greater access for patients who require or prefer non- opioid alternatives for pain relief. The interested party further stated that such a G-code would help promote patient access to this alternative to opioids by clarifying that Medicare anesthesia rules do not apply to cryoablation for postoperative pain when furnished by the same surgeon. We are seeking public comments on whether a new G-code is needed to account for the additional intraoperative time required to perform cryoablation therapy, including service elements and valuation of work and practice expense, including potential crosswalk codes. D. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act As discussed in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. See further details and full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006), the CY 2021 PFS final rule (85 FR 84502), and the CY 2024 PFS final . See further details and full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006), the CY 2021 PFS final rule (85 FR 84502), and the CY 2024 PFS final rule (88 FR 78861 through 78866) and in 42 CFR 410.78 and 414.65. 1. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act a. Changes to the Medicare Telehealth Services List In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a regulatory process for adding services to or deleting services 31 See Medicare NCCI 2024 Coding Policy Manual, Chapter 13, pgs. 6–7 (revised Jan. 1, 2025), available at: https://www.cms.gov/files/document/ 13-chapter13-ncci-medicare-policy-manual- 2025finalcleanpdf.pdf. 32 AHA Coding Clinic® , Q3 2024 vol. 11, no. 3 (effective with discharges Aug. 1, 2024). VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32387 from the Medicare Telehealth Services List in accordance with section 1834(m)(4)(F)(ii) o S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32387 from the Medicare Telehealth Services List in accordance with section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed and assigned to categories established through notice and comment rulemaking. Under the process we established beginning in CY 2003, we evaluated whether a service should be assigned to the Medicare Telehealth Services List and designated as Category 1: Services similar to professional consultations, office visits, and office psychiatry services currently on the Medicare Telehealth Services List or Category 2: Services that were not similar to those on the current Medicare Telehealth Services List. In the CY 2021 PFS final rule (85 FR 84507), we created a third category of criteria for adding services to the Medicare Telehealth Services List on a temporary basis following the end of the PHE for the COVID–19 pandemic. This new category described services that were added to the Medicare Telehealth Services List during the PHE, for whic List on a temporary basis following the end of the PHE for the COVID–19 pandemic. This new category described services that were added to the Medicare Telehealth Services List during the PHE, for which there was likely to be clinical benefit when furnished via telehealth, but there was not yet sufficient evidence available to consider the services for permanent addition under the Category 1 or Category 2 criteria. Services added on a temporary, Category 3 basis ultimately needed to meet the criteria under Category 1 or 2 to be permanently added to the Medicare Telehealth Services List. To add specific services on a Category 3 basis, we would conduct a clinical assessment to identify those services for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth. In the CY 2024 PFS final rule (88 FR 78861 through 78866), we consolidated these three categories and implemented a revised 5-step process for making additions, deletions, and changes to the Medicare Telehealth Services List (5- step process), beginning for the CY 2025 Medicare Telehealth Services List. The 5-step process review criteria are set forth in the CY 2024 PFS final ru es to the Medicare Telehealth Services List (5- step process), beginning for the CY 2025 Medicare Telehealth Services List. The 5-step process review criteria are set forth in the CY 2024 PFS final rule (88 FR 78861 through 78866), includes the following steps: (1) Determine whether the service is separately payable under the PFS; (2) Determine whether the service is subject to the provisions of section 1834(m) of the Act; (3) Review the elements of the service as described by the HCPCS code and determine whether each of them is capable of being furnished using an interactive telecommunications system as defined in § 410.78(a)(3); (4) Consider whether the service elements of the requested service map to the service elements of a service on the list that has a permanent status described in previous final rulemaking; and (5) Consider whether there is evidence of clinical benefit analogous to the clinical benefit of the in-person service when the patient, who is located at a telehealth originating site, receives a service furnished by a physician or practitioner located at a distant site using an interactive telecommunications system. Rather than categorizing a service as ‘‘Category 1 iginating site, receives a service furnished by a physician or practitioner located at a distant site using an interactive telecommunications system. Rather than categorizing a service as ‘‘Category 1’’, ‘‘Category 2,’’ or ‘‘Category 3,’’ each service is now assigned a ‘‘permanent’’ or ‘‘provisional’’ status. A service is assigned a ‘‘provisional’’ status if it meets steps 1, 2, and 3 of our review process, and, if while there is not enough evidence to demonstrate that the service is of clinical benefit, there is enough evidence to suggest that further study may demonstrate such benefit. b. Proposal To Modify the Medicare Telehealth Services List and Review Process Section 1834(m)(4)(F)(ii) of the Act requires that the Secretary establish a process that provides, on an annual basis, for the addition or deletion of services to the definition of telehealth services for which payment can be made when furnished via telehealth under the conditions specified in section 1834(m) of the Act. As specified at § 410.78(f), except for a temporary policy that was limited to the PHE for COVID–19, we make changes to the list of Medicare telehealth services through the annual PFS rulemaking process specified at § 410.78(f), except for a temporary policy that was limited to the PHE for COVID–19, we make changes to the list of Medicare telehealth services through the annual PFS rulemaking process. Our current 5- step review process reflects the stepwise method by which we consider requests to add services to, remove services from, or change the status of, services on the Medicare Telehealth Services List, beginning with the CY 2025 Medicare Telehealth Services List (88 FR 78861 through 78871). We are proposing, beginning for the CY 2026 Medicare Telehealth Services List, to revise the 5-step review process for reviewing requests to the Medicare Telehealth Services List. Based on feedback from interested parties, we believe that we need to simplify our telehealth list review process by focusing our review on whether the service can be furnished using an interactive telecommunications system. The current 5-step review process has proven to be unclear for requestors. Interested parties, including requestors, have emphasized that it is difficult to ascertain the level of clinical evidence needed for a service with a provisional designation to be redesignated permanent. Additionall es, including requestors, have emphasized that it is difficult to ascertain the level of clinical evidence needed for a service with a provisional designation to be redesignated permanent. Additionally, for new services or services with low utilization, interested parties have had a difficult time providing peer-reviewed evidence applicable to the service and/or the Medicare beneficiary patient population. Lastly, based on feedback from interested parties and our own internal review, the 5-step process insufficiently accounts for the vital role of professional judgment exercised by physicians and other practitioners. We continue to believe that physicians and other practitioners, given their in-depth knowledge of their beneficiaries’ clinical needs, are best positioned to exercise their professional judgment in determining whether a service can be safely furnished via telehealth and whether furnishing a service via telehealth will provide clinical benefit justifying its use. We therefore are proposing to remove Step 4 (Consider whether the service elements of the requested service map to the service elements of services on the list that has a permanent status described in previous re are proposing to remove Step 4 (Consider whether the service elements of the requested service map to the service elements of services on the list that has a permanent status described in previous final rulemaking) and Step 5 (Consider whether there is evidence of clinical benefit analogous to the clinical benefit of the in-person service when the patient, who is located at a telehealth originating site, receives a service furnished by a physician or practitioner located at a distant site using an interactive telecommunications system) from our review criteria and retain Steps 1 through 3 (detailed below). Under this proposal, services on the Medicare Telehealth Services List would no longer be designated ‘‘permanent’’ or ‘‘provisional’’. All services listed or added on the Medicare Telehealth Services List would be considered included on a permanent basis. Note, CMS would still reserve the right to remove services included on the Medicare Telehealth Services List based on internal review or feedback received from interested parties in accordance with section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). If finalized, all codes currently on the list (provisional or permanent) review or feedback received from interested parties in accordance with section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). If finalized, all codes currently on the list (provisional or permanent) will remain on the Medicare Telehealth Services List. Because CMS has already determined that services with a ‘‘provisional’’ designation satisfy the standards represented in Steps 1 through 3 in prior rulemaking cycles, we do not believe further review would be required to justify their inclusion on the Medicare Telehealth Services List under the revised process. We continue to request information from interested parties about service(s) that may be appropriate for addition to or deletion from the list of Medicare telehealth services and their effects on beneficiary access, safety, and quality of care. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32388 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules We are proposing to retain Steps 1 through 3 and eliminate Steps 4 through 5 because we believe that the standards 32388 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules We are proposing to retain Steps 1 through 3 and eliminate Steps 4 through 5 because we believe that the standards represented in Steps 1 through 3 alone are sufficient guardrails to ensure that only services separately payable under the PFS, subject to the provisions of section 1834(m) of the Act, and capable of being furnished using an interactive telecommunications system are considered Medicare telehealth services. For additional information, these steps are further discussed in the CY 2024 PFS final rule (88 FR 78861 through 78866). We do not believe Steps 4 through 5 are necessary, because as discussed above, we believe the complex professional judgment of the physician or practitioner is sufficient to ensure a service can be safely furnished via telehealth and that the service will be clinically beneficial to the beneficiary. We believe that the determination to utilize the complex professional judgment of the physician or practitioner will better allow practitioners to determine if telehealth is appropriate for that specific Medicare beneficiary and that specific clinical scenario. We expe judgment of the physician or practitioner will better allow practitioners to determine if telehealth is appropriate for that specific Medicare beneficiary and that specific clinical scenario. We expect that physicians and other practitioners would consider the entirety of the circumstances, including the clinical profile and needs of the beneficiary, to determine the appropriate modality for furnishing the service. This specification is similar to the requirements set forth for the process by which CMS updates the list of covered surgical procedures in Medicare when furnished within an ambulatory surgical center (ASC) (also called the ASC covered procedures list (CPL)), which were established in the 2021 OPPS Final Rule (85 FR 86148 through 86149). In addition, this specification is similar to our policy regarding the in-person visit requirements for telehealth behavioral health services (‘‘. . . the practitioner is not precluded from scheduling in- person visits at a more frequent interval, should such visit be determined to be clinically appropriate or preferred by the patient’’ (86 FR 65057)) and for audio-only telehealth services (‘‘practitioners should always use their clinic terval, should such visit be determined to be clinically appropriate or preferred by the patient’’ (86 FR 65057)) and for audio-only telehealth services (‘‘practitioners should always use their clinical judgment in deciding to furnish services via telehealth, including in the patient’s home, to ensure that appropriate care is being delivered; including scheduling in-person care as needed’’ (89 FR 97761)). We strive to balance the goals of increasing practitioner and patient choice of service modality with the consideration of patient safety for all Medicare beneficiaries. Notably, the addition of a service to the Medicare Telehealth Services List does not mean that it is appropriate to be furnished via telehealth to every Medicare beneficiary in every clinical scenario—as always, the physician or practitioner should use his or her complex professional judgment to determine the appropriate service modality on a case-by-case basis. As technology advances and more services may be safely furnished via telehealth and paid under the PFS, it is increasingly important for physicians or practitioners to exercise their professional judgment in determining the generally appropriate service mo urnished via telehealth and paid under the PFS, it is increasingly important for physicians or practitioners to exercise their professional judgment in determining the generally appropriate service modality for their patients to receive a service. We believe our proposal to remove steps 4 through 5 of the 5-step review process would expand and build upon our intent to simplify and reduce the administrative burden of submission and review of services to the Medicare Telehealth Services List. We believe our proposed policy would allow patients and physicians or practitioners to determine the most appropriate service modality for an individual patient while continuing to ensure patient safety. As discussed above, physicians and other practitioners are best positioned to make patient-specific service modality determinations. Physicians and other practitioners have the greatest familiarity with and understanding of the needs of their individual patients and will use their complex professional judgment to determine whether a service can be safely furnished via telehealth, given their patients’ clinical profiles and needs, among other essential considerations. We believe physicians and ot al judgment to determine whether a service can be safely furnished via telehealth, given their patients’ clinical profiles and needs, among other essential considerations. We believe physicians and other practitioners would consider important safety factors when determining the appropriate service modality for their specific beneficiaries. We continue to encourage the review and use of clinical practice guidelines, peer-reviewed literature, and similar materials that illustrate the typical setting of care, population of beneficiaries, and clinical scenarios that practitioners would encounter when furnishing the Medicare Telehealth service using only interactive, two-way audio-video communications technology or two- way, real-time audio-only communication technology for services furnished to a patient in their home, as permitted in accordance with 42 CFR 410.78(a)(3). We are proposing to refine the regulatory process for adding services to or deleting services from the Medicare Telehealth Services List by removing Steps 4 and 5 and maintaining the current Steps 1 through 3. The steps are listed in detail below: Step 1. Determine whether the service is separately payable under the PF th Services List by removing Steps 4 and 5 and maintaining the current Steps 1 through 3. The steps are listed in detail below: Step 1. Determine whether the service is separately payable under the PFS. When considering whether to add, remove, or change the status of a service on the Medicare Telehealth Services List, we first determine whether the service, as described by the individual HCPCS code, is separately payable under the PFS because, as further discussed in CY 2024 PFS final rule (88 FR 78861 through 78866), Medicare telehealth services are limited to those services for which separate Medicare payments can be made under the PFS. Before gathering evidence and preparing to submit a request to add a service to the Medicare Telehealth Services List, the submitter should therefore first check the payment status for a given service and ensure that the service (as identified by a HCPCS code), is a covered and separately payable service under the PFS (as identified by payment status indicators A, C, T, or R on our public use files). Step 2. Determine whether the service is subject to the provisions of section 1834(m) of the Act. If we determine at Step 1 that a service is separat indicators A, C, T, or R on our public use files). Step 2. Determine whether the service is subject to the provisions of section 1834(m) of the Act. If we determine at Step 1 that a service is separately payable under the PFS, we apply Step 2 under which we determine whether the service at issue is subject to the provisions of section 1834(m) of the Act. Section 1834(m) of the Act provides for payment to a physician or other practitioner for a service furnished via an interactive telecommunications system, notwithstanding that the furnishing physician or practitioner and patient are not in the same location, at the same amount that would have been paid if the service was furnished without the telecommunications system. We have historically interpreted this to mean that only services that are ordinarily furnished with the furnishing physician or practitioner and patient in the same location can be classified as a ‘‘telehealth service’’ for which payment can be made under section 1834(m) of the Act. Given that there may be a range of services delivered using certain telecommunications technology that, though they are separately payable under the PFS, do not fall within the definition of the Act. Given that there may be a range of services delivered using certain telecommunications technology that, though they are separately payable under the PFS, do not fall within the definition of telehealth service set forth in section 1834(m) of the Act, the aim of Step 2 is therefore to determine whether the service at issue is, in whole or in part, inherently a face-to-face service. Services that fall outside the definition of telehealth services generally include services that do not require the presence of, or involve interaction with, the patient (for example, remote interpretation of diagnostic imaging tests, and certain care management services). Other examples include virtual check-ins, e- VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32389 visits, and remote patient monitoring services which involve the use of telecommunications technology to facilitate interactions between the patient and practitioner, but do not serve as a substitute for an in- d remote patient monitoring services which involve the use of telecommunications technology to facilitate interactions between the patient and practitioner, but do not serve as a substitute for an in-person encounter. In determining whether a service is subject to the provisions of section 1834(m) of the Act, we therefore review during this Step 2 whether one or more of the elements of the service, as described by the particular HCPCS code at issue, ordinarily involve direct, face- to-face interaction between the patient and physician or practitioner such that the use of an interactive telecommunications system to deliver the service would be a substitute for an in-person visit. Step 3. Review the elements of the service as described by the HCPCS code and determine whether each of them is capable of being furnished using an interactive telecommunications system as defined in § 410.78(a)(3). Step 3 is corollary to Step 2 and is used to determine whether one or more elements of a service are capable of being delivered via an interactive telecommunication system as defined in § 410.78(a)(3). In Step 3, we consider whether one or more face-to-face component(s) of the service, if furnis are capable of being delivered via an interactive telecommunication system as defined in § 410.78(a)(3). In Step 3, we consider whether one or more face-to-face component(s) of the service, if furnished via audio-video communications technology, would be equivalent to the service being furnished in-person, and we seek information from requesters to demonstrate evidence of substantial clinical improvement in different beneficiary populations that may benefit from the requested service when furnished via telehealth, including, for example, in rural populations. The services are not equivalent when the clinical actions, or patient interaction, would not be of similar content as an in- person visit, or could not be completed. Additionally, we are proposing to simplify our Medicare Telehealth Services List review process by removing the distinction between provisional and permanent services and focusing our review on whether the service can be furnished using an interactive, two-way audio-video telecommunications system. We are seeking comments on our proposal to refine the Medicare Telehealth Services List review process. We also invite comments regarding safety and/or quality concern video telecommunications system. We are seeking comments on our proposal to refine the Medicare Telehealth Services List review process. We also invite comments regarding safety and/or quality concerns. We would like to re- emphasize that a service’s presence on the Medicare telehealth list does not indicate that CMS believes that telehealth may be appropriate in all circumstances; instead, we rely on physicians and other practitioners to use their professional judgment to make appropriate determinations based on the needs of the individual patient. c. Requests To Add Services to the Medicare Telehealth Services List for CY 2026 We received several requests to add various services to the Medicare Telehealth Services List, effective for CY 2026, some of which we believe would meet the proposed revised criteria for being added to the Medicare Telehealth Services List. That is, we reviewed these services and found that they would meet the criteria of the 3-step process proposed in section D(1)(b). The requested services are listed in Table 8. Consistent with the deadline for our receipt of code valuation recommendations from the American Medical Association’s Relative Value Scale Upda D(1)(b). The requested services are listed in Table 8. Consistent with the deadline for our receipt of code valuation recommendations from the American Medical Association’s Relative Value Scale Update Committee (AMA RUC) and other interested parties (83 FR 59491) and with the process set forth in prior calendar years, for CY 2026, requests to add services to the Medicare Telehealth Services List must have been submitted to and received by CMS by February 10, 2025. Consistent with the deadline for our receipt of code valuation recommendations from the AMA RUC and other interested parties (83 FR 59491) and with the process set forth in prior calendar years, for CY 2027, requests to add services to the Medicare Telehealth Services List must be submitted to and received by CMS by February 10, 2026. The deadline for each request to add a service to the Medicare Telehealth Services List must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process to make changes to the Medicare Telehealth Services List, requesters are advised that any information submitted as part of a request is subject to publ Because we use the annual PFS rulemaking process to make changes to the Medicare Telehealth Services List, requesters are advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request to add services to the Medicare Telehealth Services List, including where to send these requests, and to view the current Medicare Telehealth Service List, see our website at https://www.cms.gov/ Medicare/Medicare-General- Information/Telehealth/index.html. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32390 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules The following is a discussion of the requests received for the addition of services to the Medicare Telehealth Services List: (1) Multiple-Family Group Psychotherapy We received a request to add CPT code 90849 (Multiple-Family Group Psychotherapy) to the Medicare Telehealth Services List. This code describes the provision of psychotherapy to multiple adult or adolescent patients and their add CPT code 90849 (Multiple-Family Group Psychotherapy) to the Medicare Telehealth Services List. This code describes the provision of psychotherapy to multiple adult or adolescent patients and their family members simultaneously. This code was requested to be added in the CY 2022 PFS Final Rule, but we did not add it to the Medicare Telehealth Services List at the time because these services were not separately payable and had a restricted payment status, indicating that claims must be adjudicated on a case-by-case basis when furnished in- person 86 FR 65052. In the CY 2023 PFS Final Rule, we finalized a change in the procedure status indicator for CPT code 90849, which is now assigned an A for active status meaning that the service is now separately payable under the PFS. Based on our review, we believe this service now meets step 1 of our review process because it is currently assigned status indicator A, meets step 2 of our review process because it is a service ordinarily furnished with the furnishing practitioner and patient in the same location and therefore is subject to the provisions of section 1834(m) of the Act, and meets step 3 because that all elements of this servic ed with the furnishing practitioner and patient in the same location and therefore is subject to the provisions of section 1834(m) of the Act, and meets step 3 because that all elements of this service may be furnished using an interactive telecommunications system as defined in § 410.78(a)(3). Therefore, we are proposing to add this service to the Medicare Telehealth Services List. We welcome public comments on this proposal. (2) Group Behavioral Counseling for Obesity We received a request to add CPT code G0473 (Face-to-face behavioral counseling for obesity, group (2–10), 30 minutes) to the Medicare Telehealth Services List. This code includes a 30- minute group session that consists of a dietary assessment, counseling, and behavioral therapy, as well as one face- to-face visit per week for each week for the first month, one face-to-face visit every other week for months two through six, and one face-to-face visit per month for months seven through twelve (if an individual loses 3kg in the first six months). Based on our review, we believe this service meets step 1 of our review process because it is currently assigned status indicator A, meets step 2 of our review process becau in the first six months). Based on our review, we believe this service meets step 1 of our review process because it is currently assigned status indicator A, meets step 2 of our review process because it is a service ordinarily furnished with the furnishing practitioner and patient in the same location and therefore is subject to the provisions of section 1834(m) of the Act, and meets step 3 because that all elements of this service may be furnished using an interactive telecommunications system as defined in 410.78(a)(3). Therefore, we propose to add this service to the Medicare Telehealth Services List. We welcome public comments on this proposal. (3) Infectious Disease Add-On We received a request to add CPT code G0545 (Visit complexity inherent to hospital inpatient or observation care VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32392 Federal Register 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32392 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules the same day, which suggests that the interaction between the clinical staff and the patient described by this service is severable from the kind of professional service that falls under the scope of section 1834(m) of the Act. We understand that before the broad adoption of telecommunications technology for patient interactions nearly 6 years ago, these interactions may have typically taken place in person, and we considered the request to add this service to the telehealth list in that context. However, the interaction described explicitly by the code does not indicate an interaction between the patient and a physician or other practitioner. Because such an interaction falls outside the scope of the definition of Medicare telehealth service, it does not meet step 2 of our review process. Therefore, we are not proposing adding HCPCS code G0248 to the Medicare list of telehealth services. We welcome public comments on this ehealth service, it does not meet step 2 of our review process. Therefore, we are not proposing adding HCPCS code G0248 to the Medicare list of telehealth services. We welcome public comments on this proposal. (7) Telemedicine E/M Services We received a request to add the telemedicine E/M services (CPT codes 98000–98015) to the Medicare Telehealth Services List. These services do not satisfy the criteria under Step 1 of our process. Specifically, they are not separately payable under the Medicare PFS, as they are currently assigned status indicator I (Not valid for Medicare purposes). Given that these services are not separately payable when furnished in person, they likewise will not be separately payable when furnished via telehealth. Therefore, this service does not meet Step 1 of our review process. We are not proposing to add them to the Medicare list of telehealth services. We welcome public comments on this proposal. (8) Clarification on DMHT/RPM/RTM We have received a number of questions regarding Digital Mental Health Treatment (DMHT), Remote Physiologic Monitoring (RPM), and Remote Therapeutic Monitoring (RTM) services and the applicability of the telehealth rules. We wou questions regarding Digital Mental Health Treatment (DMHT), Remote Physiologic Monitoring (RPM), and Remote Therapeutic Monitoring (RTM) services and the applicability of the telehealth rules. We would like to clarify that these services, which are inherently non-face-to-face, do not meet the definitions of 1834(m) of the Act, fall outside the scope of the definition of Medicare telehealth service, and do not meet step 2 of our review process. These services are not subject to section 1834(m) of the Act. (9) Services Requested To Be Transitioned From Provisional to Permanent We received a number of submissions requesting for services on the Medicare Telehealth Services List designated as ‘‘provisional’’ to be designated as ‘‘permanent.’’ If our proposal to eliminate these designations is finalized, these codes will remain on the Medicare Telehealth Services List. If not, rather than selectively adjudicating only those services for which we received requests for potential permanent status, we believe it would be appropriate to complete a comprehensive analysis of all provisional codes currently on the Medicare Telehealth Services List before determining which codes should be made p tus, we believe it would be appropriate to complete a comprehensive analysis of all provisional codes currently on the Medicare Telehealth Services List before determining which codes should be made permanent. We are therefore proposing to not making determinations to recategorize provisional codes as permanent at this time. For CY 2026, we propose to revise the Medicare Telehealth Services criteria. We propose to remove steps 4 and 5 from the review process. Using these revised criteria, we propose to add 5 new codes to the Medicare Telehealth Services list that are not on the CY 2025 Medicare Telehealth Services list. After consideration of the priorities discussed above, we believe that these proposed policies will increase the flexibility for physicians or other practitioners to exercise their complex professional judgment, factoring in patient safety considerations, and for flexibility for patients to choose the modality of care in which to receive services. The services we propose adding to the Medicare Telehealth Services List are listed in Table A–D2. (10) Deleted Services In section II.I. of this proposed rule, we proposed to delete HCPCS code G0136. This code is currently e adding to the Medicare Telehealth Services List are listed in Table A–D2. (10) Deleted Services In section II.I. of this proposed rule, we proposed to delete HCPCS code G0136. This code is currently on the Medicare Telehealth Services List, so it will also be deleted from the list if finalized. d. Frequency Limitations on Medicare Telehealth Subsequent Care Services in Inpatient and Nursing Facility Settings, and Critical Care Consultations When adding some services to the Medicare Telehealth Services List in the past, we have included certain frequency restrictions on how often physicians and other practitioners may furnish the service via telehealth. These include a limitation of one subsequent hospital care service furnished through telehealth every three days, added in the CY 2011 PFS final rule (75 FR 73317 through 73318), one subsequent nursing facility visit furnished through telehealth every 14 days, added in the CY 2011 PFS final rule (75 FR 73318), and one critical care consultation service furnished through telehealth per day, added in the CY 2017 final rule (81 FR 80198). In establishing these limits, we cited concerns regarding these patients’ potential acuity and co sultation service furnished through telehealth per day, added in the CY 2017 final rule (81 FR 80198). In establishing these limits, we cited concerns regarding these patients’ potential acuity and complexity. We temporarily removed these frequency restrictions during the PHE for COVID–19. In the March 31, 2020 COVID–19 interim final rule with comment period (IFC) (85 FR 19241), we stated that we did not believe the frequency limitations for certain subsequent inpatient visits, subsequent NF visits, and critical care consultations furnished via Medicare telehealth were appropriate or necessary for the duration of the PHE because this would have been a patient population who would have otherwise not had access to clinically appropriate in-person treatment. Although the frequency limitations resumed effect on May 12, VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32394 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules § 410.32(b)(3): General Supervision, Direct Supervision, and Personal Supervision. Notwithstanding the temporary measures implemented in response to the PHE for COVID–19 and extended thereafter, direct supervision has historically required the physician (or other supervising practitioner) to be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the service. It has not historically been interpreted as mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. Again, notwithstanding the temporary measures implemented in response to the PHE for COVID–19 and extended thereafter, we have historically established this ‘‘immediate availability’’ requirement to mean in- person, physical, not virtual, availability (see the April 6, 2020 IFC (85 FR 19245) and the CY 2022 PFS final ru have historically established this ‘‘immediate availability’’ requirement to mean in- person, physical, not virtual, availability (see the April 6, 2020 IFC (85 FR 19245) and the CY 2022 PFS final rule (86 FR 65062)). Direct supervision is required for various types of services, including most incident-to-services under § 410.26, many diagnostic tests under § 410.32, pulmonary rehabilitation services under § 410.47, cardiac rehabilitation and intensive cardiac rehabilitation services under § 410.49, and certain hospital outpatient services as provided under § 410.27(a)(1)(iv). In the March 31, 2020 COVID–19 IFC, we amended the definition of ‘‘direct supervision’’ for the duration of the PHE for COVID–19 (85 FR 19245 through 19246) at § 410.32(b)(3)(ii) to state that the necessary presence of the physician (or other practitioner) for direct supervision includes virtual presence through audio/video real-time communications technology. Instead of requiring the supervising physician’s (or other practitioner’s) physical presence, the amendment permitted a supervising physician (or other practitioner) to be considered ‘‘immediately available’’ through virtual presence using two-way, rea other practitioner’s) physical presence, the amendment permitted a supervising physician (or other practitioner) to be considered ‘‘immediately available’’ through virtual presence using two-way, real-time audio/visual technology for diagnostic tests, incident-to services, pulmonary rehabilitation services, and cardiac and intensive cardiac rehabilitation services. We made similar amendments at § 410.27(a)(1)(iv) to specify that direct supervision for certain hospital outpatient services may include virtual presence through audio/ video real-time communications. The CY 2021 PFS final rule (85 FR 84538 through 84540), CY 2024 PFS final rule (88 FR 78878), and CY 2025 PFS Final rule (89 FR 97764) subsequently extended these policies through December 31, 2025. In the CY 2024 PFS proposed rule, we solicited comments on whether we should consider extending the definition of direct supervision to permit virtual presence beyond December 31, 2024. Specifically, we stated we were interested in input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually; for instance, if virtual direct supervision of certain types of services is mor input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually; for instance, if virtual direct supervision of certain types of services is more or less likely to present patient safety concerns, or if this flexibility would be more appropriate for certain types of services, or when certain types of auxiliary personnel are performing the supervised service. We stated we were also interested in potential program integrity concerns such as overutilization or fraud and abuse that interested parties may have in regard to this policy (88 FR 52302). As discussed in the CY 2024 PFS final rule (88 FR 78878), in the absence of evidence that patient safety is compromised by virtual direct supervision, we were concerned about an abrupt transition to our pre-PHE policy that defines direct supervision to require the physical presence of the supervising practitioner. We noted that an immediate reversion to the pre-PHE definition of direct supervision would prohibit virtual direct supervision, which may present a barrier to access to many services, such as incident-to- services, and that physicians and/or other supervising practitioners, in rvision would prohibit virtual direct supervision, which may present a barrier to access to many services, such as incident-to- services, and that physicians and/or other supervising practitioners, in certain instances, would need time to reorganize their practice patterns established during the PHE to reimplement the pre-PHE approach to direct supervision without the use of audio/video technology. We acknowledged the utilization of this flexibility and recognize that many practitioners have stressed the importance of maintaining it. This flexibility has been available and widely utilized since the beginning of the PHE, and we recognized that it may enhance patient access. In the CY 2025 PFS final rule (89 FR 97763), we acknowledged the utilization of this flexibility and stated we recognized that many practitioners have stressed the importance of maintaining it but were seeking additional information regarding potential patient safety and quality of care concerns. Given the importance of certain services being furnished under direct supervision in ensuring quality of care and patient safety, and in particular the ability of the supervising practitioner to intervene if complication of certain services being furnished under direct supervision in ensuring quality of care and patient safety, and in particular the ability of the supervising practitioner to intervene if complications arise, we stated that we believed an incremental approach is warranted, particularly in instances where unexpected or adverse events may arise for procedures which may be riskier or more intense. In light of these potential safety and quality of care implications, and exercising an abundance of caution, we finalized the revision of the regulation at § 410.26(a)(2) to state that for the following services furnished after December 31, 2025, the presence of the physician (or other practitioner) required for direct supervision shall continue to include virtual presence through audio/video real-time communications technology (excluding audio-only): services furnished incident to a physician’s service when they are provided by auxiliary personnel employed by the physician and working under his or her direct supervision and for which the underlying HCPCS code has been assigned a PC/TC indicator of ‘5’; and services described by CPT code 99211 (office and other outpatient visit for the evalu or her direct supervision and for which the underlying HCPCS code has been assigned a PC/TC indicator of ‘5’; and services described by CPT code 99211 (office and other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional). In response to overwhelming support and requests to extend this policy permanently for a wider set of services than the ones that were finalized in the CY 2025 PFS Final Rule, we are proposing to continue to build on this incremental approach to allow certain services to be furnished under direct supervision that allows ‘‘immediate availability’’ of the supervising practitioner using audio/video real-time communications technology (excluding audio-only). We are proposing to permanently adopt a definition of direct supervision that allows ‘‘immediate availability’’ of the supervising practitioner using audio/video real-time communications technology (excluding audio-only), for all services described under § 410.26, except for services that have a global surgery indicator of 010 or 090. This information can be found in the PFS PPRVU public use file excluding audio-only), for all services described under § 410.26, except for services that have a global surgery indicator of 010 or 090. This information can be found in the PFS PPRVU public use file (https:// www.cms.gov/medicare/payment/fee- schedules/physician/pfs-relative-value- files). These global surgery indicators are defined in IOM Pub. 100–04, chapter 23, section 50.6 as 010 ‘‘Minor procedure with preoperative relative values on the day of the procedure and postoperative relative values during a 10-day postoperative period included in the fee schedule amount; evaluation and management services on the day of the procedure and during this 10-day postoperative period generally not payable’’ and 090 ‘‘Major surgery with a 1-day preoperative period and 90-day postoperative period included in the fee schedule payment amount.’’ The VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32395 purpose of excluding these services is to ensure the quality of care and patie 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32395 purpose of excluding these services is to ensure the quality of care and patient safety, and in particular, the ability of the supervising practitioner to intervene if complications arise, particularly in complex, high-risk instances where unexpected or adverse events may occur or for procedures that may be riskier or more intense where a patient’s clinical status can quickly change. For such services, in-person supervision would be necessary to allow for rapid on-site decision-making in the event of an adverse clinical situation. We would like to note that, similar to our guidance above regarding Medicare Telehealth services, our proposed definition of direct supervision (allowing ‘‘immediate availability’’ of the supervising practitioner using audio/video real-time communications technology (excluding audio-only) for all services described under § 410.26, except for services that have a global surgery indicator of 010 or 090), does not mean that it is appropriate to allow virtual presence for every service for every Medicare beneficiary in every clinical scena or services that have a global surgery indicator of 010 or 090), does not mean that it is appropriate to allow virtual presence for every service for every Medicare beneficiary in every clinical scenario. As always, the physician or practitioner should use his or her complex professional judgment to determine the appropriate supervision modality on a case-by-case basis. We are proposing to revise the regulation at § 410.26(a)(2) to state that the presence of the physician (or other practitioner) required for direct supervision may include virtual presence through audio/video real-time communications technology (excluding audio-only) for services without a 010 or 090 global surgery indicator. We are proposing to revise the regulations at § 410.32(b)(3)(ii) to state that the presence of the physician (or other practitioner) may include virtual presence through audio/video real-time communications technology (excluding audio-only) for services without a 010 or 090 global surgery indicator. We note that because to the definition of direct supervision applicable to cardiac, pulmonary, and intensive cardiac rehabilitation services relies on the definition of direct supervision set forth . We note that because to the definition of direct supervision applicable to cardiac, pulmonary, and intensive cardiac rehabilitation services relies on the definition of direct supervision set forth at § 410.32(b)(3)(ii), the definition of direct supervision for these services would similarly be modified to include virtual presence through audio/video real-time communications technology (excluding audio-only) for services without a 010 or 090 global surgery indicator. We are seeking comment on applying this definition to the applicable services under § 410.32 and the applicable cardiac, pulmonary, and intensive cardiac rehabilitation services. We are seeking comment on whether to adopt a definition of direct supervision that allows ‘‘immediate availability’’ of the supervising practitioner using audio/video real-time communications technology (excluding audio-only), for all services described under § 410.26, except for services that have a 000, 010, or 090 global surgery indicator. For each of these proposals, we are also seeking additional information regarding potential concerns about patient safety and quality of care for services that have a 000 global surgery indicator and if r each of these proposals, we are also seeking additional information regarding potential concerns about patient safety and quality of care for services that have a 000 global surgery indicator and if it is necessary to exclude these services from allowing the presence of the physician (or other practitioner) to include virtual presence through audio/video real-time communications technology (excluding audio-only). Global surgery indicator 000 is defined in IOM Pub. 100–04, chapter 23, section 50.6 as ‘‘Endoscopic or minor procedure with related preoperative and postoperative relative values on the day of the procedure only included in the fee schedule payment amount; evaluation and management services on the day of the procedure generally not payable’’. We believe that these services, which have no minimum postoperative period, do not have the same potential patient safety risk that services with a 010 or 090 global surgery indicator may have. We are seeking comments on these proposals. b. Proposed Changes to Teaching Physicians’ Billing for Services Involving Residents With Virtual Presence As discussed in the CY 2025 PFS final rule (89 FR 97764 through 97765), in the CY 2021 PFS s. b. Proposed Changes to Teaching Physicians’ Billing for Services Involving Residents With Virtual Presence As discussed in the CY 2025 PFS final rule (89 FR 97764 through 97765), in the CY 2021 PFS final rule (85 FR 84577 through 84585), we established a policy that after the end of the PHE for COVID– 19, teaching physicians may meet the requirements set forth at § 1842(b)(7)(A)(i)(I) to be present for the key or critical portions of services when furnished involving residents through audio/video real-time communications technology (virtual presence), but only for services furnished in residency training sites located outside of OMB- defined metropolitan statistical areas (MSAs). We made this location distinction consistent with our longstanding interest in increasing beneficiary access to Medicare-covered services in rural areas. We noted that this policy provides the ability to expand training opportunities for residents in rural settings. For all other locations, we expressed concerns that continuing to permit teaching physicians to bill for services furnished involving residents when they are virtually present, outside the conditions of the PHE for COVID–19, may not allow th cerns that continuing to permit teaching physicians to bill for services furnished involving residents when they are virtually present, outside the conditions of the PHE for COVID–19, may not allow the teaching physician to have personal oversight and involvement over the management of the portion of the case for which the payment is sought, under section 1842(b)(7)(A)(i)(I) of the Act. In addition, we stated concerns about patient populations that may require a teaching physician’s experience and skill to recognize specialized needs or testing and whether it is possible for the teaching physician to meet these clinical needs while having a virtual presence for the key portion of the service. We refer readers to the CY 2021 PFS final rule (85 FR 84577 through 84584) for a more detailed description of our specific concerns. At the end of the PHE for COVID–19, and as finalized in the CY 2021 PFS final rule, we intended for the teaching physician to have a physical presence during the key portion of the service personally provided by residents to be paid for the service under the PFS, in locations that were within an MSA. This policy applied to all services, regardless of whether the portion of the service personally provided by residents to be paid for the service under the PFS, in locations that were within an MSA. This policy applied to all services, regardless of whether the patient was co-located with the resident or for services provided virtually (for example, the service was furnished as a 3-way telehealth visit, with the teaching physician, resident, and patient in different locations). However, interested parties expressed concerns regarding the requirement that the teaching physician be physically present with the resident when a service is furnished virtually (as a Medicare telehealth service) within an MSA. Some interested parties stated that during the PHE for COVID–19, when residents provided telehealth services, and the teaching physician was virtually present, the same safe and high-quality oversight was provided as when the teaching physician and resident were physically co-located. In addition, these interested parties stated that during telehealth visits, the teaching physician was virtually present during the key and critical portions of the telehealth service, available immediately in real-time, and had access to the electronic health rec lth visits, the teaching physician was virtually present during the key and critical portions of the telehealth service, available immediately in real-time, and had access to the electronic health record. After reviewing the public comments, we finalized a temporary policy that allowed the teaching physician to have a virtual presence in all teaching settings, but only in clinical instances when the service was furnished virtually (for example, a 3-way telehealth visit, with all parties in separate locations). This permitted teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment was sought, through audio/ video real-time communications technology, in all residency training locations through December 31, 2024. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32396 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules As stated in the CY 2025 PFS final rule (89 FR 97765), we were concerned that an abrupt transition to our pre-PHE policy may present a barr Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules As stated in the CY 2025 PFS final rule (89 FR 97765), we were concerned that an abrupt transition to our pre-PHE policy may present a barrier to access to many services. We also understood that teaching physicians gained clinical experience providing services involving residents with virtual presence during the PHE for COVID–19 and could help us to identify circumstances where the teaching physician can routinely provide sufficient personal and identifiable services to the patient through their virtual presence during the key portion of the Medicare telehealth service. We sought comments and information to help us consider other clinical treatment situations where it may be appropriate to continue to permit the virtual presence of the teaching physician, while continuing to support patient safety, meeting the clinical needs for all patients and ensuring burden reduction without creating risks to patient care or increasing opportunities for fraud. As summarized in the CY 2025 PFS final rule (89 FR 97764 through 97765), commenters encouraged us to establish this policy permanently and include in -person services to promote portunities for fraud. As summarized in the CY 2025 PFS final rule (89 FR 97764 through 97765), commenters encouraged us to establish this policy permanently and include in -person services to promote access to care, stated that teaching physicians should be allowed to determine when their virtual presence would be clinically appropriate, based on their assessment of the patient’s needs and the competency level of the resident. While we continue to consider clinical scenarios where it may be appropriate to permit the virtual presence of the teaching physician, we are proposing to transition back to our pre-PHE policy, which would maintain the rural exception established in the CY 2021 PFS final rule recognizing the unique challenges and importance of expanding medical education opportunities in rural settings. We are not proposing to extend our current policy to allow teaching physicians to have a virtual presence for purposes of billing for services furnished involving residents in all teaching settings through December 31, 2025, but only when the service is furnished virtually (for example, a 3-way telehealth visit, with the patient, resident, and teaching physician in separate l l teaching settings through December 31, 2025, but only when the service is furnished virtually (for example, a 3-way telehealth visit, with the patient, resident, and teaching physician in separate locations). As always, documentation in the medical record must continue to demonstrate whether the teaching physician was physically present or present through audio/video real-time communications technology at the time of the Medicare telehealth service, which includes documenting the specific portion of the service for which the teaching physician was present through audio/video real- time communications technology. As discussed in earlier in this proposed rule, we are concerned that continuing to permit teaching physicians to bill for services furnished involving residents when they are virtually present, outside the conditions of the PHE for COVID–19, may not allow the teaching physician to have personal oversight and involvement over the management of the portion of the case for which the payment is sought in accordance with section 1842(b)(7)(A)(i)(I) of the Act. Therefore, we now believe that permitting Medicare payment to continue for this PHE flexibility is no longer necessary the payment is sought in accordance with section 1842(b)(7)(A)(i)(I) of the Act. Therefore, we now believe that permitting Medicare payment to continue for this PHE flexibility is no longer necessary. This proposal to not extend our current policy to allow teaching physicians to have a virtual presence for services furnished virtually aligns with our statutory obligations under section 1842(b)(7)(A)(i)(I) of the Act, which requires teaching physicians to provide appropriate oversight and personal involvement in resident-furnished services for which Medicare payment is sought. Under this proposal, for services provided within MSAs, physicians must maintain physical presence during critical portions of all resident- furnished services to qualify for Medicare payment, not just in-person services, ensuring consistent oversight standards. Documentation requirements remain rigorous, with medical records needing to clearly demonstrate the teaching physician’s physical presence during key service portions. However, as we discussed earlier in this proposed rule, recognizing the unique challenges faced by rural healthcare providers, we maintain flexibility for services provided outside MSAs vice portions. However, as we discussed earlier in this proposed rule, recognizing the unique challenges faced by rural healthcare providers, we maintain flexibility for services provided outside MSAs. In these rural settings, teaching physicians may continue utilizing audio/video real-time communications technology to fulfill the presence requirement, provided they maintain active, real-time observation and participation in the service. This geographical distinction aligns with our longstanding commitment to enhancing Medicare beneficiary access to covered services in rural areas. The proposed to not extend flexibilities for virtual services would not impact teaching physicians’ ability to provide virtual supervision of residents for educational purposes. Teaching physicians retain the discretion to provide greater involvement in resident-furnished services and may determine when virtual presence is appropriate based on the specific services and the experience level of the residents involved. 3. Telehealth Originating Site Facility Fee Payment Amount Update Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services fu nvolved. 3. Telehealth Originating Site Facility Fee Payment Amount Update Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001 through December 31, 2002 at $20.00, and specifies that, for telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The proposed percentage increase in the MEI for CY 2026 is 2.7 percent and is based on the expected historical percentage increase of the 2017-based MEI. For the final rule, we propose to update the MEI increase for CY 2026 based on historical data through the second quarter of 2025. Therefore, for CY 2026, the proposed payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is $31.85. Table 10 shows the Medicare telehealth originating site facility fee and the corresponding MEI percentage increase for each applicable time period. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:2 ating site facility fee and the corresponding MEI percentage increase for each applicable time period. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32397 E. Valuation of Specific Codes 1. Background: Process for Valuing New, Revised, and Potentially Misvalued Codes Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In vised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as outlined in section II.C. of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comments about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim fina upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values and typically made any appropriate adjustments and finalized those values. In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments receiv To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and re-proposed values for those codes in the CY 2017 PFS proposed rule. We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32399 consider both time and intensity in establishing work RVUs for PFS service 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32399 consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes. We observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we adjusted work RVUs to account for significant changes in time, we started by looking at the change in the time in the context of the RUC- recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we employed the different approaches to identify potential values that reconcile the recommended work RVUs wi . When the recommended work RVUs do not appear to account for significant changes in time, we employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old-time values and the new time values for particular services to identify alternative work RVUs based on changes in time components. In so doing, rather than ignoring the RUC-recommended value, we used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC- recommended value. If we believe that such changes in time are already accounted for in the RUC’s recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs dation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options. We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC’s recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure. Several interested parties, including the RU ies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure. Several interested parties, including the RUC, have expressed general objections to our use of these methodologies and suggested that our actions in adjusting the recommended work RVUs are inappropriate; other interested parties have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we employed to identify potential values that reconcile the RUC-recommended work RVUs with the recommended time values when the RUC-recom or similar codes are one of the many methodological approaches we employed to identify potential values that reconcile the RUC-recommended work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time. In response to comments, in the CY 2019 PFS final rule (83 FR 59515), we clarified that terms ‘‘reference services’’, ‘‘key reference services’’, and ‘‘crosswalks’’ as described by the commenters are part of the RUC’s process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate feedback from interested parties, we stated that we would seek to limit the use of the term, ‘‘crosswalk,’’ to those cases where we are making a comparison to a CPT code with the identical work RVU. (83 FR 59515) We note that we also occasionally make use of a ‘‘bracket’’ for code valuation. A ‘‘bracket’’ refers to when a work RVU falls between the values of two CPT codes the identical work RVU. (83 FR 59515) We note that we also occasionally make use of a ‘‘bracket’’ for code valuation. A ‘‘bracket’’ refers to when a work RVU falls between the values of two CPT codes, one at a higher work RVU and one at a lower work RVU. We look forward to continuing to engage with interested parties and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and we will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes. Table 19 contains a list of codes and descriptors for which we are proposing work RVUs for CY 2026; this includes all codes for which we received RUC recommendations by February 10, 2025. The proposed work RVUs, work time and other payment information for all CY 2026 payable codes are available on the CMS website under downloads for the CY 2026 PFS proposed rule at https://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/ PhysicianFeeSched/index.html). b. Proposed Efficiency Adjustment (1 the CMS website under downloads for the CY 2026 PFS proposed rule at https://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/ PhysicianFeeSched/index.html). b. Proposed Efficiency Adjustment (1) Background CMS has historically relied on survey data provided by the American Medical Association (AMA)/Specialty Society Relative Value Scale (RVS) Update Committee (referred to as the RUC) to estimate practitioner time, work intensity, and practice expense for the purpose of establishing RVUs for the codes used for payment under the PFS. As described in section II.C. of this proposed rule, CMS regularly revalues codes as part of its potentially misvalued codes initiative, as required by section 1848(c)(2)(K) of the Act, using RUC survey data that shows clinicians’ estimates of how long a particular service takes to complete. In the CY 2025 PFS final rule, we summarized public comments that we had received expressing concerns with using RUC data as a source of valuation and identifying a need for empirical data in the context of valuing advanced primary care management services (89 FR 97898). In response to these comments, we indicated that we were open to alternative recommendatio a need for empirical data in the context of valuing advanced primary care management services (89 FR 97898). In response to these comments, we indicated that we were open to alternative recommendations for how to price these and other services, and that we would consider all options presented to us with a preference for information with empirical evidence behind it. We also reminded commenters that we do not exclusively rely on RUC recommendations and can VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32400 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules receive data and recommendations from other outside sources as well. The limits of survey data are in part based on the nature of the surveys. There have been longstanding concerns about the use of surveys that have low response rates, low total number of responses, and a large range in responses, all of which may undermine the accuracy of recommendations relying on survey data.33 For example, a Government Accountability Office (GAO) Report found that the media , and a large range in responses, all of which may undermine the accuracy of recommendations relying on survey data.33 For example, a Government Accountability Office (GAO) Report found that the median number of responses to surveys administered by the RUC for payment year 2015 was 52, the median response rate was only 2.2 percent, and 23 of the 231 surveys had under 30 respondents. Another study conducted compared operative times in the National Surgical Quality Improvement Project to RUC survey times, adjusted for patient variables, and found a wide variation in the median RVU per hour ratio for 11 surgical specialties, with the highest specialties overreporting (via RUC values) by 27 and 23 minutes per case. All surgical specialties showed overreporting in RUC survey times compared to operative times. This resulted in high RVU per hour payments for surgeons in those specialties.34 With such low response rates, we are concerned that those practitioners who respond to the RUC surveys may be fundamentally different than those clinicians who do not respond to the surveys. Widely read journals, such as the Journal for the American Medical Association, specify that for submitting auth may be fundamentally different than those clinicians who do not respond to the surveys. Widely read journals, such as the Journal for the American Medical Association, specify that for submitting authors, ‘‘survey studies should have sufficient response rates (generally greater than or equal to 60%), and appropriate characterization of nonresponders to ensure that nonresponse bias does not threaten the validity of the findings.’’ 35 The GAO report noted that the RUC has undertaken steps to mitigate the effects of possible biases; however, the report goes on to describe the potential conflicts of interest survey respondents may have, as those that serve Medicare beneficiaries would benefit from an increase in the relative values for the services they perform.36 Another component of these surveys is the selection of another service code that is 33 https://www.gao.gov/products/gao-15-434. 34 Uppal, S., Barber, E.L., Reynolds, R.K., Rice, L.W., & Spencer, R J. 2019. Discrepancies created by surgeon self-reported operative time and its impact on procedure relative value units (RVUs) and reimbursement. Gynecologic Oncology, 154, 14. https://doi.org/10.1016/j.ygyno.2019.04.039. 35 Journal y surgeon self-reported operative time and its impact on procedure relative value units (RVUs) and reimbursement. Gynecologic Oncology, 154, 14. https://doi.org/10.1016/j.ygyno.2019.04.039. 35 Journal of the American Medical Association, Instructions for Authors. Available from: https:// jamanetwork.com/journals/jama/pages/ instructions-for-authors. 36 https://www.gao.gov/products/gao-15-434. similar to the service in question. Since there are so many procedure, radiology, and diagnostic test codes, the selection of a high-valued service for potential comparisons, either by the specialty society administering the survey, or by respondents, could further bias results. Additionally, RUC surveys contain clinical vignettes, and expert reviewers have raised concerns that these clinical vignettes are not typical and thus may lead to biased recommendations that usually overinflate time spent on the service.37 And as detailed in section II.B. of this proposed rule, we further articulate the particular challenges of using the recently completed PPI survey data, including the quality of the data, sampling variation, and lack of comparability to previous survey data— similar challenges that w rticular challenges of using the recently completed PPI survey data, including the quality of the data, sampling variation, and lack of comparability to previous survey data— similar challenges that we have experienced over time with surveys estimating the time and work intensity of individual services, used to establish the work RVUs. CMS has historically had to rely on survey data due to a lack of other more reliable sources of information, but in recent years many new methods to identify empiric inputs used in valuation have been developed.38 In the CY 2024 PFS proposed rule (88 FR 78975 through 78982), we requested comments on how we may evaluate E/ M services more regularly and comprehensively. We raised specific questions for commenters to consider, including whether the methods used by the RUC and CMS were appropriate to accurately value E/M and other HCPCS codes, and we requested that commenters provide specific recommendations on improving data collection and making better evidence- based and more accurate payments for E/M and other services. In response, as we summarized in the CY 2024 PFS final rule (88 FR 78977), commenters stated that the methods used do not lead to ac dence- based and more accurate payments for E/M and other services. In response, as we summarized in the CY 2024 PFS final rule (88 FR 78977), commenters stated that the methods used do not lead to accurate valuation and that the problems lie with the nature of E/M services and the PFS’s budget neutrality adjustment. They stated that the resources used in furnishing the work portion of E/M services are primarily a 37 Zuckerman, S., K. Merrell, R. Berenson, et al. 2016. Collecting empirical physician time data: Piloting an approach for validating work relative value units. Report prepared for the Centers for Medicare & Medicaid Services. Washington, DC: The Urban Institute. https://www.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/ PhysicianFeeSched/Downloads/Collecting- Empirical-Physician-Time-Data-Urban-Report.pdf. 38 National Academies for Sciences, Engineering, and Math. Improving Primary Care Valuation Processes to Inform the Physician Fee Schedule. Available from: https://nap.nationalacademies.org/ catalog/29069/improving-primary-care-valuation- processes-to-inform-the-physician-fee-schedule. function of the time the clinician spends with the patient and, therefore, are p.nationalacademies.org/ catalog/29069/improving-primary-care-valuation- processes-to-inform-the-physician-fee-schedule. function of the time the clinician spends with the patient and, therefore, are not amenable to efficiency gains and that the valuation process is not responsive to efficiency gains, leading to passive devaluation of E/M services under the constraints of budget neutrality. At the time, we responded that we recognized that there are opportunities to improve how all services are valued and better account for resource variation for different types of care under the PFS. For several years, we have been concerned about not accounting for the efficiencies gained in work RVUs for non-time-based services. As we discuss below, non-time-based codes, such as codes describing procedures, radiology services, and diagnostic tests, should become more efficient as they become more common, professionals gain more experience, technology is improved, and other operational improvements (including but not limited to enhancements in procedural workflows) are implemented. We would highlight, however, that there are often many years between a code’s introduction and revaluation within th including but not limited to enhancements in procedural workflows) are implemented. We would highlight, however, that there are often many years between a code’s introduction and revaluation within the RUC process, with only a few hundred out of the more than 9,000 codes paid under the PFS considered for revaluation annually by the RUC. While there is significant variability in how often codes are reviewed by the RUC, on average, CMS estimates that there are 25.49 years since a code valuation has been reviewed by the RUC (this includes 5382 out of 9970 codes which were never reviewed). When we exclude from the average those codes that have never been reviewed, the average is 17.69 years since the last review of a code by the RUC. We note that these numbers weight each code equally and the PFS itself is heavily weighted by utilization towards a much smaller number of often utilized codes. Furthermore, even when a code is reviewed by the RUC, 2 to 3 years usually pass between when the survey data was collected and its use by CMS in setting rates becomes effective. In the intervening years without revaluation, we are most likely overvaluing codes by not accounting for these efficienci rvey data was collected and its use by CMS in setting rates becomes effective. In the intervening years without revaluation, we are most likely overvaluing codes by not accounting for these efficiencies gained in the valuation of work RVUs for non-time-based services. And even when recommendations have been submitted by the RUC to CMS as potentially misvalued codes from 2009 to 2025, the RUC only recommended a decrease in the physician time and resources for the codes 39 percent of the time.39 39 American Medical Association. ‘‘AMA/ Specialty Society RVS Update Committee: An Overview of the RUC Process.’’ Available from: VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32401 Studies have demonstrated that CMS continues to overvalue non-time-based services. In a pilot project for CMS conducted by the Urban Institute in 2016,40 which compared data obtained from electronic health records and direct observation, the ratios of fee schedule time to empirical time were ofte ject for CMS conducted by the Urban Institute in 2016,40 which compared data obtained from electronic health records and direct observation, the ratios of fee schedule time to empirical time were often inflated, with the largest discrepancies in imaging and other test interpretations. In the study, the median ratio of PFS time to empiric intraservice physician time for CT and MRI scans was 2.13, for noninvasive cardiac testing was 4.00, and for mammography was 1.67. Another study compared estimated procedure time from anesthesia claims and the PFS time, and found that the mean estimated procedure time was 27 percent lower than the time used for PFS valuation.41 Expert reviewers have attributed some of the discrepancies to automation and personnel substitution that has become prevalent in the time between when CMS adopted many codes and when those codes are revalued.42 MedPAC, in their 2018 recommendations to Congress, recommended three options to offset these historic distortions, including passive devaluation: (1) an automatic reduction to the prices of new services and services with high growth rates; (2) an extension of the annual numeric target for CMS to reduce the prices of o uding passive devaluation: (1) an automatic reduction to the prices of new services and services with high growth rates; (2) an extension of the annual numeric target for CMS to reduce the prices of overpriced services; and (3) an across- the-board reduction to all fee schedule services other than ambulatory E&M services.43 For reasons we will further describe below in this section, we are proposing a modified version of this third option for procedures, radiology, and diagnostic tests. Section 1848(c)(2)(B)(ii)(I) of the Act provides that the Secretary shall, to the extent he determines to be necessary, adjust the number of RVUs to take into https://www.ama-assn.org/system/files/ruc-update- booklet.pdf. 40 Zuckerman, S., K. Merrell, R. Berenson, et al. 2016. Collecting empirical physician time data: Piloting an approach for validating work relative value units. Report prepared for the Centers for Medicare & Medicaid Services. Washington, DC: The Urban Institute.https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/ PhysicianFeeSched/Downloads/Collecting- Empirical-Physician-Time-Data-Urban-Report.pdf. 41 Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. ‘‘Vari icare/ Medicare-Fee-for-Service-Payment/ PhysicianFeeSched/Downloads/Collecting- Empirical-Physician-Time-Data-Urban-Report.pdf. 41 Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. ‘‘Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialties.’’ JAMA Surg. 2022 May 1;157(5):e220099. doi: 10.1001/ jamasurg.2022.0099. 42 Zuckerman et al, 2016. 43 MedPAC Report to Congress, 2018. Chapter 3: Rebalancing Medicare’s Physician Fee Schedule Toward Ambulatory Evaluation and Management Services.’’ Available from: https:// www.medpac.gov/wp-content/uploads/import_ data/scrape_files/docs/default-source/reports/ jun18_ch3_medpacreport_sec.pdf. account changes in medical practice. We believe that many of the efficiency gains that historically may not have been fully reflected in the valuation of work RVUs for non-time-based services represent or have been caused by changes in medical practice, as described in further detail below. To take into account changes in medical practice and better reflect the resources involved in furnishing services paid under the PFS, we are proposing to establish an efficiency adjustment to the work RVUs, as wel account changes in medical practice and better reflect the resources involved in furnishing services paid under the PFS, we are proposing to establish an efficiency adjustment to the work RVUs, as well as corresponding updates to the intraservice portion of physician time inputs for non-time- based services. Our initial proposed approach is designed to be conservative in nature, as we are concerned about making too many changes at once to the current methodology. In the future, we may consider making additional corresponding updates to the direct PE inputs for clinical labor and equipment costs. Our proposal is based on our assumption that both the intraservice portion of physician time and the work intensity (including mental effort, technical effort, physical effort, and risk of patient complications) would decrease as the practitioner develops expertise in performing the specific service. As expertise develops, learning leads to enhanced familiarity with the various aspects of a service, variations in the anatomy of each patient, and confidence in the practitioner’s own ability to handle unexpected challenges that arise. For example, one cross-specialty observational study found vice, variations in the anatomy of each patient, and confidence in the practitioner’s own ability to handle unexpected challenges that arise. For example, one cross-specialty observational study found that increased surgical experience was associated with significant reductions in operative time for coronary artery bypass grafting, total knee replacement, and bilateral reduction mammoplasty.44 While this expertise in part develops as a practitioner accumulates years of experience following the culmination of training, it also accumulates across the entire health system with the creation of a new procedure or service that practitioners must grow accustomed to. Furthermore, changes in medical practice such as enhancements in operational workflows and technology advancements after the introduction of a new procedure or service can further reduce the risk associated with the service and increase efficiencies. When a new surgical technique is introduced, operational workflows and procedures are based on previous experience with 44 Maruthappu, Mahiben, Antoine Duclos, Stuart Lipsitz, Dennis Orgill, Matthew Carty. ‘‘Surgical Learning Curves and Operational Efficiency: A Cross-Specialty Ob are based on previous experience with 44 Maruthappu, Mahiben, Antoine Duclos, Stuart Lipsitz, Dennis Orgill, Matthew Carty. ‘‘Surgical Learning Curves and Operational Efficiency: A Cross-Specialty Observational Study.’’ BMJ Open. 2015 Mar 13;5(3):e006679. a similar service, which may not directly translate to the new procedure. These workflows generally evolve over time as experience grows, and tend to result in improvements, which make the service more efficient. This is consistent with systematic reviews demonstrating that with increased case volume and years of expertise, surgeons demonstrate decreased risk of poor outcomes.45 Other studies have found that with increased experience performing new procedures, clinicians demonstrate increased operational efficiency and decreased time. For example, one systematic review found that for clinicians newly introduced to robotic thoracic surgery, a reduction in operating time based on the increasing number of cases performed.46 Another study concluded that for robotic thoracic procedures, the hourly productivity increase for experienced and proficient surgeons ranged from 11.4 work relative value units/hour (+26%) for lobectomy to 17.0 y concluded that for robotic thoracic procedures, the hourly productivity increase for experienced and proficient surgeons ranged from 11.4 work relative value units/hour (+26%) for lobectomy to 17.0 work relative value units/hour (+50%) for segmentectomy.47 These changes in practitioner experience, operational workflows, and new technologies in totality represent large-scale, system- wide changes in medical practice as described in section 1848(c)(2)(B)(ii)(I) of the Act that may not have been previously accounted for in the valuation of non-time based codes. Given the relative infrequency of service revaluation under the PFS and the limitations of reliance on survey data, we are concerned that the RVUs we have established for codes paid under the PFS may not reflect these efficiencies accrued as practitioners gain experience, operational workflows improve, and new technology is adopted. (2) Proposed Methodology for the Efficiency Adjustment To calculate the efficiency adjustment, we propose using the Medicare Economic Index (MEI) productivity adjustment. The MEI is a measure of inflation faced by physicians with respect to their practice costs and general wage levels, and include propose using the Medicare Economic Index (MEI) productivity adjustment. The MEI is a measure of inflation faced by physicians with respect to their practice costs and general wage levels, and includes inputs used in furnishing physicians’ services such as physician’s own time, non- physician employees’ compensation, rents, medical equipment, and more. Every year, the CMS Office of the 45 https://pubmed.ncbi.nlm.nih.gov/25072442/. 46 Power, Alexandra, Desmond D’Souza, Susan Moffatt-Bruce, Robert Merritt, Peter Kneuertz. ‘‘Defining the Learning Curve of Robotic Thoracic Surgery: What Does it Take? Surg Endosc. 2019 Dec;33(12):3880–3888. doi: 10.1007/s00464–019– 07035–y. Epub 2019 Aug 2. 47 https://pubmed.ncbi.nlm.nih.gov/37562675/. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32402 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Actuary (OACT) subtracts the MEI productivity adjustment from the MEI percent change moving average to calculate the final MEI update. The MEI productivity adjustment used for the final Proposed Rules Actuary (OACT) subtracts the MEI productivity adjustment from the MEI percent change moving average to calculate the final MEI update. The MEI productivity adjustment used for the final MEI update reflects the most recent historical estimate of the 10-year moving average growth of private nonfarm business total factor productivity, as calculated by the Bureau of Labor Statistics.48 Every year, the productivity adjustment for the final MEI update is calculated by OACT based on historical data. For example, in 2026 the productivity adjustment for the final MEI update will reflect historical data through 2024. OACT incorporates a 10-year moving average to minimize yearly fluctuations in productivity associated with normal business cycles. The productivity adjustment to be applied to the proposed MEI percent change moving average for CY 2026 is listed in Table 11 (0.8 percent), and it will be updated for the final rule based on the most up to date data. The MEI productivity adjustment is substantively similar to the productivity adjustment required for the hospital inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) at sections 18 adjustment is substantively similar to the productivity adjustment required for the hospital inpatient prospective payment system (IPPS) and outpatient prospective payment system (OPPS) at sections 1886(b)(3)(B)(xi)(II) and 1833(t)(3)(F)(i) of the Act, respectively. The main difference is that the MEI productivity adjustment reflects historical data at the time of the CY update and the OPPS and IPPS productivity adjustments reflect a forecast to correspond to the FY update. For CY 2026, we are proposing to apply the efficiency adjustment using a look-back period of 5 years. We considered a couple initial look-back periods. As previously described, despite the efforts to update valuation, many codes have never been revalued, and even for codes that have been revalued, there is, on average, more than 17 years since revaluation recommendations submitted by the RUC. Thus, using a look-back period of 17 years would help to account for the average amount of time that has elapsed since the last revaluation. However, using a look-back period of 17 years may be imprecise because, even when a code has been reviewed by the RUC, historic reliance on survey data may have skewed results and not st revaluation. However, using a look-back period of 17 years may be imprecise because, even when a code has been reviewed by the RUC, historic reliance on survey data may have skewed results and not properly accounted for efficiencies in the physician time and work RVU. We are also proposing to apply the efficiency adjustment to the codes that the RUC and CMS have reviewed within the look-back period of 5 years, including codes being proposed for revaluation this year, as many of the challenges discussed previously in this section, namely reliance on survey data, still apply. We realize that adjusting for the efficiencies gained would be a change in our payment methodology, and so as an initial conservative approach, we are proposing a look-back of 5 years. This represents our intended cadence for updating the efficiency adjustment (3 years), plus an additional 2 years, since it has historically taken about 2 years to make changes to PFS valuation after we receive new recommendations from the RUC. We recognize that over time, there may be variation in the efficiencies accrued service-by-service (for example, the previously cited research has identified that efficiencies have been from the RUC. We recognize that over time, there may be variation in the efficiencies accrued service-by-service (for example, the previously cited research has identified that efficiencies have been gained more in minor procedures and radiology services than in major inpatient procedures). But because PFS intraservice time is higher than empirical intraservice time on average for studied non-time based services,49 50 we believe that applying the efficiency adjustment to non-time-based services more broadly, instead of applying it only to certain services that may be more likely to accrue efficiency gains, may help to improve the overall accuracy of our valuation of these services under the PFS. Furthermore, a look-back period of 5 years is not intended to account for the full magnitude of previously unaccounted for efficiency gains in services paid under the PFS, and we may consider making refinements to the efficiency adjustment in future rulemaking to better account for these gains. To implement this efficiency adjustment, we propose to decrease the work RVUs and make corresponding changes to the intraservice physician time for codes describing non-time-based services by a facto To implement this efficiency adjustment, we propose to decrease the work RVUs and make corresponding changes to the intraservice physician time for codes describing non-time-based services by a factor equal to the MEI productivity adjustment, equivalent to if this factor had been applied every year over the past 5 years. This methodology would yield a proposed efficiency adjustment of 2.5 percent, a downward (negative) adjustment for certain codes, for CY 2026. Given the 5-year look back period, the formula sums all productivity adjustments included in the final MEI updates from CY 2022–CY 2026. The CY 2026 productivity adjustment will be updated for the CY 2026 final rule to reflect more recent historical data from the Bureau of Labor Statistics. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Using the methodology described above, we have included Table A–E2, which outlines examples of two different CPT codes that would be subject to the proposed efficiency adjustment. Table 12 is intended only as an illustrative example. For more information on the impacts of this proposed policy, see the Regulatory Impact Analysis in section VII.C.2.c. of this propo cy adjustment. Table 12 is intended only as an illustrative example. For more information on the impacts of this proposed policy, see the Regulatory Impact Analysis in section VII.C.2.c. of this proposed rule. 48 87 FR 69709. 49 Zuckerman et al, 2016. 50 Crespin, Daniel, Teague Ruder, Andrew Mulcahy, Ateev Mehotra. ‘‘Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialties.’’ JAMA Surg. 2022 May 1;157(5):e220099. doi: 10.1001/ jamasurg.2022.0099. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00054 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32405 pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, simi Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32405 pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations. We remind interested parties that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 20 and 21 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that interested parties will note the impact the particular price may have on PE relativity, as well as to identify items that are used frequently, since we believe that interested parties are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs, and we encourage interested parties to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs. In some cases, we do no reflective of typical costs, and we encourage interested parties to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs. In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we include the item in the direct PE input database without any associated price. Although including the item without an associated price means that the or the newly recommended items. In other cases, we include the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so. (6) Service Period Clinical Labor Time in the Facility Setting Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address code- specific refinements to clinical labor in the individual code sections. (7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap We note that the list of services for the upcoming calendar year that are subject to the MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services; and the list es for the upcoming calendar year that are subject to the MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services; and the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap; are displayed in the public use files for the PFS proposed and final rules for each year. The public use files for CY 2026 are available on the CMS website under downloads for the CY 2026 PFS proposed rule at https://www.cms.gov/ Medicare/Medicare-Fee-for-Service- Payment/PhysicianFeeSched/PFS- Federal-Regulation-Notices.html. For more information regarding the history of the MPPR policy, we referred readers to the CY 2014 PFS final rule with comment period (78 FR 74261 through 74263). Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109–171, enacted on February 8, 2006) amended section 1848(b)(4) of the Act to require that, for imaging services, if—(i) The TC (including the TC portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjus to require that, for imaging services, if—(i) The TC (including the TC portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The Medicare OPD fee schedule amount established under the prospective payment system (PPS) for HOPD services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under section 1833(t)(2)(D) of the Act, the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor under the PFS, for the fee schedule amount for such TC for such year. As required by section 1848(b)(4)(A) of the Act, for imaging services furnished on or after January 1, 2007, we cap the TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient Prospective Payment System (OPPS) payment amount for the service (prior to geographic adjustment). We then apply the PFS geographic adjustment to the capped payment amount. Section 1848(b)(4)(B) of the Act defines imaging services as ‘‘imaging and computer- assisted imaging services, including X- ray, ul n apply the PFS geographic adjustment to the capped payment amount. Section 1848(b)(4)(B) of the Act defines imaging services as ‘‘imaging and computer- assisted imaging services, including X- ray, ultrasound (including echocardiography), nuclear medicine (including PET), magnetic resonance imaging (MRI), computed tomography (CT), and fluoroscopy, but excluding diagnostic and screening mammography.’’ For more information regarding the history of the cap on the TC of the PFS payment amount under the DRA (the ‘‘OPPS cap’’), we referred readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662). For CY 2026, we identified new and revised codes to determine which services meet the definition of ‘‘imaging services’’ as defined at section 1848(b)(4)(B) of the Act for purposes of this cap. Beginning for CY 2026, we are proposing to include the following services on the list of codes to which the OPPS cap applies: CPT codes 0598T (Real-time fluorescence wound imaging with clinical darkness, to identify location of bacterial wound pathogens and measure wound size, per session; first anatomic site (e.g., lower extremity, right leg), 0599T (Real-time fluorescence wo with clinical darkness, to identify location of bacterial wound pathogens and measure wound size, per session; first anatomic site (e.g., lower extremity, right leg), 0599T (Real-time fluorescence wound imaging with clinical darkness, to identify location of bacterial wound pathogens and measure wound size, per session; each additional anatomic site (e.g., upper extremity, left leg) (List separately in addition to code for primary procedure)), 0944T (3D contour simulation of target liver lesion(s) and margin(s) for image-guided percutaneous microwave ablation), 0946T (Orthopedic implant movement analysis using paired computed tomography (CT) examination of the target structure, including data acquisition, data preparation and transmission, interpretation and report (including CT scan of the joint or extremity performed with paired views)), 0961T (Shortwave infrared radiation imaging, surgical pathology specimen, to assist gross examination for lymph node localization in fibroadipose tissue, per specimen (List separately in addition to code for primary procedure)), 0972T (Assistive algorithmic classification of burn healing (i.e., healing or nonhealing) by noninvasive multispectral issue, per specimen (List separately in addition to code for primary procedure)), 0972T (Assistive algorithmic classification of burn healing (i.e., healing or nonhealing) by noninvasive multispectral imaging, including system set-up and acquisition, selection, and transmission of images, with automated generation of report), 0984T (Intravascular imaging of extracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32406 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules interpretation, and report; initial vessel (List separately in addition to code for primary procedure)), 0985T (Intravascular imaging of extracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; each additional vessel (List sepa oherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; each additional vessel (List separately in addition to code for primary procedure)), 0986T (Intravascular imaging of intracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; initial vessel (List separately in addition to code for primary procedure)), 0987T (Intravascular imaging of intracranial cerebral vessels using optical coherence tomography (OCT) during diagnostic evaluation and/or therapeutic intervention, including all associated radiological supervision, interpretation, and report; each additional vessel (List separately in addition to code for primary procedure)), 70XX1 (Computed tomographic angiography (CTA), head and neck, with contrast material(s), including noncontrast images, when performed, and image postprocessing), 70XX2 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed with co noncontrast images, when performed, and image postprocessing), 70XX2 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed with concurrent CT or CT angiography of the same anatomy (List separately in addition to code for primary procedure)), 70XX3 (Computed tomographic (CT) cerebral perfusion analysis with contrast material(s), including image postprocessing performed without concurrent CT or CT angiography of the same anatomy), and 77X09 (Surface radiation therapy; superficial or orthovoltage, image guidance, ultrasound for placement of radiation therapy fields for treatment of cutaneous tumors, per course of treatment (List separately in addition to the code for primary procedure)). We believe that these codes meet the definition of imaging services under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap. 4. Valuation of Specific Codes for CY 2026 (1) Tympanostomy (CPT Code 0583T) In the CY 2025 PFS final rule (89 FR 97745 through 97746), we reviewed Category III CPT code 0583T (Tympanostomy (requiring insertion of ventilating tube), using an automated tube delivery system, iontophor CY 2025 PFS final rule (89 FR 97745 through 97746), we reviewed Category III CPT code 0583T (Tympanostomy (requiring insertion of ventilating tube), using an automated tube delivery system, iontophoresis local anesthesia) as potentially misvalued. We considered whether to establish national payment for CPT code 0583T, which is used to report tympanostomy using the TULA system, or whether to create a device-agnostic G-code which could be used to report tympanostomies using the TULA or other devices. We stated that CPT code 69433 (Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia) might serve as a sufficient base code, adequately describing most of the surgeon’s work and facility resources. In response to comments supporting the latter approach, we established separate payment for HCPCS code G0561 (Tympanostomy with local or topical anesthesia and insertion of a ventilating tube when performed with tympanostomy tube delivery device, unilateral (List separately in addition to 69433) (Do not use in conjunction with 0583T)) to be billed with CPT code 69433 in order to describe the additional resource costs associated with using the innovative tympanost arately in addition to 69433) (Do not use in conjunction with 0583T)) to be billed with CPT code 69433 in order to describe the additional resource costs associated with using the innovative tympanostomy tube delivery devices and/or systems falling under emerging technology and services categories and finalized contractor pricing for CY 2025. We have received input from interested parties expressing gratitude for the creation of HCPCS code G0561 but also continuing to request that CMS establish national pricing for CPT code 0583T. In response, we are seeking comments on whether to nationally price both codes, and what inputs for physician work, time, and direct practice expense would most accurately capture the resource costs associated with performing both procedures. For example, in response to a similar request for comment in CY 2025 PFS rulemaking, commenters recommended a direct crosswalk to the values associated with CPT code 31295 (Nasal/ sinus endoscopy, surgical, with dilation (e.g., balloon dilation); maxillary sinus ostium, transnasal or via canine fossa) which they stated was similar to CPT code 0583T with respect to the intensity and invasiveness of the procedure, prep (e.g., balloon dilation); maxillary sinus ostium, transnasal or via canine fossa) which they stated was similar to CPT code 0583T with respect to the intensity and invasiveness of the procedure, preparation time for the procedure, and total time to complete the surgery. We are seeking comments on whether interested parties continue to believe CPT code 31295 would be an accurate comparison or whether there are other services that CMS should consider. (2) Temporary Female Intraurethral Valve-Pump (CPT Codes 0596T and 0597T) For the CY 2025 PFS final rule (89 FR 97710), we reviewed CPT codes 0596T (Temporary female intraurethral valve- pump (i.e., voiding prosthesis); initial insertion, including urethral measurement) and 0597T (Temporary female intraurethral valve-pump (that is, voiding prosthesis); initial insertion, replacement) as potentially misvalued. We added pricing for 3 new supplies related to these services: (1) inFlow Measuring Device, (2) inflow Valve Pump Device, and (3) inFlow Activator Kit. The RUC reviewed and surveyed these codes as potentially misvalued for the January 2025 meeting and stated that they would flag for the RAW in 3 years. We are proposing the RUC- re Flow Activator Kit. The RUC reviewed and surveyed these codes as potentially misvalued for the January 2025 meeting and stated that they would flag for the RAW in 3 years. We are proposing the RUC- recommended work RVU of 2.43 for CPT code 0596T and the RUC- recommended work RVU of 1.05 for CPT code 0597T. We are proposing the RUC- recommended direct PE inputs for both CPT codes without refinement. (3) Limb Lengthening-Shortening— Femur (CPT Codes 27465, 27466, 27468, and 27XX0) The CPT Editorial Panel created a new Category I code, CPT code 27XX0 (Osteotomy(ies), femur, unilateral, with insertion of an externally controlled intramedullary lengthening device, including iliotibial band release when performed, imaging, alignment assessments, computations of adjustment schedules, and management of the intramedullary lengthening device) in May 2024. This code describes femur lengthening using the insertion of an externally controlled intramedullary lengthening device, including imaging. CPT code 27XX0 and the other codes within this code family, including CPT codes 27465 (Osteoplasty, femur; shortening (excluding 64876), 27466 (Osteoplasty, femur; lengthening), and 27468 (Osteoplasty, T code 27XX0 and the other codes within this code family, including CPT codes 27465 (Osteoplasty, femur; shortening (excluding 64876), 27466 (Osteoplasty, femur; lengthening), and 27468 (Osteoplasty, femur; combined, lengthening and shortening with femoral segment transfer), were surveyed during the September 2024 RUC Meeting. We are proposing the RUC- recommended work RVUs of 26.65, 21.13, and 22.65 for CPT codes 27XX0, 27465, and 27466, respectively. We are also proposing the direct PE inputs for CPT codes 27XX0, 27465, and 27466 without refinement. However, for CPT code 27468, we disagree with the RUC’s recommendation to contractor price this code. We believe CPT code 27468 is valued appropriately and should not be paid under contractor pricing based on the results of ten surveys. We are instead proposing to maintain the current work RVU and direct PE inputs for CPT code 27468 for CY 2026. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00056 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32407 (4) Limb Lengthening 16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32407 (4) Limb Lengthening-Shortening—Tibia (CPT Codes 27715 and 27XX1) The CPT Editorial Panel created a new Category I code, CPT code 27XX1, (Osteotomy(ies), tibia, including fibula when performed, unilateral, with insertion of an externally controlled intramedullary lengthening device, including imaging, alignment assessments, computations of adjustment schedules, and management of the intramedullary lengthening device) in May 2024. This code describes tibia lengthening using the insertion of an externally controlled intramedullary lengthening device, including imaging. CPT codes 27XX1 and 27715 (Osteoplasty, tibia and fibula, lengthening or shortening) were surveyed for the September 2024 RUC Meeting. We are proposing the RUC- recommended work RVU of 28.00 for CPT code 27XX1 and the work RVU of 22.50 for CPT 27715. We are also proposing the direct PE inputs for CPT codes 27XX1 and 27715 without refinement. (5) Arthrodesis Great Toe (CPT Codes 28750 and 28755) At the April 2024 Relativity Assessment Workgrou 715. We are also proposing the direct PE inputs for CPT codes 27XX1 and 27715 without refinement. (5) Arthrodesis Great Toe (CPT Codes 28750 and 28755) At the April 2024 Relativity Assessment Workgroup (RAW), the RAW identified CPT code 28750 (Arthrodesis, great toe; metatarsophalangeal joint) on the ‘‘different performing specialty from survey screen,’’ where the top specialty performing over 50 percent of the Medicare claims did not survey the service or the top two specialties did not survey the service. The RAW noted that when this service was last valued in 1995, podiatry, which now performs over half of the volume for this service, was not involved in the survey. CPT code 28755 (Arthrodesis, great toe; interphalangeal joint) which was valued by the Harvard Studies and never surveyed by the RUC, was added as part of the code family. CPT codes 28750 and 28755, were surveyed at the January 2025 AMA RUC meeting. We are proposing the RUC- recommended work RVU of 8.75 for CPT code 28750. We disagree with the RUC- recommended work RVU of 7.50 for CPT code 28755 and we are instead proposing a work RVU of 6.76. The RUC-recommended valuation would place it above the median range when c 0. We disagree with the RUC- recommended work RVU of 7.50 for CPT code 28755 and we are instead proposing a work RVU of 6.76. The RUC-recommended valuation would place it above the median range when compared to other 90-day global codes with similar work times and the current time and work values. We are proposing a work RVU of 6.76 for CPT code 28755 based on a direct crosswalk to CPT code 28122 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (for example, osteomyelitis or bossing); tarsal or metatarsal bone, except talus or calcaneus). CPT code 28122 shares the same intraservice work time of 45 minutes as compared with CPT code 28755, it has a very similar total time (230 minutes as compared with 234 minutes), and both of these codes also contain four postoperative office visits in their global periods. We are supporting this proposed work RVU of 6.76 with the total time ratio for CPT code 28755, which calculates at a work RVU of 6.64 (the total time is increasing from 172 minutes to 234 minutes for an increase of 36 percent, which results in a work RVU of 6.64 when multiplied with the current work RVU of 4.88 for CPT code 28755). Our propo l time is increasing from 172 minutes to 234 minutes for an increase of 36 percent, which results in a work RVU of 6.64 when multiplied with the current work RVU of 4.88 for CPT code 28755). Our proposed work RVU of 6.76 is further supported by a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 26785 (Open treatment of interphalangeal joint dislocation, includes internal fixation, when performed, single) at a work RVU of 6.60 and an upper bracket of CPT code 56620 (Vulvectomy simple; partial) at an RVU of 7.53. We are proposing the RUC- recommended direct PE inputs for all of the codes in this family. (6) Closure Left Atrial Appendage With Endocardial Implant (CPT Code 33340) The Relativity Assessment Workgroup (RAW) reviewed CPT code 33340 (Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation) in 2023 as part of the new technology/service screen. Around that same time, specialty societies asserted that this ndage angiography, when performed, and radiological supervision and interpretation) in 2023 as part of the new technology/service screen. Around that same time, specialty societies asserted that this service was undergoing rapid change. Therefore, the RAW recommended specialty societies conduct a survey for the April 2024 RUC meeting. We are proposing the RUC- recommended work RVU of 10.25 for CPT code 33340. We are also proposing the RUC-recommended direct PE inputs for CPT code 33340 without refinement. (7) Thoracic Branch Endograft Services (CPT Codes 33880, 33881, 33883, 33886, 33XX2, and 35XX1) At the September 2024 CPT Editorial Panel meeting, CPT approved endovascular repair of thoracic aortic aneurysms (TEVAR) coding changes. CPT deleted three codes describing the procedure and replaced them with two new codes and four revised codes in the TEVAR family. These revisions update the TEVAR code family to more accurately describe the current practice and current coding standards. The new codes are CPT code 33XX2 (Endovascular repair of the thoracic aorta by deployment of a branched endograft multipiece system involving an aorto-aortic tube device with a fenestration for the left e new codes are CPT code 33XX2 (Endovascular repair of the thoracic aorta by deployment of a branched endograft multipiece system involving an aorto-aortic tube device with a fenestration for the left subclavian artery stentgraft(s) and all aortic tube endograft extension(s) placed from the level of the left common carotid artery to the celiac artery, including preprocedure sizing and device selection, all target zone angioplasty, all nonselective catheterization(s) and left subclavian artery selective catheterization(s), all associated radiological supervision and interpretation), CPT code 35XX1 (Bypass graft, with other than vein; carotid-contralateral carotid), CPT code 33880 (Endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption); involving coverage of left subclavian artery origin, initial endoprosthesis plus descending thoracic aortic extension(s), if required, to level of celiac artery origin, radiological supervision and interpretation), CPT code 33881 (by deployment of an aorto-aortic tube endograft not involving coverage of the left subclavian artery origin and all endo ac artery origin, radiological supervision and interpretation), CPT code 33881 (by deployment of an aorto-aortic tube endograft not involving coverage of the left subclavian artery origin and all endograft extension(s) placed from the level of the left subclavian carotid artery to the celiac artery), CPT code 33883 (Proximal extension prosthesis(s) not involving coverage of the left subclavian artery origin, delayed placement after endovascular repair of the thoracic aorta, including preprocedure sizing and device selection, nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed), and CPT code 33886 (Distal extension prosthesis(s) from the level of the left subclavian artery to the celiac artery, delayed placement after endovascular repair of descending thoracic aorta, including preprocedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation). The new codes in this code family were surveyed at the January 2025 AMA RUC meeting. The RUC surveyed this code family and there were overall decreases in the work times. The R on and interpretation). The new codes in this code family were surveyed at the January 2025 AMA RUC meeting. The RUC surveyed this code family and there were overall decreases in the work times. The RUC-recommended work RVUs do not appear to fully VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32408 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules account for these decreases. Although we do not believe that changes in work time as reflected in survey values must equate to a one-to-one or linear change in the valuation of work RVUs, we believe that since the two components of work are time and intensity, decreases in the surveyed work time should typically be reflected in decreases to the work RVU. We reviewed the RUC recommendations and found them to be high, relative to other codes with the same or similar times. Based on a search of similarly timed codes in the RUC database, the RUC-recommended values exceed the work RVUs for five of the six codes. We disagree with the RUC recommended work RVU of 30.00 for CPT sed on a search of similarly timed codes in the RUC database, the RUC-recommended values exceed the work RVUs for five of the six codes. We disagree with the RUC recommended work RVU of 30.00 for CPT code 33880 and we are instead proposing a work RVU of 27.00. This valuation was higher than nearly all of the other 90-day global codes with similar time values. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with an intraservice time of 120 minutes and similar total time around 546 minutes. We are instead proposing a direct crosswalk to CPT code 32672 (Thoracoscopy, surgical; with resection-plication for emphysematous lung (bullous or non- bullous) for lung volume reduction (LVRS), unilateral includes any pleural procedure, when performed) at the previously mentioned work RVU of 27.00. CPT code 32672 shares the same intraservice work time of 120 minutes as compared with CPT code 33880, it has a similar total time (567 minutes as compared with 546 minutes), and both of these codes each have two postoperative office visits in their global periods. We are supporting this proposed work RVU of 27.00 with a pair of other 90-day as compared with 546 minutes), and both of these codes each have two postoperative office visits in their global periods. We are supporting this proposed work RVU of 27.00 with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 43820 (Gastrojejunostomy; without vagotomy) at a work RVU of 22.53 and an upper bracket of CPT code 34702 (Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the aortic bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion, when performed (for example, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)) with a work RVU of 36.00. We disagree with the RUC recommended work RVU of 26.75 for CPT code 33881 and we are instead proposing a work RVU of 22.53. The RUC’s recommended work RVU umatic disruption)) with a work RVU of 36.00. We disagree with the RUC recommended work RVU of 26.75 for CPT code 33881 and we are instead proposing a work RVU of 22.53. The RUC’s recommended work RVUs do not match the surveyed drops in work time (from 200 minutes to 110 minutes for CPT code 33881) and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 43820 has a slightly higher intraservice work time of 120 minutes as compared with CPT code 33881 which has 110 minutes, it has a very similar total time (545 minutes as compared with 506 minutes), and three postoperative office visits as compared to CPT code 33881 which has two postoperative office visits in the global period. We are supporting this proposed work RVU of 22.53 with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 34707 at a work RVU of 22.28 and an upper bracket of CPT code 43880 at an RVU of 27.18. We disagree with the RUC recommended work RVU of 39.00 for CPT code 33XX2 and we are instead proposing a work RVU of 35.00. We found that the RUC-recommended work RVU does not maintain relativity with ot disagree with the RUC recommended work RVU of 39.00 for CPT code 33XX2 and we are instead proposing a work RVU of 35.00. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 180 minutes and similar total time around 621 minutes. We are proposing a work RVU of 35.00 for CPT code 33XX2 based on a direct crosswalk to CPT code 33390 (Valvuloplasty, aortic valve, open, with cardiopulmonary bypass; simple (i.e., valvotomy, debridement, debulking, and/or simple commissural resuspension)). There were several recently reviewed codes in the RUC database search that have the exact same intraservice time with higher total times and a lower work RVU. CPT code 33390 shares the same intraservice work time of 180 minutes as compared with CPT code 33880, it has a very similar total time (621 minutes as compared with 622 minutes), and both of these codes also contain two postoperative office visits in their global periods. We are supporting this proposed work RVU with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 33647 (Repair of atrial septal defect and v l periods. We are supporting this proposed work RVU with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 33647 (Repair of atrial septal defect and ventricular septal defect, with direct or patch closure) at a work RVU of 33.00 and an upper bracket of CPT code 35216 (Repair blood vessel, direct; intrathoracic, without bypass) at an RVU of 35.00. We disagree with the RUC recommended work RVU of 24.25 for CPT code 33883 and we are instead proposing a work RVU of 19.91. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. We are proposing a work RVU of 19.91 for CPT code 33883 based on a direct crosswalk to CPT code 44320 (Colostomy or skin level cecostomy). The RUC-recommended work RVUs do not match the surveyed drops in work time (from 120 minutes to 90 minutes) for CPT code 33883 and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 44320 shares the same intraservice work time of 90 minutes as compared with CPT code 338 herefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 44320 shares the same intraservice work time of 90 minutes as compared with CPT code 33883, it has a slightly higher total time (507 minutes as compared with 486 minutes), and three postoperative office visits as compared to two post operative office visits for CPT code 33883 in the global period. We are supporting this proposed work RVU of 19.91 with a pair of other 90-day global codes with similar work time values, with a lower bracket of CPT code 33267 (Exclusion of left atrial appendage, open, any method (for example, excision, isolation via stapling, oversewing, ligation, plication, clip)) at a work RVU of 18.50 and an upper bracket of CPT code 43611 (Excision, local; malignant tumor of stomach) at an RVU of 20.38. We disagreed with the RUC recommended work RVU of 23.50 for CPT code 33886 and we are instead proposing a work RVU of 19.91. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. We are proposing a work RVU of 19. work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 90 minutes and similar total time around 486 minutes. We are proposing a work RVU of 19.91 for CPT code 33886 based on a direct crosswalk to CPT code 44320. The RUC-recommended work RVUs do not match the surveyed drops in work time (from 100 minutes to 90 minutes) for CPT code 33886 and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 44320 shares the same intraservice work time of 90 minutes as compared with CPT codes 33886, it has a slightly higher total time (507 minutes as compared with 486 minutes), and three postoperative office visits as compared to two post operative office visits for CPT code 33886 in the global period. We are supporting this proposed work RVU of 19.91 with a pair of other 90-day global codes with VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32409 similar wo E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32409 similar work time values, with a lower bracket of CPT code 33267 at a work RVU of 18.50 and an upper bracket of CPT code 43611 at an RVU of 20.38. We disagree with the RUC recommended work RVU of 27.40 for CPT code 35XX1 and we are instead proposing a work RVU of 23.53. We found that the RUC-recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 150 minutes and similar total time around 486 minutes. Furthermore, we note that there was a decrease in the intraservice time by 23 minutes and the intraservice time ratio for this code suggests that the RUC-recommendation is too high. We are proposing a work RVU of 23.53 for CPT code 35XX1 based on a direct crosswalk to CPT code 32669 (Thoracoscopy, surgical; with removal of a single lung segment (segmentectomy)). We note that CPT code 35XX1 was also valued by the RUC using a crosswalk code to maintain relativity within the family. The RUC’s recommended work RVUs do not reflect surveye segment (segmentectomy)). We note that CPT code 35XX1 was also valued by the RUC using a crosswalk code to maintain relativity within the family. The RUC’s recommended work RVUs do not reflect surveyed drops in work time (from 173 minutes to 150 minutes) for CPT code 35XX1and we are therefore selecting a crosswalk code that more accurately captures this decrease in the surveyed times. CPT code 32669 shares the same intraservice work time of 150 minutes as compared with CPT code 35XX1, it has a slightly higher total time (502 minutes as compared with 486 minutes), and both of these codes also contain two postoperative office visits in their global periods. We are supporting this proposed work RVU of 23.53 with a pair of other 090-day global codes with similar work time values, with a lower bracket of CPT code 22612 (Arthrodesis, posterior or posterolateral technique, single interspace; lumbar (with lateral transverse technique, when performed)) at a work RVU of 23.53 and an upper bracket of CPT code 35666 (Bypass graft, with other than vein; femoral-anterior tibial, posterior tibial, or peroneal artery) at an RVU of 23.66. We are proposing the RUC- recommended direct PE inputs for a t of CPT code 35666 (Bypass graft, with other than vein; femoral-anterior tibial, posterior tibial, or peroneal artery) at an RVU of 23.66. We are proposing the RUC- recommended direct PE inputs for all the codes in this family. (8) Lower Extremity Revascularization (CPT Codes 37XX1, 37X02, 37X03, 37X04, 37X05, 37X06, 37X07, 37X08, 37X09, 37X10, 37X11, 37X12, 37X13, 37X14, 37X15, 37X16, 37X17, 37X18, 37X19, 37X20, 37X21, 37X22, 37X23, 37X24, 37X25, 37X26, 37X27, 37X28, 37X29, 37X30, 37X31, 37X32, 37X33, 37X34, 37X35, 37X36, 37X37, 37X38, 37X39, 37X40, 37X41, 37X42, 37X43, 37X44, 37X45, and 37X46) In October 2018, three CPT codes (37225, 37227, and 37229) were flagged by the Relativity Assessment Workgroup for high-cost supplies review, leading to a series of significant changes in the lower extremity revascularization (LER) code family. After multiple reviews and discussions between 2018 and 2024, the CPT Editorial Panel ultimately created four new subsections and 46 new codes to replace the existing 16 codes (CPT codes 37220–37235) for LER services. According to the RUC, this comprehensive update was driven by technological advances, changes in practice settings, and the need to b ce the existing 16 codes (CPT codes 37220–37235) for LER services. According to the RUC, this comprehensive update was driven by technological advances, changes in practice settings, and the need to better differentiate between a stenosis (i.e. a straightforward lesion) and an occlusion (that is, a complex lesion) procedures. These codes were surveyed for the September 2024 RUC meeting and recommendations submitted to CMS for consideration in the CY 2026 PFS proposed rule. See table 13 for a summary of the codes, and their long descriptors. According to the RUC, not all codes received a full survey from participants. Eleven selected core codes had complete survey responses from all respondents, while the remaining 35 codes underwent an abbreviated survey process. The 35 abbreviated survey codes were split into two groups and survey respondents only received one of those two groups along with the 11 core codes. There were two notable changes made to the abbreviated survey. First, survey respondents were provided with one of the anchor codes as a comparator instead of using a reference service list; second, survey respondents were only asked one question per abbreviated code in the i respondents were provided with one of the anchor codes as a comparator instead of using a reference service list; second, survey respondents were only asked one question per abbreviated code in the intensity/complexity section. Therefore, respondents did not complete all elements of the abbreviated survey, as some elements were pre- populated. We note that this method could potentially introduce inaccuracies and bias in the survey outcomes. For CY 2026, we are proposing the RUC-recommended work RVUs for all 46 CPT codes. However, we have concerns about the survey data, specifically regarding the small sample size and large variations in responses. We encourage commenters to submit additional data for our consideration in determining the valuation of work and direct PE inputs for these CPT codes. Table 13 also shows the proposed work RVUs for the 46 CPT codes: 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32410 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S 0000 Frm 00059 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32410 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00060 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00061 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00062 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00063 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00064 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00065 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00066 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00067 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00067 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32418 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules minutes). An RVU of 13.00 for CPT code 52649 is supported by the range of CPT code 64912 (Nerve repair; with nerve allograft, each nerve, first strand (cable)) with an RVU of 12.00, the same intraservice time and 272 minutes of total time, and by CPT code 15730 (Midface flap (that is, zygomaticofacial flap) with preservation of vascular pedicle(s)) with an RVU of 13.50, the same intraservice time and 255.5 minutes of total time. We are proposing the RUC- recommended direct PE inputs for CPT codes 52500, 52XX1, 52601, 52630, and 52649 without refinement. For CPT code 52648, we are proposing to remove the 6 minutes of clinical labor time for CA021 (Perform procedures/services— NOT directly related to physician work time). Therefore, the equipment time reported under EF031 (table, power) has also been reduced by 6 minutes (from 95 minutes to 89 min rform procedures/services— NOT directly related to physician work time). Therefore, the equipment time reported under EF031 (table, power) has also been reduced by 6 minutes (from 95 minutes to 89 minutes) to reflect the removal of clinical labor activity CA021 from CPT code 52648. We note that CPT code 52648 is performed in the facility setting only and the standard is 0 minutes for CA021 in the facility. Also, supply item SL036 (cup, biopsy- specimen sterile 4oz) was reported as a non-facility PE input for CPT code 52648. Since CPT code 52648 is only performed in the facility setting, we believe inclusion of supply item SD036 as a non-facility PE input was unintentional and therefore proposing to remove. (12) Cystourethroscopy (CPT Code 52XX2) At the September 2024 CPT Editorial Panel Meeting, CPT code 0619T (Cystourethroscopy with transurethral anterior prostate commissurotomy and drug delivery, including transrectal ultrasound and fluoroscopy, when performed) was deleted and replaced with CPT code 52XX2, which describes an endoscopic procedure for the management of benign prostatic enlargement that entails using both a non-medication-coated and a medication-coated balloon to op ed with CPT code 52XX2, which describes an endoscopic procedure for the management of benign prostatic enlargement that entails using both a non-medication-coated and a medication-coated balloon to open the prostatic urethra. CPT code 52XX2 (Cystourethroscopy with initial transurethral anterior prostate commissurotomy with a non-drug- coated balloon catheter followed by therapeutic drug delivery into the prostate by a drug-coated balloon catheter, including transrectal ultrasound and fluoroscopy, when performed) was surveyed at the January 2025 AMA RUC meeting. We are proposing the RUC- recommended work RVU of 3.62 for CPT code 52XX2. For direct PE, we are proposing to refine the clinical labor associated with clinical activity CA023 (Monitor patient following procedure/ service, no multitasking) to 0 minutes for CPT code 52XX2. We note that the RUC-recommended a direct crosswalk of most clinical labor times for CPT code 52XX2 based on reference CPT code 52441 (Cystourethroscopy, with insertion of permanent adjustable transprostatic implant; single implant), however, the PE Summary of Recommendations for CPT code 52XX2 only describes patient monitoring activities done while multi-t insertion of permanent adjustable transprostatic implant; single implant), however, the PE Summary of Recommendations for CPT code 52XX2 only describes patient monitoring activities done while multi-tasking and does not describe any no-multitasking (1:1) patient monitoring time (clinical activity code CA023) like it was described in the PE SOR for CPT code 52441, reviewed for CY 2020 PFS rulemaking. We are therefore proposing to remove this clinical labor time. We also disagree with the RUC- recommended 40 minutes for the clinical labor associated with clinical activity CA025 (Clean scope) and are proposing to refine CA025 to the standard 30 minutes for a flexible scope. We would like to note that, while the PE SOR for CPT code 52XX2 did not justify non-standard times for clinical activities CA016 (Prepare, set-up and start IV, initial positioning and monitoring of patient) and CA017 (Sedate/apply anesthesia) of 2 minutes, we are not proposing to refine these clinical activity times because there was a robust explanation of these non- standard times in the PE SOR for CPT code 52441, which is a clinically similar endoscopy code requiring positioning and anesthetic activities that wa cause there was a robust explanation of these non- standard times in the PE SOR for CPT code 52441, which is a clinically similar endoscopy code requiring positioning and anesthetic activities that warrant the non-standard times for CPT codes 52441 and 52XX2. For medical supplies, we are proposing to remove the SM022 (sanitizing cloth-wipe (patient)) supply because there are five of these cloth wipes included in the SA058 supply (pack, urology cystoscopy visit). For equipment times, we are proposing to refine the time for the ES031 (scope video system (monitor, processor, digital capture, cart, printer, LED light)) and ES018 (fiberscope, flexible, cystoscopy) equipment items to account for the clinical labor times that should be included in the standard scope systems and scope equipment formulas. We disagree with the RUC- recommended 64 minutes for ES031 and ES018, and we are proposing to refine ES031 to 52 minutes and ES018 to 79 minutes in accordance with our standard equipment time formulas for scopes and scope video systems. We are proposing all other direct PE inputs for CPT code 52XX2. (13) Prostate Biopsy Services (CPT Codes 55705, 55706, 5XX00, 5XX01, 5XX02, 5XX03, 5XX04, 5 formulas for scopes and scope video systems. We are proposing all other direct PE inputs for CPT code 52XX2. (13) Prostate Biopsy Services (CPT Codes 55705, 55706, 5XX00, 5XX01, 5XX02, 5XX03, 5XX04, 5XX07, 5XX08, 5XX09, 5XX10, and 76872) At the April 2022 Relativity Assessment Workgroup (RAW), prostate biopsy services were reviewed and identified as services performed by the same physician on the same date of service 75 percent of the time or more. As a result of that review, the RAW requested action plans for September 2022 to determine if specific code bundling solutions should occur for CPT codes 55700 (Biopsy, prostate; needle or punch, single or multiple, any approach) and CPT code 76872 (Ultrasound, transrectal;). The RAW referred that issue to the CPT Editorial Panel for revision of descriptors and for clarity in reporting CPT code 55700 with CPT code 76872. At the May 2024 CPT Editorial Panel meeting, CPT deleted existing CPT code 55700, revised CPT codes 55705 (Biopsy, prostate; any approach, non-imaging- guided) and 76872 and added 9 new codes that clarify reporting for prostate biopsies and the imaging procedures that accompany them. CPT codes 55705, 55706 (Biopsies, pro e; any approach, non-imaging- guided) and 76872 and added 9 new codes that clarify reporting for prostate biopsies and the imaging procedures that accompany them. CPT codes 55705, 55706 (Biopsies, prostate, needle, transperineal, stereotactic template guided saturation sampling, including imaging guidance), 5XX00 (Biopsy, prostate, transrectal, ultrasound-guided (i.e., sextant), ultrasound-localized), 5XX01 (Biopsy, prostate, transrectal, ultrasound-guided (i.e., sextant) with MRI-fusion guidance), 5XX02 (Biopsy, prostate, transperineal, ultrasound-guided (i.e., sextant), ultrasound-localized), 5XX03 (Biopsy, prostate, transperineal, ultrasound- guided (i.e., sextant) with MRI-fusion guidance), 5XX04 (Biopsy, prostate, transrectal, MRI-ultrasound-fusion guided, targeted lesion(s) only), 5XX07 (Biopsy, prostate, transperineal, MRI- ultrasound-fusion guided, targeted lesion(s) only, first targeted lesion), 5XX08 (Biopsy, prostate, in-bore CT- or MRI-guided (i.e., sextant), with biopsy of additional targeted lesion(s), first targeted lesion), 5XX09 (Biopsy, prostate, in-bore CT- or MRI-guided targeted lesion(s) only, first targeted lesion), and 5XX10 (Biopsy, prostate, each additional additional targeted lesion(s), first targeted lesion), 5XX09 (Biopsy, prostate, in-bore CT- or MRI-guided targeted lesion(s) only, first targeted lesion), and 5XX10 (Biopsy, prostate, each additional, MRI-ultrasound fusion or in-bore CT- or MRI-guided targeted lesion (List separately in addition to code for primary procedure)), and 76872 were surveyed at the September 2024 RUC meeting. We are proposing the RUC- recommended work RVUs for all twelve CPT codes in this family. We are proposing a work RVU of 1.93 for CPT code 55705, a work RVU of 4.27 for CPT VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32419 code 55706, a work RVU of 2.63 for CPT code 5XX00, a work RVU of 3.39 for CPT code 5XX01, a work RVU of 3.23 for CPT code 5XX02, a work RVU of 3.81 for CPT code 5XX03, a work RVU of 2.61 for CPT code 5XX04, a work RVU of 3.10 for CPT code 5XX07, a work RVU of 4.00 for CPT code 5XX08, a work RVU of 3.62 for CPT code 5XX09, a work RVU of 1.05 for CPT code 5XX10, a 03, a work RVU of 2.61 for CPT code 5XX04, a work RVU of 3.10 for CPT code 5XX07, a work RVU of 4.00 for CPT code 5XX08, a work RVU of 3.62 for CPT code 5XX09, a work RVU of 1.05 for CPT code 5XX10, and a work RVU of 0.67 for CPT code 76872. We are proposing the RUC- recommended direct PE inputs for all of the codes in this family. (14) Laparoscopic Prostatectomy (CPT Codes 55840, 55842, 55845, 55866, 55867, 558X1, and 558X2) In April 2023, the RUC’s Relativity Assessment Workgroup identified CPT codes 38571 (Laparoscopy, surgical; with bilateral total pelvic lymphadenectomy) and 55866 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed) as typically reported together 75 percent or more based on 2021 Medicare claims data and referred them to the CPT Editorial Panel to possibly develop a code bundling solution. In May 2024, the CPT Editorial Panel created two new codes to report laparoscopic prostatectomy with lymph node biopsy(ies) (limited pelvic lymphadenectomy) and with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes, respectively: CPT code 558X1 (Laparoscopy, mph node biopsy(ies) (limited pelvic lymphadenectomy) and with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes, respectively: CPT code 558X1 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed; with lymph node biopsy(ies) (limited pelvic lymphadenectomy) and 558X2 ((Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes). These new codes were surveyed along with the rest of the family, CPT code 55840 (Prostatectomy, retropubic radical, with or without nerve sparing), 55842 (Prostatectomy, retropubic radical, with or without nerve sparing; with lymph :node biopsy(s) (limited pelvic lymphadenectomy)), 55845 (Prostatectomy, retropubic radical, with or without nerve sparing; with bilateral pelvic lymphadenectomy, including external iliac, hypogastric, and obturator nodes), 55866 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when perform nectomy, including external iliac, hypogastric, and obturator nodes), 55866 (Laparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed), and 55867 (Laparoscopy, surgical prostatectomy, simple subtotal (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy), includes robotic assistance, when performed) at the September 2024 RUC meeting. We are proposing the RUC’s recommended work RVU for five of the six codes in the Laparoscopic Prostatectomy family. We are proposing a work RVU of 21.36 for CPT code 55840, a work RVU of 21.36 for CPT code 55842, a work RVU of 25.18 for CPT code 55845, a work RVU of 22.46 for CPT code 55866, a work RVU of 22.46 for CPT code 558X1, and a work RVU of 19.53 for CPT code 55867. We disagree with the RUC’s recommended work RVU of 29.35 for CPT code 558X2 and we are instead proposing a work RVU of 27.41 based on a crosswalk to CPT code 50543 (Laparoscopy, surgical; partial nephrectomy). The RUC’s recommended work RVU of 29.35 is based on a crosswalk to CPT code 27059 (Radical resection of tumor (for example, sarcoma walk to CPT code 50543 (Laparoscopy, surgical; partial nephrectomy). The RUC’s recommended work RVU of 29.35 is based on a crosswalk to CPT code 27059 (Radical resection of tumor (for example, sarcoma), soft tissue of pelvis and hip area; 5 cm or greater). However, CPT code 27059 is a procedure typically performed on an inpatient basis, with nearly 200 minutes of additional total time higher than the surveyed work time for CPT code 558X2 (608 minutes as compared with 434 minutes), due to the inclusion of five inpatient office visits in its global period. CPT code 558X2 will typically be performed on an outpatient basis and does not contain any inpatient office visits in its global period, which leads us to believe that CPT code 27059 is not the most accurate choice of CPT code for a valuation crosswalk. Instead, we believe that it is more accurate to propose a work RVU of 27.41 for CPT code 558X2 based on the crosswalk to CPT code 50543. This crosswalk code is another type of surgical laparoscopy which more closely matches the intraservice work time (240 minutes against 230 minutes) and total work time (557 minutes against 434 minutes) of CPT code 558X2. We also note that the inten laparoscopy which more closely matches the intraservice work time (240 minutes against 230 minutes) and total work time (557 minutes against 434 minutes) of CPT code 558X2. We also note that the intensity of CPT code 558X2 is anomalously high in relation to the rest of this code family at the RUC’s recommended work RVU of 29.35, roughly 30–40 percent higher than any of its peer codes. While we agree that CPT code 558X2 should have the highest intensity amongst this group of codes, we believe that our proposed work RVU of 27.41 reflects a more accurate intensity relative to the rest of the family. For the direct PE inputs, we are proposing to correct what appears to be an error in the recommendations for CPT code 55867. The RUC- recommended 106 minutes of clinical labor time for the CA039 (Post-operative visits (total time)) activity based on two Level 4 office visits included in the global period for CPT code 55867. However, this CPT code instead contains one Level 3 and one Level 4 office visit which sum to 89 minutes of clinical labor time, not 106 minutes. We are proposing to make this correction to the CA039 clinical labor time for CPT code 55867, which also carries over to the fice visit which sum to 89 minutes of clinical labor time, not 106 minutes. We are proposing to make this correction to the CA039 clinical labor time for CPT code 55867, which also carries over to the equipment time for the power table (EF031) and the surgical light (EF014). We are proposing the direct PE inputs as recommended by the RUC in all other cases for this code family. (15) Endovascular Therapy With Imaging (CPT Codes 61624, 61626, 75894, and 75898) In April 2022, the Relativity Assessment Workgroup (RAW) requested action plans to evaluate potential code bundling solutions for the following code pairs: CPT code 61624 (Transcatheter permanent occlusion or embolization [for example, for tumor destruction, to achieve hemostasis, to occlude a vascular malformation], percutaneous, any method; central nervous system [intracranial, spinal cord]) and CPT code 75894 (Transcatheter therapy, embolization, any method, radiological supervision and interpretation), CPT code 61624 and CPT code 75898 (Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis), CPT code 61626 (Transcatheter permanent occlusion de 75898 (Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis), CPT code 61626 (Transcatheter permanent occlusion or embolization [e.g., for tumor destruction, to achieve hemostasis, to occlude a vascular malformation], percutaneous, any method; non-central nervous system, head or neck [extracranial, brachiocephalic branch]) and CPT code 75894, and CPT code 61626 and CPT code 75898. The RUC reviewed these codes during the April 2024 RUC meeting. For CY 2026, the RUC-recommended a work RVU of 20.00 for CPT code 61624, an RVU of 15.31 for CPT code 61626, an RVU of 2.25 for CPT code 75894, and an RVU of 1.85 for CPT code 75898. We are proposing the RUC- recommended work RVU of 2.25 for CPT code 75894 and work RVU of 1.85 for CPT code 75898. However, we have concerns about the survey data due to the significant variations in both work values and intraservice times reported by respondents. These variations can suggest that the proposed RVU values at the 25th percentile may not accurately VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S s can suggest that the proposed RVU values at the 25th percentile may not accurately VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32420 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules reflect the actual work involved in performing these services. As a result, we are seeking public comments regarding the proposed work RVUs for CPT codes 75894 and 75898. We disagree with the RUC- recommended work RVUs for CPT codes 61624 and 61626. For CPT code 61624, we are proposing a work RVU of 17.06 instead of the RUC-recommended 20.00. This proposal is based on a crosswalk to CPT code 49622 (Repair of parastomal hernia, any approach (that is, open, laparoscopic, robotic), initial or recurrent, including implantation of mesh or other prosthesis, when performed; incarcerated or strangulated). This crosswalk is supported by a range of CPT code 33224 (Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or implantable defibrillator pulse generator (in ge of CPT code 33224 (Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or implantable defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator)) with a work RVU of 9.04, 135 minutes intra-service time and 204 minutes total time, and CPT code 93590 (Percutaneous transcatheter closure of paravalvular leak; initial occlusion device, mitral valve.) with a work RVU of 21.70, 135 minutes intraservice time and 223 minutes total time. The intraservice time for CPT code 61624 decreased from 232 to 150 minutes, reducing by 82 minutes, and the total time decreased from 362 to 246 minutes, reducing by 116 minutes, which supports a lower RVU. The lower work RVU proposal of 17.06 reflects the significant decreases in both intraservice time and total time for CPT code 61624. For CPT code 61626, we are proposing a work RVU of 13.46 instead of the RUC-recommended work RVU of 15.31. This proposal is based on a crosswalk to CPT code 49594 (Repair of anterior abdominal hernia[s] [that is, epigastric, incisional, ventral, umbilical, spigelian], any approach [ nded work RVU of 15.31. This proposal is based on a crosswalk to CPT code 49594 (Repair of anterior abdominal hernia[s] [that is, epigastric, incisional, ventral, umbilical, spigelian], any approach [that is, open, laparoscopic, robotic], initial, including implantation of mesh or other prosthesis when performed, total length of defect[s]; 3 cm to 10 cm, incarcerated or strangulated). This crosswalk is supported by a range of CPT code 55881 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation) with a work RVU of 9.80, 120 minutes intra-service time and 202 minutes total time, and CPT code 93580 (Percutaneous transcatheter closure of congenital interatrial communication (that is, Fontan fenestration, atrial septal defect) with implant) with a work RVU of 17.97, 120 minutes intraservice time and 210 minutes total time. The intraservice time for CPT code 61626 decreased by 53 minutes, and the total time decreased by 90 minutes, which supports a lower RVU. The lower work RVU proposal of 13.46 reflects the significant decreases in both intraservice time and total time for CPT code 616 nd the total time decreased by 90 minutes, which supports a lower RVU. The lower work RVU proposal of 13.46 reflects the significant decreases in both intraservice time and total time for CPT code 61626. We are also proposing the RUC- recommended direct PE inputs for CPT codes 61624, 75894, and 75898 without refinement. However, we disagree with a few RUC-recommended direct PE inputs for CPT code 61626. We are proposing to refine the clinical staff time for the CA011 activity ’Provide education/obtain consent’ to the standard of 2 minutes for CPT code 61626. Since no rationale was provided in the PE Summary of Recommendations for extending clinical staff time beyond the standard 2 minutes for the CA011 activity, we believe 2 minutes is more appropriate than the RUC-recommended 5 minutes. We are also proposing to change the medical supply quantity of the SD172 (guidewire, cerebral (Bentson)) supply from 1 to 0 because CPT code 61626 describes non-central nervous system procedures, while SD172 is a cerebral guidewire; thus, we believe this supply is not typically used in this service. Additionally, regarding the clinical labor associated with CA024 (Clean room/equipment by clinical s SD172 is a cerebral guidewire; thus, we believe this supply is not typically used in this service. Additionally, regarding the clinical labor associated with CA024 (Clean room/equipment by clinical staff), we believe that the RUC’s recommendation of 3 minutes for CA024 was not properly accounted for in one of the equipment time formula inputs. Therefore, we are proposing an increase of 3 minutes to the equipment time for the angiography room (EL011), which increases from 124 to 127 minutes for this code to incorporate this missing time associated with the CA024 activity. Lastly, for CPT code 61626, the equipment time for the professional PACS workstation (ED053) should be half of the physician preservice time plus the full physician intraservice time. We believe this was an unintended error, and we are proposing 152 minutes after rounding up from 151.5 minutes. Although we are proposing the direct PE inputs for CPT codes 75894 and 75898 without refinement, we have concerns over one of the RUC- recommended direct PE inputs, CA021 (Perform procedure/service—NOT directly related to physician work time) as the involvement of additional vascular interventional technologists remains unc the RUC- recommended direct PE inputs, CA021 (Perform procedure/service—NOT directly related to physician work time) as the involvement of additional vascular interventional technologists remains unclear. According to the RUC recommendation, CPT codes 61624 and 61626 should not be reported in conjunction with CPT codes 75894 and 75898. And the RUC’s recommendation of 60 minutes of clinical labor time for CPT code 75894 and 45 minutes for CPT code 75898 associated with the CA021 activity did not include an adequate explanation for these activities when CPT codes 75894 and 75898 are performed in the absence of CPT codes 61624 and 61626. Thus, we are proposing the direct PE inputs as recommended by the RUC; however, due to the concerns mentioned above, we are seeking public comments regarding the recommended CA021 clinical labor time of 60 minutes for CPT code 75894 and 45 minutes for CPT code 75898, specifically what intraservice clinical labor time would be typical for these procedures. (16) Guided High Intensity Focused Ultrasound (CPT Code 61715) In September 2023, the CPT Editorial Panel created a new Category I code to describe magnetic resonance image guided high intensity foc . (16) Guided High Intensity Focused Ultrasound (CPT Code 61715) In September 2023, the CPT Editorial Panel created a new Category I code to describe magnetic resonance image guided high intensity focused ultrasound (MRgFUS) intracranial ablation for treatment of a severe central tremor that is recalcitrant to other medical treatments for CY 2025 to replace the existing Category III code. For CY 2025, we finalized the implementation of CPT code 61715 (Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation of target, intracranial, including stereotactic navigation and frame placement, when performed) as a global-only code with direct PE inputs in the facility setting only, as recommended by the RUC. After implementation, an interested party raised concerns about the lack of non-facility pricing for the new CPT code 61715, which would result in an untenable non-facility payment equal to the established facility payment. The interested party expressed concerns about access to the service in the non- facility setting given the facility payment rate and provided information about the appropriateness of the service in the non-facility setting an essed concerns about access to the service in the non- facility setting given the facility payment rate and provided information about the appropriateness of the service in the non-facility setting and the payments set by the MACs for the predecessor code. The interested party stated that the predecessor code, CPT code 0398T, was paid $9,750 in the non- facility setting by one MAC, and for CY 2025, CPT code 61715 is paid at $1,180 in the non-facility setting due to being set equal to the facility payment, absent established non-facility PE RVUs. In an effort to temporarily resolve this issue for CY 2025, we implemented PC/TC splits for CPT code 61715, with contractor-pricing for the global and technical components, which would restore MAC discretion in pricing this VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32421 service, including in the non-facility setting. For CY 2026, we are seeking comments on non-facility pricing of this service to address the issue perm / Wednesday, July 16, 2025 / Proposed Rules 32421 service, including in the non-facility setting. For CY 2026, we are seeking comments on non-facility pricing of this service to address the issue permanently. When considering potential crosswalk or reference codes for proposed direct PE inputs in the non-facility setting, we found all codes in the CPT code 615XX, 616XX, 617XX, and 618XX series are only valued in the facility setting and therefore were not tenable crosswalk codes for the non- facility direct PE. Additionally, there are MRI-guidance ultrasound ablation Category III codes that could be commensurate for non-facility direct PE, such as CPT code 0071T (Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue), and the previous predecessor code of CPT code 61715, CPT code 0398T, but they are/were contractor-priced under the PFS and do not have direct PE inputs for consideration. We considered the prostate tissue MRI-guided ultrasound ablation codes, CPT codes 55881 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, issue MRI-guided ultrasound ablation codes, CPT codes 55881 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation) and 55882 (Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducer for delivery of thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed) as possible references because they are valued in the non-facility setting, but they include very high-cost disposable supplies and equipment that are specific to the CPT codes including SA136 (TULSA–PRO Disposable Kit) and EQ410 (TULSA– PRO TDC Cart), as well as some other direct PE inputs that may not be typical for CPT code 61715. We also considered partial crosswalks of CPT codes for portions of CPT code 61715, such as CPT codes 77372 (Radiation treatment delivery, stereotactic radiosurgery (SRS), complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based), 61800 (Applicati