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

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 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 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 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 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 Sec. 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”, “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. Update 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 Sec. [thinsp]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 proposed, 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. 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.

Therefore, we proposed 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 later in this section). Under this update, 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, we 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 and (42 CFR 410.78(f)). We noted in the CY 2026 PFS proposed rule (90 FR 32593 through 32597), if finalized, that all codes currently on the list (provisional or permanent) would remain on the Medicare Telehealth Services List. Because we had 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 noted in the CY 2026 PFS proposed rule to 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.

We proposed 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 in the proposed rule, 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 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 we update 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 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 modality for their patients to receive a service.

We believe our update 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 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 in the proposed rule, 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 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 Sec. 410.78(a)(3). We proposed 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 in this section:

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 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 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 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-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- 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 Sec. 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 Sec. 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 proposed 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 sought comments on our proposal to refine the Medicare Telehealth Services List review process. We also invited 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 we believe 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.

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

Comment: Many commenters generally supported our proposal to simplify our review process to add services to the Medicare Telehealth Services List, including removing steps 4 and 5 and eliminating the provisional and permanent categories. The commenters appreciated that this simplified process would reduce the administrative burden, enhance provider flexibility, and provide greater clarity, stability, and predictability for providers. The commenters also supported our emphasis on clinical judgment and supporting practitioners in practicing, to the extent possible, on the most clinically sophisticated tasks and making the most of their professional training. The commenters also supported that this policy change could improve access for beneficiaries while preserving patient-centered care, without compromising patient safety. Some commenters requested that we monitor the impact of this policy change to ensure beneficiary safety, quality, and access. A few commenters did not support our proposal because they believe that the elimination of steps 4 and 5 of the review process does not support a consistent, evidence-based safeguard to ensure that the outcomes of telehealth services are comparable to those of in-person services.

Response: We appreciate the commenters for their feedback. We continue to believe that the 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 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 will continue to consider the feedback from interested parties for future rulemaking.

After consideration of public comments, we are finalizing as proposed. 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 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 in section D(1)(b) of the proposed rule. The requested services are listed in Table A-D1.

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 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.

[GRAPHIC] [TIFF OMITTED] TR05NO25.012

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 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 (87 FR 69404), 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 service may be furnished using an interactive telecommunications system as defined in Sec. 410.78(a)(3). Therefore, we proposed to add this service to the Medicare Telehealth Services List. We requested public comments on this proposal.

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

Comment: Commenters supported the addition of CPT code 90849 (Multiple-Family Group Psychotherapy) to the Medicare Telehealth Services List. Commenters cited that the service described by CPT code 90849 demonstrates its ability to be furnished via telehealth due to being similar to other forms of group psychotherapy that are included on the Medicare Telehealth Services List. Commenters also cited that telehealth platforms are well-equipped for this type of service and that the availability of this service via telehealth particularly benefits families in areas that do not have clinicians readily available or for families that may have constraints that inhibit coordinating in-person care.

Response: We appreciate the commenters for their feedback.

After consideration of public comments, we are finalizing as proposed to add Multiple-Family Group Psychotherapy services (CPT code 90849) to the Medicare Telehealth Services List, beginning in CY 2026. (2) Group Behavioral Counseling for Obesity

We received a request to add CPT code G0473 (Face-to-face behavioral counseling for obesity, group (2 to 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 2 through 6, and one face-to-face visit per month for months 7 through 12 (if an individual loses 3kg in the first 6 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 Sec. 410.78(a)(3). Therefore, we proposed to add this service to the Medicare Telehealth Services List. We requested public comments on this proposal.

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

Comment: Several commenters supported the addition of CPT code G0473 (Face-to-face behavioral counseling for obesity, group (2 to 10), 30 minutes) to the Medicare Telehealth Services List, stating that this service may be furnished via telehealth due to being similar to other similar group counseling codes that are already included on the Medicare Telehealth Services List. The commenters stated that when this service is furnished via telehealth specifically, patients may experience reduced stigma, enhanced privacy, improved adherence, and family involvement that can enable dietary and lifestyle planning to support long-term participation in the 12-month Intensive Behavioral Therapy for Obesity program.

Response: We appreciate the commenters for their feedback.

After consideration of public comments, we are finalizing as proposed to add Group Behavioral Counseling for Obesity (CPT code G0473) to the Medicare Telehealth Services List, beginning in CY 2026. (3) Infectious Disease Add-On

We received a request to add CPT code G0545 (Visit complexity inherent to hospital inpatient or observation care associated with a confirmed or suspected infectious disease by an infectious diseases consultant, including disease transmission risk assessment and mitigation, public health investigation, analysis, and testing, and complex antimicrobial therapy counseling and treatment (add-on code, list separately in addition to hospital inpatient or observation evaluation and management visit, initial, same day discharge, or subsequent)) to the Medicare Telehealth Services List. This code can include service elements such as disease transmission risk assessment and mitigation, public health investigation and analysis, and complex antimicrobial therapy counseling. Based on our review, we believe this service meets step 1 of our review process because it is currently assigned status indicator A (meaning that the service is separately payable under the PFS), 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 Sec. 410.78(a)(3). Therefore, we proposed to add this service to the Medicare Telehealth Services List. We requested public comments on this proposal.

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

Comment: Several commenters supported the addition of HCPCS code G0545 to the Medicare Telehealth Services List. The commenters supported this addition because this service is similar to other add-on codes that are currently on the Medicare Telehealth Services List and stated that the presence of this service on the Medicare Telehealth Services List would enhance beneficiary access. The commenters stated that there is a gap in access to infectious disease clinicians, who have expertise in risk assessment, public health investigation, and complex therapies without unnecessary delays or travel for patients, particularly in areas with limited in-person infectious disease resources.

Response: We appreciate the commenters for their feedback.

After consideration of public comments, we are finalizing as proposed to add the Infections Disease Add-on (CPT code G0545) to the Medicare Telehealth Services List, beginning in CY 2026. (4) Auditory Osseointegrated Sound Processor

We received a request to add CPT codes 92622 (Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; first 60 minutes) and 92623 (Diagnostic analysis, programming, and verification of an auditory osseointegrated sound processor, any type; each additional 15 minutes (List separately in addition to code for primary procedure)) to the Medicare Telehealth Services List. Based on our review, we believe these services meet step 1 of our review process because they are currently assigned status indicator A (meaning that the service is separately payable under the PFS), meet step 2 of our review process because they are services ordinarily furnished with the furnishing practitioner and patient in the same location and therefore subject to the provisions of section 1834(m) of the Act, and meet step 3 because that all elements of these services may be furnished using an interactive telecommunications system as defined in Sec. 410.78(a)(3). Therefore, we proposed to add these services to the Medicare Telehealth Services List. We requested public comments on these proposals.

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

Comment: Several commenters supported the addition of CPT codes 92622 and 92623 to the Medicare Telehealth Services List. The commenters supported this addition because this service is similar to other audiology codes that are currently on the Medicare Telehealth Services List. Commenters also stated that telehealth platforms are well-equipped for this type of service, eliminating barriers related to geography, transportation, and physical mobility.

Response: We appreciate the commenters for their feedback.

After consideration of public comments, we are finalizing as proposed to add Auditory Osseointegrated Sound Processor services (CPT codes 92622 and 92623) to the Medicare Telehealth Services List, beginning in CY 2026. (5) Dialysis

We received a request to add dialysis procedures described by CPT codes 90935 (Hemodialysis procedure with single evaluation by a physician or other qualified health care professional), 90937 (Hemodialysis procedure requiring repeated evaluation(s) with or without substantial revision of dialysis prescription), 90945 (Dialysis procedure other than hemodialysis (for example, peritoneal dialysis, hemofiltration, or other continuous renal replacement

therapies), with single evaluation by a physician or other qualified health care professional), and 90947 (Dialysis procedure other than hemodialysis (for example, peritoneal dialysis, hemofiltration, or other continuous renal replacement therapies) requiring repeated evaluations by a physician or other qualified health care professional, with or without substantial revision of dialysis prescription) to the Medicare Telehealth Services List. These codes describe reviewing medical records, obtaining an interval history, performing an expanded problem focused or detailed physical examination, formulating and/or revising diagnosis and treatment plan(s) (moderate or high complexity medical decision-making), and discussing diagnosis and treatment. On either a single or two or more visits, the practitioner assesses the patient and response so far to dialysis, writes and/or reviews orders, and supervises dialysis.

We proposed not to add these services to the Medicare Telehealth Services List at this time, as we do not believe that we have enough information to determine if these services meet step 3 of the Medicare Telehealth review process. It is not clear under what clinical circumstances this service could be furnished via telehealth and how all service elements would be performed when furnished via telehealth. We sought comments on whether the elements of the service are capable of being delivered via an interactive telecommunication system as required for Medicare telehealth services under Sec. 410.78(a)(3). We also sought comments regarding the service elements clinical staff at the originating site are performing and how these patient interactions compare to service elements that the professional may be furnishing via telehealth. When adding ESRD-related services (CPT codes 90963 through 90966, 90967 through 90970) to the Medicare Telehealth Service list in the CY 2015 (80 FR 41783) and CY 2017 (81 FR 80194) final rules with comment period, we noted the clinical examination of the access site must still be furnished face-to-face “hands-on” (without the use of an interactive telecommunications system) by a physician, CNS, NP, or PA. We sought comment to see if this requirement would also be appropriate for CPT codes 90935, 90937, 90945, and 90947 or if any other service elements need to be furnished “hands-on.” We noted in the proposed rule that we required more information to determine whether this requirement of a “hands-on” clinical examination by a physician, CNS, NP, or PA would inhibit furnishing these services via telehealth, or if a practitioner at the originating site could perform this requirement.

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

Comment: As requested, several commenters provided more information about under what clinical circumstances this service could be furnished via telehealth. The commenters provided information that these codes are generally used to treat critically ill, potentially hospitalized patients who are best treated in-person rather than via telehealth. These commenters acknowledged that there may be extremely limited circumstances in which patients in rural areas may benefit from these services being on the Medicare Telehealth Services List, but that in most cases, these patients would require an in-person visit. A commenter who had originally supported the addition of these codes has since determined that the addition of these services is no longer necessary.

We received a few comments requesting that we add these services to the Medicare Telehealth Services List, however, the commenters did not provide more information under what clinical circumstances this service could be furnished via telehealth and how all service elements would be performed when furnished via telehealth. A few commenters further requested the addition of these services, stating that some components of the service can be furnished via telehealth, and that the addition of these services can increase provider flexibility and increase access to care.

Response: We continue to believe that these services do not meet step 3 of the Medicare Telehealth review process. We are not persuaded that all service elements could be furnished via telehealth, since we did not receive this information. We look forward to reviewing additional information and considering this for future rulemaking.

After consideration of public comments, we are finalizing as proposed to not add these services to the Medicare Telehealth Services List. (6) Home INR Monitoring

We received a request to add Home INR Monitoring (HCPCS code G0248) to the Medicare Telehealth Services List for CY 2026. This service, as described by HCPCS code G0248, encompasses a face-to-face demonstration of the use and care of the INR monitor, obtaining at least one blood sample, providing instructions for reporting home INR test results, and documenting the patient's ability to perform testing and report results. In response to this request for the CY 2025 PFS proposed rule, commenters explained in detail that the interaction with the patient described by this service is generally delivered by individuals considered to be clinical staff and not a physician or practitioner as defined under section 1834(m)(4) of the Act. “Clinical staff” means someone who is supervised by a physician or other qualified health care professional and is allowed by law, regulation, and facility policy to perform or assist in a specialized professional service but does not individually report that professional service. After reviewing these comments and receiving additional information from interested parties, especially those that reminded us that the patient interactions for this service typically occur with clinical staff, it is clear that this is not a service that is generally furnished via a telecommunications system by a physician or a practitioner, as defined under section 1834(m)(4) of the Act, but rather is a technical part of a service delivered by clinical staff employed or otherwise providing services for a supplier. Indeed, the patient interaction portion of the service is valued under the PFS as typically involving the clinical staff of a supplier rather than the professional work of a physician or practitioner. Furthermore, there is no restriction on billing for this service and a physician/practitioner visit code on 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 proposed not adding HCPCS code G0248 to the Medicare list of telehealth services. We requested public comments on this proposal.

We received public comments on this proposal. The following is a summary of

the comments we received and our responses.

Comment: Many commenters, including suppliers of home PT/INR monitoring services, requested additional clarifications regarding HCPCS code G0248 not meeting step 2 of the Medicare Telehealth Services review process.

Response: We would like to clarify that HCPCS code G0248, falls outside the scope of the definition of a Medicare telehealth service in section 1834(m) of the Act and so does not meet step 2 of our review process. This service is not subject to section 1834(m) of the Act. This service may include activities, including initial set-up and training, that are not typically or ordinarily furnished in-person. Because this service is delivered by clinical staff employed or otherwise providing services for a supplier, this service is not subject to the same rules concerning telehealth services that apply to physicians and practitioners.

After consideration of public comments, we are finalizing as proposed to not add Home INR Monitoring (HCPCS code G0248) to the Medicare Telehealth Services List. (7) Telemedicine E/M Services

We received a request to add the telemedicine E/M services (CPT codes 98000 through 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 proposed not to add them to the Medicare list of telehealth services. We requested public comments on this proposal.

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

Comment: Some commenters requested that we reconsider our proposal to not add these services to the Medicare Telehealth Services List, stating that reporting CPT codes with telehealth modifiers creates confusion and increases the risk of billing errors. Others supported our interpretation of section 1834(m) of the Act and our proposal not to add these services to the Medicare Telehealth Services List, as our interpretation of section 1834(m) of the Act requires that telemedicine services be reimbursed at parity with in-person visits. These commenters also appreciated maintaining equivalent billing requirements across all telehealth services and stated that this reduces administrative burden.

Response: These services do not meet Step 1 of our review process, and are not eligible to be added to the Medicare Telehealth Services List. We did not propose the removal of Step 1 of the review process. While CMS appreciates the comment, Step 1 is vital to ensuring that CMS is paying for telehealth services in accordance with section 1834(m) of the Act.

After consideration of public comments, we are finalizing as proposed to not add the telemedicine E/M services (CPT codes 98000 through 98015) to the Medicare Telehealth Services List. (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 would like to clarify that these services, which are inherently non-face-to-face, do not meet the definitions of section 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.

Comment: A few commenters requested that we clarify if a telehealth place of service should be used for these services.

Response: No, under current regulation, a telehealth place of service would not be used for services that 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.” We noted in the proposed rule that 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 permanent. Therefore, we proposed to not make determinations to recategorize provisional codes as permanent at this time. For CY 2026, we proposed to revise the Medicare Telehealth Services criteria. We proposed to remove steps 4 and 5 from the review process. Using these revised criteria, we proposed 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 previously, we believe that these 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 proposed adding to the Medicare Telehealth Services List are listed in Table A-D2.

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

Comment: Commenters supported our proposal to simplify our review process to add services to the Medicare Telehealth Services List, including removing steps 4 and 5 and eliminating the provisional and permanent categories, and supported our proposal to utilize this process for the CY 2026 PFS Final Rule. Commenters appreciated that this simplified process would reduce administrative burden, enhance provider flexibility, and provide greater clarity, stability, and predictability for providers. Commenters also supported our emphasis on clinical judgment and patient-centered care.

Response: We appreciate commenters for their feedback.

After consideration of public comments, we are finalizing as proposed. (10) Deleted Services

In section II.I. of the CY 2026 PFS proposed rule (90 FR 32593 through 32597), we proposed to delete HCPCS code G0136. We noted in the proposed rule that this code is currently on the Medicare Telehealth Services List, so it will also be deleted from the list if finalized.

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

Comment: Many commenters generally did not support the deletion of G0136 from the Medicare Telehealth Services List.

Response: Please see section II.X.4.a.(1) of this final rule for additional discussion of the HCPCS code G0136.

After consideration of public comments, we are not finalizing as proposed to delete HCPCS code G0136 from the Medicare Telehealth Services List. [GRAPHIC] [TIFF OMITTED] TR05NO25.013

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 3 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 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, 2023 (upon expiration of the PHE), through enforcement discretion during the remainder of CY 2023 and notice-and-comment rulemaking for CY 2024 and CY 2025, Medicare telehealth frequency limitations were suspended for CY 2025 (89 FR 97758 through 97760) for certain subsequent inpatient visits, subsequent NF visits, and critical care consultations.

In the CY 2024 (88 FR 78877) and CY 2025 PFS final rules (89 FR 97758 through 97760), we solicited comments from interested parties on how physicians and other practitioners have been ensuring that Medicare beneficiaries receive subsequent inpatient and nursing facility visits, as well as critical care consultation services since the expiration of the PHE. As discussed in those final rules, many commenters supported permanently removing these frequency limitations, stating that they are arbitrary and re-imposing the limitations would result in decreased access to care; that physicians and other practitioners should be allowed to use their professional judgment to determine the type of visit, how many visits, and the type of treatment that is the best fit for the patient so long as the standard of care is met; and that lifting these limitations during the PHE has been instructive and demonstrates the value of continuing such flexibilities. Some commenters did not support removing these frequency limitations, citing patient acuity and safety. However, our analysis of claims data from 2020 to 2023 indicates that the volume of services that would be affected by implementing these limitations is relatively low; in other words, these services are not being furnished via telehealth with such frequency that, if the frequency limits were in place, they would be met or exceeded very often or for many beneficiaries. Claims data from 2020 to 2023 suggest that less than 5 percent of beneficiaries who received one or more of these services (subsequent care services in inpatient and nursing facility settings, and critical care consultations) received them as telehealth services. In addition, we have solicited comments on this policy for 2 years and have received overwhelming support for continuing this flexibility, with minimal commenters not supporting the removal of frequency limitations.

We believe that physicians and other practitioners, who have the greatest familiarity and insight into the needs of individual beneficiaries, can use their complex professional judgment to determine whether they can safely furnish a service via telehealth, given the entirety of the circumstances, including the clinical profile and needs of the beneficiary, to determine the appropriate service modality. We strive to balance the goals of increasing physician or practitioner and patient choice of service modality with consideration of patient safety for all Medicare beneficiaries. As technology advances and more services may be safely furnished via telehealth and paid under the PFS, it is increasingly important for physicians and other practitioners to exercise their professional judgment in determining the generally appropriate service modality for their patients to receive a service. Notably, the removal of these frequency limitations does not mean that these services are 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.

We proposed to permanently remove frequency limitations on furnishing these services via telehealth for the following codes relating to Subsequent Inpatient Visits, Subsequent Nursing Facility Visits, and Critical Care Consultation Services:

1. Subsequent Inpatient Visit CPT Codes:

99231 (Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically

appropriate history and/or examination and straightforward or low level of medical decision making. When using total time on the date of the encounter for code selection, 25 minutes must be met or exceeded.);

99232 (Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. when using total time on the date of the encounter for code selection, 35 minutes must be met or exceeded.); and

99233 (Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. when using total time on the date of the encounter for code selection, 50 minutes must be met or exceeded.)

2. Subsequent Nursing Facility Visit CPT Codes:

99307 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. when using total time on the date of the encounter for code selection, 10 minutes must be met or exceeded.);

99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using total time on the date of the encounter for code selection, 15 minutes must be met or exceeded.);

99309 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. when using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded.); and

99310 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. when using total time on the date of the encounter for code selection, 45 minutes must be met or exceeded.)

3. Critical Care Consultation Services: HCPCS Codes:

G0508 (Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth.); and

G0509 (Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth.)

We solicited comments on these proposals, specifically additional information regarding potential concerns about patient safety and quality of care.

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

Comment: Several commenters generally supported the permanent removal of frequency limitations for Subsequent Inpatient Visits, Subsequent Nursing Facility Visits, and Critical Care Consultation Services. The commenters stated that removal of these frequency limitations could enhance continuity of care, provide greater flexibility for clinicians, and allow clinicians to use their judgment in determining the appropriate cadence of telehealth interactions based on patient needs. Some commenters did not support our proposal, citing quality of care and safety concerns. One of these concerns was specifically for nursing residents, who may have complex health conditions that require careful monitoring and assessment, or conditions that make telehealth visits difficult. A few commenters supported our proposal but encouraged us to pair the removal of frequency limitations with safeguards such as enhanced claims monitoring or evidence-based utilization management.

Response: We appreciate the information from commenters regarding both patient safety concerns and concerns regarding supporting healthcare access. We believe that the complex professional judgment of the physician or practitioner will better allow practitioners to determine if the frequency of telehealth services are appropriate for that specific Medicare beneficiary and that specific clinical scenario. We may consider additional safeguards for future rulemaking.

After consideration of public comments, we are finalizing as proposed. 2. Other Non-Face-to-Face Services Involving Communications Technology Under the PFS a. Direct Supervision Via Use of Two-Way Audio/Video Communications Technology

Under Medicare Part B, certain types of services, including diagnostic tests described at Sec. 410.32 and services incident to a physician's (or other practitioner's) professional service described at Sec. 410.26 (“incident to” services), are required to be furnished under specific minimum levels of supervision by a physician or other practitioner. We define three levels of supervision at Sec. 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 to 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 rule (86 FR 65062)).

Direct supervision is required for various types of services, including most “incident to” services at Sec. 410.26, many diagnostic tests at Sec. 410.32, pulmonary rehabilitation services at Sec. 410.47, cardiac rehabilitation and intensive cardiac rehabilitation services at Sec. 410.49, and certain hospital outpatient services as provided at Sec. 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 Sec. 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, 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 Sec. 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 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 providing 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 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 complications arise, we stated that we believe 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 Sec. 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 provided “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 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 rules (89 FR 97758), we proposed to continue to build on this incremental approach to allow certain services to be provided under direct supervision that allows “immediate availability” of the supervising practitioner using audio/ video real-time communications technology (excluding audio-only). We proposed 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 at Sec. 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 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 received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters generally supported the permanent adoption of this policy and its revised definition, citing that virtual direct supervision does not inherently give rise to patient safety issues and that this policy could assist in a time of provider shortages. Some commenters supported the exclusion of codes with 010 and 090 global surgery services, citing that clinical staff supervised via virtual direct supervision do not perform complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures. A commenter requested that our definition be revised to remove the exclusion of services with 010 or 090 global surgery indicators and allow virtual direct supervision for all services paid under the PFS, since we have revised many telehealth policies to defer to clinical judgment throughout this final rule.

Some commenters suggested additional refinements to our proposal. The commenters provided conflicting recommendations to revise our definition to exclude services in which injected contrast is used. Some commenters recommended that we ensure that trained and authorized staff are present in the event of an adverse reaction to injected contrast, while other commenters stated additional clarifications in the definition are not needed, and submitted additional information supporting that virtual supervision of contrast administration is as safe as onsite supervision. The commenters also provided conflicting recommendations for the creation of a billing modifier, medical record

documentation, or other means of data collection. Those who supported this recommendation stated that this would allow for better tracking, but those who did not support this recommendation stated that this revision would increase administrative burden without any benefit for patient care. The commenters provided other recommended revisions to this policy, including allowing audio-only supervision for facilities in low-connectivity regions. A few commenters did not support this proposal, stating that they had patient safety and care concerns and believe that virtual direct supervision increases the risk for adverse outcomes.

Response: We appreciate the commenters for their support and suggestions on how we may refine our policy and will take them under consideration for future rulemaking. At this time, we believe that excluding services with 010 or 090 global surgery indicators is necessary to ensure 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.

Comment: Some commenters did not support our proposal, opposing virtual direct supervision for auxiliary personnel who are authorized under their own statutory benefit category to bill Medicare for their services. Reiterating concerns previously expressed in comments in the CY 2025 PFS final rule, some commenters opposed our proposal to permanently allow for the virtual direct supervision because doing so would increase the amount of physician “incident to” billing (a Medicare outpatient provision that applies in the office or clinic setting and allows medical services to be provided by auxiliary personnel as an “incident to” the services of the billing practitioner and under their supervision) for services provided by PAs and NPs, which would obscure the extent to which PAs and NPs are actually performing the services. These commenters suggested that CMS allow for virtual supervision for only those medical professionals who are unauthorized to bill Medicare or, alternatively, establish a method through which CMS is able to collect information about the health professional actually providing the service under “incident to” billing.

Response: We appreciate the commenter's input regarding the appropriate attribution of services performed by PAs and NPs when those services are billed “incident to” a physician's service. However, we believe that any potential obscuration of the extent to which PAs and NPs are providing virtual direct supervision resulting from “incident to” billing is vastly outweighed by the flexibility and enhanced access to services resulting from allowing these practitioners to furnish virtual direct supervision. Regarding the commenters' suggestion that CMS establish a method through which we would collect the information of the health professional actually providing the service under “incident to” billing, we thank the commenters for their suggestion and may consider that through future rulemaking.

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

We noted in the CY 2026 PFS proposed rule (90 FR 32593) that, similar to our guidance described in the proposed rule regarding Medicare Telehealth services, our 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 at Sec. 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 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 proposed to revise the regulation at Sec. 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 received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters generally supported the permanent adoption of this policy and its revised definition.

Response: We appreciate commenters for their input.

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

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

Comment: Commenters generally supported the permanent adoption of this policy and its revised definition.

Response: We appreciate the commenters for their input.

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

We noted in the proposed rule that because the definition of direct supervision applicable to cardiac, pulmonary, and intensive cardiac rehabilitation services relies on the definition of direct supervision set forth at Sec. 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 solicited comments on applying this definition to the applicable services at Sec. 410.32 and the applicable cardiac, pulmonary, and intensive cardiac rehabilitation services.

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

Comment: Several commenters generally supported the permanent adoption of this policy and its revised definition.

Response: We appreciate the commenters for their input.

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

We solicited comments 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 at Sec. 410.26, except for services that have a 010, or 090 global surgery indicator. For each of the proposals, we also sought 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 noted that 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 solicited comments on these proposals.

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

Comment: A few commenters requested that services with a 000-day global period indicator to be excluded from virtual direct supervision restrictions, as these services are minor and could potentially be safely supervised virtually. Other commenters wanted us not to allow virtual direct supervision for services with a 000-day global period indicator, as some commenters believe that 000-day global services are of similar risk as services with a 010-day indicator. The commenters requested that we work with interested parties to categorize additional procedures that would be appropriate for virtual direct supervision.

Response: We appreciated the commenters for their feedback. Regarding concerns with the allowance of virtual direct supervision for services with a 000-day global services indicator, we do not agree that 000-day global services represent a similar level of risk as those with a 010-day indicator. 000-day global procedures are services that do not include any follow-up care included in the valuation, where as 010-day global services include the valuation of follow-up care extending out 10-days from the procedure. We believe this reflects significantly higher clinical intensity than 000-day global services. We welcome additional information from stakeholders on this policy.

After consideration of public comments, we are finalizing as proposed to not exclude services with a 000 global surgery indicator and to allow the presence of the physician (or other practitioner) to include virtual presence through audio/video real-time communications technology (excluding audio-only). 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. b. 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 section 1842(b)(7)(A)(i)(I) of the Act 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 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 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 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.

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 solicited 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 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 proposed 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 proposed not 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 three-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 the proposed rule, we were 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 believe that permitting Medicare payment to continue for this PHE flexibility is no longer necessary. As noted in the proposed rule, 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.

We noted in the proposed rule that 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 in the 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.

We noted in the proposed rule that the proposal to not extend flexibilities for virtual services would not impact on 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.

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

Comment: A few commenters supported our proposal, stating that stronger oversight of residents in teaching settings is appropriate outside of a Public Health Emergency. However, the vast majority of commenters did not support our proposal. The commenters stated that over the past 5 years, this policy has proven to be effective, safe, and educationally sound. Both residents and teaching physicians have gained experience in providing virtual care, and continuation of this policy would support residents in being fully educated and prepared for virtual care in independent practice. In addition, continuation of this flexibility allows the ability for practitioners to pivot to virtual clinics for residents in cases of illness, inclement weather, or physical clinic closures. Ending this flexibility would also reduce care capacity, limit flexibilities in patient care, and would not allow for the full professional judgment of the teaching physician. Commenters also expressed concerns about the discontinuation of this policy and its impact on provider shortages and filling Graduate Medical Education slots for necessary vacancies in specialties such as psychiatry or pediatrics. Commenters also requested that this policy be expanded beyond services furnished as a 3-way telehealth visit, with the teaching physician, resident, and patient in different locations, and include services where the resident and patient are in the same location with the teaching physician being present remotely. The commenters stated that if we were to discontinue the current flexibility, we should revise our proposed policy to include MSAs, as there are significant provider shortages in suburban and urban areas, or use a more expansive definition to include additional rural areas. Other commenters stated that the MSA requirement is arbitrary, as few teaching hospitals operate in rural areas.

Response: We agree with commenters 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, and that this policy benefits teaching physicians, residents, and beneficiaries.

Comment: Commenters requested clarification regarding the proposed supervision policy change that appears to introduce a more restrictive standard for Medicare payment of resident-furnished services, imposing stricter requirements than those required for in-person services.

Response: We would like to clarify that we are not making any changes to the requirements currently in place for the supervision policy for teaching physicians. In the case of evaluation and management services, the teaching physician must be present during the portion of the service that determines the level of service billed, whether that service be furnished in-person or via telehealth.

After consideration of public comments, we are finalizing to permanently allow teaching physicians to have a virtual presence in all teaching settings, only in clinical instances when the service is (a 3- way telehealth visit, with the teaching physician, resident, and patient in different locations). This will continue to permit teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment is sought, through audio/ video real-time communications technology, for all residency training 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. In accordance with section 1842(b)(7)(A)(i)(I) of the Act, the teaching physician must have personal oversight and involvement over the management of the portion of the case for which the payment is sought. 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 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. In the CY 2026 PFS proposed rule (90 FR 32593), we proposed to update the MEI increase for CY 2026 based on historical data through the second quarter of 2025. Therefore, for CY 2026, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is $31.85. Table A-D3 shows the Medicare telehealth originating site facility fee and the corresponding MEI percentage increase for each applicable time period. [GRAPHIC] [TIFF OMITTED] TR05NO25.014

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

Comment: A commenter expressed concern about the proposed increase to the telehealth originating site facility fee and its impact on beneficiary cost-sharing. Other commenters appreciated the proposal, as it accounts for inflation and maintains real value.

Response: We appreciated commenters for their feedback. Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services 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.

After consideration of public comments, we are finalizing as proposed. 4. Distant Site Requirements

We received many comments that requested CMS clarify policies related to, but separate from, our telehealth proposals. The following is a summary of the comments we received and our responses.

Comment: A few commenters expressed concerns regarding the perception of an expiring flexibility for telehealth practitioners to use their currently enrolled location instead of their home address when providing services from their home due to a lack of a proposal to extend this flexibility in the proposed rule. In these comments, interested parties voiced concerns about the safety and privacy of health professionals who work from home and furnish telehealth services. The commenters requested that CMS take

steps to protect telehealth practitioners by adjusting enrollment requirements so that individual practitioners did not have to list their home addresses on enrollment forms. In the CY 2024 and CY 2025 PFS final rules we stated that, through CY 2025, we would permit a distant site practitioner to use their currently enrolled practice location instead of their home address when providing telehealth services from their home.

Response: Given that CMS issued an FAQ (located at https://www.cms.gov/medicare/quality/physician-compare-initiative/frequently-asked-questions) providing additional information on how to suppress street address details as providers continue to use their currently enrolled practice location instead of their home address when providing telehealth services from their home, we do not believe that additional “extensions” are required via rulemaking. We remind interested parties that we defer to State law regarding licensure requirements for distant site Medicare telehealth practitioners. In addition, we note that a separate Medicare enrollment is required for each State in which the practitioner furnishes and intends to bill for covered Medicare services. We would also like to clarify that in the future any updates to this policy will be issued via subregulatory guidance.