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

In the last several years of rulemaking, we have expanded the scope of care coordination services (formerly referred to as care management services) that are billable using HCPCS code G0511. More recently, in the CY 2025 PFS final rule, we unbundled the individual HCPCS codes that make up G0511 (89 FR 97999 through 98000). We have also been engaged in a multi-year examination of coordinated and collaborative care services in professional settings, and as a result, established codes and separate payment to independently recognize and pay for these important services. As stated in the CY 2016 PFS Final Rule (80 FR 71080 through 71088), the care coordination included in services, such as office visits, does not always adequately describe the non-face-to- face care management work involved in primary care and similar care relationships. We noted that payment for office visits may not reflect all the services and resources required to

furnish comprehensive, coordinated care management for certain categories of beneficiaries, such as those who are returning to a community setting following discharge from a hospital or skilled nursing facility (SNF) stay.

Over the last decade, we have updated RHC and FQHC payment policies as appropriate. We remain committed to improving how Medicare payment recognizes the resources involved in furnishing covered services. These services encompass aspects of advanced primary care furnished by interprofessional care teams and typically concentrate on the delivery of appropriate preventive care to patients and the management of individuals' chronic conditions as they progress over time. As a result, we reaffirmed our support of primary care and recognized care management as one of the critical components of primary care by implementing significant changes aimed at better capturing the resources required for care management services, including chronic care management (CCM), principal care management (PCM), general behavior health integration (BHI), chronic pain management (CPM), transitional care management (TCM), remote physiologic monitoring (RPM), remote therapeutic monitoring (RTM), community health integration (CHI), principal illness navigation (PIN), PIN-peer support services and Advanced Primary Care Management (APCM). For RHCs and FQHCs, we established payment for these suites of care coordination services outside of the RHC AIR and FQHC PPS. That is, payment is made in addition to the otherwise billable visit.

In the CY 2025 PFS final rule (89 FR 97870 through 97874), we discussed how we established coding and payment under the PFS for a newly defined set of APCM services described and defined by three new HCPCS G-codes. This new coding reflects the recognized effectiveness and growing adoption of the advanced primary care approach to care. It also encompasses a broader range of services and simplifies the billing and documentation requirements, as compared to existing care management codes. The coding for APCM incorporates elements of several existing care management services into a bundle that we have already considered to be care coordination services paid separately to RHCs and FQHCs using HCPCS code G0511 (for example, CCM and PCM). In addition, the coding for APCM incorporates elements of communication technology-based services (CTBS) into a bundle that we have already considered to be virtual communications paid separately to RHCs and FQHCs using HCPCS code G0071. Therefore, to allow RHCs and FQHCs the ability to simplify the billing and documentation requirements associated with furnishing APCM services we finalized in the CY 2025 PFS final rule to allow RHCs and FQHCs to bill for these services and receive separate payment.

Further, the APCM code sets vary by the degree of complexity of patient conditions (that is, non-complex and complex CCM for multiple chronic conditions or PCM for a single high-risk condition), and whether the number of minutes spent by clinical staff or the physician or non-physician practitioner (NPP) is used to meet time thresholds for billing. In the CY 2025 final rule, we adopted the three new APCM codes G0556, G0557, and G0558 as being payable in addition to the otherwise billable visit.

RHCs and FQHCs are required to use the more specific coding, that is, the three HCPCS G-codes listed above when furnishing APCM. These services are paid in addition to the otherwise billable visit under the RHC AIR methodology or FQHC PPS because we believe that they are similar to the other care coordination services, such as, CCM, PCM, and RPM. That is, APCM involves non-face to-face care coordination of which the costs associated with these services are not captured in the RHC AIR or FQHC PPS rate. Similarly to the care coordination services, payment for APCM is based on the PFS national non-facility rate. It is important to note that if RHCs and FQHCs furnish APCM services, the HCPCS codes for APCM are per calendar month bundles. Consequently, if the RHC or FQHC furnishes APCM then they would not bill for certain other individual care coordination services. For further discussion on duplicative services and concurrent billing restrictions regarding APCM policies, please refer to the CY 2025 PFS final rule (89 FR 97710). b. Integrating Behavioral Health Into Advanced Primary Care Management (APCM)

In the CY 2018 PFS final rule, we established requirements and separate payment for general Behavioral Health Integration (BHI) and Psychiatric Collaborative Care Model (CoCM) services furnished in RHCs and FQHCs (82 FR 53169 through 53180). General BHI and Psychiatric CoCM services are based on a model of behavioral health integration that enhances usual primary care by adding two key services to the primary care team: care management support for patients receiving behavioral health treatment and regular psychiatric inter-specialty consultation. In the CY 2018 PFS final rule, we also initiated the use of HCPCS codes G0511 and G0512 to pay for general care coordination services and CoCM services, respectively.

In the CY 2026 PFS proposed rule (90 FR 32549), we discussed how we recognize that patients with chronic health conditions are “more likely to have related behavioral health concerns and find it easier to improve chronic conditions when these concerns are also addressed.” \154\ Integrating behavioral health with primary care has been shown to improve outcomes like reduced depression severity, and enhancing patient's experience of care.\155\ We further explained that in response to comments received for CY 2025 rulemaking, for services paid under the PFS, we proposed to create optional add-on codes for APCM services that would facilitate providing complementary BHI services. Section II.G.1. of this final rule provides more detail on the final policies under the PFS.

\154\ https://integrationacademy.ahrq.gov/about/integrated- behavioral- health#:~:text=Integrated%20behavioral%20health%20offers%20many,these %20concerns%20are%20also%20addressed.

\155\ Balasubramanian, Bijal, Deborah Cohen, Katelyn Jetelina, Miriam Dickinson, Melinda Davis, Rose Gunn, Kris Gowen, Frank DeGruy 3rd, Benjamin Miller, Larry Green. “Outcomes of Integrated Behavioral Health with Primary Care.” J Am Board Fam Med. 2017 Mar- Apr;30(2):130-139.doi: 10.3122/jabfm.2017.02.160234.

We also discussed how we adopted the coding for the defined set of APCM services described and defined by HCPCS codes G0556, G0557, and G0558 to allow RHCs and FQHCs the ability to simplify the billing and documentation requirements associated with furnishing APCM services. In addition, and similarly to the discussion in section II.G of this final rule, since RHCs and FQHCs that fulfill the requirements to bill for APCM services must comply with requirements that ensure the integrity of the services provided, we believe that these settings should also be able to provide BHI and CoCM with simpler billing and documentation requirements. Therefore, for CY 2026, in alignment with the PFS and goals associated with APCM services, we proposed to adopt the add-on codes for APCM that would facilitate billing for BHI and CoCM services when RHCs and FQHCs provide advanced primary care. As we stated, we believe allowing for the use of these add-on codes would encourage RHCs and FQHCs to provide complementary BHI services, thereby improving access to BHI and CoCM for

primary care patients in the RHC and FQHC settings. For further discussion regarding the optional add-on codes, please see section II.G.2 of this final rule.

We further discussed that in the CY 2025 PFS final rule (89 FR 98010), commenters suggested that we consider unbundling HCPCS code G0512, similarly to what we did with HCPCS code G0511. That is, unbundle the services that comprise HCPCS code G0512 and permit billing of HCPCS codes 99492, 99493, and 99494. Commenters explained that allowing RHCs and FQHCs to report the dedicated CPT codes would support and encourage the adoption of CoCM in these settings. In addition, we explained that since we proposed using add-on codes for APCM services to facilitate payment of BHI and CoCM services when they are furnished by RHCs and FQHCs providing advanced primary care services, we would also need to unbundle HCPCS code G0512 to effectuate that policy. We stated that RHCs and FQHCs that are furnishing BHI and CoCM as advanced primary care services would not be able to bill for certain other individual CPT codes, such as, 99492, 99493, and 99484.

Therefore, we proposed to require RHCs and FQHCs to report the individual codes that make up the CoCM HCPCS code, G0512 beginning January 1, 2026. Similar to what was finalized in the CY 2025 PFS final rule (89 FR 98000 through 98010) for the general care management HCPCS code G0511, HCPCS code G0512 would no longer be payable when billed by RHCs and FQHCs; instead, RHCs and FQHCs would be required to bill the individual CPT and HCPCS codes that make up HCPCS G0512. The current list of base codes and add-on codes that make up G0512 are listed in Table B-BA1, titled “Psychiatric Collaborative Care Model HCPCS Codes and Descriptors.” Payment for these services would be based on the national non-facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes. We proposed to revise Sec. 405.2464(c) to reflect our proposal on payment of CoCM services for RHCs and FQHCs. [GRAPHIC] [TIFF OMITTED] TR05NO25.102

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

Comment: Most commenters supported our proposal to adopt the optional add-on codes for APCM that would facilitate billing for BHI and CoCM services when RHCs and FQHCs provide advanced primary care management. Commenters agreed that adoption of the optional add-on codes would facilitate billing for BHI and CoCM services provided by RHCs and FQHCs, incentivize RHCs and FQHCs to adopt integrated care services, strengthen integrated behavioral health in primary care, minimize documentation requirements, increase access to critical behavioral health services and provide flexibility for RHCs when choosing the most appropriate care management option for their patients and clinic's capacity.

A few commenters expressed their support for these proposals but had concerns. Some commenters were concerned about the RHC uptake of the new codes. These commenters requested CMS to provide additional support via resources, education, guidance and training on the billing codes to effectuate the use of these services and to minimize billing and compliance barriers. Other commenters requested CMS provide clarity around payment, duplication and assignment, and requested that CMS provide a table in the final rule that would summarize when APCM may be billed with CCM, PCM, RPM, RTM, and CTBS across settings. These commenters stated that RHCs are small healthcare providers with limited resources and capacity to provide new, innovative services.

A few commenters requested clarity on how the BHI and CoCM services will be categorized for RHCs with regard to the 50 percent threshold. They explained that RHCs are currently surveyed based on the total number of hours spent providing primary care versus behavioral health care and can be cited if their hours spent providing the latter exceed 50 percent. These commenters expressed concern that counting BHI and CoCM as behavioral health services would discourage RHCs from providing these services and requested that CMS count BHI and CoCM as primary care, given that they are add-on codes for APCM, and that CMS provide sub-regulatory guidance to that effect.

A few commenters had concerns about cost-sharing and indicated that beneficiaries receiving care at RHCs and FQHCs are often financially unstable and the monthly cost for some of these recurring services may discourage them from seeking them out. These commenters supported the proposal to allow for billing of BHI and CoCM codes in conjunction with APCM codes but urged CMS to remove cost-sharing from all APCM codes. Another commenter expressed concerns about cost-sharing requirements stating that for many Part B beneficiaries, these costs may discourage patients from accessing behavioral health services, generally. Lastly, these commenters recommended that CMS categorize components of APCM and behavioral health services as preventive services which they believe would eliminate the cost-sharing barrier for underserved RHC and FQHC patients.

A commenter urged CMS to delay the implementation of the proposal to adopt the add-on codes for APCM that would facilitate billing for BHI and CoCM services for RHCs and FQHCs, stating that creating optional add-on codes could cause the conversion factor to decrease and reduce payment. The commenter urged CMS to delay implementation and requested that CMS engage interested parties in conversation on potential implications to budget neutrality and the downstream impacts on the PFS conversion factor.

A few commenters stated that they did not agree with the proposal until the current APCM codes have been widely implemented and researched. Other commenters recommended CMS not create optional add-on codes for behavioral health services with APCM stating that FQHC's have varying levels of integration, which include coordination and co- location of primary care and behavioral health facilities and services. These commenters stated that add-on codes for APCM may be difficult for FQHCs to implement and would not encourage increased utilization. They requested that CMS ensure adequate payment for BHI and CoCM services, if we move forward with finalizing this proposal.

Response: We thank commenters for their supportive comments. Regarding commenter concerns for additional support via guidance on new billing codes to effectuate the use of these services, we plan to issue sub-regulatory guidance and other educational resources that will help RHCs and FQHCs minimize billing and compliance barriers by providing clarity around payment, assignment and duplication of codes.

Regarding the comments about the categorization of BHI and CoCM

services and the total hours spent providing primary care versus behavioral health services, we note that in the CY 2025 PFS final rule we discuss finalized policy around primary care and behavioral health services. In the discussion we explain that CMS will no longer determine or enforce the standard of RHCs “being primarily engaged in furnishing primary care services.' This policy was implemented via the sub-regulatory guidance contained in the State Operations Manual Appendix G--Guidance for Surveyors: Rural Health Clinics (RHCs). In the CY 2025 PFS final rule, we stated that we believe this change would provide RHCs with additional flexibility to provide outpatient specialty services on-site or hire additional providers with specialized expertise to meet the needs of their community (89 FR 98518 and 98519).

Regarding commenters' requests for waiving coinsurance costs, we are aware that the copayment and/or deductible in RHCs and the copayment in FQHCs can be a barrier for some beneficiaries, but we do not have the statutory authority to waive these charges. Because these services are typically furnished non-face-to-face, and therefore, are not visible to the patient, it is important that adequate information is given to patients during the consent process on cost-sharing responsibilities and the benefits of care management services. RHCs and FQHCs should also provide information on the availability of assistance to qualified patients in meeting their cost-sharing obligations, or any other programs to provide financial assistance, if applicable. Regarding the comment about preventive services, as we discuss in section II.G.4 of this final rule, we solicited comments on how CMS could consider including preventive services within the APCM bundles. We thank the commenter for this feedback, and we may take the comments into consideration for possible future rulemaking.

About commenters' concerns on the impact this proposal may have on budget neutrality and downstream impacts on the PFS conversion factor, we note physicians and practitioners are paid under the PFS. Section 1848 of the Act is the section of the statute that governs payment under the PFS and, the provisions related to budget neutrality and the conversion factor (CF) are under the PFS in subsections (c) and (d) of this section. Payments to RHCs and FQHCs are not governed by section 1848 of the Act; instead, they are governed by sections 1833(f), 1833(a)(3) and 1834(o) (FQHC PPS), of the Act. Under these sections, generally, RHCs are paid under an all-inclusive rate (AIR) methodology and FQHCs are paid under the FQHC PPS for all medically necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). Both the RHC AIR and FQHC PPS rates were initially designed to reflect the cost of all services and supplies that an RHC or FQHC furnished to a patient in a single day. Given this, neither payment structure is subject to budget neutrality under statute, and it is important to reiterate that our proposal was to pay for these services as add-on services to APCM which is paid separately from the RHC AIR and FQHC PPS and is based on the PFS national non-facility payment rate.

After consideration of public comments, we are finalizing our proposal to adopt the add-on codes for APCM that would facilitate billing for BHI and CoCM services when RHCs and FQHCs provide advanced primary care, as proposed. For CY 2026, RHCs and FQHCs furnishing APCM services may report HCPCS code G0568, G0569, or G0570 when they integrate behavioral health services with these services.

Comment: A commenter stated that they appreciated CMS's proposal to allow FQHCs and RHCs to bill APCM codes along with mental health and substance use disorder (SUD) services. They noted that these types of facilities have different models for and types of integration, and as such, they recommended CMS work with interested parties from these facilities before finalizing coding or payment policies to ensure that any new policies are not inadvertently limiting access to these types of services or creating additional burdens for FQHCs and RHCs. The commenter also encouraged CMS to revisit and expand the codes that can be used to meet the definition of a qualifying behavioral health visit.

Response: We appreciate the commenter's feedback regarding the billing of APCM codes by FQHCs and RHCs in conjunction with mental health and SUD services. CMS is committed to ensuring that policies do not inadvertently limit access to essential healthcare services or impose undue burdens on providers and suppliers. We agree with commenters that there are FQHCs and RHCs that have established models of care planning and integration of behavioral health services. We believe that the policies we are finalizing for CY 2026 allow these settings flexibility to furnish APCM with BHI or CoCM or they can continue to furnish these services as they currently do. As we discuss in the CY 2025 PFS final rule (89 FR 97999--98010), for care coordination services, FQHCs and RHCs must bill the individual CPT or HCPCS codes that describes the service they furnish, which includes BHI services. Payment for these services is based on the national non- facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes. With regard to HCPCS code G0512 (RHC/FQHC psychiatric CoCM, 70 min+), please see below for our final policy to unbundle this code.

Comment: A commenter supported CMS' proposal to recognize Mental Health Counselors (MHCs) and Marriage and Family Therapists (MFTs) as Medicare practitioners and to make their services mandatory FQHC benefits. The commenter stated that this aligns with New York State Medicaid policy and will significantly expand the behavioral health workforce available to Medicare patients, particularly in rural and underserved communities.

Response: We appreciate the commenters' support of MHCs and MFTs being recognized as Medicare practitioners in FQHCs. We remind commenters, in the CY 2024 PFS final rule (88 FR 79067-79060), we discuss how section 4121(b) of CAA, 2023 amended section 1861(aa)(1)(B) of the Act by extending the scope of RHC services to include those furnished by MFTs and MHCs as eligible for payment, which is incorporated into FQHC services through section 1861(aa)(3)(A) of the Act. Therefore, effective January 1, 2024, RHC and FQHCs are paid under the RHC AIR and FQHC PPS, respectively, when MFTs and MHCs furnish RHC and FQHC services defined in Sec. Sec. 405.2411 and 405.2446.

We also received several comments on our proposal to require RHCs and FQHCs to unbundle HCPCS codes G0512 and bill the respective individual codes that make up G0512, beginning January 1, 2026. We did not receive comments on our proposal to revise Sec. 405.2464(c) to reflect changes for payment of CoCM services for RHCs and FQHCs. The following is a summary of the comments we received and our responses.

Comment: Many commenters largely supported our proposal to unbundle HCPCS code G0512 and bill for the respective individual codes that make up G0512. Commenters stated that this change would eliminate barriers to providing CoCM services in the RHC and FQHC settings. Commenters stated

that this change would enhance transparency by giving clinics and policymakers better insight into utilization patterns across different practice types, geographic regions, and patient populations. Other commenters stated that this change will better capture clinical complexity, strengthen financial sustainability for safety-net providers and expand access to evidence-based collaborative care in underserved communities. Some commenters stated that this change will allow for greater streamlining of work for FQHCs, RHCs, and CMS. Other commenters stated that this proposal would support quality improvement initiatives and outcome measurement efforts.

A commenter supported the proposal stating that this change will likely improve payment accuracy and more accurately reflect the diverse range of services furnished in these settings and aligning payment more closely with the actual care delivered; however, the commenter requested CMS to clearly state which clinical staff may perform these services under physician direction and explore opportunities to enhance transparency, service attribution and outcomes tracking by rendering provider or clinical staff, while minimizing additional administrative burden for billing the individual codes for CoCM rather than relying on the bundled HCPCS G0512 code.

A few commenters recommended that CMS provide robust guidance, education and technical assistance to avoid undue administrative burden and potential unbundling billing confusion. Other commenters urged CMS to prioritize timely updates and resources to RHCs to ensure full participation in chronic care management programs. Some commenters discussed the issues that they experienced with unbundling HCPCS code G0511 which was finalized in the CY 2025 PFS final rule and noted how this policy's implementation has been extended twice (that is, July 1, 2025 and then September 1, 2025). The commenters requested that CMS provide technical support with the current unbundling process and apply lessons learned to the proposal for unbundling HCPCS code G0512.

Response: We thank commenters for their supportive comments. With regard to which clinical staff may perform psychiatric CoCM, these services are team-based collaborative approaches to care that focus on integrative treatment of patients with primary care and mental or behavioral health conditions. Psychiatric CoCM is a specific model of care provided by a primary care team consisting of a primary care provider and a health care manager who works in collaboration with a psychiatric consultant. CPs, CSWs, MFTs, and MHCs are RHC and FQHC practitioners and furnish medically necessary, face-to-face services that may be stand-alone billable visits in RHCs and FQHCs. They can also serve as the behavioral health care manager for psychiatric CoCM services. In order to facilitate the integration and coordination of the patient's primary care and mental or behavioral health conditions, these care management services are furnished under the direction of the RHC or FQHC primary care practitioner. Only services furnished by an RHC or FQHC practitioner or auxiliary personnel that are within the scope of service elements can be counted toward the time that is required to bill for psychiatric CoCM services and does not include administrative activities such as transcription or translation services. More information regarding psychiatric CoCM services furnished in RHCs and FQHCs is available in Pub. 100-02 Medicare Benefit Policy Manual, Chapter 13, section 230.4.

For the commenters who expressed a need for robust guidance on billing and the unbundling HCPCS code G0512, we plan to issue sub- regulatory guidance via updating multiple resources including the RHC and FQHC Medicare Benefit Policy Manual, MLN publications and the RHC and FQHC web pages to help RHCs/FQHCs understand how to navigate the unbundling process. Regarding commenters who noted the implementation issues of unbundling HCPCS code G0511, we acknowledge that there were Medicare claim processing issues that presented billing challenges for RHCs and FQHCs. We have since resolved those issues and intend to use lessons learned from those issues and apply to the unbundling process for HCPCS G0512.

After consideration of public comments, we are finalizing our proposal to require RHCs and FQHCs to report the individual codes that make up the CoCM HCPCS code, G0512 beginning January 1, 2026. That is, HCPCS code G0512 will no longer be payable when billed by RHCs and FQHCs; instead, RHCs and FQHCs will be required to bill the individual CPT and HCPCS codes that make up HCPCS G0512. The current list of base codes and add-on codes that make up G0512 are listed in Table B-BA1, titled “Psychiatric Collaborative Care Model HCPCS Codes and Descriptors.” Payment for these services will be based on the national non-facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes. We are also finalizing the revisions to Sec. 405.2464(c) to reflect the change for payment of CoCM services for RHCs and FQHCs.

We note, in Table 34 of the CY 2026 PFS proposed rule (90 FR 32550- 32551) we included two codes in the current list of base codes and add- on codes that make up HCPCS code G0512 that we haven't recognized for payment for RHCs and FQHCs previously. Specifically, CPT code 99494 (1st/subesq psyc collab care; Add-on CoCM (any month), each additional 30 minutes per calendar month) and HCPCS code G2214 (Init/sub psych care m 1st 30; Initial or subsequent psychiatric collaborative care management, 30 minutes of behavioral health care manager time per calendar month).

As discussed in the CY 2025 PFS final rule (89 FR 98000-98010), RHCs and FQHCs are required to bill using the individual codes that made up G0511 to receive separate payment for care coordination services. As part of the payment policy, we stated that RHCs and FQHCs can bill the add-on codes for additional time spent once the minimum threshold of time was met to account for a complete encounter. For this final rule, we clarify and to be consistent with how we paid for the services that made up HCPCS code G0511, beginning January 1, 2026, RHCs and FQHCs can bill CPT code 99494.

In the CY 2021 PFS final rule (85 FR 84547-84548), for practitioners billing under the PFS, we established a G-code to describe 30 minutes of behavioral health care manager time. That is, HCPCS code G2214 (Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional) was established to capture shorter increments of time spent. For example, when a patient is seen for services, but is then hospitalized or referred for specialized care, and the number of minutes required to bill for services using the current coding is not met. At the time of the CY 2021 PFS rulemaking we did not address the applicability of G2214 for RHC and FQHC purposes. For this final rule, we clarify and to be consistent with how we pay for CoCM, beginning January 1, 2026, RHCs and FQHCs can bill CPT code G2214.

Comment: A commenter urged CMS to implement a policy to allow FQHCs

and RHCs to bill for Community Health Integration (CHI) and Principal Illness Navigation (PIN) services, using the same set of HCPCS codes available to traditional healthcare providers. The commenter further stated that FQHCs and RHCs should be afforded the opportunity to bill for CHI and PIN services with no cap or limit on the volume of services rendered to a beneficiary per calendar month.

Response: We refer the commenter to the CY 2025 PFS final rule (89 FR 97999-98010) where we discussed and finalized the policy to bill individual HCPCS code for CHI and PIN services.

Comment: We received comments that were out of scope for these proposals. Several commenters encouraged CMS to revise the definition of a behavioral health visit for RHCs and FQHCs to expand the types of HCPCS codes that can be billed as a qualifying visit. Another commenter would like CMS to allow Opioid Treatment Programs that have formal care coordination agreements with RHCs and FQHCs, to bill the CoCM add-on codes for team-based care, including medications for opioid use disorder.

Response: We thank the commenters for their feedback; however, these comments are outside the scope of these proposals. We may take these comments into consideration for further evaluation. c. Payment for Communication Technology-Based Services (CTBS) and Remote Evaluation Services--HCPCS Code G0071

In the CY 2019 PFS final rule (83 FR 59683 through 59688), we established requirements and separate payment for certain CTBS and remote evaluation services in RHCs and FQHCs. Effective January 1, 2019, RHCs and FQHCs are paid for HCPCS code G0071 (Virtual Communication Services), when HCPCS code G0071 is on an RHC or FQHC claim, either alone or with other payable services, and at least 5 minutes of communication technology-based or remote evaluation services are furnished by an RHC or FQHC practitioner to a patient who has had an RHC or FQHC billable visit within the previous year, and the medical discussion or remote evaluation is for a condition not related to an RHC or FQHC service provided within the previous 7 days, and does not lead to an RHC or FQHC visit within the next 24 hours or at the soonest available appointment. At that time, HCPCS code G0071 comprised individual HCPCS codes G2012 (CTBS) and G2010 (remote evaluation services). For respective CTBS code descriptors, please refer to Table B-BA2. The payment rate for HCPCS G0071 was set at the average of the PFS national non-facility payment rates for HCPCS code G2012 and HCPCS code G2010 for remote evaluation services. (1) Updates to CTBS and Remote Evaluation Services Under the PFS

In the CY 2021 PFS final rule (85 FR 84532 through 84533), for practitioners billing under the PFS, we discuss additional policies as they relate to CTBS services. One of which was the establishment of HCPCS code G2250, which allows billing of CTBS by certain non-physician practitioners (NPPs), consistent with the scope of these practitioners' benefit categories, who cannot independently bill for evaluation and management (E/M) services.

In the CY 2026 PFS proposed rule (90 FR 32551--32553), we noted that at the time of the CY 2021 PFS rulemaking we did not address the applicability of G2250 for RHC and FQHC purposes. However, we acknowledged that the code descriptor for HCPCS code G2250 mirrors that of the existing HCPCS code G2010 in that both codes describe the remote assessment of recorded video and/or images submitted by an established patient (for example, store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment. We explained that since HCPCS code G2250 describes remote evaluation services similarly to HCPCS code G2010 and certain non- physician practitioners are recognized as RHC and FQHC practitioners, we proposed to consider HCPCS code G2250 as billable for separate payment when this service is furnished in an RHC or FQHC.

We also discussed that in the CY 2025 PFS final rule (89 FR 97791 through 97794), for practitioners billing under the PFS, the CPT Editorial Panel established new CPT code 98016 describing a brief virtual check-in encounter that is intended to evaluate the need for a more extensive visit (that is, a visit described by one of the office/ outpatient E/M codes). We stated that the code descriptor for CPT code 98016 mirrored the existing HCPCS code G2012, which is described as a brief communication technology-based service, for example, virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5 to 10 minutes of medical discussion). We further stated that given the similarity between CPT code 98016 and HCPCS code G2012, we finalized the replacement of HCPCS code G2012 with CPT 98016. That is, HCPCS code G2012 was terminated effective December 31, 2024.

In the CY 2026 PFS proposed rule (90 FR 32552), we stated that we inadvertently did not discuss the applicability of this code termination to RHCs and FQHCs; however, given our alignment with the PFS, beginning January 1, 2025, for HCPCS code G0071, CPT code 98016 was used for purposes of computing the payment rate. (2) CTBS and Remote Evaluation Services

In the CY 2026 PFS proposed rule (90 FR 32552--32554) we discussed the connection between APCM, CTBS and remote evaluation services. APCM includes elements of CTBS and remote evaluation services, however in the CY 2025 PFS final rule, we did not address how there are potential duplicative services with APCM and these services for RHCs and FQHCs (89 FR 98010 through 98012). We stated that similarly with unbundling of G0512, we believe that we would also need to unbundle HCPCS code G0071 to better effectuate the payment policy for APCM. We explained that RHCs and FQHCs that are furnishing CTBS or remote evaluation services as advanced primary care services would not be able to bill for certain other individual CPT codes, such as, G2010, G2250, and 98016. Therefore, we proposed to require RHCs and FQHCs to report the individual codes that make up HCPCS code G0071 beginning January 1, 2026. Payment for these services would be based on the national non- facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes. We proposed revising 405.2464(e) to reflect our proposal for payment of CTBS and remote evaluation services for RHCs and FQHCs.

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We received several comments on our proposals to require RHCs and FQHCs to report the individual codes that make up the CTBS and Remote Evaluation Services HCPCS code G0017 beginning January 1, 2026. We did not receive

comments on our revisions to Sec. 405.2464(e) to reflect changes for payment of CTBS and remote evaluation services for RHCs and FQHCs. The following is a summary of the comments we received and our responses.

Comment: Many commenters were supportive of our proposal to unbundle G0071 and require RHCs and FQHCs to report and bill for the individual codes (HCPCS G2210, G2250, and CPT 98016) that make up G0071. Some of the commenters stated that unbundling G0017 would provide a streamlined framework for adding other care coordination services and improve transparency. Commenters thanked CMS for their efforts to ensure that RHCs and FQHCs are appropriately paid. Some commenters stated that allowing RHCs and FQHCs to bill individual codes would create payment parity while other commenters believe that the proposal would improve care access.

A few commenters expressed their support for unbundling G0071 but had some concerns. Commenters recommended that CMS provide robust guidance and resources, apply lessons learned with unbundling HCPCS G0511 and provide technical assistance to help RHCs and FQHCs implement the change, mitigate issues, and avoid service disruption, undue burden and confusion. A commenter requested clear guidance on overlap with APCM months to know when standalone CTBS codes are ineligible due to APCM bundling. Another commenter recommended CMS delay the unbundling of G0071 to allow more time to engage interested parties and give consideration to primary care physicians already facing a complex array of coding options for care management. The commenter expressed concern that the unbundling of G0071 alongside the introduction of new time- based CPT codes under APCM risks adding further confusion, particularly for smaller practices and could exacerbate administrative burden, reduce reimbursement for providers, and create confusion. This commenter recommended that CMS finalize this update and invest in targeted education and technical assistance to support the adoption of G2250. A few commenters believed that there would be an increase in utilization and urged CMS to increase the payment rate for APCM bundling to better account for patient care costs and the loss of concurrent billing with G0071.

Response: We thank commenters for their supportive comments. Regarding commenters' requests for robust guidance, we will issue sub- regulatory guidance via updating multiple resources including the RHC and FQHC Medicare Benefit Policy Manual, MLN publications and the RHC and FQHC web pages to help RHCs and FQHCs understand how to navigate the unbundling process and mitigate potential implementation, billing and compliance issues that could accompany the unbundling of HCPCS G0071.

For those commenters who expressed concern about the loss of concurrent billing with G0071 and requested an increase in APCM payment rates, similar to our decision about the payment rate for HCPCS codes G0511 and our proposal for HCPCS code G0512 payment rate, HCPCS code G0071 will be based on the national non-facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes.

After consideration of the public comments, we are finalizing requiring RHCs and FQHCs to report the individual codes that make up HCPCS code G0071. That is, beginning January 1, 2026, RHCs and FQHCs furnishing these services must report HCPCS codes G2010, G2250, and CPT code 98016 to receive separate payment. Payment for these services will be based on the national non-facility PFS payment rate when the individual code is on an RHC or FQHC claim, either alone or with other payable services and the payment rates are updated annually based on the PFS amounts for these codes. We are finalizing revisions to Sec. 405.2464(e) to reflect the changes for payment of CTBS and remote evaluation services for RHCs and FQHCs. d. Aligning With the PFS for Care Coordination Services (1) Background

Under the PFS, certain care management/coordination services are categorized as designated care management services and assigned general supervision for purposes of “incident to” billing. As we discuss in the CY 2017 PFS final rule (81 FR 80238), generally, we do not believe it is clinically necessary for the individuals on the team who provide these services other than the treating practitioner (namely, clinical staff) to have the treating practitioner immediately available to them at all times, as would be required under a higher level of supervision. We also discussed how the regulations under Sec. 410.26(b), at that time, provided for an exception to assign general supervision to CCM services (and similarly, for the non-face-to-face portion of TCM services), because these are generally non-face-to-face care management/care coordination services that would commonly be provided by clinical staff when the billing practitioner (who is also the supervising practitioner) is not physically present; and the CPT codes comprise solely (or to a significant degree) non-face-to-face services provided by clinical staff (81 FR 80255).

For practitioners billing under the PFS, to better define general supervision and to assign general supervision not only to CCM services and the non-face-to-face portion of TCM services, but also to the then proposed codes, we amended Sec. Sec. 410.26(a)(3) and 410.26(b). We amended Sec. 410.26(a)(3) to better describe general supervision in the context of these services and amended Sec. 410.26(b) to assign general supervision to “designated care management services”, stating that we will designate such services through notice and comment rulemaking (81 FR 80255 through 80256). We state at Sec. 410.26(b)(5) that designated care management services can be furnished under general supervision of the physician (or other practitioner) when these services or supplies are provided incident to the services of a physician (or other practitioner). The physician (or other practitioner) supervising the auxiliary personnel need not be the same physician (or other practitioner) who is treating the patient more broadly. However, only the supervising physician (or other practitioner) may bill Medicare for incident to services.

Since CY 2017, when new care management/coordination services are proposed under the PFS, we also proposed to add the new codes, when applicable, to the list of designated care management services for which we allow general supervision. Each year, along with the proposed rule and the final rule, we have published the codes for designated care management services assigned general supervision as supporting documentation. For example, for the CY 2025 PFS final rule, the file is titled “CY 2025 Final Rule List of Designated Care Management Services.” (2) RHC and FQHC Care Coordination Services

In the CY 2026 PFS proposed rule (90 FR 32554-32555) we observed that over the last several years we have been increasing our focus on care coordination. We explained that these services have evolved to focus on preventing and managing chronic

disease, improving a beneficiary's transition from the hospital to the community setting, or on integrative treatment of patients with behavioral health conditions. Care coordination services are typically non-face-to-face services that do not require the skill level of an RHC or FQHC practitioner. We noted our acknowledgement that the care coordination included in services such as office visits does not always describe adequately the non-face-to-face care management work involved and may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of beneficiaries.

We noted that RHCs and FQHCs cannot bill under the PFS for RHC or FQHC services and individual practitioners working at RHCs and FQHCs cannot bill under the PFS for RHC or FQHC services while working at the RHC or FQHC (80 FR 71081). We explained that since this is the case, we have proposed payment policies for RHCs and FQHCs that complement the new services for care coordination established under the PFS to align use of the RHC and FQHC resources for those services with a separate payment.

We noted that over the last decade, the number of new care coordination services established under the PFS has increased. As these services are proposed, we review and evaluate the new care coordination codes each year as established under the PFS to determine their applicability to RHCs and FQHCs. Our general process is to review the descriptor and policies under the PFS for each new HCPCS code to determine if the services are provided face-to-face with a practitioner or auxiliary personnel with a patient, or have some face-to-face component with a practitioner or auxiliary personnel or are strictly non-face-to-face; that is, the care coordination services are being performed behind the scenes and not in the presence of the patient. We stated that if the new care coordination service met the non-face-to- face criteria for RHCs and FQHCs, we would propose in the proposed rule adding it to the list of care coordination services that can be paid separately from a billable visit for RHCs and FQHCs. We noted that there is a detailed history on the payment for care coordination services available in the CY 2025 PFS final rule (89 FR 97998 through 98010).

We further explained that the increase in frequency of this complementary rulemaking has prompted us to consider operational efficiencies that we believe could result in more transparency and clarity in determining applicable care coordination services for RHCs and FQHCs. In the CY 2025 PFS final rule (89 FR 98012), we solicited comment on how we can improve the transparency regarding which HCPCS codes are considered care coordination services. We stated that our goal is to classify care coordination services established under the PFS that extend to RHCs and FQHCs. We also stated that we believe establishing a streamlined policy regarding which services are separately paid for RHCs and FQHCs versus which services are included as part of the visit creates transparency. We further stated that we believe establishing a policy where codes are communicated and updated through subregulatory guidance such as manuals, website pages, and change requests may be more efficient.

In the CY 2026 PFS proposed rule (90 FR 32555), we noted that only a few commenters responded to our request for information on how we can improve transparency and predictability regarding which HCPCS codes are considered care coordination services. These commenters agreed with a streamlined approach and that communicating these updates through sub- regulatory guidance would be more transparent and efficient. Commenters stated that by distinguishing services that are separately payable from those services included in a visit, we would provide RHCs and FQHCs the clarity needed to accurately submit claims for Medicare reimbursement.

In response to the comment solicitation, we proposed adopting services that are established and paid under the PFS and designated as care management services as care coordination services for purposes of separate payment for RHCs and FQHCs. We stated that we believe this would improve transparency and efficiency for RHCs and FQHCs since these services and their designation as care management services go through notice and comment rulemaking. In addition, as discussed under Sec. Sec. 405.2413 and 405.2415, we noted that service and supplies furnished incident to TCM and care coordination services can be furnished under general supervision.

In the CY 2026 PFS proposed rule (90 FR 32555), we discussed the proposed process but first reiterated what happens under the PFS to help explain the connection between that payment system to the proposed payment policy for RHCs and FQHCs. Under the PFS, when new care management/coordination services are proposed under the PFS, we also propose to add the new codes, when applicable, to the list of designated care management services for which we allow general supervision. Each year, along with the proposed rule and the final rule, we have published the codes for designated care management services assigned general supervision as supporting documentation. For example, for the CY 2025 PFS final rule, the file is titled “CY 2025 Final Rule List of Designated Care Management Services.” We stated that under our proposal, services designated as care management services and added to the list of designated care management services would also be furnished in RHCs and FQHCs and paid separately as described in Sec. 405.2464(c). Interested parties can look for opportunities to review and comment on new services in the respective sections of the PFS proposed and final rules. When services are finalized under the PFS, we proposed to update RHC and FQHC sub- regulatory guidance to reflect the new care coordination services. We stated that we expect to adopt any new care management services that are proposed and finalized in the CY 2027 PFS rule and displayed on the list of the designated care management services to be care coordination services for RHCs and FQHCs.

We then clarified how the payment for these services would be based and made. That is, any new care coordination HCPCS codes will be paid separately from the RHC AIR methodology or FQHC PPS at the national non-facility PFS payment rate, either alone or with other payable visits. We noted that some of the current RHC and FQHC care coordination services are not listed on the current list of designated care management services, however, we confirmed the continuation of making separate payments for these RHC and FQHC care coordination services since they have been previously adopted through notice and comment rulemaking. These services include CCM, PCM, BHI, CPM, RPM, RTM, CHI, PIN and PIN-peer support services, and APCM.

We solicited comments on whether the proposed process which is to align with the care coordination services paid under the PFS as care management services is sustainable moving forward or is there a more effective approach for adopting new care coordination codes established under the PFS as care management codes that would improve transparency and efficiency for RHCs and FQHCs.

We received several public comments on our proposal to adopt services that are established and paid under the PFS and designated as care management services as care coordination services for purposes of separate payment for

RHCs and FQHCs. The following is a summary of the comments we received and our responses.

Comment: Commenters were very supportive of the proposal and our proposed process. Commenters believe aligning with the PFS will allow familiarity with the same set of codes across settings of care, streamline documentation requirements, reduce provider stress and staff time, lower both administrative barriers and financial burdens for healthcare providers, ensure providers are adequately paid for these services, increase clarity, improve efficiency, and promote care coordination.

Response: We thank the commenters for their support of this proposal. We agree that adopting services that are established and paid under the PFS and designated as care management services as care coordination services that can be furnished in RHCs and FQHCs will address potential barriers for healthcare providers and promote transparency across settings of care.

We received a few comments on our comment solicitation on whether the proposed process is sustainable moving forward or if there is a more effective approach for adopting new care coordination codes.

Comment: A commenter suggested that any services which are partially paid for under the PFS and partially paid for under the RHC AIR or FQHC PPS rate be considered care coordination and be paid under one payment system. The commenter believed that this structure would streamline work, and CMS would no longer have to include separate proposals for updates to coding and payments related to care coordination. Some commenters suggested CMS consider all care coordination services as health promotion services and stated that these services are not subject to copayments. Another commenter suggested we provide clear implementation guidance for RHC and FQHC practitioners. A commenter recommended that CMS conduct an evaluation to separately pay remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) services from the RHC AIR and FQHC PPS to better support the scope and value of these services.

Response: We thank the commenters for their suggestions. We are unclear about what the commenter meant by partially paid services, but note that we are finalizing this proposal so that we do not have to make separate proposals for updates to coding and payments related to care coordination services in future rulemaking. We are also unclear about what another commenter meant by health promotion services, however we do not have the statutory authority to waive co-payments for care coordination services. We agree that it is important to communicate any changes made to the list of care coordination services and will update the list on an annual basis through sub-regulatory guidance to provide transparency and clarity for RHCs and FQHCs. We note that RPM and RTM services are currently paid separately from the RHC AIR and FQHC PPS as care coordination services.

After consideration of public comments, we are finalizing our proposal to adopt services that are established and paid under the PFS and designated as care management services as care coordination services for purposes of separate payment for RHCs and FQHCs. We believe that this alignment with designated care management services under the PFS promotes transparency across settings of care.

When new care management/coordination services are proposed under the PFS and are also proposed to be added to the list of designated care management services, RHC and FQHC interested parties should look for opportunities to review and comment on these new services in the respective sections of the PFS proposed and final rules. Under this process, services designated as care management services and added to the list of designated care management services would also be furnished in RHCs and FQHCs and paid separately as described in Sec. 405.2464(c). When these services are finalized under the PFS, we will update the list of care coordination services annually through sub- regulatory guidance to provide RHCs and FQHCs the clarity needed to accurately submit claims for Medicare payment.

We note, as discussed in section II.G. of this final rule, the optional add-on codes for APCM services are considered a “designated care management service” under Sec. 410.26(b)(5) and, as such, can be provided by auxiliary personnel under the general supervision of the billing practitioner. Therefore, exemplifies the alignment with our final policy discussed in section III.B.2.b of this final rule. 3. Services Using Telecommunications Technology a. Background

Section 3704 of the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act) (Pub. L. 116-136, March 27, 2020) directed the Secretary to establish payment for RHC and FQHC services that are provided as Medicare telehealth services by RHCs and FQHCs serving as a distant site (that is, where the practitioner is located) during the PHE for COVID-19. Separately, section 3703 of the CARES Act expanded CMS' emergency waiver authority to allow for a waiver of any of the statutory telehealth payment requirements under section 1834(m) of the Act for telehealth services furnished during the PHE. Specifically, section 1834(m)(8)(B) of the Act, as added by section 3704 of the CARES Act, required that the Secretary develop and implement payment methods for FQHCs and RHCs that serve as a distant site during the PHE for the COVID-19 pandemic. The payment methodology outlined in the CARES Act requires that rates shall be based on rates that are similar to the national average payment rates for comparable telehealth services under the Medicare PFS. We established payment rates for these services furnished by RHCs and FQHCs based on the average PFS payment amount for all Medicare telehealth services, weighted by volume in a Special Edition Medicare Learning Network Article (SE20016). We subsequently finalized a policy to extend use of this payment methodology for these services through CY2025.

Section 303 of the Consolidated Appropriations Acs (CAA), 2022, section 4113(c) of CAA, 2023, section 3207(c) of the American Relief Act, 2025, and section 2207(c) of the Full-Year Continuing Appropriations and Extensions Act, 2025 each subsequently extended these flexibilities. Most recently, section 2207(c) of the Full-Year Continuing Appropriations and Extensions Act, 2025 amended section 1834(m)(8) of the Act to continue payment for RHC and FQHC services as Medicare telehealth services through September 30, 2025.

In addition to the statutory and associated rulemaking changes noted previously, we established various flexibilities related to use of telecommunications technology through rulemaking; for example, in the CY 2022 PFS final rule with comment period (86 FR 65211), we revised the regulatory requirement that an RHC or FQHC mental health visit must be a face-to-face (that is, in-person) encounter between an RHC or FQHC patient and an RHC or FQHC practitioner, and we revised the regulations under Sec. 405.2463 to state that an RHC or FQHC mental health visit can also include encounters furnished through interactive, real-time, audio/video telecommunications technology or audio-only interactions in cases where beneficiaries are not

capable of, or do not consent to, the use of devices that permit a two- way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder.

We also revised Sec. 405.2469, to add a supplemental wraparound payment to be made to the FQHC when a covered face-to-face (that is, in-person) encounter or an encounter where services are furnished using interactive, real-time, telecommunications technology or audio-only interactions in cases where beneficiaries do not wish to use or do not have access to devices that permit a two-way, audio/video interaction for the purposes of diagnosis, evaluation or treatment of a mental health disorder occurs between a MA enrollee and a practitioner as set forth in Sec. 405.2463. We noted that these changes aligned with similar changes for Medicare telehealth services for behavioral health paid under the PFS. We also noted that this change would allow RHCs and FQHCs to report and be paid for mental health visits furnished via real-time, telecommunication technology in the same way they currently do when these services are furnished in-person.

In addition, in the CY 2022 PFS final rule (86 FR 65210 and 65211), we revised the regulations at Sec. Sec. 405.2463 and 405.2469 to state that there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record. In the CY 2025 PFS final rule, we announced that we would continue to delay the in-person visit requirement for mental health services furnished via communication technology by RHCs and FQHCs to beneficiaries in their homes until January 1, 2026.

We stated in the CY 2026 PFS proposed rule (90 FR 32555-32556) that subsequent to the publication of the CY 2025 PFS final rule, section 2207(d) of the Full-Year Continuing Appropriations and Extensions Act, 2025 (Pub. L. 119-4, March 15, 2025) legislated the in-person visit requirement for mental health visits following September 30, 2025; therefore we are implementing conforming regulatory changes as discussed in section III.B.3.d. of this final rule.

As an additional regulatory flexibility, in the CY 2025 PFS final rule (89 FR 98013 through 98017), we extended our policy to deem the presence of the physician (or other practitioner) to include virtual presence for the purposes of direct supervision through audio/video real-time communications technology (excluding audio-only) through December 31, 2025. b. Direct Supervision Via Use of Two-Way Audio/Video Communications Technology

Under Medicare Part B, certain types of services are required to be furnished under specific minimum levels of supervision by a physician or practitioner. See section II.D.2 of this final rule for the discussion regarding direct supervision for services provided using telecommunications technologies under the PFS.

In the CY 2024 PFS final rule (88 FR 79067), we explained that extending this definition of direct supervision for RHCs and FQHCs under our regulations at Sec. Sec. 405.2413, 405.2415, 405.2448, and 405.2452 through December 31, 2024, would align the timeframe of this policy with many of the previously discussed PHE-related telehealth policies that were extended under provisions of the CAA, 2023. In addition, we were concerned about an abrupt transition to the pre-PHE policy of requiring the physical presence of the supervising practitioner beginning after December 31, 2024, given that RHCs and FQHCs have established new patterns of practice during the PHE for COVID-19. We also believed that RHCs and FQHCs would need time to reorganize their practices established during the PHE to reimplement the pre-PHE approach to direct supervision without the use of audio/ video technology. Similar to services furnished in physician office setting, RHC and FQHC services and supplies furnished incident to physician's services are limited to situations in which there is direct physician supervision of the person performing the service, except for certain care coordination services which may be furnished under general supervision. For CY 2024 we continued to define “immediate availability” as including real-time audio and visual interactive telecommunications through December 31, 2024, and solicited comment on whether we should consider extending the definition of “direct supervision” to permit virtual presence beyond December 31, 2024; specifically, we solicited comment on potential patient safety or quality concerns when direct supervision occurs virtually in RHCs and FQHCs; for instance, if certain types of services are more or less likely to present patient safety concerns, or if this flexibility would be more appropriate when certain types of auxiliary personnel are performing the supervised service. We were also interested in potential program integrity concerns such as overutilization or fraud and abuse that interested parties may have had in regard to this policy. In the CY 2025 final rule, (89 FR 98015) we finalized our policy to maintain the virtual presence flexibility on a temporary basis, that is, the presence of the physician (or other practitioner) would include virtual presence through audio/video real-time communications technology (excluding audio-only) through December 31, 2025 as such a policy continues to support access and preserve workforce capacity. (1) CY 2026 Direct Supervision in RHCs/FQHCs

We have considered information from interested parties, particularly in response to the CY 2024 PFS proposed rule where we solicited comment on potential patient safety or quality concerns when direct supervision occurs virtually in RHCs and FQHCs; for instance, if certain types of services are more or less likely to present patient safety concerns, or if this flexibility would be more appropriate when certain types of auxiliary personnel are performing the supervised service. We were also interested in potential program integrity concerns such as overutilization or fraud and abuse that interested parties may have regarding this policy.

As discussed in the CY 2025 final rule (89 FR 98014 through 98015), in response to our proposal to extend this definition through the end of 2025, commenters supported the proposal to allow virtual direct supervision through real-time audio/video communications technology in RHCs and FQHCs, citing benefits such as reduced inefficiencies, improved accessibility, better alignment with other outpatient providers, and enhanced healthcare delivery without compromising patient safety or program integrity.

In the CY 2026 PFS proposed rule (90 FR 32556-32557) we explained that given the information presented by interested parties on safety and effectiveness, we believe direct supervision provided via two-way real

time audio-video telecommunications technology meets the statutory requirements specific to RHCs and FQHCs at section 1861(aa)(2)(B) of the Act regarding necessary physician supervision and guidance. We noted that for services paid under the PFS, 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 under Sec. 410.26, except for services that have global surgery indicators of, 010, or 090 (90 FR 32394 and 32395). These 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”. These are services that describe a surgical service as well as its post-operative period of either 10 days, or 90 days, respectively.

We stated that in the interests of aligning our approach toward direct supervision for RHCs and FQHCs with that for services paid under the PFS, we believed that we should permanently adopt this flexibility in RHCs and FQHCs, as such flexibility continues to support access and preserve workforce capacity. However, we noted that, as we discussed in IOM Pub. 100-02, chapter 13, section 40.4, the Medicare global billing requirements do not apply to RHCs and FQHCs, and global billing codes are not accepted for RHC or FQHC billing or payment. Since services that have global surgery indicators are not applicable in the RHC and FQHC settings, we proposed revisions at Sec. 405.2401(b) to define “Direct Supervision” to mean that the physician (or other supervising practitioner) must be present in the RHC or FQHC and immediately available to furnish assistance and direction throughout the performance of the service. It does not mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. The presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only).

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

Comment: Commenters supported our proposal to permanently allow “direct supervision” in RHCs and FQHCs through real-time, interactive audio-video technology. Commenters state that this policy will expand access to care, particularly in rural and underserved areas and will address workforce shortages, improve continuity of care, and help modernize service delivery. Several commenters emphasized the benefits of enhanced patient access, physician-led team-based collaboration, and interdisciplinary coordination facilitated by virtual supervision.

Response: We appreciate the support of commenters.

Comment: A commenter requested that CMS permanently amend regulations for RHCs and FQHCs that require physician supervision of nurse practitioners in these facilities, and which do not allow, pursuant to 42 CFR 491.7(a), for an RHC or FQHC to be under the medical direction of a nurse practitioner, even when authorized under state law. The commenter stated these requirements are burdensome and unnecessary.

Response: This comment is out of scope for this final rule because it does not relate to this specific proposal included in the proposed rule, however we appreciate the feedback and may evaluate further.

After consideration of public comments, we are finalizing our proposal 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). Specifically, we are finalizing revisions at Sec. 405.2401(b) to include a definition of “Direct Supervision” to mean that the physician (or other supervising practitioner) must be present in the RHC or FQHC and immediately available to furnish assistance and direction throughout the performance of the service. It does not mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. The presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only). c. Payment for Medical Visits Furnished Via Telecommunications Technology

In the CY 2026 PFS proposed rule (90 FR 32557-32558), we discussed how widespread use of telecommunications technology to furnish services during the PHE has illustrated interest within the medical community and among Medicare beneficiaries in furnishing and receiving care through the use of technology beyond the PHE. During the PHE, RHCs and FQHCs, much like other health care providers, had to change how they furnish care to meet the needs of their patients. RHCs and FQHCs heavily utilized the temporary authority to be paid for their services when provided as Medicare telehealth services during the PHE. We stated that eliminating flexibilities under which RHC and FQHC services have been furnished to beneficiaries via telecommunications technology for over 5 years and resuming payment solely for in-person, face-to-face medical visits, would cause disruptions in access to services from RHC and FQHC practitioners. This would be particularly problematic for the underserved populations that these settings furnish services to since it could fragment care. We explained that we believe that we need to preserve the flexibilities under which RHC and FQHC services have been furnished to beneficiaries via telecommunications technology temporarily and to do so through an approach that these settings are familiar with to mitigate burden while we consider how to incorporate services furnished through telecommunications technology on a more permanent basis.

For these reasons, in the event that Congress no longer authorized payment to be made for telehealth services furnished via a telecommunications system by RHCs and FQHCs using a payment methodology based upon payment rates that are similar to the national average payment rates for comparable telehealth services under the PFS, we proposed, on a temporary basis, to facilitate payment for non- behavioral health visits (hereafter referred to in this discussion as “medical visit services”) furnished via telecommunications technology using an approach that closely aligns with this methodology. Like the methodology we used during and after the PHE, we proposed that RHCs and FQHCs would continue, in accordance with 42 CFR 405.2464(g), to bill for RHC and FQHC medical visit services furnished using telecommunications technology, including services furnished using audio-only communications technology, by reporting HCPCS code G2025 on the claim for the period beginning with the PHE for COVID-19 and ending on December 31, 2026. Since the costs associated with medical visit services furnished via telecommunications

technology are not included in the calculations for the RHC AIR methodology and FQHC PPS, we proposed the need for a a proxy that would represent such resources used when furnishing these services. Therefore, we proposed, similar to the methodology described in section 1834(m)(8) of the Act, to continue to calculate the payment amount for these services billed using HCPCS code G2025 based on the average amount for all Medicare telehealth services paid under the PFS, weighted by volume for those services reported under the PFS. We believed that continuing to use this weighted average is appropriate while we contemplate permanent policies for these services since there is a wide range of payment rates for the Medicare telehealth services paid under the PFS. As discussed in the CY 2025 final rule (89 FR 98015 through 98016), we believe that RHCs and FQHCs generally furnish services that are similar to and at a frequency the same as physicians and other practitioners paid under the PFS. While we do not have actual cost information, we believe that this weighted average is an appropriate proxy since it addresses certain resource costs experienced by professionals and would mitigate any potential over or under payments. Costs associated with these services would continue to not be used in determining payments under the RHC AIR methodology or the FQHC PPS. We proposed to facilitate payment for non-behavioral health visits furnished via telecommunications technology and pay for such services in accordance with such methodology through December 31, 2026.

We believe that the proposed approach would preserve the telecommunication technology flexibility under which RHC and FQHC services have been furnished for over 5 years and would not impact access to care for Medicare beneficiaries who currently benefit from these services while CMS contemplates next steps. We noted that this is a temporary stopgap approach to preserve access concerns. (1) Alternative Payment of Medical Visits Furnished Via Telecommunication Technology

As we discussed in the CY 2026 PFS proposed rule (90 FR 32558), we considered reevaluating the regulations regarding face-to-face visit requirements for encounters between a beneficiary and an RHC or FQHC practitioner in light of contemporary medical practices. That is, we considered proposing a revision to the regulatory requirement that an RHC or FQHC medical visit must be a face-to-face (that is, in-person) encounter between a beneficiary and an RHC or FQHC practitioner to also include encounters furnished through interactive, real-time, audio and video telecommunications technology. This would result in payment for services furnished via telecommunication technology to be made under the RHC AIR methodology and under the FQHC PPS, similar to how we revised the regulations for mental health visits. We believe interested parties may prefer the per visit payment that aligns with the RHC AIR or FQHC PPS. However, we did not propose this alternative because we determined that it would have unintended consequences, especially in cases where the RHC AIR or FQHC PPS per-visit rates would be significantly higher than the PFS rate that would apply if other entities furnished the same service to the same beneficiary in the same location.

We explained that we believe that continuing to pay temporarily for RHC and FQHC services furnished via telecommunication technologies in the same manner as we have done over the past several years preserves the flexibility for RHCs and FQHCs to continue access to care, mitigates administrative burden, and mitigates potential program integrity concerns. However, we solicited comment on the alternative proposal we considered. That is, revising the definition of a visit to include interactive, real-time, audio/video telecommunication technology which would result in a capitated payment under the RHC AIR methodology or FQHC PPS.

The following is a summary of the comments we received and our responses.

Comment: Commenters supported continuing to pay for non-behavioral services in RHCs and FQHCs furnished via telecommunications technology, stressing that virtual care is essential for rural and underserved populations. They highlighted that for many beneficiaries, particularly those who are elderly, homebound, or living in isolated areas, telehealth is not simply a convenience but the only practical way to access care. Several commenters also emphasized the need for CMS to work with Congress to make current flexibilities permanent, including allowing patients to receive telehealth from their homes, to avoid confusion and prevent disruptions in access once temporary waivers expire.

Commenters diverged, however, on how CMS should structure payment. Some commenters supported CMS' proposal to continue to pay RHCs and FQHCs with HCPCS code G2025 which reflects a weighted average of the PFS rates of all services on the telehealth list. MedPAC stated this approach preserves access while preventing unnecessary increases in beneficiary cost-sharing and Medicare spending. They warned that paying higher rates under the RHC AIR and FQHC PPS would not only raise taxpayer costs but could also create incentives for providers to overuse telehealth or shift away from in-person care. They further stated that paying for medical visits furnished via telehealth would often result in beneficiaries and taxpayers paying much more for the same service than they currently do because the FQHC PPS and RHC AIR payment system rates are higher than the PFS-equivalent rate. In addition, because beneficiary coinsurance for services billed under the RHC AIR methodology is set based on RHC charges and not payment rates, rural beneficiaries would experience especially high increases in coinsurance if CMS switched from paying PFS-equivalent rates to those based on the RHC AIR methodology.

Some commenters, in contrast, expressed preference for our alternative approach, arguing that telehealth visits should be paid at the PPS or AIR rates. They emphasized that the costs of operating FQHCs and RHCs such as staffing, facilities, compliance, and IT systems, are the same regardless of whether visits are in person or virtual. The current payment rate for HCPCS code G2025, typically around $90 per visit, was described as inadequate to cover these costs, undermining clinics' ability to sustain telehealth infrastructure in the long term. These commenters argued that treating telehealth visits as full encounters would ensure payment equity, reduce administrative burdens, and support the financial stability of safety-net providers serving the most vulnerable communities.

Response: We recognize that many commenters supported the alternative proposal to permanently redefine an RHC or FQHC “visit” to include audio-video telecommunication technology and to pay such services at the AIR or PPS rates, and reiterate, that our proposal was intended as a temporary, stopgap measure; we believe that continuing to pay for these visits using HCPCS code G2025 which reflects PFS rates is preferable to preserve access to services furnished via telecommunication technologies for beneficiaries, while avoiding sudden payment disruptions to maintain predictability for providers and allowing CMS time to consider permanent policies informed by additional data and experience.

Extending this methodology through December 31, 2026 also provides flexibility for CMS to respond to any statutory changes Congress may enact regarding telehealth in these settings.

After consideration of public comments, we are finalizing our proposal to continue to pay for RHC and FQHC medical visit services furnished using telecommunications technology, including services furnished using audio-only communications technology, with HCPCS code G2025 through December 31, 2026 in accordance with Sec. 405.2464(g). d. Conforming Regulatory Text Changes

Subsequent to the publication of the CY 2025 PFS final rule, section 2207(d) of the Full-Year Continuing Appropriations and Extensions Act, 2025 amended sections 1834(y)(2) and 1834(o)(4)(B) of the Act by extending the delay of in-person requirements for mental health services furnished through telecommunication technology for RHCs and FQHCs, respectively, through September 30, 2025. We therefore proposed to make conforming regulatory text changes to the applicable RHC and FQHC regulations in 42 CFR part 405, subpart X, specifically, at Sec. 405.2463, “What constitutes a visit,' we proposed to amend paragraph (b)(3) and, at Sec. 405.2469 “FQHC supplemental payments,” we proposed to amend paragraph (d). Both of these provisions would require that, beginning October 1, 2025, there must be an in-person mental health service furnished within 6 months prior to the furnishing of the telecommunications service and that an in-person mental health service (without the use of telecommunications technology) must be provided at least every 12 months while the beneficiary is receiving services furnished via telecommunications technology for diagnosis, evaluation, or treatment of mental health disorders, unless, for a particular 12-month period, the physician or practitioner and patient agree that the risks and burdens outweigh the benefits associated with furnishing the in-person item or service, and the practitioner documents the reasons for this decision in the patient's medical record.

Comment: Some commenters requested that these in-person requirements continue to not apply beyond 2025, stating that many patients seen virtually are at a distance that would make an in-person session impossible.

Response: After considering public comments, we are finalizing technical changes to the regulatory text that we believe more closely align with statutory requirements. Specifically, we are amending the applicable RHC and FQHC regulations in 42 CFR part 405, subpart X, specifically, at Sec. 405.2463, “What constitutes a visit,' we proposed to amend paragraph (b)(3) and, at Sec. 405.2469 “FQHC supplemental payments,” to clarify that the in-person visit requirements will not apply to any services furnished before October 1, 2025.

We wish to clarify that the intent of these edits is solely to conform the regulations to the statutory delay of the in-person visit requirements prior to October 1, 2025. More broadly, we believe it is important to maintain consistency across care settings when applying requirements of this nature. CMS will address the approach to these in- person visit requirements for RHCs and FQHCs in future guidance.

Comment: Some commenters requested that CMS extend the delay of the implementation of these requirements specifically for Certified Community Behavioral Health Clinics (CCBHCs), Community Mental Health Centers (CMHCs), and other licensed behavioral health clinics beyond 2026.

Response: These comments are out of scope for this final rule because they do not relate to this specific proposal included in the proposed rule.

After consideration of comments, we are finalizing revisions to 42 CFR part 405, subpart X, specifically, at Sec. 405.2463(b)(3), “What constitutes a visit,” and, at Sec. 405.2469(d), “FQHC supplemental payments,” to clarify that the in-person visit requirements will not apply to any services furnished before October 1, 2025. e. Miscellaneous Comments

We received several comments that were out of scope from what we proposed in the CY 2026 PFS final rule for RHCs and FQHCs. The following is a summary of the comments we received and our response.

Comment: A few commenters suggested that CMS amend Sec. 405.2463(c)(1)(iii) to allow RHCs to bill a medical or mental health visit and an Annual Wellness Visit (AWV) separately when furnished on the same day and allow RNs to furnish and bill AWVs. If this is not feasible, commenters suggested CMS consider, at minimum, an add-on payment when an AWV is performed on the same day as a medical visit. Some commenters requested that CMS permit RHCs to bill and receive an additional payment for HCPCS code G2211 like practitioners that are paid under the PFS, which they believe would fully account for additional time, intensity, and practice expense inherent to the longitudinal care that HCPCS code G2211 was designed to capture. A commenter recommended that CMS evaluate the adequacy of the RHC AIR and FQHC PPS base rates under the Medicare Economic Index (MEI) methodology and consider supplemental adjustments where necessary to support the long-term sustainability of these safety-net providers. Another commenter would like to see simplified billing or bundled options for any new codes to reduce administrative barriers for RHCs that may not have dedicated billing staff. A commenter recommended that CMS conduct an evaluation to separately pay medical nutrition therapy (MNT) services from the RHC AIR and FQHC PPS to better support the scope and value of these services. A few commenters wanted CMS to support healthcare in rural settings by allowing registered nurses (RNs) to bill the CPT codes for care coordination. A commenter would like CMS to permit pharmacists the authority to bill directly under Medicare and not refer to pharmacists as “auxiliary personnel” as they play a role behind the scenes for care coordination services.

Response: We thank the commenters for their feedback; however, these comments are outside the scope of what we proposed for CY 2026 for RHCs and FQHCs. We will take these comments into consideration for further evaluation.