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

For CPT code 98979, we disagreed with the RUC's recommendation of 0.66 work RVUs and proposed a work RVU of 0.31, with 10 minutes or intraservice/total time. We proposed this work RVU for CPT code 98979 based on the total time ratio between CPT code 98980's time of 20 minutes and CPT code 98979's time of 10 minutes. This ratio equals 50 percent, and 50 percent of the current work RVU of 0.62 for CPT code 98980 equals a work RVU of 0.31 for CPT code 98979. Although we do not believe that the decrease in time described in the code descriptor must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant reductions in time for codes with equivalent intensity should generally be reflected in decreases to work RVUs. In the case of CPT code 98979, we believe it would be more accurate to propose the total time ratio at a work RVU of 0.31 to account for these decreases in work time compared to CPT code 98980. We also proposed using this time ratio with the current direct PE inputs for CPT code 98980. We are proposing 5 minutes of CA021 intraservice clinical labor time and 15 minutes of CA037 post-service clinical labor time for CPT code 98979. We proposed this clinical labor using the RN/LPN/MTA (L037D) blend as this has historically been the typical clinical labor type for remote therapeutic monitoring services.

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

Comment: Several commenters had mixed views on the proposed refinements to CPT code 98979. While some commenters supported the proposal, many commenters did not support our proposal based on the time ratio compared to CPT code 98980, as they stated that the RTM platform and staffing expense is fixed and does not decrease based on minutes of treatment management services. The commenters who did not support the proposal believe that there was strong relativity to the reference code. Many commenters requested that CMS finalize the RUC recommendations, including increased clinical labor and revision of the clinical labor type from RN/LPN/MTA to PTA.

Response: We continue to believe that since the two components of work are time and intensity, significant reductions in time for codes with equivalent intensity should generally be reflected in decreases to work RVUs. After reviewing Medicare claims data for this service, we continue to believe that clinical labor using the RN/LPN/MTA (L037D) blend is currently the typical clinical labor type for CPT codes 98980 and 98981, which we believe will also be the same for CPT code 98979.

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

For CPT code 98980, we disagreed with the RUC's recommendation of 0.78 work RVUs and are proposing to maintain the current work RVU of 0.62, the current 20 minutes of intraservice/total work time, and the current direct PE inputs. For CPT code 98981, we disagreed with the RUC's recommendation of 0.70 work RVUs and proposed to maintain the current work RVU of 0.61 and the current direct PE inputs; the RUC recommended, and we are proposing to maintain the current 20 minutes of intraservice/total work time. These proposals were due to wanting to maintain relativity between RPM and RTM codes describing equivalent amounts of treatment management time and effort. RTM coding will be placed on the New Technology list to be reviewed after 3 years of data are available for this CPT 2026 code structure, and we look forward to reviewing the additional data at that time to refine the valuation for this code more accurately.

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

Comment: Many commenters requested that CMS finalize the RUC recommendations, including increased clinical labor and revision of the clinical labor type from RN/LPN/MTA to PTA. Some commenters did not support the proposal to maintain relativity with RPM codes, since this survey data showed growth in provider experience of furnishing RTM services. Commenters specified that therapists now have more experience with RTM services and can more accurately answer surveys than when the codes were created.

Response: We appreciate the commenters for their feedback. After reviewing Medicare claims data for this service, we continue to believe that clinical labor using the RN/LPN/MTA (L037D) blend is currently the typical clinical labor type for CPT codes 98980 and 98981. We continue to believe that it is important to maintain relativity between RPM and RTM treatment management services.

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

For the PE-only CPT code 98975, the RUC's recommendations include a “Remote musculoskeletal therapy monitoring program enrollment fee.” We did not propose a price for this input at this time as we believe this type of fee has not traditionally been included as a form of direct PE and would constitute forms of indirect PE under our methodology. We understand that as the PE data age, these issues involving the use of software and other forms of digital tools become more complex. However, in general we believe that this type of cost is most similar to indirect PE costs rather than direct costs, which must be individually allocable to a particular patient for a particular service. Additionally, we believe that indirect technology costs associated with RTM are better accounted for in the data transmission RTM codes (CPT codes 98985 and 98977, discussed below) that will also be reported during the beneficiary's course of treatment. We look forward to continuing to seek out new data sources to help in updating the PE methodology. The RTM coding will be placed on the New Technology list to be reviewed after 3 years of data are available for this 2026 CPT code structure, and we look forward to reviewing the additional data at that time to refine the valuation for this code more accurately. We proposed to maintain the current direct PE inputs for CPT code 98975.

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

Comment: Several commenters generally did not support CMS'

proposals for CPT code 98975, specifically not proposing the RUC's recommended changes to the clinical labor type and the program enrollment fee for CPT code 98975. Commenters also requested clarification that CMS will adopt the parenthetical changes for this code, specifically the requirement that this service now requires 2 days of monitoring in a 30-day period for reporting, as opposed to 16.

Response: We appreciate the commenters for their feedback. The RUC recommended “Remote musculoskeletal therapy monitoring program enrollment fee” does not constitute a form of direct PE under our methodology. After reviewing Medicare claims data for this service, we are not finalizing our proposal to retain the current clinical labor type, as physical therapists are currently the dominant specialty that furnishes this service, and the PTA (L039B) blend is the typical clinical labor type. We will be adopting all descriptors, guidelines, prefatory language, and parenthetical changes made to the Remote Monitoring section of the 2026 edition of the CPT codebook, including for CPT code 98975.

After consideration of public comments, we are finalizing as proposed, with the exception of revising the clinical staff type to PTA from RN/LPN/MTA.

For the PE-only CPT codes 98985 and 98977, the RUC's recommendations included a “Remote musculoskeletal therapy monitoring monthly supply fee,” which is a per-click vendor fee that has not traditionally been included as a form of direct PE. We understand that as these technologies evolve, the issues involving the use of software and other forms of digital tools become more difficult to account for accurately in our standard PE methodology. We acknowledge that for CPT codes 98985 and 98977, the overall payment rate is driven by practice expense supply and equipment inputs rather than physician work or clinical staff time. We have concerns with the RUC-recommended PE inputs for device supply and equipment, as these inputs are difficult to accurately account for due to lack of substantive invoices and other types of supportive data. As MedPAC noted in their comment to the CY 2011 PFS proposed rule, “using price information voluntarily submitted by specialty societies, individual practitioners, suppliers, and product developers may not result in objective and accurate prices because each group has a financial stake in the process”. We have repeatedly stated, such as in the CY 2018 final rule, that “we do not believe that very small numbers of voluntarily submitted invoices are likely to reflect typical resource costs and create the potential for overestimation of supply and equipment costs” (82 FR 52998). Given our concerns with the RUC-recommended PE inputs and our inability to verify the pricing for these inputs, we believe that using Hospital Outpatient Prospective Payment System (OPPS) cost data to value CPT codes 98985 and 98977 may more accurately reflect the actual costs of these technologies as opposed to the PE inputs as recommended by the AMA RUC. We assume the costs incurred in furnishing these PE-only codes would be the same across settings of care (physician office and hospital outpatient), since these codes do not have any physician work and only account for PE associated with device supply and data transmission. Under section 1848(c)(2)(N) of the Act, we have authority to establish or adjust PE RVUs using cost, charge, or other data from suppliers or providers of services. We proposed to use OPPS cost data to establish the valuation for the practice expense portion of Remote Therapeutic Monitoring CPT codes 98985 and 98977. We believe that the OPPS cost data is more accurate than the PE inputs recommended by the RUC. OPPS practice expense data obtained from cost reports is regularly updated, auditable, and required to adhere to national standards for reporting. For example, in the CY 2015 PFS final rule (79 FR 67569), we noted that “routinely updated, auditable resource cost information submitted contemporaneously by a wide array of providers across the country is a valid reflection of “relative” resources and could be useful to supplement the resource cost information developed under our current methodology based upon a typical case that are developed with information from a small number of representative practitioners for a small percentage of codes in any particular year”. We proposed to utilize the OPPS total geometric mean cost for CPT code 98977 to inform the valuation of CPT codes 98985 and 98977 when paid under the PFS. We proposed to calculate this value by dividing the OPPS Geometric Mean Cost (GMC) for CPT code 98977, which is represented in a dollar amount, by the estimated CY 2025 PFS conversion factor (CF), which represents the dollar value of an RVU, in order to convert the GMC dollar amount into RVUs. The resulting value will be our proposed PE RVU for CPT codes 98985 and 98977. We proposed the same valuation for both CPT codes 98985 and 98977 since the device is supplied to the beneficiary for the full 30-day period, regardless of the number of days that data is transmitted.

We also proposed to maintain the current clinical staff type for the RTM codes (RN/LPN/MTA), as opposed to the RUC recommendation of physical therapy assistant, since the dominant specialty type that bills this code, family medicine, did not participate in the survey.

We solicited comments specifically on data to support the recommended PE inputs for this code, including invoices, additional data, or evidence to support the position. We received public comments on these proposals. The following is a summary of the comments we received and our responses.

Comment: Several commenters had mixed support for CMS' proposal for the same valuation for CPT codes 98985 and 98977. The commenters who supported the proposal stated that this would reduce administrative burden and the risk of coding confusion. Some commenters supported the reasoning that the device is supplied to the beneficiary for the full 30-day period, regardless of the number of days that data is transmitted. We received confirmation of this information from practitioners who furnish RTM services and vendors who supply RTM devices, stating that this aligns the actual technology costs, as these costs are tied to the number of patients receiving these services in a given 30-day period, not the number of days of data collected in those 30 days. Commenters who supported this proposal stated that the proposed valuation more accurately represents the reality of practice expense for these services. Commenters who did not support this proposal stated that a lower valuation for CPT code 98985 would pay for the actual use of the equipment and allow CMS to further ensure program integrity by accurately tracking spending. These commenters also believe that a lower valuation for CPT code 98985 would also incentivize more days of data collection, which would provide more value when determining a plan of care and reward adherence.

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

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

Response: We appreciate the commenters for their support of our proposal to use OPPS data. As we stated in the proposed rule, we have authority to establish or adjust PE RVUs using cost, charge, or other data from suppliers or providers of services. Although the use of invoice data may be beneficial when valuing certain services, exclusively using invoices for the valuation of these PE-only services may not result in objective and accurate prices because each interested party that submits invoices has a financial stake in the process. By using OPPS practice expense data, we have built in guardrails since the data obtained from cost reports is regularly updated, auditable, and required to adhere to national standards for reporting. We note that we did not develop direct PE inputs for these services from OPPS claims. We proposed to calculate the PE RVU by dividing the OPPS Geometric Mean Cost (GMC) for CPT code 98977, which is represented in a dollar amount, by the estimated CY 2025 PFS conversion factor (CF), which represents the dollar value of an RVU, in order to convert the GMC dollar amount into RVUs. The resulting value was our proposed PE RVU for CPT codes 98985 and 98977. There are no separate PE inputs for these services outside of this RVU calculation.

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

A few commenters also believe that since CPT code 98977 requires using Food and Drug Administration (FDA)-regulated medical devices, which involve higher costs than non-device, app-only alternatives, using OPPS cost data would not appropriately reflect the costs of furnishing this service.

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

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

Comment: We received many comments confusing the OPPS cost data CMS proposed to use to value CPT codes 98985 and 98977. Many commenters pointed out that the payment rates for remote monitoring services using Ambulatory Payment Classifications under the OPPS differ drastically from the current and RUC-recommended payment rates for the PFS.

Response: Under the OPPS, we calculate a geometric mean cost for HCPCS codes paid under the OPPS. HCPCS codes are assigned to APCs using clinical criteria and geometric mean cost data. We would like to clarify that our proposal for using OPPS cost data to inform the valuation of CPT codes 98985 and 98977 is using the Geometric Mean Cost (GMC) from the OPPS, not the Ambulatory Payment Classifications (APC).

Comment: A commenter requested that, since CPT code 98977 has limited OPPS cost-reporting, CMS should utilize the more frequently reported cost-reporting for CPT code 99454 to inform the PFS valuation for CPT codes 98985 and 98977. The commenter stated that this would align with CMS' proposal to maintain relativity between RPM and RTM services, since PE costs for these services are similar.

Response: We appreciate the additional information provided around the use of the OPPS GMC to inform the valuation of CPT codes 98985 and 98977. We believe that it would be appropriate to utilize the most up- to-date cost data by using the CY 2026 GMC value for CPT code 98977 in our calculations for CPT codes 98985 and 98977. The CY 2026 GMC values are more comparable than the CY 2025 GMC values used to inform the valuation of these services in the PFS proposed rule and will assist in maintaining relativity between RPM and RTM.

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

Response: We appreciate commenters for their input on this issue. We believe that it would be appropriate to utilize the most up-to-date cost data by using the CY 2026 GMC values in our calculations for CPT codes 98985 and 98977. We agree with commenters that the use of OPPS data, where appropriate, is a potential solution to a much larger challenge within the current PE methodology. We are interested in feedback and additional data from interested parties that could assist us in improving PE inputs and methodology for services that are primarily valued through technology costs for future rulemaking.

After consideration of public comments, we are finalizing calculating this value by dividing the CY 2026 OPPS Geometric Mean Cost (GMC) for CPT code 98977, which is represented

in a dollar amount, by the CY 2026 non-qualifying APM PFS conversion factor (CF), which represents the dollar value of an RVU, to convert the GMC dollar amount into RVUs. The resulting value will be our finalized PE RVU for CPT codes 98985 and 98977.

The RUC recommended and CMS proposed to contractor price the PE- only CPT codes 98984 and 98976.

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

Comment: The majority of commenters did not support CMS' proposal to contractor price CPT codes 98984 and 98976. The commenters suggested CMS retain the current active pricing for these codes as finalized in the CY 2022 PFS final rule.

Response: We appreciate the commenters for their input. In the CY 2022 PFS final rule, we finalized actively pricing CPT code 98976 by crosswalking to the PE RVU for comparable RPM CPT code 99454, since that code includes payment for the device used to collect and transmit data. We agree with commenters that this crosswalk methodology would still be appropriate to value CPT code 98976. We are finalizing the same valuation for CPT codes 99445 and 99454, since the device is supplied to the beneficiary for the full 30-day period, regardless of the number of days that data is transmitted, and more accurately represents the reality of practice expense for these services. We believe the same coding structure exists with CPT codes 98976 and 98984 and believe that using the same valuation for both codes would be appropriate.

After consideration of public comments, we are finalizing actively pricing CPT codes 98976 and 98984 by crosswalking the PE RVU to CPT code 99454.

CPT codes 98986 and 98978 are PE-only codes. We proposed to contractor price CPT code 98986 and proposed to maintain contractor pricing for CPT code 98978.

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

Comment: Several commenters did not support CMS' proposal to contractor price CPT codes 98986 and 98978. Many commenters requested these codes be actively priced and finalize the RUC recommendation for the device supply. Commenters requested that CMS crosswalk these codes to CPT codes 98976 and 98977. Commenters requested that CMS actively price these codes and review them in the future after more data is collected. A few commenters did not support payment under the PFS for these services, as they believe that there is limited evidence that CBT RTM services will meaningfully improve clinical outcomes and that utilization of these services may reduce direct clinical time that patients receive.

Response: We continue to believe that the technologies for this service are still evolving and there is significant pricing variability for these technologies. We will continue to work with our Medicare Administrative Contractors (MACs) to better understand the kinds of devices and device costs they are encountering as they review claims for payment.

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

We solicited comments on whether there are differences in the valuation of remote physiologic and remote therapeutic monitoring, specifically whether the services have similar costs and/or practice expense inputs. We proposed similar valuations for what we have historically viewed as similar remote monitoring services (for example, RTM and RPM treatment management, RTM and RPM device supply, RTM and RPM data transmission), but we were interested in gaining more information regarding any differences in work (in the case of timed codes, if there are varying levels of intensity between remote therapeutic vs. physiologic monitoring), clinical staff time, supplies, equipment, etc. We were particularly interested in comments that include data or evidence to support the position.

Comment: Several commenters had mixed views on whether there are differences in the valuation of remote physiologic and remote therapeutic monitoring. Commenters who believe these services were similar stated that equal valuation of RTM and RPM codes will promote consistency and fairness in reimbursement and support broader adoption of remote monitoring services. These commenters also believe that clinical workflows, physician oversight, and labor requirements are essentially identical across both service types. Commenters who believe the services were similar were concerned that one service being valued higher than the other would discourage use of the service. Commenters who believe these services do not have similar valuation believe so due to different clinical use cases, the evolving nature of the technologies involved, and the relatively new nature of RTM coverage. A few commenters requested that CMS extend relativity between RTM and RPM codes to all codes within these code families, such as the device supply codes.

Response: We appreciate the commenters for providing further information about the differences in remote physiologic and remote therapeutic monitoring, and how these services could be improved in the future. We will consider this information for future rulemaking. (33) Hearing Device Services (CPT Codes 92628, 92629, 92631, 92632, 92634, 92635, 92636, 92637, 92638, 92639, 92641, and 92642)

At the February 2024 CPT Editorial Panel meeting, 12 new Category I codes were created to report hearing devices services (for example, air-conduction hearing aids) including hearing aid candidacy determination, hearing aid selection, hearing aid fitting, follow-up after fitting, hearing aid verification, and assistive-device services. The current CPT codes, 92590-92595, were recommended for deletion. CPT codes 92628-92642 were reviewed at the April 2024 RUC HCPAC meeting for CY 2026.

The following is a list of the new CPT codes and their long descriptors: CPT code 92628 (Evaluation for hearing aid candidacy, unilateral or bilateral, including review and integration of audiologic function tests, assessment, and interpretation of hearing needs (for example, speech-in-noise, suprathreshold hearing measures) discussion of candidacy results, counseling on treatment options with report, and, when performed, assessment of cognitive and communication status; first 30 minutes), CPT code 92629 (Evaluation for hearing aid candidacy, unilateral or bilateral, including review and integration of audiologic function tests, assessment, and interpretation of hearing needs (for example, speech-in-noise, suprathreshold hearing measures) discussion of candidacy results, counseling on treatment options with report, and, when performed, assessment of cognitive and communication status; each additional 15 minutes), CPT code 92631 (Hearing aid selection services, unilateral or bilateral, including review of audiologic function tests and hearing aid candidacy evaluation, assessment of visual and dexterity limitations, and psychosocial factors, establishment of device type, output requirements, signal processing strategies and additional features, discussion of device recommendations with report; first 30

minutes), CPT code 92632 (Hearing aid selection services, unilateral or bilateral, including review of audiologic function tests and hearing aid candidacy evaluation, assessment of visual and dexterity limitations, and psychosocial factors, establishment of device type, output requirements, signal processing strategies and additional features, discussion of device recommendations with report; each additional 15 minutes), CPT code 92634 (Hearing aid fitting services, unilateral or bilateral, including device analysis, programming, verification, counseling, orientation, and training, and, when performed, hearing assistive device, supplemental technology fitting services; first 60 minutes), CPT code 92635 (Hearing aid fitting services, unilateral or bilateral, including device analysis, programming, verification, counseling, orientation, and training, and, when performed, hearing assistive device, supplemental technology fitting services; each additional 15 minutes), CPT code 92636 (Hearing aid post-fitting follow-up services, unilateral or bilateral, including confirmation of physical fit, validation of patient benefit and performance, sound quality of device, adjustment(s) (for example, verification, programming adjustment(s), device connection(s), and device training), as indicated, and, when performed, hearing assistive device, supplemental technology fitting services; first 30 minutes), CPT code 92637 (Hearing aid post-fitting follow-up services, unilateral or bilateral, including confirmation of physical fit, validation of patient benefit and performance, sound quality of device, adjustment(s) (for example, verification, programming adjustment(s), device connection(s), and device training), as indicated, and, when performed, hearing assistive device, supplemental technology fitting services; each additional 15 minutes), CPT code 92638 (Behavioral verification of amplification including aided thresholds, functional gain, speech in noise, when performed), CPT code 92639 (Hearing-aid measurement, verification with probe-microphone), CPT code 92641 (Hearing device verification, electroacoustic analysis), and CPT code 92642 (Hearing assistive device, supplemental technology fitting services (for example, personal frequency modulation (FM)/digital modulation (DM) system, remote microphone, alerting devices)).

The RUC is recommending contractor pricing for all twelve codes in the family. However, section 1862(a)(7) of the Act prohibits Medicare payment under Part A or Part B for any expenses incurred for hearing aids or examinations therefore, it has been our established policy not to pay for these hearing device services on the PFS, as their predecessor CPT codes 92590-92595 all have non-payable status codes. Therefore, we proposed to maintain the same policy of assigning non- payable status codes to each of the twelve new CPT codes in this family.

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

Comment: Several commenters stated that although they appreciated the opportunity to comment on the payment status of these codes, they disagreed with CMS' proposal to continue to assign non-payable status codes to each of these codes. Commenters stated that they had concerns with potential scope of practice limitations that may impact implementation, certain codes in the family contain services that are not suitable for pediatric cases, and the bundled codes pose challenges for documenting medical necessity. Some commenters suggested CMS to finalize contractor pricing for each of these codes, as the RUC recommended, while other commenters requested that CMS pause the deletion of CPT codes 92590-92595 and the implementation of CPT codes 92628-92641 until these potential issues could be addressed.

Response: As we stated in the proposed rule, section 1862(a)(7) of the Act prohibits Medicare payment under Part A or Part B for any expenses incurred for hearing aids or examinations. We therefore continue to believe that the 12 new CPT codes in this family should maintain the same non-payable status as their predecessor codes. With regards to CPT codes 92590-92595, the CPT Editorial Panel will be deleting these codes for CY 2026 which is outside the control of CMS. We did not propose to maintain the current coding through the creation of G codes, as we believe that the new code set creates a more granular structure to describe these services and which will maintain the same non-payable status under which the predecessor codes were valued.

Comment: Several commenters expressed concerns with provider education associated with the codes in this family. Commenters stated that the CY 2026 effective date may not provide sufficient time for health systems, commercial payers, and state Medicaid programs to update their systems to accommodate the new codes. Commenters stated that several of the new codes would benefit from greater specificity and clarification and expressed concerned about the time-based structure of certain codes which could allow for potential overlap between codes.

Response: We appreciate the concerns of the commenters with the need for provider education associated with these new codes, as well as their concerns with the structure of the coding as designed by the CPT Editorial Panel. However, these issues are outside the scope of this rule as we do not address provider education associated with new coding in the PFS final rule.

After consideration of the comments, we are finalizing our proposal to assign non-payable status codes to each of the twelve new CPT codes in this family. (34) Scalp Cooling Services (CPT Codes 97007, 97008, and 97009)

At the September 2024 CPT Editorial Panel meeting, CPT deleted two Category II CPT codes and created three new Category I CPT codes, CPT code 97007 (Mechanical Scalp cooling, including individual cap supply with head measurement, fitting, and patient education), 97008 (mechanical scalp cooling; including hair preparation, individual cap placement, therapy initiation, and pre-cooling period), and 97009 (mechanical scalp cooling; each 30 minutes)) to report scalp cooling services to address chemotherapy induced alopecia. The new codes were surveyed for the January 2025 RUC meeting and the RUC determined that the code family requires no physician work and are practice expense (PE) only services. As such, the RUC did not recommend, and we are not proposing work RVUs for these codes.

We disagree with the RUC-recommended 5 minutes of service period clinical staff time in direct PE input CA021 (Perform procedure/ service--not directly related to physician work time) for CPT code 97007. We proposed 27 minutes of clinical labor time for CA021 based off reference CPT code 99453 (Remote monitoring of physiologic parameter(s) (for example, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment). We have received feedback from interested parties that 5 minutes does not adequately account for the full duration of time required to educate, measure, fit, and calibrate the cap. We agree with interested parties and believe that the 27 minutes of clinical staff time in CA021 for CPT code 99453 better accounts for the full duration of time required for this service. We are proposing all other direct PE inputs, supplies, and equipment as recommended by the RUC

for CPT code 97007. We are also proposing all direct PE inputs, supplies, and equipment as recommended by the RUC for CPT codes 97008 and 97009 without refinement.

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

Comment: Some commenters supported the proposed direct PE inputs for CPT code 97007 and recommended that CMS finalize as proposed. Commenters stated that they appreciated CMS deviating from the RUC- recommended values for this code and the allotted additional clinical staff time for clinical activity CA021.

Response: We appreciate the commenters for their support.

Comment: Several commenters disagreed with our proposed increase in clinical staff time for CPT code 97007 and requested that CMS finalize the RUC-recommendations for this code. Commenters stated that this portion of clinical staff work, which CMS increased to 27 minutes based off reference CPT code 99453, is more complex for the reference code than the setup and patient education required in CPT code 97007 since the reference code requires the explanation of outputs and obtaining the initial readings for the remote physiologic device. The cap for scalp cooling does not require any data elements to be processed and recorded by the patient for CPT code 97007 and therefore would only require 5 minutes for CA021 as recommended by the RUC.

Response: We acknowledge the commenters' feedback. However, we continue to believe that our proposed increase in CA021 clinical staff time for CPT code 97007 is appropriate for the required clinical activities during this portion of the scalp cooling service. We stated in the proposed rule that this additional clinical staff time better accounts for the full duration of time required to educate, measure, fit, and calibrate the cap, as suggested initially by interested parties and then repeated again by commenters. Based on the additional information that we have received on this topic, we do not believe that these tasks could typically be carried out in 5 minutes as recommended by the RUC.

Comment: Several commenters disagreed with the proposed direct PE inputs for all the codes in this family. The commenters requested CMS to increase the direct PE inputs for CPT code 97007 from the proposed 36 total clinical staff minutes to 103 total clinical staff minutes. Commenters also requested an increase in total clinical staff minutes for CPT code 97008 from the RUC-recommended value of 9 minutes to 52 minutes with the addition of the following equipment items: scalp cooling system and a medical recliner chair (EF009) for 30 minutes. For CPT code 97009, commenters requested an increase in total clinical staff minutes from the RUC-recommended value of 6 minutes to 23 minutes and the same equipment items: scalp cooling system and a medical recliner chair (EF009) for 30 minutes. The commenters stated that this service utilizes infusion center resources for lengthy periods of time and that the requested clinical staff times are based on a time and motion study of 10 cancer centers; commenters disagreed with the RUC- recommended values and believe that the RUC did not include all necessary resources and were under-reported. Commenters also had concerns regarding equity and access for this service and requested that CMS set the medically unlikely edits for CPT code 97009 to 6.

Response: We acknowledge commenters' request for additional clinical staff time for all the codes in this family as well as additional equipment for CPT codes 97008 and 97009. We also acknowledge that the commenters are basing this request from a time and motion study that they are relying on to be an additional data source beyond the RUC review process to validate their request. We are interested in and open to alternate data sources other than the RUC review and survey process when making valuation decisions for CPT codes. However, for this code family, we continue to believe that the proposed clinical staff time for CPT code 97007 sufficiently accounts for the clinical activities of cap fitting and calibration and patient education. We also continue to believe that the RUC-recommended direct PE inputs sufficiently account for the clinical activities described in CPT code 97008 and 97009.

For the requested equipment item, the medical recliner chair (EF009), 60 minutes of time is included for the chemotherapy infusion codes, such as CPT code 96365 (Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour) and CPT code 96366 (Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)), which would be billed during the same patient encounter and account for portions of the time in the chair used by the patient. We agree with commenters that this does not account for the full time in the medical recliner chair for each chemotherapy with scalp cooling service session. Therefore, we are adding 30 minutes of equipment time for the medical recliner chair (EF009) for CPT code 97008 and 97009.

For the scalp system coolant, we did not receive any RUC- recommendations for the system equipment and interested parties have reported that the system is leased equipment and could be shared by multiple patients. As such, we believe that this cost can be accurately captured with our indirect PE methodology. We acknowledge commenters' concerns regarding access to this service and are open to further discussions in the future. The request for medically unlikely edits is out of scope for the PFS rule but can be addressed via the National Correct Coding Initiative (https://www.cms.gov/national-correct-coding-initiative-ncci).

After consideration of the public comments, we are finalizing the direct PE inputs for the scalp cooling services as proposed, with the addition of 30 minutes of equipment time for the medical recliner chair in CPT codes 97008 and 97009. We did not propose, and we are not finalizing a work RVU for the three codes in this family.

[GRAPHIC] [TIFF OMITTED] TR05NO25.032

[GRAPHIC] [TIFF OMITTED] TR05NO25.033

[GRAPHIC] [TIFF OMITTED] TR05NO25.034

[GRAPHIC] [TIFF OMITTED] TR05NO25.035

[GRAPHIC] [TIFF OMITTED] TR05NO25.036

[GRAPHIC] [TIFF OMITTED] TR05NO25.037

[GRAPHIC] [TIFF OMITTED] TR05NO25.038

[GRAPHIC] [TIFF OMITTED] TR05NO25.039

[GRAPHIC] [TIFF OMITTED] TR05NO25.040

[GRAPHIC] [TIFF OMITTED] TR05NO25.041

[GRAPHIC] [TIFF OMITTED] TR05NO25.042

[GRAPHIC] [TIFF OMITTED] TR05NO25.043

[GRAPHIC] [TIFF OMITTED] TR05NO25.044

[GRAPHIC] [TIFF OMITTED] TR05NO25.045

[GRAPHIC] [TIFF OMITTED] TR05NO25.046

[GRAPHIC] [TIFF OMITTED] TR05NO25.047

[GRAPHIC] [TIFF OMITTED] TR05NO25.048

[GRAPHIC] [TIFF OMITTED] TR05NO25.049

[GRAPHIC] [TIFF OMITTED] TR05NO25.050

[GRAPHIC] [TIFF OMITTED] TR05NO25.051

[GRAPHIC] [TIFF OMITTED] TR05NO25.052

[GRAPHIC] [TIFF OMITTED] TR05NO25.053

[GRAPHIC] [TIFF OMITTED] TR05NO25.054

[GRAPHIC] [TIFF OMITTED] TR05NO25.055

[GRAPHIC] [TIFF OMITTED] TR05NO25.056

[GRAPHIC] [TIFF OMITTED] TR05NO25.057

[GRAPHIC] [TIFF OMITTED] TR05NO25.058

[GRAPHIC] [TIFF OMITTED] TR05NO25.059

[GRAPHIC] [TIFF OMITTED] TR05NO25.060

[GRAPHIC] [TIFF OMITTED] TR05NO25.061

[GRAPHIC] [TIFF OMITTED] TR05NO25.062

[GRAPHIC] [TIFF OMITTED] TR05NO25.063

[GRAPHIC] [TIFF OMITTED] TR05NO25.064

[GRAPHIC] [TIFF OMITTED] TR05NO25.065

[GRAPHIC] [TIFF OMITTED] TR05NO25.066

[GRAPHIC] [TIFF OMITTED] TR05NO25.067

[GRAPHIC] [TIFF OMITTED] TR05NO25.068

[GRAPHIC] [TIFF OMITTED] TR05NO25.069

[GRAPHIC] [TIFF OMITTED] TR05NO25.070

[GRAPHIC] [TIFF OMITTED] TR05NO25.071

[GRAPHIC] [TIFF OMITTED] TR05NO25.072

[GRAPHIC] [TIFF OMITTED] TR05NO25.073

[GRAPHIC] [TIFF OMITTED] TR05NO25.074

[GRAPHIC] [TIFF OMITTED] TR05NO25.075

[GRAPHIC] [TIFF OMITTED] TR05NO25.076

[GRAPHIC] [TIFF OMITTED] TR05NO25.077

[GRAPHIC] [TIFF OMITTED] TR05NO25.078

[GRAPHIC] [TIFF OMITTED] TR05NO25.079

[GRAPHIC] [TIFF OMITTED] TR05NO25.080

[GRAPHIC] [TIFF OMITTED] TR05NO25.081

[GRAPHIC] [TIFF OMITTED] TR05NO25.082

[GRAPHIC] [TIFF OMITTED] TR05NO25.083

[GRAPHIC] [TIFF OMITTED] TR05NO25.084

[GRAPHIC] [TIFF OMITTED] TR05NO25.085

[GRAPHIC] [TIFF OMITTED] TR05NO25.086

[GRAPHIC] [TIFF OMITTED] TR05NO25.087

In the CY 2024 PFS final rule (88 FR 78970 through 78982), we finalized separate payment for the office/outpatient evaluation and management (O/O E/M) visit complexity add-on code, HCPCS code G2211 (Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established)).

In the CY 2024 PFS final rule, we noted that the O/O E/M visit complexity add-on code “reflects the time, intensity, and PE resources involved when practitioners furnish the kinds of O/O E/M visit services that enable them to build longitudinal relationships with all patients (that is, not only those patients who have a chronic condition or single high-risk disease) and to address the majority of a patient's health care needs with consistency and continuity over longer periods of time.” (88 FR 78970 through 78971). We explained in the CY 2024 PFS final rule that it is the relationship between the patient and the practitioner that is the determining factor for when the add-on code should be billed. The add-on code captures the inherent complexity of the visit that is derived from the longitudinal nature of the practitioner and patient relationship. The first part of the code descriptor, the “continuing focal point for all needed health care services,” describes a relationship between the patient and the practitioner when the practitioner is the continuing focal point for all health care services that the patient needs. The second part of the add-on code also describes a relationship involving medical services that are part of ongoing care related to a patient's single, serious condition or a complex condition. There is previously unrecognized but important cognitive effort of utilizing the longitudinal relationship in making a diagnosis, developing a treatment plan, and weighing the factors that affect a

longitudinal doctor-patient relationship. The practitioner must decide what course of action and choice of words in the visit itself would lead to the best health outcome in the single visit while simultaneously building up an effective, trusting longitudinal relationship with the patient. Weighing these various factors, even for a seemingly simple condition, makes the entire visit inherently complex, which is what this add-on code is intended to capture (88 FR 78973 through 78974).

Interested parties have recommended that CMS either establish separate payment for an evaluation and management inherent complexity add-on code specific to home-based visits or expand use of the O/O E/M visit complexity add-on code HCPCS code G2211 to be reported alongside home and residence E/M visits furnished to beneficiaries in nursing facilities, assisted living facilities, and the beneficiary's home. Interested parties have explained that home-based primary care practices provide access to primary care services for patients who otherwise would not be able to leave the house to see a primary care practitioner, and include the development of longitudinal, “high- touch” relationships with their patients.

In the CY 2024 PFS final rule (88 FR 78818, 78971), we stated that the values we established for the revised O/O E/M CPT codes in the CY 2021 PFS final rule were finalized in concert with separate payment for HCPCS code G2211 (85 FR 84569, 87 FR 69588), and that we finalized work RVUs for the nursing facility E/M visit codes (87 FR 69604 through 69606) and the home or residence services code family (87 FR 69608 and 69609) subsequently in the CY 2023 PFS final rule. We stated that we may nevertheless consider in future rulemaking whether home or residence evaluation and management services bear unrecognized resource costs and whether HCPCS code G2211 should be applicable to home or residence E/M visits. We have noted that the application of the add-on code is not based on the characteristics of particular patients (even though the rationale for valuing the code is based on recognizing the typical complexity of patient needs), but rather the relationship between the patient and the practitioner (88 FR 78973). In part, HCPCS code G2211 recognizes the resource costs involved in building trust in a long-term practitioner-patient relationship that are not reflected in the valuation of the O/O E/M code set. The same appears to be true about the home and residence evaluation and management code set. Building trust as part of a longitudinal practitioner-patient relationship may be particularly significant in the context of home and residence E/M visits. Typically, home visits occur at least monthly and people with serious illness may receive weekly visits. These visits involve developing and following through on a longitudinal care plan with proactive contacts regarding all of a person's health care needs. The follow-through based on a trusting practitioner/patient relationship is critical to keeping patients stable and preventing exacerbations. For these reasons, we believed it was appropriate to extend the application of HCPCS code G2211 to home and residence E/M visits in the CY 2026 MPFS. Therefore, we proposed to allow HCPCS code G2211 to be billed as an add-on code with the home or residence evaluation and management visits code family (CPT codes 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350). The HCPCS code G2211 refined descriptor would read as follows, “(Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (Add- on code, list separately in addition to home or residence or office/ outpatient evaluation and management service, new or established))”.

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

Comment: Many comments supported our proposed refinement to HCPCS code G2211 to make this add-on code payable when reported with home residence E/M visits. Many commenters recommended that we make the add- on code applicable to other or all types of E/M visits and to home visits reported by community health centers and rural health clinics. A commenter also suggested making the transitional care management (TCM) services codes new base codes for HCPCS code G2211. Another handful of commenters opposed our proposal.

Many commenters, including those who supported our proposal, expressed concerns over the CY 2024 PFS final rule estimate of the utilization of HCPCS code G2211 resulting in a negative impact to the conversion factor for that year. Some commenters expressed concern that our proposal to make the home residence E/M visit codes base codes for the HCPCS code G2211 add-on code would trigger larger budget neutrality adjustments going forward. Many commenters recommended a prospective budget neutrality adjustment to the 2026 Conversion Factor (CF) to account for the estimated utilization that was not realized in CY 2024.

Response: We appreciate the commenters for their feedback that this policy will support ongoing, longitudinal care relationships with primary care providers for populations with complex co-morbidities. We also acknowledge receipt of recommendations beyond the scope of this proposal, requesting additional service codes be designated base codes to which the HCPCS code G2211 add-on code would apply, requesting that we revisit the modifier 25 payment policy restriction on certain services or procedures reported on the same day by the same practitioner, and recommendations to provide patient education about applicability of patient co-pays.

Regarding the concerns about utilization estimates, we acknowledge that the CY 2024 utilization estimate exceeded actual reporting of HCPCS code G2211 in CY 2024. We remind commenters that we do not make retrospective budget neutrality adjustments and would not compare actual claims reported for new coding against the utilization estimates made in the PFS final rule for the year in which such reporting began. As noted in the CY 2024 PFS final rule (88 FR 78975), CMS makes budget neutrality calculations on a prospective annual basis and uses claims data for the services as they become available in subsequent years, to inform budget neutrality adjustments. Utilization is variable and for new coding, estimates sometimes do not anticipate the volume of reporting that is actually realized.

We continue to anticipate that utilization of the inherent complexity add-on code will continue to increase over time, consistent with utilization patterns for other new services, and we remain interested and appreciative of feedback regarding how to encourage its appropriate use.

After reviewing all the comments, we are finalizing as proposed, to allow HCPCS code G2211 to be billed as an add-on code with the home or residence E/M visits code family (CPT codes 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350). We are also finalizing refinement of the HCPCS code G2211 code descriptor to read as follows, “(Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious

condition or a complex condition. (Add-on code, list separately in addition to home or residence or office/outpatient evaluation and management service, new or established)) ”.

Lastly, we note that the add-on code for inherent complexity intends to address the lack of distinction between E/M codes used to describe visits that involve a longitudinal relationship between the practitioner and patient compared to visits that do not. Similar to the discussion in section II.B. of this final rule regarding site of service payment differentials, we look forward to ongoing feedback on improved approaches to recognize those differences more holistically without use of an add-on code and recognize that there continues to be an imbalance in payment for E/M visits that are part of ongoing care. At the same time, we recognize we would need to address any potential changes through future notice and comment rulemaking.

In the CY 2025 PFS final rule (89 FR 97859 through 97902), we finalized separate coding and payment for Advanced Primary Care Management (APCM) services (HCPCS codes G0556, G0557, and G0558).

[GRAPHIC] [TIFF OMITTED] TR05NO25.088

[GRAPHIC] [TIFF OMITTED] TR05NO25.089

[GRAPHIC] [TIFF OMITTED] TR05NO25.090

[GRAPHIC] [TIFF OMITTED] TR05NO25.091

In the CY 2017 PFS final rule (81 FR 80230), we began making separate payment to practitioners who provide behavioral health integration (BHI) services to patients using the Psychiatric Collaborative Care Model (CoCM) (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) using HCPCS codes G0502, G0503, and G0504.

In the CY 2018 PFS final rule (82 FR 53077 through 53078), these codes were replaced by CPT codes 99492 (Initial psychiatric collaborative care management, first 70 minutes in the first calendar 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, with the following required elements: outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional, initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan, review by the psychiatric consultant with modifications of the plan if recommended, entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant, and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies), 99493 (Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent 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, with the following required elements: tracking patient follow-up and progress using the registry, with appropriate documentation, participation in weekly caseload consultation with the psychiatric consultant, ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers, additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant, provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies, monitoring of patient outcomes using validated rating scales, and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment), and 99494 (Initial or subsequent psychiatric collaborative care management, each additional 30 minutes in a calendar 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 (List separately in addition to code for primary procedure)), respectively.

In the CY 2017 PFS final rule (81 FR 80230), we also began making separate payment to practitioners who provide general BHI services to patients, using HCPCS code G0507. BHI is a term that refers broadly to collaborative care that integrates behavioral health services with primary care. BHI is a team-based approach to care that focuses on integrative treatment of patients with medical and mental or behavioral health conditions. In the CY 2018 PFS final rule (82 FR 53077 through 53078), HCPCS code G0507 was replaced by CPT code 99484.

CPT code 99484 is for care management services for behavioral health conditions, at least 20 minutes of clinical staff time, directed by a physician or other qualified health care professional, per calendar month, with the following required elements: initial assessment or follow-up monitoring, including the use of applicable validated rating scales, behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes, facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or

psychiatric consultation, and continuity of care with a designated member of the care team.

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.” \76\ Integrating behavioral health with primary care has been shown to improve outcomes like reduced depression severity, and enhancing patient's experience of care.\77\ In the CY 2025 PFS final rule (89 FR 97897), we summarized comments that we had received on our APCM services proposals discussing the importance of behavioral health on overall health and urging us to consider including behavioral health in future rulemaking as it relates to advanced primary care, citing the growing need for fully integrated physical and behavioral health. In our response, we agreed with commenters that behavioral health integration services are complementary to APCM services and that behavioral health is important in the context of overall health. We stated that we will take comments recommending strategies for further integration into consideration for future rulemaking. We further stated that we continue to be interested in the use of behavioral health integration services as they relate to advanced primary care and welcome input from interested parties, including how evolving changes in practice may warrant reconsideration of payment and coding policies.

\76\ https://integrationacademy.ahrq.gov/about/integrated- behavioral- health#:~:text=Integrated%20behavioral%20health%20offers%20many,these %20concerns%20are%20also%20addressed.

\77\ 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 believe that the physicians and practitioners who furnish APCM services should be able to provide BHI services and CoCM without needing to document their time spent performing the service because this would help facilitate a more holistic, team-based approach to care coordination and reduce burden. Otherwise, the practice would need to develop a time documentation system for BHI and CoCM, but not APCM. Functionally, we also believe that many practices that develop the interdisciplinary teams to provide advanced primary care are also the ones most likely ready to furnish BHI and CoCM services, so alignment in billing requirements would streamline processes. Therefore, for CY 2026, we proposed to create optional add-on codes for APCM services that would facilitate providing complementary BHI services by removing the time-based requirements of the existing BHI and CoCM codes. We believe that removing the time-based requirements will reduce burden on practitioners by reducing the documentation requirements for billing. By reducing the documentation requirements, we also believe primary care practitioners may be more likely to offer and furnish BHI and CoCM services, which would improve access to BHI and CoCM for primary care patients. These proposed optional add-on codes for APCM services would be considered a “designated care management service” at Sec. 410.26(b)(5) and, as such, could be provided by auxiliary personnel under the general supervision of the billing practitioner. In the CY 2024 PFS final rule (88 FR 78939), we summarized comments received for Principal Illness Navigation services that discussed that patients with severe mental illness and substance use disorders may only see behavioral health practitioners regularly, which we believe makes the integration of behavioral health and primary care important for this population to improve access. We are opting to not create an add-on code for CPT code 99494 as this code is for an additional 30 minutes of initial or subsequent psychiatric collaborative care management in a calendar month, and the APCM codes, and proposed add-on codes do not require the counting of minutes to bill.

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

Comment: Several commenters supported that these proposed optional add-on codes for APCM services would be considered a “designated care management service” at Sec. 410.26(b)(5) and, as such, could be provided by auxiliary personnel under the general supervision of the billing practitioner.

Response: We appreciate the commenters for their supportive comments. 2. Behavioral Health Integration Add-On Codes for APCM (HCPCS Codes G0568, G0569, G0570)

We proposed the establishment of three new G-codes to be billed as add-on services when the APCM base code (HCPCS codes G0556, G0557, and G0558) is reported by the same practitioner in the same month. HCPCS code G0568, an add-on code based on CPT code 99492, HCPCS code G0569, an add-on code based on CPT code 99493 for CoCM services delivered to patients also receiving APCM services, and HCPCS code G0570, an add-on code for general behavioral health integration services based on CPT code 99484. We did not propose to create an add-on code for CPT code 99494, as that code describes additional time, and these codes do not require the counting of minutes.

Our proposed code descriptors are listed below.

HCPCS code G0568: Initial psychiatric collaborative care management, in the first calendar 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, with the following required elements: outreach to and engagement in treatment of a patient directed by the treating physician or other qualified health care professional, initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan, review by the psychiatric consultant with modifications of the plan if recommended, entering patient in a registry and tracking patient follow-up and progress using the registry, with appropriate documentation, and participation in weekly caseload consultation with the psychiatric consultant, and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies (list separately in addition to the Advanced Primary Care Management code).

HCPCS code G0569: Subsequent psychiatric collaborative care management, in a subsequent 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, with the following required elements: tracking patient follow-up and progress using the registry, with appropriate documentation, participation in weekly caseload consultation with the psychiatric consultant, ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers, additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the

psychiatric consultant, provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies, monitoring of patient outcomes using validated rating scales, and relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment (list separately in addition to Advanced Primary Care Management code).

HCPCS code G0570: Care management services for behavioral health conditions, directed by a physician or other qualified health care professional, per calendar month, with the following required elements: initial assessment or follow-up monitoring, including the use of applicable validated rating scales, behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes, facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation, and continuity of care with a designated member of the care team (list separately in addition to Advanced Primary Care Management code).

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

Comment: Several commenters supported our proposal to create three new G-codes to be billed as add-on services when the APCM base code (HCPCS codes G0556, G0557, and G0558) is reported by the same practitioner in the same month. They stated that this change will encourage primary care practices to provide integrated mental health care, including BHI and CoCM services, and improve Medicare beneficiaries' access to whole person, team-based care.

Response: We appreciate the commenters for their supportive comments.

Comment: Several commenters expressed support for the fact that these codes do not require the counting of minutes. The commenters stated that counting minutes is administratively burdensome and takes away time that practitioners would otherwise spend on patient care. However, a few commenters stated that the counting and documentation of minutes of service provided is necessary to ensure the appropriate services are delivered to beneficiaries and were concerned that without this requirement beneficiaries would not receive the care they need.

Response: We appreciate the commenters for their thoughtful comments. While we proposed not to require the counting of minutes for these add-on codes, we would expect that the care delivered to Medicare beneficiaries would be appropriately documented in the medical record, regardless of whether the counting of minutes is required.

Comment: A commenter stated that continuing to document the behavioral health services delivered and patient interactions associated with billing the add-on codes was unnecessarily burdensome and recommended that we allow practitioners to attest that they have the ability to provide integrated behavioral health services without documenting each required element of the service.

Response: We appreciate the commenter for the feedback and acknowledge that some administrative burden remains to bill the proposed add-on codes. However, at this time, we continue to believe that it is important that the elements of the particular add-on service are documented in the medical record, though we may consider this comment in future rulemaking.

Comment: A few commenters expressed concern that the creation of add-on codes would be confusing and unnecessarily burdensome when similar, standalone CPT codes already exist. The commenters suggested that we work with the American Medical Association to remove the time- based thresholds for the associated CPT codes: 99492, 99493, and 99484. Additionally, a few commenters questioned why we had not created an add-on code based on CPT code 99494.

Response: We appreciate the commenters for the suggestion. While we understand that there is always a learning curve when new HCPCS codes are introduced, we continue to believe that removing the time-based requirements for HCPCS codes G0568, G0569, and G0570 when billed in conjunction with an APCM base code (HCPCS codes G0556, G0557, and G0558) will ultimately reduce administrative burden, as it aligns the documentation requirements of the APCM codes with the add-on codes. The time-based requirements for CPT codes 99492, 99493, and 99484 remain in the instance these CPT codes are billed on a standalone basis, outside of the provision of APCM services. 3. Valuation of Behavioral Health Integration Add-On Codes for APCM Services

In consideration that the services described by the proposed add-on codes are meant to be directly comparable to the existing CoCM and BHI codes, we proposed a direct crosswalk to the current work RVU values of CPT code 99492 for HCPCS code G0568 (work RVU 1.88), CPT code 99493 for HCPCS code G0569 (work RVU 2.05), and CPT code 99484 for HCPCS code G0570 (work RVU 0.93). We also proposed a direct crosswalk to the current direct PE inputs for CPT codes 99492 (non-facility RVU 2.48, facility RVU 0.80), 99493 (non-facility RVU 1.93, facility RVU 0.86), and 99484 (non-facility RVU 0.66, facility RVU 0.30), to HCPCS codes G0568, G0569, and G0570, respectively. We solicited comments on this approach.

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

Comment: Several commenters expressed their support for the proposed direct crosswalk to the current work RVU values and direct PE inputs to CPT code 99492 for HCPCS code G0568, CPT code 99493 for HCPCS code G0569, and CPT code 99484 for HCPCS code G0570. A commenter stated that instead of directly crosswalking the work RVU and direct PE inputs for the add-on codes, we should pay more than the current CPT codes.

Response: We appreciate the commenters for their responses to our proposal. In consideration that the services described by the proposed add-on codes are meant to be directly comparable to the existing CoCM and BHI codes, we continue to believe it is appropriate to directly crosswalk to the existing work RVUs and direct PE inputs for these services.

After consideration of the public comments, we are finalizing the establishment of three new G-codes to be billed as add-on services when the APCM base code (HCPCS codes G0556, G0557, and G0558) is reported by the same practitioner in the same month: HCPCS code G0568, an add-on code based on CPT code 99492 for an initial month of CoCM services delivered to patients also receiving APCM services, HCPCS code G0569, an add-on code based on CPT code 99493 for CoCM services delivered to patients also receiving APCM services, and HCPCS code G0570, an add-on code for general behavioral health integration services based on CPT code 99484, and are

finalizing the valuation of these codes as proposed. 4. Request for Information Related to APCM and Prevention

Having a usual source of primary care can be positively associated with better receipt of recommended prevention services \78\ and effective management of chronic disease,\79\ which per the Trump Administration's Executive Order, “Establishing the President's Make America Healthy Again Commission,” \80\ is a top priority for CMS. APCM coding and payment has represented CMS' recent efforts to promote team-based primary care. In the CY 2025 PFS final rule (89 FR 97863), commenters recommended that cost sharing be eliminated for APCM services, indicating that any amount of cost sharing could be prohibitive and may limit the uptake of APCM services. A few commenters suggested that APCM services are preventive services that should be exempt from beneficiary cost sharing.

\78\ Blewett, Lynn, Pamela Jo Johnson, Brian Lee, and Peter Scal. When a Usual Source of Care and Usual Provider Matter: Adult Prevention and Screening Services. Journal of General Internal Medicine. Volume 23, pages 1354-1360. Published May 28, 2008.

\79\ Luo, Jiajun, Muhammad Kibriya, Paul Zakin, Andrew Craver, Liz Connellan, Saira Tasmin, Tamar Polonsky, Karen Kim, Habibul Ahsan, Briseis Aschebrook-Kilfoy. “Urban Spatial Accessibility of Primary Care and Hypertension Control and Awareness on Chicago's South Side: A Study From the COMPASS Cohort. Circ Carvdiovasc Qual Outcomes. 2022 Sep; 15(9):e008845. Doi: 10.1161/ CIRCOUTCOMES.121.008845. Epub 2022 Sep 6.

\80\ https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/.

At the time, we responded to comments stating that CMS did not see how APCM fit within the benefit categories for preventive services. After further consideration and analysis, there are some service elements of APCM that are substantively similar to certain aspects of the “personalized prevention plan services” described under section 1861(hhh)(1) of the Act. For example, the personalized prevention plan includes a health risk assessment, which includes identification of chronic diseases, injury risks, modifiable risk factors, and urgent health needs. This is substantively similar to the service element of APCM that requires an overall systematic needs assessment (which includes both medical and psychosocial needs). The personalized prevention plan includes “improving self-management, or community- based lifestyle interventions to reduce health risks and promote self- management,” which is substantively similar to the APCM service element of “oversight of self-management.” However, as APCM is a bundle of different care management and communication technology-based services, there are other service elements of the APCM codes that may be covered under Medicare Part B and carry cost sharing obligations.

The blending of prevention and treatment services makes intuitive sense for those familiar with advanced primary care practices, which must simultaneously balance ensuring patients receive their needed preventive services and treatment services. Indeed, effective care management often means balancing prevention and treatment in the life an individual patient. For example, for a patient with a recent history of a Deep Venous Thrombosis (DVT) on anticoagulation medication, a primary care team must often balance whether or not to hold the patient's anticoagulation in order for the patient to receive a colonoscopy (where removal of a polyp while the patient is on anticoagulation can lead to excessive bleeding).\81\ The primary care team must balance the relative risks of holding the anticoagulation medication, with the relative risks of delaying cancer screening, for the optimal health and wellbeing of the patient.

\81\ O'Donnel, Michael and Seth A. Gross. “Management of Anticoagulation and Colonoscopy.” Current Treatment Options in Gastroenterology. Volume 19, pages 1-13(2021). Published January 16, 2021.

Given these factors, we solicited comments on how CMS should consider the application of cost sharing for APCM services, particularly, if we were to include preventive services within the APCM bundles. How should we account for cost sharing if APCM includes both preventive services and other Part B services? Should CMS consider including the Annual Wellness Visit, depression screening, or other preventative services in the APCM bundle, and if so, which services and why?

Should CMS consider other changes to APCM or additional coding to further recognize the work of advanced primary care practices in preventing and managing chronic disease?

Additionally, we have often described how primary care teams are central to the relative success of Medicare Shared Savings ACOs. In 2023, as in previous years, ACOs comprised of larger proportions of primary care clinicians had significantly higher net per capita savings than ACOs comprised of smaller proportions of primary care clinicians.

Should CMS consider new payments to Shared Savings Program ACOs for prospective monthly APCM payments to be delivered to primary care practices that satisfy the APCM billing requirements, with the payments reconciled under the ACO benchmark?

If so, how should CMS consider consent and other features of APCM in these contexts?

Should CMS consider other updates to APCM payments or Shared Savings Program policies that would drive increased participation of primary care practitioners in ACOs?

We received public comments on this solicitation.

While we appreciate the commenters for their feedback, we will take the comments into consideration for possible future rulemaking.

In the CY 2026 PFS proposed rule, we inadvertently omitted the following section regarding Outpatient Therapy Services and KX Modifier Thresholds. However, we included this section as part of the CY 2026 PFS correcting document (90 FR 39158). 1. Technical Correction (Sec. 410.62(a))

In the CY 2009 PFS final rule (73 FR 69874 through 69875) we finalized the addition of a new paragraph at Sec. 410.62(c) for the services of speech-language pathologists (SLPs) in private practice (SLPPPs) allowed through the amendments in section 143 of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA); and, we also finalized a new condition of payment at Sec. 410.62(a)(3)(ii) requiring these SLPPPs to meet the qualifications of SLPs at 42 CFR part 484 that is specified in the basic rule for outpatient speech- language pathology services at Sec. 410.62(a).

During a recent review of the regulations at Sec. 410.62, we noticed an error in Sec. 410.62(a). That is, the basic rule at Sec. 410.62(a) does not correctly reflect the policy that for Medicare Part B to pay for outpatient speech-language pathology services, those services are required to be delivered only by SLPs--including the SLPPPs specified at paragraph (a)(3)(ii)--meeting the requirements for an SLP at Sec. 484.115. Instead, Sec. 410.62(a) states that except as specified in paragraph (a)(3)(ii) of this section rather than paragraph (a)(3)(iii) which was paragraph (a)(3)(ii) before being redesignated as paragraph (a)(3)(iii) when the condition of payment was added for the services of SLPPPs. We inadvertently did not update the exception paragraph during CY 2009 PFS rulemaking to reflect the correct policy under which the

individual furnishing services incident to the services of physicians, physician assistants (PAs), clinical nurse specialists (CNSs), or nurse practitioner (NPs) does not have to meet the state licensure requirement at Sec. 484.115 (although they are required to meet the other standards and conditions that apply to SLPs). Therefore, we proposed to revise Sec. 410.62(a) to reflect the policy related to qualifications for individuals furnishing services incident to the services of physicians, PAs, CNSs, and NPs by correctly referencing paragraph (a)(3)(iii) in place of paragraph (a)(3)(ii). We also proposed to make a conforming regulatory change at Sec. 410.26(c)(2) to refer readers to Sec. 410.62(a)(3)(iii) instead of Sec. 410.62(a)(3)(ii) for the correct policy related to the qualifications for individuals providing speech-language pathology services furnished incident to the services of physicians, PAs, CNSs, and NPs.

We did not receive public comments on this provision, and therefore, we are finalizing as proposed. 2. KX Modifier Thresholds

The KX modifier thresholds were established through section 50202 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9, 2018) (BBA) and were formerly referred to as the therapy cap amounts. These per-beneficiary amounts under section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year based on the percentage increase in the Medicare Economic Index (MEI). Specifically, these amounts are calculated by updating the previous year's amount by the percentage increase in the MEI for the upcoming calendar year and rounding to the nearest $10.00. Thus, for CY 2026, we proposed to increase the CY 2025 KX modifier threshold amount by the most recent forecast of the 2017-based MEI. For CY 2026, the proposed MEI increase is estimated to be 2.7 percent and is based on the expected historical percentage increase of the 2017-based MEI. Multiplying the CY 2025 KX modifier threshold amount of $2,410 by the proposed CY 2026 percentage increase in the MEI of 2.7 percent ($2,410 x 1.027) and rounding to the nearest $10.00 results in a proposed CY 2026 KX modifier threshold amount of $2,480 for physical therapy and speech-language pathology services combined and $2,480 for occupational therapy services. We also proposed to update the MEI increase for CY 2026 based on historical data through the second quarter of 2025, and we proposed to use such data, if appropriate, to determine the final MEI percentage increase and the CY 2026 KX modifier threshold amounts in the CY 2026 PFS final rule.

Section 1833(g)(7)(B) of the Act describes the targeted medical review (MR) process for services of physical therapy, speech-language pathology, and occupational therapy services. The threshold for targeted MR is $3,000 through CY 2027. Effective beginning with CY 2028, the MR threshold levels will be annually updated by the percentage increase in the MEI, per section 1833(g)(7)(B) of the Act. Consequently, for CY 2026, the MR threshold is $3,000 for physical therapy and speech-language pathology services combined and $3,000 for occupational therapy services. Section 1833(g)(5)(E) of the Act states that CMS shall identify and conduct targeted medical review using factors that may include the following:

The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this title.

The therapy provider has a billing pattern for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day.

The therapy provider is newly enrolled under this title or has not previously furnished therapy services under this part.

The services are furnished to treat a type of medical condition.

The therapy provider is part of a group that includes another therapy provider identified using the factors described previously in this section.

We track each beneficiary's incurred expenses for therapy services annually and count them towards the KX modifier and MR thresholds by applying the PFS rate for each service less any applicable multiple procedure payment reduction (MPPR) amount for services of CMS- designated “always therapy” services (see the CY 2011 PFS final rule at 75 FR 73236). We also track therapy services furnished by critical access hospitals (CAHs), applying the same PFS-rate accrual process, even though they are not paid for their therapy services under the PFS and may be paid on a cost basis (effective January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through 74410).

When the beneficiary's incurred expenses for the year for outpatient therapy services exceed one or both of the KX modifier thresholds, therapy suppliers and providers use the KX modifier on claims for subsequent medically necessary services. Using the KX modifier, the therapist and therapy provider attest that the services above the KX modifier thresholds are reasonable and necessary and that documentation of the medical necessity for the services is in the beneficiary's medical record. Claims for outpatient therapy services exceeding the KX modifier thresholds without the KX modifier included are denied.

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

Comment: A commenter stated their appreciation of issuing the KX modifier threshold amounts and the MR threshold amount for CY 2026.

Response: We appreciate the commenter for their remarks.

Comment: A commenter requested that we issue the CY 2026 KX modifier thresholds in time to ensure consistent education by the A/B MACs that they believe will reduce claim denials and simplify the therapist's care planning.

Response: We would like to clarify that the A/B MACs are notified through our usual subregulatory change management process allowing them sufficient time to update the allowed dollar amount for CY 2026 outpatient KX modifier thresholds to $2,480. As such, claims from providers or therapists for therapy services above the CY 2026 KX modifier threshold amounts will not be denied unless the provider does not believe them to be medically necessary and foregoes the inclusion of the KX modifier on the claim for services as is appropriate.

We stated in the correction notice to the CY 2026 PFS proposed rule that we would use the MEI update based on historical data through the second quarter of 2025 to determine the final MEI percentage increase and the CY 2026 KX modifier threshold amounts in the CY 2026 PFS final rule. Since the projected 2026 MEI update based on historical data through the 2nd quarter of 2025 remains at 2.7 percent, we are finalizing the CY 2026 KX modifier threshold amounts as proposed; that is $2,480 for physical therapy and speech-language pathology services combined and $2,480 for occupational therapy services.

1. Updates to Payment for Digital Mental Health Treatment (DMHT) and Comment Solicitation on Payment Policy for Software as a Service (SaaS) a. Updates to Payment for DMHT

In the CY 2025 PFS final rule (89 FR 97923 through 97928), we established Medicare payment to billing practitioners for digital mental health treatment (DMHT) devices furnished incident to professional behavioral health services used in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care. We use the term “DMHT device” to include the term digital cognitive behavioral therapy we used in prior rulemaking (88 FR 79012 through 79013) and in general to refer to software devices cleared, approved, or granted De Novo authorization by the Food and Drug Administration (FDA) that are intended to treat or alleviate a mental health condition, in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care, by generating and delivering a mental health treatment intervention that has a demonstrable positive therapeutic impact on a patient's health. We use the terms “behavioral health conditions” and “mental disorders” interchangeably and to mean psychiatric disorders as referenced in FDA regulation, 21 CFR 882.5801. This includes substance use disorders. The FDA definition of devices encompasses certain software intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals.\82\ As the field of innovative products including digital therapeutics and computerized behavioral therapy devices for behavioral health treatment develops and expands the FDA continues to apply a risk-based framework to review and classify computerized behavioral therapy devices.

\82\ Sec. 201(h)(1) of the Federal Food, Drug, and Cosmetic Act.

Effective January 1, 2025, we finalized three HCPCS G-codes for DMHT devices, to be billed by physicians and practitioners who are authorized to furnish services for the diagnosis and treatment of mental illness: G0552 (Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan); HCPCS code G0553 (First 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month); and HCPCS code G0554 (Each additional 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing information related to the use of the DMHT device, including patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month. (List separately in addition to HCPCS code G0553)). We note that in the CY 2026 PFS proposed rule (90 FR 32593 through 32597), we inadvertently transcribed the code descriptors for HCPCS codes G0553 and G0554 with the wording we had proposed in the CY 2025 PFS proposed rule, rather than as refined and finalized (89 FR 97927).

Additionally, we finalized the conditions of payment for these codes. To be payable under the PFS, the DMHT device must have been cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or granted De Novo authorization by FDA and in each instance classified at 21 CFR 882.5801. In addition, the billing practitioner must incur the cost of the DMHT device furnished to the beneficiary, and the furnishing of the DMHT device must be incident to the billing practitioner's professional services in association with ongoing behavioral health treatment under a plan of care by the billing practitioner. Furthermore, we finalized that the billing practitioner must diagnose the patient with a mental health condition and prescribe or order the DMHT device. In the CY 2026 PFS proposed rule (90 FR 32352, 32503), we clarified that the patient must have a mental health condition diagnosis, but the billing practitioner does not need to be the practitioner who made the diagnosis. The patient could then use the DMHT device in settings according to how the device has been classified by FDA for use at 21 CFR 882.5801, which could include the home or an office or other outpatient setting if consistent with the FDA classification for use. Also, payment may only be made for DHMT devices for mental health treatment in accordance with the use indicated in their FDA classification at 21 CFR 882.5801. We continue to be vigilant about waste, fraud and abuse as we develop payment policy for devices that may function like DMHT devices but whose technology platforms may differ from those of DMHT devices classified at 21 CFR 882.5801. We seek to ensure that DMHT devices are not only safe for patients but also beneficial for patients. Our objective in requiring that DMHT devices be classified at 21 CFR 882.5801 as a condition of payment was to set guardrails within our payment policy for patient safety and benefit. While partly in recognition of our inability to evaluate every DMHT device, in this way we limited payment to devices which are required to comply with the special controls requiring clinical data to validate the model of behavioral therapy as implemented by the device. While presently use cases for insomnia, substance use disorder, depression and anxiety have been classified by the FDA at 21 CFR 882.5801, future use cases are not necessarily limited to these. It is possible that additional DMHT devices for other use cases with similar characteristics may be classified under this code section.

As stated in the CY 2025 PFS final rule (89 FR 97926) and in the CY 2026 PFS proposed rule (90 FR 32503), updating our payment policies will be an iterative process relating first to behavioral health treatment and by extension to chronic conditions. Behavioral health conditions are some of the most prevalent chronic diseases in the country. Among adults aged 18 or older in 2023, 22.8 percent (or 58.7 million people) had any mental illness and 48.5 million people aged 12 or older (or 17.1 percent) had a substance use disorder (SUD) in the past year. These behavioral health conditions are often chronic in nature. Individuals with Major Depressive Disorder, for example, often have recurrent episodes throughout their lives.\83\

\83\ https://www.samhsa.gov/data/sites/default/files/NSDUH%202023%20Annual%20Release/2023-nsduh-main-highlights.pdf.

The technologies and platforms for digital therapeutics are evolving rapidly. We are at an early stage of Medicare payment for DMHT devices as supplies furnished incident to professional behavioral health services used in

conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care. In considering the next stage in the development of our payment policy, we have been reviewing interested parties' recommendations to make payment for FDA authorized devices under other classifications, including Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions under 21 CFR 876.5960; Biofeedback device under 21 CFR 882.5050; Digital therapy device to reduce sleep disturbance for psychiatric conditions under 21 CFR 882.5705; Digital therapy device for Attention Deficit Hyperactivity Disorder under 21 CFR 882.5803; and Computerized behavioral therapy device for the treatment of fibromyalgia symptoms to be codified at 21 CFR 882.5804. We noted that Medicare coverage of biofeedback is limited by a long-standing national coverage determination. See, Medicare National Coverage Determinations Manual Chapter 1, Part 1 (Sections 10--80.12) Coverage Determinations, Section 30.1, Biofeedback, https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/ncd103c1_part1.pdf.

We proposed to expand our payment policies for HCPCS codes G0552, G0553, and G0554 to also make payment for DMHT devices cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and in each instance classified at 21 CFR 882.5803, Digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD). The 21 CFR 882.5803 classification is for software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment. Comparable to the special controls for device classification 21 CFR 882.5801 Computerized behavioral therapy device for psychiatric disorders, the 21 CFR 882.5803 device classification's special controls require the use of a validated measure to evaluate effectiveness of the device to provide therapy for ADHD or any of its individual symptoms. The special controls for device classification 21 CFR 882.5801 require that clinical data must be provided to describe a validated model of behavioral therapy for the psychiatric disorder; and to validate the model of behavioral therapy as implemented by the device. Comparable to the 21 CFR 882.5801 device classification, the 21 CFR 882.5803 device classification is intended to provide therapy as an adjunct to clinician supervised treatment. We believe that it is important to expand our coding and payment policies to include such devices classified at 21 CFR 882.5803 to more fully reflect the range of behavioral health disorders treated by FDA-authorized products. We also proposed that all the conditions of payment for HCPCS codes G0552, G0553, and G0554 finalized in the CY 2025 PFS final rule (89 FR 97927) would apply to DMHT devices classified at 21 CFR 882.5803. These conditions of payment for DMHT device coding are that the billing practitioner is incurring the cost of furnishing the DMHT device to the beneficiary as a supply, that furnishing of the DMHT device is incident to the billing practitioner's professional services in association with ongoing behavioral health treatment under a plan of care by the billing practitioner, and that payment may only be made for DHMT devices for mental health treatment in accordance with the use indicated in their FDA classification (89 FR 97927).

Additionally, we solicited comments on whether we should establish coding and payment policies for devices classified under the following FDA regulation sections that were recommended to us by interested parties: Computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions at 21 CFR 876.5960; Digital therapy devices to reduce sleep disturbance for psychiatric conditions at 21 CFR 882.5705; and Computerized behavioral therapy device for the treatment of fibromyalgia symptoms to be codified at 21 CFR 882.5804.

Medicare FFS claims data for HCPCS codes G0552, G0553, and G0554 have remained low in volume since we established these codes in the CY 2025 PFS final rule. We understand there may be several reasons for this. We are aware per interested parties and commenters that one of the conditions of payment that we established for these codes, that the billing practitioner is incurring the cost of furnishing the DMHT device to the patient, may not align with direct-to-consumer delivery and payment models that existed before the final rule was issued.

At this time, we do not believe we can appropriately price all the DMHT devices for which we would make payment under our current policies and proposals, and therefore, we did not propose any changes to the existing contractor-priced status for HCPCS code G0552. As we have noted, the technologies and DMHT therapies are evolving rapidly. We have recognized that our payment policy, too, will evolve. Given the dynamic nature of the development of these devices and the variation in methods of action for potential technology platforms, we do not have sufficient information needed to establish national pricing for devices described by HCPCS code G0552 at this time. We recognized that the ongoing nationwide behavioral health workforce shortage combined with increasing demand for behavioral health care services may limit access to behavioral health services for some Medicare beneficiaries.\84\ We recognized that digital therapeutic devices may offer innovative means to access certain behavioral health care services. We acknowledged that the field of digital therapeutics is evolving and continue to solicit comments from the public on this topic, including the CPT Editorial Panel. We have continued to aim to both provide access to vital behavioral health services and to gather further information about the delivery of digital behavioral health therapies, their effectiveness, their adoption by practitioners as complements to the behavioral health care that they furnish, and their use by patients for the treatment of behavioral health conditions. We have continued to seek information and may consider national pricing through future rulemaking.

\84\ https://bhw.hrsa.gov/data-research/projecting-health-workforce-supply-demand.

We sought comments on the possibility of establishing for CY 2026 additional separate coding and payment for a broader based set of services describing digital tools used by practitioners intended for maintaining or encouraging a healthy lifestyle, as part of a mental health treatment plan of care. Specifically, we sought information about clinical practice involving use of such tools. On what reliable evidence do practitioners inform their clinical judgment that use of such digital tools is warranted or beneficial to their treatment of the patient? What role do these digital tools typically have within plans of behavioral health treatment? What appropriate crosswalks would we consider for the purposes of nationally pricing a code to describe digital tools that do not require FDA clearance, approval or authorization and therefore do not entail the development costs of FDA clearance, approval or authorization or meet other conditions of payment for HCPCS code G0552, primarily that the practitioner must bear the cost of the DMHT device as a supply incident to their services. For example, we could consider the inputs assigned to CPT code 98016 (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 evaluation and management service provided within the previous 7 days nor leading to an evaluation and management service or procedure within the next 24 hours or soonest available appointment, 5 to 10 minutes of medical discussion) or CPT code 99421 (Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5 to 10 minutes). Since the resource costs reflected in the practice expense should be lower for services involving digital tools that do not require FDA clearance, approval, or authorization or meet the condition of payment that the billing practitioner bears the cost of supplying the DMHT device for HCPCS code G0552, we anticipated that the corresponding valuation for any additional coding would be appropriately lower than G0552. We solicited comments on these potential crosswalks or any other services that may best approximate the resource costs involved in cases where practitioners furnish a digital tool as part of a mental health treatment plan of care and furnish initial education and onboarding, per course of treatment that augments a behavioral therapy plan, and monthly treatment management services directly related to the patient's use of these digital tools. We also solicited comments on these potential crosswalks or any other services that may best approximate the resource costs involved in cases where practitioners do not furnish the digital tool and do not furnish initial education and onboarding for the tool but nonetheless incorporate use of the tool as part of a mental health treatment plan of care.

Additionally, we sought comments on other related digital device policies for our consideration in future rulemaking. Specifically, we received a request from an interested party to create a new add-on G code to existing CPT codes 96112, 96113, 96116, 96121, 96130, 96131, 96132, and 96133 (code descriptors can be found in Table A-I1), for physicians' or non-physician practitioners' psychological/ neuropsychological evaluations so they may report administration of an FDA authorized eye-tracking technology to aid in the diagnosis of Autism Spectrum Disorder (ASD) in pediatric patients, including staff time with the patient, data submission and output.

The interested party stated that the device collects data based on the clinical presentation of a patient, then an analysis algorithm is applied to the collected data to generate output. The interested party raised concerns that currently there are delays and waitlists to obtain diagnostic evaluations for children at risk for ASD. Their solution is to use this ASD diagnosis tool at the point of care after a parent or physician identifies a risk of ASD in a child. According to the interested party, this digital device can help reduce ASD diagnosis delays to be seen by a diagnostic specialist. The interested party is requesting the following code descriptor, Algorithm-driven neurological assessment for likelihood of Autism Spectrum Disorder (ASD) diagnosis, and of ASD-measures' severity (for example, social disability, verbal and non-verbal ability), derived from validated quantitative analysis of looking behavior, and recommends for CMS to either establish a national rate for the add-on code using a crosswalk to CPT code 93243 (External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report), CPT code 93247 (External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; scanning analysis with report), or to allow contractor pricing.

We solicited comments from the public regarding whether creating an add-on G code and contractor pricing is needed for the administration of an FDA authorized eye-tracking technology and other technology to aid in the diagnosis of ASD in pediatric patients; or whether it would be more appropriate to go through the CPT Editorial Panel process to obtain a Category III CPT code for this treatment.

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

Comment: Many commenters reported inconsistency among Medicare Administrative Contractors (MACs) in setting payment rates for HCPCS code G0552. Many of these commenters stated that they believe uncertainty among practitioners about adequate payment has resulted in a barrier to practitioners' adoption of this technology. The overwhelming majority of these commenters recommended that we adopt a national rate for HCPCS code G0552. Other commenters recommended that CMS provide guidance to the MACs regarding the appropriate considerations for evaluating the medical necessity of a DMHT device and for establishing pricing data sources specific to DMHT devices. They also recommended that CMS instruct the MACs to develop a timely and transparent process for claims review and require that individuals with behavioral health expertise be involved in the coverage determination and claims review processes.

Response: We appreciate the commenters for their recommendations. In response to the comments, we will work with the CMS MACs to improve the understanding of the billing rules for HCPCS code G0552. As we stated in the CY 2025 PFS final rule (89 FR 97928), we still do not believe that we have enough information to appropriately price all the DMHT devices for which we propose to make payment. As we have noted, the technologies and DMHT therapies are evolving rapidly. Given the dynamic nature of the development of these devices and the variation in methods of action for potential technology platforms, we do not have sufficient information needed to establish national pricing for devices under HCPCS code G0552 at this time. However, we continue to welcome information on this and may consider national pricing through future rulemaking.

Comment: Many commenters made specific comments about our proposal to make payment for DMHT devices cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and in each instance classified at 21 CFR 882.5803, Digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD). The majority of commenters supported this proposal. Some commenters opposed including devices from any other FDA classification in addition to devices classified at 21 CFR 882.5801 as finalized in the CY 2025 PFS final rule.

The commenters stated that adding more devices under HCPCS code G0552 would lead to a misleading code descriptor, confusion for the provider community with uncertainty about which devices would be payable, imprecise valuations, and increased variability in pricing among the MACs. These commenters instead suggested that CMS assign a national price for all devices under HCPCS code G0552. Others were opposed to allowing payment of devices specifically classified at 21 CFR 882.5803, Digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD) because they believe these devices were not representative of the Medicare population.

Response: We appreciate commenters for their feedback. As we stated in the

CY 2026 PFS proposed rule, we believe that it is important to expand our coding and payment policies to include such devices classified at 21 CFR 882.5803 to more fully reflect the range of behavioral health disorders treated by FDA-authorized products. The classification at 21 CFR 882.5803 is for software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment. Comparable to the special controls for device classification under 21 CFR 882.5801, Computerized behavioral therapy device for psychiatric disorders, the 21 CFR 882.5803 device classification's special controls require the use of a validated measure to evaluate effectiveness of the device to provide therapy for ADHD or any of its individual symptoms. The special controls for device classification under 21 CFR 882.5801 require that clinical data must be provided to describe a validated model of behavioral therapy for the psychiatric disorder; and to validate the model of behavioral therapy as implemented by the device. Comparable to the 21 CFR 882.5801 device classification, the 21 CFR 882.5803 device classification is intended to provide therapy as an adjunct to clinician supervised treatment. We believe it is appropriate to group these devices under a single HCPCS code, G0552. We are finalizing payment for DMHT devices cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and in each instance classified at 21 CFR 882.5803, Digital therapy device for Attention Deficit Hyperactivity Disorder (ADHD), as proposed. Furthermore, we are clarifying here that the patient must have a mental health condition diagnosis, but the billing practitioner does not need to be the practitioner who made the diagnosis. As proposed, all HCPCS code G0552 billing requirements applicable to devices classified at 21 CFR 882.5801 will be applicable to devices classified at 21 CFR 882.5803, that is:

The billing practitioner is incurring the cost of furnishing the DMHT device to the beneficiary as a supply,

That furnishing of the DMHT device is incident to the billing practitioner's professional services in association with ongoing behavioral health treatment under a plan of care by the billing practitioner, and

Payment may only be made for DHMT devices for mental health treatment in accordance with the use indicated under their FDA classification.

Comment: Many commenters recommended CMS to expand the number of devices payable under our DMHT payment policy, HCPCS code G0552, to include, “Computerized behavioral therapy devices for treating symptoms of gastrointestinal conditions” classified under 21 CFR 876.5960; and for “Computerized behavioral therapy device for the treatment of fibromyalgia symptoms” to be codified at 21 CFR 882.5804. A few commenters offered their support for making payments for “Digital therapy devices to reduce sleep disturbance for psychiatric conditions” classified under 21 CFR 882.5705. The commenters, who did not mention these devices' classifications, suggested instead expanding coding and payment for digital treatment of mental health and medical conditions through alternative approaches. Some suggested the creation of a code specific to each device, others suggested developing future coding according to device indications, others suggested coding by FDA classification, others suggested relying on CPT coding, and others suggested payment for devices under bundled services. Some commenters further suggested various criteria or processes by which to evaluate and decide which devices to make eligible for payment. Some commenters offered their suggestions for approaching coverage determinations.

Response: We appreciate commenters who responded to our solicitation regarding whether we should establish coding and payment policies for devices classified under the three FDA regulations discussed earlier. At this time, we are not further expanding payment under our DMHT payment policy. We will continue to solicit input from interested parties for coding and payment policies to expand payment for FDA cleared and authorized digital mental health treatment devices. We may consider expanding our payment policy to include them under future rulemaking.

Comment: Many commenters were opposed to the possibility of establishing for CY 2026 additional separate coding and payment for a broader based set of services describing digital tools used by practitioners intended for maintaining or encouraging a healthy lifestyle, as part of a mental health treatment plan of care. These commenters believe that no payment should be made for digital tools which have not been cleared or authorized by the FDA as devices. A few commenters stated they were encouraged by our comment solicitation and shared how they believe clinical practices may rely on information to form clinical judgments about using such digital tools and whether such use may be warranted and beneficial to patient care. Some commenters expressed concern that we intended to finalize payment for these tools under HCPCS code G0552.

Response: We appreciate all the comments we received. At this time, after consideration of all these comments we are not finalizing any new coding and payment for such digital tools. To reiterate, HCPCS code G0552 makes payment available for the supply of digital mental health treatment devices and initial education and onboarding, per course of treatment that augments a behavioral therapy plan. Devices paid for under HCPCS code G0552 must be cleared or authorized by the FDA and classified under either 21 CFR 882.5801, or beginning January 1, 2026, under 21 CFR 882.5803.

Comment: We received public comments on the comment solicitation regarding whether creating an add-on G code and contractor pricing is needed for the administration of an FDA authorized eye-tracking technology and other technology to aid in the diagnosis of ASD in pediatric patients; or whether it would be more appropriate to go through the CPT Editorial Panel process to obtain a Category III CPT code for this treatment.

Response: We appreciate the commenters for their comments. After consideration of public comments, we express appreciation for the feedback from commenters and will take the comments into consideration for possible future rulemaking.

[GRAPHIC] [TIFF OMITTED] TR05NO25.092