Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program

We have previously issued requests for information (RFIs) to gather public input on the transition to digital quality measurement (dQM) for CMS programs.\430\ This RFI provided updates on our progress and seeks input as we continue our path forward in the dQM transition.

\430\ We refer readers to the following rules which contain the previous RFIs: FY 2022 IPPS/LTCH PPS final rule (86 FR 45342 through 86 FR 45349); FY 2023 IPPS/LTCH PPS final rule (87 FR 49181 through 87 FR 49188); CY 2022 Physician Fee Schedule (PFS) final rule (86 FR 65377 through 86 FR 65382); CY 2023 PFS proposed rule (87 FR 46259 through 87 FR 46262); CY 2022 Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center (ASC) final rule (86 FR 63815 through 86 FR 63822); and CY 2022 End-Stage Renal Disease (ESRD) PPS final rule (86 FR 61941 through 86 FR 61948).

In the CY 2026 PFS proposed rule, we solicited comments on our anticipated approach to the use of Health Level Seven[supreg] (HL7[supreg]) Fast Healthcare Interoperability Resources[supreg] (FHIR[supreg]) in electronic clinical quality measure (eCQM) reporting (90 FR 32710 through 32715). Currently, several CMS programs use, or are considering using, eCQMs for various clinicians, facilities, providers, and other organizations to report their respective quality performance data. These CMS programs include the Medicare Shared Savings Program (Shared Savings Program) and the Quality Payment Program, particularly the Merit-Based Incentive Payment System (MIPS) quality performance category. Specifically, we also solicited feedback on key components of the ongoing dQM transition related to FHIR-based eCQMs for the Shared Savings Program and the MIPS quality performance category. These components include: (1) FHIR-based eCQM conversion progress; (2) Data standardization for quality measurement and reporting; (3) The timeline under consideration for FHIR-

based eCQM reporting; (4) Measure development and reporting tools; and (5) FHIR Reporting and Data Aggregation for ACOs (90 FR 32710 through 32715).

We received many comments on this RFI and we thank commenters for their responses. Although we will not be addressing the comments received in response to this RFI in this final rule, we value the input received and will take the comments into consideration to help us consider potential future rulemaking of policies for transition to digital quality measurement in CMS programs. f. MIPS Performance Category Measures and Activities (1) Quality Performance Category (a) Background

Section 1848(q)(1)(A)(i) and (ii) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to certain specified performance standards and, using such methodology, to provide for a final score for each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act provides that the Secretary must use the quality performance category in determining each MIPS eligible clinician's final score, and section 1848(q)(2)(B)(i) of the Act describes the measures that must be specified under the quality performance category.

We refer readers to Sec. Sec. 414.1330 through 414.1340 and the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77097 through 77162 and 82 FR 53626 through 53641, respectively), and the CY 2019, CY 2020, CY 2021, CY 2022, CY 2023, CY 2024, and CY 2025 PFS final rules (83 FR 59754 through 59765, 84 FR 63949 through 62959, 85 FR 84866 through 84877, 86 FR 65431 through 65445, 87 FR 70047 through 70055, 88 FR 79329 through 79338, and 89 FR 98373 through 98375, respectively) for a description of previously established policies and statutory basis for policies regarding the quality performance category.

In the CY 2026 PFS proposed rule (90 FR 32715), we proposed to:

Amend the definition of the term “high priority measure” to remove references to health equity at Sec. 414.1305; and

Modify the MIPS quality measure set as described in Appendix 1 of this final rule, including the addition of new measures, updates to specialty sets, removal of existing measures, and substantive changes to existing measures. (b) High Priority Measure Definition

The Meaningful Measures Initiative provides for the identification of high priority areas for quality measurement and quality improvement, which identifies the core quality of care issues that advance our work to improve patient outcomes (83 FR 59719). To further identify priority areas for MIPS quality measurement, we defined the term “high priority measure” at Sec. [thinsp]414.1305, beginning with the CY 2019 performance period/2021 MIPS payment year, as an “outcome (including intermediate-outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure” (83 FR 59761). In the CY 2023 PFS final rule (87 FR 70047 through 70049), we finalized an amended definition of the term “high priority measure” to include quality measurement pertaining to health equity. We also codified this revised definition at Sec. [thinsp]414.1305 beginning with the CY 2023 performance period/2025 MIPS payment year (87 FR 70047 through 70048). In the CY 2023 PFS final rule (87 FR 70047), we noted significant and persistent inequities in healthcare outcomes exist in the United States and that we are committed to developing innovative solutions that support access to high quality care and promote health equity, including the exploration of solutions to measure health equity within MIPS. Consequently, we stated that we believed it was imperative to include quality measures pertaining to health equity as high priority measures in order to incentivize the adoption of health equity measures by MIPS eligible clinicians. In the CY 2023 PFS final rule (87 FR 70049) we defined health equity as “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, and other factors that affect access to care and health outcomes.” This definition was adopted during the Public Health Emergency (PHE) for COVID-19. At the time we believed that adding the term health equity to our definition of a “high priority measure” was the best way to address health disparities exacerbated by the pandemic. On September 12, 2023, the Department of Health and Human Services (HHS) announced the end of the Federal PHE for COVID-19 in a statement effective May 11, 2023.\431\ Now that the PHE has ended, we believe that these disparities are best addressed through other mechanisms. We believe that our definition of “health equity” was confusing and that health disparities are best addressed through efforts to improve overall healthcare quality for all beneficiaries. Therefore, in the CY 2026 PFS proposed rule (90 FR 32715) we proposed to remove “health equity” from the definition of “high priority measure”. Additionally, we requested public input to identify measures around well-being and nutrition as new high priority areas for quality measurement and quality improvement. The following is a summary of the comments we received and our responses.

\431\ Available at https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.

Comment: Several commenters supported the proposal to remove health equity from the definition of a high priority measure because the change would align the definition across CMS quality reporting programs. The commenters stated that the alignment would allow clinicians and health IT developers to focus on a consistent set of measure types across the care continuum, supporting streamlined reporting and reducing burden and confusion.

Response: We thank the commenters for their feedback.

Comment: Many commenters did not agree with the removal of health equity from the high priority measure definition. Commenters believe that disparities across racial, ethnic, socioeconomic, and other lines continue to exist and stated the view that removing health equity from the definition of a high priority measure undermines efforts to address those disparities and diminishes efforts to improve quality and outcomes across all patient populations.

A few commenters also stated that health equity is integral to improving healthcare quality and patient safety and experience. A few commenters stated that development of quality measures focused on health equity should be prioritized. A few commenters stated the view that reducing disparities in health outcomes cannot be achieved simply through efforts to improve health care quality for all but instead requires targeted efforts. A commenter stated that it does not regard measures assessing health, happiness, and life satisfaction as substitutes for health equity measures.

Response: We share the goal of improving healthcare quality and

patient safety and experience, but we continue to believe that health disparities are best addressed through other mechanisms including improvements to healthcare quality and patient safety. We encourage the commenters to continue to identify gaps in care quality, which could be addressed through other internal clinician and health care organization quality improvement efforts separate from Federal quality reporting programs such as MIPS. We are reshaping the MIPS quality measure inventory to focus on different high-priority measures, as determined by the current administration, fewer process measures, and more outcome-based measures that align across quality reporting programs \432\ (for example, XXX) and payers. Any new measures added to MIPS to support this effort will continue to be developed in accordance with current processes. While we agree that the previous definition may have been important for driving high quality care for all, the removal of health equity does not preclude related quality actions from continuing. Further, the removal of health equity does not lessen the focus on improving health care quality and patient safety and experience. Instead, replacing it with a wellness-based subcategory broadens the perspective to emphasize prevention, holistic care, mental and behavioral health, and lifestyle approaches that promote well-being for all individuals. This expanded framing encourages a more inclusive and proactive approach that supports better health across diverse populations. By highlighting wellness and comprehensive care, the new structure helps clinicians and organizations focus on practical strategies that strengthen overall patient outcomes and community health.

\432\ See, for example, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization final rule.

Comment: A few commenters requested CMS to clarify how reporting of equity-focused data will be advanced without health equity explicitly included in the high-priority measure definition. A commenter stated that although they supported the proposed revision of the high priority measure definition to remove health equity, they believe continued collection and analysis of equity-related data is important and will play a role in the Make America Healthy Again efforts.

Response: We note that the removal of health equity from the definition of a high priority measure does not preclude related quality action from continuing and does not lessen the focus on improving health care quality and patient safety and experience. Instead, replacing it with a wellness-based subcategory broadens the perspective to emphasize prevention, holistic care, mental and behavioral health, and lifestyle approaches that promote well-being for all individuals. This expanded framing encourages a more inclusive and proactive approach that supports better health across diverse populations. By highlighting wellness and comprehensive care, the new structure helps clinicians and organizations focus on practical strategies that strengthen overall patient outcomes and community health.

Comment: A commenter noted that if CMS removes health equity from the high priority measure definition, the agency should consider eliminating high priority measures in general because the commenter believes it adds complexity without adding value to the program.

Response: We are finalizing to remove health equity from the high priority definition. However, we do not agree that we should remove high priority measures at this time as they align with our National Quality Strategy. They are important to ensure clinicians focus on the most impactful aspects of patient care, driving improvement in crucial areas. For example, high priority measures include outcome, patient safety, and patient experience measures, which focus on the most important results of healthcare interventions. Additionally, high priority measures are included in our data submission requirements for traditional MIPS as clinicians must submit collected data for at least 6 quality measures (including one outcome measure or high priority measure in the absence of an applicable outcome measure), or a complete specialty measure set. Further, high priority measures are included in our data submission for MVPs as an MVP Participant must select and report, if applicable, 4 quality measures, including 1 outcome measure (or, if an outcome measure is not available, 1 high priority measure).

Comment: A commenter requested that CMS continue to invest in developing and refining health equity related measures, provide technical assistance and resources to support implementation of those measures, especially for small and rural practices, and align health equity measurement across programs to reduce burden and confusion. A commenter stated that in light of the proposed removal of health equity measures from the definition of a high priority quality measure, they wished to highlight the importance of considering environmental and social factors to ensuring success of surgical care.

Response: We are committed to the success of small and rural practices and efforts for alignment which reduce burden and confusion. We note that we currently offer assistance through the CMS help desk which may be reached at [email protected]. For more information about the resources available please see https://www.cms.gov/about-cms/information-systems/hpms/help-desk-information. We thank commenters for highlighting the importance of considering environmental and social factors to ensuring surgical care success. We are committed to improving healthcare quality including surgical care.

After consideration of the comments on this proposal we are finalizing our revision to the definition of “high priority measure” as proposed. Specifically, we are amending the definition of the term “high priority measure” at Sec. [thinsp]414.1305 to mean an “outcome (including intermediate-outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure” beginning with the CY 2026 performance period/2028 MIPS payment year. (c) Selection of Quality Measures (i) Addition of New Quality Measures (A) Pre-Rulemaking Process

Prior to introducing a new MIPS quality measure in a proposed rule, we receive public input on measures through the pre-rulemaking process (referred to as the Pre-Rulemaking Measure Review (PRMR)) established in accordance with section 1890A of the Act. Although section 1848(q)(2)(D)(viii) of the Act provides that the pre-rulemaking process under section 1890A of the Act is not required to apply to the selection of MIPS quality measures, we have found that the pre- rulemaking process provides a comprehensive review of measures from multi-stakeholder workgroups and have accordingly elected for such measures to be reviewed utilizing the PRMR process (87 FR 70048). Under the established PRMR process (additional information regarding the PRMR process is available at https://p4qm.org/PRMR), CMS has

contracted with a Consensus-Based Entity (CBE), which is responsible for convening a multi-stakeholder panel comprised of clinicians, patients, measure experts, and health information technology specialists to provide input on measures CMS is considering for use in Medicare.

The pre-rulemaking process begins with CMS's publication of measures under consideration for use in Medicare (the MUC List). Each measure on the MUC List is reviewed by one of several committees convened by the PQM for the purpose of providing multi-stakeholder input to the Secretary. The PRMR process includes opportunities for public comments through a 21-day public comment period, as well as public listening sessions. The PQM posts the compiled comments and listening session inputs received during the public comment period and the listening sessions within 5 days of the close of the public comment period. More details regarding the PRMR process may be found in the PQM Guidebook of Policies and Procedures for Pre-Rulemaking Measure Review and Measure Set Review.

The final vote of a multistakeholder committee convened by the CBE may result in the following disposition of a measure: recommended, recommended with conditions, do not recommend, or no consensus. A “no consensus” recommendation signals continued disagreement among the committee despite being presented with perspectives from public comments, committee member feedback and discussion, and highlights the multi-faceted assessments of quality measures. Quality measures that are considered for potential implementation in MIPS starting with CY 2026 performance period/2028 payment year period were included on the 2024 Measures Under Consideration (MUC) List (available at https://mmshub.cms.gov/sites/default/files/2024-MUC-List.xlsx). The new MIPS quality measures as finalized are described in Table Group A of Appendix 1 of this final rule. There may be cases in which the CBE does not recommend a measure to move forward to the rulemaking process and eventual implementation due to a measure not being endorsed by the CBE or other CBE, but we go forth with proposing a measure. We note that section 1848(q)(2)(D)(iii)(v)(III) of the Act does not preclude the Secretary from proposing and implementing measures that are not endorsed by a CBE as long as the measure is evidence-based. (ii) Removal of Quality Measures

In the CY 2025 PFS final rule, we codified previously established criteria for the removal of MIPS quality measures from the MIPS quality measure inventory at Sec. 414.1330. In the CY 2017 Quality Payment Program final rule (81 FR 77136 through 77137), we established the following criteria for measure removal to include: If the Secretary determines that the MIPS quality measure is no longer meaningful, such as MIPS quality measures that are topped out; and, if a measure steward is no longer able to maintain the quality measure. In the CY 2019 PFS final rule (83 FR 59763), we expanded the criteria for measure removal to include MIPS quality measures that reached an extremely topped-out status (for example, a measure with an average mean performance within the 98th to 100th percentile range); the MIPS quality measure may be proposed for removal in the next rulemaking cycle, regardless of whether or not it is in the midst of the topped-out measure lifecycle, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made, after taking into account any other relevant factors.

Also, in the CY 2019 PFS final rule (83 FR 59764), we established other criteria for measure removal, specifically MIPS quality measures that are: duplicative; not maintained or updated to reflect current clinical guidelines, which are not reflective of a clinician's scope of practice; and low-bar, standard of care process measures. As described in the CY 2019 PFS final rule (83 FR 59765), we established an approach to incrementally remove process measures where prior to removal, consideration will be given to, but will not be limited to the following:

Whether the removal of the process measure impacts the number of measures available for a specific specialty.

Whether the MIPS quality measure addresses a priority area highlighted in the Measure Development Plan: https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measuredevelopment.html.

Whether the MIPS quality measure promotes positive outcomes in patients.

Considerations and evaluation of the measure's performance data.

Whether the MIPS quality measure is designated as high priority or not.

Whether the MIPS quality measure has reached extremely topped-out status within the 98th to 100th percentile range, due to the extremely high and unvarying performance where meaningful distinctions and improvement in performance can no longer be made.

In the CY 2020 PFS final rule (84 FR 62958 through 62959), we expanded the criteria for measure removal to include MIPS quality measures that do not meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods and not available for MIPS quality reporting by or on behalf of all MIPS eligible clinicians. For MIPS quality measures that do not meet case minimum and reporting volumes required for benchmarking after being in the program for 2 consecutive CY performance periods, we noted that we will factor in other considerations (such as, but not limited to: The robustness of the measure; whether it addresses a measurement gap; if the measure is a patient-reported outcome; and consideration of the MIPS quality measure in developing MVPs) prior to determining whether to remove the MIPS quality measure. (iii) Inventory of Quality Measures

Section 1848(q)(2)(D)(i) of the Act requires the Secretary, through notice and comment rulemaking, to establish an annual final list of quality measures from which MIPS eligible clinicians may choose for the purpose of assessment under MIPS. Section 1848(q)(2)(D)(i)(II) of the Act requires that the Secretary annually update the list by removing measures from the list, as appropriate; adding new measures to the list, as appropriate; and determining whether measures that have undergone substantive changes should be included on the updated list.

Previously finalized MIPS quality measures can be found in the CY 2025 PFS final rule (89 FR 98599 through 98954), CY 2024 PFS final rule (88 FR 79556 through 79964), CY 2023 PFS final rule (87 FR 70250 through 70633), CY 2022 PFS final rule (86 FR 65687 through 65968), CY 2021 PFS final rule (85 FR 85045 through 85377), CY 2020 PFS final rule (84 FR 63205 through 63513), CY 2019 PFS final rule (83 FR 60097 through 60285), CY 2018 Quality Payment Program final rule (82 FR 53966 through 54174), and CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816). We are finalizing changes to the MIPS quality measure inventory, as set forth in Appendix 1 of this final rule, including the following: the addition of new measures; updates to specialty sets (that is, creation of new specialty sets;

addition and/or removal of measures; and substantive changes to existing measures within specialty sets); removal of existing measures; and substantive changes to existing measures. For the CY 2026 performance period, we are finalizing an inventory of 190 MIPS quality measures.

On January 4, 2025, we announced that we will be accepting recommendations for potential new specialty measure sets or revisions to existing specialty measure sets for year 10 (CY 2017 performance period/2019 MIPS payment year through CY 2026 performance period/2028 MIPS payment year) of MIPS under the Quality Payment Program.\433\ The recommendations we received were based on the MIPS quality measures finalized in the CY 2025 PFS final rule and the 2024 MUC List; the recommendations include the addition or removal of current MIPS quality measures from existing specialty sets, and/or the creation of new specialty sets. All specialty set recommendations submitted for consideration were assessed and vetted, and as a result, the recommendations that we agree with are finalized in this rule. We are finalizing modifications to existing specialty sets as described in Table Group B of Appendix 1 of this final rule. Specialty and subspecialty sets are not inclusive of every specialty or subspecialty. We develop and maintain specialty measure sets to assist MIPS eligible clinicians with selecting quality measures that are most relevant to their scope of practice.

\433\ Message to the Quality Payment Program listserv on January 4, 2025, entitled “The Centers for Medicare & Medicaid Services (CMS) is Soliciting Stakeholder Recommendations for Potential Consideration of New Specialty Measure Sets and/or Revisions to the Existing Specialty Measure Sets for the 2026 Performance Year of the Merit-based Incentive Payment System (MIPS).”

In CY 2026 PFS proposed rule (90 FR 32874 through 33255) we proposed to modify the quality performance category measure inventory, a set of 190 MIPS quality measures, for the CY 2026 performance period/ 2028 MIPS payment year, which included the following:

Implementation of 5 new MIPS quality measures including 3 high priority measures, one of which is a patient reported outcome measure;

Removal of 10 MIPS quality measures: 1 quality measure at the measure steward's request due to not being aligned with current clinical guidelines, 4 quality measures that are extremely topped out, 1 quality measure that has reached the end of the topped-out measure lifecycle, 1 measure where the measure steward is no longer able to maintain the quality measure, 3 process measures, and;

Substantive changes to 32 MIPS quality measures.

In the CY 2026 PFS (90 FR 32874 through 33255) we proposed new MIPS quality measures for inclusion in MIPS for the CY 2026 performance period/2028 payment year and future years can be found in Table Group A of Appendix 1 of this final rule. For the CY 2026 performance period/ 2028 MIPS payment year, we proposed 5 new MIPS quality measures, which include 3 high priority measures, one of which is also a patient- reported outcome measure.

In addition to establishing new individual MIPS quality measures and modifying existing specialty sets as described in Tables Group A and Group B of Appendix 1 of this final rule, we refer readers to Table Group C of Appendix 1 of this PFS final rule for a list of MIPS quality measures finalized for removal and applicable rationale for each measure. In the 2025 PFS final rule (89 FR 98388), we codified previously finalized removal criteria for MIPS quality measures at 42 CFR 414.1330(c). Of the 10 MIPS quality measures finalized for removal, 1 MIPS quality measure is being removed at the measure steward's request and is not aligned with current clinical guidelines), 4 MIPS quality measures are extremely topped out, 1 MIPS quality measure has reached the end of the topped-out measure lifecycle, 1 MIPS quality measure is no longer able to be maintained by the measure steward, and 3 are process measures. For a detailed discussion of our rationale for the removal of these measures please see Table Group C of Appendix 1 of this final rule. We have continuously communicated to interested parties our desire to reduce the number of process measures within the MIPS quality measure set (see, for example, 83 FR 59763 through 59765). The finalized policy to remove the MIPS quality measures described in Table Group C of Appendix 1 of this final rule would lead to a more parsimonious inventory of meaningful, robust measures in the program.

Additionally, we are finalizing substantive changes to 30 MIPS quality measures, which can be found in Table Group D of the Appendix 1 in this final rule. We have previously established criteria that would apply when we are considering making substantive changes to a quality measure (81 FR 77137, and 86 FR 65441 through 65442). On an annual basis, we review the established MIPS quality measure inventory to consider updates to the measures. Possible updates to measures may be minor or substantive. The finalized inventory of 190 MIPS quality measures includes 187 MIPS quality measures available for utilization in traditional MIPS and MVPs, and 3 MIPS quality measures available only for utilization in MVPs (as finalized in the CY 2024 PFS final rule (88 FR 79897 through 77902)).

We refer readers to Table Groups A through DD of Appendix 1 of this final rule for a summary of the new measures finalized, the measures finalized for removal, and the substantive changes finalized. We received public comments on these proposals. The comments and responses may be found in Appendix 1 of this final rule. (2) Cost Performance Category (a) Background

Section 1848(q)(2)(A)(ii) of the Act includes resource use as a performance category under MIPS. We refer to this performance category as the cost performance category. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories of MIPS are used in determining the MIPS final score for each MIPS eligible clinician. In general, MIPS eligible clinicians are evaluated under all four of the MIPS performance categories, including the cost performance category.

Section 1848(q)(2)(B)(ii) of the Act provides that, for the cost performance category, the measurement of resource use (that is, cost) for such period must be in accordance with section 1848(p)(3) of the Act, using the methodology under section 1848(r) as appropriate, and, as feasible and applicable, accounting for the cost of drugs under Medicare Part D. Section 1848(p)(3) of the Act provides that costs shall be evaluated, to the extent practicable, based on a composite of appropriate measures of costs established by the Secretary that eliminate the effect of geographic adjustments in payment rates, and take into account risk factors (such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals) and other factors determined appropriate by the Secretary. Section 1848(r) of the Act specifies a series of steps and activities for the Secretary to undertake to involve physicians, practitioners, and other interested parties in enhancing the infrastructure for cost measurement, including for purposes of MIPS and Advanced APMs under section 1833(z) of the Act.

In the CY 2026 PFS proposed rule (90 FR 32718), we proposed the following updates to the cost performance category beginning with the CY 2026

performance period/2028 MIPS payment year:

Modify the MIPS cost measure inventory as described in Appendix 4 of this rule;

Update the operational list of care episode and patient condition groups and codes to reflect changes to service and diagnosis codes that define care episodes and patient condition groups, as identified through the annual maintenance of episode-based measures; and

Adopt a 2-year informational-only feedback period for new cost measures, where a measure will not impact MIPS cost performance category scores, final scores, or payment adjustments until the third year it is implemented.

For a description of the statutory authority for and existing policies pertaining to the cost performance category, we refer readers to Sec. Sec. 414.1350 and 414.1380(b)(2) and the CY 2017 Quality Payment Program final rule (81 FR 77162 through 77177), CY 2018 Quality Payment Program final rule (82 FR 53641 through 53648), CY 2019 PFS final rule (83 FR 59765 through 59776), CY 2020 PFS final rule (84 FR 62959 through 62979), CY 2021 PFS final rule (85 FR 84877 through 84881), CY 2022 PFS final rule (86 FR 65445 through 65461), CY 2023 PFS final rule (87 FR 70055 through 70057), CY 2024 PFS final rule (88 FR 79339 through 79349), and CY 2025 PFS final rule (89 FR 98390 through 98408).

More details on the finalized proposals in this section, which we solicited comments on, are provided in section IV.A.4.d.(2)(b) through section IV.A.4.d.(2).(d). of this final rule. We also refer readers to section V.B.5.c. of this final rule for discussion on the burden estimates for these proposals. (b) Selection of Cost Measures

In accordance with our statutory authority as described in section IV.A.4.d.(2)(a) of this final rule and at Sec. [thinsp]414.1350(a), we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category. We refer readers to the CY 2026 PFS proposed rule (90 FR 32718) for additional context on the considerations for cost measure selection. (c) Inventory of Cost Measures

As discussed previously, we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category. There are currently 35 cost measures in the cost performance category for the CY 2025 performance period/2027 MIPS payment year, comprising 33 episode-based measures covering a range of conditions and procedures and 2 population-based measures. Previously finalized MIPS cost measures can be found in the CY 2018 Quality Payment Program final rule (82 FR 53641 through 53648), CY 2019 PFS final rule (83 FR 59765 through 59776), CY 2020 PFS final rule (84 FR 62959 through 62979), CY 2021 PFS final rule (85 FR 84877 through 84881), CY 2022 PFS final rule (86 FR 65445 through 65461), CY 2023 PFS final rule (87 FR 70055 through 70057), CY 2024 PFS final rule (88 FR 79339 through 79349), and CY 2025 PFS final rule (89 FR 98390 through 98408). We refer readers to the CY 2026 PFS proposed rule (90 FR 32718 through 32719) for more context on how we establish the inventory of cost measures, including the pre-rulemaking requirements.

We neither proposed any new MIPS cost measures nor proposed to remove any MIPS cost measures for the CY 2026 performance period/2028 MIPS payment year. In the CY 2026 PFS proposed rule (90 FR 32719) we proposed substantive changes to one cost measure, which can be found in Table Group A of Appendix 4 of this final rule, beginning with the CY 2026 performance period/2028 MIPS payment year.

We solicited and received public comments on the proposal to modify one cost measure. We refer readers to Table Group A of Appendix 4 of this final rule for a summary of the public comments received regarding the proposed modifications to one cost measure beginning in the CY 2026 performance period and the discussion regarding final decisions.

After consideration of public comments, and for the reasons stated in the aforementioned Table Group A of Appendix 4 of this final rule and the CY 2026 PFS proposed rule (90 FR 33258 through 33261), we are finalizing the modifications to the one cost measure as proposed. (d) Revisions to the Operational List of Care Episode and Patient Condition Groups and Codes

In accordance with section 1848(r)(2)(H) of the Act, in the CY 2026 PFS proposed rule (90 FR 32719) we proposed to revise the operational list beginning with the CY 2026 performance period/2028 MIPS payment year to reflect changes to codes used to identify existing care episode and patient condition groups, based on new information gathered during annual maintenance of episode-based measures and the Medicare Spending Per Beneficiary (MSPB) Clinician measure. We conduct annual maintenance for measures implemented in MIPS to ensure that the codes used for the measure specifications remain up to date. For example, we may update the service or diagnosis codes associated with a cost measure's specifications to retain the intent of the measure when these codes are changed in, added to, or deleted from the applicable code sets. During our annual maintenance review process for MIPS cost measures, we worked with the measure developer to identify several non-substantive changes to service and diagnosis codes that should be reflected in the operational list care episode and patient condition groups so that, to the extent feasible, there is alignment between the operational list and measure specifications. More information on the annual maintenance process is available at the CMS Measures Management System (MMS) page at https://mmshub.cms.gov/measure-lifecycle/measure-use/maintenance/annual-update.

For context on the statutory requirements for care episode and patient condition groups and changes to the operational list, we refer readers to the CY 2026 PFS proposed rule (90 FR 32719 through 32720).

Our revisions to the operational list are available for review on our QPP Cost Measure Information page at https://www.cms.gov/medicare/quality/value-based-programs/cost-measures/about.

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

Comment: Commenters were supportive of the proposed updates to the operational list of care episode and patient condition groups and codes.

Response: We thank the commenters for their support.

Comment: A commenter stated that updates to the operational list of care episode and patient condition groups and codes, such as diagnosis code updates, could change TPCC measure attribution. This commenter suggested that CMS involve specialty societies and technical expert panels when making any coding updates to avoid unintended consequences for cost measures, including changes to triggering logic or attribution methodologies.

Response: The operational list of care episode and patient condition groups and codes only contains care episode and patient condition groups. The TPCC measure is not based on care episode or patient condition groups and is therefore not included in this document. The operational list is annually updated

through rulemaking, as statutorily required under section 1848(r)(2)(H). In the CY 2026 PFS proposed rule (90 FR 32719), we proposed updates to the operational list so that the list reflects the most recent non-substantive updates we made to the Medicare Spending Per Beneficiary (MSPB) Clinician measure and episode-based measures through annual maintenance. We refer readers to the CY 2026 PFS proposed rule (90 FR 32718 through 32719) for a description of the cost measure maintenance process. We refer readers to Table Group A of Appendix 4 of this final rule for more information on modifications to the TPCC measure.

After consideration of public comments, we are finalizing as proposed to revise the operational list beginning with the CY 2026 performance period/2028 MIPS payment year to reflect changes to codes used to identify existing care episode and patient condition groups. (e) Adopt a 2-Year Informational-Only Feedback Period for New MIPS Cost Measures (i) Background on Informational-Only Feedback Period

Section 1848(q)(2)(B) of the Act provides that MIPS measures and activities must be specified for a performance period for each of the four performance categories, including the cost performance category as set forth in section 1848(q)(2)(B)(ii) of the Act. Section 1848(q)(5)(A) of the Act requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician according to performance standards with respect to applicable measures and activities specified in accordance with section 1848(q)(2)(B) with respect to each performance category. Section 1848(q)(5)(A) of the Act further directs the Secretary to provide for a composite assessment (that is, a MIPS final score) for each MIPS eligible clinician for the applicable performance period for such MIPS payment year using such methodology. At Sec. [thinsp]414.1350(a), we specify cost measures for a performance period to assess the performance of MIPS eligible clinicians on the cost performance category.

Currently, we assess a MIPS eligible clinician's performance on any measure we have specified for the MIPS cost performance category for a performance period that is attributed to a MIPS eligible clinician in accordance with Sec. 414.1350(b)(8), calculating a score on the clinician's performance with respect to the cost measure in accordance with Sec. 414.1380(b)(2). As we discussed in detail in the CY 2025 PFS final rule when we modified our scoring methodology (89 FR 98438 through 98446), we score cost measures by comparing a MIPS eligible clinician's attributed costs to benchmark ranges based on the median cost of all MIPS eligible clinicians attributed the same cost measure, plus or minus standard deviations (Sec. 414.1380(b)(2)(i)(B)). We then calculate the cost performance category score as set forth in Sec. 414.1380(b)(2)(iii), which we incorporate into our calculation of the MIPS final score in accordance with Sec. Sec. 414.1380(c) and 414.1350(d). We then compare the MIPS final score with the performance threshold established for that MIPS payment year to calculate the MIPS payment adjustment in accordance with section 1848(q)(6) of the Act and Sec. 414.1405. Section 1848(q)(12) of the Act further provides that we must make available timely confidential feedback to MIPS eligible clinicians regarding their performance in the cost performance category.

Many interested parties have requested more timely and transparent feedback on cost measures, specifically mentioning an informational- only feedback period for MIPS cost measures. We refer readers to the CY 2026 PFS proposed rule (90 FR 32719 through 32720) for more discussion on the types of information MIPS eligible clinicians receive about cost measures, the feedback we received, and relevant considerations. We believe that an informational-only feedback period would provide MIPS eligible clinicians with information and time to develop performance improvement strategies before their performance on new cost measures affects payment or is incorporated into MIPS final scores. (ii) Adopt an Informational-Only Feedback Period of 2 Years for New Cost Measures

Section 1848(q)(1)(A) of the Act requires that the Secretary develop a methodology for assessing the total performance of each MIPS eligible clinician, provide a MIPS final score for each MIPS eligible clinician using such methodology, and to determine and apply a MIPS payment adjustment factor for each MIPS eligible clinician using the MIPS final score. As discussed previously, section 1848(q)(5) of the Act more specifically requires the Secretary to develop a methodology for assessing the total performance of each MIPS eligible clinician on measures and activities specified under section 1848(q)(2)(B) of the Act and to provide for a MIPS final score. As part of this methodology, we are proposing an informational-only feedback period of 2 years for new cost measures finalized for use in MIPS beginning with the CY 2026 performance period/2028 MIPS payment year.

Specifically, in the CY 2026 PFS proposed rule (90 FR 32719 through 32722) we proposed that, beginning with the CY 2026 performance period/ 2028 MIPS payment year, we would score all new cost measures for the first 2 years after the measure is initially finalized for informational-only purposes; we would not incorporate any informational-only scores on cost measures into MIPS eligible clinicians' cost performance category score or MIPS final score. If a MIPS eligible clinician is attributed a cost measure during its informational-only feedback period, then we would calculate a measure score in accordance with our scoring policies at Sec. 414.1380(b)(2) and confidentially provide the score, as well as MIPS performance feedback (see 82 FR 53799 through 53801), to the clinician on an annual basis. As we would not include the informational-only score in our calculation of cost performance category scores or MIPS final scores, MIPS eligible clinicians' performance on the new cost measures would not affect our calculation of their MIPS payment adjustments.

We further proposed that we would begin incorporating these cost measures' scores into MIPS eligible clinicians' cost performance category and MIPS final scores beginning with the cost measure's third year in MIPS, after this 2-year informational-only feedback period. Once we begin incorporating these measures' scores into MIPS eligible clinicians' cost performance category and MIPS final scores, then MIPS eligible clinicians' performance on these measures would also affect their MIPS payment adjustments.

While we did not propose to adopt any new cost measures in this final rule, we proposed that this policy would begin with the CY 2026 performance period/2028 MIPS payment year. We proposed that beginning with the CY 2026 performance period/2028 MIPS payment year, this policy would be in place prior to any new cost measures being added to the MIPS cost performance category through future rulemaking.

We proposed that this informational-only feedback period policy will not be applied to any existing cost measures already finalized for MIPS prior to the CY 2026 performance period/2028 MIPS payment year. We further proposed that modifications to existing cost measures will not alter whether a measure is considered a new or existing measure.

We proposed this policy for measures that have not previously been implemented in MIPS so that MIPS eligible clinicians receive initial performance feedback on new cost measures without affecting their MIPS payment adjustments. The measures within the current cost measure inventory have already been implemented through the rulemaking process and are finalized for use in MIPS scoring for the CY 2025 performance period/2027 MIPS payment year. As a result, MIPS eligible clinicians have already made decisions about their MIPS participation for the CY 2025 performance period/2027 MIPS payment year based on the inclusion of existing cost measures in MIPS scoring and payment adjustments. Further, many of the existing cost measures have been in use in MIPS for several years, so MIPS eligible clinicians have become more familiar with the measure specifications and opportunities for improvement. We anticipated that this proposed informational-only feedback period will drive performance improvement for MIPS eligible clinicians, while continuing to support the statutory requirement for clinicians to be scored on cost as part of their composite performance score, as specified under section 1848(q)(5)(A) of the Act.

The timeline for new cost measures adopted after the effective date of this proposal would be as follows:

First CY Performance Period/MIPS Payment Year: Informational-only feedback period.

Second CY Performance Period/MIPS Payment Year: Informational-only feedback period.

Third CY Performance Period/MIPS Payment Year: Cost measure scores will be incorporated into MIPS eligible clinicians' cost performance category and MIPS final scores, affecting their MIPS payment adjustments for the performance period's corresponding payment year.

We also proposed that cost measures within an informational-only feedback period can be included in an MVP if they are clinically relevant. MVPs aim to improve value through assessing linked performance categories, including cost and quality (86 FR 65391). As such, we will include cost measures eligible for scoring as well as measures in the informational-only feedback period in MVPs, when appropriate, consistent at Sec. 414.1365(c)(2). CMS may create an MVP that only includes cost measures in an informational-only feedback period in instances where these are the only relevant cost measures for an MVP. Any cost measures would continue to be determined for use in an MVP in accordance with the MVP development criteria and the MVP cost reporting requirements as set forth in the CY 2022 PFS final rule (86 FR 65405 through 65409; 86 FR 65412, respectively).

We proposed that an MVP, including any cost measures within their informational-only feedback period, would continue to be scored according to all scoring policies outlined in Sec. 414.1365(d), including Sec. 414.1365(d)(3)(ii). Section 414.1365(d)(3)(ii) provides that we calculate the cost performance category score for the cost measures included in the MVP that an MVP participant selects and reports using the methodology at Sec. 414.1380(b)(2), the same as for any cost measures. As we proposed to codify this informational-only feedback period policy at Sec. 414.1380(b)(2) as discussed below, cost measures included in an MVP (that an MVP participant selects and reports) that are in their informational-only feedback period would be treated in the same manner as if the MVP participant was attributed the cost measure under traditional MIPS.

In other words, we proposed that, if a new cost measure in its informational-only feedback period is included in an MVP, then we would calculate a measure score in accordance with our proposed scoring policy at Sec. 414.1380(b)(2) and confidentially provide the score, as well as MIPS performance feedback, to the MVP participants that select and report that MVP on an annual basis. We will not incorporate any informational-only scores on cost measures into the MVP participant's cost performance category score or MIPS final score.

The proposal will provide MIPS eligible clinicians the ability to receive informational-only feedback on their cost measure performance and their performance within an MVP, without delaying the creation of clinically meaningful MVPs in MIPS. We will provide this informational- only feedback in accordance with MIPS feedback policies, as outlined in section 1848(q)(12) of the Act. We have also heard feedback from interested parties requesting that we implement MVPs through a gradual process, where there is transparency and time for MIPS eligible clinicians to adapt to changes (86 FR 65394 through 65395). We believe that including cost measures in MVPs that are in the informational-only feedback period aligns with these requests, providing transparency and time to adapt to new cost measures that a MIPS eligible clinician may be attributed within an MVP. In addition, we seek to align scoring of MVPs with scoring of traditional MIPS whenever possible, in accordance with the MVP scoring policy outlined in the CY 2022 PFS final rule (86 FR 65419 through 65421).

We also proposed that we will not publicly report MIPS eligible clinicians' performance on cost measures within their informational- only feedback period. Public reporting of information regarding performance of eligible clinicians and groups, as required by section 1848(q)(9) of the Act, allows patients to use data to inform their care decisions. The goal of an informational-only feedback period is to provide MIPS eligible clinicians time and information to become familiar with new cost measures prior to affecting MIPS eligible clinicians. We believe that public reporting while a measure is within this feedback period would be inconsistent with the goals of this policy.

In addition, the 2-year informational-only feedback period aligns with the current structure of public reporting, where for the first 2 years that a measure is in use in MIPS, it cannot be publicly reported, as outlined at Sec. 414.1395(c). The cost measures will be available for consideration for public reporting starting in the third year that they are in use (that is, the first year that new cost measures are included in MIPS eligible clinicians' cost performance category and MIPS final scores).

Additionally, we proposed to codify this informational-only feedback period by amending Sec. 414.1380(b)(2). Specifically, we proposed to add this policy under several new paragraphs at Sec. 414.1380(b)(2)(vi). First, we proposed that Sec. 414.1380(b)(2)(vi) will provide that, beginning with the 2028 MIPS payment year, CMS will calculate a score for each new cost measure in accordance with the scoring policy set forth in this paragraph (b)(2) for informational- only purposes during the measure's informational-only feedback period.

Second, we proposed to define the terms “new cost measure” and “informational-only feedback period” for the purposes of this paragraph (b)(2)(vi) at Sec. 414.1380(b)(2)(vi)(A). We proposed to define “new cost measures” at Sec. 414.1380(b)(2)(vi)(A)(i) as meaning a measure that CMS has newly specified for the MIPS cost performance category for a performance period at Sec. 414.1350 beginning with the 2028 MIPS payment year. We will further provide at Sec. 414.1380(b)(2)(vi)(A)(i) that this term excludes any cost measures that CMS has specified for the MIPS cost performance category prior to the 2028

MIPS payment year or CMS modifies at any time. We proposed to define “informational-only feedback period” at Sec. 414.1380(b)(2)(vi)(A)(ii) as meaning a 2-year period beginning with the first day of the first performance period and ending with the final day of the second performance period for the 2 applicable MIPS payment years for which CMS initially has specified the new cost measure.

Third, we proposed to add paragraphs (B), (C), and (D) to Sec. 414.1380(b)(2)(vi) to codify our proposed scoring of a new cost measure during and after its informational-only feedback period. We will provide at Sec. 414.1380(b)(2)(vi)(B) that, during a new cost measure's informational-only feedback period, CMS will not include any scores for the new cost measure calculated for informational-only purposes under this paragraph (b)(2)(vi) in CMS's calculation of a MIPS eligible clinician's cost performance category score under paragraph (b)(2)(iii) or a MIPS eligible clinician's MIPS final score under paragraph (c) of Sec. 414.1380. At Sec. 414.1380(b)(2)(vi)(C), we will provide that, during a new cost measure's informational-only feedback period, CMS will confidentially provide each MIPS eligible clinician with their measure score under this paragraph (b)(2)(vi) for informational-only purposes. Also, we would provide at Sec. 414.1380(b)(2)(vi)(C) that CMS will provide performance feedback to the MIPS eligible clinician in accordance with section 1848(q)(12) of the Act. We would provide at Sec. 414.1380(b)(2)(vi)(D) that, upon completion of a new cost measure's informational-only feedback period, CMS will include its calculation of any scores for the cost measure in CMS' calculation of a MIPS eligible clinician's cost performance category score under paragraph (b)(2)(iii) and a MIPS eligible clinician's MIPS final score under paragraph (c) of Sec. 414.1380.

Finally, we proposed to modify the paragraph at Sec. 414.1380(b)(2)(iii) to exclude cost measure scores calculated for informational-only purposes as provided in paragraph (b)(2)(vi).

We did not propose any modification to the remaining text as currently codified at Sec. 414.1380(b)(2)(iii).

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

Comment: Many commenters supported our proposal to implement an informational-only feedback period for new cost measures. Commenters stated that the informational-only feedback period would have various positive impacts, such as maintaining stability in MIPS, providing the public with more time to understand cost measures in practice, increasing transparency for cost measures, optimizing clinician performance, and allowing time for clinician education on cost measures.

Response: We appreciate the commenters' support of our proposal to implement an informational-only feedback period for new cost measures. The proposed informational-only feedback period will improve cost performance category transparency and promote clinician understanding of cost measures and awareness of performance improvement opportunities.

Comment: A commenter noted support for the proposal to delay public reporting of new cost measures during the 2-year informational-only feedback period, citing the potential for early performance data to be misleading.

Response: We appreciate the commenter's support of our proposal and our intention to align the informational-only feedback period with the public reporting timeline for cost measures.

Comment: Some commenters requested that CMS expand the informational-only feedback period policy. Specifically, some commenters requested that the policy be applied retroactively to MIPS cost measures in use for previous performance periods. Some commenters noted that this retroactive application would provide clinicians with more information before cost measure scores are tied to performance to ensure equitable treatment of clinicians attributed previously implemented cost measures. A commenter requested that CMS allow for an extended informational-only feedback period of up to 3 years for complex cost measures or changes to data systems. Another commenter requested that CMS apply the informational-only feedback period policy to newly eligible MIPS clinicians or to clinicians who have not yet been scored on a particular measure.

Response: MIPS eligible clinicians receive notice in advance of the cost measures on which they may be scored through several avenues. As we detailed in the CY 2026 PFS proposed rule (90 FR 32720), clinicians receive notice through (1) the cost measure development process, which requires input from clinicians, specialty societies, and other interested parties as outlined in section 1848(r)(2) of the Act and the CY 2019 PFS final rule (83 FR 59770); (2) the Pre-Rulemaking Measure Review (PRMR) process, where measures are assessed for their potential use in MIPS; (3) and the notice-and-comment rulemaking process, where we propose and finalize any cost measures for use in a future MIPS performance period. During this time, clinicians have access to measure specifications and testing information for review. Furthermore, the MIPS cost measures have already been implemented through the rulemaking process and are finalized for use in MIPS scoring for the CY 2025 performance period/2027 MIPS payment year. As a result, MIPS eligible clinicians have already made decisions about their MIPS participation for the CY 2025 performance period/2027 MIPS payment year based on the inclusion of existing cost measures in MIPS scoring and payment adjustments. In addition, many of the existing cost measures have been in use in MIPS for several years, so MIPS eligible clinicians have become more familiar with the measure specifications and opportunities for improvement. Since the MIPS cost performance category is calculated using administrative claims data and clinicians do not report data for the cost performance category, we do not believe that data system updates warrant changes to the informational-only feedback policy. While we appreciate that newly eligible clinicians may need resources and assistance when first participating in the MIPS program, expanding the informational-only feedback period to apply for any newly eligible clinicians or clinicians not previously scored on a cost measure would create additional burden to track and score appropriately, and may lead to confusion for clinicians when anticipating which cost measures will impact their MIPS score.

Comment: Some commenters requested that CMS apply the informational-only feedback period to cost measures that have undergone substantive changes. A commenter stated that substantially revised cost measures introduce uncertainty for MIPS clinicians. Another commenter stated that applying this policy to cost measures with substantive changes would give clinicians more time to understand the impact of the measure revisions.

Response: The policy currently intends to provide time for clinicians to become familiar with new MIPS cost measures. We will propose and finalize any substantive changes ahead of the performance period so that clinicians are able to understand and provide feedback on the changes to the measure specifications prior to MIPS program implementation. We will consider this feedback for potential future rulemaking.

Comment: A commenter requested that CMS add additional flexibilities to

the policy to account for the effects of extreme and uncontrollable circumstances and public health emergencies (PHEs).

Response: During the prior COVID-19 PHE, clinicians and groups continued to receive feedback on cost measures. In the event of a future PHE, we would use a similar approach to cost performance category feedback, if feasible. Should the PHE extend beyond the informational-only feedback period, our existing policies, codified at Sec. 414.1380(c)(2), offer flexibilities to any impacted MIPS participant, such as reweighting the cost performance category. We can consider additional flexibilities for this policy in future rulemaking if a need is identified.

Comment: Several commenters stated the importance of more frequent (for example, quarterly), actionable performance feedback and raised concerns that this feedback was not yet available for cost measures.

Response: As described in the CY 2025 final rule (89 FR 98398), we currently provide annual MIPS Performance Feedback that includes information on MIPS eligible clinicians' performance for the previous performance period. This feedback typically becomes available during the summer in between the performance period and the MIPS payment year. We provide these reports on an annual basis, as we calculate cost measures following the end of the performance period. We calculate and score the cost measures following the end of the performance period because we need to review all claims that fall within the scope of a cost measure for a given performance period. However, we are continuing to work towards providing meaningful and timely information on cost measures generally and we recognize the importance of providing this information for measures implemented in MIPS.

Comment: A commenter stated that CMS should clarify how scoring will work for MVPs that include cost measures still in the informational-only feedback period and should ensure that MVP participation remains fair and transparent in light of the informational-only feedback period proposal.

Response: As discussed in the CY 2026 PFS proposed rule (90 FR 32721), an MVP, including any cost measures within their informational- only feedback period, would continue to be scored according to all scoring policies outlined in Sec. [thinsp]414.1365(d), including Sec. [thinsp]414.1365(d)(3)(ii). However, we would not include the informational-only score in our calculation of cost performance category scores or MIPS final scores, therefore MIPS eligible clinicians' performance on the new cost measures would not affect our calculation of their MIPS payment adjustments. Although we would not include the informational-only score in cost performance category or MIPS final score calculation, cost measures included in an MVP (that an MVP participant selects and reports) that are in their informational- only feedback period would be treated in the same manner as if the MVP participant was attributed the cost measure under traditional MIPS.

After consideration of public comments, we are finalizing the informational-only feedback period policy as proposed. (3) Improvement Activities Performance Category (a) Background

Section 1848(q)(2)(A)(iii) of the Act includes clinical practice improvement activities as a performance category under MIPS. We refer to this performance category as the improvement activities performance category. As required by section 1848(q)(2) and (5) of the Act, the four performance categories of MIPS are used in determining the MIPS final score for each MIPS eligible clinician. In general, MIPS eligible clinicians are evaluated under all four of the MIPS performance categories, including the improvement activities performance category.

Section 1848(q)(2)(C)(v)(III) defines the term “clinical practice improvement activities” as an activity that relevant eligible professional organizations and other relevant stakeholders identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act provides that, for the improvement activities category, the Secretary shall specify subcategories of clinical practice improvement activities, including at least six subcategories as specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act. These statutorily enumerated subcategories are: (1) expanded practice access (such as same day appointments for urgent needs and afterhours access to clinician advice); (2) population management (such as monitoring health conditions of individuals to provide timely health care interventions or participation in a qualified clinical data registry); (3) care coordination (such as timely communication of test results, timely exchange of clinical information to patients and other providers, and use of remote monitoring or telehealth); (4) beneficiary engagement (such as the establishment of care plans for individuals with complex care needs, beneficiary self-management assessment and training, and using shared decision- making mechanisms); (5) patient safety and practice assessment (such as through use of clinical or surgical checklists and practice assessments related to maintaining certification); and (6) participation in an alternative payment model, as defined in section 1833(z)(3)(C) of the Act (section 1848(q)(2)(B)(iii)(I) through (VI) of the Act).

For previous discussions on the general background of the improvement activities performance category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77177 and 77178), the CY 2018 Quality Payment Program final rule (82 FR 53648 through 53661), the CY 2019 Physician Fee Schedule (PFS) final rule (83 FR 59776 and 59777), the CY 2020 PFS final rule (84 FR 62980 through 62990), CY 2021 PFS final rule (85 FR 84881 through 84886), the CY 2022 PFS final rule (86 FR 65462 through 65466), the CY 2023 PFS final rule (87 FR 70057 through 70061), and the CY 2024 PFS final rule (88 FR 79350 and 88 FR 79351). We also refer readers to Sec. 414.1305 for the relevant definitions of improvement activities and attestation, Sec. 414.1320 for standards establishing the performance period, Sec. 414.1325 for the data submission requirements, Sec. 414.1355 for standards related to the improvement activity performance category generally, Sec. 414.1360 for data submission criteria for the improvement activity performance category, and Sec. 414.1380(b)(3) for improvement activities performance category scoring.

In the CY 2026 PFS proposed rule (90 FR 32722 through 32725), we proposed various updates to the Improvement Activities Inventory beginning with the CY 2026 performance period/2028 MIPS payment year, as described further later in this section. First, we proposed to remove the Achieving Health Equity subcategory. Second, we proposed adding a new subcategory to the improvement activities performance category: Advancing Health and Wellness. Third, we proposed adding three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we proposed modifying seven existing improvement activities currently specified for the performance category. Fifth, we proposed removing eight improvement activities currently specified for the performance category.

We refer readers to section V.B.5.e of this final rule for discussion of the burden estimates for these proposals. (b) Improvement Activities Inventory (i) Annual Call for Activities Background

In the CY 2017 Quality Payment Program final rule (81 FR 77190), for the first year of MIPS, we implemented the initial Improvement Activities Inventory consisting of approximately 95 activities (81 FR 77817 through 77831). We made several steps to ensure the Inventory was inclusive of activities aligned with statutory and program requirements. As part of this process, we conducted numerous interviews with high performing organizations of all sizes and conducted an environmental scan to identify existing models, activities, or measures that met all or part of the improvement activities performance category, including patient-centered medical homes, the Transforming Clinical Practice Initiative (TCPI), Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys, and Agency for Healthcare Research and Quality's (AHRQ) Patient Safety Organizations. In addition, we reviewed the comments we received in response to the MIPS and APMs Request for Information (RFI) related to the improvement activities performance category, as described in the CY 2016 PFS final rule with comment period (80 FR 71259 and 71260). For the MIPS and APMs RFI, we sought input on what activities could be classified as clinical practice improvement activities according to the definition under section 1848(q)(2)(C)(v)(III) of the Act.

Beginning with the CY 2018 performance period/2020 MIPS payment year (82 FR 53656 through 53659), we introduced an informal process for interested parties to submit new improvement activities or modifications for our consideration and potential inclusion in the comprehensive Improvement Activities Inventory. In the CY 2018 Quality Payment Program final rule (82 FR 53656 through 53659), beginning with the CY 2019 performance period/2021 MIPS payment year, we finalized a formal Annual Call for Activities process for the addition of possible new activities and for possible modifications to current activities in the Improvement Activities Inventory. This process requires interested parties to submit a nomination form similar to the one we used for the CY 2018 performance period/2020 MIPS payment year (82 FR 53656 through 53659). To submit a request for a new activity or a modification to an existing activity, the interested party must submit a nomination form (OMB control # 0938-1314) available at www.qpp.cms.gov during the Annual Call for Activities. (ii) Update the Improvement Activities Inventory

In the CY 2018 Quality Payment Program final rule (82 FR 53660), we finalized that we would establish improvement activities through notice-and-comment rulemaking. For our previously finalized Improvement Activities Inventories, we refer readers to Table H in the CY 2017 Quality Payment Program final rule (81 FR 77817) Appendix, Tables F and G in the CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229) Appendix, Tables A and B in the CY 2019 PFS final rule (83 FR 60286 through 60303) Appendix 2, Tables A, B, and C in the CY 2020 PFS final rule (84 FR 63514 through 63538) Appendix 2, Tables A, B, and C in the CY 2021 PFS final rule (85 FR 85370 through 85377) Appendix 2, Tables A, B, and C in the CY 2022 PFS final rule (86 FR 65969 through 65997) Appendix 2, and Tables A, B, and C in the CY 2023 PFS final rule (70633 through 70650) Appendix 2. We also refer readers to the Quality Payment Program website and the Explore Measures and Activities tool at https://qpp.cms.gov/mips/explore-measures?tab=improvementActivities&py=2025 for a complete list of the current improvement activities. In the CY 2017 Quality Payment Program final rule (81 FR 77539), we codified the definition of improvement activities at Sec. [thinsp]414.1305, consistent with the statutory definition at section 1848(q)(2)(C)(v)(III) of the Act, to mean an activity that relevant MIPS eligible clinicians, organizations, and other relevant interested parties identify as improving clinical practice or care delivery and that the Secretary determines, when effectively executed, is likely to result in improved outcomes.

In the CY 2026 PFS proposed rule (90 FR 32722 through 32725), we proposed various updates to the improvement activities performance category, beginning with the CY 2026 performance period/2028 MIPS payment year. First, we proposed removing the Achieving Health Equity subcategory. Second, we proposed adding a new subcategory to the improvement activities performance category: Advancing Health and Wellness. Third, we proposed adding three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we proposed modifying seven existing improvement activities currently specified for the performance category. Fifth, we proposed removing eight improvement activities currently specified for the performance category. Generally, the three proposed new activities will fill gaps in the Improvement Activities Inventory and the seven proposed modified activities represent updates to the clinical goals of each modified activity. Our proposal to remove eight improvement activities reflects changes in our priorities and an intent to maintain an inventory of activities that are focused on driving improved patient outcomes directly. While we acknowledge the importance of clinical work and research that address the needs of specific populations, we proposed to exclude activities that do not have a direct and measurable impact on improving patient health outcomes. If MIPS-eligible clinicians or groups identify a need for clinical quality improvement specific to a unique population under their care, they can select from existing activities in the inventory that are designed to support such targeted efforts. Our proposal focuses on removing activities that do not lead to demonstrable improvements in patient outcomes, rather than those that address specific population needs through evidence-based clinical intervention. For example, IA_PSPA_19 (Implementation of formal quality improvement methods, practice changes or other practice improvement processes) allows for significant flexibility in the focus area of the quality improvement completed and MIPS-eligible clinicians or groups may be able to use this activity to improve clinical quality specific to a unique population under their care. (iii) Update to Subcategories Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

As discussed previously, section 1848(q)(2)(B)(iii) of the Act provides that the Secretary specifies clinical practice improvement activities under subcategories, which must include at least six enumerated subcategories. Under section 1848(q)(2)(B)(iii) of the Act, we established the current subcategories for the improvement activities performance category at Sec. 414.1355(c). (1) Proposal To Remove Achieving Health Equity Subcategory Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

In the CY 2026 PFS proposed rule (90 FR 32724), we proposed to remove the “Achieving Health Equity” (AHE)

subcategory beginning with the CY 2026 performance period/2028 MIPS payment year. We will also remove this subcategory from regulation at Sec. 414.1355(c)(7), replacing it with a new subcategory as described in later in this section.

This proposal to remove the AHE subcategory would not de-emphasize our focus on improving access, enhancing care coordination, and strengthening patient engagement. The removal of this subcategory would also be aligned with other CMS programs, Hospital Quality Reporting Programs, and other MIPS performance categories, such as the Quality performance category.). Additionally, maintaining a separate subcategory can lead to overlap with other domains such as care coordination, population management, and behavioral health integration, thus increasing burden. Integrating the principle of whole-person care and applying it within the broader framework of Advancing Health and Wellness allows CMS to promote a more holistic, prevention-focused approach that supports access across all activities.

As further discussed, we also proposed to recategorize five existing improvement activities from the Achieving Health Equity (AHE) subcategory to other established subcategories to better align with the substantive focus of these activities' descriptions. This proposed recategorization also reflects a strategic shift to emphasize emerging priorities such as wellness and prevention.

We solicited public comments on our proposal to remove the Advancing Health Equity subcategory from the improvement activities performance category and from Sec. 414.1355(c)(7) beginning with the CY 2026 performance year/2028 MIPS payment year.

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

Comment: Many commenters opposed the removal of the Achieving Health Equity subcategory, expressing concern that its elimination would diminish efforts to address disparities in healthcare access, quality, affordability, and outcomes. Some commenters believe the replacement of the Achieving Health Equity subcategory with a wellness- based subcategory is too limited in scope to meaningfully address health disparities, whereas the Achieving Health Equity directly targets systemic inequities and social determinants of health through focused, equity-driven improvement activities. A few commenters made suggestions to keep improvement activities that focus on upstream drivers of health. A commenter recommended placing these new activities under the Patient Safety and Practice Assessment (PSPA) and Expanded Practice Assess (EPA) subcategories.

Response: The removal of the Achieving Health Equity subcategory does not lessen the focus on improving access to care, enhancing patient well-being, or supporting preventative measures that influence health outcomes. Instead, replacing it with a wellness-based subcategory broadens the perspective to emphasize prevention, holistic care, mental and behavioral health, and lifestyle approaches that promote well-being for all individuals. This expanded framing encourages a more proactive approach that supports better health across all populations. By highlighting wellness and comprehensive care, the new structure helps clinicians and organizations focus on practical strategies that strengthen overall patient outcomes and community health.

Comment: A commenter who did not agree with the proposal to remove the Achieving Health Equity subcategory stated how specific improvement activities, such as IA_AHE_7 and IA_AHE_10, could be recategorized, and that individual improvement activities should be evaluated on merit. Another commenter also stated that we should work with interested parties to retain certain improvement activities.

Response: Following a comprehensive assessment of the Improvement Activities Inventory, we determined that reassigning five improvement activities from the Achieving Health Equity subcategory would align the Inventory with CMS' evolving priorities--specifically, preventive care, nutrition, and patient well-being (90 FR 32724). This determination was also supported by interested party comments received from the CY 2026 PFS proposed rule. IA_AHE_7 and IA_AHE_10 are being reassigned to the Beneficiary Engagement and Patient Safety and Practice Assessment subcategories, respectively, to ensure more accurate alignment between each activity's purpose and its designated subcategory. We will continue to work with interested parties across HHS and will assess new improvement activities during the Call for Improvement Activities process to ensure improvement activities continue to meet our priorities.

Comment: A few commenters supported the removal of the Achieving Health Equity subcategory. Other commenters supported the recategorization of improvement activities from the Achieving Health Equity subcategory.

Response: We appreciate commenters' support for our proposal.

After consideration of public comments, we are finalizing removing the Achieving Health Equity subcategory as proposed. (2) Add New Advancing Health and Wellness Subcategory Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

In the CY 2026 PFS proposed rule (90 FR 32724), we proposed to add a new subcategory, titled “Advancing Health and Wellness” (AHW), beginning with the CY 2026 performance period/2028 MIPS payment year. This proposed addition emphasizes CMS' priority of overall health promotion and addresses broader aspects of healthcare that go beyond the direct treatment of diseases.

We proposed to amend Sec. 414.1355(c)(7) by adding a new subcategory, “Advancing Health and Wellness” (AHW), to replace the “Achieving Health Equity” subcategory. Our proposal to add the AHW subcategory for the improvement activities performance category will address gaps in MIPS eligible clinicians' involvement in preventive care and health promotion. Our goal for this new subcategory is to ensure that care is tailored to meet the needs of patients, including their mental health and chronic disease management and prevention.

As discussed in sections IV.A.4.d.(3)(b)(iii) and IV.A.4.d.(3)(b)(vii) of this final rule, we also proposed to reassign one existing improvement activity (IA_PM_13 “Chronic Care and Preventative Care Management for Empaneled Patients”) to this new AHW subcategory. This activity allows a MIPS eligible clinician to manage chronic and preventive care for empaneled patients and would align with the “Advancing Health and Wellness” subcategory description. We will be adding more activities to this subcategory in future rulemaking.

We solicited public comments on the proposal to adopt a new subcategory, “Advancing Health and Wellness,” to the improvement activities performance category and at Sec. 414.1355(c)(7) beginning with the CY 2026 performance year/2028 MIPS payment year.

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

Comment: Many commenters supported the addition of the

Advancing Health and Wellness subcategory. However, a commenter also recommended that we clearly define and establish how “well-being” will be measured before it is adopted as a formal requirement.

Response: We appreciate the commenter's request for clarification on how well-being may be measured within the Advancing Health and Wellness subcategory. “Well-being” is intended to reflect overall health status beyond the treatment of specific conditions. Measurement approaches can include patient-reported outcome measures, clinical indicators such as preventive service use or chronic condition management, and functional outcomes like improvements in mobility or daily activities. To support implementation, we added an improvement activity from the CMS inventory to this new subcategory. At this time, we are not prescribing a single definition of well-being but instead allowing flexibility for practices to demonstrate improvement through established improvement activities. We will continue to assess possible improvement activities and will consider additional refinements in future rulemaking.

After consideration of public comments, we are finalizing the addition of the Advancing Health and Wellness subcategory as proposed. (iv) Adopt New Improvement Activities Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

In the CY 2026 PFS proposed rule (90 FR 32724), we proposed to adopt three new improvement activities beginning with the CY 2026 performance period/2028 MIPS payment year. We proposed that the IA_PM_27 (Improvement Detection of Cognitive Impairment in Primary Care) and IA_PM_28 (Integrating Oral Health Care in Primary Care) activities will be included in the Population Management subcategory. We proposed that the IA_PSPA_34 (Patient Safety in Use of Artificial Intelligence [AI]) activity will be included in the Patient Safety and Practice Assessment subcategory.

The first new improvement activity, IA_PM_27, titled “Improving Detection of Cognitive Impairment in Primary Care,” will allow MIPS eligible clinicians to increase the detection of cognitive impairment, especially in its early stages, by tracking baseline detection rates for mild cognitive impairment (MCI), dementia, and cognitive impairment. If rates are below 1.0, clinicians would increase Annual Wellness Visit uptake, ensure structured cognitive assessments, and address memory concerns during intake for patients 65+. Detection rates will be remeasured quarterly, with a focus on Medicare patients aged 65 and older. The second new improvement activity, IA_PM_28, titled “Integrating Oral Health Care in Primary Care,” will allow MIPS eligible clinicians to include an oral health risk assessment and intraoral screening in primary care, educate patients on the importance of oral health, and provide counseling on its impact on systemic diseases. For patients without a dental home or those with oral health needs, a dental referral would be provided.

The third new improvement activity, IA_PSPA_34, titled “Patient Safety Use of Artificial Intelligence,” will involve developing a new data-collection field within patient safety reporting systems for AI- attributable events. This will include events where actual harm was caused to a patient because AI technology was used, as well as near misses. Once a MIPS-eligible clinician has identified an event, a process to identify the cause and plan for future mitigation will be documented.

We refer readers to Table F-B1 in Appendix 2 of this final rule for more information regarding each of these proposed improvement activities.

We solicited public comments on proposals to add each of these activities to the improvement activities performance category beginning with the CY 2026 performance period/2028 MIPS payment year.

We received public comments on these proposals. The comments and responses may be found in Appendix 2 of this final rule. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the addition of the three new improvement activities.

Response: We thank the commenters for their support.

After consideration of public comments, we are finalizing the addition of three new improvement activities as proposed. (v) Modify Existing Improvement Activities Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

In the CY 2026 PFS proposed rule (90 FR 32724 and 32725), we proposed to modify seven existing improvement activities beginning with the CY 2026 performance period/2028 MIPS payment year. First, IA_AHE_1, IA_AHE_3, IA_AHE_6, IA_AHE_7, and IA_AHE_10, currently specified for the Achieving Health Equity subcategory, will be reassigned to other subcategories to better align each individual activity's purpose with its subcategory. We proposed to reassign IA_AHE_1 and IA_AHE_6 to the “Expanded Practice Access” (EPA) subcategory, IA_AHE_3 and IA_AHE_7 to the “Beneficiary Engagement” (BE) subcategory, and IA_AHE_10 to the “Patient Safety and Practice Assessment” (PSPA) subcategory. Second, we proposed to also reassign IA_PM_13, “Chronic Care and Preventative Care Management for Empaneled Patients,” to the new “Advancing Health and Wellness” subcategory. Third, we proposed several modifications to IA_BMH_1, currently titled “Diabetes Screening.” Specifically, we proposed to expand the scope of the activity. Currently, IA_BMH_1 is focused on screening only diabetic patients taking anti-psychotic medications.

The proposed modifications to IA_BMH_1 would broaden the relevant patient population by requiring a comprehensive physical health screening on all patients taking anti-psychotic medications. This modified activity will encompass a broader range of health conditions, beyond just diabetes, that may be impacted by antipsychotic medications. While diabetes remains a key focus due to its significant association with antipsychotic use, the expanded title reflects the inclusion of additional monitoring components, such as obesity, hypertension, dyslipidemia, movement disorders (for example, tardive dyskinesia), and other relevant physical health conditions. Diabetes would remain relevant for this improvement activity as it is a major comorbidity linked to antipsychotic medications, and monitoring for diabetes will remain an integral part of the comprehensive health assessment for these patients under this activity. We also proposed to modify the title of IA_BMH_1, renaming it to “Antipsychotic- Medication-Associated Physical Health Condition Assessment and Monitoring.” This proposed title better reflects the substantive modifications we proposed for this activity.

We refer readers to Table F-B2 in Appendix 2 of this final rule for more information regarding each of these proposed modifications to existing improvement activities.

We solicited public comments on our proposals to modify each of these activities currently specified for the improvement of activities performance category beginning with the CY 2026 performance period/2028 MIPS payment.

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

Comment: Commenters were supportive of the title modification of IA_BMH_1 but requested more clarity around the activity's requirements. One commenter stated that there were discrepancies between the rationale, which references comprehensive physical health screenings, and the proposed activity description, which instead focuses on implementing process improvements unrelated to screenings.

Response: We appreciate the support for the proposed title modification of IA_BMH_1. We will seek to address any discrepancies in the validation criteria for this modified activity for CY 2026. This will list the criteria used to audit and validate data submitted for MIPS performance categories and will provide guidance on what is expected for each improvement activity to be considered complete. Validation criteria for CY 2025 can be found at https://qpp.cms.gov/mips/improvement-activities.

After consideration of public comments, we are finalizing all improvement activity modifications as proposed. (vi) Remove Existing Improvement Activities Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

In the CY 2026 PFS proposed rule (90 FR 32725), we proposed to remove eight previously finalized improvement activities beginning with the CY 2026 performance period/2028 MIPS payment year: IA_AHE_5, IA_AHE_8, IA_AHE_9, IA_AHE_11, IA_AHE_12, IA_PM_6, IA_PM_26, and IA_ERP_3. We proposed removal of these specific improvement activities in accordance with our activity removal policy set forth at Sec. 414.1355(d). Specifically, we proposed to remove each of these eight improvement activities under Removal Factor 7, which provides that we may remove an improvement activity if we determine it is obsolete (Sec. 414.1355(d)(7)). When we codified this Removal Factor at Sec. 414.1355(d)(7) in the CY 2025 PFS final rule (89 FR 98408 and 98409), we stated that, when we originally established this removal factor, we employed a commonly used definition of “obsolete” as in `out of date' (89 FR 98409). We further stated that, in the context of the Quality Payment Program, this means an activity that no longer reflects current clinical best practices, that is no longer available for implementation (for example, when a program or initiative upon which an activity depends has been ended or closed), and/or that, because of the nature of the activity, cannot be attested to year after year with a reasonable expectation of clinical quality improvement year after year (89 FR 98409).

We proposed to remove these activities to evolve the Improvement Activities Inventory and emphasize activities that demonstrably improve patient health outcomes while also encouraging the most efficient use of healthcare resources. Removal Factor 7, Activity is obsolete, supports our proposals to remove these activities as they do not reflect CMS' current prioritization of best clinical practices emphasizing holistic, coordinated, and data-driven approaches to care improvement. CMS' quality strategy and clinical standards have evolved to emphasize proactive, whole-person approaches to care, including prevention, behavioral health integration, and coordinated management of chronic conditions. Our proposal to remove IA_ERP_3 would also align with recent FDA and CDC guidance regarding updating vaccination recommendations and expiration of the PHE for COVID- 19.434 435 We refer readers to Table F-B3 in Appendix 2 of this final rule for more information regarding our proposals to remove each of these existing improvement activities.

\434\ https://www.nejm.org/doi/full/10.1056/NEJMsb2506929?logout=true.

\435\ https://archive.cdc.gov/www_cdc_gov/coronavirus/2019-ncov/your-health/end-of-phe.html.

We solicited public comments on our proposals to remove each of these activities from the improvement activities performance category beginning with the CY 2026 performance period/2028 MIPS payment.

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

Comment: Most commenters opposed the removal of eight related improvement activities, stating that doing so could weaken progress toward inclusive, equitable care. A few commenters who opposed the proposal to remove the Achieving Health Equity subcategory stated that the removal of eight measures from the subcategory do not meet the criteria for removal under the “obsolete” designation, as they reflect current clinical best practices and were intentionally adopted to support improved patient health outcomes and advance whole- population health.

Response: Although we acknowledge the commenters' responses, we determined that these eight improvement activities meet the criteria for removal under the “obsolete” removal criterion. We refer to the previous section which explains our reasoning for these removals.

Comment: A few commenters suggested maintaining or reclassifying IA_AHE_9, the only nutrition-focused activity, to ensure continued attention to food insecurity and nutrition risk.

Response: While we acknowledge the importance of nutrition, this specific improvement activity is not fully aligned with the Agency's priorities of health, wellness, and prevention, although we do take note of this improvement activity's elements that can be integrated into the new health and wellness framework. As part of ongoing efforts to align MIPS Improvement Activities with CMS' broader strategic priorities, we are refining the Inventory to focus on activities that promote whole-population health. This approach emphasizes prevention, wellness, and outcomes that benefit all patients across care settings, rather than initiatives targeted toward specific subpopulations, such as IA_AHE_9 does. We thank the commenters for their suggestions, as proper nutrition is fundamental to maintaining health, preventing chronic disease, and supporting resilience. We may consider how we can elevate nutrition as part of a broader wellness agenda for possible nutrition-oriented improvement activities in future rulemaking.

After consideration of public comments, we are finalizing the removal of the eight improvement activities as proposed. (4) MIPS Promoting Interoperability Performance Category (a) Background

Section 1848(q)(2)(A)(iv) of the Act includes the meaningful use of certified electronic health record (EHR) technology (CEHRT) as a performance category under MIPS. We refer to this performance category as the MIPS Promoting Interoperability performance category (and in past rulemaking, we referred to it as the advancing care information performance category).

Section 1848(q)(2)(B)(iv) of the Act provides that the requirements established under section 1848(o)(2) of the Act for determining whether a MIPS eligible clinician is a meaningful EHR user also apply to our assessment of a

MIPS eligible clinician's performance on measures and activities with respect to the MIPS Promoting Interoperability performance category. Section 1848(o)(2)(D) of the Act generally provides that the requirements for being a meaningful EHR user under section 1848(o)(2) continue to apply for purposes of the MIPS Promoting Interoperability performance category.

Under section 1848(o)(2)(A) of the Act, a MIPS eligible clinician must meet three requirements related to the meaningful use of CEHRT during a performance period for a MIPS payment year. Specifically, under section 1848(o)(2)(A) of the Act, the MIPS eligible clinician must: (1) demonstrate to the satisfaction of the Secretary the use of CEHRT in a meaningful manner, which shall include the use of electronic prescribing as determined to be appropriate by the Secretary; (2) demonstrate to the satisfaction of the Secretary that their CEHRT is connected in a manner that provides, in accordance with law and standards applicable to the exchange of information, for electronic exchange of health information to improve the quality of care, such as promoting care coordination, and demonstrates (through a process specified by the Secretary, such as use of an attestation), that they have not knowingly and willfully taken action (such as to disable functionality) to limit or restrict the compatibility or interoperability of the CEHRT; and (3) use CEHRT to submit information on clinical quality measures and such other measures as selected by the Secretary.

For our previously established policies regarding the MIPS Promoting Interoperability performance category, we refer readers to regulations at Sec. Sec. 414.1375 and 414.1380(b)(4) and the CY 2017 Quality Payment Program final rule (81 FR 77199 through 77245), CY 2018 Quality Payment Program final rule (82 FR 53663 through 53688), CY 2019 PFS final rule (83 FR 59785 through 59820), CY 2020 PFS final rule (84 FR 62991 through 63006), CY 2021 PFS final rule (85 FR 84886 through 84895), CY 2022 PFS final rule (86 FR 65466 through 65490), CY 2023 PFS final rule (87 FR 70060 through 70087), CY 2024 PFS final rule (88 FR 79308 through 79312 and 88 FR 79351 through 79365), the 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking final rule (89 FR 54662 through 54718), and CY 2025 PFS final rule (89 FR 98414 through 98427).

In the CY 2026 PFS proposed rule, we proposed to:

Modify the Security Risk Analysis measure to include a second component requiring an affirmative attestation of having conducted security risk management in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule;

Modify the High Priority Practices Safety Assurance Factors for Electronic Health Record (EHR) Resilience (SAFER) Guide Measure by requiring an affirmative attestation of completing an annual self-assessment using the SAFER Guides published in January of 2025; and

Adopt the Public Health Reporting Using Trusted Exchange Framework and Common AgreementTM (TEFCATM) measure as an optional bonus measure under the Public Health and Clinical Data Exchange objective.

Rectify an incongruency by amending regulation at Sec. 414.1380(b)(4)(ii)(C) to provide that, beginning with the CY 2026 performance period/2028 MIPS payment year, the total number of bonus points available to be earned when reporting one bonus measure, more than one bonus measure, or all bonus measures is a total of five bonus points for the MIPS Promoting Interoperability performance category.

For both the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, we proposed to--

Adopt and codify at Sec. 414.1380(b)(4)(iii) and Sec. 495.24(f)(3), respectively, a measure suppression policy beginning with the CY 2026 performance period/2028 MIPS payment year and the EHR reporting period in CY 2026; and

Suppress the Electronic Case Reporting measure by excluding the measure from scoring for MIPS eligible clinicians for the CY 2025 performance period/2027 MIPS payment year and eligible hospitals and critical access hospitals (CAHs) for the EHR reporting period in CY 2025. (b) Definition of Certified EHR Technology

In accordance with Sec. 414.1375(b)(1), to earn a performance category score for the MIPS Promoting Interoperability performance category, a MIPS eligible clinician must be a meaningful EHR user for MIPS and use CEHRT during the performance period, as both terms are defined in Sec. 414.1305. In the CY 2025 PFS final rule, we discussed modifications we had previously finalized related to the CEHRT definition for the Quality Payment Program (QPP), including for the MIPS Promoting Interoperability performance category, at Sec. 414.1305 (89 FR 98414 and 98415). Currently, we define CEHRT, for purposes of MIPS, as EHR technology (which could include multiple technologies) certified under the Office of National Coordinator for Health Information Technology's (ONC) \436\ Health Information Technology (IT) Certification Program that meets the Base EHR definition at 45 CFR 170.102 and is certified as meeting additional ONC health IT certification criteria as adopted and updated in 45 CFR 170.315 as enumerated in paragraph (2) of the CEHRT definition at Sec. 414.1305, including as necessary to report on applicable objectives and measures specified for MIPS. We provide Table C-G5 in this final rule, which sets forth the objectives and measures for the MIPS Promoting Interoperability performance category for the CY 2026 performance period/2028 MIPS payment year and the associated ONC health IT certification criteria set forth at 45 CFR 170.315, as is currently applicable. Given the central role of using CEHRT that meets this definition at Sec. 414.1305 for purposes of earning a score for the MIPS Promoting Interoperability performance category, we highlight recent updates to the ONC Health IT Certification Program's certification criteria.

\436\ On July 29, 2024, notice was posted in the Federal Register that ONC would be dually titled to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (89 FR 60903). We will continue to refer to ONC in historical actions prior to this date and in actions involving the ONC Health IT Certification Program. We will otherwise use ASTP/ONC to refer to the office.

In the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI- 1) final rule (89 FR 1236 through 1238), ONC adopted the certification criterion, “decision support interventions (DSI)” at 45 CFR 170.315(b)(11) to replace the “clinical decision support (CDS)” certification criterion at 45 CFR 170.315(a)(9), the latter of which is included in the Base EHR definition 45 CFR 170.102 until December 31, 2024. HTI-1's finalized DSI criterion at 45 CFR 170.315(b)(11) requires that Health IT Modules must, among other functions, enable a limited set of identified users to select (that is, activate) evidence-based DSIs and Predictive DSIs (as defined at 45 CFR 170.102) \437\ and support “source attributes” \438\--categories of technical

performance and quality information--for both evidence-based and Predictive DSIs. Further, ONC finalized that a Health IT Module may meet the Base EHR definition by either being certified to the existing CDS version of the certification criterion at 45 CFR 170.315(a)(9) or being certified to the revised DSI criterion at 45 CFR 170.315(b)(11), for the period up to, and including, December 31, 2024. On and after January 1, 2025, ONC finalized that only the DSI criterion at 45 CFR 170.315(b)(11) is included in the Base EHR definition (89 FR 1281). ONC further finalized that the adoption of the CDS criterion at 45 CFR 170.315(a)(9) expired on January 1, 2025 (89 FR 1281).

\437\ 45 CFR 170.315(b)(11)(iii)(A) and (B).

\438\ 45 CFR 170.315(b)(11)(iv)(A) and (B).

In addition to the DSI criterion, to which Health IT Modules must be certified to meet the Base EHR definition after January 1, 2025, ONC finalized other updates in the HTI-1 final rule, for which health IT developers must update and provide Health IT Modules to their customers by January 1, 2026. These include updates resulting from the following finalized policies:

The “[t]ransmission to public health agencies--electronic case reporting” criterion at 45 CFR 170.315(f)(5) was updated to specify consensus-based, industry-developed electronic standards and implementation guides (IGs) to replace functional, descriptive requirements in the existing criterion (89 FR 1226). We have identified this criterion as required for the Electronic Case Reporting measure. We note that on July 31, 2025, ONC issued a notice of enforcement discretion regarding these new standards-based requirements, which remains in effect.\439\

\439\ Office of the National Coordinator for Health IT, Electronic Case Reporting Certification Criterion Enforcement Discretion Notice located at: https://www.healthit.gov/topic/electronic-case-reporting-certification-criterion-enforcement-discretion-notice.

The United States Core Data for Interoperability (USCDI) version 3 was adopted at 45 CFR 170.213(b), and ONC finalized that USCDI version 1 at 45 CFR 170.213(a) will expire on January 1, 2026. This change impacts several ONC health IT certification criteria that reference the USCDI, including the “transitions of care” certification criterion at 45 CFR 170.315(b)(1), the “Clinical information reconciliation and incorporation--Reconciliation” certification criterion at 45 CFR 170.315(b)(2) and the “View, download, and transmit to 3rd party” certification criterion at 45 CFR 170.315(e)(1) (89 FR 1214). The “transitions of care” certification criterion at 45 CFR 170.315(b)(1) is included in the “Base EHR definition” while the “Clinical information reconciliation and incorporation--Reconciliation” certification criterion at 45 CFR 170.315(b)(2) is required for the “Support Electronic Referral Loops by Receiving and Reconciling Health Information” measure and the “View, download, and transmit 3rd party” certification criterion is required for the “Provide Patients Electronic Access to their Health Information” measure. We note that on March 21, 2025, ONC issued a notice of enforcement discretion regarding implementation of USCDI version 3, which remains in effect.\440\

\440\ Office of the National Coordinator for Health IT, USCDI v3 Data Elements Enforcement Discretion Notice, located at: https://www.healthit.gov/topic/uscdi-v3-data-elements-enforcement-discretion-notice.

The “standardized application programming interface (API) for patient and population services” certification criterion at Sec. 170.315(g)(10), which is included in the Base EHR definition, was modified to include newer versions of certain standards (including USCDI version 3) and updated functionality to support the criterion (89 FR 1283 through 1295).

We refer readers to the HTI-1 final rule (89 FR 1192) and resources available on the ASTP/ONC website for complete information regarding the updates to ONC health IT certification criteria.\441\

\441\ For more information, visit: https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-certification-program.

Lastly, in the Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule (90 FR 36541 and 36542), published as part of the FY 2026 IPPS/LTCH final rule, ASTP/ONC finalized a subset of new and revised standards and ONC health IT certification criteria proposed in the HTI-2 proposed rule for the ONC Health IT Certification Program, including the following policies:

ASTP/ONC updated the “electronic prescribing” certification criterion in 45 CFR 170.315(b)(3) to incorporate National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2023011, require support for electronic prior authorization transactions in accordance with this standard, and revise other elements of the criterion. We have identified the use of health IT certified to this criterion as required for the Electronic Prescribing measure. ASTP/ONC finalized that health IT developers must update Health IT Modules certified to the “electronic prescribing” criterion by January 1, 2028.

ASTP/ONC finalized the adoption of a “real-time prescription benefit” certification criterion in 45 CFR 170.315(b)(4), in order to implement section 119(b)(3) of Title I of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). ASTP/ONC finalized the inclusion of this certification criterion in the Base EHR definition in 45 CFR 170.102 after January 1, 2028.

ASTP/ONC finalized a set of three health IT certification criteria (at 45 CFR 170.315(g)(31), (32), and (33)) focused on electronic prior authorization and adopted a set of HL7 FHIR IGs developed by the HL7 Da Vinci Project \442\ to support these criteria. ASTP/ONC finalized these criteria to make available Health IT Modules that can enable health care providers to conduct prior authorization transactions using payer APIs established in the CMS Interoperability and Prior Authorization final rule (89 FR 8858 through 8871). Use of such Health IT Modules will support MIPS eligible clinicians required to report on the Electronic Prior Authorization measure for the MIPS Promoting Interoperability performance category beginning with the CY 2027 performance period/2029 MIPS payment year, as well as eligible hospitals and critical access hospitals required to report on the Electronic Prior Authorization measure for the Medicare Promoting Interoperability Program beginning with the EHR reporting period in CY 2027.

\442\ For more information about the HL7 Da Vinci Project, see: https://www.hl7.org/about/davinci/index.cfm.

We refer readers to section IV.A.4.d.(4)(i). of this final rule, the HTI-4 final rule (90 FR 36541), and resources available on the ASTP/ONC website for complete information regarding the updates to ONC Health IT Certification Program.\443\

\443\ For more information, visit: https://www.healthit.gov/topic/laws-regulation-and-policy/health-data-technology-and-interoperability-certification-program.

(c) Modification to the Security Risk Analysis Measure (i) Background

The HIPAA Security Rule \444\ (45 CFR part 160 and subparts A and C of part

164) contains, among other things, the administrative safeguards that covered entities and business associates (45 CFR 160.103) must be implemented, such as the standard and implementation specifications for security management processes. Among those safeguards are implementation specifications that require covered entities and business associates to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI) held by the covered entity or business associate (45 CFR 164.308(a)(1)(ii)(A)) and to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with the general requirements of the HIPAA Security Rule at 45 CFR 164.306(a) and the risk management requirements at 45 CFR 164.308(a)(1)(ii)(B).

\444\ The U.S. Department of Health and Human Services has proposed to modify the HIPAA Security Rule to strengthen the cybersecurity of electronic protected health information, including proposals to revise the existing requirements to conduct a risk analysis and risk management. See generally HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health Information proposed rule (90 FR 898).

For MIPS eligible clinicians, ensuring the privacy and security of ePHI is essential for demonstrating meaningful use of CEHRT as discussed in the CY 2026 PFS proposed rule (90 FR 32727). In the Medicare and Medicaid Programs; Electronic Health Record Incentive Program final rule (Stage 1 final rule) (75 FR 44368 through 44369), the Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2 final rule (Stage 2 final rule) (77 FR 54002 and 54003), and the Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 through 2017 final rule (Stage 3 final rule) (80 FR 62793 through 62794), we discussed the benefits of safeguarding electronic health information and our determination that protecting electronic health information is essential to all other aspects of meaningful use. In the Stage 1 final rule, we noted that, while CEHRT provides tools for protecting health information, processes and possibly tools outside the scope of CEHRT are required (75 FR 44369). In the Stage 2 final rule, we also noted that unintended, unlawful, or both disclosures of protected health information could diminish individuals' confidence in EHRs and electronic health information exchange; ensuring that health information is adequately protected and secured will assist in addressing the unique risks and challenges that may be presented by EHRs (77 FR 54002). On these bases, we adopted and maintained the Security Risk Analysis measure based on the HIPAA Security Rule risk analysis requirement at 45 CFR 164.308(a)(1)(ii)(A) for the Medicare EHR Incentive Program for Eligible Professionals, the predecessor to the MIPS Promoting Interoperability performance category.\445\ Additional information on the initial adoption of this measure can be found in prior rulemaking for the predecessor Medicare EHR Incentive Program for Eligible Professionals, including the Stage 1 final rule (75 FR 44369), Stage 2 final rule (77 FR 54002 and 54003), and Stage 3 final rule (80 FR 62793 through 62794). In the CY 2017 Quality Payment Program final rule, we adopted the Protect Patient Health Information objective for the MIPS Promoting Interoperability performance category and included the Security Risk Analysis measure within this objective (81 FR 77219 through 77220). We subsequently modified this measure in the CY 2019 PFS final rule (83 FR 59789 and 59790).

\445\ Section 101(b) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) sunset the Medicare EHR Incentive Program for Eligible Professionals, set forth at section 1848(o) of the Act. As discussed previously, section 1848(o)(2) of the Act has been incorporated into the MIPS Promoting Interoperability performance category's requirements via section 1848(q)(2)(B)(iv) of the Act. See CY 2017 Quality Payment Program final rule (81 FR 77018 and 77019) for more information regarding the sunsetting of the Medicare EHR Incentive Program for Eligible Professionals.

To earn a score for the MIPS Promoting Interoperability performance category, a MIPS eligible clinician must attest “Yes” or “No” as to whether they have conducted or reviewed a security risk analysis as required under the HIPAA Security Rule at 45 CFR 164.308(a)(1)(ii)(A) during the year in which the performance period occurs. MIPS eligible clinicians must attest “Yes” to the measure to be considered a meaningful EHR user. The measure is not scored individually at Sec. 414.1380(b)(4)(ii) and does not contribute to the MIPS eligible clinician's MIPS Promoting Interoperability performance category score for the Protect Patient Health Information objective and measures. An attestation of “No” demonstrates that the MIPS eligible clinician did not complete the actions included in the measure as required by Sec. 414.1375(b)(2)(ii)(A) and did not satisfy the definition of a meaningful EHR user at Sec. 414.1305. Therefore, if the MIPS eligible clinician submits a “No” attestation for this measure, they would not earn a score for the MIPS Promoting Interoperability performance category, resulting in a score of zero, in accordance with Sec. 414.1375(b)(2). We refer readers to Tables C-G2 and C-G3 in the CY 2026 PFS proposed rule for more information regarding the proposed measures and scoring methodology for the MIPS Promoting Interoperability performance category, including the Security Risk Analysis measure (90 FR 32737 through 32744). (ii) Modification to the Security Risk Analysis Measure Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

While the Security Risk Analysis measure currently requires MIPS eligible clinicians to attest to conducting a security risk analysis as required under the HIPAA Security Rule, the Security Risk Analysis measure does not currently require MIPS eligible clinicians to manage their security risk or attest to having implemented security measures to manage their security risk. Codified at 45 CFR 164.308(a)(1)(ii)(B), the HIPAA Security Rule implementation specification for risk management requires the implementation of security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with 45 CFR 164.306(a). The HIPAA Security Rule does not prescribe a specific methodology for conducting a risk analysis or managing risk (45 CFR 164.308(a)(1)(ii)(A) and (B)). We refer readers to the Security Risk Assessment Tool (https://www.healthit.gov/topic/privacy-security-and-hipaa/security-risk-assessment-tool) developed by ASTP/ONC in collaboration with the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), and OCR's cybersecurity newsletters and other risk analysis materials \446\ for educational resources on conducting a security risk assessment as required by the HIPAA Security Rule. Additional information is also available in the National Institute of Standard and Technology (NIST) special publication, Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide.\447\

\446\ U.S. Department of Health and Human Services, Office of Civil Rights newsletters and risk analysis materials located at: https://www.hhs.gov/hipaa/for-professionals/security/guidance/index.html.

\447\ See NIST SP 800-66, rev. 2, located at: https://csrc.nist.gov/pubs/sp/800/66/r2/final.

In the CY 2026 PFS proposed rule, we proposed to modify the existing Security Risk Analysis measure to add a second attestation, requiring MIPS eligible clinicians to attest “Yes” to having implemented security measures

sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level such that they are compliant with 45 CFR 164.306(a) as required by the HIPAA Security Rule implementation specification for risk management (90 FR 32727 and 32728). This second attestation would be in addition to the current requirement under the measure for MIPS eligible clinicians to attest “Yes” to having conducted or reviewed a security risk analysis. With the modification to this measure, MIPS eligible clinicians would be required to submit two affirmative (“Yes”) attestations to comply with Sec. 414.1375(b)(2)(ii)(A), in which they have: (1) conducted or reviewed a security risk analysis as required under the HIPAA Security Rule at 45 CFR 164.308(a)(1)(ii)(A); and (2) conducted security risk management activities as required under the HIPAA Security Rule at 45 CFR 164.308(a)(1)(ii)(B), specifically the implementation of security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with 45 CFR 164.306. Also, we proposed to modify the measure specifications to better align with the requirements of the HIPAA Security Rule.

The proposed modifications to the Security Risk Analysis measure would increase accountability among MIPS eligible clinicians who have not taken steps to reduce risks and vulnerabilities to ePHI and would provide transparency regarding the efforts of MIPS eligible clinicians that are already taking steps to manage this risk. Furthermore, the proposal is in alignment with the finalized modification to the Security Risk Analysis measure in the Medicare Promoting Interoperability Program (90 FR 37045 through 37048).

To reflect the proposed addition of the security risk management component, we proposed the modified measure would read as follows: First, conduct or review a security risk analysis and second, conduct security risk management activities, in accordance with the HIPAA Security Rule requirements at 45 CFR 164.308(a)(1)(ii)(A) and (B). Security risk analysis and management activities include addressing the security of data created or maintained by CEHRT (to include encryption), in accordance with 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3). The encryption implementation specified at 45 CFR 164.312(a)(2)(iv) must be implemented if it is reasonable and appropriate; if encryption is not reasonable and appropriate, then the MIPS eligible clinician would adopt an equivalent alternative measure if it is reasonable and appropriate to do so.

To meet the requirements of the modified Security Risk Analysis measure, we proposed that MIPS eligible clinicians would be required to separately attest “Yes” to both components of the modified measure, specifically attest “Yes” that they have met the existing security risk analysis requirement component, and attest “Yes” that they have met the security risk management component to be considered a meaningful EHR user beginning with the CY 2026 performance period/2028 MIPS payment year.

We did not propose modifications to the timeframe regarding when a MIPS eligible clinician must complete the actions specified for the Security Risk Analysis measure as currently provided at Sec. 414.1375(b)(2)(ii)(A). As set forth at Sec. 414.1375(b)(2)(ii)(A), a MIPS eligible clinician may attest “Yes” regarding their completion of the actions included in this measure so long as they complete the required actions any time during the calendar year in which the performance period occurs.

Also, we did not propose modifications to the current scoring methodology for the Security Risk Analysis measure, as described in section IV.A.4.d.(4).(h).(ii). of this final rule. To meet the requirements of the MIPS Promoting Interoperability performance category, MIPS eligible clinicians will need to affirmatively (“Yes”) attest to the two components of the measure; otherwise, MIPS eligible clinicians will receive a score of zero for the entire MIPS Promoting Interoperability performance category. If a MIPS eligible clinician attests “No” to not completing the risk analysis component, the risk management component, or both components, or did not report the measure, then they will fail to earn a score for the MIPS Promoting Interoperability performance category (and receive a score of zero) as currently provided at Sec. 414.1375(b)(2)(ii)(A).

We solicited public comment on the proposal to modify the Security Risk Analysis measure beginning with the CY 2026 performance period/ 2028 MIPS payment year. Also, we solicited public comment regarding compliance with the security risk management requirements and the potential impact the proposed modification to the Security Risk Analysis measure would have on risk management compliance and any potential burden from the proposal. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposal to modify the Security Risk Analysis measure. A few commenters indicated that requiring MIPS eligible clinicians to attest to having conducted security risk management activities in addition to security risk analysis strengthens cybersecurity preparedness and aligns with the HIPAA Security Rule. A few commenters stated that the proposal provides an appropriate balance between safeguarding patient data and minimizing mandatory reporting requirements without increasing burden.

Response: We appreciate the support from commenters regarding the proposal to modify the Security Risk Analysis measure. We agree that adding the security risk management attestation requirement to the Security Risk Analysis measure aligns with the HIPAA Security Rule and would assist MIPS eligible clinicians in strengthening their cybersecurity preparedness. Also, we agree that the change to the Security Risk Analysis measure will increase accountability for reducing risks and vulnerabilities to ePHI while balancing the need to safeguard patient data with minimal reporting requirements.

Comment: A commenter expressed support of the proposal by noting that the measure requirements could cover software that is not certified under the ONC Health IT Certification Program, and that it could be a requirement to participate in QPP.

Response: We appreciate the support from the commenter.

Comment: Several commenters requested that CMS provide additional support or incentives for the implementation of security risk analysis and security risk management. A few commenters encouraged CMS and ASTP/ ONC to provide fact sheets, guidance, and educational materials specific to security risk analysis and security risk management. Another commenter requested that CMS work with physician organizations to ensure that MIPS eligible clinicians receive the necessary education and training to ensure that they are complying with requirements and understand the distinction between the Security Risk Analysis measure and existing HIPAA Security Rule requirements.

Response: We note that the requirements of the Security Risk Analysis measure, including the security risk analysis activities and the security risk management activities, reflect requirements under the HIPAA Security Rule; the Security Risk Analysis measure does not create

additional requirements beyond the scope of the HIPAA Security Rule requirements. OCR has developed many resources such as guidance materials, trainings, videos, tools, frequently asked questions, and newsletters to support implementation and compliance of security risk analysis and management activities.\448\ ONC and OCR developed the HIPAA Security Risk Assessment Tool,\449\ which includes features that make it useful in assisting small and medium-sized practices and business associates perform a risk assessment.

\448\ U.S. Department of Health and Human Services, Office of Civil Rights, Security Rule Guidance Material located at: https://www.hhs.gov/hipaa/for-professionals/security/guidance/index.html?language=es.

\449\ HIPAA Security Risk Assessment Tool located at: https://www.healthit.gov/providers-professionals/security-risk-assessment-tool.

Comment: A few commenters expressed concerns regarding the expansion of the Security Risk Analysis measure requirements and associated burden. The commenters indicated that small, rural, and under-resourced MIPS eligible clinicians would experience financial and resource burden due to the implementation of security risk management. A commenter indicated that risk management activities would create burden for health systems and organizations with large numbers of hospitals and clinics.

Response: As covered entities and business associates under the HIPAA Security Rule, MIPS eligible clinicians are already required to conduct security risk management activities. We believe that the requirement to attest to having conducted security risk management activities will not result in undue burden to small and rural practices, or larger health systems or organizations.

Comment: A few commenters requested that CMS provide sufficient time for organizations to implement security risk management processes after performing a security risk analysis, citing concern that clinician practices may have difficulty implementing all changes identified during a risk assessment conducted within the same calendar year. Commenters recommended that MIPS eligible clinicians should be allowed to attest “Yes” in instances when a security risk management plan is in place, but implementation is in progress.

Response: We recognize that implementing security measures to manage risk often requires complex technical changes, organizational project management, and planned timelines. The presence of a risk management plan and a good faith effort to progress in implementing necessary risk management efforts is sufficient for a MIPS eligible clinician to attest “Yes” for the security risk management component of the Security Risk Analysis measure. MIPS eligible clinicians that conduct the security risk analysis in quarter 4 of the calendar year would therefore only need to create a risk management plan and begin the process of implementation of such plan during the calendar year in which the performance period occurs. We recognize that security risk analysis activities and risk management plan activities, including the creation of a plan, are often a continuous and iterative processes that occur throughout the calendar year. As long as both activities (conduct a security risk analysis and create a risk management plan) occur during the calendar year in which the performance period occurs, the requirements of the measure will be met.

Comment: Several commenters did not support the security risk analysis measure modification and expressed concern that the proposed modification is duplicative or unnecessarily burdensome because MIPS eligible clinicians are already required by the HIPAA Security Rule to conduct regular security risk analyses and address identified vulnerabilities. A few commenters expressed concern that a distinction between security risk analysis and security risk management adds complexity to the measure.

Response: As covered entities and business associates under the HIPAA Security Rule, MIPS eligible clinicians are already required to conduct security risk management activities. The addition of the security risk management component to the Security Risk Analysis measure is designed to complement the HIPAA Security Rule rather than introduce complexity by specifying separate requirements for protecting patient health information. Therefore, we do not agree that the requirement to attest “Yes” to having conducted risk management activities creates an additional administrative or regulatory burden, introduces an additional compliance step other than attesting “Yes” or “No” once a year to CMS, adds significant technical or compliance complexity, or places MIPS eligible clinicians at additional financial risk. The security risk management attestation reflects a MIPS eligible clinician's acknowledgment of having performed activities that meet the requirements of the HIPAA Security Rule implementation specification for risk management at 45 CFR 164.308(a)(1)(ii)(B). The addition of the security risk management component augments our past efforts to incorporate security as a fundamental structural component for the meaningful use of CEHRT.

Regarding the comment pertaining to the distinction between security risk analysis and security risk management, we believe that such distinction is necessary given that activities associated with security risk analysis and security risk management differ. Security risk analysis refers to the process of assessing threats to the privacy and security of protected health information, whereas security risk management refers to the creation of a plan to address and remediate threats.

Comment: A commenter recommended that CMS consider a performance- based measure to allow CMS to differentiate MIPS eligible clinician performance rather than an unscored required attestation.

Response: We note that the purpose of the Security Risk Analysis measure is not to assess the degree of compliance with the HIPAA Security Rule nor to compare MIPS eligible clinicians to each other regarding such compliance. Rather, compliance with the HIPAA Security Rule represents a broad minimum set of requirements for all covered entities under HIPAA. Therefore, we believe it is appropriate for the Security Risk Analysis measure to remain as an unscored attestation at this time rather than a performance-based measure in the MIPS Promoting Interoperability performance category.

After consideration of public comments, we are finalizing, as proposed, the proposal to modify the Security Risk Analysis measure by requiring MIPS eligible clinicians to attest “Yes” to having conducted security risk management in addition to the current requirement of the measure requiring MIPS eligible clinicians to attest “Yes” to having conducted or reviewed a security risk analysis as required by the HIPAA Security Rule. The finalized measure with two components is as follows: First, conduct or review a security risk analysis; and second, conduct security risk management activities, in accordance with the HIPAA Security Rule at 45 CFR 164.308(a)(1)(ii)(A) and (B). Security risk analysis and management activities include addressing the security of data created or maintained by CEHRT (to include encryption), in accordance with 45 CFR 164.312(a)(2)(iv) and 164.306(d)(3). The encryption implementation specified at 45 CFR 164.312(a)(2)(iv) must be implemented if it is reasonable and appropriate; if encryption is not reasonable and appropriate, then the MIPS eligible

clinician would adopt an equivalent alternative measure if it is reasonable and appropriate to do so. Also, we note that in the FY 2026 IPPS/LTCH PPS final rule, we adopted such an update for the Security Risk Analysis measure under the Medicare Promoting Interoperability Program for eligible hospitals and CAHs (90 FR 37045 through 37048). (d) Modification to the High Priority Practices Safety Assurance Factors for EHR Resilience (SAFER) Guide Measure (i) Background

The 2025 SAFER Guides are an evidence-based set of recommendations in the form of eight stand-alone, subject-oriented chapters (previously nine chapters comprising the 2016 SAFER Guides) that present the health IT community, including MIPS eligible clinicians that use health IT, with best practice recommendations to improve the safety and safe use of EHRs.\450\ The SAFER Guides were first released in 2014 and updated in 2016. In the CY 2022 PFS final rule, we adopted the SAFER Guides measure under the Protect Patient Health Information objective in the MIPS Promoting Interoperability performance category beginning with the CY 2022 performance period/2024 MIPS payment year (86 FR 65475 through 65477). In the CY 2024 PFS final rule, we modified the requirements for the SAFER Guides measure beginning with the CY 2024 performance period/ 2026 MIPS payment year (88 FR 79354 through 79356), to require MIPS eligible clinicians to conduct, and attest “Yes,” to having completed an annual self-assessment using the High Priority Practices SAFER Guide. In the CY 2026 PFS proposed rule and this final rule, we refer to the measure as the “High Priority Practices SAFER Guide” measure given that the MIPS Promoting Interoperability performance category only requires MIPS eligible clinicians to affirmatively attest to having completed an annual assessment using the High Priorities Practices SAFER Guide rather than all SAFER Guides.

\450\ ASTP/ONC SAFER Guides located at: https://www.healthit.gov/topic/safety/safer-guides.

(ii) Modification to the High Priority Practices SAFER Guide Measure Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year

In January of 2025, ASTP/ONC published an updated set of SAFER Guides (hereafter referred to as the 2025 SAFER Guides) located at: https://www.healthit.gov/topic/safety/safer-guides. The 2025 SAFER Guides consist of eight guides organized into three broad groups of Foundational Guides, Infrastructure Guides, and Clinical Process Guides. All Guides have been revised and contain new recommendations as well as the comprehensive consolidation of recommendations that were similar and overlap in function or intent with the 2016 SAFER Guides. For example, the “System Configuration” and “System Interfaces” chapters have been consolidated into a single chapter titled, “System Management.” The entirety of the content recommendations, bibliography, and implementation guidance have been organized into a comprehensive table, which promotes the adoption of best safety practices for health IT. This update represents the most comprehensive revision of the SAFER Guides since they were first released. Table C-G1 provides the titles of the various guides, and chapters within the guides, that collectively comprise the 2016 SAFER Guides and the 2025 SAFER Guides, respectively.

When we finalized requiring a “Yes” attestation to account for completion of the self-assessment in the CY 2024 PFS final rule, as opposed to allowing a “Yes” or “No” attestation, some commenters expressed concern that the 2016 SAFER Guides contained outdated references and did not reflect current practices (88 FR 79355 through 79357). Additionally, some commenters recommended that CMS and ONC review and make updates to the 2016 SAFER Guides, regarding data privacy protection and present-day safety practices (88 FR 79355 through 79357). In the CY 2026 PFS proposed rule, we proposed to modify the requirement of the High Priority Practices SAFER Guide measure to reference the updated 2025 version of the High Priority Practices SAFER Guide as a direct response to such concerns (90 FR 32729 through 32730). The 2025 version of the High Priority Practices SAFER Guide is updated and streamlined to focus on the highest risk, most commonly occurring issues that can be addressed through technology or practice changes to build system resilience. [GRAPHIC] [TIFF OMITTED] TR05NO25.134

We proposed to modify the High Priority Practices SAFER Guide measure, which currently requires MIPS eligible clinicians to attest “Yes” to completing an annual self-assessment, by specifying that MIPS eligible clinicians utilize the 2025 version of the High Priority Practices SAFER Guide beginning with the CY 2026

performance period/2028 MIPS payment year. At Sec. 414.1375(b)(2)(ii)(D), to earn a score for the MIPS Promoting Interoperability performance category, a MIPS eligible clinician is required to submit an affirmative attestation regarding their completion of the annual self-assessment to meet the requirement of the High Priority Practices SAFER Guide measure during the year in which the performance period occurs. For the CY 2025 performance period/2027 MIPS payment year, MIPS eligible clinicians complete this annual self- assessment using the 2016 version of the High Priority Practices SAFER Guide. We proposed to modify this measure by requiring that MIPS eligible clinicians complete this annual self-assessment using the 2025 version of the High Priority Practices SAFER Guide beginning with the CY 2026 performance period/2028 MIPS payment year.

We did not propose any modifications to the scoring methodology for this measure. To meet the requirements of the MIPS Promoting Interoperability performance category, MIPS eligible clinicians will need to affirmatively (“Yes”) attest to meeting the requirement of the measure; otherwise, MIPS eligible clinicians will receive a score of zero for the entire MIPS Promoting Interoperability performance category. If a MIPS eligible clinician attests “No” because they have not completed an annual self-assessment using the 2025 version of the High Priority Practices SAFER Guide, or did not report the measure, then they will fail to earn a score for the MIPS Promoting Interoperability performance category (and receive a score of zero) as currently provided at Sec. 414.1375(b)(2)(ii)(D). We refer readers to the CY 2024 PFS final rule for further information regarding the High Priority Practices SAFER Guide measure and its requirements (88 FR 79354 through 79356).

Both the 2016 and the 2025 SAFER Guides are available on the ASTP/ ONC website located at: https://www.healthit.gov/topic/safety/safer-guides. We encourage MIPS eligible clinicians to begin to familiarize themselves with the 2025 SAFER Guides.

We solicited public comment on the proposal to modify the High Priority Practices SAFER Guide measure by requiring MIPS eligible clinicians to conduct an annual self-assessment using the 2025 High Priority Practices SAFER Guide (instead of the 2016 version) at any point during the calendar year in which the performance period occurs, beginning with the CY 2026 performance period/2028 MIPS payment year. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposal to modify the High Priority Practices SAFER Guide measure requiring the use of the most recently updated 2025 version of the High Priority Practices SAFER Guide. Several commenters indicated that the 2025 version better reflects current practices in health IT and data protection as compared to the 2016 version.

Response: We appreciate the support from commenters regarding the modification to the High Priority Practices SAFER Guide measure that will require the use of the updated 2025 version of the High Priority Practices SAFER Guide. We agree that the 2025 version of the SAFER Guides has improved alignment with current data security, including cybersecurity practices, compared to the 2016 version of the SAFER Guides.

Comment: A few commenters requested clarification regarding which version of the High Priority Practices SAFER Guide would be acceptable to use for meeting the measure requirement for the CY 2025 performance period. The commenters inquired if MIPS eligible clinicians can voluntarily attest to using the 2025 version of the High Priority Practices SAFER Guide for the CY 2025 performance period before it becomes required starting with the CY 2026 performance period. The commenters indicated that such clarification would be important to ensuring consistent expectations for MIPS eligible clinicians and helping health IT vendors guide their customers appropriately.

Response: Please note that we did not propose changes to the High Priority Practices SAFER Guide measure for the CY 2025 performance period/2027 MIPS payment year in the CY 2026 PFS proposed rule. For the CY 2025 performance period/2027 MIPS payment year, the High Priority Practices SAFER Guide measure requires affirmatively attesting (“Yes”) to completing an annual self-assessment using the 2016 version of the High Priority Practices SAFER Guide. In regard to the comments inquiring about the possibility of being able to voluntarily attest to completing an annual self-assessment using the 2025 version of the High Priority Practices SAFER Guide for the CY 2025 performance period/2027 MIPS payment year, we believe that providing the availability of two different reporting options for the same measure may cause confusion regarding the reporting requirements for the High Priority Practices SAFER Guide measure. Beginning with the CY 2026 performance period/2028 MIPS payment year, the use of the 2025 version of the High Priority Practices SAFER Guide will be required for affirmatively attesting (“Yes”) to completing an annual self- assessment. MIPS eligible clinicians can begin to familiarize themselves with the 2025 SAFER Guides, specifically the High Priority Practices SAFER Guide during CY 2025. We believe that allowing a full calendar year for MIPS eligible clinicians to review the 2025 version of the High Priority Practices SAFER Guide will allow for the uniform utilization beginning with the CY 2026 performance period/2028 MIPS payment year and subsequent years. Both the 2016 and the 2025 SAFER Guides are available on the ASTP/ONC website located at: https://www.healthit.gov/topic/safety/safer-guides.

Comment: A few commenters expressed concern regarding the reporting and implementation burden of the proposal by requiring the 2025 version of the High Priority Practices SAFER Guide beginning with the CY 2026 performance period/2028 MIPS payment year, particularly for MIPS eligible clinicians with limited resources. A few commenters requested that CMS make the High Priority Practices SAFER Guide measure voluntary. A few commenters recommended that CMS allow delaying the requirement of the use of the 2025 version of the High Priority Practices SAFER Guide measure for MIPS Promoting Interoperability performance category reporting. A commenter recommended that CMS reduce the administrative burden for clinical practices by shifting from an annual reporting schedule to a less frequent reporting interval. Another commenter suggested that CMS collaborate with vendors to enact periodic assessments of the burden and effectiveness of using the SAFER Guides while also exploring alternative options to assess organizational health IT capabilities. A commenter expressed the importance of having streamlined tools and education materials to help MIPS eligible clinicians with limited resources use the 2025 version of High Priority Practices SAFER Guide self-assessment more effectively.

Response: While we acknowledge the concerns expressed by commenters regarding the potential burden or resource constraints from completing the self-assessment, we reiterate that the

2025 SAFER Guides have been updated and streamlined to focus on the highest risk, most commonly occurring issues that can be addressed through technology or practice changes. We reiterate that the High Priority Practices SAFER Guide measure only requires that MIPS eligible clinicians attest “Yes” to having conducted an annual self-assessment using the High Priority Practices SAFER Guide; there are no requirements to meet a specific implementation status or implement any specific practices identified in the self-assessment. We defer to eligible MIPS clinicians to determine if they should adopt specific best practices contained within the SAFER Guides. We believe that there is value in completing a self-assessment using the High Priority Practices SAFER Guide. We, therefore, disagree that this measure update would introduce administrative burden, particularly for MIPS eligible clinicians with limited resources, given that a substantial portion of the information between the 2016 and 2025 versions of the High Priority Practices SAFER Guide remain the same.

We do not agree with commenters' suggestions to reduce the frequency of requiring the completion of an annual self-assessment. The High Priority Practices SAFER Guide measure only requires that MIPS eligible clinicians complete an annual self-assessment at any point during the calendar year in which the measure reporting period occurs. Additionally, we anticipate that the burden of completing an annual self-assessment using the 2025 version of the High Priority Practices SAFER Guide could be reduced after the completion of an initial self- assessment if a given EHR configuration does not substantially change in a subsequent calendar year. We are committed to obtaining feedback from all interested parties through the rulemaking process regarding modifications to the High Priority Practices SAFER Guide measure and take into consideration the burden of completing an annual self- assessment using an updated version of the High Priority Practices SAFER Guide.

Regarding the comment pertaining to the availability of educational resources and materials to assist MIPS eligible clinicians with the completion of an effective annual self-assessment using the 2025 version of the High Priority Practices SAFER Guide, the 2025 High Priority Practices Guide includes an extensive set of references offering additional information and evidence. The 2025 SAFER Guides are located on the ASTP/ONC website at https://www.healthit.gov/topic/safety/safer-guides. Additionally, there are public resources available to MIPS eligible clinicians regarding conducting a self-assessment using the SAFER Guides such as a journal article entitled, “Guidelines for US Hospitals and Clinicians on Assessment of Electronic Health Record Safety Using SAFER Guides” (located at: https://jamanetwork.com/journals/jama/article-abstract/2788984).

Comment: A few commenters requested that the High Priority Practices SAFER Guide measure remain voluntary until CMS has enacted an assessment that establishes the efficacy of the SAFER Guides in improving EHR safety in care delivery settings for MIPS eligible clinicians.

Response: We note that the High Priority Practices SAFER Guide measure is a required measure, not voluntary, for the MIPS Promoting Interoperability performance category. The SAFER Guides, including the High Priority Practices SAFER Guide, are based on the available evidence from literature and consensus expert opinion. Subject matter experts in patient safety, informatics, quality improvement, risk management, human factors engineering, and usability collaborated to update the SAFER Guides. The SAFER Guides were reviewed by an external group of practicing clinicians, informaticians, and information technology professionals. The SAFER Guides can help identify potential risks, prioritize safety concerns, and implement strategies to mitigate those risks. Most importantly, the 2025 SAFER Guides were published largely in response to concerns that the 2016 SAFER Guides were outdated and no longer relevant (88 FR 59264 through 59265). Considering the rapid advancement of health IT, the information in the 2025 SAFER Guides reflects the current state of health IT practice.

Comment: A commenter expressed concern that the proposed modification to the High Priority Practices SAFER Guide measure is duplicative to the proposed modification to the Security Risk Analysis measure that adds a security risk management component, noting that both focus on the safety of the implementation and safe use of EHR technology.

Response: The High Priority Practices SAFER Guide measure and the Security Risk Analysis measure both aim to assess and enhance areas such as patient safety and security. However, there are notable differences. The SAFER Guides are a set of tools and recommendations focused on optimizing the safety and safe use of EHRs that help MIPS eligible clinicians identify and address potential risks by providing a distinct framework to proactively identify and mitigate those risks. The High Priority Practices SAFER Guide specifically identifies “high risk” and “high priority” recommended safety practices that broadly address EHR safety concerns discussed in greater detail in the other SAFER Guides.\451\ The High Priority Practices SAFER Guide self- assessment is useful and complementary to conducting a security risk analysis and development of a management plan, as all are necessary steps to ensuring EHR safety. The Security Risk Analysis measure and proposed modification, consistent with the HIPAA Security Rule requirements, involve a comprehensive assessment of all potential risks to the confidentiality, integrity, and availability of ePHI created or maintained by CEHRT and development of a management plan to address any identified risks. A self-assessment using the High Priority Practices SAFER Guide would not constitute a complete security risk analysis and management plan, nor would a security risk analysis and management plan constitute a self-assessment using the High Priority Practices SAFER Guide.

\451\ The 2025 SAFER Guides are available on the ASTP/ONC website located at https://www.healthit.gov/topic/safety/safer-guides.

Comment: A commenter expressed concern regarding the High Priority Practices SAFER Guide measure's design as an attestation, noting that the design is not consistent with the Quality Payment Program's performance-based scoring design. Another commenter expressed appreciation that the measure remains as an attestation minimizing reporting burden.

Response: The purpose of this measure is not to assess the degree of compliance in implementing the High Priority Practices SAFER Guide, nor to compare MIPS eligible clinicians to each other. The High Priority Practices SAFER Guide measure only requires a MIPS eligible clinician attest to having completed an annual self-assessing using the 2025 version of High Priority Practices SAFER Guide and, thus, we believe it is appropriate for the High Priority Practices SAFER Guide measure to remain as an unscored attestation in the MIPS Promoting Interoperability performance category. We note that currently there is not a requirement to implement any recommendation contained within the 2025 High Priority Practices SAFER Guide.

After consideration of public comments, we are finalizing, as proposed, the proposal to modify the

High Priority Practices SAFER Guide measure by requiring MIPS eligible clinicians to conduct an annual self-assessment using the 2025 version of the High Priority Practices SAFER Guide at any point during the calendar year in which the performance period occurs, beginning with the CY 2026 performance period/2028 MIPS payment year and subsequent years. Also, we note that in the FY 2026 IPPS/LTCH PPS final rule, we adopted a corresponding update for the SAFER Guides measure under the Medicare Promoting Interoperability Program for eligible hospitals and CAHs (90 FR 37049 through 37051). (e) Public Health and Clinical Data Exchange Objective: Adoption of the Public Health Reporting Using the Trusted Exchange Framework and Common AgreementTM (TEFCATM) Measure as an Optional Bonus Measure Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year (i) Background

Under section 1848(o)(2)(A)(ii) of the Act, the MIPS Promoting Interoperability performance category encourages health information exchange, including for public health purposes through the Public Health and Clinical Data Exchange objective. Effective and efficient responses to public health events require rapid, accurate exchange of electronic health information between health care providers, and Federal, State, tribal, local, and territorial public health agencies (PHAs). Health care providers and MIPS eligible clinicians collect this electronic health information for patient care, and PHAs use the information for public health purposes such as tracking a disease, initiating contact tracing, or pinpointing the source of a disease or outbreak of foodborne illness.

Currently, there are 5 measures under the MIPS Promoting Interoperability performance category Public Health and Clinical Data Exchange objective: Immunization Registry Reporting, Electronic Case Reporting, Syndromic Surveillance Reporting, Public Health Registry Reporting, and Clinical Data Registry Reporting. Two of the measures, Immunization Registry Reporting and Electronic Case Reporting, are required under the objective; 3 of the measures, Syndromic Surveillance Reporting, Public Health Registry Reporting and Clinical Data Registry Reporting, are optional bonus measures. MIPS eligible clinicians may receive a total of five bonus points for reporting on one or more optional measures.

Measures under the Public Health and Clinical Data Exchange objective promote the exchange of health information for specific public health use cases with PHAs and other entities using CEHRT. However, one difficulty with the electronic exchange of health information for many different public health purposes is that exchange between PHAs and MIPS eligible clinicians requires different processes for each measure under the Public Health and Clinical Data Exchange objective. For instance, health information exchange for the Electronic Case Reporting measure may be based on several point-to-point connections among MIPS eligible clinicians, intermediaries, and PHAs, but these connections and agreements may be different for other use cases such as those associated with the Immunization Registry Reporting measure. TEFCA establishes a common governance and technical framework for nationwide health information exchange. We anticipated that participation in TEFCA could help reduce the difficulty of public health information exchange over time. Facilitating health information exchange with PHAs through the TEFCA framework has the potential to increase standardization of connections to PHAs and reduce reporting burden for MIPS eligible clinicians and PHAs. (ii) Background on TEFCA

Section 4003(b) of the 21st Century Cures Act, enacted in 2016, amended section 3001(c) of the Public Health Service Act and required HHS to take steps to ensure full network-to-network exchange of health information. Specifically, in section 3001(c)(9)(A) of the Public Health Service Act, the Congress directed the National Coordinator, in collaboration with NIST and other agencies within HHS, to “develop or support a trusted exchange framework, including a common agreement among health information networks nationally.” Since the enactment of the 21st Century Cures Act, HHS has pursued development of the TEFCA framework.

The electronic exchange of health information allows MIPS eligible clinicians, other healthcare providers, and patients to access and securely share a patient's vital medical information electronically.\452\ The framework of TEFCA standardizes health information exchange across many different networks, which further enables nationwide network-to-network exchange of health information. This standardization across networks simplifies health information exchange by reducing the number of connections that health care providers, MIPS eligible clinicians, PHAs, and other interested parties need to make to send and receive health information. TEFCA supports this standardization by creating baseline governance, legal, and technical requirements that enable secure health information exchange across different networks nationwide, including: a common method for authenticating trusted network participants, a common set of rules for trusted exchange, organizational and operational policies to enable the exchange of health information among networks, and a process for filing and adjudicating noncompliance with the terms of the Common Agreement.\453\ We anticipate that TEFCA can help expand the nationwide availability of secure health information exchange capabilities in public health reporting.

\452\ For additional information about health information exchange, visit: https://www.healthit.gov/topic/health-it-and-health-information-exchange-basics/what-hie.

\453\ Additional information on TEFCA can be found on the ASTP/ ONC website located at: https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-tefca.

CMS, the Centers for Disease Control and Prevention (CDC), and ASTP/ONC have been working closely with PHAs and other interested parties to expand the use of TEFCA for sharing health information for public health purposes. TEFCA is an important part of a shared vision for building a modernized public health infrastructure that connects previously siloed public health and health care systems. Early efforts to enable public health reporting through TEFCA exchange have focused on electronic case reporting, which is likely to be the primary mechanism of public health information exchange supported by entities that are part of TEFCA during CY 2026. (iii) Adoption of Public Health Reporting Using TEFCA Measure as an Optional Bonus Measure Beginning With the CY 2026 Performance Period/ 2028 MIPS Payment Year

In the CY 2026 PFS proposed rule, we proposed to adopt an optional bonus measure under the Public Health and Clinical Data Exchange objective for health information exchange with a PHA that occurs using TEFCA (the Public Health Reporting Using TEFCA measure) beginning with the CY 2026 performance period/2028 MIPS payment year (90 FR 32730 through 33732). Specifically, we proposed to

adopt the following optional bonus measure:

Public Health Reporting Using TEFCA. The MIPS eligible clinician must: (1) Participate as a signatory to a Framework Agreement (as that term is defined by the Common Agreement for Nationwide Health Information Interoperability as published in the Federal Register and on the ASTP/ONC website); \454\ (2) Not be suspended from participating in TEFCA Exchange; (3) Submit health information using TEFCA to a PHA consistent with one or more of the measures under the Public Health and Clinical Data Exchange objective; (4) Be in active engagement Option 2 (Validated Data Production) with a PHA to transfer health information for one or more of the measures under the Public Health and Clinical Data Exchange objective; and (5) Use the functions of CEHRT to exchange with the PHA.

\454\ See Common Agreement for Nationwide Health Information Interoperability Version 2.1 November 2024 located at: https://www.healthit.gov/sites/default/files/2024-11/Common_Agreement_2.1.pdf.

We proposed that a MIPS eligible clinician would be able to claim five bonus points under the Public Health and Clinical Data Exchange objective if the MIPS eligible clinician has attested that they are in active engagement Option 2 (Validated Data Production) with a PHA to submit electronic production data for one or more of the measures under the Public Health and Clinical Data Exchange objective using TEFCA. We refer readers to 90 FR 32730 through 33732 of the CY 2026 PFS proposed rule. As previously finalized in the CY 2023 PFS rule, for the measures in the Public Health and Clinical Data Exchange objective, MIPS eligible clinicians are required to report their level of active engagement as either Option 1 (Pre-production and Validation) or Option 2 (Validated Data Production), and may only spend one performance period at Option 1 (Pre-production and Validation) level of active engagement before advancing to Option 2 (Validated Data Production) to fulfill measure requirements (87 FR 70071 through 70074). Also, we proposed that this bonus measure would only be available where the MIPS eligible clinician is in active engagement Option 2 (Validated Data Production) with a PHA to transfer health information for one or more of the measures under the Public Health and Clinical Data Exchange objective.

Furthermore, under the proposal, to attest “Yes” for the Public Health Reporting Using TEFCA measure, a MIPS eligible clinician must be a signatory to a Framework Agreement,\455\ meaning either the Common Agreement or an agreement that includes the Participant/Sub-participant Terms of Participation,\456\ and is not suspended under the respective agreement. Additionally, to attest “Yes” for such bonus measure, a MIPS eligible clinician must transmit electronic health information for at least 1 measure under the Public Health and Clinic Data Exchange objective using TEFCA.

\455\ The Common Agreement defines “Framework Agreement(s)” as: “any one or combination of the Common Agreement, a Participant- QHIN Agreement, a Participant-Subparticipant Agreement, or a Downstream Subparticipant Agreement, as applicable.” See Common Agreement for Nationwide Health Information Interoperability Version 2.1 (Nov 2024) located at: https://www.healthit.gov/sites/default/files/2024-11/Common_Agreement_2.1.pdf.

\456\ Participant/Subparticipant Terms of Participation (Apr. 2024) located at: https://rce.sequoiaproject.org/wp-content/uploads/2024/05/Common-Agreement-v2.0-Exhibit-1_508.pdf.

For more information regarding the exchange of public health data using TEFCA, we refer readers to the TEFCA Public Health Exchange Purpose Implementation Standard Operating Procedure (SOP).\457\ The Public Health Exchange Purpose Implementation SOP currently identifies electronic case reporting and electronic laboratory reporting as exchange use cases, but the SOP can also be used for any allowable public health purpose. CMS, CDC, and ASTP/ONC are focused on establishing a foundation for MIPS eligible clinicians to use TEFCA to meet their public health reporting needs for the benefit of both public health and clinical care.

\457\ For more information, visit: https://rce.sequoiaproject.org/wp-content/uploads/2024/08/XP-Implementation-SOP-Public-Health-PH.pdf.

Finally, the MIPS eligible clinician must use the functions of CEHRT to engage in exchange with a PHA. We believe there are numerous certified health IT capabilities that can support exchange under a Framework Agreement with a PHA. For instance, MIPS eligible clinicians may exchange information under a Framework Agreement by using technology certified to the ONC health IT certification criterion, “Transmission to public health agencies--electronic case reporting” at 45 CFR 170.315(f)(5). This criterion is associated with the exchange use cases currently identified under the TEFCA Public Health Exchange Purpose Implementation SOP. We further recognize that MIPS eligible clinicians may connect to entities that connect directly or indirectly to a Qualified Health Information Network\TM\ \458\ (QHIN) using certified health IT in a variety of ways. This includes the other ONC health IT certification criterion at 45 CFR 170.315(f) associated with the Public Health and Clinical Data Exchange objective measures, and we believe that we should allow for substantial flexibility in how MIPS eligible clinicians use certified health IT to exchange health information under a Framework Agreement. We solicited public comment on the ONC health IT certification criteria that can support the proposed bonus measure.

\458\ A Qualified Health Information Network is a health information network that facilitates TEFCA exchange by undergoing technology and security testing, onboarding, and designation. For more information, visit: https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-tefca.

We proposed that a MIPS eligible clinician may earn a total of five bonus points if the MIPS eligible clinician attests “Yes” to one, more than one, or all of the following optional bonus measures: the Public Health Reporting Using TEFCA measure, the Public Health Registry Reporting measure, the Clinical Data Registry Reporting measure, or the Syndromic Surveillance Reporting measure. In the CY 2022 PFS final rule, we previously finalized that, beginning with the CY 2022 performance period/2024 MIPS payment year, MIPS eligible clinicians may attest “Yes” to more than one optional bonus measure in the Public Health and Clinical Data Exchange Objective, but the MIPS eligible clinician can only earn a total of five bonus points even if the MIPS eligible clinician attests “Yes” to multiple bonus measures (86 FR 65474 and 65475). As set forth in Table C-G3 in section IV.A.4.d.(4).(h).(i). of this final rule, we have specified optional bonus measures for only the Public Health and Clinical Data Exchange objective. We did not codify such policy in regulation at that time.

Currently, regulations at Sec. 414.1380(b)(4) sets forth our scoring policy for bonus measures across all objectives in the MIPS Promoting Interoperability performance category, but does not clearly reflect the finalized policy as described in the CY 2022 PFS final rule (86 FR 86 FR 65474 and 65475). Specifically, regulations at Sec. 414.1380(b)(4)(ii)(C) currently provide that, for the 2023 performance period/2025 MIPS payment year and subsequent years, each optional measure is worth five points, as specified by CMS. Such language may imply that we will provide five points for performance of each individual optional measure; this language does not account for the maximum total of five bonus points scoring policy that

was previously finalized in the CY 2022 PFS final rule (86 FR 65474 and 65475). In the CY 2023 PFS final rule (87 FR 70228), the current regulation codified at Sec. 414.1380(b)(4) inadvertently did not reflect the intent of the allocation of bonus points for optional bonus measures as previously finalized (86 FR 86 FR 65474 and 65475). To rectify such incongruency beginning with the CY 2026 performance period/2028 MIPS payment year, we proposed to amend the regulation at Sec. 414.1380(b)(4)(ii)(C) to address our previously finalized scoring methodology.

Specifically, we proposed to amend the regulation by adding a new paragraph at Sec. 414.1380(b)(4)(ii)(C)(3) to provide that, beginning with the CY 2026 performance period/2028 MIPS payment year, the total number of bonus points available to be earned when reporting one bonus measure, more than one bonus measure, or all bonus measures is a total of five bonus points. We did not propose any substantive modifications to the remaining regulation text as currently codified at Sec. 414.1380(b)(4)(ii)(C). We proposed technical modifications to reorganize the current regulation text as new paragraphs at Sec. 414.1380(b)(4)(ii)(C)(1) and (C)(2).

Because the Public Health Reporting Using TEFCA measure would be an optional bonus measure, we did not propose any exclusions. Also, we proposed that if a MIPS eligible clinician uses TEFCA to fulfill any of the required Public Health and Clinical Data Exchange objective measures, such as Electronic Case Reporting or Immunization Registry Reporting that MIPS eligible clinician will be able to claim the five bonus points if it affirmatively attests “Yes” to the Public Health Reporting Using TEFCA measure in addition to earning points for fulfilling the requirements of the required measure(s).

MIPS eligible clinicians can participate in TEFCA as Participants with a QHIN, or as Sub-participants through an entity such as a regional HIE or Health Information Network (HIN) that is a QHIN participant, through a health system, or through an EHR vendor.

We solicited public comment on the proposal to adopt the Public Health Reporting Using TEFCA measure as an optional bonus measure under the Public Health and Clinical Data Exchange objective beginning with the CY 2026 performance period/2028 MIPS payment year.

Also, we solicited public comment on the proposal to modify the regulation at Sec. 414.1380(b)(4)(ii)(C) to clarify the scoring of optional bonus measures under the Public Health and Clinical Data Exchange objective beginning with the CY 2026 performance period/2028 MIPS payment year. The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposal for CMS to adopt the Public Health Reporting Using TEFCA measure as a new optional bonus measure under the Public Health and Clinical Exchange objective. Commenters indicated that this new measure would encourage and incentivize the adoption of TEFCA. A commenter noted that the proposed new optional bonus measure, Public Health Reporting Using TEFCA, aligns with adoption of the same optional bonus measure under the Medicare Promoting Interoperability Program.

Response: We appreciate the support from commenters regarding the proposal to adopt the Public Health Reporting Using TEFCA measure. The goal of the new Public Health Reporting Using TEFCA optional bonus measure is to encourage public health information exchange, technical modernization, and improved public health capacity. Also, the new Public Health Reporting Using TEFCA optional bonus measure will create further alignment between the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program.

Comment: A few commenters supported the proposal to adopt the Public Health Reporting Using TEFCA measure as an optional bonus measure, but expressed concern that the limited TEFCA adoption among PHAs may prevent many MIPS eligible clinicians from reporting the measure and attaining bonus points. Commenters noted that there is a lack of participation in TEFCA from state and local PHAs and recommended that CMS work with ASTP/ONC to expand TEFCA's supported public health use cases. Also, commenters expressed concern that the presence of the new bonus measure may undermine the incentive to report on other public health bonus measures given that MIPS eligible clinicians cannot receive points for each bonus measure. A few commenters recommended that CMS allow MIPS eligible clinicians to receive more than five bonus points when reporting on multiple bonus measures in the Public Health and Clinical Data Exchange objective.

Response: The goal of the new Public Health Reporting Using TEFCA optional bonus measure is to encourage the use of networks participating in nationwide exchange under TEFCA without unfairly penalizing MIPS eligible clinicians who are not yet ready to participate and may need additional time and flexibility. We will continue to collaborate with other agencies including the CDC and ASTP/ ONC to identify potential opportunities to expand TEFCA's supported public health use cases. MIPS eligible clinicians who are not ready to participate in health information exchange under TEFCA can still receive the five bonus points by reporting on either the Public Health Registry Reporting measure or the Clinical Data Registry Reporting measure, or both. We will monitor performance on the new optional bonus measure and work with the CDC and ASTP/ONC to continue to monitor participation in TEFCA among PHAs, and determine if there is low rate of participation affecting the ability of MIPS eligible clinicians to report on this new Public Health Reporting Using TEFCA optional bonus measure and other bonus measures.

With regard to the comment pertaining to increasing the availability of bonus points for each optional bonus measure reported, we believe that providing available bonus points for each reported optional bonus measure would diminish the incentive to satisfactorily perform on the required measures. We believe that limiting optional bonus measures to a total maximum of five bonus points provides an appropriate balance between maintaining the primary importance of scoring well on required measures while also offering an incentive to participate in optional measures.

Comment: A few commenters recommended that CMS consider the readiness of PHAs for TEFCA participation and CMS resolve interoperability and data integrity issues with vendors and PHAs. Commenters recommended that CMS provide funding and technical assistance to small and rural practices, and community-based clinicians to encourage TEFCA participation. A commenter recommended that CMS pursue federal investments in health IT infrastructures at state, local, tribal, and territorial PHAs. Another commenter requested that CMS consider the long development timeframe for implementation of new health IT functionality when proposing new requirements.

Response: We note that the Public Health Reporting Using TEFCA measure is an optional bonus measure with no technical integration requirements for MIPS eligible clinicians who determine that reporting on the optional bonus measure is infeasible. While we

proposed that the functions of CEHRT must be used to exchange information with a PHA using TEFCA under the optional bonus measure, we did not identify specific standards or ONC health IT certification criteria that need to be adopted for this optional bonus measure. We recognize that the state of technology, available technical standards, and the technological readiness of MIPS eligible clinicians, including small and rural practices, may impact participation in TEFCA. We will continue to collaborate with other agencies to explore potential opportunities for technical support to promote participation and data exchange under TEFCA and strengthen public health reporting capabilities. We will continue to work with federal, state, local, tribal, and territorial partners to advance interoperability in public health reporting.

Comment: A few commenters recommended that CMS explicitly name the TEFCA Exchange Purpose Implementation Standard Operating Procedure, Level 2 in the measure text.

Response: In the TEFCA Exchange Purpose Implementation Standard Operating Procedure, Level 2 use cases refer to more specific data exchange contexts with accompanying exchange standards.\459\ Although we recognize the value of focusing on more mature and standardized use cases, such as the Level 2 exchange use cases, the new Public Health Reporting Using TEFCA optional bonus measure aims to provide flexibility for MIPS eligible clinicians to engage in public health reporting under TEFCA across a variety of use cases. Limiting the measure to Level 2 use cases at this time could restrict participation and hinder measure adoption. However, we will monitor rates of participation and consider proposing refinements to the measure in future rulemaking based on feedback and real-world experience with TEFCA-supported exchanges.

\459\ TEFCA Exchange Purpose (XP) Implementation SOP: Public Health, located at: https://rce.sequoiaproject.org/wp-content/uploads/2024/08/XP-Implementation-SOP-Public-Health-PH.pdf.

Comment: A commenter recommended that CMS allow MIPS eligible clinicians to claim the bonus under Active Engagement Option 1 (Pre- Production and Validation) rather than Active Engagement Option 2 (Validated Data Production). Another commenter encouraged CMS to continue allowing flexibility in how certified health IT capabilities are leveraged to meet the requirements of the measure.

Response: As the intent of the measure is to incentivize the electronic exchange of health information with PHAs, we believe performance is best reflected by validated data production under Active Engagement Option 2, in which MIPS eligible clinicians are actively exchanging production-level data with PHAs. Awarding the bonus only for production data transfer provides an appropriate balance, incentivizing meaningful use of such means of public health data exchange while still promoting flexibility in certified health IT capabilities necessary to accommodate diverse technical environments and resources. The new Public Health Reporting Using TEFCA optional bonus measure is designed to allow MIPS eligible clinicians to leverage various certified health IT capabilities to exchange data under TEFCA, ensuring they can choose the solutions that best fit their operational needs. We remain committed to supporting adaptable approaches that promote participation while minimizing burden, and we will continue to evaluate opportunities to enhance flexibility.

Comment: A few commenters recommended that TEFCA participation remain as an optional public health reporting method rather than becoming a requirement within the MIPS Promoting Interoperability performance category. A commenter recommended that CMS maintain all public health and registry reporting measures as attestation-based and voluntary. Another commenter expressed concern that TEFCA reporting may impose integration costs on specialty groups and requested that CMS consider a phase-in period before adding new requirements for measures involving public health reporting with TEFCA. Another commenter requested clarification as to whether or not MIPS eligible clinicians can attest to both the new Public Health Reporting Using TEFCA optional bonus measure and the Enabling Exchange Under TEFCA measure in the Health Information Exchange objective.

Response: We do not believe it is appropriate for all public health reporting measures in the MIPS Promoting Interoperability performance category to be voluntary; we consider public health reporting an important aspect of the meaningful use of CEHRT. The Public Health Reporting Using TEFCA measure is an optional bonus measure with no technical integration requirements for MIPS eligible clinicians who determine that reporting on the bonus measure is infeasible. While the functions of CEHRT must be used, we have not identified specific standards or ONC health IT certification criteria that need to be adopted for this optional bonus measure; there should not be additional integration costs to meet the requirements of this optional bonus measure if both the MIPS eligible clinician and the applicable PHA are Participants/Sub-participants under TEFCA.

We note that MIPS eligible clinicians may attest to both the Public Health Reporting Using TEFCA optional bonus measure and the Enabling Exchange Under TEFCA measure in the Health Information Exchange objective provided that they meet the requirements for both measures.

After consideration of public comments, we are finalizing, as proposed, the proposal to adopt the Public Health Reporting Using TEFCA measure as an optional bonus measure under the Public Health and Clinical Data Exchange objective beginning with the CY 2026 performance period/2028 MIPS payment year. For the Public Health Reporting Using TEFCA optional bonus measure, a MIPS eligible clinician must: (1) Participate as a signatory to a Framework Agreement (as such term is defined by the Common Agreement for Nationwide Health Information Interoperability as published in the Federal Register and on the ASTP/ ONC website); \460\ (2) Not be suspended from participating in TEFCA Exchange; (3) Submit health information using TEFCA to a PHA consistent with one or more of the measures under the Public Health and Clinical Data Exchange objective; (4) Be in active engagement Option 2 (Validated Data Production) with a PHA to transfer health information for one or more of the measures under the Public Health and Clinical Data Exchange objective; and (5) Use the functions of CEHRT to exchange with the PHA. Also, we note that in the FY 2026 IPPS/LTCH PPS final rule, we adopted this optional bonus measure under the Medicare Promoting Interoperability Program for eligible hospitals and CAHs (90 FR 37051 through 37056).

\460\ See Common Agreement for Nationwide Health Information Interoperability Version 2.1 November 2024 located at: https://www.healthit.gov/sites/default/files/2024-.11/Common_Agreement_2.1.pdf.

Also, we are finalizing, as proposed, the proposal to modify the regulation at Sec. 414.1380(b)(4)(ii)(C) to clarify the scoring of optional bonus measures under the Public Health and Clinical Data Exchange objective beginning with the CY 2026 performance period/2028 MIPS payment year. A MIPS eligible clinician may earn a total of five bonus points if the MIPS eligible clinician attests “Yes” to one, more than one, or

all of the following optional bonus measures: the Public Health Reporting Using TEFCA measure, the Public Health Registry Reporting measure, the Clinical Data Registry Reporting measure, or the Syndromic Surveillance Reporting measure.

(f) Adoption of a Measure Suppression Policy for the MIPS Promoting Interoperability Performance Category Beginning with the CY 2026 Performance Period/2028 MIPS Payment Year and for the Medicare Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitals (CAHs) Beginning with the EHR Reporting Period in CY 2026

For MIPS, section 1848(q)(1)(A)(i) and (ii) of the Act provides, in relevant part, that the Secretary shall develop a methodology for assessing the total performance of each MIPS eligible clinician according to certain specified performance standards for a performance period and use such methodology to provide for a composite performance score (that is, MIPS final score) for each such clinician for each performance period. As discussed previously in the CY 2026 PFS proposed rule, section 1848(q)(2)(A)(iv) of the Act requires that we assess a MIPS eligible clinician's performance as a meaningful user of CEHRT to calculate the MIPS final score (90 FR 32725). Section 1848(q)(2)(B)(iv) of the Act provides that we apply the requirements established for a performance period under section 1848(o)(2) of the Act to determine whether a MIPS eligible clinician is a meaningful user of CEHRT.

For the Medicare Promoting Interoperability Program, sections 1886(b)(3)(B)(ix) and 1814(l)(4) of the Act (as amended by the Health Information Technology for Economic and Clinical Health Act, Title XII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA), Pub. L. 111-5) authorize downward payment adjustments under Medicare, beginning with FY 2015 for eligible hospitals and CAHs that do not successfully demonstrate meaningful use of CEHRT for the applicable electronic health record (EHR) reporting period. Section 602 of Title VI, Division O of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) added section (d) hospitals in Puerto Rico as eligible hospitals under the Medicare EHR Incentive Program and extended the participation timeline for these hospitals such that downward payment adjustments were authorized beginning in FY 2022 for section (d) Puerto Rico hospitals that do not successfully demonstrate meaningful use of CEHRT for the applicable EHR reporting period.

For both the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program, sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, respectively, set forth three substantively similar criteria to determine whether a MIPS eligible clinician or an eligible hospital or CAH is a meaningful user of CEHRT. In addition, sections 1848(o)(2)(B)(i) and 1886(n)(3)(B)(i) of the Act, respectively, provide, in relevant part, that the Secretary shall select measures for purposes of the third criterion for assessing and determining if a MIPS eligible clinician, an eligible hospital, or a CAH is a meaningful user of CEHRT (sections 1848(o)(2)(A)(iii) and 1886(n)(3)(A)(iii) of the Act, respectively).

In the CY 2026 PFS proposed rule, we identified a need for additional flexibility in whether we use a measure to calculate scores or otherwise determine whether MIPS eligible clinicians meet the definition of a meaningful EHR user in the MIPS Promoting Interoperability performance category and eligible hospitals and CAHs meet the definition for the Medicare Promoting Interoperability Program (90 FR 32732 through 37234). This would account for the impact of changing conditions that are beyond the control of MIPS eligible clinicians, eligible hospitals, and CAHs, which arise outside of rulemaking for a given performance period or EHR reporting period. Such flexibility would allow us to ensure that MIPS eligible clinicians,\461\ eligible hospitals, and CAHs are not impacted negatively by external factors as determined by CMS when they are being assessed for meeting measure requirements or meeting the definition of a meaningful user.

\461\ In the CY 2024 PFS final rule, the Medicare Shared Savings Program aligned its CEHRT use requirements for Accountable Care Organizations (ACOs) with the MIPS Promoting Interoperability performance category's requirements (88 FR 79124 through 79132). As codified at Sec. 425.507, beginning with performance years on or after January 1, 2025, unless otherwise excluded, an ACO participant, ACO provider/supplier, and ACO professional that is a MIPS eligible clinician, Qualifying APM Participant (QP), or Partial Qualifying APM Participant (Partial QP) (each as defined at Sec. 414.1305) must: (1) report the objectives and measures for MIPS Promoting Interoperability performance category; and (2) earn a performance category score for the MIPS Promoting Interoperability performance category.

In the CY 2026 PFS proposed rule, we noted that a measure suppression policy would provide CMS with the flexibility to not score a measure for circumstances outside the control of MIPS eligible clinicians meeting the requirements of the MIPS Promoting Interoperability performance category and eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program (90 FR 32732). There may be circumstances that could impede the assessment of performance or a fair comparison of performance across applicable participants, creating the potential to unduly penalize a significant portion of MIPS eligible clinicians, eligible hospitals, and CAHs. We believe that there are certain circumstances that would warrant the necessity to suppress the scoring of a measure.

On this basis, for both the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program, beginning with the CY 2026 performance period/2028 MIPS payment year for MIPS eligible clinicians and the EHR reporting period in CY 2026 for eligible hospitals and CAHs, we proposed to adopt a measure suppression policy to permit CMS to exclude a measure from scoring or the determination of a meaningful EHR user for an applicable performance period/MIPS payment year or EHR reporting period in an applicable CY (90 FR 32733). Specifically, we proposed that such a measure suppression policy would allow CMS to exclude a measure from scoring due to circumstances that impede the effective measurement of a measure within the measure's applicable objective or to exclude such a measure from the determination of a meaningful EHR user for measures that are not scored. We have previously finalized similar measure suppression policies for the MIPS quality performance category (Sec. 414.1380(b)(1)(vii)(A)) and MIPS cost performance category (Sec. 414.1380(b)(2)(v)(A) and (B)). We modeled the proposed measure suppression policy based on the measure suppression policies previously finalized for the MIPS quality performance category and MIPS cost performance category at 90 FR 32732 through 37234 of the CY 2026 PFS proposed rule. We proposed the measure suppression policy for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program with some substantive differences, as compared to the similar measure suppression policies we previously finalized, to reflect more specific requirements of the MIPS Promoting Interoperability performance category

and Medicare Promoting Interoperability Program.

For an applicable performance period/MIPS payment year or EHR reporting period, we proposed that CMS would determine whether certain circumstances exist warranting suppression of a measure within the MIPS Promoting Interoperability performance category or Medicare Promoting Interoperability Program based on CMS's consideration of one or more of the following factors:

The nature, breadth, and duration of the circumstance's effect on MIPS eligible clinicians', eligible hospitals', and CAHs' ability to fulfill the measure requirement.

The availability of certified health IT modules to fulfill the measure.

The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance.

Out-of-date or conflicting technical standards.

Technical or operational capacity of required partners.

Other factors as determined by CMS.

The aforementioned factors would provide a basis for CMS to determine when circumstances may warrant CMS to suppress the scoring of a measure, particularly when circumstances arise that may impact a significant portion or all MIPS eligible clinicians, eligible hospitals, and CAHs. We believe that there may be circumstances that affect the ability of MIPS eligible clinicians, eligible hospitals, and CAHs to meet the requirements of a measure that are outside of their control, such as technical or operational limitations experienced by required partners that limit the ability of MIPS eligible clinicians, eligible hospitals, and CAHs to complete specific elements of a measure. Also, there may be circumstances in which the timeline for the availability of certified health IT modules or updated technical standards may be delayed or incongruent with measure implementation requirements and, as a result, we believe that MIPS eligible clinicians, eligible hospitals, and CAHs should not be penalized or unfairly scored on a measure. If we transition to performance-based measures in the future, we may find that the data being reported may not be consistent due to various factors causing the data to not be valid or accurate.

Under the measure suppression policy, we proposed for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, our decision to suppress a measure would still require the measure to be reported. However, regardless of what data, attestation, or other information the MIPS eligible clinician, eligible hospital, or CAH reported for the measure, it would not affect the score for the applicable objective or the determination of a meaningful EHR user for measures that are not scored. For example, for a measure that requires a “Yes” or “No” response, the MIPS eligible clinician's, eligible hospital's, or CAH's score for the objective in which the measure is found would not be negatively impacted, regardless of whether it reported a “Yes” or a “No,” as long as they reported a response.

In the CY 2026 PFS proposed rule, we noted that establishing a measure suppression policy would allow us to identify measures affected by one or more of the aforementioned factors outside of rulemaking to timely address such a situation (90 FR 32733). For any measure for which we determine it must be suppressed based on one or more of the factors we have identified, we would notify MIPS eligible clinicians, eligible hospitals, and CAHs of the suppression via existing communication channels. The proposed policy would allow us to disseminate via a listserv announcement (MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program) and publish on a CMS website (MIPS Promoting Interoperability performance category) measures identified as being suppressed for an applicable CY performance period/MIPS payment year and EHR reporting period in an applicable CY, no later than the beginning of the applicable data submission period when technically feasible, which starts in January of the CY following the applicable performance period/EHR reporting period.

We proposed to adopt the measure suppression policy for the MIPS Promoting Interoperability performance category beginning with the CY 2026 performance period/2028 MIPS payment year and the Medicare Promoting Interoperability Program for eligible hospitals and CAHs beginning with the EHR reporting period in CY 2026.

We proposed to codify the measure suppression policy at Sec. 414.1380(b)(4)(iii) for the MIPS Promoting Interoperability performance category and Sec. 495.24(f)(3) for the Medicare Promoting Interoperability Program. Specifically, we proposed to codify at Sec. 414.1380(b)(4)(iii) that, beginning with the CY 2026 performance period/2028 MIPS payment year, if certain circumstances occur impacting CMS' assessment of performance of MIPS eligible clinicians on a measure specified for the MIPS Promoting Interoperability performance category at Sec. 414.1375, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS' calculation of the MIPS Promoting Interoperability performance category objective score at Sec. 414.1380(b)(4) or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. In addition, we proposed to codify at Sec. 495.24(f)(3) that beginning with the EHR reporting period in CY 2026, if certain circumstances occur impacting CMS' assessment of performance of eligible hospitals and CAHs on a measure specified for the Medicare Promoting Interoperability Program, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS' calculation of the Medicare Promoting Interoperability Program objective score or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. Also, we proposed to codify at both Sec. Sec. 414.1380(b)(4)(iii) and 495.24(f)(3) that CMS would determine whether certain circumstances exist warranting suppression of a measure based on one or more of the following factors:

The nature, breadth, and duration of the circumstance's effect on MIPS eligible clinicians', eligible hospitals', and CAHs' ability to fulfill the measure requirement.

The availability of certified health IT modules to fulfill the measure.

The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance.

Out-of-date or conflicting technical standards.

Technical and operational capacity of required partners.

Other factors as determined by CMS.

We solicited public comment on the proposal to adopt and codify a measure suppression policy for the MIPS Promoting Interoperability performance category beginning with the CY 2026 performance period/2028 MIPS payment year at Sec. 414.1380(b)(4)(iii), and the Medicare Promoting Interoperability Program beginning with the EHR reporting period in CY 2026 at Sec. 495.24(f)(3). The following is a summary of the comments we received and our responses.

Comment: Many commenters supported the proposal to adopt a measure suppression policy. Some

commenters stated that it would offer pragmatic program flexibility; some commenters cited the recent pause in Electronic Case Reporting onboarding among PHAs as an example of an issue warranting measure suppression due to circumstances outside a MIPS eligible clinician's, eligible hospital's, or CAH's control.

Response: We appreciate the support from commenters regarding the proposal to adopt a measure suppression policy. We agree that a measure suppression policy will provide pragmatic flexibility for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program.

Comment: A few commenters requested clarification regarding why the reporting of a suppressed measure would be required. The commenters requested that reporting of a suppressed measure be voluntary.

Response: The statutory authority for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, respectively, requires MIPS eligible clinicians, eligible hospitals, and CAHs to report on measures selected by the Secretary through rulemaking for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program. Consequently, as we developed the measure suppression policy for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, we did not intend or propose to remove or modify reporting requirements. We reiterate that in the event we determine it necessary to suppress a measure, measure suppression would not remove the measure from the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program nor change the requirement to report on the measure for the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program; thus, a suppressed measure is required to be reported for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program.

In regard to the technical and operational dynamics, the suppression of a measure for MIPS eligible clinicians, eligible hospitals, and CAHs for an applicable performance period/MIPS payment year or EHR reporting period is a feasible modification that can be made to the CMS systems (pertaining to the submission of data for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program) prior to the opening of an applicable submission period for the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program while changes to measure requirements such as removing a measure or converting a measure to be optional would require more significant modifications to CMS systems that would not be able to completed prior to the opening of an applicable submission period. To prevent the delay of the opening of the submission period and disruption of the data submission process, we determined that it would be operationally feasible to update the CMS systems for the suppression of a measure given that such modification can be completed within a condensed timeframe of a few months. The measure suppression policy provides CMS with the flexibility to determine circumstances in which a measure would not be assessed for performance, enabling MIPS eligible clinicians, eligible hospitals, and CAHs to still meet the reporting requirements for the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program without having their scores negatively impacted due to circumstances outside of their control.

In addition to the technical and operational impact to CMS systems, we believe that removing the reporting requirement for a suppressed measure may cause confusion among MIPS eligible clinicians, eligible hospitals, and CAHs as to their reporting responsibilities, as participants may be in different phases of measure implementation and reporting, particularly depending on the timeframe in which we identify a need to utilize the measure suppression policy for an applicable performance period/MIPS payment year or EHR reporting period. Also, we want to continue gathering available data on a measure even under conditions of measure suppression, which could assist in our understanding of the extent of the circumstance that led to suppression. For the aforementioned reasons, we believe that it is appropriate to continue requiring the reporting of a suppressed measure(s).

Comment: A few commenters requested that CMS provide additional information surrounding the criteria CMS will apply when determining whether to implement the measure suppression policy for a given year and how input from MIPS eligible clinicians, eligible hospitals, and CAHs is considered to inform CMS' decision to suppress a measure. A commenter encouraged CMS to provide specific, real-world examples of circumstances that would warrant suppression. Another commenter requested clarification regarding the duration of a suppressed measure. Separately, commenters requested that CMS provide advance notice and information about available exclusions to measures.

Response: For an applicable performance period/MIPS payment year or EHR reporting period, we will determine whether certain circumstances exist warranting suppression of a measure within the MIPS Promoting Interoperability performance category or Medicare Promoting Interoperability Program based on CMS' consideration of one or more of the following factors identified in the CY 2026 PFS proposed rule (90 FR 32733):

The nature, breadth, and duration of the circumstance's effect on MIPS eligible clinicians', eligible hospitals', and CAHs' ability to fulfill the measure requirement.

The availability of certified health IT modules to fulfill the measure.

The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance.

Out-of-date or conflicting technical standards.

Technical or operational capacity of required partners.

Other factors as determined by CMS.

As we discussed in the CY 2026 PFS proposed rule, CMS would consider the aforementioned factors to determine when circumstances may warrant the suppression of a measure, particularly when circumstances arise that may impact a significant portion or all MIPS eligible clinicians, eligible hospitals, and CAHs (90 FR 32733).

We believe that there may be circumstances that affect the ability of MIPS eligible clinicians, eligible hospitals, and CAHs to meet the requirements of a measure that are outside of their control, such as technical or operational limitations experienced by required partners that limit the ability of MIPS eligible clinicians, eligible hospitals, and CAHs to complete specific elements of a measure. Also, there may be circumstances in which the timeline for the availability of certified health IT modules or updated technical standards may be delayed or incongruent with measure implementation requirements and, as a result, we believe that MIPS eligible clinicians, eligible hospitals, and CAHs should not be penalized or unfairly scored on a measure. If we

transition to performance-based measures in the future, we may find that the data being reported may not be consistent due to various factors causing the data to not be valid or accurate.

We note that the duration of suppression for a measure would be for the entire CY of an applicable performance period or EHR reporting period. If prolonged issues persist regarding a given circumstance, CMS would assess the circumstance to determine if a measure would warrant suppression for a subsequent performance period/EHR reporting period.

We intend to rarely utilize the measure suppression policy, which will allow us to account for the impact of circumstances arising during a given performance period or EHR reporting period that are beyond the control of MIPS eligible clinicians, eligible hospitals, and CAHs. We recognize that there may be situations where MIPS eligible clinicians, eligible hospitals, CAHs; health IT vendors; or other interested parties may bring to our attention, or the attention of ASTP/ONC or the CDC regarding public health measures, circumstances these individuals or groups wish us to consider for the suppression of a measure, particularly if CMS is not aware of certain dynamics that could impact a substantial numbers of MIPS eligible clinicians, eligible hospitals, and CAHs. Also, it is possible that we may identify on our own or with the collaboration of other governmental partners a situation that we determine requires measure suppression for a particular measure. Suppression of the Electronic Case Reporting measure for the MIPS Promoting Interoperability performance category for the CY 2025 performance period and the Medicare Promoting Interoperability Program for the EHR reporting period in CY 2025, as discussed in section XX of this final rule, is the most immediate example of a situation we have determined warrants the suppression of a measure. We recognize that there could be an array of other potential circumstances that could result in a measure to be suppressed. For example, if there were a months-long network outage in a large national Health Information Exchange or TEFCA QHIN, such case could result in MIPS eligible clinicians, eligible hospitals, and CAHs having to choose between claiming a hardship (if an available option for the MIPS eligible clinician, eligible hospital, or CAH) or failing to meet the requirements of the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program if their primary means of fulfilling the Health Information Exchange objective were unavailable. In such a case, we would also recognize that there are no applicable exclusions available under the Health Information Exchange objective for either program, and thus, we could consider measure suppression. Given that we cannot anticipate every scenario where measure suppression may be warranted, we specified that we would consider “other factors as determined by CMS” when deciding whether measure suppression is warranted for an applicable performance period/ MIPS payment year or EHR reporting period.

Comment: A few commenters did not support the proposal given that there are existing measure exclusion criteria already providing a process to accommodate MIPS eligible clinicians, eligible hospitals, and CAHs presented with challenges outside their control.

Response: We note that not all measures within the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program include exclusions and, therefore, we do not believe that the availability of an exclusion for certain measures is sufficient to address circumstances outside the control of MIPS eligible clinicians, eligible hospitals, and CAHs that impact their ability to meet the requirements of all measures. Although we agree that measure exclusions often represent one avenue for MIPS eligible clinicians, eligible hospitals, and CAHs to avoid undue negative effects if they meet the requirements of the applicable exclusion, we believe that a measure suppression policy accounts for an array of circumstances that may prevent MIPS eligible clinicians, eligible hospitals, and CAHs from meeting the requirements of a measure. We note that a measure exclusion pertains to a particular MIPS eligible clinician's, eligible hospital's, or CAH's circumstance; whereas, the measure suppression policy pertains to circumstances affecting a significant portion or all MIPS eligible clinicians, eligible hospitals, and CAHs.

Comment: Another commenter expressed concern that the measure suppression policy would prevent MIPS eligible clinicians, eligible hospitals, and CAHs from achieving full points in the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program.

Response: In the CY 2026 PFS proposed rule, we proposed to adopt a measure suppression policy that would suppress the scoring of a measure in order to avoid unfairly and negatively impacting a significant portion or all MIPS eligible clinicians, eligible hospitals, and CAHs due to factors outside of their control (90 FR 32732 through 32734). We noted that regardless of the data, attestation, or other information the MIPS eligible clinician, eligible hospital, or CAH reported for the measure, it would not affect the score for the applicable objective or the determination of a meaningful EHR user for measures that are not scored. Furthermore, we provided the following example, for a measure requiring a “Yes” or “No” response, a MIPS eligible clinician's, eligible hospital's, or CAH's score for the objective, in which the measure is found, would not be negatively impacted, regardless of whether a “Yes” or “No” was reported as long as the measure is reported (90 FR 32733).

We appreciate public comments bringing to our attention that in proposing to suppress the scoring of a measure, the effect of such action could be the antithesis of our goal of preventing an unfair and negative impact by unintentionally hindering the ability for a MIPS eligible clinician, eligible hospital, and CAH to achieve the maximum points available under the affected objective as well as the total score for the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program. The intention of the measure suppression policy is to prevent undue negative effects under the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program for MIPS eligible clinicians, eligible hospitals, and CAHs due to circumstances that are outside their control. As such, we believe that it would better reflect our intent, as well as serve the best interest of MIPS eligible clinicians, eligible hospitals, and CAHs, to score a suppressed measure by allocating the maximum available points or providing full credit for an affected measure to ensure that MIPS eligible clinicians, eligible hospitals, and CAHs are not impacted negatively by external factors as determined by CMS when they are being assessed for meeting measure requirements or meeting the definition of a meaningful EHR user (90 FR 32732). Thus, we clarify in response to public comments and consistent with our intention for the measure suppression policy, that a suppressed measure will receive the maximum available points or full credit as long as the suppressed measure is reported. We note that a suppressed measure will not be assessed for performance, but MIPS eligible

clinicians, eligible hospitals, and CAHs will be able to receive the maximum points available for a measure or full credit for a measure under an objective that contributes to the score of an objective.

For example, under the Electronic Prescribing objective, there are two measures (e-Prescribing measure and Query of Prescription Drug Monitoring Program (PDMP) measure) that have an allocation of 10 points each. If the e-Prescribing measure was suppressed, a MIPS eligible clinician, eligible hospital, or CAH would receive the maximum points available for the e-Prescribing measure. The e-Prescribing measure is a performance-based measure with a numerator and denominator. Given that the e-Prescribing measure is a performance-based measure, such measure is structured to receive a range of points dependent on performance. For performance-based measures that are suppressed, we would allocate the maximum available points for the measure as long as the suppressed measure is reported.

As another example, under the Public Health and Clinical Data Exchange objective, there is a cohort of two required measures for the MIPS Promoting Interoperability performance category (Immunization Registry Reporting measure and Electronic Case Reporting measure) and a cohort of six required measures for the Medicare Promoting Interoperability Program (Immunization Registry Reporting measure, Electronic Case Reporting measure, Syndromic Surveillance Reporting measure, Electronic Laboratory Reporting measure, Antimicrobial Use Surveillance measure; and Antimicrobial Resistance Surveillance measure). The measures under the Public Health and Clinical Data Exchange objective are attestation-based measures. The Public Health and Clinical Data Exchange objective has a total allocation of 25 points (each required measure does not have individual points attributed to it) and each required measure under such objective must meet the measure reporting requirements of the measure in order for a MIPS eligible clinician, eligible hospital, or CAH to meet the requirements of the Public Health and Clinical Data Exchange objective. For a MIPS eligible clinician, eligible hospital, or CAH to receive the total allocation of 25 points for such objective, they must attest “Yes” or claim an exclusion for each of the required measures in order for such measures to be recognized as meeting the requirements for such objective and thus, receive credit for meeting the requirements of each required measure. If the Electronic Case Reporting measure within the Public Health and Clinical Data Exchange objective is suppressed, a MIPS eligible clinician, eligible hospital, or CAH would receive full credit for the Electronic Case Reporting measure as long as the attestation-based measure is reported (attest “Yes” or “No,” or claim an applicable exclusion).

We note that if a suppressed measure is not reported, a MIPS eligible clinician, eligible hospital, and CAH would fail the measure requirement resulting in the MIPS eligible clinician, eligible hospital, and CAH receiving zero points for the suppressed measure or zero points for an objective in which the suppressed measure is one of a cohort of required measures to report due to not meeting the requirement to report the suppressed measure. Thus, we are modifying the proposed measure suppression policy accordingly.

Comment: A few commenters made recommendations regarding how the measure suppression policy could be applied to a measure, including circumstances impeding effective measurement. Specifically, a commenter recommended that CMS could require MIPS eligible clinicians, eligible hospitals, and CAHs to provide a rationale for their inability to meet a measure's requirements before CMS determines whether the measure should be suppressed. Another commenter encouraged CMS to publish a request for information (RFI) requesting feedback from healthcare organizations regarding which measures are burdensome or difficult to fulfill due to the measure suppression factors listed by CMS. Another commenter requested that announcements and sub-regulatory guidance regarding measure suppression be provided via multiple avenues to increase the likelihood that all affected parties receive prompt notification.

Response: We note that the factors we would consider in determining whether or not to suppress a measure would include circumstances affecting the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance. In regard to the comment requesting that CMS require MIPS eligible clinicians, eligible hospitals, and CAHs to submit a rationale for not being able to meet the requirements of measure prior to a measure being suppressed, we note that the suppression of a measure applies to all MIPS eligible clinicians meeting the requirements of the MIPS Promoting Interoperability performance category, and eligible clinicians and CAHs participating in the Medicare Promoting Interoperability Program. We would utilize the measure suppression policy when we are aware of a circumstance affecting all or a significant portion of MIPS eligible clinicians, eligible hospitals, or CAHs. As a result, it would be burdensome and unnecessary to require each MIPS eligible clinician, eligible hospital, or CAH to individually provide a rationale for their inability to meet a measure's requirements. Moreover, we do not intend for the measure suppression policy to be a means for individual MIPS eligible clinicians, eligible hospitals, and CAHs to request for a measure to be suppressed due to the MIPS eligible clinician's, eligible hospital's, or CAH's particular circumstances or inability to meet the requirements of a measure. We anticipate communicating with MIPS eligible clinicians, eligible hospitals, and CAHs in advance of the data submission period regarding the identification of a suppressed measure. Additionally, we anticipate that such rare circumstances in which we would utilize the measure suppression policy should require minimal to no additional action on the part MIPS eligible clinicians, eligible hospitals, and CAHs submitting data.

In regard to the comment requesting that CMS publish an RFI requesting feedback from healthcare organizations regarding which measures are burdensome or difficult to fulfill due to the measure suppression factors, we disagree that such RFIs are necessary or practical. Publishing RFIs each time CMS considers utilizing the measure suppression policy would likely be impractical, particularly due to changing conditions that may arise at any point during a given performance period or EHR reporting period, including outside of rulemaking. The measure suppression policy is intended to allow CMS to more timely address circumstances effecting MIPS eligible clinicians, eligible hospitals, and CAHs to meet the requirements of a measure due to external factors outside of their control. MIPS eligible clinicians, eligible hospitals, and CAHs are encouraged to contact CMS 462 463 regarding any feedback or issues that they may be encountering as it pertains

to the requirements of the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program. A suppressed measure is required to be reported, but is not assessed for performance under the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program.

\462\ For the MIPS Promoting Interoperability performance category, contact the Quality Payment Program Service Center by sending an email to [email protected] or creating a ticket at: https://cmsqualitysupport.servicenowservices.com/ccsq_support_central.

\463\ For the Medicare Promoting Interoperability Program, send an email to [email protected] or [email protected].

In the event that CMS decides to suppress a measure, we will notify MIPS eligible clinicians, eligible hospitals, and CAHs of the measure's suppression via existing communication channels, including the dissemination of a listserv announcement (MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program) and posting on a CMS website (MIPS Promoting Interoperability performance category) identifying suppressed measures for an applicable CY performance period/MIPS payment year and EHR reporting period in an applicable CY, no later than the beginning of the applicable data submission period when technically feasible, which starts in January of the CY following the applicable performance period/EHR reporting period.

After consideration of public comments, we are finalizing with modification the proposal to adopt a measure suppression policy that will not assess the performance of a suppressed measure and will allow MIPS eligible clinicians meeting the reporting requirements of the MIPS Promoting Interoperability performance category and eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program to receive the maximum available points for a measure or full credit for a measure that is part of a cohort of required measures to report under an objective as long as the identified suppressed measure is reported. The activation of the measure suppression policy does not change the data reporting requirements of the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program when a measure is identified as being suppressed for an applicable performance period/MIPS payment year and EHR reporting period. We recognize that some measures within the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program have specific points allocated to a measure, such as an attestation-based measure, or a range of points that could be earned for a measure, such as performance-based measures with a numerator and denominator structure; or specific points allocated to an objective in which a cohort of measures are required for reporting to meet the requirements of the objective. As such, we are modifying the measure suppression policy as proposed in Sec. 414.1380(b)(4)(iii) for the MIPS Promoting Interoperability performance category and Sec. 495.24(f)(3) for the Medicare Promoting Interoperability Program to reflect the following: A suppressed measure that is reported will receive the total number of allocated points for an attestation-based measure, the maximum number of points that could be received for a performance-based measure, or full credit for a measure within an objective in which such measure is part of a cohort of required measures to report. We are adopting and codifying a measure suppression policy for the MIPS Promoting Interoperability performance category beginning with the CY 2026 performance period/2028 MIPS payment year at Sec. 414.1380(b)(4)(iii), and the Medicare Promoting Interoperability Program beginning with the EHR reporting period in CY 2026 at Sec. 495.24(f)(3).

Specifically, we are codifying at Sec. 414.1380(b)(4)(iii) that, beginning with the CY 2026 performance period/2028 MIPS payment year, if certain circumstances occur that impact CMS' assessment of the performance of MIPS eligible clinicians on a measure selected for the MIPS Promoting Interoperability performance category at Sec. 414.1375, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS' assessment of performance while allocating the maximum points available or providing full credit for the affected measure as long as the affected measure is reported, resulting in a suppressed measure contributing to the MIPS Promoting Interoperability performance category objective score at Sec. 414.1380(b)(4); or excluding it from the determination of a meaningful EHR user if the affected measure is not scored.

In addition, we are codifying at Sec. 495.24(f)(3) that, beginning with the EHR reporting period in CY 2026, if certain circumstances occur that impact CMS' assessment of the performance of eligible hospitals and CAHs on a measure selected for the Medicare Promoting Interoperability Program, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS' assessment of performance while allocating the maximum points available or providing full credit for the affected measure as long as the affected measure is reported, resulting in the suppressed measure contributing to the Medicare Promoting Interoperability Program objective score at Sec. 495.24(f)(1)(i)(D); or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. Also, we are codifying at both Sec. Sec. 414.1380(b)(4)(iii) and 495.24(f)(3) that CMS determines whether certain circumstances exist warranting suppression of a measure based on CMS' consideration of one or more of the following factors:

The nature, breadth, and duration of the circumstance's effect on MIPS eligible clinicians', eligible hospitals', and CAHs' ability to fulfill the measure requirement.

The availability of certified health IT modules to fulfill the measure.

The circumstance affects the measure such that calculating the measure score would lead to misleading or inaccurate results, which may include performance or compliance.

Out-of-date or conflicting technical standards.

Technical and operational capacity of required partners.

Other factors as determined by CMS. (g) Suppression of the Electronic Case Reporting Measure by Excluding the Measure From Scoring for the MIPS Promoting Interoperability Performance Category for the CY 2025 Performance Period/2027 MIPS Payment Year and the Medicare Promoting Interoperability Program for the EHR Reporting Period in CY 2025 (i) Background: Public Health and Clinical Data Exchange Objective

The Public Health and Clinical Data Exchange objective of the MIPS Promoting Interoperability performance category for MIPS eligible clinicians and the Medicare Promoting Interoperability Program for eligible hospitals and CAHs has been an important mechanism for encouraging healthcare data exchange for public health purposes. Effective responses to public health events require fast, accurate exchange of data between health care providers and Federal, State, and local public health agencies (PHAs). MIPS eligible clinicians, eligible hospitals, and CAHs collect these data for patient care, and PHAs need them to protect the public, whether to track an outbreak, initiate contact tracing, find gaps in vaccine coverage, or pinpoint the source of a foodborne outbreak.

For the MIPS Promoting Interoperability performance category, there have been two required measures and three optional bonus measures under the Public Health and Clinical Data Exchange objective through the CY

2025 performance period/2027 MIPS payment year: Immunization Registry Reporting (required); Electronic Case Reporting (required); Syndromic Surveillance Reporting (optional); Public Health Registry Reporting (optional); and Clinical Data Registry Reporting (optional). For background on this objective and its associated measures, we refer readers to the CY 2019 PFS final rule (83 FR 59815 through 59817). In the CY 2022 PFS final rule, we finalized the requirement for MIPS eligible clinicians to report 2 of the 5 measures associated with the Public Health and Clinical Data Exchange objective, beginning with the CY 2022 performance period/2024 MIPS payment year: Immunization Registry Reporting and Electronic Case Reporting (86 FR 65469 through 65475). For background on this objective and its associated measures, we refer readers to the CY 2023 PFS final rule (87 FR 70071 through 70074). In section XX of this final rule, we are adopting a sixth measure as an optional bonus measure: Public Health Reporting Using TEFCA measure as an optional bonus measure under the Public Health and Clinical Data Exchange objective. Thus, beginning with the CY 2026 performance period/2028 MIPS payment year, there will be 2 required measures and four optional bonus measures under the Public Health and Clinical Data Exchange objective for the MIPS Promoting Interoperability performance category: Immunization Registry Reporting (required); Electronic Case Reporting (required); Syndromic Surveillance Reporting (optional); Public Health Registry Reporting (optional); Clinical Data Registry Reporting (optional); and Public Health Reporting Using TEFCA (optional).

For the Medicare Promoting Interoperability Program for eligible hospitals and CAHs, there have been 8 measures under the Public Health and Clinical Data Exchange objective through the EHR reporting period in CY 2025: Immunization Registry Reporting (required); Electronic Case Reporting (required); Syndromic Surveillance Reporting (required); Electronic Laboratory Reporting (required); Antimicrobial Use Surveillance (required); Antimicrobial Resistance Surveillance (required); Public Health Registry Reporting (optional); and Clinical Data Registry Reporting (optional). In the FY 2026 IPPS/LTCH PPS final rule (90 FR 37056), we adopted a ninth measure as an optional bonus measure: Public Health Reporting Using TEFCA. In the FY 2022 IPPS/LTCH PPS final rule (86 FR 45470 through 45478), we finalized the requirement for eligible hospitals and CAHs to report four measures associated with the Public Health and Clinical Data Exchange objective, beginning with the EHR reporting period in CY 2022: Immunization Registry Reporting; Electronic Case Reporting; Syndromic Surveillance Reporting; Electronic Laboratory Reporting. We subsequently finalized the requirement for eligible hospitals and CAHs to also report Antimicrobial Use Surveillance and Antimicrobial Resistance Surveillance in the FY 2024 IPPS/LTCH PPS final rule (87 FR 49335 through 49337). Thus, beginning with the EHR reporting period in CY 2026, there will be 6 required measures and 3 optional bonus measures under the Public Health and Clinical Data Exchange objective for the Medicare Promoting Interoperability Program: Immunization Registry Reporting (required); Electronic Case Reporting (required); Syndromic Surveillance Reporting (required); Electronic Laboratory Reporting (required); Antimicrobial Use Surveillance (required); Antimicrobial Resistance Surveillance (required); Public Health Registry Reporting (optional); Clinical Data Registry Reporting (optional); and Public Health Reporting Using TEFCA (optional).

The Public Health and Clinical Data Exchange objective of the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program has been an important mechanism for encouraging data exchange between MIPS eligible clinicians, eligible hospitals, CAHs, and PHAs. Requiring MIPS eligible clinicians, eligible hospitals, and CAHs to report on required measures provides an ongoing incentive for EHR vendors to implement the necessary capabilities in their products and encourages MIPS eligible clinicians, eligible hospitals, and CAHs to engage in the reporting activities described in the measures.

As noted previously, MIPS eligible clinicians, eligible hospitals, and CAHs are required to report the Electronic Case Reporting measure for the Public Health and Clinical Data Exchange objective as specified for the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program, respectively. The Electronic Case Reporting measure currently requires that the MIPS eligible clinician, eligible hospital, or CAH be in active engagement with a PHA to submit electronic case reporting of reportable conditions. A MIPS eligible clinician, eligible hospital, or CAH is required to report their level of active engagement as either Option 1 (Pre-production and Validation) or Option 2 (Validated Data Production).

As described in the CY 2023 PFS final rule (87 FR 70072) and the FY 2023 IPPS/LTCH PPS final rule (87 FR 49338), we currently define “active engagement” as when the MIPS eligible clinician, eligible hospital, or CAH is in the process of moving towards sending “production data” to a PHA or clinical data registry (CDR), or is sending production data to a PHA or CDR. We further noted that the term “production data” refers to data generated through clinical processes involving patient care; the term is used to distinguish between this data and “test data” which may be submitted for the purposes of enrolling in and testing electronic data transfers (87 FR 70072; 87 FR 49337 through 49340).

In the CY 2023 PFS final rule (70071 through 70074) and the FY 2023 IPPS/LTCH PPS final rule (87 FR 49337 through 49340), we finalized that, beginning with the CY 2023 performance period/2025 MIPS payment year and the EHR reporting period in CY 2023, respectively, a MIPS eligible clinician, eligible hospital, or CAH must indicate its level of active engagement at either Option 1 (Pre-production and Validation) or Option 2 (Validated Data Production) to fulfill the Electronic Case Reporting measure and other measures specified for the Public Health and Clinical Data Exchange objective. We further finalized that generally, beginning with the CY 2024 performance period/2026 MIPS payment system and the EHR reporting period in CY 2024, MIPS eligible clinicians, eligible hospitals, and CAHs may spend only one performance period at the Option 1 (Pre-production and Validation) level of active engagement for the Electronic Case Reporting measure and other measures specified for the Public Health and Clinical Data Exchange objective, and MIPS eligible clinicians, eligible hospitals and CAHs must progress to the Option 2 (Validated Data Production) level of active engagement in the next EHR reporting period for which they report the measure (87 FR 70071 through 70074; 87 FR 49340 through 49342). The only exception to this requirement that we finalized is that, in the event a MIPS eligible clinician, eligible hospital, or CAH chooses to switch between one or more PHAs or CDRs, they will be permitted to spend on additional performance period at Option 1 (Pre-production and Validation) to assist with onboarding to the new CDR or PHA (87 FR 70071 through 70074; 87 FR 49340 through 49342).

Additional information on the history of the Electronic Case Reporting measure can be found in prior rulemakings for the predecessor Medicare EHR Incentive Programs for Eligible Professionals and for Eligible Hospitals and Critical Access Hospitals,\464\ the MIPS Promoting Interoperability performance category,\465\ and the Medicare Promoting Interoperability Program.\466\

\464\ We refer readers to Stage 1 final rule (75 FR 1844), Stage 2 final rule (77 FR 13698), and Stage 3 final rule (80 FR 62762).

\465\ We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77008), CY 2018 Quality Payment Program final rule (82 FR 53568), the CY 2019 PFS final rule (83 FR 59815), the CY 2022 PFS final rule (86 FR 65469 through 65475), and the CY 2023 PFS final rule (87 FR 70071 through 70082).

\466\ We refer readers to the FY 2022 IPPS/LTCH PPS final rule (86 FR 45470 through 45478).

For both the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, the Electronic Case Reporting measure also includes three exclusions. A MIPS eligible clinician, eligible hospital, or CAH meeting one or more of the three established criteria may claim an exclusion from performing and reporting the Electronic Case Reporting measure for the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program, respectively. The first exclusion criterion specifies that the MIPS eligible clinician, eligible hospital, or CAH does not treat or diagnose any reportable diseases for which data are collected by its jurisdiction's reportable disease system during the performance period or EHR reporting period (Exclusion 1). The second exclusion criterion specifies that the MIPS eligible clinician, eligible hospital, or CAH operates in a jurisdiction for which no PHA is capable of receiving electronic case reporting data in the specific standards required to meet the CEHRT definition at the start of the performance period (Exclusion 2). The third exclusion criterion specifies that the MIPS eligible clinician, eligible hospital, or CAH operates in a jurisdiction where no PHA has declared readiness to receive electronic case reporting data as of six months prior to the start of the performance period (Exclusion 3). We interpret “capable of receiving electronic case reporting data in the specific standards required” in Exclusion 2 to mean that there is not a PHA in a MIPS eligible clinician's, eligible hospital's, or CAH's jurisdiction that has the ability to advance, and has advanced, a MIPS eligible clinician, eligible hospital, or CAH registered with the PHA to Active Engagement Option 2: Validated Data Production in the timeframe required for the MIPS eligible clinician, eligible hospital, or CAH to achieve Validated Data Production under the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program. For information regarding the 2025 measure specifications for the Electronic Case Reporting measure for the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program, we refer readers to: https://qpp.cms.gov/docs/pi_specifications/Measure%20Specifications/2025-MIPS-Promoting-Interoperability-Measure-Electronic-Case-Reporting-Updated-April-2025.pdf and https://www.cms.gov/files/document/cms-specifications-manual-ehr-period-cy-2025.pdf. (ii) Suppression of the Electronic Case Reporting Measure for the CY 2025 Performance Period and the EHR Reporting Period in CY 2025

As discussed in the CY 2026 PFS proposed rule (90 FR 32735), MIPS eligible clinicians, eligible hospitals, and CAHs have been required to register with a PHA and send testing files (Pre-production and Data Validation files) to report the Electronic Case Reporting measure at the Option 1 level of active engagement (87 FR 70071 through 70074; 87 FR 49338 through 87 FR 49342). Beginning with the CY 2024 performance period/2026 MIPS payment system and the EHR reporting period in CY 2024, MIPS eligible clinicians, eligible hospitals, and CAHs may spend only one performance period at the Option 1 (Pre-production and Validation) level of active engagement for the Electronic Case Reporting measure, and they must progress to the Option 2 (Validated Data Production) level of active engagement in the next performance period or EHR reporting period for which they report the measure (87 FR 70071 through 70074; 87 FR 49338 through 87 FR 49342). Therefore, beginning with the CY 2025 performance period and EHR reporting period in CY 2025, many MIPS eligible clinicians, eligible hospitals, and CAHs may need to submit case files (that is, production data) using CEHRT to their PHA to report that they have progressed to the Option 2 level of active engagement for the Electronic Case Reporting measure.

In regard to the level of engagement pertaining to Option 1 and Option 2 for the CY 2025 performance period and EHR reporting period in CY 2025, we noted in the CY 2026 PFS proposed rule that the CDC temporarily paused its electronic case reporting registration and onboarding of new health care organizations (HCOs) in order to establish a more efficient and automated process (90 FR 32735 and 32736). During such time, the CDC has been evaluating the onboarding process for HCOs and their EHR vendors to establish a more sustainable long-term path for broadscale adoption and integration of healthcare and electronic case reporting data. On June 6, 2025, we shared this information through the Quality Payment Program (QPP) and Medicare Promoting Interoperability Program listserv announcements and published this information on the QPP Resource Library web page (located at: https://qpp-cm-prod-content.s3.amazonaws.com/uploads/3268/2025-MIPS-Promoting-Interoperability-CDC-Pause-In-eCR-Onboarding.pdf) and CMS QualityNet Hospital Inpatient Notifications web page (located at: https://qualitynet.cms.gov/files/68437ab1416b533f04e5f5f0?filename=2025-59-IP.pdf). Due to this temporary pause, some MIPS eligible clinicians, eligible hospitals, and CAHs may not meet the electronic case reporting registration and onboarding requirements by the end of the CY 2025 performance period and EHR reporting period in CY 2025. The onboarding process includes a timeframe that accounts for connecting to intermediaries to send electronic case reporting data to PHAs with HCOs and EHR vendors. This temporary pause is enabling the CDC to evaluate the onboarding process for HCOs and their EHR vendors. The CDC is enhancing its electronic case reporting modernization initiatives and creating a sustainable long-term strategy for the widespread adoption and integration of healthcare and electronic case reporting data.

To avoid undue adverse consequences for MIPS eligible clinicians, eligible hospitals, and CAHs as a result of such circumstances, which are outside of their control, we proposed to suppress the Electronic Case Reporting measure (90 FR 32735 and 32736). Specifically, we proposed to exclude the Electronic Case Reporting measure from scoring under the MIPS Promoting Interoperability performance category for the CY 2025 performance period and the Medicare Promoting Interoperability Program for the EHR reporting period in CY 2025.

We proposed that we would suppress the Electronic Case Reporting measure by excluding it from calculations for scoring purposes, but MIPS eligible clinicians, eligible hospitals, and CAHs

would continue to be required to report the measure, in which they would either attest “Yes” or “No” to meeting the requirements pertaining to Option 1 and Option 2, or claim an applicable exclusion. We noted that as long as MIPS eligible clinicians, eligible hospitals, and CAHs report responses, their score for the Public Health and Clinical Data Exchange objective of the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program, as applicable, would not be adversely affected irrespective of the responses reported for this measure.

We proposed to suppress the Electronic Case Reporting measure through rulemaking in order to notify MIPS eligible clinicians, eligible hospitals, and CAHs of how we intend to address the issues related to CDC's pause on onboarding, which may affect MIPS eligible clinicians', eligible hospitals', and CAHs' ability to meet requirements of the Electronic Case Reporting measure for the MIPS Promoting Interoperability performance category for the CY 2025 performance period and the Medicare Promoting Interoperability Program for the EHR reporting period in CY 2025. In the absence of a measure suppression policy currently for the CY 2025 performance period and the EHR reporting period in CY 2025, we noted that we would utilize the CY 2026 PFS proposed rule to seek public comment regarding the proposal to suppress the Electronic Case Reporting measure due to the CDC's pause on onboarding and subsequently, and this final rule to communicate the official suppression status of the Electronic Case Reporting measure and address the scoring of the Electronic Case Reporting measure.

In the CY 2026 PFS proposed rule, we noted that the Public Health and Clinical Data Exchange objective requirements and the 25 points attributed to the objective under the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program would remain the same (90 FR 32736). The Electronic Case Reporting measure would continue to be a required measure even though we proposed to suppress it by excluding it from our scoring calculations. The 25 points attributed to the Public Health and Clinical Data Exchange objective under the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program would apply to the measure(s) in the objective that are required and not suppressed. Moreover, we noted that the proposal does not affect the measure specifications nor the required reporting of the measure, but merely affects whether the measure is scored for purposes of the applicable objective.

We solicited public comment on the proposal to suppress the Electronic Case Reporting measure by excluding the measure from scoring for MIPS eligible clinicians meeting the requirements of the MIPS Promoting Interoperability performance category, and eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program for the CY 2025 performance period and the EHR reporting period in CY 2025.

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

Comment: Many commenters supported the proposal to suppress the scoring of the Electronic Case Reporting measure for the CY 2025 performance period/EHR reporting period in CY 2025, citing the pause in PHA onboarding of new health care organizations for reporting these data.

Response: We appreciate the support from commenters regarding the proposal to suppress the Electronic Case Reporting measure for the CY 2025 performance period/EHR reporting period in CY 2025.

Comment: A few commenters noted that vendor and PHA onboarding issues could persist beyond CY 2026, preventing MIPS eligible clinicians, eligible hospitals, and CAHs from advancing to Option 2 of active engagement in a timely manner and requested that CMS suppress the requirement that MIPS eligible clinicians, eligible hospitals, and CAHs may only spend one performance period in Option 1 (Pre-Production and Validation) before progressing to Option 2 (Validated Data Production). A few commenters recommended that CMS extend the suppression of the Electronic Case Reporting measure through the CY 2026 performance period/EHR reporting period in CY 2026 to align with the enforcement discretion recently issued by ASTP/ONC regarding the electronic case reporting certification updates.

Response: During the CY 2026 performance period/EHR reporting period in CY 2026, we will continue to work with the CDC to assess whether the Electronic Case Reporting measure warrants suppression for the CY 2026 performance period/EHR reporting period in CY 2026. However, at this juncture, we decline to suppress the Electronic Case Reporting measure beyond the CY 2025 performance period and the EHR reporting period in CY 2025 without more specific information regarding the extent of the effect, if any, the existing circumstance will have on the CY 2026 performance period/EHR reporting period in CY 2026.

In regard to the comment requesting that CMS suspend its requirement to only allow MIPS eligible clinicians, eligible hospitals, and CAHs to spend one performance period in Option 1 (Pre-Production and Validation) before progressing to Option 2 (Validated Data Production), we do not believe that a change to the requirement is necessary given that a significant portion of MIPS eligible clinicians, eligible hospitals, and CAHs attested “Yes” to Option 1 for the CY 2024 performance period/EHR reporting period in CY 2024 and the Electronic Case Reporting measure is suppressed for the CY 2025 performance period/EHR reporting period in CY 2025, which provides additional time for MIPS eligible clinicians, eligible hospitals, and CAHs to progress from Option 1 (Pre-Production and Validation) to Option 2 (Validated Data Production).

On July 31, 2025, ASTP/ONC issued a notice of enforcement discretion regarding the electronic case reporting certification criteria under the ONC Health IT Certification Program.\467\ We note that the enforcement discretion takes effect immediately and will remain in place until December 31, 2026, or until the U.S. Department of Health and Human Services completes a deregulatory action revising the electronic case reporting certification criterion, whichever comes first. The enforcement discretion announces that ASTP/ONC will not exercise its direct review authority under 45 CFR 170.580 for any non- conformity, potential or actual, that arises solely from certified health IT not complying with the adopted standards finalized in 45 CFR 170.315(f)(5) so long as the health IT remains conformant with either 45 CFR 170.315(f)(5)(i) or the requirements in (f)(5)(ii). The enforcement discretion notices also states that ASTP/ONC will not take any enforcement action under 45 CFR 170.565 against an ONC-ACB based on non-compliance with 45 CFR 170.550 for certifying a Health IT Module that is presented for certification to the “transmission to public health agencies--electronic case reporting” certification criterion (45 CFR 170.315(f)(5)), where the Health IT Module demonstrates and maintains conformance with paragraph (f)(5)(i) or certain functional requirements of

paragraph (f)(5)(ii). The enforcement discretion announced by ASTP/ONC would reduce certification criteria compliance requirements and provides developers flexibility to align with the evolving HL7 standards. Developers are encouraged to continue preparing for broader adoption of modern electronic case reporting standards. This enforcement discretion permits developers to focus on meeting the functional capabilities of the certification criterion rather than specific technical standards. At this juncture, we do not believe that the enforcement discretion that reduces the certification compliance burden for health IT developers warrants suppressing the Electronic Case Reporting measure for the CY 2026 performance period/EHR reporting period in CY 2026 for MIPS eligible clinicians, eligible hospitals, and CAHs given that enforcement discretion does not change the functionality of electronic case reporting.

\467\ Office of the National Coordinator for Health IT, Electronic Case Reporting Certification Criterion Enforcement Discretion Notice located at: https://www.healthit.gov/topic/electronic-case-reporting-certification-criterion-enforcement-discretion-notice.

Comment: A few commenters did not support the proposal to suppress the Electronic Case Reporting measure because they believe that the MIPS eligible clinicians, eligible hospitals, and CAHs that can successfully report on the measure will be detrimentally impacted by a blanket suppression policy by being unable to receive credit for their work. A few commenters did not support the proposal because they believed it would remove the incentive to perform electronic case reporting. A commenter recommended that CMS only provide an exclusion from reporting to any MIPS eligible clinician, eligible hospital, or CAH that was unable to register for electronic case reporting during the CY 2025 performance period/EHR reporting period in CY 2025. A few commenters recommended that, rather than suppression, MIPS eligible clinicians, eligible hospitals, and CAHs claim an exclusion following existing policies, while a commenter recommended that CMS consider introducing a fourth exclusion option that MIPS eligible clinicians, eligible hospitals, and CAHs could claim if they provide documentation of attempted onboarding, but could not complete onboarding during the CY 2025 performance period/EHR reporting period in CY 2025. Another commenter suggested that CMS consider offering bonus points to MIPS eligible clinicians, eligible hospitals, and CAHs that can attest to meeting the requirements of the Electronic Case Reporting measure rather than suppress the scoring of the Electronic Case Reporting measure. A commenter recommended that CMS suppress the Electronic Case Reporting measure for only MIPS eligible clinicians, eligible hospitals, and CAHs that are not able to meet the requirements of the measure and redistribute the points to another objective. Another commenter recommended the removal of the points value from the Electronic Case Reporting measure entirely rather than redistributing the points to another objective and inflating the weight of another measure or objective.

Response: In this final rule, we are finalizing with modification the proposal to suppress the Electronic Case Reporting measure for the CY 2025 performance period/EHR reporting period in CY 2025. Based on public comments, we acknowledge that the proposal to suppress the Electronic Case Reporting measure by excluding the measure from scoring could potentially impede and hinder a MIPS eligible clinician's, eligible hospital's, or CAH's ability to achieve that maximum points available under the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program. We did not intend for the proposal to have such a potential consequence. The proposal to suppress the Electronic Case Reporting measure was merely intended to prevent negative implications for MIPS eligible clinicians, eligible hospitals, and CAHs that are not able to meet the measure requirements resulting from circumstances outside of their control, specifically arising from CDC's temporary pause in its electronic case reporting registration and onboarding of new HCOs (90 FR 32735 and 32736).

Thus, we believe that it would be in the best interest of MIPS eligible clinicians, eligible hospitals, and CAHs to receive full credit for reporting the suppressed Electronic Care Reporting measure, which is a measure that is part of a cohort of required measures to report under the Public Health and Clinical Data Exchange objective. While the suppressed Electronic Case Reporting measure will not be assessed for performance, MIPS eligible clinicians, eligible hospitals, and CAHs reporting the suppressed Electronic Case Reporting measure will receive full credit as long as they report the measure. If the suppressed Electronic Case Reporting measure is not reported, a MIPS eligible clinician, eligible hospital, and CAH would fail the reporting requirements under the Public Health and Clinical Data Exchange objective (receive zero points). We believe that such an approach would not cause confusion or create complexities in understanding the implementation of measure suppression.

We believe the most appropriate approach to ensure that MIPS eligible clinicians, eligible hospitals, and CAHs do not experience an increase in burden or negative effects resulting from circumstances outside of their control is to allow MIPS eligible clinicians, eligible hospitals, and CAHs reporting the suppressed Electronic Case Reporting measure to receive full credit. Also, we believe that such an approach is operationally feasible to implement prior to the opening of the submission period for reporting data pertaining to the requirements for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program without delaying the opening of the submission period and disrupting the reporting of non- suppressed measures. Thus, we disagree with commenters recommending alternative options such as the following: CMS establishing an exclusion from reporting the Electronic Case Reporting measure if a MIPS eligible clinician, eligible hospital, CAH was unable to register for electronic case reporting during the CY 2025 performance period/EHR reporting period in CY 2025 and CMS requesting that an affected MIPS eligible clinician, eligible hospital, and CAH submit supporting documentation; CMS providing bonus points to MIPS eligible clinicians, eligible hospitals, and CAHs that are able to meet the measure requirements; CMS suppressing the Electronic Case Reporting measure for only MIPS eligible clinicians, eligible hospitals, and CAHs that are not able to meet the requirements of the measure and redistribute the points to another objective; and CMS removing the points value of the Electronic Case Reporting measure entirely rather than redistributing the points to another objective and inflating the weight of another measure or objective. Such alternative options as recommended by commenters would not be technically and operationally feasible to implement prior to the opening of the submission period.

To report the suppressed Electronic Case Reporting measure, MIPS eligible clinicians, eligible hospitals, and CAHs will either attest “Yes” or “No” to meeting the requirements pertaining to Option 1 and Option 2, or claim an applicable exclusion. As long as MIPS eligible clinicians, eligible hospitals, and CAHs report responses, they will receive full credit for reporting the suppressed Electronic Case Reporting measure, which will contribute to

meeting the cohort of required measures under the Public Health and Clinical Data Exchange objective of the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program, as applicable. We note that a MIPS eligible clinician's, eligible hospital's, and CAH's score for the Public Health and Clinical Data Exchange objective would not be adversely affected irrespective of the responses reported for such measure. We note that if an applicable exclusion is claimed, the suppressed Electronic Case Reporting measure will receive full credit, which will contribute to meeting the cohort of required measures under the Public Health and Clinical Data Exchange objective.

The Electronic Case Reporting measure is included in the Public Health and Clinical Data Exchange objective. The Public Health and Clinical Data Exchange objective includes a cohort of two required measures for the MIPS Promoting Interoperability performance category and a cohort of six required measures for the Medicare Promoting Interoperability Program. In the event that a MIPS eligible clinician, eligible hospital, or CAH claims an exclusion for the suppressed Electronic Case Reporting measure and claims exclusions for the other required measures within the Public Health and Clinical Data Exchange objective, they will receive full credit for reporting the suppressed Electronic Case Reporting measure and consequently, will receive the total available points (25) for the Public Health and Clinical Data Exchange objective. In the absence of any measure suppression, if an exclusion is claimed for each required measure under the Public Health and Clinical Data Exchange objective, the total points allocated to such objective would be redistributed to another objective. Such redistribution will not occur when the Electronic Case Reporting measure is suppressed and all other required measure(s) under such objective have an exclusion claimed because in the case of reporting the suppressed Electronic Case Reporting measure, such measure will receive full credit even when an exclusion is claimed, which will contribute to meeting the cohort of required measures under the Public Health and Clinical Data Exchange objective.

Comment: A few commenters requested clarification regarding the relationship between measure suppression and the currently available measure exclusions and the hardship policy.

Response: As discussed in more detail in section XX of this final rule regarding the adoption of a measure suppression policy, we note that the suppression of the Electronic Case Reporting measure merely excludes a measure from being assessed for performance. The suppressed Electronic Case Reporting measure is required to be reported, which means MIPS eligible clinicians, eligible hospitals, and CAHs will either attest “Yes” or “No” to meeting the requirements pertaining to Option 1 and Option 2 or claim an applicable exclusion. As long as MIPS eligible clinicians, eligible hospitals, and CAHs report responses, they will receive full credit for reporting the suppressed Electronic Case Reporting measure, which will contribute to meeting the cohort of required measures under the Public Health and Clinical Data Exchange objective. We note that a MIPS eligible clinician's, eligible hospital's, and CAH's score for the Public Health and Clinical Data Exchange objective of the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program, as applicable, would not be adversely affected irrespective of the responses reported for such measure. The hardship exception policy remains in place as an option for MIPS eligible clinicians, eligible hospitals, and CAHs with individual specified circumstances that prevent reporting of other required measures, but it would not be necessary to apply for a hardship exception if the sole circumstance for applying is related to the suppressed measure because measure suppression would already prevent negative effects from attesting “No” to the measure. While three exclusions are available for the Electronic Case Reporting measure and MIPS eligible clinicians, eligible hospitals, and CAHs may submit an applicable exclusion as their response to the measure if applicable, such available exclusions may not address every situation where a MIPS eligible clinician, eligible hospital, and CAH has been negatively impacted by the CDC's onboarding pause during the CY 2025 performance period/EHR reporting period in CY 2025.

Comment: A few commenters encouraged CMS and CDC to provide clear communication and give timely updates about the resumption of electronic case reporting onboarding. A commenter requested that CMS encourage CDC to reopen registration and onboarding for electronic case reporting and cautioned that measure suppression would have an impact on the ability of PHAs to monitor disease trends and efficiently manage outbreaks.

Response: We will share the public comments received with the CDC given that the CDC is responsible for the resumption of electronic case reporting onboarding. We note that all States and the District of Columbia continue to have statutory or regulatory requirements for case reporting and they allow several reporting methods even if an automated electronic method is not yet available.\468\

\468\ https://www.pew.org/en/research-and-analysis/reports/2024/12/state-public-health-data-reporting-policies-and-practices-vary-widely.

Comment: A few commenters recommended that CMS not require MIPS eligible clinicians, eligible hospitals, and CAHs to report on a suppressed measure.

Response: We disagree with commenters regarding the recommendation for MIPS eligible clinicians, eligible hospitals, and CAHs to not be required to report on a suppressed measure. As discussed in the CY 2026 PFS proposed rule (90 FR 32733) and section XX of this final rule regarding the adoption of a measure suppression policy, we note that we do not have any intention of removing or modifying reporting requirements. We reiterate that in the event a measure suppression becomes necessary, as with the Electronic Case Reporting measure for the CY 2025 performance period/EHR reporting period in CY 2025, suppression would not remove the measure from the MIPS Promoting Interoperability performance category or the Medicare Promoting Interoperability Program, nor change the requirement to report on the measure for the respective program. In regard to the technical and operational dynamics, it is not operationally feasible to modify CMS systems to remove the Electronic Case Reporting measure prior to the opening of the submission period without risking delay in the opening of the submission period for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program or disrupting the reporting of non-suppressed measures. However, we have determined that it is operationally feasible to update the CMS systems prior to the opening of the submission period. In addition to the technical and operational impact to CMS systems, we believe that removing the reporting requirement for a suppressed measure may cause confusion among eligible clinicians, hospitals, and CAHs as to their reporting responsibilities, as participants may be in different phases

of measure implementation and reporting. Also, we want to continue gathering available data on the Electronic Case Reporting measure to help us better understand the impacts of the circumstance that led to suppression. For the aforementioned reasons, we believe that it is appropriate to continue requiring the reporting of the suppressed Electronic Case Reporting measure.

Comment: A few commenters requested that CMS clarify its expectations regarding the level of active engagement for the CY 2026 performance period/EHR reporting period in CY 2026 in terms of the expectations for MIPS eligible clinicians, eligible hospitals, and CAHs impacted by onboarding difficulties during the CY 2025 performance period/EHR reporting period in CY 2025. A commenter requested clarification regarding how to manage active engagement attestations subsequent to EHR transitions. Commenters gave the example of a MIPS eligible clinician who is in active engagement Option 2, but replacing the EHR forces the MIPS eligible clinician to re-establish a new public health reporting interface. Commenters requested guidance regarding which active engagement option would be most appropriate for attestation in that circumstance.

Response: Regarding the required level of active engagement, there is no change to the previously finalized policy (87 FR 70074) that MIPS eligible clinicians, eligible hospitals, and CAHs may only spend one MIPS performance period/EHR reporting period in Option 1 (Pre- Production and Validation) before progressing to Option 2 (Validated Data Production). Therefore, if a MIPS eligible clinician, eligible hospital, or CAH attested to spending a prior MIPS performance period/ EHR reporting period in Option 1, they would be required to progress to Option 2 in the next MIPS performance period/EHR reporting period in which the suppressed measure is no longer suppressed. Similarly, if an EHR replacement forces a MIPS eligible clinician, eligible hospital, or CAH to re-establish a new public health reporting interface and re- register with their PHA, current policy requires them to attest to Option 2 (Validated Data Production) that year if they have already spent one EHR reporting period or performance period in Option 1 (Pre- Production and Validation) (87 FR 70074).

After consideration of public comments, we are finalizing with modification the proposal to suppress the Electronic Case Reporting measure. In suppressing the Electronic Case Reporting measure, we will not assess the Electronic Case Reporting measure for performance for MIPS eligible clinicians meeting the requirements of the MIPS Promoting Interoperability performance category for the CY 2025 performance period, and eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program for the EHR reporting period in CY 2025. While the Electronic Case Reporting measure is identified as being suppressed for the purposes of assessing performance, the measure continues to be a required measure for reporting data under the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program. MIPS eligible clinicians, eligible hospitals, and CAHs reporting the suppressed Electronic Case Reporting measure (attest “Yes” or “No” to meeting the requirements pertaining to Option 1 and Option 2, or claim an applicable exclusion) will be able to receive full credit for the measure under the Public Health and Clinical Data Exchange objective. A MIPS eligible clinician's, eligible hospital's, and CAH's score for the Public Health and Clinical Data Exchange objective would not be adversely affected irrespective of the responses reported for the suppressed Electronic Case Reporting measure. If the suppressed Electronic Case Reporting measure is not reported, a MIPS eligible clinician, eligible hospital, and CAH would fail to meet the requirements under the Public Health and Clinical Data Exchange objective (receive zero points). In the event that a MIPS eligible clinician, eligible hospital, or CAH claims an exclusion for the suppressed Electronic Case Reporting measure and claims exclusions for the other required measures within the Public Health and Clinical Data Exchange objective, the available points for the Public Health and Clinical Data Exchange objective would not be redistributed to another objective (point redistribution for cases when an exclusion is claimed for all of the measures within the Public Health and Clinical Data Exchange objective) because in the case of reporting the suppressed Electronic Case Reporting measure, such measure will receive full credit resulting in meeting the requirements of the Public Health and Clinical Data Exchange objective and thus, will receive the maximum available points within the objective even when an exclusion is claimed. (h) Requirements for the MIPS Promoting Interoperability Performance Category for the CY 2026 Performance Period/2028 MIPS Payment Year (i) Objectives and Measures for the CY 2026 Performance Period/2028 MIPS Payment Year

For reference, Table C-G2 sets forth the objectives and measures for the MIPS Promoting Interoperability performance category that would be required for the CY 2026 performance period/2028 MIPS payment year. Table C-G2 reflects finalized modifications to previously established objectives and measures, including the establishment a new optional bonus measure, under the MIPS Promoting Interoperability performance category.

[GRAPHIC] [TIFF OMITTED] TR05NO25.135

[GRAPHIC] [TIFF OMITTED] TR05NO25.136

[GRAPHIC] [TIFF OMITTED] TR05NO25.137

[GRAPHIC] [TIFF OMITTED] TR05NO25.138

[GRAPHIC] [TIFF OMITTED] TR05NO25.139

[GRAPHIC] [TIFF OMITTED] TR05NO25.140

[GRAPHIC] [TIFF OMITTED] TR05NO25.141

(ii) Scoring Methodology for the CY 2026 Performance Period/2028 MIPS Payment Year

For reference, Table C-G3 sets forth the finalized scoring methodology for the MIPS Promoting Interoperability performance category for the CY 2026 performance period/2028 MIPS payment year, which includes the new optional bonus measure, Public Health Reporting Using TEFCA. When earning bonus points, a MIPS eligible clinician can receive a maximum of 5 points regardless of the number of bonus measures reported.

[GRAPHIC] [TIFF OMITTED] TR05NO25.142

(iii) Point Redistribution

Many required measures have exclusions associated with them as set forth in Table C-G2 in this final rule. If a MIPS eligible clinician believes that an exclusion for a particular measure applies to them, they may claim it when they submit their data. The maximum points available for each objective as displayed in Table C-G3 in this final rule do not include the points that would be redistributed if a MIPS eligible clinician claims an exclusion for a specific measure. Table C- G4 in this final rule sets forth how points would be redistributed among the objectives and measures specified for the MIPS Promoting Interoperability performance category for the CY 2026 performance period/2028 MIPS payment year in the

event a MIPS eligible clinician claims an exclusion for a given measure. [GRAPHIC] [TIFF OMITTED] TR05NO25.143

(iv) ONC Health IT Certification Criteria

Table C-G5 outlines the objectives and measures for the MIPS Promoting Interoperability performance category for the CY 2026 performance period/2028 MIPS payment year and the associated ONC health IT certification criteria at 45 CFR 170.315 that are applicable for the CY 2026 performance period/2028 MIPS payment year. We refer readers to the CY 2024 PFS final rule (88 FR 79307 through 79312) for discussion of and amendments to the definition of CEHRT at Sec. 414.1305.

[GRAPHIC] [TIFF OMITTED] TR05NO25.144