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 ence, new information developed under section 1848(n)(9)(A) of the Act, and input from physician specialty societies and other interested parties. For more information about past revisions to the operational list that we made as we developed, proposed, and finalized episode-based measures, we refer readers to the CY 2023 PFS final rule (87 FR 70056 through 70057), CY 2024 PFS final rule (88 FR 79348), and CY 2025 PFS final rule (89 FR 98404). The current operational list and prior operational lists are available at the QPP Cost Measure Information page at https://www.cms.gov/medicare/quality/ value-based-programs/cost-measures/ about. In accordance with section 1848(r)(2)(H) of the Act, we are proposing 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 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. Our proposed 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- measu nual- update. Our proposed 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 invite public comments on our proposals in this section. (e) Proposal to Adopt a Two-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 gory. 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 § 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 § 414.1350(b)(8), calculating a score on the clinician’s performance with respect to the cost measure in accordance with § 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 (§ 414.1380(b)(2)(i)(B)). We then calculate the cost performance cate anges based on the median cost of all MIPS eligible clinicians attributed the same cost measure, plus or minus standard deviations (§ 414.1380(b)(2)(i)(B)). We then calculate the cost performance category score as set forth in § 414.1380(b)(2)(iii), which we incorporate into our calculation of the MIPS final score in accordance with §§ 414.1380(c) and 414.1350(d). We then compare the MIPS final score with VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00369 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32720 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 § 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. MIPS eligible clinicians receive ample notice in advance of the cost measures on which they may be scored through several avenues: (1) the cost measure ir performance in the cost performance category. MIPS eligible clinicians receive ample notice in advance of the cost measures on which they may be scored through several avenues: (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. Once measures are finalized for use in MIPS, we score MIPS eligible clinicians’ performance on these measures as discussed previously and provide feedback to each clinician on their performance after the close of each performance period, as described in the CY 2025 PFS final rule (89 FR 98398 and 98399; 89 FR 98445). While MIPS eligible clinicians have information available about new cost measures on which they may be assessed prior , as described in the CY 2025 PFS final rule (89 FR 98398 and 98399; 89 FR 98445). While MIPS eligible clinicians have information available about new cost measures on which they may be assessed prior to the start of the performance period, they do not receive a score or performance feedback on any new cost measure until partially through the second performance period in which the measure is in use. We have received several requests from interested parties that we make performance feedback available earlier to MIPS eligible clinicians, such as prior to or during the performance period for which new measures are used to calculate MIPS performance category scores, final scores, and payment adjustments. Clinicians and specialty societies have provided this feedback through the notice-and-comment rulemaking process (89 FR 98398 and 98399), PRMR public comments, and other engagement not associated with a specific rule or public comment period. PRMR public comments are available for download here: https://p4qm.org/ PRMR/Resources. For example, some commenters have stated that MIPS eligible clinicians do not know in real time which cost measures they will be assessed on, which episodes an here: https://p4qm.org/ PRMR/Resources. For example, some commenters have stated that MIPS eligible clinicians do not know in real time which cost measures they will be assessed on, which episodes and patients will be attributed to them, and what costs outside of their practice they are being held accountable for until after the performance period is over; they stated that, without frequent and actionable data, MIPS eligible clinicians cannot make changes to their care (89 FR 98398). While we are continuing to work towards providing meaningful and timely information on cost measures generally, we recognize the importance of providing this information for measures implemented in MIPS. In addition, many commenters on the CY 2025 PFS proposed rule suggested that we adopt an informational-only feedback period for a minimum of 2 years after adoption of a new cost measure (89 FR 98398). Our understanding of this suggestion is that we would score the cost measure as attributed to each MIPS eligible clinician and share that score confidentially with the MIPS eligible clinician for informational-only purposes without including the score in our calculation of the cost performance category s ligible clinician and share that score confidentially with the MIPS eligible clinician for informational-only purposes without including the score in our calculation of the cost performance category score or MIPS final score. Commenters stated this informational- only feedback period would help MIPS eligible clinicians understand which new cost measures they may be assessed on prior to these measures affecting MIPS payment adjustments (89 FR 98398). Similarly, some commenters stated that more timely and detailed performance feedback would provide MIPS eligible clinicians with an opportunity to improve their cost performance (89 FR 98445). We believe that providing feedback prior to MIPS payment adjustments through an informational-only feedback period would allow MIPS eligible clinicians more time to improve their cost performance before new measures affect payment. We have considered this feedback when exploring an informational-only feedback period for MIPS cost measures. We believe that an informational-only feedback period supports our goals for the Quality Payment Program of encouraging clinicians to provide high- value, high-quality care to their patients in a cost-efficient that an informational-only feedback period supports our goals for the Quality Payment Program of encouraging clinicians to provide high- value, high-quality care to their patients in a cost-efficient manner. An informational-only feedback period would allow MIPS eligible clinicians time to develop familiarity with the cost measures and better understand the impact of new measures within the context of MIPS, prior to scores for these measures affecting their MIPS final scores or payment adjustments. Even though MIPS eligible clinicians have ample notice of cost measure specifications prior to the performance period as previously discussed, they may not be able to predict how they will perform on a new cost measure. Specifically, as previously discussed, we score a MIPS eligible clinician’s performance on a cost measure based on how their attributed costs compare to benchmark ranges (§ 414.1380(b)(2)). We determine these cost measure benchmarks based on the range of costs attributed to all MIPS eligible clinicians for the same cost measure during the same performance period (§§ 414.1380(b)(2) and 414.1380(b)(2)(i)), rather than a benchmark determined based on historical data, for the ll MIPS eligible clinicians for the same cost measure during the same performance period (§§ 414.1380(b)(2) and 414.1380(b)(2)(i)), rather than a benchmark determined based on historical data, for the reasons discussed in the CY 2025 PFS final rule (89 FR 98440). As a result, MIPS eligible clinicians do not have performance targets by which to predict their performance before or during the performance period. 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) Proposal To Adopt an Informational- Only Feedback Period of Two 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 requi 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, we propose 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00370 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P y score or MIPS final score. If a MIPS eligible clinician is attributed a VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00370 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32721 cost measure during its informational- only feedback period, then we would calculate a measure score in accordance with our scoring policies at § 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 propose 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 inc 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 are not proposing to adopt any new cost measures in this proposed rule, we are proposing that this policy would begin with the CY 2026 performance period/2028 MIPS payment year. If finalized as proposed beginning with the CY 2026 performance period/2028 MIPS payment year, then this policy would be in place prior to any new cost measures being added to the MIPS cost performance category in future rulemaking. We propose that this informational- only feedback period policy would 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 propose that modifications to existing cost measures would not alter whether a measure is considered a new or existing measure. We are pro CY 2026 performance period/2028 MIPS payment year. We further propose that modifications to existing cost measures would not alter whether a measure is considered a new or existing measure. We are proposing 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 anticipate that this proposed informational-only feedback period would drive performance improvement fo have become more familiar with the measure specifications and opportunities for improvement. We anticipate that this proposed informational-only feedback period would 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 would 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 propose 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 qua ithin 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 would include cost measures eligible for scoring as well as measures in the informational-only feedback period in MVPs, when appropriate, consistent with § 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 propose 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 § 414.1365(d), including § 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 partic in § 414.1365(d), including § 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 § 414.1380(b)(2), the same as for any cost measures. As we are proposing to codify this informational-only feedback period policy at § 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 propose 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 § 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 would not incorporate any informational-only scores on cost measures into the MVP participant’s cost performance category score or MIPS final scor hat select and report that MVP on an annual basis. We would not incorporate any informational-only scores on cost measures into the MVP participant’s cost performance category score or MIPS final score. This proposal would 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 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 propose that we would not publicly report MIPS eligible l 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 propose that we would 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00371 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32722 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 report asure 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 in § 414.1395(c). The cost measures would 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 propose to codify this informational-only feedback period by amending § 414.1380(b)(2). Specifically, we propose to add this policy under several new paragraphs at § 414.1380(b)(2)(vi). First, we propose that § 414.1380(b)(2)(vi) would 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 propose to define the terms ‘‘new cost measure’’ and ‘‘informational-on rth in this paragraph (b)(2) for informational-only purposes during the measure’s informational-only feedback period. Second, we propose to define the terms ‘‘new cost measure’’ and ‘‘informational-only feedback period’’ for the purposes of this paragraph (b)(2)(vi) at § 414.1380(b)(2)(vi)(A). We propose to define ‘‘new cost measures’’ at § 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 under § 414.1350 beginning with the 2028 MIPS payment year. We would further provide at § 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 propose to define ‘‘informational-only feedback period’’ at § 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 propose to add paragraphs (B), (C), and (D) to § 414.1380(b)(2)(vi) to codify our period for the 2 applicable MIPS payment years for which CMS initially has specified the new cost measure. Third, we propose to add paragraphs (B), (C), and (D) to § 414.1380(b)(2)(vi) to codify our proposed scoring of a new cost measure during and after its informational-only feedback period. We would provide at § 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 § 414.1380. At § 414.1380(b)(2)(vi)(C), we would 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 § 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 § s. Also, we would provide at § 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 § 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 § 414.1380. Finally, we propose to modify the paragraph at § 414.1380(b)(2)(iii) to exclude cost measure scores calculated for informational-only purposes as provided in paragraph (b)(2)(vi). We are not proposing any modification to the remaining text as currently codified at § 414.1380(b)(2)(iii). We invite comments on this proposal. (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 s 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) expa al 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 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 § 414.1305 for the relevant definitions of improvement activities and attestation, § 414.1320 for standards establishing the performance period, § 414.1325 for the data submission requirements, § 414.1355 for standards related to the improvement activity performance category generally, § 414.1360 for data submission criteria for the ce period, § 414.1325 for the data submission requirements, § 414.1355 for standards related to the improvement activity performance category generally, § 414.1360 for data submission criteria for the improvement activity performance category, and § 414.1380(b)(3) for improvement activities performance category scoring. We are proposing various updates to the Improvement Activities Inventory beginning with the CY 2026 performance period/2028 MIPS payment year, as described further later VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00372 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32723 in this section. First, we propose to remove the Achieving Health Equity subcategory. Second, we propose to add a new subcategory to the improvement activities performance category: Advancing Health and Wellness. Third, we propose to add three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we propose to modify seven existing impro add three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we propose to modify seven existing improvement activities currently specified for the performance category. Fifth, we propose to remove eight improvement activities currently specified for the performance category. We refer readers to section V.B.5.e of this proposed 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 took 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 pat ganizations 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 Activit ), 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). In order 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) Proposals To 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 rulema ate 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 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 § 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. We are proposing various updates to the improvement activities performance category, beginning with the CY 2026 performance period/2028 MIPS payment year. First, we propose to remove the Achieving Health Equity subcategory. Second, we propose adding a new subcategory to the improvement activities performance category: Advancing Health and Wellness. Third, we propose adding three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we propose modi ess. Third, we propose adding three new improvement activities into two of our existing subcategories: (1) Population Management and (2) Patient Safety and Practice Assessment. Fourth, we propose modifying seven existing improvement activities currently specified for the performance category. Fifth, we propose to remove eight improvement activities currently specified for the performance category. Generally, the three proposed new activities would 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 propose 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 selec ble 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. (iii) Proposals To Update 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00373 Fmt 4701 Sfmt 4702 E:\FR\ ategories, which must include at least six enumerated subcategories. Under section 1848(q)(2)(B)(iii) of the VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00373 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32724 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Act, we established the current subcategories for the improvement activities performance category at § 414.1355(c). (1) Proposal To Remove Achieving Health Equity Subcategory Beginning With the CY 2026 Performance Period/ 2028 MIPS Payment Year We are proposing to remove of the ‘‘Achieving Health Equity’’ (AHE) subcategory beginning with the CY 2026 performance period/2028 MIPS payment year. We would also remove this subcategory from our regulation at § 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 QPP programs that have shifted focus t ur focus on improving access, enhancing care coordination, and strengthening patient engagement. The removal of this subcategory would also be aligned with other QPP programs that have shifted focus to identifying improvement objectives on topics of prevention, nutrition, and well-being. As discussed below, we are also proposing 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 are seeking public comments on our proposal to remove the Advancing Health Equity subcategory from the improvement activities performance category and from § 414.1355(c)(7) beginning with the CY 2026 performance year/2028 MIPS payment year. (2) Proposal To Add New Advancing Health and Wellness Subcategory Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year We are proposing to add a new subcategory, titled ‘‘Advancing Health and Wellness’’ (AHW), beginning with the CY 2026 performance period/2028 MI h the CY 2026 Performance Period/2028 MIPS Payment Year We are proposing 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 would emphasize CMS’s priority of overall health promotion and address broader aspects of healthcare that go beyond the direct treatment of diseases. We are proposing to amend § 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 would 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 proposed rule, we are also proposing to reassign one existing improvement activity (IA_PM_ 13 ‘‘Chronic Care and Preventative Care Management for Empaneled Patients’’) to this new AHW subcateg of this proposed rule, we are also proposing 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. If this proposal to add this subcategory is finalized, we would consider adding more activities to this subcategory in future rulemaking. We are seeking public comments on our proposal to adopt a new subcategory, ‘‘Advancing Health and Wellness,’’ to the improvement activities performance category and at § 414.1355(c)(7) beginning with the CY 2026 performance year/2028 MIPS payment year. (iv) Proposals To Adopt New Improvement Activities Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year We propose to adopt three new improvement activities beginning with the CY 2026 performance period/2028 MIPS payment year. We propose that the IA_PM_XX (Improvement Detection of Cognitive Impairment in Primary Care) and IA_PM_XX (Integrating Oral Health Care in Primary Care) activities would period/2028 MIPS payment year. We propose that the IA_PM_XX (Improvement Detection of Cognitive Impairment in Primary Care) and IA_PM_XX (Integrating Oral Health Care in Primary Care) activities would be included in the Population Management subcategory. We propose that the IA_PSPA_XX (Patient Safety in Use of Artificial Intelligence [AI]) activity would be included in the Patient Safety and Practice Assessment subcategory. The first new improvement activity, IA_PM_XX, titled ‘‘Improving Detection of Cognitive Impairment in Primary Care,’’ would 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 would be remeasured quarterly, with a focus on Medicare patients aged 65 and older. The second new improvement activity, IA_PM_XX, titled ‘‘Integrating Oral Health Care in Primary Care,’’ would allow MIPSeligible clinicians to ly, with a focus on Medicare patients aged 65 and older. The second new improvement activity, IA_PM_XX, titled ‘‘Integrating Oral Health Care in Primary Care,’’ would allow MIPSeligible 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_XX, titled ‘‘Patient Safety Use of Artificial Intelligence,’’ would involve developing a new data- collection field within patient safety reporting systems for AI-attributable events. This would 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 would be documented. We refer readers to Table F–B1 in Appendix 2 for more information regarding each of these proposed improvement activities. We are seeking public comments on our proposals to add each of these activities to the im ders to Table F–B1 in Appendix 2 for more information regarding each of these proposed improvement activities. We are seeking public comments on our proposals to add each of these activities to the improvement activities performance category beginning with the CY 2026 performance period/2028 MIPS payment year. (v) Proposals To Modify Existing Improvement Activities Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year We are proposing 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, would be reassigned to other subcategories to better align each individual activity’s purpose with its subcategory. We propose 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 propose to also reassign IA_ PM_13, ‘‘Chronic Care and Preventative Care Management for Empaneled Patients,’’ to AHE_10 to the ‘‘Patient Safety and Practice Assessment’’ (PSPA) subcategory. Second, we propose 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 propose several modifications VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00374 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32725 to IA_BMH_1, currently titled ‘‘Diabetes Screening.’’ Specifically, we propose 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 would 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 ity would 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 would remain an integral part of the comprehensive health assessment for these patients under this activity. We also propose 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 are proposing for this activity. We refer readers to Table F–B2 in Appendix 2 for more information regarding each of these proposed modifications to existing improvement activities. We are seeking public comments on our proposals to modify each of these acti F–B2 in Appendix 2 for more information regarding each of these proposed modifications to existing improvement activities. We are seeking public comments on our proposals to modify each of these activities currently specified for the improvement activities performance category beginning with the CY 2026 performance period/2028 MIPS payment. (vi) Proposals To Remove Existing Improvement Activities Beginning With the CY 2026 Performance Period/2028 MIPS Payment Year Additionally, we are proposing 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 are proposing removal of these specific improvement activities in accordance with our activity removal policy set forth at § 414.1355(d). Specifically, we propose 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 (§ 414.1355(d)(7)). When we codified this Removal Factor at § 414.1355(d)(7) in the CY 2025 PFS final rule (89 FR 98408 and 98409), we stated that, w mprovement activity if we determine it is obsolete (§ 414.1355(d)(7)). When we codified this Removal Factor at § 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 are proposing 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’s current prioritizati 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’s current prioritization of best clinical practices and are no longer available for implementation as they have been suspended for CY 2025. 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– 19.373 374 We refer readers to Table F–B3 in Appendix 2 for more information regarding our proposals to remove each of these existing improvement activities. We are seeking 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. (4) 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 373 https://www.nejm.org/doi/full/10.1056/ NEJMsb2506929?logout=true. 374 https://archive.cdc.gov/www_cdc_g ealth record (EHR) technology (CEHRT) as a performance category under MIPS. We refer to this 373 https://www.nejm.org/doi/full/10.1056/ NEJMsb2506929?logout=true. 374 https://archive.cdc.gov/www_cdc_gov/ coronavirus/2019-ncov/your-health/end-of- phe.html. performance category as the 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 MIPS. 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 t e 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 Promoting Interope HRT; 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 Promoting Interoperability performance category, we refer readers to our regulations at §§ 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00375 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32726 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 2025 / Proposed Rules 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 this proposed rule, we are proposing 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. For both the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, we are proposing re under the Public Health and Clinical Data Exchange objective. For both the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program, we are proposing to: • Adopt and codify at § 414.1380(b)(4)(iii) and § 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 § 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 § 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, including for the M ms are defined in § 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, including for the MIPS Promoting Interoperability performance category, at § 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) 375 Health Information Technology (IT) Certification Program that meets the Base EHR definition at 45 CFR 170.102 and 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 § 414.1305, including as necessary to report on applicable objectives and measures specified for MIPS. In section IV.A.4.d.(4)(h)(i) of this proposed rule, we provide Table 62, which sets forth the objectives and measures for the 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 170.3 ures for the 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 § 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. In the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI–1) final rule (89 FR 1205 through 1210), 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. The finalized DSI criterion at 45 CRF 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 Pre DSI criterion at 45 CRF 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) 376 and support ‘‘source attributes’’ 377— categories of technical performance and quality information—for both evidence- based and Predictive DSIs. ONC further finalized that a Health IT Module may 375 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 to refer to the office. 376 45 CFR 170.315(b)(11)(iii)(A) and (B). 377 45 CFR 170.315(b)(11)(iv)(A) and (B). 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, tified 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 criterion at 45 CFR 170.315(a)(9) expired on January 1, 2025 (89 FR 1281). 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 cri ensus-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. • 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 R 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. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00376 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32727 • The ‘‘standardized application programming interface (API) for patient and population services’’ certification criterion at 45 CFR 170.315(g)(10), which is included in the Base EHR definition, was updated to include newer versions of certain standards, including USCDI version 3 and updated functionality to support the criterion (89 FR 1283). We refer readers to the HTI–1 final rule (89 FR 1192) and resources available on the ONC’s website for complete information regarding the updates to ONC health IT certif rt the criterion (89 FR 1283). We refer readers to the HTI–1 final rule (89 FR 1192) and resources available on the ONC’s website for complete information regarding the updates to ONC health IT certification criteria.378 (c) Proposal to Modify the Security Risk Analysis Measure (i) Background The HIPAA Security Rule 379 (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 implement, 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 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). For MIPS eligible clinicians, ensuring the privacy and security of ePHI is essential for demonstrating meaningful use of CEHRT. 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 378 For more information, visit: https:// www.healthit.gov/topic/laws-regulation-and-policy/ health-data-technology-and-interoperability- certification-program. 379 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 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). (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 present e 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.380 Additional information on the initial adoption of this measure can be found in prior rulemakings 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 (81 FR 77219 through 77220), 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. We subsequently modified this measure in the CY 2019 PFS final rule ( or the MIPS Promoting Interoperability performance category and included the Security Risk Analysis measure within this objective. We subsequently modified this measure in the CY 2019 PFS final rule (83 FR 59790). To earn a score for the MIPS Promoting Interoperability performance 380 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. 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 considere equired 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 § 414.1380(b)(4)(ii) and does not contribute to the MIPS eligible clinician’s 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 § 414.1375(b)(2)(ii)(A) and did not satisfy the definition of a meaningful EHR user at § 414.1305. Therefore, if the MIPS eligible clinician submits a ‘‘No’’ attestation for this measure, they would not earn a score for the Promoting Interoperability performance category, resulting in a score of zero, in accordance with § 414.1375(b)(2). We refer readers to Tables 59 and 60 in sections IV.A.4.d.(4)(h)(i) and IV.A.4.d.(4)(h)(ii), respectively, of this proposed rule for more information on the proposed objectives and measures and scoring methodology for the Promoting Interoperability perfor .d.(4)(h)(i) and IV.A.4.d.(4)(h)(ii), respectively, of this proposed rule for more information on the proposed objectives and measures and scoring methodology for the Promoting Interoperability performance category, including the Security Risk Analysis measure. (ii) Proposal To Modify 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) propriate 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/ VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00377 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32728 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 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 to OCR’s cybersecurity newsletters and other risk analysis materials,381 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.382 In this sectio ute of Standard and Technology (NIST) special publication, Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide.382 In this section of the proposed rule, we propose to modify the existing Security Risk Analysis measure to add a second attestation, requiring MIPS eligible clinicians to also 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. 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. If the proposed modification to this measure is finalized, MIPS eligible clinicians would be required to submit two affirmative (‘‘Yes’’) attestations to comply with § 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) conduct security ri th § 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) conduct 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 are proposing to modify the measure specifications to better align with the requirements of the HIPAA Security Rule. The modifications we propose to the Security Risk Analysis measure would increase accountability among MIPS eligible clinicians that have not taken steps to reduce risks and vulnerabilities 381 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. 382 See NIST SP 800–66, rev. 2, located at: https:// csrc.nist.gov/pubs/sp/800/66/r2/final. to ePHI and would provide transparency regarding the efforts of MIPS eligible clinicians that are already taking steps to m 800–66, rev. 2, located at: https:// csrc.nist.gov/pubs/sp/800/66/r2/final. to ePHI and would provide transparency regarding the efforts of MIPS eligible clinicians that are already taking steps to manage this risk. Furthermore, the proposed modification to the Security Risk Analysis measure would align with the Medicare Promoting Interoperability Program’s proposal in the FY 2026 Hospital Inpatient Protective Payment System/Long-Term Care Hospital Prospective Payment System (IPPS/ LTCH PPS) proposed rule (90 FR 18357 and 18358) to modify its Security Risk Analysis measure. To reflect the proposed addition of the risk management component, the proposed 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 requirements under 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 y 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 measure as proposed, we propose MIPS eligible clinicians would need to separately attest ‘‘Yes’’ to both components of the proposed revised Security Risk Analysis measure. A MIPS eligible clinician would be required to both 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 of the modified Security Risk Analysis measure to be considered a meaningful EHR user beginning with the CY 2026 performance period/2028 MIPS payment year. We are not proposing to modify when a MIPS eligible clinician must complete the actions specified for the Security Risk Analysis measure as currently provided at § 414.1375(b)(2)(ii)(A). As set forth at § 41 not proposing to modify when a MIPS eligible clinician must complete the actions specified for the Security Risk Analysis measure as currently provided at § 414.1375(b)(2)(ii)(A). As set forth at § 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. We also are not proposing to modify the current scoring approach for the Security Risk Analysis measure, as described in section IV.A.4.d.(4)(h)(ii) of this proposed rule. To meet the requirements of the Promoting Interoperability performance category, MIPS eligible clinicians would need to affirmatively (‘‘Yes’’) attest to the two components of the measure; otherwise, MIPS eligible clinicians would receive score of zero for the entire Promoting Interoperability performance category. If a MIPS eligible clinician attests ‘‘No’’ because they have not completed the risk analysis component, the risk management component, or neither component, or did not report the measure, then they would fail to earn a score for the Promoting Interoperabili ave not completed the risk analysis component, the risk management component, or neither component, or did not report the measure, then they would fail to earn a score for the Promoting Interoperability performance category (and receive a score of zero) as currently provided at § 414.1375(b)(2)(ii)(A). We seek public comment on this proposal to modify the Security Risk Analysis measure beginning with the CY 2026 performance period/2028 MIPS payment year. Also, we seek public comment regarding compliance with 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 this proposal. (d) Proposal To Modify 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 ine 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.383 The SAFER Guides were first released in 2014 and updated in 2016. In the CY 2022 PFS final rule (86 FR 65475 through 65477), CMS adopted the High Priority Practices SAFER Guide measure under the Protect Patient Health Information Objective in the Promoting Interoperability performance category beginning with the CY 2022 performance period/2024 MIPS payment year. In the CY 2024 PFS final rule, we modified the requirements for the High Priority Practices SAFER Guide 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- 383 ASTP SAFER Guides located at: https:// www.healthit.gov/topic/safety/safer-guides. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00378 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00378 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32729 assessment using the High Priority Practices SAFER Guide. (ii) Proposed 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 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 recommendati uides. 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 58 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 protections and present-day safety practices (88 FR 79355 through 79357). Our pr , some commenters recommended that CMS and ONC review and make updates to the 2016 SAFER Guides, regarding data privacy protections and present-day safety practices (88 FR 79355 through 79357). Our proposal 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 is a direct response to such concerns. 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. We are proposing 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 § 414.1375(b)(2)(ii)(D), to earn a score for the Promoting Interoperability performance category, a MIPS eligible clinician is required to submit an affirmative attestation regarding their t year. At § 414.1375(b)(2)(ii)(D), to earn a score for the 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 are proposing 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 are not proposing any modifications to the scoring policies for this measure as previously finalized. To meet the requirements of the Promoting Interoperability performance category, MIPS eligible clinicians would need to affirmatively (‘‘Yes’’) attest to meeting the requirement of the measure; otherwise, MIPS eligible clinicians would receive score of zero for the entire Promot , MIPS eligible clinicians would need to affirmatively (‘‘Yes’’) attest to meeting the requirement of the measure; otherwise, MIPS eligible clinicians would receive score of zero for the entire 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 would fail to earn a score for the Promoting Interoperability performance category (and receive a score of zero) as currently provided at § 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00379 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G e VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00379 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00380 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32731 Framework Agreement (as that term is defined by the Common Agreement for Nationwide Health Information Interoperability as published in the Federal Register (89 FR 93309) and on ASTP/ONC’s website); 386 (2) is not suspended from participating in TEFCA Exchange; (3) submits 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) 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; and (5) uses the functions of CEHRT to exchange with the PHA. Under our proposal, a MIPS eligible clinician would be more of the measures under the Public Health and Clinical Data Exchange objective; and (5) uses the functions of CEHRT to exchange with the PHA. Under our proposal, 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. As previously finalized in the CY 2023 PFS rule (87 FR 70071 through 70074), 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. Under our proposal, this bonus measure would only be available where the MIPS eligible clinician is in acti nt before advancing to Option 2 (Validated Data Production) to fulfill measure requirements. Under our proposal, 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 TEFCA Framework Agreement,387 meaning either the 386 Agreement located at: https:// www.healthit.gov/sites/default/files/2024-11/ Common_Agreement_2.1.pdf. 387 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:// Common Agreement or an agreement that includes the Participant/Sub- participant Terms of Participation,388 and is not suspended under the respe roperability Version 2.1 (Nov 2024) located at: https:// Common Agreement or an agreement that includes the Participant/Sub- participant Terms of Participation,388 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 one measure under the Public Health and Clinic Data Exchange objective using TEFCA. For more information about exchange of public health data using TEFCA, we refer readers to the TEFCA Public Health Exchange Purpose Implementation Standard Operating Procedure (SOP).389 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. Finally, the MIPS eligible clinician must use the functions of CEHRT to engage in exchange with a PHA. We believe there are numerous cert needs for the benefit of both public health and clinical care. 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 TEFCA Framework Agreement with a PHA. For instance, MIPS eligible clinicians may exchange information under a TEFCA 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 NetworkTM 390 (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 www.healthit.gov/sites/default/files/2024–11/ Common_Agreement_2.1.pdf. 388 Participant/Subparticipant Terms of Participation (Apr. 2024) located at: https:// rce.sequoi 170.315(f) associated with the www.healthit.gov/sites/default/files/2024–11/ Common_Agreement_2.1.pdf. 388 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. 389 For more information, visit: https:// rce.sequoiaproject.org/wp-content/uploads/2024/ 08/XP-Implementation-SOP-Public-Health-PH.pdf. 390 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. 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 TEFCA Framework Agreement. We seek public comment on ONC health IT certification criteria that can support the proposed bonus measure. We propose that a MIPS eligible clinician may earn a total of five bonus points if the MIPS eligible c blic comment on ONC health IT certification criteria that can support the proposed bonus measure. We propose 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 5 bonus points even if the MIPS eligible clinician attests ‘‘Yes’’ to multiple bonus measures (86 FR 65474 and 65475). As set forth in Table 60 in section IV.A.4.d.(4)(h)(i) of this proposed 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, our regul proposed 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, our regulation at § 414.1380(b)(4) sets forth our scoring policy for bonus measures across all objectives in the 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, § 414.1380(b)(4)(ii)(C) currently provides 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 5 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 § 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 70228), the current regulation codified at § 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00381 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32732 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules incongruency beginning with the CY 2026 performance period/2028 MIPS payment year, we are proposing to amend the regulation at § 414.1380(b)(4)(ii)(C) to address our previously finalized scoring policy. Specifically, we are proposing to amend our regulation by adding a new paragraph at § 414.1380(b)(4)(ii)(C)(3) to provide that, beginning with the CY 2026 performance period/2028 MIPS payment year, the total number 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 are not proposing any substantive modifications to the remaining regulation text as currently codified at § 414.1380( than one bonus measure, or all bonus measures is a total of five bonus points. We are not proposing any substantive modifications to the remaining regulation text as currently codified at § 414.1380(b)(4)(ii)(C). we are proposing technical modifications to reorganize the current regulation text as new paragraphs at § 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 are not proposing any exclusions. Also, we are proposing 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 would 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 a regional HIE or Health Information Network (HIN) that is a QHIN participant, through a health system, or through an EHR ve cipate in TEFCA as Participants with a QHIN, or as Sub-participants through a regional HIE or Health Information Network (HIN) that is a QHIN participant, through a health system, or through an EHR vendor. We seek 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 seek public comment on the proposal to modify the regulation at § 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. (f) Proposal To Adopt 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 develo d 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 section IV.A.4.d.(4)(a), 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. 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 ty 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 Critical Access Hospitals (CAHs) that do not successfully demonstrate meaningful use of certified electronic health record technology (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 subsection (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, secti ly 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 MIPS eligible clinician, an eligible hospital, or CAH is a meaningful user of CEHRT (sections 1848(o)(2)(A)(iii) and 1886(n)(3)(A)(iii) of the Act, respectively). We have 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. This would account for the im user in the MIPS Promoting Interoperability performance category and eligible hospitals and CAHs meet the definition for the Medicare Promoting Interoperability Program. 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,391 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. 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. There may be circumstances that could impede the assessment of 391 In the CY 2024 PFS final rule (88 FR 79124 through 79132), the Medicare Shared Savings Program aligned i ng Interoperability Program. There may be circumstances that could impede the assessment of 391 In the CY 2024 PFS final rule (88 FR 79124 through 79132), the Medicare Shared Savings Program aligned its CEHRT use requirements for Accountable Care Organizations (ACOs) with the MIPS Promoting Interoperability performance category’s requirements. As codified at § 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 § 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. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00382 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32733 performance or a fair comparison of perform A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32733 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 propose 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. Specifically, we propose that such a measure suppression policy would allow CMS to exclude a measure from scoring due to circumstances that impede the effective measurement of od in an applicable CY. Specifically, we propose 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 (§ 414.1380(b)(1)(vii)(A)) and MIPS cost performance category (§§ 414.1380(b)(2)(v)(A) and (B)). We have modeled the proposed measure suppression policy we are proposing for the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program on such policies, with some substantive differences 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 propose that CMS would determine whether certain circumstances exist warranting suppression of a measure within the MIPS Promoting Interoperability performance cate nt year or EHR reporting period, we propose 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 • 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; or • 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 cularly 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 are proposing for the MIPS Promoting Interoperability performance category a be consistent due to various factors causing the data to not be valid or accurate. Under the measure suppression policy we are proposing 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. Establishing a measure suppression IT modules to fulfill the measure; 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. For any measure for which we determine asure; 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. For any measure for which we determine it must be suppressed based on one of more of the factors we have identified, we would notify MIPS eligible clinicians, eligible hospitals, and CAHs of the suppression via existing communication channels. This proposal 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 are proposing to adopt this measure suppression policy for the MIPS Promoting Interoperability performance category beginning with the CY 2026 performance period/2028 MIPS payment year and the iod. We are proposing to adopt this 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 propose to codify the proposed measure suppression policy at § 414.1380(b)(4)(iii) for the MIPS Promoting Interoperability performance category and § 495.24(f)(3) for the Medicare Promoting Interoperability Program. Specifically, we propose to codify at § 414.1380(b)(4)(iii) that, beginning with the CY 2026 performance period/2028 MIPS payment year, if certain circumstances occur impacting CMS’s assessment of performance of MIPS eligible clinicians on a measure specified for the Promoting Interoperability performance category under § 414.1375, CMS may, in its sole discretion, suppress the affected measure by excluding it from CMS’s calculation of the MIPS Promoting Interoperability performance category objective score under § 414.1380(b)(4) or excluding it from the determination of a meaningful EHR user if the affected measure is not scored. In addition, w oting Interoperability performance category objective score under § 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 propose to codify at § 495.24(f)(3) that beginning with the EHR reporting period in CY 2026, if certain circumstances occur impacting CMS’s assessment of performance of eligible hospitals and CAHs on a measure specified for the Medicare Promoting Interoperability Program, CMS may, in VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00383 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32734 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules its sole discretion, suppress the affected measure by excluding it from CMS’s 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 are proposing to codify at both § 414.1380(b)(4)(iii) and § 495.24(f)(3) that CMS would determine whether certain circumstances exist warranting suppression of a measure asure is not scored. Also, we are proposing to codify at both § 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; or • Other factors as determined by CMS. We seek public comment on our proposals 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 § 414.1380(b)(4)(iii), and the Medicare Promoting Interoperability Program beginning with the EHR reporting period in CY 2026 at § 495.24(f)(3). (g) Proposal To Sup ce period/2028 MIPS payment year at § 414.1380(b)(4)(iii), and the Medicare Promoting Interoperability Program beginning with the EHR reporting period in CY 2026 at § 495.24(f)(3). (g) Proposal To Suppress 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 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 d 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 are two required measures and three optional measures under the Public Health and Clinical Data Exchange objective: Immunization Registry Reporting; Electronic Case Reporting; 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 59795, 59815 through 59817). In the CY 2022 PFS final rule (86 FR 65469 through 65475), we finalized the requirement for MIPS eligible clinicians to report two of the 5 measures associated with the Public Health and Clinical Data Exchange objective, beginning with the performance period in CY 2022: Immunization Registry Reporting and Electronic Case Reporting. For backgr ures associated with the Public Health and Clinical Data Exchange objective, beginning with the performance period in CY 2022: Immunization Registry Reporting and Electronic Case Reporting. For background on this objective and its associated measures for MIPS eligible clinicians, we refer readers to the CY 2023 PFS final rule (87 FR 70071 through 70074). For the Medicare Promoting Interoperability Program for eligible hospitals and CAHs, there are eight measures under the Public Health and Clinical Data Exchange objective: Immunization Registry Reporting; Electronic Case Reporting; Syndromic Surveillance Reporting; Electronic Laboratory Reporting; Antimicrobial Use Surveillance; Antimicrobial Resistance Surveillance; Public Health Registry Reporting (optional); and Clinical Data Registry Reporting (optional). In the Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes proposed rule, we proposed a ninth measure, which would be optional if finalized: Public Health Reporting Using TEFC Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes proposed rule, we proposed a ninth measure, which would be optional if finalized: Public Health Reporting Using TEFCA (90 FR 18360). In the Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program (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 report Antimicrobial Use Surveillance and Antimicrobial Resistance Surveillanc Reporting; Electronic Laboratory Reporting. We subsequently finalized the requirement for eligible hospitals and CAHs to report Antimicrobial Use Surveillance and Antimicrobial Resistance Surveillance in the FY 2024 IPPS/LTCH PPS final rule (87 FR 49335 through 49337). 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 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 Inter 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00384 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t ta to a PHA or CDR. We further noted that the term ‘‘production VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00384 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32735 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 E ption 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- n 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,392 the MIPS Promoting Interoperability performance 392 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). category,393 and the Medicare Promoting Interoperability Program.394 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 R 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 is 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 is 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 is 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 perio inician, 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 393 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 r e (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). 394 We refer readers to the FY 2022 IPPS/LTCH PPS final rule (86 FR 45470 through 45478). 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. We note that the policy proposals for the Medicare Promoting Interoperability Program appeared in the Federal Register on April 30, 2025 (90 FR 18002) as part of the FY 2026 IPPS/ LTCH PPS proposed rule. The proposed rule contains proposals for program scoring (90 FR 18361) that are unchanged with respect to Electronic Case Reporting measure; scoring changes to the measure are outlined in the FY 2025 IPPS/LTCH PPS final rule (89 FR 69604). (ii) Prop scoring (90 FR 18361) that are unchanged with respect to Electronic Case Reporting measure; scoring changes to the measure are outlined in the FY 2025 IPPS/LTCH PPS final rule (89 FR 69604). (ii) Proposal To Suppress the Electronic Case Reporting Measure for the CY 2025 Performance Period and the EHR Reporting Period in CY 2025 As discussed previously in section IV.A.4.d.(4)(g)(i), 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 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 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 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00385 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32736 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules the CY 2025 performance period and EHR reporting period in CY 2025, we have recently been informed by the Centers for Disease Control and Prevention (CDC) that it has temporarily paused electronic case reporting registration eriod and EHR reporting period in CY 2025, we have recently been informed by the Centers for Disease Control and Prevention (CDC) that it has temporarily paused electronic case reporting registration and onboarding of new health care organizations (HCOs) to establish a more efficient and automated process. During such time, the CDC will evaluate the onboarding process for HCOs and their EHR vendors and 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 webpage (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 webpage (located at: https:// qualitynet.cms.gov/files/ 68437ab1416b533f04e5 f5f0?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 t.cms.gov/files/ 68437ab1416b533f04e5 f5f0?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 will enable 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 are proposing to suppress the Electronic Case Reporting measure. Specifically, we propose to exclude the Electronic Case Reporting measure from scoring under the MIPS Promoting Interoperability performance category fo suppress the Electronic Case Reporting measure. Specifically, we propose 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. Specifically, we propose 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. As long as the MIPS eligible clinicians, eligible hospitals, and CAHs report responses, their score for the Public Health and Clinical Data Exchange objective of the 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. If this proposal is finalized as proposed, MIPS eligible clinicians, eligible hospitals, and CAHs s applicable, would not be adversely affected irrespective of the responses reported for this measure. If this proposal is finalized as proposed, MIPS eligible clinicians, eligible hospitals, and CAHs should report the Electronic Case Reporting measure in accordance with the applicable specifications. However, if this proposal is not finalized, we encourage MIPS eligible clinicians, eligible hospitals, and CAHs to claim an exclusion, if applicable. Please note that we are proposing 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 in effect for the CY 2025 performance period and the EHR reporting period in CY 2025, we are utilizing t r the EHR reporting period in CY 2025. In the absence of a measure suppression policy currently in effect for the CY 2025 performance period and the EHR reporting period in CY 2025, we are utilizing this proposed rule and subsequently, the upcoming CY 2026 PFS final rule that will be published by November 1, 2025, to communicate and seek public comment on our proposed approach to address scoring of the Electronic Case Reporting measure due to the CDC’s pause on onboarding. We note 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 if we finalize this proposal. The Electronic Case Reporting measure would continue to be a required measure even though we are proposing to suppress it by excluding it from our scoring calculations. If this proposal is finalized as proposed, the 25 points attributed to the Public Health and Clinical Data Exchange objective the MIPS Promoting Interoperability performance category and the Medicare Promoting Interoperability Program would apply to the measu tributed to the Public Health and Clinical Data Exchange objective 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 note that this 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 seek public comment on the proposals 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. (h) Proposed Requirements for the Promoting Interoperability Performance Category for the CY 2026 Performance Period/2028 MIPS Payment Year (i) Proposed Objectives and Measures for the CY 2026 Performance Period/ 2028 MIPS Payment Year For reference, Table 59 sets forth the objectives and measures for the Pr Period/2028 MIPS Payment Year (i) Proposed Objectives and Measures for the CY 2026 Performance Period/ 2028 MIPS Payment Year For reference, Table 59 sets forth the objectives and measures for the Promoting Interoperability performance category that would be required for the CY 2026 performance period/2028 MIPS payment year. Table 59 reflects proposed modifications to previously established objectives and measures, including the proposal to establish a new optional bonus measure, under the Promoting Interoperability performance category. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00386 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32737 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00387 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00388 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00389 Fmt 4701 Sfmt 4725 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00388 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00389 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00390 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00391 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00392 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00393 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00394 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00395 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00396 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00397 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00398 Fmt 4701 Sfmt 4702 E:\FR\ H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00397 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 > H P G H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00398 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32749 On August 5, 2024, the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI–2) proposed rule appeared in the Federal Register (89 FR 63498). The HTI–2 proposed rule includes a proposal for a PDMP certification criterion at 45 CFR 170.315(f)(9) entitled ‘‘Prescription Drug Monitoring Program (PDMP) Databases—Query, receive, validate, parse, and filter’’ that would enable the bi-directional interaction and electronic health information exchange between certified Health IT Modules and PDMP databases using a consistent approach to querying PDMP data (89 FR 63547). Specifically, the proposed certification criterion would enable the query of prescription drug monitoring systems and the receipt, validation, parsing, and filtering of medication information from PDMPs. The proposed criterion would be a functional cr would enable the query of prescription drug monitoring systems and the receipt, validation, parsing, and filtering of medication information from PDMPs. The proposed criterion would be a functional criterion agnostic to a specific PDMP standard, but would include transport, content, and vocabulary standards where appropriate. ONC has not finalized the proposal to date. In the CY 2019 PFS final rule, CMS adopted the Query of PDMP measure under the e-Prescribing objective of the Promoting Interoperability performance category to support HHS initiatives aimed at improving the treatment of opioid and substance use disorders by helping MIPS eligible clinicians avoid inappropriate prescriptions (83 FR 59795). The Query of PDMP measure provides that, for at least one Schedule II opioid or Schedule III or IV drug electronically prescribed using CEHRT during the performance period, the MIPS eligible clinician uses data from CEHRT to conduct a query of a PDMP for prescription drug history as described in the CY 2024 PFS final rule (88 FR 79353 and 79354). We are interested in continuing to make improvements to the Promoting Interoperability performance category that promote patient safety an cribed in the CY 2024 PFS final rule (88 FR 79353 and 79354). We are interested in continuing to make improvements to the Promoting Interoperability performance category that promote patient safety and encourage appropriate prescribing of controlled substances while minimizing provider burden. We further believe improved technology approaches and increased PDMP integration into EHR systems can enable increased utilization of PDMPs and associated positive outcomes for patients. Therefore, we are seeking public comment through this RFI to potentially inform future rulemaking for the Query of PDMP measure related to the following policy considerations: (1) changing the Query of PDMP measure from an attestation-based measure (‘‘Yes’’ or ‘‘No’’) to a performance-based measure (numerator and denominator), as well as alternative measures designed to more effectively assess the degree to which participants are utilizing PDMPs; and (2) expanding the types of drugs to which the Query of PDMP measure could apply. (ii) RFI on Changing the Query of PDMP Measure From an Attestation-Based Measure to a Performance-Based Measure The Query of PDMP measure was initially finalized in the CY 2019 PFS f sure could apply. (ii) RFI on Changing the Query of PDMP Measure From an Attestation-Based Measure to a Performance-Based Measure The Query of PDMP measure was initially finalized in the CY 2019 PFS final rule (83 FR 59800 through 598045) as a performance-based measure with a numerator and denominator described as follows: • Denominator: Number of Schedule II opioids 403 electronically prescribed using CEHRT by the MIPS eligible clinician during the performance period. • Numerator: The number of Schedule II opioid prescriptions in the denominator for which data from CEHRT is used to conduct a query of a PDMP for prescription drug history except where prohibited and in accordance with applicable law. A numerator of at least one is required to fulfill this measure. In the CY 2020 and CY 2021 PFS final rules (84 FR 62992 through 62994 and 85 FR 84887 through 84888), we described the concerns expressed by interested parties that they believed it was premature for the Promoting Interoperability performance category to require the Query of PDMP measure and score it based on performance. In the CY 2022 PFS proposed rule (86 FR 39410), we discussed our support of efforts to expand the use lity performance category to require the Query of PDMP measure and score it based on performance. In the CY 2022 PFS proposed rule (86 FR 39410), we discussed our support of efforts to expand the use of PDMPs, describing federally supported activities aimed at developing a more robust and standardized approach to EHR–PDMP integration, and additional discussions on the feedback we have received from health IT vendors and MIPS eligible clinicians thus far. In the CY 2023 PFS final rule (87 FR 70062 through 70067), we finalized the Query of PDMP measure to require a ‘‘Yes’’ or a ‘‘No’’ attestation from MIPS eligible clinicians participating in the Quality Payment Program beginning with the CY 2023 performance period/2025 MIPS payment year. A ‘‘Yes’’ response would indicate that, for at least one Schedule II opioid or Schedule III or IV drug electronically prescribed using CEHRT 403 In the CY 2019 PFS final rule, the Query of PDMP only included Schedule II opioids (83 FR 59800 through 59804). We finalized the expansion of the Query of PDMP measure to include Schedule II opioids and Schedule III and IV drugs beginning with the CY 2023 performance period in the CY 2023 PFS final rule (87 4). We finalized the expansion of the Query of PDMP measure to include Schedule II opioids and Schedule III and IV drugs beginning with the CY 2023 performance period in the CY 2023 PFS final rule (87 FR 70062 through 70067). during the performance period, the MIPS eligible clinician uses data from CEHRT to conduct a query of a PDMP for a prescription drug history. Given recent progress in a variety of areas, there is now a clearer trajectory moving forward to enhance the Promoting Interoperability performance category’s capacity to incentivize use of PDMPs, and thereby, to improve the quality of health care and promote care coordination. Notably, PDMPs are now widely available across all 50 States and several localities, and PDMP integration with HIEs, EHRs, and PDSs has increased since the Query of PDMP measure was finalized as an attestation measure. Therefore, to further promote the utilization of PDMPs and to support appropriate prescribing for controlled substances, we are inviting public comment and feedback on the potential modification or replacement of the Query of PMDP measure from an attestation measure to a performance- based measure to inform potential future rulemaki ng public comment and feedback on the potential modification or replacement of the Query of PMDP measure from an attestation measure to a performance- based measure to inform potential future rulemaking and include the following questions: • Should CMS propose to adopt a performance-based (numerator/ denominator) reporting requirement for the Query of PDMP measure? If so, how should the numerator and denominator be defined? For example, one approach we are considering to potentially inform future rulemaking is the following description of a numerator and a denominator, which is updated from the numerator and denominator established in the CY 2019 PFS final rule (83 FR 59800 through 59804), when the Query of PDMP measure was initially finalized as a performance-based measure and only included Schedule II opioids: ++ Denominator: Number of Schedule II opioid or Schedule III or IV drugs electronically prescribed using CEHRT by the MIPS eligible clinician during the performance period. ++ Numerator: The number of prescriptions of Schedule II opioid or Schedule III or IV drugs in the denominator for which data from CEHRT is used at the time of prescribing to conduct a query of a PDMP fo Numerator: The number of prescriptions of Schedule II opioid or Schedule III or IV drugs in the denominator for which data from CEHRT is used at the time of prescribing to conduct a query of a PDMP for prescription drug history. • What are potential barriers for MIPS eligible clinicians meeting the Query of PDMP measure as a performance-based measure? • How should CMS account for varying levels of readiness and capacity for performance-based reporting, particularly for small and rural providers, including MIPS eligible clinicians? VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00399 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32750 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules • Are there specific exclusions that we should consider for performance- based reporting? • What timeframe would allow for systems and process changes to account for a change of the Query of PDMP measure from an attestation measure to a performance-based measure while minimizing burden? • Would adoption and use of Health IT Modules certified to the ‘‘Prescription Drug Monitoring Program f PDMP measure from an attestation measure to a performance-based measure while minimizing burden? • Would adoption and use of Health IT Modules certified to the ‘‘Prescription Drug Monitoring Program (PDMP) Databases—Query, receive, validate, parse, and filter’’ certification criterion proposed by ONC in the HTI– 2 proposed rule (89 FR 63547), if this criterion were to be finalized, help to mitigate previously identified burden associated with implementing and reporting on a performance-based ‘‘Query of PDMP’’ measure? • How would the adoption and use of Health IT Modules certified to the proposed ‘‘Prescription Drug Monitoring Program (PDMP) Databases—Query, receive, validate, parse, and filter’’ certification criterion, if it were finalized, impact the numerator and denominator of a potential performance- based PDMP measure? We are also requesting feedback on a broader set of performance-based measurement concepts that could help to advance our priorities with respect to the use of PDMPs to support the prevention and treatment of opioid use disorders. We are specifically interested in creating performance-based measures that allow MIPS eligible clinicians to leverage technology PDMPs to support the prevention and treatment of opioid use disorders. We are specifically interested in creating performance-based measures that allow MIPS eligible clinicians to leverage technology to improve care and reduce burden. • What are other measure concepts we should consider that would allow us to focus on outcomes related to overdose prevention? • Should we explore measures related to monitoring data from PDMPs that could assess multiple opioid prescriptions, opioid prescriptions from multiple prescribers, combined opioid and benzodiazepine prescriptions, or very high standardized dosage of opioids prescribed? • What measure concepts related to the use of PDMPs are likely to involve the lowest effort and provide the highest value to the health care community? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or form empt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. (iii) RFI on the Modification of the Query of PDMP Measure To Include All Schedule II Drugs Under the Controlled Substances Act (CSA),404 the Drug Enforcement Administration classifies drugs, substances, and certain chemicals used to make drugs into five distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. A drug’s abuse rate is a factor used to determine its classification; for example, Schedule I medications have the highest abuse potential while medications in Schedule V have a low abuse potential.405 We refer readers to Table 64 for information on each Schedule, including abuse potential, medicinal use, if any, a ighest abuse potential while medications in Schedule V have a low abuse potential.405 We refer readers to Table 64 for information on each Schedule, including abuse potential, medicinal use, if any, and drug examples. For additional information, we refer readers to the listing of drugs and their schedule located at CSA Scheduling at: https:// www.deadiversion.usdoj.gov/schedules/ orangebook/c_cs_alpha.pdf. 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 404 Public Law 91–513, tit. II, 84 Stat. 1236, 1242– 84 (1970); codified, as amended, at 21 U.S.C. 801 et seq. 405 United States Drug Enforcement Administration website located at: https:// www.dea.gov/drug-information/drug-scheduling. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00400 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00401 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00402 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Propo m 00402 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32753 that makes data available for a range of public health use cases. If these approaches are implemented in certified health IT in the future, should we consider streamlining or reduce the number of measures required in the Promoting Interoperability performance category? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the P commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. (k) RFI Regarding Data Quality Gaps and discrepancies in data accuracy, completeness, reliability, and consistency undermine the integrity of health information exchange. We believe MIPS eligible clinicians should be able to seamlessly exchange high- quality health information with patients, providers, and payers across systems. For the purposes of this discussion, we define data quality as the degree to which health information is accurate, complete, timely, consistent, and reliable. These factors increase the overall quality of health information that touches several aspects of the health care continuum: clinical information, patient safety, claims, provider data, eligibility, benefits, and administrative data.412 Poor data quality poses direct threats to patient safety, especially when providers, including MIPS eligible clinicians, treat patients based on inaccurate or incomplete information.413 Accountability, transparency, and improvement efforts also suffer when health care a hen providers, including MIPS eligible clinicians, treat patients based on inaccurate or incomplete information.413 Accountability, transparency, and improvement efforts also suffer when health care actors evaluate—or are evaluated based on— care quality and outcomes that do not reflect true performance due to unreliable or low quality data.414 Poor quality data also poses risks beyond health care delivery and administration. Because health care data captured by EHRs serve as the foundation for public health reporting and clinical research using real world evidence, widespread deficits in data quality can adversely affect clinical innovation and public health decision-making.415 We encourage MIPS eligible clinicians to work with their health IT vendors to ensure the richest, highest quality data are sent to their exchange partners. This partnership can help ensure data validation; reduce burden between MIPS eligible clinicians and their exchange partners; and reduce unintended consequences and risks that come with low-quality data. For example, timely, complete data are needed for monitoring adverse events such as antimicrobial resistance. When providers send accurate data the firs nces and risks that come with low-quality data. For example, timely, complete data are needed for monitoring adverse events such as antimicrobial resistance. When providers send accurate data the first time, this reduces the need for prolonged testing and email exchanges between providers, PHAs, payers, and patients. As the prevalence of electronic health information continues to grow, and as providers and payers continue to move to a value-based care model, the need for high-quality data will become increasingly important.416 We want to both encourage and support MIPS eligible clinicians use of modern technologies and standards to ensure data are usable, complete, accurate, timely, and consistent. We are seeking public comment on the following questions: • What data quality challenges does your health care organization experience (for example, discrepancies in data accuracy, completeness, reliability, and consistency)? How are you working to address data quality challenges? What data quality challenges persist longitudinally across your patient population(s)? • What are the primary barriers to collecting high-quality data? What resources do you believe could help your organization quality challenges persist longitudinally across your patient population(s)? • What are the primary barriers to collecting high-quality data? What resources do you believe could help your organization address these challenges? 414 Fukami T. Enhancing Healthcare Accountability for Administrators: Fostering Transparency for Patient Safety and Quality Enhancement. Cureus. 2024 Aug 2;16(8):e66007. Located at: https://pubmed.ncbi.nlm.nih.gov/ 39221336. 412 Schneider EC, Squires D. From last to first— Could the US health care system become the best in the world? New England Journal of Medicine. 2017 Sep 7;377(10):901–3. Located at: https:// www.nejm.org/doi/full/10.1056/nejmp1708704. 413 How to Use Digital Health Data to Improve Outcomes. Located at: https://hbr.org/2022/09/how- to-use-digital-health-data-to-improve-outcomes. 415 Weng C. Clinical data quality: a data life cycle perspective. Biostat Epidemiol. 2020;4(1):6–14. Located at: https://pubmed.ncbi.nlm.nih.gov/ 32258941. 416 For more information on EHR adoption over time, visit: https://www.healthit.gov/data/ quickstats/national-trends-hospital-and-physician- adoption-electronic-health-records. • What solutions have MIPS eligible information on EHR adoption over time, visit: https://www.healthit.gov/data/ quickstats/national-trends-hospital-and-physician- adoption-electronic-health-records. • What solutions have MIPS eligible clinicians found most effective to address data quality? • What steps should CMS consider to drive further improvement in the quality and usability of health information being exchanged? How can CMS partner with MIPS eligible clinicians, industry, and Federal agencies to drive further improvements in the quality and usability of health information being exchanged? What methods should CMS and other partners explore to further rectify data quality issues in the health care community? Please note, this is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to th from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency’s full consideration, are not generally considered information collections and therefore not subject to the PRA. B. Additional CY 2026 Modifications to the Quality Payment Program 1. MIPS Final Score Methodology a. Performance Category Scores (1) Background Sections 1848(q)(1)(A)(i) and (ii) and (5)(A) of the Act provide, 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 and, using such methodology, provide for a final score for each MIPS eligible clinician. Section 1848(q)(6)(A) of the Act specifies that, to then determine a MIPS payment adjustment factor for each MIPS eligible clinician for an applicable MIPS payment year, we must compare the MIPS eligible clinician’s final score for the given year to the performance threshold we established for that same yea MIPS eligible clinician for an applicable MIPS payment year, we must compare the MIPS eligible clinician’s final score for the given year to the performance threshold we established for that same year in accordance with section 1848(q)(6)(D) of the Act. We refer readers to section IV.B.2. of this proposed rule for further discussion of the performance threshold, and our calculation of MIPS payment adjustment factors, and our proposals with respect thereto. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00403 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32754 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules Section 1848(q)(2)(A) of the Act provides that the Secretary must assess each MIPS eligible clinician with respect to four performance categories in determining each MIPS eligible clinician’s final score: quality, resource use (referred to as ‘‘cost’’), clinical practice improvement activities (referred to as ‘‘improvement activities’’), and meaningful use of certified EHR technology (referred to as ‘‘Promoting Interoperability’’). Section 1848(q)(2)(B) of the ractice improvement activities (referred to as ‘‘improvement activities’’), and meaningful use of certified EHR technology (referred to as ‘‘Promoting Interoperability’’). Section 1848(q)(2)(B) of the Act describes the measures and activities that must be specified under each performance category. Section 1848(q)(3) of the Act provides that we must establish performance standards with respect to the measures and activities specified under the four performance categories for a performance period, considering historical performance standards, improvement, and the opportunity for continued improvement. To calculate a final score for each MIPS eligible clinician for the performance period of an applicable MIPS payment year, section 1848(q)(5)(A) of the Act provides that we must develop a methodology for assessing the total performance of each MIPS eligible clinician according to the performance standards we have established with respect to applicable measures and activities specified for each performance category, using a scoring scale of 0 to 100. In calculating the final score, we must apply different weights for the four performance categories, subject to certain exceptions, as set ach performance category, using a scoring scale of 0 to 100. In calculating the final score, we must apply different weights for the four performance categories, subject to certain exceptions, as set forth in section 1848(q)(5) of the Act and at § 414.1380. Unless we assign a different scoring weight pursuant to these exceptions, for the CY 2026 performance period/2028 MIPS payment year, the scoring weights for each performance category are as follows: 30 percent for the quality performance category; 30 percent for the cost performance category; 15 percent for the improvement activities performance category; and 25 percent for the Promoting Interoperability performance category. For the CY 2026 performance period/ 2028 MIPS payment year, we propose to update our scoring methodologies to respond to statutory requirements and impacts observed in performance data. Specifically, we propose to— • Modify the existing approach for identifying measures impacted by limited measure choice and subject to topped out measure benchmarks by applying the existing analysis to MVPs; • Apply defined topped out benchmarks for certain topped out measures for clinicians impacted by limited measure choic bject to topped out measure benchmarks by applying the existing analysis to MVPs; • Apply defined topped out benchmarks for certain topped out measures for clinicians impacted by limited measure choice; and • Modify the benchmarking methodology for scoring administrative claims-based measures in the quality performance category. The policies proposed in this section of the proposed rule for scoring the quality performance category within traditional MIPS would apply to MVP scoring under § 414.1365(d)(3)(i) since a quality performance category score for MVP Participants is calculated in accordance with § 414.1380(b)(1) based on measures included in the MVP. We are not proposing any changes to our scoring policies for the cost, improvement activities, or Promoting Interoperability performance categories. (2) Scoring the Quality Performance Category for the Following Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs, QCDR Measures, the CAHPS for MIPS Survey Measure, and Administrative Claims Measures We refer readers to the CY 2017, CY 2018, and CY 2019 Quality Payment Program final rules, the CY 2020, CY 2021, CY 2022, CY 2023, and CY 2024 PFS final rules, and § 414 Administrative Claims Measures We refer readers to the CY 2017, CY 2018, and CY 2019 Quality Payment Program final rules, the CY 2020, CY 2021, CY 2022, CY 2023, and CY 2024 PFS final rules, and § 414.1380(b)(1) for our current policies regarding, among other things, quality measure benchmarks, calculating total measure achievement points, calculating the quality performance category score, including achievement and improvement points, the small practice bonus, and scoring flexibilities (81 FR 77276 through 77308, 82 FR 53716 through 53748, 83 FR 59841 through 59855, 84 FR 63011 through 63018, 85 FR 84898 through 84913, 86 FR65490 through 65509, 87 FR 70088 through 70091, and 88 FR 79368 and 79369). In the CY 2025 PFS final rule (89 FR 98427 through 98439), we finalized policies for scoring topped out measures in specialty measure sets with limited measure choice at § 414.1380(b)(1)(iv)(C) and § 414.1380(b)(1)(ii)(E) and a Complex Organization Adjustment for virtual groups and APM Entities at § 414.1380(b)(1)(vii)(C). (a) Scoring for Topped Out Measures With Limited Measure Choice (i) Background on Scoring Topped Out Measures We refer readers to the CY 2017, CY 2018, and CY 2019 Qu ties at § 414.1380(b)(1)(vii)(C). (a) Scoring for Topped Out Measures With Limited Measure Choice (i) Background on Scoring Topped Out Measures We refer readers to the CY 2017, CY 2018, and CY 2019 Quality Payment Program final rules, the CY 2023 and 2025 PFS final rules (81 FR 77282 through 77287, 82 FR 53721 through 53727, 83 FR 59761 through 59765, 88 FR 70090 and 70091, and 89 FR 98429 through 98435), and § 414.1380(b)(1)(iv) for established topped out measure scoring policies. Topped out measures are measures for which measure performance is considered so high and unvarying that meaningful distinctions and improvements in performance can no longer be made (81 FR 77136). Section 1848(q)(3)(B) of the Act requires that in establishing performance standards with respect to measures and activities, we consider, among other things, the opportunity for continued improvement. Topped out measures do not provide an opportunity for continued improvement, nor do payment adjustments based on topped out measures incentivize clinicians to improve their care. As a result, we finalized policies in the CY 2018 Quality Payment Program final rule (82 FR 53723 through 53727) to identify and cap th opped out measures incentivize clinicians to improve their care. As a result, we finalized policies in the CY 2018 Quality Payment Program final rule (82 FR 53723 through 53727) to identify and cap the scoring potential of such measures. Additionally, we established practices for the removal of such measures, such as establishing the topped out measure lifecycle, to continue to drive quality improvement in areas where such improvement is possible and necessary. The topped out measure lifecycle is described in the CY 2018 Quality Payment Program final rule (82 FR 53721 and 53727). We established at § 414.1380(b)(1)(iv)(B) that we would cap scoring for topped out measures at 7 measure achievement points in the second consecutive year that the measure benchmark is identified as topped out. If a measure has been identified as topped out for 3 consecutive years after being originally identified through the benchmarks, such measure may then be proposed for removal through notice-and-comment rulemaking (83 FR 59761). This timeline, however, is not fixed. We noted our concern that removal of topped out measures would leave clinicians with fewer than 6 applicable measures to report and that rulemaking (83 FR 59761). This timeline, however, is not fixed. We noted our concern that removal of topped out measures would leave clinicians with fewer than 6 applicable measures to report and that such removal in those instances would impact some specialties more than others (82 FR 53721). We stated that consideration for ensuring available applicable measures would be made when considering measure removals (83 FR 59763). Although in the CY 2018 Quality Payment Program final rule (82 FR 53727), we established the topped out scoring cap to encourage MIPS eligible clinicians to submit measures that are not topped out, we created an exemption to this policy in the CY 2025 PFS final rule (89 FR 98430) for certain measures, which are frequently used by certain specialties impacted by limited measure choice. To address scoring VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00404 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32755 scenarios in which limited measure choice compels clinicians to report topped out measure S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32755 scenarios in which limited measure choice compels clinicians to report topped out measures with scoring caps, we finalized in the CY 2025 PFS final rule (89 FR 98429 through 98432) at § 414.1380(b)(1)(iv)(C) that beginning with the CY 2025 performance period/ 2027 MIPS payment year, topped out measures frequently used by certain specialties reporting specialty measure sets that are impacted by limited measure choice (specified in accordance with § 414.1380(b)(1)(ii)(E)) are not subject to the 7-point scoring cap. As part of the CY 2025 PFS final rule, we finalized at § 414.1380(b)(1)(ii)(E) that beginning with the CY 2025 performance period/2027 MIPS payment year, we will annually publish a list in the Federal Register of topped out measures determined to be impacted by limited measure choice (89 FR 98432). Measures included in the list are scored from 1 to 10 measure achievement points according to defined topped out measure benchmarks calculated from performance data in the baseline period, in which a performance rate of 97 percent corresponds to 10 percent of the perfor ent points according to defined topped out measure benchmarks calculated from performance data in the baseline period, in which a performance rate of 97 percent corresponds to 10 percent of the performance threshold for the corresponding performance year. In the CY 2025 PFS final rule (89 FR 98432 through 98435), we also finalized our approach for identifying the list of measures impacted by limited measure choice and subject to defined topped out measure benchmarks. Specifically, we finalized that each specialty measure set is reviewed by collection type to identify if the prevalence of topped out measures within such a set hinders a clinician’s ability to successfully participate in the MIPS quality performance category. To make such a determination, we finalized that we analyze the ability of clinicians reporting the specialty measure sets under review to reasonably achieve 75 percent of available quality achievement points based upon the measures available to them and program requirements. Specifically, at the collection type level, each measure is assigned points based upon the current benchmarking data: new measures receive 7 or 5 points based on year in the program, measures rements. Specifically, at the collection type level, each measure is assigned points based upon the current benchmarking data: new measures receive 7 or 5 points based on year in the program, measures with benchmarks are given points based upon the highest decile achievable with a less than perfect score (less than 100 percent or greater than 0 percent for inverse measures), and measures with no available historic benchmark are given 0 points. All measure set points are added together to get an output of scoring potential; the Medicare Part B claims collection type measure sets have an additional 6 points added to the output to account for the small practice bonus. The sum of quality achievement points for each measure set are then compared to the analysis threshold, which is currently 75 percent of available quality achievement points, based upon the number of available measures. Any measure sets that are not able to meet or exceed the threshold are flagged as ’at-risk.’ Additional factors that we take into consideration include whether the topped out measure within the specialty measure set under review is considered a cross-cutting measure or is a broadly applicable measure, whi ctors that we take into consideration include whether the topped out measure within the specialty measure set under review is considered a cross-cutting measure or is a broadly applicable measure, which we consider to be a measure included in three or more specialty sets. We also consider in reviewing topped out measures within a specialty measure set whether the specialty measure set contains more than ten measures, by collection type (89 FR 98432 through 98435). (ii) Proposed Measures To Be Subject to the Defined Topped Out Measure Benchmark for the CY 2026 Performance Period/2028 MIPS Payment Year Beginning with the CY 2026 performance period/2028 MIPS payment year, we are proposing to modify this previously finalized approach for identifying measures impacted by limited measure choice (89 FR 98432 through 98435) by applying the analysis and criteria to MVPs, in addition to the analysis of specialty measure sets. For the CY 2026 performance period/2028 MIPS payment year, we are also proposing to continue to use an analysis threshold of 75 percent of available quality achievement points in our determination of which measures would not be subject to the 7-measure achievement point proposing to continue to use an analysis threshold of 75 percent of available quality achievement points in our determination of which measures would not be subject to the 7-measure achievement point cap. We refer readers to section IV.B.2.b.(2) of this proposed rule where we are proposing a performance threshold of 75 points for the CY 2026 through CY 2028 performance periods/2028 through 2030 MIPS payment years. MVPs, like specialty measure sets, contain a limited set of quality measures for a clinician to choose from. We have received feedback from interested parties and independently verified that clinicians reporting MVPs in which there is high presence of topped out measures receiving the 7-point cap are often facing both limited measure choice and limited scoring opportunities. Given the limited number of available measures, the prevalence of topped out measures within an MVP may similarly hinder a clinician’s ability to successfully participate in the MIPS quality performance category. Using the same methodology applicable to topped out measures within specialty measure sets, we propose to conduct an analysis of each MVP to identify if the prevalence of topped out measures category. Using the same methodology applicable to topped out measures within specialty measure sets, we propose to conduct an analysis of each MVP to identify if the prevalence of topped out measures within such MVP hinders a clinician’s ability to successfully participate in the MIPS quality performance category. According to the approach finalized in the CY 2025 PFS final rule for specialty measure sets (89 FR 98432 through 98435), at the collection type level, each quality measure in an MVP would be assigned points based upon the current benchmarking data: new measures would receive 7 or 5 points based on year in the program, measures with benchmarks would be given points based upon the highest decile achievable with a less than perfect score (less than 100 percent or greater than 0 percent for inverse measures), and measures with no available historic benchmark would be given 0 points. All points would be added together to get an output of scoring potential; the Medicare Part B claims collection type measures would have an additional 6 points added to the output to account for the small practice bonus. The sum of quality achievement points for each MVP would be compared to the aims collection type measures would have an additional 6 points added to the output to account for the small practice bonus. The sum of quality achievement points for each MVP would be compared to the analysis threshold, which is currently 75 percent of available quality achievement points, based upon the number of available measures. Any MVPs that are not able to meet or exceed the threshold would be flagged as ‘at-risk.’ Additional factors that we would take into consideration would include whether the topped out measure within the MVP under review is considered a cross -cutting measure or is a broadly applicable measure, which we would consider to be a measure included in three or more MVPs or specialty sets. We would also consider in reviewing topped out measures within an MVP whether the MVP contains more than ten measures, by collection type. Table 66 contains the list of measures that meet the criteria for topped out measures impacted by limited measure choice in specialty measure sets and MVPs, and for which we are proposing to apply the defined topped out measure benchmark for the CY 2026 performance period/2028 MIPS payment year. We had considered proposing MIPS CQM 424: re sets and MVPs, and for which we are proposing to apply the defined topped out measure benchmark for the CY 2026 performance period/2028 MIPS payment year. We had considered proposing MIPS CQM 424: Perioperative Temperature Management to be subject to the defined topped out measure benchmark for the CY 2026 performance period/2028 MIPS payment year since it met the criteria for topped out measures in specialty measure sets impacted by limited measure choice, according to the methodology finalized in the CY 2025 VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00405 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 32756 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules PFS final rule (89 FR 98432 through 98435). However, we are not proposing that measure for the defined topped out measure benchmark for the CY 2026 performance period/2028 MIPS payment year because it is being proposed for removal for the CY 2026 performance period/2028 MIPS payment year in section IV.A.4.d.(1)(c)(ii) of this proposed rule. BILLING CODE 4120–01–P 3 S L A S O P O R P h t i w D O R P 4 4 1 ng proposed for removal for the CY 2026 performance period/2028 MIPS payment year in section IV.A.4.d.(1)(c)(ii) of this proposed rule. BILLING CODE 4120–01–P 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00406 Fmt 4701 Sfmt 4725 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00407 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00408 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00409 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 32760 Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules This modification in our scoring methodology for cost measures aligns the assignment of achievement points for cost measures so that clinicians with costs near the measure’s 50th percentile (median) do not receive a disproportionately low score. Our intended goal for this modification of achievement points for cost measures so that clinicians with costs near the measure’s 50th percentile (median) do not receive a disproportionately low score. Our intended goal for this modification to the scoring methodology was to ensure that MIPS eligible clinicians who deliver care at an average cost near the median costs for all MIPS eligible clinicians attributed the measure receive scores at, or very close to, the performance threshold-derived score (89 FR 98442 and 98443). Additionally, this modification addressed MIPS eligible clinicians’ concerns that cost measure scoring negatively impacts their final scores more than other performance categories, including disparate negative effects for MIPS eligible clinicians who are scored on the cost performance category compared to clinicians not scored on the cost performance category (89 FR 98443). (iii) Proposed Modification to Scoring Methodology for Administrative Claims- Based Quality Measures in the Quality Performance Category Beginning With CY 2025 Performance Period/2027 MIPS Payment Year Given the similarities between scoring cost measures and administrative claims-based quality measures, we are proposing to modify the y Beginning With CY 2025 Performance Period/2027 MIPS Payment Year Given the similarities between scoring cost measures and administrative claims-based quality measures, we are proposing to modify the methodology for scoring the administrative claims- based measures within the quality performance category beginning with the CY 2025 performance period/2027 MIPS payment year. The proposed administrative claims-based quality measure scoring methodology would be based on standard deviation, median, and an achievement point value that is derived from the performance threshold. Specifically, for a MIPS eligible clinician whose performance rate under an administrative claims-based measure would be equal to the median performance rate for all MIPS eligible clinicians that are scored on that measure, we would assign an achievement point value equal to 10 percent of the performance threshold. For example, for the CY 2026 performance period/2028 MIPS payment year, the median would have an achievement point value of 7.5, based on a performance threshold of 75 points as proposed in section IV.B.2.b.(2) of this proposed rule. For each administrative claims-based quality measure, the cut-offs for ment point value of 7.5, based on a performance threshold of 75 points as proposed in section IV.B.2.b.(2) of this proposed rule. For each administrative claims-based quality measure, the cut-offs for benchmark ranges would be calculated based on standard deviations from the median. The benchmark ranges, the median, and the performance threshold-derived achievement point values aligned with the median would be dynamic and responsive to changes in performance rates assessed by administrative claims- based quality measures and performance thresholds for each CY performance period/MIPS payment year. The performance threshold- derived point values could change based on the performance threshold established for each performance period/MIPS payment year. The standard deviations from the median used to determine cutoffs for benchmark ranges for each year would be reviewed for any necessary updates on an annual basis based on performance across MIPS eligible clinicians and the performance threshold established for the performance period/MIPS payment year. We would perform analyses when the performance threshold changes to set the benchmark ranges. To determine the benchmark ranges, we woul shold established for the performance period/MIPS payment year. We would perform analyses when the performance threshold changes to set the benchmark ranges. To determine the benchmark ranges, we would adhere to the following principles: (1) center the majority of performance rates around the performance threshold- derived point value; (2) determine benchmark ranges according to the statistical distribution curve of the performance rate; and (3) distribution of achievement points for administrative claims-based quality measures should be reflective of overall program performance. We refer readers to Table 69 for an example of how the proposed administrative claims-based quality measure scoring methodology could be implemented for a specific quality measure when the performance threshold is set to 75 points. VerDate Sep 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00410 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00411 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00412 Fmt 4701 Sfmt 4702 701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 23:26 Jul 15, 2025 Jkt 265001 PO 00000 Frm 00412 Fmt 4701 Sfmt 4702 E:\FR\FM\16JYP3.SGM 16JYP3 3 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 134 / Wednesday, July 16, 2025 / Proposed Rules 32763 mean or median (selected once every 3 years) of the MIPS final scores for all MIPS eligible clinicians with respect to a prior period specified by the Secretary. We have determined that the performance threshold may be established with respect to the applicable year at any time as long as the performance threshold continues to be based on a prior period specified by the Secretary. In other words, we could establish a performance threshold that would apply to multiple MIPS payment years. We note that we may not always establish the performance threshold for multiple MIPS payment years, but we will consider this as an option as we continue to ensure that the performance threshold is truly reflective of MIPS eligible clinicians’ performance in MIPS. Due to several large programmatic changes (such as, tr