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

In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18328 through 18335), we proposed refinements to two measures that are currently in the Hospital IQR Program measure set: (1) Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following Acute Ischemic Stroke Hospitalization, beginning with the July 1, 2023-June 30, 2025 reporting period/FY 2027 payment determination; and (2) Hospital-Level, Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) measure beginning with the April 1, 2023-March 31, 2025 reporting period/FY 2027 payment determination. a. Modification of the Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate Following Acute Ischemic Stroke Hospitalization Measure Beginning With the FY 2027 Payment Determination (1) Background

Every year more than 795,000 people in the U.S. have a stroke.\277\ In 2022, strokes were the fifth leading cause of death in the U.S.\278\ Strokes are also associated with a high morbidity rate, causing over half of stroke survivors ages 65 years or older to suffer from reduced mobility.\279\ Between 2019 and 2020 alone, stroke-related costs totaled almost $56.2 billion in the U.S., including costs for healthcare services, medications, and missed workdays.\280\

\277\ CDC. (2024). Stroke Facts. Available at: https://www.cdc.gov/stroke/data-research/facts-stats/index.html.

\278\ CDC. (2024). Leading Causes of Death. Available at: https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

\279\ CDC. (2024). Stroke Facts. Available at: https://www.cdc.gov/stroke/data-research/facts-stats/index.html.

\280\ Ibid.

Stroke outcomes can vary greatly depending on the facility where patients receive care.\281\ This was demonstrated

in a study of Medicare patients ages 65 years or older admitted to a hospital for acute ischemic stroke, which found that stroke patients treated at hospitals with a higher volume of stroke patients had lower mortality rates and better outcomes.\282\ This association is likely due to high-volume hospitals having more experience in treating strokes and developing improved processes of care.\283\ Research has shown that improving processes for responding to strokes leads to better patient outcomes. For example, having a dedicated stroke team on call provides hospitals with expertise in a variety of relevant areas including emergency medicine, vascular neurology, radiology, pharmacology, and laboratory analysis. Similarly, setting up organized workflows for diagnosing and treating stroke improves response times for a condition for which patient outcomes are highly dependent on the timeliness of treatment.\284\

\281\ Neves, G., Cole, T., Lee, J., Bueso, T., Shaw, C., & Montalvan, V. (2022). Demographic and institutional predictors of stroke hospitalization mortality among adults in the United States. eNeurologicalSci, 26, 100392. https://doi.org/10.1016/j.ensci.2022.100392.

\282\ Stein LK, Mocco J, Fifi J, Jette N, Tuhrim S, Dhamoon MS. Correlations Between Physician and Hospital Stroke Thrombectomy Volumes and Outcomes: A Nationwide Analysis. Stroke. 2021 Aug;52(9):2858-2865. doi: 10.1161/STROKEAHA.120.033312. Epub 2021 Jun 7. PMID: 34092122.

\283\ Ibid.

\284\ Herpich, Franziska MD1,2; Rincon, Fred MD, MSc, MB.Ethics, FACP, FCCP, FCCM1,2. Management of Acute Ischemic Stroke. Critical Care Medicine 48(11):p 1654-1663, November 2020. [verbar] DOI: 10.1097/CCM.0000000000004597.

To improve stroke outcomes for patients, we adopted the Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate Following Acute Ischemic Stroke Hospitalization measure (hereinafter referred to as the MORT-30-STK measure) in the Hospital IQR Program beginning with the FY 2016 payment determination (78 FR 50798 through 50802). The MORT-30-STK measure assesses the hospital-level, risk-standardized mortality rate after admission for acute ischemic stroke to any non-federal acute care hospital. The measure includes Medicare fee-for-service (FFS) patients ages 65 years or older and the outcome is all-cause 30-day mortality.

When this measure was adopted, most Medicare patients were enrolled in the Medicare FFS Program.\285\ However as of November 2024, roughly 50 percent of Medicare beneficiaries--34.4 million people--were enrolled in Medicare Advantage (MA) plans.\286\ Including MA beneficiaries in hospital outcome measures would help ensure that hospital quality is measured across all Medicare beneficiaries, and would address concerns about differences in care quality for MA and Medicare FFS beneficiaries.\287\ \288\ Moreover, inclusion of MA beneficiaries increases the size of the measure's cohort, which enhances the reliability of the measure scores and allows more low- volume hospitals to receive measure results.

\285\ Freed M, Biniek JF, Damico A, Neuman T. (2024). Medicare Advantage in 2024: Enrollment Update and Key Trends. Kaiser Family Foundation. Available at: https://www.kff.org/medicare/issue-brief/medicare-advantage-in-2024-enrollment-update-and-key-trends/.

\286\ Centers for Medicare & Medicaid Services. (2025). Medicare Enrollment Dashboard. Available at: https://data.cms.gov/tools/medicare-enrollment-dashboard. Accessed: March 25, 2025.

\287\ Ochieng N and Biniek JF. (2022). Beneficiary Experience, Affordability, Utilization, and Quality in Medicare Advantage and Traditional Medicare: A Review of the Literature. Available at: https://www.kff.org/medicare/report/beneficiary-experience-affordability-utilization-and-quality-in-medicare-advantage-and-traditional-medicare-a-review-of-the-literature/.

\288\ Medicare Payment Advisory Commission. (2022). The Medicare Advantage program: Status report and mandated report on dual- eligible special needs plans. Available at: https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_Ch12_SEC.pdf.

(2) Overview of Measure Updates

In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18329 through 18331), we proposed modifications to the current MORT-30-STK measure with updates in the Hospital IQR Program beginning with the FY 2027 payment determination. Specifically, we proposed to make two substantive updates to the MORT-30-STK measure: (1) we would expand the measure's inclusion criteria to include MA patients; and (2) we would shorten the performance period from 3 years to 2 years. The addition of MA encounter data to the measure roughly doubles the cohort size, improves measure reliability, and more accurately reflects the quality of care for both Medicare FFS and MA beneficiaries.

The measure modifications align with our Meaningful Measures 2.0 priority area of “Seamless Care Coordination”, which includes leveraging processes and activities to ensure successful transitions of care and coordination.\289\ This measure promotes successful transitions of care for stroke patients discharged from acute care settings, as well as reduces short-term, preventable mortality rates. Patient outcomes depend on many aspects of care including communication between providers, prevention of and response to complications, patient safety, and coordinated transitions to the outpatient and rehabilitation care settings. The modifications to the measure would better reflect overall patient outcomes in each hospital and inform quality improvement activities.

\289\ Centers for Medicare & Medicaid Services. (2025). Cascade of Meaningful Measures. Available at: https://www.cms.gov/medicare/quality/cms-national-quality-strategy/cascade-measures.

We proposed (90 FR 18329 through 18331) to implement these changes beginning with the FY 2027 payment determination. The new reporting period for the measure for the FY 2027 payment determination would be changed from July 1, 2022, through June 30, 2025 to July 1, 2023, through June 30, 2025. (3) Technical Updates

We are also making two technical updates beginning with the FY 2027 payment determination. Specifically, the technical updates to the measure include: (1) updating the risk adjustment model to use individual International Classification of Diseases (ICD-10) codes instead of Hierarchical Condition Categories (HCCs) to improve the measure's risk adjustment methodology; and (2) removing the exclusion of patients with a principal diagnosis code of COVID-19 or with a secondary diagnosis code of COVID-19 coded as present on admission on the index admission claim. We refer readers to section X.C.5. of the preamble of this final rule for further discussion on removal of the COVID-19 diagnosis exclusion to measures in the Hospital IQR Program.

We are updating the measure's risk adjustment methodology to use individual ICD-10 codes. The current risk adjustment strategy for this measure involves grouping ICD-10 diagnosis codes from CMS's HCC system into clinically relevant categories. Then we evaluate the HCCs for statistical association with the measure's outcome.\290\ However, research has indicated that using individual ICD-10 codes in place of HCCs could significantly improve the model performance of the mortality measures.\291\ To better leverage the data and analytical advances since the measure was initially developed, we created a new approach to use individual ICD-10 codes for risk adjustment instead of grouping them

into categories. With this new approach, the ability of the risk adjustment model to account for stroke severity was significantly better (c-statistic improved from 0.79 to 0.91).\292\ We did not adjust for social risk variables in the measure as neither of the two social risk factors tested (Area Deprivation Index and dual eligibility) showed significant effect. Given these findings and the complex pathways that could explain any relationship between social risk and mortality/complications, we chose not to adjust the measure for social risk.\293\

\290\ Centers for Medicare & Medicaid Services. 2024 Condition- Specific Mortality Measures Updates and Specifications Report. Available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology.

\291\ Krumholz, H. M., Coppi, A. C., Warner, F., Triche, E. W., Li, S. X., Mahajan, S., Li, Y., Bernheim, S. M., Grady, J., Dorsey, K., Lin, Z., & Normand, S. T. (2019). Comparative Effectiveness of New Approaches to Improve Mortality Risk Models From Medicare Claims Data. JAMA network open, 2(7), e197314. https://doi.org/10.1001/jamanetworkopen.2019.7314.

\292\ Yale New Haven Health Services Corporation--Center for Outcomes Research and Evaluation. (March 2024). 2024 Supplemental Measure Methodology: Condition[hyphen] and Procedure[hyphen]Specific Mortality/Complications. Available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology.

\293\ Ibid.

For measure specification details on the updates to this measure, we refer readers to the Condition-Specific Mortality Measures Updates and Specifications Report available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology. (4) Measure Calculation

The modified MORT-30-STK measure would continue to measure 30-day, all-cause mortality. We define mortality as death from any cause within 30 days of the start of the index admission for patients discharged from the hospital with a principal discharge diagnosis of acute ischemic stroke. The cohort for the modified measure would include admissions for patients ages 65 years or older discharged from the hospital with a principal diagnosis of acute ischemic stroke, who were enrolled in Medicare FFS or MA for the 12 months prior to the date of admission, as well as enrolled in Medicare FFS or MA during the index admission.

The updates to the measure exclude all of the following admissions from its cohort:

Patients with inconsistent or unknown vital status, or other unreliable demographic data (for example, age and gender).

Patients who were transferred from another acute care facility.

Patients enrolled in the Medicare hospice program any time in the 12 months prior to the index hospitalization.

Patients who were discharged against medical advice.

If a patient has more than one eligible stroke hospitalization during the reporting period, then we randomly select one index admission for inclusion in the cohort and exclude the other admissions within that reporting period.\294\ The measure currently adjusts for factors including age, comorbidities, indications of patient frailty, and stroke severity upon admission when comparing a patient's risk of death at each facility.\295\

\294\ Centers for Medicare & Medicaid Services. (2024). 2024 Measures Under Consideration (MUC) List. Available at: https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.

\295\ Centers for Medicare & Medicaid Services. 2024 Condition- Specific Measure Updates and Specifications Report. Available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology.

The modifications to the MORT-30-STK measure would still be calculated using a risk-standardized mortality rate. This is calculated by first determining the ratio of the number of predicted deaths to the number of expected deaths and then multiplying the ratio by the national unadjusted mortality rate. The ratio is greater than one for hospitals that have more deaths than would be expected for an average hospital with similar cases and less than one if the hospital has fewer deaths than would be expected for an average hospital with similar cases. This approach is analogous to a ratio of an “observed” or “crude” rate to an “expected” or risk-adjusted rate used in other similar types of statistical analyses. It allows for a comparison of a particular hospital's performance to an average hospital's performance with the same case mix.

We proposed (90 FR 18329 through 18331) to expand the applicable population to include MA patients ages 65 years or older in addition to Medicare FFS patients ages 65 years or older. Inclusion of MA beneficiaries has important benefits for the reliability and validity of the measure. The combination of MA beneficiaries with Medicare FFS beneficiaries significantly increases the size of the measure's cohort, which enhances the reliability of the measure scores, leading to more hospitals receiving results and increasing the chance of identifying meaningful differences in quality for some low-volume hospitals. With the improvements to the measure reliability, we proposed to shorten the MORT-30-STK measure reporting period from 3 to 2 years. Based on our analysis that included MA patients in addition to the existing MORT-30- STK measure cohort, we found that the measure could achieve a satisfactory level of reliability with a 2-year reporting period. The median reliability for the 2-year performance period is 0.911, ranging from 0.623 to 0.994.\296\ Shortening the reporting period would allow measure results to reflect more recent hospital performance, and therefore provide more actionable insights for quality improvement.

\296\ Yale New Haven Health Services Corporation--Center for Outcomes Research and Evaluation. (November 2024). Stroke Mortality Measure Submission to PQM: Figures and Tables. Available at: https://p4qm.org/measures/4595.

For more information regarding the modifications to the MORT-30-STK measure specifications, we refer readers to the 2024 Condition-Specific Measure Updates and Specifications Report available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology. (5) Pre-Rulemaking Process and Measure Endorsement (a) Recommendation From the Pre-Rulemaking Measure Review (PRMR) Process

We refer readers to the FY 2025 IPPS/LTCH PPS final rule (89 FR 69457 through 69458) for details on the PRMR process, including the voting procedures used to reach consensus on measure recommendations. The PRMR Hospital Committee met on January 15 and 16, 2025, to review measures included by the Secretary on the publicly available “2024 Measures Under Consideration List” (MUC List), including the MORT-30- STK measure (MUC2024-043),\297\ \298\ and provided a recommendation on the potential use of this measure in the Hospital IQR Program.

\297\ Centers for Medicare & Medicaid Services. (2024). 2024 Measures Under Consideration (MUC) List. Available at: https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.

\298\ Centers for Medicare & Medicaid Services. (2024). 2024 Overview of the List of Measures Under Consideration. Available at: https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.

The voting results of the PRMR Hospital Recommendation Committee for the proposed updates to the MORT-30-STK measure within the Hospital IQR Program were: 18 committee members recommended adopting the measure into the Hospital IQR Program without conditions; 7 committee members recommended adoption with conditions; 1 committee member voted not to recommend the measure for adoption.\299\ Taken together, 96 percent of the votes were to recommend with conditions. Thus, the committee reached consensus and recommended the updates to the MORT-30-STK

measure within the Hospital IQR Program with conditions.\300\

\299\ Battelle--Partnership for Quality Measurement. (February 2025). 2024-2025 Pre-Rulemaking Measure Review (PRMR) Recommendations Report. Available at: https://p4qm.org/sites/default/files/2025-02/PRMR-2024-2025-MUC-Recommendations-Report-Final.pdf.

\300\ Ibid.

The conditions that the committee recommended were: (1) CBE endorsement; (2) CMS consider restructuring the measure to reduce the time lag and provide hospitals with more timely and useful data; and (3) CMS consider adding risk stratification for pre-existing do-not- resuscitate orders.\301\ As discussed later in this section, the CBE voted to endorse the measure and therefore the first condition has been met. Regarding the second condition to reduce the reporting period, we proposed (90 FR 18329 through 18331) to update the MORT-30-STK measure to shorten the reporting period from 3 to 2 years, which our analysis shows is the shortest reporting period for which the results remain reliable and valid, and which significantly improves the timeliness of the data for this measure.

\301\ Ibid.

Regarding the third condition, upon further review of the model, the proposed ICD-10 stroke mortality risk indeed includes stroke model ICD-10 Code Z66 (Do not resuscitate).\302\ We have thus taken into consideration the conditions raised by the PRMR Hospital Committee in connection with the proposed modifications to the MORT-30-STK measure in the Hospital IQR Program.

\302\ Centers for Medicare & Medicaid Services. 2024 Condition- and Procedure-Specific Mortality/Complication Measures Supplemental Methodology Report. Available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology.

(b) Measure Endorsement

We refer readers to the FY 2025 IPPS/LTCH PPS final rule (89 FR 69458 through 69459) for details on the measure endorsement and maintenance (E&M) process, including the measure evaluation procedures the E&M Committees use to evaluate measures and whether they meet endorsement criteria. The measure developer submitted the MORT-30-STK measure to the CBE in 2016 but it was not endorsed because the measure was not risk adjusted for stroke severity. When the measure developer submitted the measure to the CBE in 2021, the CBE did not endorse the measure because the committee did not reach consensus on whether in- hospital stroke mortality is an appropriate measure of quality and if there was sufficient evidence that clinical actions could be performed to reduce stroke mortality. The measure developer submitted the measure (CBE #4595) for endorsement again for the Fall 2024 cycle, which reflects the proposed modifications in the measure.\303\ The CBE voted to endorse the measure on February 7, 2025.\304\

\303\ Battelle--Partnership for Quality Measurement. Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following Acute Ischemic Stroke Hospitalization with Claims-Based Risk Adjustment for Stroke Severity. Available at: https://p4qm.org/measures/4595.

\304\ Battelle--Partnership for Quality Measurement. (April 2025). Fall 2024 Cycle Endorsement and Maintenance (E&M) Technical Report: Management of Acute Events and Chronic Conditions. Available at: https://p4qm.org/articles/now-available-final-fall-2024-e-m-reports.

(6) Data Sources, Submission, and Public Reporting

This measure is calculated using administrative claims data routinely generated and submitted to CMS for all Medicare beneficiaries, which includes MA and Medicare FFS beneficiaries. Therefore, hospitals would not be required to report any additional data for this measure. We proposed (90 FR 18329 through 18331) to add MA encounter data to the measure calculation in order to calculate measure results that include those patients. The MORT-30-STK measure would be calculated and publicly reported on an annual basis using a rolling 24 months of prior data for the measurement period, consistent with the approach currently used for the Thirty-day Risk-Standardized Death Rate Among Surgical Inpatients with Complications measure (89 FR 69545 through 69552) and the CMS Patient Safety and Adverse Events Composite (PSI 90) measure, currently reported in the Hospital-Acquired Condition (HAC) Reduction Program (78 FR 50712 through 50718). We would then publicly report measure results on the Compare tool, currently available at: https://www.medicare.gov/care-compare, beginning in July 2026 or as soon as feasible.

We invited public comment on our proposal to modify the MORT-30-STK measure beginning with the FY 2027 payment determination.

Comment: Many commenters supported the proposed inclusion of MA beneficiaries in hospital quality measures, citing the growing proportion of MA beneficiaries and emphasizing that this change would improve the reliability and accuracy of performance data. A few commenters supported the proposal to include MA data and requested that CMS monitor the quality and reliability of MA encounter data to ensure the accuracy and fairness of the MORT-30-STK measure.

Many commenters supported the proposed shortening of the performance period for this measure from 3 years to 2 years, agreeing that the shorter measurement window would better reflect current care quality by reducing the lag between quality improvement efforts and their impact on measure scores. A commenter further recommended the measure transition to a 1 year timeframe in the future, as data would be even more actionable and reflective of recent care.

Response: We thank commenters for their support.

Comment: Some commenters did not support the proposed inclusion of MA beneficiaries to the MORT-30-STK measure. Commenters were concerned about the risk of hospitals being unfairly penalized for factors outside their control, such as MA plan prior authorization delays and denials of post-acute services, noting these are well-documented adverse practices in MA plans that could impact post-discharge stroke outcomes. A commenter urged CMS to provide increased oversight to ensure that MA plans are providing the same services to patients post- discharge that are available to Medicare FFS patients.

Several commenters encouraged CMS to conduct additional evaluation of MA data for accuracy and comparability between FFS and MA populations before including MA data in the measure. Several commenters recommended a phased implementation approach with confidential feedback reports to allow hospitals to validate their measure results before the start of public reporting. A few commenters recommended stratifying measure results by MA and FFS beneficiaries to allow hospitals to identify demographic or clinical differences between the two populations. A few commenters requested CMS determine whether including MA data would lead to administrative burden for hospitals.

Response: We appreciate the commenters' concerns regarding the inclusion of MA beneficiaries and the potential for challenges around data accuracy, transparency, and the impact of MA plan practices. We continue to encourage hospitals to work closely with insurers, including MA plans, to coordinate the highest quality care for their patients. Over half of the Medicare population receives Medicare benefits through the MA program. Inclusion of MA beneficiaries in the population supports the program's goal of incentivizing high-quality care for all patients and improves the reliability and validity of the hospital outcome measures. The increased size of the measure's cohort leads to more hospitals reaching the minimum threshold for reporting and receiving results,

therefore increasing the opportunity to identify meaningful differences in quality for some low[hyphen]volume hospitals.

We agree that transparency is important for both beneficiaries and providers, and we provide hospitals with annual confidential feedback reports on their measure performance. Additionally, routine measure evaluation reports are publicly available through the QualityNet website at: https://qualitynet.cms.gov. For the complete measure methodology report and measure risk adjustment statistical model, we refer readers to the QualityNet website at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology and the Partnership for Quality Measurement's website at: https://p4qm.org/measures/4595. Additionally, as a part of our routine monitoring and evaluation of measures, we will monitor for any unintended consequences resulting from this change.

We also thank commenters for their feedback on potential differences between Medicare FFS and MA populations and plan designs. In our analysis using admissions from January 1-December 30, 2022, on mortality rates between FFS beneficiaries and MA beneficiaries, we found the unadjusted mortality rate for the FFS and MA beneficiaries combined cohort to be 12.9 percent. The observed mortality rate for FFS beneficiaries was 13.5 percent compared to 12.2 percent for MA beneficiaries, showing a difference of 1.3 percentage points between FFS and MA beneficiaries.\305\ This measure does not show significant variation in mortality rates between the two cohorts and therefore the risk for being penalized is low based on the available sample. Also, keeping FFS and MA patients together for purposes of this measure's calculation will keep the hospitals' total volume higher for more precise measure scores. Based on this information, we did not propose a phased implementation approach.

\305\ Centers for Medicare & Medicaid Services. 2024 Condition- and Procedure-Specific Mortality/Complication Measures Supplemental Methodology Report. Available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology.

As for potential administrative burdens, hospitals would not be required to submit data other than claims data, which is already routinely generated and submitted to CMS for all Medicare beneficiaries, including both MA and FFS beneficiaries. Therefore, this modification will not impose additional reporting burden on hospitals. We refer readers to section XIII.B.4.b. for additional details on our information collection burden estimate for the proposal to modify the MORT-30-STK measure (90 FR 18408).

Comment: Many commenters supported the notification of technical updates. Many commenters supported CMS's notification of the transition of risk adjustment methodologies from HCCs to ICD-10 codes. Many commenters noted this change would enhance the accuracy of risk adjustment by better capturing patient comorbidities and clinical factors influencing outcomes, ultimately leading to fairer performance measurement. A few commenters recommended CMS monitor the impact of the updates on the measure's predictive accuracy.

Many commenters supported CMS's notice of the technical update to remove the COVID-19 exclusion from the MORT-30-STK measure, given that the Public Health Emergency (PHE) has ended and COVID-19 cases have significantly declined.

Response: We thank commenters for their support.

Comment: Several commenters raised concerns about CMS's notification to switch risk adjustment methodologies from HCCs to ICD- 10 codes, emphasizing the potential for unintended consequences. A commenter noted that HCCs are used in other CMS programs, such as the Transforming Episode Accountability Model (TEAM), and questioned the rationale for adopting ICD-10 codes in quality measures while retaining HCCs elsewhere. A commenter recommended a phased implementation approach, to ensure that hospitals have time to understand the impact to their performance scores and provide feedback. A commenter recommended parallel reporting of measure results from HCC and ICD-10- based models and extensive testing to ensure accuracy and reliability. Another commenter suggested increasing the number of allowable diagnosis codes on claims to better capture patient complexity.

Response: We appreciate the commenters sharing their concerns regarding the change from HCC to ICD-10 based models. As a part of our routine monitoring and evaluation we will watch for any unintended consequences from this updated risk model. The measure developer conducts annual measure re-evaluations to ensure the risk-standardized complication model is continually assessed and remains valid, given possible changes in clinical practice and coding standards over time.\306\ Modifications made to the measure cohort, risk model, and outcomes are informed by review of the most recent literature related to measure conditions or outcomes, feedback from various stakeholders, empirical analyses, and assessment of coding trends that reveal shifts in clinical practice or billing patterns.\307\ We solicited input from a workgroup composed of up to 20 clinical and measure experts, inclusive of internal and external consultants and subcontractors. As a part of annual re-evaluations, one of the activities we undertook was reviewing select pre-existing ICD-10 code-based specifications with our workgroup to confirm appropriateness unaffected by the updates, as well as reviewing any potentially clinically relevant codes that “neighbor” existing codes used in the measure to identify any warranted specification changes.\308\ We will consider this feedback as we continue to assess and update the measure.

\306\ Centers for Medicare & Medicaid Services. 2025 Condition- Specific Mortality Measures Updates and Specifications Report. Available at: https://qualitynet.cms.gov/inpatient/measures/mortality/methodology.

\307\ Ibid.

\308\ Ibid.

Comment: Several commenters were concerned with the notice of the technical update to remove COVID-19 exclusions, citing the ongoing clinical complexity and variability of COVID-19 as a factor in patient recovery. A few commenters recommended CMS closely monitor the impact of this change and remain flexible in reinstating exclusions if conditions change.

Response: We appreciate the commenter's concerns. Given the end of the federal COVID-19 PHE on May 11, 2023, it is important CMS provide hospitals and beneficiaries with a complete picture of the care quality provided for all patients. While hospitals and other types of health care facilities may face continuing challenges due to the long-term effects of the COVID-19 PHE, we do not agree these challenges represent such a significant threat to health care operations that patients with a secondary COVID-19 diagnosis should be excluded from the measure's cohorts.

After consideration of the public comments received, we are finalizing modifications of the MORT-30-STK measure as proposed beginning with administrative claims and encounter data from July 1, 2023, through June 30, 2025, associated with the FY 2027 payment determination. We will also be implementing all technical updates as outlined in the proposed rule.

b. Modification to the Hospital-Level, Risk-Standardized Complication Rate Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) Measure Beginning With the FY 2027 Payment Determination (1) Background

THA and TKA are commonly performed procedures for the Medicare population that improve quality of life.\309\ From April 1, 2018-March 31, 2021, there were 563,236 THA and TKA procedures performed on Medicare FFS patients 65 years and older.\310\ By 2040, the number of THA procedures is projected to increase by 176 percent and the number of TKA procedures is projected to increase by 139 percent.\311\ While these procedures can dramatically improve a person's quality of life, they are costly. Based on projections of the annual demand for THA and TKA procedures, researchers estimate that Medicare expenditures on Total Joint Arthroplasty could climb to $50 billion by 2030.\312\ Complications such as joint infections and sepsis following elective THA and TKA procedures are rare, but the results can be devastating. Evidence shows that periprosthetic joint infection rates following THA and TKA were 1.9 percent (1.5 percent to 2.2 percent) and 1.5 percent (1.3 percent to 1.7 percent) following TKA and THA, respectively.\313\ From 2011 to 2021, reported 30- and 90-day death rates following THA are 0.49 percent and 0.47 percent, respectively.\314\ Rates for pulmonary embolism following THA range from 0.5 percent to 1.22 percent \315\ and range from 0.5 percent to 0.9 percent \316\ following TKA. Rates for wound infection in Medicare population-based studies vary between 0.21 percent and 1.0 percent.\317\ Rates for sepsis/septicemia range from 0.09 percent during the index admission to 0.3 percent 90 days following discharge for primary TKA. Rates for bleeding and hematoma following TKA range from 0.94 percent to 1.7 percent.\318\

\309\ Barahona M, Bustos F, Navarro T, Chamorro P, Barahona MA, Carvajal S, Bra[ntilde]es J, Hinzpeter J, Barrientos C, Infante C. Similar Patient Satisfaction and Quality of Life Improvement Achieved with TKA and THA According to the Goodman Scale: A Comparative Study. J Clin Med. 2023 Sep 21;12(18):6096. Available at: https://pubmed.ncbi.nlm.nih.gov/37763035/ #:~:text=Regarding%20improvement%20in%20quality%20of,lower%20satisfac tion%20rates%20for%20TKA.

\310\ 2022 Procedure-Specific Complication Measure Updates and Specifications Report: Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA). Available at: https://www.cms.gov/files/document/2022-measure-updates-procedure-specific-complication-measure-updates-and-specifications-report.pdf.

\311\ Gupta, N, Turnow M, Doad, J. et al., Trends in Reimbursement for All Billable Total Joint Replacement Procedures: An Analysis of the Medicare Part B Database from 2013-2011. J. Orthop. Ex. & Inn. 2024; 5(2). https://doi.org/10.60118/001c.120219. Available at: https://journaloei.scholasticahq.com/article/120219-trends-in-reimbursement-for-all-billable-total-joint-replacement-procedures-an-analysis-of-the-medicare-part-b-database-from-2013-2021.

\312\ Wilson, N.A., et al., Hip and knee implants: current trends and policy considerations. Health Aff (Millwood), 2008. 27(6): p. 1587-98.

\313\ Jin X, Gallego Luxan B, Hanly M, et al., Estimating Incidence Rates of Periprosthetic Joint Infection After Hip and Knee Arthroplasty for Osteoarthritis Using Linked Registry and Administrative Health Data. Bone Joint J. 2022; 104-B(9): 1060-1066. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9948458.

\314\ Turan O, Pan X, Kunze KN, et al., 30-Day to 10-Year Mortality Rates Following Total Hip Arthroplasty: A meta-Analysis of the Last Decade. Hip Int. 2024; 34(1): 4-14. Available at: https://pubmed.ncbi.nlm.nih.gov/36705090.

\315\ Arshi A, Leong NL, Wang C, Buser Z, Wang JC, SooHoo NF. Outpatient total hip arthroplasty in the United States: A population-based comparative analysis of complication rates. J Am Acad Orthop Surg. 2019;27(2):61-7.

\316\ Khatod M, Inacio M, Paxton EW, et al. Knee replacement: epidemiology, outcomes, and trends in Southern California: 17,080 replacements from 1995 through 2004. Acta Orthop. 2008;79(6):812- 819.

\317\ Browne J, Cook C, Hofmann A, Bolognesi M. Postoperative morbidity and mortality following total knee arthroplasty with computer navigation. Knee. Mar 2010;17(2):152-156.

\318\ Huddleston JI, Maloney WJ, Wang Y, Verzier N, Hunt DR, Herndon JH. Adverse Events After Total Knee Arthroplasty: A National Medicare Study. The Journal of Arthroplasty. 2009;24(6, Supplement 1):95-100.

The Hospital-Level, Risk-Standardized Complication Rate Following Elective Primary THA and/or TKA measure (hereinafter referred to as the COMP-HIP-KNEE measure) was first adopted in the Hospital IQR Program in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53516 through 53518). The measure estimates a hospital-level, risk-standardized complication rate associated with elective primary THA and/or TKA procedures. More recently, in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49263 through 49267), we adopted a re-evaluated COMP-HIP-KNEE measure into the Hospital IQR Program that included expanded outcomes. In the FY 2024 IPPS/LTCH PPS final rule (88 FR 59067 through 59070), the re-evaluated COMP-HIP-KNEE measure was adopted in the Hospital VBP Program in accordance with statutory requirements of section 1886(o)(2)(C)(i) of the Act and 42 CFR 412.164(b), which state that measures must be publicly reported for 1 year in the Hospital IQR Program prior to the beginning of the performance period in the Hospital VBP Program. In that same final rule, we finalized removal of the re-evaluated COMP- HIP-KNEE measure in the Hospital IQR Program beginning with the FY 2030 payment determination to prevent duplicative reporting of the measure in a quality reporting program and value-based program, and to simplify administration of both programs (88 FR 59168 through 59170). The clinical outcomes of the COMP-HIP-KNEE measure are a high priority for CMS and this measure provides important data on patient safety and complications. Therefore, in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18331 through 18335), we proposed modifications to the COMP-HIP- KNEE measure in the Hospital IQR Program beginning with the FY 2027 payment determination, prior to its removal from the Hospital IQR Program beginning with the FY 2030 payment determination (88 FR 59168 through 59170). We refer readers to section VI.L.2.a. of the preamble of this final rule for more details on our proposal to adopt these same updates for the COMP-HIP-KNEE measure into the Hospital VBP Program beginning with the FY 2033 program year. If finalized as proposed (90 FR 18331 through 18335), the updated COMP-HIP-KNEE measure will have been publicly reported in the Hospital IQR Program for at least 1 year in accordance with statutory requirements before adoption into the Hospital VBP Program. (2) Overview of Measure Updates

We proposed (90 FR 18331 through 18335) modifications to the current COMP-HIP-KNEE measure in the Hospital IQR Program beginning with the FY 2027 payment determination. Specifically, we proposed (90 FR 18331 through 18335) to modify the COMP-HIP-KNEE measure with two substantive updates: (1) expand the measure's inclusion criteria to include MA patients; and (2) shorten the performance period from 3 years to 2 years. The addition of MA encounter data to the measure roughly doubles the cohort size, improves measure reliability, and more accurately reflects the quality of care for both Medicare FFS and MA beneficiaries. We will remove the updated COMP-HIP-KNEE measure in the Hospital IQR Program beginning with the FY 2030 payment determination, as finalized in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59168 through 59170), to prevent duplicative reporting of the measure in a quality reporting program and value-based program, and to simplify administration of both programs.

The modifications of the updated COMP-HIP-KNEE measure would support the Meaningful Measures 2.0

priority area of “Chronic Conditions” that aims to improve disease- specific outcomes, reduce preventable emergency department usage and admissions, and reduce mortality.\319\

\319\ Centers for Medicare & Medicaid Services. (2025). Cascade of Meaningful Measures. Available at: https://www.cms.gov/medicare/quality/cms-national-quality-strategy/cascade-measures.

(3) Technical Updates

We are also making two technical updates to the updated COMP-HIP- KNEE measure. Specifically, technical updates to the measure include: (1) update the risk adjustment model to use individual ICD-10 codes instead of HCCs to improve the measure's risk adjustment methodology; and (2) remove the exclusion of patients with a principal diagnosis code of COVID-19 or with a secondary diagnosis code of COVID-19 coded as present on admission on the index admission claim. We refer readers to section X.C.5. of the preamble of this final rule for further discussion on removal of the COVID-19 diagnosis exclusion to measures in the Hospital IQR Program.

We are updating the COMP-HIP-KNEE measure's risk-adjustment methodology to use individual ICD-10 codes using patient-level demographics (age), patient-level health status and clinical conditions (case-mix adjustment; severity of illness; comorbidities), and patient functional status (body function). These clinically relevant risk variables would be identified from inpatient and outpatient claims in the 12 months prior to the procedure. The current risk adjustment strategy for this measure involves grouping ICD-10 diagnosis codes from CMS's HCC system into clinically relevant categories. Then we evaluate the HCCs for statistical association with the measure's outcome.\320\ However, research has indicated that using individual ICD codes in place of HCCs could significantly improve the model performance of the mortality measures.\321\ To better leverage the data and analytical advances since the measure was initially developed, we created a new approach to use individual ICD-10 codes for risk adjustment instead of grouping them into categories. With this new approach, the discriminative performance of the risk adjustment model as measured by c-statistic was significantly better and the calibration performance also proved to be satisfactory.\322\ We did not adjust for social risk variables in the measure as neither of the two social risk factors tested (Area Deprivation Index and dual eligibility) showed significant effect. Given these findings and the complex pathways that could explain any relationship between social risk and mortality/ complications, we chose not to adjust the measure for social risk.

\320\ Centers for Medicare & Medicaid Services. 2024 Condition- and Procedure-Specific Mortality/Complication Measures Supplemental Methodology Report. Available at: https://qualitynet.cms.gov/files/67ee94ebe8ad069a97a9bbbb?filename=2024_MortComp_SuppMthdRpt_IQR.pdf.

\321\ Krumholz, H.M., Coppi, A.C., Warner, F., Triche, E.W., Li, S.X., Mahajan, S., Li, Y., Bernheim, S.M., Grady, J., Dorsey, K., Lin, Z., & Normand, S.T. (2019). Comparative Effectiveness of New Approaches to Improve Mortality Risk Models From Medicare Claims Data. JAMA network open, 2(7), e197314. https://doi.org/10.1001/jamanetworkopen.2019.7314.

\322\ Battelle--Partnership for Quality Measurement. (February 2025). 2024-2025 Pre-Rulemaking Measure Review (PRMR) Recommendations Report. Available at: https://p4qm.org/sites/default/files/2025-02/PRMR-2024-2025-MUC-Recommendations-Report-Final.pdf.

For measure specification details on the updates to this measure, we refer readers to the Measure Methodology Report in the Hip and Knee Arthroplasty Complications (ZIP) folder on the QualityNet website, available at: https://qualitynet.cms.gov/files/67eea958e8ad069a97a9ccc5?filename=2024_ArchiveMethodologyComp.zip. (4) Measure Calculation

The outcome for the updated COMP-HIP-KNEE measure would be a complication occurring during the index admission (not coded as present on admission) through 90 days post-date of the index admission. Complications are counted in the measure only if they occur during the index hospital admission or during a readmission. The complication outcome is a dichotomous (yes/no) outcome. If a patient experiences one or more of these complications in the applicable period, the complication outcome for that patient would be counted in the measure as a “yes”.

The updated measure includes one of the following complications:

Acute myocardial infarction during the index admission or a subsequent inpatient admission that occurs within 7 days from the start of the index admission.

Pneumonia or other acute respiratory complication during the index admission or a subsequent inpatient admission that occurs within 7 days from the start of the index admission.

Sepsis/septicemia/shock during the index admission or a subsequent inpatient admission that occurs within 7 days from the start of the index admission.

Surgical site bleeding or other surgical site complication during the index admission or a subsequent inpatient admission within 30 days from the start of the index admission.

Pulmonary embolism during the index admission or a subsequent inpatient admission within 30 days from the start of the index admission.

Death during the index admission or within 30 days from the start of the index admission.

Mechanical complication during the index admission or a subsequent inpatient admission that occurs within 90 days from the start of the index admission.

Periprosthetic joint infection/wound infection or other wound complication during the index admission or a subsequent inpatient admission that occurs within 90 days from the start of the index admission.

The code list used to define the mechanical complication outcome includes clinically vetted mechanical complication ICD-10 codes. For a full list of these codes, we refer readers to the FY 2023 IPPS/LTCH PPS final rule (87 FR 49264).

We proposed (90 FR 18331 through 18335) to expand the COMP-HIP-KNEE measure cohort to include both Medicare FFS and MA beneficiaries, aged 65 years or older, having a qualifying elective primary THA or TKA procedure during the index admission. Beneficiaries must be enrolled in Medicare FFS or MA for the 12 months prior to the date of admission and enrolled in Medicare FFS or MA during the index admission. Our analysis found that the addition of MA admissions into the COMP-HIP-KNEE measure approximately doubled the admissions in the cohorts and led to improved measure reliability and more hospitals and beneficiaries included for measure calculation.\323\ Based on the results of that analysis, we found that the measure could achieve a satisfactory level of reliability (median reliability score 0.801, ranging from 0.560 to 0.997, with the 25th and 75th percentiles 0.683 and 0.891, respectively) with a 2-year reporting period and are therefore proposing to shorten the reporting period from 3 to 2 years.\324\ This median reliability estimate exceeds the reliability of 0.6, which the CBE considers acceptable. Shortening the reporting period would allow measure results to reflect more recent hospital performance and, therefore, provide

more actionable insights for quality improvement.

\323\ Yale New Haven Health Services Corporation--Center for Outcomes Research and Evaluation. (March 2024). 2024 Supplemental Measure Methodology: Condition[hyphen] and Procedure[hyphen]Specific Mortality/Complications. Available at: https://p4qm.org/measures/1550.

\324\ Ibid.

Consistent with the COMP-HIP-KNEE measure currently reported in the Hospital IQR Program, the proposed (90 FR 18331 through 18335) update to the COMP-HIP-KNEE measure would exclude patients from the measure cohort index admissions for patients who did not have at least 90 days post-discharge enrollment in Medicare FFS or MA, who were discharged against medical advice, or who had more than two THA/TKA procedure codes during the index hospitalization.\325\

\325\ Battelle--Partnership for Quality Measurement. Hospital- level, risk-standardized complication rate (RSCR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) Measure Specifications. Available at: https://p4qm.org/measures/1550.

The modifications to the COMP-HIP-KNEE measure would still be calculated using a hospital risk-standardized complication rate by producing a ratio of the number of “predicted” complications (that is, the adjusted number of complications at a specific hospital based on its patient population) to the number of “expected” complications (that is, the number of complications if an average quality hospital treated the same patients) for each hospital and then multiplying the ratio by the national observed complication rate. For each hospital, the numerator of the ratio is the number of complications within the specified time period (up to 90 days) predicted on the basis of the hospital's performance with its observed case mix, and the denominator is the number of complications expected based on the nation's performance with that hospital's case mix. This approach is analogous to a ratio of “observed” to “expected” used in other types of statistical analyses. It would allow for a comparison of a particular hospital's performance to an average hospital's performance with the same case mix.

For measure specification details on the updates to this measure, we refer readers to the Measure Methodology Report in the Hip and Knee Arthroplasty Complications (ZIP) folder on the QualityNet website, available at: https://qualitynet.cms.gov/files/67eea958e8ad069a97a9ccc5?filename=2024_ArchiveMethodologyComp.zip. (5) Pre-Rulemaking Process and Measure Endorsement (a) Recommendation From the Pre-Rulemaking Measure Review (PRMR) Process

We refer readers to the FY 2025 IPPS/LTCH PPS final rule (89 FR 69457 through 69458) for details on the PRMR process including the voting procedures used to reach consensus on measure recommendations. The PRMR Hospital Committee met on January 15 and 16, 2025, to review measures included by the Secretary on the publicly available 2024 MUC List, including the COMP-HIP-KNEE measure (MUC2024-042),\326\ and to vote on a recommendation regarding use of this measure in the Hospital IQR Program.

\326\ Centers for Medicare & Medicaid Services. (2024). 2024 Measures Under Consideration (MUC) List. Available at: https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports.

The PRMR Hospital Recommendation Committee reached consensus and voted to recommend this measure for the Hospital IQR Program with conditions.\327\ Eighteen of 27 members of the committee recommended adopting the measure into the Hospital IQR Program without conditions; 8 members of the committee recommended adoption with conditions; 1 member of the committee did not recommend this measure for adoption. Taken together, 96 percent of the votes were to recommend this measure for the Hospital IQR Program with conditions. Thus, the committee reached consensus and recommended the updated COMP-HIP-KNEE measure for adoption into the Hospital IQR Program with conditions.\328\

\327\ Battelle--Partnership for Quality Measurement. (February 2025). 2024-2025 Pre-Rulemaking Measure Review (PRMR) Recommendations Report. Available at: https://p4qm.org/sites/default/files/2025-02/PRMR-2024-2025-MUC-Recommendations-Report-Final.pdf.

\328\ Ibid.

The committee supported this measure, particularly with the addition of MA data to improve statistical reliability and make the measure more relevant for rural areas, with a call for transparency and analytical rigor to understand the impact of additional MA data. The committee raised concerns regarding the potentially uneven distribution of MA program participation, the shifting of benchmarks with new MA beneficiaries, and the implications of surgical procedures moving to ambulatory care settings which may leave more complex patients in inpatient facilities. Thus, the committee members submitted the following conditions for recommendations into the Hospital IQR Program: (1) stratified reporting; (2) providing hospitals with feedback on outcome variations between MA beneficiaries and Medicare Shared Savings Program (MSSP) populations; (3) breaking down performance data by payer; (4) re-evaluating the risk model as the measure matures to identify any adjustments needed for variation at the patient level across plans; and (5) considering if the reporting period is sufficient to avoid time lags that may hinder data usefulness and measure improvement.\329\

\329\ Ibid.

In response to concerns about uneven distributions among MA and Medicare FFS beneficiaries, based on our analysis, the observed complication rate for MA beneficiaries was 3.7 percent, 3.2 percent among Medicare FFS beneficiaries only, and 3.4 percent complication rate for MA and Medicare FFS beneficiaries, showing a difference of 0.5 percentage points between Medicare FFS only and MA only beneficiaries.\330\ Thus, the variation between the two cohorts did not vary significantly for complication rates and does not raise concerns regarding uneven distribution of two cohorts for this measure. In regard to providing hospitals with stratified reporting results, we note that hospitals currently receive confidential feedback reports containing details on measure results, but they do not stratify results by payer. We will consider providing additional confidential feedback to hospitals in the future, including results stratified by MA and Medicare FFS beneficiaries. Regarding evaluating the risk adjustment model, as a part of routine measure maintenance, we conduct ongoing monitoring and evaluation analyses to watch for any unintended consequences. Regarding the condition related to lag time between performance and when results are received, one of the proposed updates is to shorten the reporting period from 3 to 2 years, which our current analysis shows is the shortest reporting period for which the results remain reliable and valid and which significantly improves the timeliness of the data for this measure. However, we will continue to analyze measure results and if the evidence shows that a reporting period that is shorter than 2 years produces valid and reliable measure results, we will consider proposing to adopt that shorter reporting period in the future. After taking these recommendations and concerns into consideration, we proposed (90 FR 18331 through 18335)

to adopt the updated COMP-HIP-KNEE measure in the Hospital IQR Program.

\330\ Yale New Haven Health Services Corporation--Center for Outcomes Research and Evaluation. (March 2024). 2024 Supplemental Measure Methodology: Condition[hyphen] and Procedure[hyphen]Specific Mortality/Complications. Available at: https://qualitynet.cms.gov/files/67eea958e8ad069a97a9ccc5?filename=2024_ArchiveMethodologyComp.zip.

(b) Measure Endorsement

We refer readers to the FY 2025 IPPS/LTCH PPS final rule (89 FR 69458 through 69459) for details on the E&M process including the procedures the CBE's E&M Committees use to evaluate measures and determine whether they meet endorsement criteria. The COMP-HIP-KNEE measure (CBE #1550) was reviewed by the CBE in the Fall 2020 cycle, and was re-endorsed July 2021.\331\ The updated COMP-HIP-KNEE measure was most recently submitted to the CBE's E&M Cost and Efficiency Committee in the Fall 2024 E&M review cycle, which included the modifications we proposed (90 FR 18331 through 18335) to adopt as well as the technical updates to the risk methodology. The E&M Cost and Efficiency Committee voted on this measure on February 10, 2025, but did not reach consensus because only 73 percent of the committee voted to endorse or endorse this measure with conditions, below the 75 percent required by the CBE to reach consensus.\332\ \333\ As a result, the measure was not re- endorsed by the CBE. The E&M Cost and Efficiency Committee discussed concerns about the case mix of patients, noting the shift from inpatient to outpatient for these elective procedures and that healthier patients may be directed to ambulatory surgical centers, leaving acute care hospitals with higher-risk individuals, which could affect case mix and measure outcomes. Another concern discussed was the limited scope of the measure which only includes inpatient complications, and whether this limited scope provides utility and relevance for patients. Additional concerns discussed include the overall approach to adjusting low-volume provider performance to the average, and that scores for lower volume providers may be misleading to patients.

\331\ Battelle--Partnership for Quality Measurement. Hospital- level, risk-standardized complication rate (RSCR) following elective primary total hip arthroplasty (THA) and/or total knee arthroplasty (TKA) Measure Specifications. Available at: https://p4qm.org/measures/1550.

\332\ Battelle--Partnership for Quality Measurement. (March 2025). Fall 2024 Cycle Endorsement and Maintenance (E&M) Technical Report: Cost and Efficiency. Available at: https://p4qm.org/articles/now-available-final-fall-2024-e-m-reports.

\333\ Battelle--Partnership for Quality Measurement. (July 2024). Endorsement and Maintenance (E&M) Guidebook. Available at: https://p4qm.org/sites/default/files/2024-08/Del-3-6-Endorsement-and-Maintenance-Guidebook-Final_0.pdf.

The measure developer then submitted an appeal of the decision not to re-endorse the measure, citing the following rationales: (1) procedural error in the endorsement process with an excessive focus on outpatient setting exclusions; and (2) misapplication of measure evaluation criteria, particularly risk adjustment.\334\ The CBE convened the E&M Fall 2024 Appeals Committee meeting on March 31, 2025. The Appeals Committee voted to grant the appeals request, with a vote of 100 percent for both rationales, and overturn the decision not to re-endorse the measure. Thus, the COMP-HIP-KNEE measure was endorsed with the following conditions: (1) explore the proportion of procedures done in the ambulatory surgical centers and hospital outpatient department setting and evaluate the need for adjustment based on the impact of case mix; and (2) explore additional approaches to the reliability assessment to account for low-volume facilities.

\334\ Battelle--Partnership for Quality Measurement. (2025). E&M Fall 2024 Appeals Committee Meeting Summary Report. This report will be available through this link: https://p4qm.org/EM/news-events.

Regarding the impact of case mix, we note that this measure focuses on higher-risk patients and is intentionally narrow to capture significant complications, such as sepsis, pulmonary embolism, or a second surgery, which should be treated in the inpatient setting. We wish to emphasize that those having elective THA or TKA procedures within the inpatient setting must meet certain criteria, resulting in a smaller cohort of patients, and in communities where there are no ambulatory care centers the patient would be treated in the hospital outpatient department and would not be counted in this measure. Regarding the second condition for endorsement, to explore additional approaches to the reliability assessment to account for low-volume facilities, we emphasize that the goal of this measure and adjusting for low-volume is to make performance scores available for as many providers as possible while trying to avoid misclassification or profiling of providers. We note that scores are not available for facilities with fewer than 25 cases, because the number of cases may be too small for meaningful results. Based on our evaluation of the endorsement criteria, the conditions for endorsement have been met. (6) Data Source, Submission and Public Reporting

The updated COMP-HIP-KNEE measure would use index admission diagnoses and in-hospital comorbidity data from Medicare FFS claims or MA claims/encounters, or both. Additional comorbidities prior to the index admission are assessed using Part A inpatient, outpatient, and Part B office visit Medicare FFS claims and MA encounters in the 12 months prior to index (initial) admission. Enrollment status would be obtained from the Medicare Enrollment Database which contains beneficiary demographic, benefit/coverage, and vital status information. This measure uses readily available administrative claims data routinely generated and submitted to CMS for all Medicare beneficiaries, which includes MA and Medicare FFS beneficiaries. The updated COMP-HIP-KNEE measure would be calculated and publicly reported on an annual basis using a rolling 24 months of prior data for the measurement period, consistent with the approach currently used for the Thirty-day Risk-Standardized Death Rate among Surgical Inpatients with Complications (89 FR 69545 through 69552) and CMS Patient Safety and Adverse Events Composite (PSI 90) measure, currently reported in the HAC Reduction Program (78 FR 50712 through 50718). As a claims-based measure, hospitals would not be required to submit data other than claims data, which we would use to calculate the measure. In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18290 through 18291), we also proposed to adopt the modifications to the COMP-HIP-KNEE measure in the Hospital VBP Program, beginning with the FY 2033 program year, after the updated measure has been publicly reported in the Hospital IQR Program for 1 year. Table X.C.1. summarizes the timelines for the current and proposed reporting of the COMP-HIP-KNEE measure in the Hospital IQR and VBP Programs.

[GRAPHIC] [TIFF OMITTED] TR04AU25.273

We proposed (90 FR 18331 through 18335) to publicly report the updated COMP-HIP-KNEE measure in accordance with our previously established public reporting policy for the Hospital IQR Program.\335\ Such reporting would be undertaken on the Compare tool available at: https://www.medicare.gov/care-compare, or its successor website, beginning in July 2026 or as soon as feasible.

\335\ See the FY 2025 IPPS/LTCH PPS final rule (89 FR 69577) for a brief overview of public display requirements under the Hospital IQR Program and our current public reporting policy.

We invited public comment on our proposal to adopt the updated COMP-HIP-KNEE measure into the Hospital IQR Program beginning with administrative claims and encounter data from April 1, 2023, through March 31, 2025, associated with the FY 2027 payment determination.

Comment: Most commenters supported the proposed inclusion of MA beneficiaries in hospital quality measures, citing the growing proportion of MA beneficiaries and the need for measures to reflect the full Medicare population served by hospitals. Many commenters emphasized this change would improve the reliability and accuracy of performance data, particularly for hospitals with a large proportion of MA beneficiaries. Many commenters supported the proposed shortening of the performance period of this measure from 3 years to 2 years, noting that this change would provide more timely and actionable data for hospitals, payers, and patients. Many commenters agreed that shorter measurement windows would better reflect current care quality and reduce the lag between quality improvement efforts and their impact on metrics. Commenters highlighted that a 2-year period strikes a balance between statistical reliability, timeliness, and relevance, particularly with the inclusion of MA beneficiaries, which increases the denominator size.

Response: We thank commenters for their support.

Comment: Many commenters expressed concerns about the challenges of data collection and reporting with the proposed addition of MA encounter data. Some commenters did not support the proposed inclusion of MA beneficiaries in this measure cohort, citing potential challenges with data accuracy, transparency, and the differences between MA and FFS plans and populations. Many commenters stated concerns about the risk of being unfairly penalized for factors outside their control, such as MA plan prior authorization delays and denials of post-acute services, noting these are observed adverse practices by some MA plans that could impact surgical outcomes from THA or TKA. Commenters recommended addressing these data collection challenges, increasing the number of allowable diagnosis codes on claims, and ensuring transparency in measure development.

Response: We appreciate the commenters' concerns regarding the inclusion of MA beneficiaries and the potential for challenges around data accuracy, transparency, and accessibility. We reiterate that with over half of the Medicare population now receiving its benefits through the MA program, including this population in the Hospital IQR Program supports quality improvement goals of high-quality, safe care for all patients. Additionally, the inclusion of MA beneficiaries has several important benefits for the reliability and validity of the hospital outcome measures. The increased size of the measure's cohort leads to more hospitals reaching the minimum threshold for reporting and receiving results, therefore increasing the opportunity to identify meaningful differences in quality for some low-volume hospitals.

We thank commenters for their feedback on potential differences between Medicare FFS and MA populations and plan designs. In our statistical analysis of complication rates using unique admissions, to potentially include MA beneficiaries, using FFS beneficiaries and MA beneficiaries, we found the unadjusted complication rate for the FFS and MA beneficiaries combined cohort to be 3.4 percent. The observed complication rate for FFS beneficiaries was 3.2 percent compared to 3.7 percent for MA beneficiaries, showing a difference of 0.5 percentage points between FFS and MA beneficiaries.\336\ Based on this analysis, the rates of complication did not vary significantly between the two populations on average and therefore hospitals are not likely to be unfairly penalized with the inclusion of MA beneficiaries into the measure's cohort. Further, this risk-adjusted complication measure methodology does account for additional medical conditions that might impact higher complication rates such as malignant neoplasm of the pelvis, sacrum, coccyx, lower limbs, or bone/bone marrow or a disseminated malignant neoplasm coded in the principal discharge diagnosis field on the index admission claim.

\336\ Centers for Medicare & Medicaid Services. 2024 Condition- and Procedure-Specific Mortality/Complication Measures Supplemental Methodology Report. Available at: https://qualitynet.cms.gov/inpatient/measures/complication/methodology.

We agree that transparency is important for both beneficiaries and

providers, and we provide hospitals with annual confidential feedback reports on their measure performance. Additionally, routine measure evaluation reports are publicly available through QualityNet on our website at: https://qualitynet.cms.gov. For the complete measure methodology report and measure risk adjustment statistical model, we specifically refer readers to QualityNet on our website at: https://qualitynet.cms.gov/inpatient/measures/complication/reports and the Partnership for Quality Measurement's website at: https://p4qm.org/measures/1550. Additionally, as a part of routine monitoring and evaluation of measures, we will monitor for any unintended consequence of this change.

Comment: A few commenters raised concerns about the potential for increased administrative burden with the addition of MA beneficiaries, noting the prior authorization process used by MA plans places a significant administrative burden on both acute care hospitals and post-acute care providers. A commenter recommended providing a clearer understanding of data collection methods, assessing the associated burden, and determining whether the benefits outweigh the new reporting challenges.

Response: We would like to clarify that the inclusion of MA encounter data in COMP-HIP-KNEE does not require any additional data collection or submission from hospitals. As we previously discussed (90 FR 18335), the inclusion of MA encounter data in this measure uses readily available administrative claims data routinely generated and submitted to CMS for all Medicare beneficiaries, which includes MA and Medicare FFS beneficiaries. Specifically, the MA encounter data used for this measure are submitted by Medicare Advantage Organizations (MAOs) to CMS. Similarly, FFS claims are submitted through existing hospital billing processes. As such, the proposed modifications do not impose additional data submission burden on hospitals. We refer readers to section XIII.B.4.b. for additional details on our information collection burden estimate for the proposal to modify the COMP-HIP-KNEE measure (90 FR 18408). Lastly, we will continue to monitor for unintended consequences as a part of our routine monitoring and evaluation of the Hospital IQR Program measure set.

Comment: Several commenters recommended a phased implementation approach, including confidential feedback reports and dry runs, or a delay to allow hospitals to validate MA data, ensure robust risk adjustment methodologies, and assess its impact before public reporting or payment penalties.

Response: We thank the commenters for their feedback and recommendations to possibly delay or use a phased implementation approach. We will provide confidential feedback reports to hospitals on their measure performance. Additionally, we will continue to monitor for unintended consequences as a part of our routine monitoring and evaluation of the Hospital IQR Program measure set. We note the current approach to first adopt the modified COMP-HIP-KNEE measure, to include MA beneficiaries and shorten the reporting period, into the Hospital IQR Program beginning with the FY 2027 payment determination, followed by adoption into the Hospital VBP Program beginning with the FY 2033 program year, is a phased implementation approach. This phased approach allows for hospitals to have about 6 years to assess the impact of MA beneficiary inclusion before payment adjustments would take effect.

Comment: A commenter stated concerns that THA and TKA procedures differ significantly in recovery timelines, patient satisfaction, and functional improvement. The commenter recommended separate reporting pathways for each procedure to yield more accurate data and promote informed decision-making based on the measure results.

Response: We thank commenters for the recommendation to separately report THA and TKA complication rates and highlight that there may potentially be differences in recovery timelines, patient satisfaction, and functional improvement. We note the risk model adjusts for the procedure type by knee or hip replacement, which demonstrated good calibration in our risk model. Combining the TKA and THA in the same cohort while adjusting for procedure type allows for a large enough sample size to both improve reliability and increase the number of hospitals eligible to report on this measure.

Comment: A commenter was concerned that the CBE's E&M Cost and Efficiency Committee's reasons for not re-endorsing the updated COMP- HIP-KNEE measure have not been adequately addressed. The commenter also shared the same concerns regarding the need to evaluate differences in patient populations between inpatient and outpatient settings, as well as exploring additional approaches to adjust performance for low-volume facilities.

Response: We acknowledge the commenter's concerns regarding the need to evaluate differences in patient populations between inpatient and outpatient settings. However, we wish to note that the Appeals Committee voted to grant the appeals request, with a vote of 100 percent for both rationales, and overturn the decision not to re- endorse the measure. Based on our evaluation of the endorsement criteria, the conditions for endorsement have been met. We refer readers to section X.C.3.5.b. for additional details regarding endorsement considerations.

Comment: Many commenters supported the technical update notifications for this measure. Many commenters supported CMS's notification of the technical update to transition risk adjustment methodologies from HCCs to ICD-10 codes, noting the increased granularity and clinical relevance of ICD-10 codes. Many commenters noted this change would enhance the accuracy of risk adjustment by better capturing patient comorbidities and clinical factors influencing outcomes. Commenters highlighted that ICD-10 codes align with current documentation practices and provide greater specificity, which is important for fair performance measurement.

Many commenters supported CMS's notice of the technical update to remove the COVID-19 exclusion from the COMP-HIP-KNEE measure, given that the PHE has ended and COVID-19 cases have significantly declined.

Response: We thank commenters for their support.

Comment: Some commenters raised concerns about CMS's notice of technical update to switch risk adjustment methodologies from HCCs to ICD-10 codes, emphasizing the potential for unintended consequences and operational challenges. Commenters noted that HCCs are widely used in other CMS programs, such as TEAM, and questioned the rationale for adopting ICD-10 codes in quality measures while retaining HCCs elsewhere. Commenters noted the risk of inconsistencies across programs and the possibility of hospitals seeing changes in performance scores due to the model itself rather than actual care quality, especially for rural or safety-net hospitals. Concerns were also raised about the abrupt nature of the transition, with commenters recommending a phased approach, parallel reporting of HCC- and ICD-10-based models, and extensive testing to ensure accuracy and reliability. Some commenters suggested increasing the number of allowable diagnosis codes on claims to better

capture patient complexity. Some commenters recommended monitoring the impact of this transition on predictive accuracy and ensuring transparency in the implementation process. Others emphasized the need for transparency in developing the new models, including clinical validation and stakeholder feedback. Recommendations included delaying the transition, aligning methodologies across programs, and providing hospital-specific reports to help facilities understand the impact of the changes.

Response: We appreciate commenter concerns regarding the change from HCC- to ICD-10 based models. As a part of our routine monitoring and evaluation we will watch for any unintended consequences of this updated risk model. We wish to note that we conduct annual measure re- evaluations to ensure that the risk-standardized complication model is continually assessed and remains valid, given possible changes in clinical practice and coding standards over time.\337\ Modifications made to the measure cohort, risk model, and outcomes are informed by review of the most recent literature related to measure conditions or outcomes, feedback from various stakeholders, empirical analyses, and assessment of coding trends that reveal shifts in clinical practice or billing patterns.\338\ We solicited input from a workgroup composed of up to 20 clinical and measure experts, inclusive of internal and external consultants and subcontractors. As a part of annual re- evaluations, one of the activities we undertook was to review select pre-existing ICD-10 code-based specifications with our workgroup to confirm appropriateness unaffected by the updates, as well as review any potentially clinically relevant codes that “neighbor” existing codes used in the measure to identify any warranted specification changes.\339\ We agree transparency is important, and additional details on our annual re-evaluation can be found on the QualityNet website (available at: https://qualitynet.cms.gov/inpatient/measures/complication/reports).

\337\ Centers for Medicare & Medicaid Services. 2025 Procedure- Specific Complication Measure Updates and Specifications Report. Available at: https://qualitynet.cms.gov/inpatient/measures/complication/methodology.

\338\ Ibid.

\339\ Ibid.

Comment: Several commenters were concerned with the notice of the technical update to remove COVID-19 exclusions, citing the ongoing clinical complexity and variability of COVID-19 as a factor in patient recovery. Commenters noted concerns that hospitals still experiencing pandemic-related patient-risk disparities may face unintended consequences from the inclusion of COVID-19 cases in outcome measures. Commenters recommended that CMS closely monitor the impact of this change and remain flexible in reinstating exclusions if conditions change.

Response: We appreciate the commenter's concerns. Given the end of the federal COVID-19 PHE on May 11, 2023, it is important we provide hospitals and beneficiaries with a complete picture of the care quality provided for all patients. While hospitals and other types of health care facilities may face continuing challenges due to the long-term effects of the COVID-19 pandemic, we do not agree that these challenges continue to represent such a significant threat to health care operations that patients with a secondary COVID-19 diagnosis should be excluded from the measure's cohorts. Such patients, as with all patients treated by hospitals, should receive the best quality care from their providers, and incorporating them into quality measures represents the best way for us to incentivize high-quality care for all.

After consideration of the public comments received, we are finalizing modifications of the COMP-HIP-KNEE measure as proposed and implementing the technical updates, beginning with administrative claims and encounter data from April 1, 2023, through March 31, 2025, associated with the FY 2027 payment determination.

4. Removals in the Hospital IQR Program Measure Set

In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18336 through 18337), we proposed to remove four measures: (1) Hospital Commitment to Health Equity measure beginning with the CY 2024 reporting period/FY 2026 payment determination; (2) COVID-19 Vaccination Coverage among Healthcare Personnel measure beginning with the CY 2024 reporting period/FY 2026 payment determination; (3) Screening for Social Drivers of Health measure beginning with the CY 2024 reporting period/FY 2026 payment determination; and (4) Screen Positive Rate for Social Drivers of Health measure beginning with the CY 2024 reporting period/FY 2026 payment determination. We provide more details on each of these proposals in the subsequent sections. a. Removal of the Hospital Commitment to Health Equity Measure Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination

We refer readers to the FY 2023 IPPS/LTCH PPS final rule where we adopted the Hospital Commitment to Health Equity (hereafter referred to as HCHE) measure into the Hospital IQR Program (87 FR 49191 through 49201). In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18336), we proposed to remove the HCHE measure beginning with the FY 2026 payment determination due to the costs associated with achieving a high score on the measure outweighing the benefit of its continued use in the program. When adopted, we intended the collection of data described in the five domains of this measure to provide hospital leadership with meaningful and actionable health data to drive quality improvements to eliminate health disparities. Based on feedback received from hospitals as well as a re-focus on clinical outcome measures, for which the HCHE measure, as a structural measure, does not directly measure clinical outcomes, the burden of collecting this measure may outweigh the benefits. As stated in section XIII.B.4.d, removal of this measure would alleviate an estimate annual burden of approximately 509 hours, at a cost of $28,188, across all participating IPPS hospitals.

One of the goals of the Hospital IQR Program is to move forward in the least burdensome manner possible, while maintaining a parsimonious set of the most meaningful quality measures and continuing to incentivize improvement in the quality of care provided to patients. Removing this measure from the Hospital IQR Program is an effective way to accomplish this goal. Our priority is a re-focus on measurable clinical outcomes as well as identifying quality measures on topics of prevention, nutrition, and well-being, and as such we refer readers to our request for comment on “Measure Concepts under Consideration for Future Years in the Hospital IQR Program-Request for Information (RFI): Well-Being and Nutrition” in section X.C.2.a. The Hospital IQR Program continues to incentivize the improvement of care quality and health outcomes for all patients through measurement and transparency with other measures. It may be costly for hospitals to continue reporting on the HCHE measure and achieve high performance scores, and removal of this measure would make room both in the program's measure set to enhance the program's focus on measurable clinical

outcomes and for hospital leadership to focus on other priority quality and safety areas. We acknowledge that some hospitals may have expended resources to implement some or all of the activities described in the HCHE measure attestation statements in order to be able to attest “yes” for measure reporting purposes, however, hospitals that had already implemented such activities prior to adoption of the measure would have been able to attest “yes” without expending similar resources.

If finalized, hospitals that do not report their CY 2024 reporting period data for the HCHE measure to CMS would not be considered noncompliant with the measure for purposes of their FY 2026 payment determination (that is, hospitals that do not report CY 2024 reporting period data would not be penalized for FY 2026 payments due to this measure). Any HCHE measure data received by CMS would not be used for public reporting or payment purposes.

If not finalized, hospitals that do not report their CY 2024 reporting data for the HCHE measure to CMS would be considered noncompliant with the measure for their FY 2026 payment determination, and would receive a letter of noncompliance after August 1, 2025, at which time the required 30 day reconsideration period would begin. Payment adjustments would apply to FY 2026 payment determinations fee- for-service claims as previously finalized.

We invited public comment on our proposal to remove the HCHE measure from the Hospital IQR Program beginning with the FY 2026 payment determination.

Comment: Many commenters supported the removal of the HCHE measure, emphasizing concerns about its administrative burden and limited impact on improving patient outcomes, with several commenters questioning the value of structural measures. Commenters stated that the burden outweighs the benefits, highlighting challenges in implementation such as a lack of infrastructure, training, and staff capacity to collect and act on the data meaningfully. Some commenters stated these challenges were particularly acute for small and rural hospitals.

A few commenters supported the removal of the measure, citing the lack of CBE endorsement, measure testing, and validity. Commenters expressed concern about the measure's scoring methodology, specifically the complexity of the reporting requirements and the actionability of the data.

A few commenters supported the removal as part of broader efforts to streamline quality reporting programs and reduce regulatory burden. They agreed that eliminating measures like HCHE would allow hospitals to redirect resources toward higher-priority initiatives and patient care, focusing on more tangible interventions and measurable outcomes rather than attestation-based requirements. A commenter noted that the measure duplicates efforts already met through existing standards, such as The Joint Commission's National Patient Safety Goal NPSG.16.01.01-- Improve Health Care Equity; the commenter encouraged CMS to align measures with existing standards.

Response: We thank the commenters for their support. We agree that the removal of this measure will reduce the administrative burden on hospitals. We note that the HCHE measure went through the rigorous measure development lifecycle outlined at the CMS Measures Management System website \340\ which includes measure testing and reliability analysis. Further, section 1886(b)(3)(B)(viii)(IX)(bb) of the Act permits the Secretary to specify a measure without endorsement if a feasible and practical measure has not been endorsed by the CBE, provided due consideration is given to measures that have been endorsed or adopted by a consensus organization.

\340\ CMS. Blueprint Measure Lifecycle Overview. Available at: https://mmshub.cms.gov/blueprint-measure-lifecycle-overview. Accessed: June 21, 2025.

Comment: A few commenters supported the removal of the measure and stated they remain committed to ensuring quality care for all patients and investing in culturally responsive care models.

Response: We appreciate commenters' support and commitment to maintaining quality care for all patients.

Comment: Many commenters opposed the removal of the HCHE measure, emphasizing its critical role in advancing health equity and addressing disparities in care delivery. Commenters highlighted that the measure provides structured accountability for hospital leadership to prioritize equity work, collect data on social determinants of health, and implement quality improvement initiatives.

Several commenters noted that removing the measure would signal a retreat from CMS's stated goals of reducing disparities and improving care for vulnerable populations, including those with severe mental illness, racial and ethnic minorities, rural populations, those with low socioeconomic status, and dual eligibles. Other commenters stated that removing the HCHE measure contradicts the goals of the Make America Healthy Again initiative.

Response: We acknowledge commenters' concerns. We agree that holding hospitals accountable for high-quality healthcare delivery to all beneficiaries is important and remains a priority for the Hospital IQR Program. We remain focused on identifying measures that balance feasibility, burden, and impact, while aligning with shifting national priorities as the health system continues to evolve. We are identifying ways to reduce provider reporting burden, while continuing to hold hospitals accountable for measurable clinical health outcomes and patient safety. We appreciate the commenters' support for the Make America Healthy Again initiative, and will review suggestions received on the new measure RFI in section XX.X of this final rule as we consider relevant measures to introduce in the future.

Comment: A few commenters stated concern that removal of the measure could result in decreased quality of care, reduce transparency and accountability, and exacerbate gaps in care quality, ultimately resulting in worsened health outcomes and higher costs. Several commenters cited examples of persistent disparities in care, including maternal mortality rates across the population and differences between urban and rural health outcomes. A commenter noted removal of this measure would widen an existing gap between medical and behavioral health institutions, emphasizing that addressing social needs such as food insecurity, housing instability, and transportation barriers is essential for improving health outcomes, particularly chronic diseases, and reducing preventable hospital admissions.

Response: We acknowledge commenters' concerns and encourage hospitals to continue to close identified gaps in patient care. We urge hospitals and health systems to continue to incorporate industry standards that may address challenges that could impact safe high- quality healthcare delivery. Despite removal of these measures, hospitals will still be able to collect data that is important to their patient care initiatives and reflects the unique needs of their specific patient population.

Comment: Several commenters stated that the benefits of this measure, that is reducing the costs associated with health inequities, outweigh CMS's estimated burden of implementing the HCHE measure. A few commenters

stated that structural measures incur a low reporting burden, as hospitals do not incur financial penalties provided they report complete and accurate data. A commenter stated that CMS should prioritize the benefits for Medicare beneficiaries and taxpayers, with burden to providers as a secondary consideration.

Response: We appreciate commenters' input regarding the burden associated with reporting on the HCHE measure. We agree with commenters that the reporting burden associated with structural measures is typically small; however, we believe that costs are multi-faceted and include administrative costs to hospitals, maintaining information collection systems, and analyzing reported data. At this time, we remain focused on identifying outcome measures that balance feasibility, burden, and impact, while aligning with national priorities. We are identifying ways to reduce provider reporting burden, while continuing to hold hospitals accountable for measurable clinical health outcomes and patient safety. We have determined the multi-faceted costs associated with this measure outweigh the benefits of its continued use in the program at this time.

Comment: Several commenters expressed concerns about the proposed effective date for the removal of the HCHE measure, which is the FY 2026 payment determination. Some commenters suggested extending submission deadlines until after the final rule is published or waiving penalties for non-submission of 2024 data to reduce unnecessary burden for hospitals. A few commenters expressed concern about the timing of the removal of the measure, given its recent adoption. Some commenters noted that hospitals have already invested resources in collecting and submitting data for the 2024 reporting year, stating that hospitals should not be penalized for anticipating regulatory requirements and urged CMS to avoid changes applicable to past reporting years in future rulemaking. A commenter expressed concern that the removal of the HCHE measure may discourage future engagement if hospitals feel their prior efforts are rendered obsolete by abrupt shifts in program direction. The commenter requested CMS provide advance notice and justification when removing newly adopted measures and minimize disruptive reversals to foster long-term strategic planning.

Response: We acknowledge commenters' concern regarding the timing around removal of this measure. However, because we have determined that the cost of reporting on this measure outweighs the benefits of retaining it in the program, we are removing this measure at the earliest feasible reporting period so that hospitals will not need to expend additional resources on reporting a measure for which we have determined that the costs outweigh the benefits. Hospitals that do not report their CY 2024 reporting period data for the HCHE measure to CMS will not be considered noncompliant with the measure for purposes of their FY 2026 payment determination (that is, hospitals that do not report CY 2024 reporting period data will not be penalized for FY 2026 payments due to this measure). Any HCHE measure data received by CMS will not be used for public reporting or payment purposes.

Comment: A commenter stated that this proposal is misaligned with the Conditions of Participation (CoPs) at 42 CFR 482.21(b)(4), which require hospitals to measure quality indicators on patient outcomes and address disparities in processes of care, services, and operations. The commenter requested that CMS clarify how hospitals continuing to collect SDOH data voluntarily, consistent with Domain 3 of the HCHE measure, will be evaluated and ensure that regulatory expectations across programs are aligned to avoid confusion and conflict.

Response: While both the Hospital IQR Program and the Quality Assessment and Performance Improvement (QAPI) Program require hospitals to report performance data; they are separate programs. The Hospital IQR Program measures the quality of hospital inpatient services while QAPI is a comprehensive intra-facility approach for quality improvement. QAPI allows hospitals to choose which topics and data analysis methods to use in meeting these standards so that their QAPI programs may be tailored to their unique patient populations and facility needs. Hospitals have the flexibility to develop their own quality initiatives/projects or join other local/state/federal quality efforts as part of their QAPI program; as such, facilities may choose to use their Hospital IQR Program data in their QAPI program. We regularly update Hospital IQR Program requirements without interfering with QAPI; hospitals must still comply with the requirement at Sec. 482.21(b)(4) independent of the change removing the measure. If a hospital chooses to use data from the measure in their QAPI program, they may continue to collect that data at their own discretion. The removal of this measure does not have an impact on other quality programs or initiatives in which the hospital may participate or other mandated requirements.

Comment: Many commenters recommended refining the HCHE measure rather than removing it entirely. They suggested modifications to reduce the administrative burden while preserving the measure's intent and improving value. Commenters proposed adjustments to scoring methodologies, reporting frequency, or voluntary submission to make the measure more feasible for hospitals to implement. A few commenters encouraged CMS to explore alternative mechanisms for tracking equity- related efforts and integrating social needs into care delivery, such as voluntary documentation of Z-codes.

Response: We thank the commenters for their recommendations and will consider them as we evaluate any potential future measures in this subject. We are identifying ways to reduce provider reporting burden, while holding hospitals accountable for measurable clinical outcomes and patient safety. Hospitals are encouraged to continue to engage in activities to close gaps in care and collect data that is important to their patient care initiatives and reflect the needs of their patient population regardless of whether it is required for the Hospital IQR Program.

After consideration of the public comments we received, we are finalizing our proposal to remove the HCHE measure from the Hospital IQR Program beginning with the FY 2026 payment determination. b. Removal of the COVID-19 Vaccination Coverage Among Healthcare Personnel Measure Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination

We refer readers to the FY 2022 IPPS/LTCH PPS final rule where we adopted the COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) measure (hereafter referred to as HCP COVID-19 Vaccination measure) into the Hospital IQR Program (86 FR 45374 through 45382) and the FY 2024 IPPS/LTCH PPS final rule where we modified the HCP COVID-19 Vaccination measure to account for updated vaccine guidance (88 FR 59137 through 59144).

In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18336 through 18337), we proposed to remove the HCP COVID-19 Vaccination measure beginning with the CY 2024 reporting period/FY 2026 payment determination under removal Factor 8, the costs associated with a measure outweigh the benefit of its continued use in the

program. We noted that reporting on this measure currently requires reporting data on COVID-19 vaccination coverage among HCP for at least 1 week every month. This requires hospitals to track current vaccination status for all employees, licensed independent practitioners, adult students/trainers and volunteers and other contract personnel and log in to the National Healthcare Safety Network (NHSN) system to report the data monthly either manually in NHSN or by uploading a comma-separated value (CSV) file (86 FR 45377). The estimated burden of collecting this information annually across all 3,050 hospitals is between $1,378,600 and $1,608,570 annually. We refer readers to section XIII.B.4.e. of this final rule for more details on this estimated burden calculation.

When we first adopted the HCP COVID-19 Vaccination measure, the U.S. was in a PHE with millions of cases and over 550,000 COVID-19 deaths (86 FR 45374). While preventing the spread of COVID-19 remains a public health goal, the PHE ended on May 11, 2023.\341\ In addition, the number of deaths due to COVID-19 in the U.S. has decreased since the adoption of this measure. In March 2021, when this measure was being proposed, the United States was averaging over 5,000 deaths per week. In April 2023, the last full month of the PHE, weekly number of deaths due to COVID-19 averaged around 1,300.\342\ With the end of the PHE and the decrease in COVID-19 deaths, we believe the continued costs and burden to providers of tracking and monthly reporting on this measure outweigh the benefit of continued information collection on COVID-19 vaccination coverage among HCP. As it may be costly for hospitals to continue to report on the HCP COVID-19 Vaccination measure, removal of this measure would allow for the Hospital IQR Program to focus on goals such as clinical outcomes.

\341\ https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.

\342\ Provisional COVID-19 Deaths, by Week, in The United States, Reported to CDC. Available at: https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00. Accessed: March 27, 2025.

If finalized, hospitals that do not report their CY 2024 reporting period data for the HCP COVID-19 Vaccination measure to CMS would not be considered noncompliant with the measures for purposes of their FY 2026 payment determination (that is, hospitals that do not report CY 2024 reporting period data would not be penalized for FY 2026 payments due to this measure). Any HCP COVID-19 Vaccination measure data received by CMS would not be used for public reporting or payment purposes.

If not finalized, hospitals that do not report their CY 2024 reporting data for the HCP COVID-19 Vaccination measure to CMS would be considered noncompliant with the measure for their FY 2026 payment determination, and would receive a letter of noncompliance after August 1, 2025, at which time the required 30 day reconsideration period would begin. Payment adjustments would apply to FY 2026 payment determinations fee-for-service claims as previously finalized.

We invited public comment on our proposal to remove the HCP COVID- 19 Vaccination measure from the Hospital IQR Program beginning with the FY 2026 payment determination.

Comment: Many commenters supported the removal of the HCP COVID-19 Vaccination measure and agreed the burden imposed by tracking COVID-19 vaccination among healthcare personnel outweighs the benefits of its continued use in the Hospital IQR Program. Many commenters supported removal of this measure because it is labor-intensive, particularly due to changing vaccination definitions, and requires significant staff time and resources that are diverted from other clinical priorities. Many commenters agreed that this measure no longer aligns with an urgent public health priority or provides meaningful or actionable data for quality improvement. Commenters supported removal of this measure noting it has become outdated, especially since the COVID-19 PHE declaration ended in May 2023.

Response: We thank commenters for their support.

Comment: Several commenters did not support the removal of this measure, emphasizing that tracking COVID-19 vaccination coverage among healthcare personnel is essential for infection prevention and control in healthcare settings. Commenters expressed concern that removing this measure could lead to decreased vaccination rates among healthcare personnel, thereby increasing the risk of hospital-acquired infections and compromising patient safety for vulnerable patient populations, such as those who are immunocompromised, undergoing cancer treatment, or pregnant. Several commenters highlighted that vaccination is a critical strategy to minimize preventable harm and maintain safe healthcare environments. A few commenters did not support the removal of this measure because it would contradict the healthcare industry's obligation to uphold high standards of care and infection prevention.

A few commenters did not agree with removing this measure because they stated this measure is important for maintaining vaccination data for public health surveillance. Commenters noted that systematic reporting of healthcare personnel vaccination rates is essential for monitoring and responding to future infectious disease outbreaks. Some commenters were concerned that removing this measure could hinder institutional accountability and reduce attention to vaccination programs, potentially compromising healthcare system resilience.

Response: We acknowledge commenter concerns about patient safety, protecting vulnerable populations, and maintaining public health surveillance and readiness. We agree that patient safety practices and high-quality healthcare for all patients is a priority, and we expect participating hospitals to support safe practices that protect patients from infections and other preventable harms. The removal of the HCP COVID-19 Vaccination measure is not intended to interfere with infection control practices, but rather to balance the associated tracking and reporting burden against the benefit of collecting this data now that the PHE has ended.

Comment: A few commenters did not agree with removing the HCP COVID-19 Vaccination measure based on their assertion that it undermines efforts to address health equity and persistent disparities in healthcare outcomes. Commenters noted that vulnerable populations, including racial and ethnic minorities, rural communities, economically disadvantaged groups, and pregnant women, remain disproportionately affected by infectious diseases like COVID-19. Commenters recommended retaining the HCP COVID-19 Vaccination measure or delaying its removal until alternative indicators are developed to ensure continuity in health equity monitoring.

Response: We acknowledge commenters' concerns about protecting vulnerable populations. We reiterate that preventing the spread of COVID-19 remains a public health goal and that the removal of the HCP COVID-19 Vaccination measure is not intended to place vulnerable populations at higher risk, but rather to alleviate the associated tracking and reporting burden now that the PHE has expired. We note that this measure was not proposed for removal from certain quality programs, such as PCHQR, that focus on care settings for especially vulnerable patients. We expect all

hospitals to continue to strive toward the highest quality of care for all patients.

Comment: A few commenters did not agree with removing this measure, asserting that the benefits of tracking vaccination coverage outweigh the costs. Commenters stated that this measure is important for transparency and promotes vaccine uptake. Commenters expressed concern that removing the measure could lead to gaps in accountability and preparedness, ultimately resulting in higher costs associated with preventable infections.

Response: We acknowledge commenters' concerns. We note that hospitals are not restricted from tracking HCP vaccinations that are appropriate for the setting of care and the population served. The removal of the HCP COVID-19 Vaccination measure is intended to alleviate the burden associated with data collection and reporting on a monthly cadence.

Comment: A few commenters expressed concerns about the proposed applicability date of the removal of the HCP COVID-19 Vaccination measure which is the FY 2026 payment determination. Commenters noted this creates confusion and burden among hospitals and that hospitals have already invested significant resources to complete the process of submitting CY 2024 quality data. Commenters recommended avoiding proposing to remove measures applicable to past reporting periods, especially for relatively new measures.

Response: We understand commenters' concern regarding the timing around removal of these measures and the confusion and burden this may impose on hospitals who have already submitted CY 2024 quality data. However, because we have determined that the cost of reporting on these measures outweighs the benefits of retaining them in the program, it would place an undue burden on hospitals to continue requiring reporting on these measures for an additional year. We note that hospitals that do not report their CY 2024 reporting period data for the HCP COVID-19 Vaccination measure to CMS will not be considered noncompliant with the measure for purposes of their FY 2026 payment determination (that is, hospitals that do not report CY 2024 reporting period data will not be penalized for FY 2026 payments due to this measure). Any HCP COVID-19 Vaccination measure data received by CMS will not be used for public reporting or payment purposes.

After consideration of public comments we received, we are finalizing our proposal to remove the HCP COVID-19 Vaccination measure beginning with the FY 2026 payment determination. c. Removal of Two Social Drivers of Health Measures Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination

In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18337), we proposed to remove two social drivers of health (SDOH) process measures from the Hospital IQR Program beginning with the FY 2026 payment determination: Screening for Social Drivers of Health (SDOH-1) measure (adopted at 87 FR 49201 through 49215); and Screen Positive Rate for Social Drivers of Health (SDOH-2) measure (adopted at 87 FR 49215 through 49220).

As discussed in the proposed rule, we proposed to remove the SDOH measures beginning with the FY 2026 payment determination under removal Factor 8, the costs associated with the measure outweigh the benefit of its continued use in the program (90 FR 18337). We have previously heard from some hospitals concerned with the costs and resources associated with screening patients via manual processes, manually storing such data, training hospital staff, and altering workflows for these measures. As stated in section XIII.B.4.f., removal of SDOH-1 would alleviate an estimated annual burden for hospitals and patients of 626,009 hours, at a cost of $16,059,753, across all participating IPPS hospitals (90 FR 18409). Also, as stated in section XIII.B.4.g., removal of SDOH-2 would alleviate an estimated annual burden of 509 hours, at a cost of $28,188, across all participating IPPS hospitals (90 FR 18409). Further, we noted (90 FR 18337) that these measures document an administrative process and report aggregate level results, and do not measure the extent to which providers are ultimately connecting patients with resources or services and whether patients are benefiting from these screenings. We stated that the costs of the use of these measures in the Hospital IQR Program outweigh the benefits to providers and patients. Removal of these measures would alleviate the burden on hospitals to manually screen each patient and submit data each reporting cycle, allowing hospitals to focus resources on measurable clinical outcomes. This will also remove the patient burden associated with repeated SDOH screenings across multiple healthcare facilities. We acknowledge that some hospitals may have expended resources to implement SDOH screenings, however, hospitals that had already implemented such screenings prior to adoption of the measures would not have expended similar resources. The objectives of the Hospital IQR Program continue to incentivize the improvement of care quality and health outcomes for all patients through transparency and use of appropriate quality measures.

We stated in the proposed rule (90 FR 18337) that, if finalized, hospitals that do not report to CMS their CY 2024 reporting period data for the SDOH measures would not be considered noncompliant with the measures for purposes of their FY 2026 payment determination (that is, hospitals that do not report CY 2024 reporting period data would not be penalized for FY 2026 payments due to this measure), as well as that any SDOH measure data received by CMS would not be used for public reporting or payment purposes.

We additionally stated that, if not finalized, hospitals that do not report their CY 2024 reporting data for the SDOH measures to CMS would be considered noncompliant with the measures for their FY 2026 payment determination, and would receive a letter of noncompliance after August 1, 2025, at which time the required 30 day reconsideration period would begin. Payment adjustments would apply to FY 2026 payment determinations fee-for-service claims as previously finalized.

We invited public comment on our proposal to remove the SDOH measures from the Hospital IQR Program beginning with the FY 2026 payment determination.

Comment: Many commenters were supportive of removing these measures and emphasized that the measures require significant resources for data collection, which could distract hospitals from focusing on direct patient outcomes and other quality improvement initiatives. Several commenters supported the measures' removal because the measures do not show whether hospitals are addressing the specific risk factors impacting patients in response to screenings.

Response: We thank the commenters for their support.

Comment: A few commenters supported removal due to concerns about a lack of testing and the measures' scoring reliability, or that the measures have not been endorsed by the CBE.

Response: We thank the commenters for their insights. We note that the two SDOH measures went through the

rigorous measure development lifecycle outlined at the CMS Measures Management System website \343\ which includes measure testing and reliability analysis. Further, section 1886(b)(3)(B)(viii)(IX)(bb) of the act permits the Secretary to specify a measure without endorsement if a feasible and practical measure has not been endorsed by the CBE, provided due consideration is given to measures that have been endorsed or adopted by a consensus organization.

\343\ CMS. Blueprint Measure Lifecycle Overview. Available at: https://mmshub.cms.gov/blueprint-measure-lifecycle-overview. Accessed: June 21, 2025.

Comment: Many commenters did not support CMS's proposal to remove the two SDOH measures from the Hospital IQR Program. Many commenters described how SDOH significantly impacts health outcomes and the types of care and services patients may require in the hospital. These commenters stated that screening for SDOH is fundamental to patient- centered care, including clinical outcomes, treatment adherence, and reducing preventable healthcare utilization (for example, emergency department visits and readmissions).

Response: Removal of these measures from the Hospital IQR Program does not prevent hospitals from measuring and addressing patients' social needs, as clinically appropriate. Further, these SDOH measures are only reported in the aggregate and do not measure the extent to which providers are ultimately connecting patients with resources or services and whether patients are benefiting from these screenings.

Comment: Many commenters disagreed that the SDOH measures' removal would reduce burden. Many commenters also highlighted the ultimate cost savings arising from SDOH screening, through improved chronic disease management and prevention of avoidable hospitalizations. Commenters also noted that hospitals have already incurred the cost to set up the systems to collect these data, and that removal now would have minor impacts on costs. Several commenters stated that eliminating these measures without a transition plan could disrupt established care practices, undermine quality, and present ethical challenges.

Response: We are removing these measures from the Hospital IQR Program to reduce the burden incurred by patients and providers for screening, data storage, and data reporting. Removal of these measures does not prevent hospitals from measuring and addressing patients' social needs as is clinically appropriate. We acknowledge that hospitals may have expended resources to implement SDOH screenings, however, removing these measures at this time will alleviate additional burden with regard to data collection and submission requirements, especially with screening patients via manual processes and other manual collection and data storage mechanisms.

Comment: Several commenters recommended against removing measures for the FY 2026 payment determination because hospitals must proceed with collecting data for CY 2024, or else face penalties if the measures are not removed.

Response: We understand commenters' concern regarding the timing around removal of these measures. These measures are being removed on this timeline to maximize the alleviation of burden on patients and providers, rather than continuing to require collection and reporting of measures whose benefit has been determined to be outweighed by the cost and burden of implementation at this time which includes operational cost and IT infrastructure. Hospitals that do not report to CMS their CY 2024 reporting period data for the SDOH measures will not be considered noncompliant with the measures for purposes of their FY 2026 payment determination (that is, hospitals that do not report CY 2024 reporting period data will not be penalized for FY 2026 payments due to this measure), and any SDOH measure data received by CMS will not be used for public reporting or payment purposes

Comment: Several commenters suggested that CMS retain these measures and improve data collection and interoperability to address hospital concerns about burden. Several commenters requested that CMS allow for voluntary reporting of the SDOH measures or pause the measures to avoid disrupting ongoing efforts to collect social risk data. A few commenters expressed the importance of identifying and documenting Z codes and noted the importance of SDOH-related screening for capturing applicable Z codes. A commenter suggested stratifying performance reports based on SDOH-associated ICD-10 diagnoses.

A few commenters recommended maintaining the current SDOH measures and developing an additional measure to encourage hospitals to connect patients to community resources. As an example, some commenters specifically identified the National Committee for Quality Assurance's (NCQA's) Healthcare Effectiveness Data and Information Set (HEDIS) Social Needs Screening and Interventions (SNS-E) measure. Some commenters requested that CMS help hospitals connect patients with social needs to resources and community-based organizations in order to link SDOH screening with patient outcomes.

Response: We appreciate the commenters' concerns and feedback regarding the importance of collecting SDOH data from patients and acknowledge that some patients may face challenges following discharge that may be related to SDOH. We recognize that some clinicians may find value in obtaining SDOH information as part of clinical decision making, such as discharge planning and patient care, and acknowledge feedback from some commenters stating that they value collection of this information. We agree that healthcare outcomes may be different for those experiencing unstable housing or food insecurity. Hospitals may find ways to address these concerns in their workflow because they recognize the importance of these items and the removal of this requirement should not, in any way, preclude hospitals from collecting and using this information.

Comment: Many commenters stated that the SDOH measures align with CMS's broader goals, including ensuring high-quality healthcare for all patients and implementing the Make America Healthy Again initiative. In response to the request for comment, “Measure Concepts under Consideration for Future Years in the Hospital IQR Program--Request for Information (RFI): Well-Being and Nutrition,” several commenters urged CMS to keep the SDOH measures and invest resources into improving the applicability and actionability of these measures as a way to improve well-being and nutrition.

Response: We appreciate commenters' support for the goals of the Make America Healthy Again initiative and the constructive role that quality measures can play in ensuring quality healthcare for all. Because we have determined that the cost of reporting on these measures outweighs the benefits of retaining them in the program, it would place an undue burden on hospitals to require reporting on these measures as we explore alternative approaches to implementing measures related to well-being and nutrition. We will consider the feedback commenters provided in future policymaking.

Comment: A commenter stated that this proposal is misaligned with the Conditions of Participation (CoPs) at 42 CFR 482.21(b)(4), which require hospitals to measure quality indicators

on patient outcomes and address disparities in processes of care, services and operations. The commenter requested that CMS clarify how hospitals continuing to collect SDOH data voluntarily will be evaluated and ensure that regulatory expectations across programs are aligned to avoid confusion and conflict.

Response: While both the Hospital IQR Program and the Quality Assessment and Performance Improvement Program (QAPI) require hospitals to report performance data; they are separate programs. The Hospital IQR Program measures the quality of hospital inpatient services while QAPI is a comprehensive intra-facility approach for quality improvement. QAPI allow hospitals to choose which topics and data analysis methods to use in meeting these standards so that their QAPI programs may be tailored to their unique patient populations and facility needs. Hospitals have the flexibility to develop their own quality initiatives/projects or join other local/state/federal quality efforts as part of their QAPI program; as such, facilities may choose to use their Hospital IQR Program data in their QAPI program. We regularly update the Hospital IQR Program requirements without interfering with QAPI; hospitals must still comply with the requirement at 482.21(b)(4) independent of the changes removing the measures. If a hospital chooses to use data from these measures in their QAPI program, they may continue to collect that data at their own discretion. The removal of this measure does not have an impact on other quality programs or initiatives in which the hospital may participate or other mandated requirements.

After consideration of the comments we received, we are finalizing our proposal to remove the Screening for Social Drivers of Health and Screen Positive Rate for Social Drivers of Health measures beginning with the FY 2026 payment determination. 5. Technical Updates to the Specifications of the Hospital IQR Program Measures Beginning With the FY 2027 Program Year To Include Patients Diagnosed With COVID-19

We notified the public of our intent to apply a technical update to remove the COVID-19 exclusion from all of the following Hospital IQR Program measures:

MORT-30-STK, most recently discussed in the FY 2014 IPPS/ LTCH PPS final rule (78 FR 50798 through 50802) and modified in this final rule.

COMP-HIP-KNEE, most recently discussed in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49263 through 49267) and modified in this final rule.

Excess Days in Acute Care after Hospitalization for Acute Myocardial Infarction (AMI Excess Days), most recently modified in the FY 2023 IPPS/LTCH PPS final rule (87 FR 49269 through 49272).

Excess Days in Acute Care after Hospitalization for Heart Failure (HF Excess Days), most recently discussed in the FY 2016 IPPS/ LTCH PPS final rule (80 FR 49682 through 49690).

Excess Days in Acute Care after Hospitalization for Pneumonia (PN Excess Days), most recently discussed in the FY 2017 IPPS/LTCH PPS final rule (81 FR 57142 through 57148).

Hybrid Hospital-Wide All-Cause Readmission Measure (HWR), most recently modified in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59165 through 59168), updated in the CY 2025 OPPS/ASC final rule (89 FR 94495 through 94499), and modified in this final rule.

Hybrid Hospital-Wide All-Cause Risk Standardized Mortality Measure (HWM), most recently modified in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59161 through 59165) and modified in this final rule.

During the COVID-19 PHE, we updated the measures listed previously to exclude patients diagnosed with COVID-19, including a primary or secondary diagnosis present on admission of COVID-19, from both the index admissions and readmissions. We stated that we were making these updates pursuant to the technical updates policy finalized in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53504 through 53505). Under this policy, we finalized a subregulatory process to make nonsubstantive updates to measures used for the Hospital IQR Program (77 FR 53504 through 53505). We reiterated this policy in the FY 2020 IPPS/LTCH PPS final rule, for the Hospital Readmissions Reduction Program, stating our position that the subregulatory process is the most expeditious manner possible to ensure that quality measures remain fully up to date while preserving the public's ability to comment on updates that so fundamentally change a measure that it is no longer the same measure that we originally adopted (84 FR 42385 through 42387).

We are providing notice in this final rule that we intend to remove the COVID-19 exclusion from the measures listed previously beginning with the FY 2027 program year. The exclusion began as a response to the COVID-19 PHE which expired May 11, 2023. This technical update will modify these measures to remove the exclusion of COVID-19 diagnosed patients from the index admissions and readmissions, including the removal of the exclusion of certain ICD-10 codes that represented patients with a secondary diagnosis of COVID-19, and the history of COVID-19 risk variable. Given the PHE expired approximately 2 years ago, hospitals have had adequate time to adjust to the presence of COVID-19 as an ongoing virus. Using data from the last 4 years, July 2020-June 2024, our internal analysis showed a decline of the number of patients excluded from the various measure cohorts. Therefore, removing the exclusion of COVID-19 patients will ensure that these measures continue to account for outcomes as intended and meet the goals of the Hospital IQR Program to promote quality care for all.

Technical specifications for all of the Hospital IQR Program measures, as well as additional resources, can be found on the QualityNet website (available at: https://qualitynet.cms.gov/inpatient/iqr).

Comment: Several commenters supported removing the COVID-19 exclusion from quality measures in the Hospital IQR Program and agreed that it is reasonable to treat COVID-19 like other comorbid conditions since the PHE ended over two years ago. A few commenters agreed that hospitals have improved treatments and infection control, making the exclusion unnecessary. One commenter recommended the importance of flexibility, urging CMS to remain vigilant and prepared to reinstate the exclusion if needed.

Response: We thank the commenters for their support.

Comment: A few commenters were concerned with removing the exclusion and recommended delaying public reporting until hospitals have had sufficient time to assess the data and address any discrepancies or concerns. One commenter recommended additional analysis before removing the exclusion from these measures to provide an accurate reflection of hospital quality.

Response: We acknowledge commenter concerns about having sufficient time to address discrepancies in data prior to public reporting. We note that our internal analysis using data from July 2021-June 2024, 371 admissions out of 261,616 admissions (0.14 percent) were excluded for a COVID-19 diagnosis, also showing a decline in the number of patients excluded from the various measure cohorts. We wish to reiterate that removing the exclusion of COVID-19

patients is intended to ensure that these measures continue to account for outcomes as intended and to meet the goals of the Hospital IQR Program. As a part of our routine monitoring and evaluation of measures we will continue to watch for any unintended consequences of this change and be prepared to make updates as necessary.

We will implement these technical updates as outlined in the proposed rule. 6. Summary of Previously Finalized and Newly Modified Hospital IQR Program Measures a. Summary of Hospital IQR Program Measures for the FY 2027 Payment Determination

This table summarizes the newly modified and previously finalized Hospital IQR Program measure set for the FY 2027 payment determination: BILLING CODE 4120-01-P

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