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 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 minimu A 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 ation 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. We agree that transparency is important for both beneficiaries and 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. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00472 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00473 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00473 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37008 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 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 ces 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- ev 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). Comment: Several commenters were concerned with the notice of the technical update to remove COVID–19 exclusions, citing the ongoing clinical 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. 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 COVI at 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, 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 als 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 he 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 t m–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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00474 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37009 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 bee station 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 r ay 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 out 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 permi 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. 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 fro p 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 340 CMS. Blueprint Measure Lifecycle Overview. Available at: https://mmshub.cms.gov/blueprint- measure-lifecycle-overview. Accessed: June 21, 2025. 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 hospit den, 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 esse uld 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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00475 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k re. A few commenters VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00475 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37010 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 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 burde ime, 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 ng 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 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 a o 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 § 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 mea nt 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 hem 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 erred 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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00476 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37011 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 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 a n 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. 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 341 https://www.hhs.gov/coronavirus/covid-19- public-health-emergency/index.ht a would not be penalized for FY 2026 payments due to this measure). Any HCP COVID–19 Vaccination measure data received by 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. 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 b cination 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 r easure, 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 th ommenters 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 dispar 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 pat ting 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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00477 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37012 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 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. ctions. 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 ay 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 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, acr 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 a le, 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 yments 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 i her 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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00478 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37013 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 consider ection 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. 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 easures 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 343 CMS. Blueprint Measure Lifecycle Overview. Available at: https://mmshub.cms.gov/blu Removal of these measures does not prevent hospitals from measuring and addressing patients’ social needs as is 343 CMS. Blueprint Measure Lifecycle Overview. Available at: https://mmshub.cms.gov/blueprint- measure-lifecycle-overview. Accessed: June 21, 2025. 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 an o 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 f 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 obt ce 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 m 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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00479 Fmt 4701 Sfmt 4700 E:\ onditions of Participation (CoPs) at 42 CFR 482.21(b)(4), which require hospitals to measure quality indicators VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00479 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37014 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 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 uniq lity 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 measure ents. 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 CH 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 F ary 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 exclusi iously 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 sup 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 he 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 VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00480 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37015 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 t 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 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00481 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 37016 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00482 Fmt 4701 Sfmt 4725 E:\FR\FM\04AUR2.SGM 04AUR2 / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00483 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 37018 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 2 S H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00483 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 37018 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00484 Fmt 4701 Sfmt 4725 E:\FR\FM\04AUR2.SGM 04AUR2 / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00485 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 37020 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00486 Fmt 4701 Sfmt 4725 E:\FR\FM\04AUR2.SGM 04AUR2 / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00487 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00488 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 3 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37023 basis, or if it must be the same elements missing across all patients for the allowance to apply. Response: We wish to clarify that the allowance of missing data applies to CCDEs only, specifically up to two missing lab values and two missing vital signs. This missing data allowance applies per patient on an individual basis. We refer readers to the eCQI Resource Center for more details on the measure specifications.350 351 Comment: A commenter requested clarification on whether the reporting period of July 1, 2024 through June 30, 2025 included the addition of MA patients as finalized in the FY 2024 IPPS/LTCH PPS final rule. Response: We wish to clarify that the July 1, 2024 through June 30, 2025 performance period impacting the FY 2027 payment determination did include MA patients as finalized in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59161 through 59168). We refer readers to the eCQI Resource Center for more details on the 2024 reporting period measure specifications.352 3 s finalized in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59161 through 59168). We refer readers to the eCQI Resource Center for more details on the 2024 reporting period measure specifications.352 353 Comment: A few commenters recommended CMS lower the threshold even further, such as 60 percent, to alleviate reporting burdens and encourage broader participation. A commenter recommended allowing an additional missing lab value for a total of three to better align with clinical workflows. A commenter urged CMS to eliminate the linking variable and CCDE threshold requirements altogether. Response: We thank the commenters for their recommendations. We selected the 70 percent threshold and the allowance of two missing lab values and two missing vital signs to maintain statistical validity, while providing opportunity for more successful submissions for more hospitals, based on the results of an internal analysis. Results show that the majority of hospitals can meet the 70 percent threshold, which was selected to retain 350 eCQI Resource Center. May 2025. Core Clinical Data Elements for the Hybrid Hospital- Wide Readmission Measure with Claims and Electronic Health Record Data—HWR. Ava d, which was selected to retain 350 eCQI Resource Center. May 2025. Core Clinical Data Elements for the Hybrid Hospital- Wide Readmission Measure with Claims and Electronic Health Record Data—HWR. Available at: https://ecqi.healthit.gov/ecqm/hosp-inpt/2026/ cms0529v6?qt-tabs_measure=specifications-and- data-elements. 351 eCQI Resource Center. May 2025. Core Clinical Data Elements for the Hybrid Hospital- Wide All-Condition All-Procedure Risk- Standardized Mortality Measure—HWM. Available at: https://ecqi.healthit.gov/ecqm/hosp-inpt/2026/ cms0844v6?qt-tabs_measure=specifications-and- data-elements. the integrity of the data for statistical calculation amongst missing data.354 Comment: Commenters urged CMS to continue monitoring hospital experiences with reporting on these measures by reviewing performance data, particularly under the new proposed thresholds, and work with hospitals and stakeholders to refine the measure specifications and adjust voluntary reporting as necessary. A commenter noted that the internal analysis performed by CMS suggested an improved ability to meet the proposed measure reporting thresholds but emphasized that hospitals participating in voluntary reportin nter noted that the internal analysis performed by CMS suggested an improved ability to meet the proposed measure reporting thresholds but emphasized that hospitals participating in voluntary reporting are likely those with more resources. A few commenters specifically suggested examining the impacts of the thresholds on small and rural hospitals and urged CMS to consider the lack of bed availability at skilled nursing facilities. Response: We remain committed to monitoring hospital experiences on reporting the hybrid measures, particularly for small and rural hospitals and for hospitals/facilities with fewer resources, and working with stakeholders toward future measure refinement and improvement. Comment: Many commenters raised concerns about the feasibility of mandatory reporting for the Hybrid Hospital-Wide Readmission (HWR) and Mortality (HWM) measures. Many commenters emphasized the need for CMS to address multiple technical and data processing issues before transitioning to mandatory reporting. A few commenters urged CMS to conduct further analysis and testing to ensure the measures are clinically valid and equitable before making them mandatory, particularly under the new r atory reporting. A few commenters urged CMS to conduct further analysis and testing to ensure the measures are clinically valid and equitable before making them mandatory, particularly under the new reporting thresholds. Many commenters recommended extending voluntary reporting for at least one or two additional years to allow hospitals to address operational challenges, refine workflows, and ensure accurate data submission. Response: We appreciate the commenters raising their concerns about mandatory reporting. In the CY 2025 OPPS/ASC final rule (89 FR 94495 through 94499), we addressed several technical and data processing issues in response to feedback we received from hospitals from the 2024 Voluntary Reporting period. After conducting an internal analysis on hospitals’ submission data from this reporting 352 eCQI Resource Center. May 2025. Hybrid HWR Measure Information. Available at: https:// ecqi.healthit.gov/ecqm/hosp-inpt/2024/cms0529v4. 353 eCQI Resource Center. May 2025. Hybrid HWM Measure Information. Available at: https:// ecqi.healthit.gov/ecqm/hosp-inpt/2024/cms0844v4. 354 Jakobsen, J.C., Gluud, C., Wetterslev, J. et al. When and how should multiple imputation be use rid HWM Measure Information. Available at: https:// ecqi.healthit.gov/ecqm/hosp-inpt/2024/cms0844v4. 354 Jakobsen, J.C., Gluud, C., Wetterslev, J. et al. When and how should multiple imputation be used for handling missing data in randomised clinical trials—a practical guide with flowcharts. BMC Med Res Methodol 17, 162 (2017). https://doi.org/ 10.1186/s12874-017-0442-1 period, we extended voluntary reporting for an additional two years to allow hospitals more time to address any technical issues, with mandatory reporting beginning with the FY 2028 payment determination (89 FR 94499). We refer readers to the CY 2025 OPPS/ ASC final rule (89 FR 94495 through 94499) for further details and a discussion surrounding the challenges faced by hospitals, as well as our corresponding updates to the measures. Our proposal to lower the thresholds to 70 percent and allow up to two missing lab values and two missing vital signs will provide hospitals with even greater flexibility to continue to address operational challenges and refine workflows as mandatory reporting approaches. We remain committed to monitoring hospitals’ ability to report on these measures and will work with stakeholders to ress operational challenges and refine workflows as mandatory reporting approaches. We remain committed to monitoring hospitals’ ability to report on these measures and will work with stakeholders to make any necessary measure refinements in the future. Comment: A few commenters highlighted delays and inaccuracies regarding the calculation of CCDE values in the CMS feedback reports. A commenter acknowledged the ‘‘Update to Hospital-Specific Reports for Hybrid HWR and HWM Measures’’ that CMS released on June 2, 2025, but expressed concern that they would not receive the corrected results until well after the next filing deadline. Response: As we stated in our Update to Hospital-Specific Reports for Hybrid HWR and HWM Measures,355 there was an issue impacting the reports released on May 14, 2025 that marked CCDE values as missing for excluded patients even though they were correctly submitted. This resulted in incorrect percentages of successfully linked vital signs and lab test results to be calculated and displayed on the Hospital-Specific Reports. We would like to notify commenters that as of June 9, 2025, the updated Hospital-Specific Reports with the corrected CCDE values and pe to be calculated and displayed on the Hospital-Specific Reports. We would like to notify commenters that as of June 9, 2025, the updated Hospital-Specific Reports with the corrected CCDE values and percentages are now available on the Measure Details Dashboard in the Hospital Quality Reporting (HQR) System.356 Comment: A few commenters suggested that CMS provide more robust support, such as more comprehensible hospital-specific reports, technical 355 CMS. June 2025. Update to Hospital-Specific Reports for Hybrid HWR and HWM Measures. Available at: https://www.qualityreporting center.com/globalassets/listserves/2025/iqr/2025- 57-ip_listserve_update-to-hsrs-for-hybrid-hwr-and- hwm-measures_06022025_vfinal-508.pdf. 356 eCQI Resource Center. (June 2025). Updated Hospital-Specific Reports for Hybrid HWR and HWM Measures Now Available. Available at: https://ecqi.healthit.gov/updated-hospital-specific- reports-hybrid-hwr-and-hwm-measures-now- available. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00489 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37024 Federal Register / Vol. 90, No. 147 / Monday, August 265001 PO 00000 Frm 00489 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37024 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations guidance, and dedicated office hours for questions. Response: We wish to note there are several additional ways for hospitals and EHR vendors to receive technical assistance to support implementation of these measures, which include CCSQ Support Central 357 and ONC JIRA.358 Additional resources about the hybrid measures, including fact sheets, frequently asked questions, and webinar recordings, are available on our QualityNet website at: https:// qualitynet.cms.gov/inpatient/measures/ hybrid/resources. We will continue to identify opportunities to improve our responsiveness and the quality of available technical assistance. Comment: A few commenters noted a lack of transparency regarding the discussion surrounding challenges and outcomes experienced by hospitals during the voluntary submission period for discharges in 2024 Voluntary Reporting. A commenter requested public release of this information before making reporting mandatory to allow hospitals th tals during the voluntary submission period for discharges in 2024 Voluntary Reporting. A commenter requested public release of this information before making reporting mandatory to allow hospitals the chance to learn from the data that resulted from this reporting period. Response: We received feedback directly from hospitals via email and help desk questions, in addition to soliciting public comment on the CY 2025 OPPS/ASC proposed rule (89 FR 59502) regarding challenges faced by hospitals when reporting on these measures. We refer the commenter to the CY 2025 OPPS/ASC final rule (89 FR 94495 through 94499) for further details and a discussion surrounding the challenges faced by hospitals, as well as our corresponding updates to the measures. In addition, we will continue to provide hospital-specific reports to allow hospitals to learn from the data resulting from the prior reporting period. Comment: A few commenters suggested that, if CMS retains the hybrid measures as mandatory for FY 2028, CMS should remove any completeness thresholds, until it can perform a thorough analysis of submissions during the voluntary period. A commenter recommended that CMS maintain the mandatory re FY 2028, CMS should remove any completeness thresholds, until it can perform a thorough analysis of submissions during the voluntary period. A commenter recommended that CMS maintain the mandatory reporting requirement, while postponing the requirement to meet the data completeness thresholds until reporting and measure definition issues with the inclusion of MA patients are resolved. A few commenters suggested postponing mandatory reporting until hospitals achieve a threshold of 90 357 Available at: https://cmsqualitysupport. servicenowservices.com/ccsq_support_central. 358 Available at: https://oncprojectracking. healthit.gov/olp/. percent, as commenters were concerned with the validity of a 70 percent threshold. A commenter recommended CMS allow hospitals to submit data using the 70 percent threshold for internal feedback and data analysis only but avoid any payment update penalties or publicly reporting these results until data completeness improves significantly. Response: We thank the commenters for their recommendations. Based on our internal analysis, we concluded that a 70 percent threshold significantly improves hospitals’ ability to meet the reporting requirements while nk the commenters for their recommendations. Based on our internal analysis, we concluded that a 70 percent threshold significantly improves hospitals’ ability to meet the reporting requirements while still maintaining statistical validity. At this time, we are requiring mandatory reporting beginning with the FY 2028 payment determination as hospitals were already given an extended voluntary reporting period to properly adjust to reporting on these measures in the CY 2025 OPPS/ASC Final Rule (89 FR 94499). Mandatory reporting will provide CMS with a larger data set, especially with the 70 percent thresholds, that will be useful to analyze hospital performance and ensure all patients are being provided quality care. We remain committed to monitoring hospitals’ ability to report on these measures and intend to raise these thresholds accordingly as hospital performance improves. Comment: Several commenters expressed concerns about the inclusion of MA patients in the measure cohorts, noting challenges with capturing Medicare Beneficiary Identifiers (MBIs) for MA patients, as these identifiers are often incomplete or missing due to third-party data integration issues or format variabili g challenges with capturing Medicare Beneficiary Identifiers (MBIs) for MA patients, as these identifiers are often incomplete or missing due to third-party data integration issues or format variability in claims documentation. A few commenters recommended that CMS monitor the impact of MA inclusion on data completeness and consider temporary exclusions or adjustments where MA data completeness is lower. Additionally, a few commenters suggested stratifying performance data by coverage type to ensure fair assessment and providing technical guidance to improve MBI capture rates. A commenter urged CMS to provide hospitals with feedback reports for at least the first reporting period in which MA patients are included, before the inclusion of MA patients becomes mandatory. Response: We thank commenters for their feedback regarding reporting MBIs for MA patients and acknowledge these challenges. We note that the inclusion of MA patients was finalized in the FY 2024 IPPS/LTCH PPS final rule beginning with the FY 2027 payment determination (88 FR 59161 through 59168) which corresponds to the performance period of July 1, 2024 through June 30, 2025. We subsequently made the submission of CC eginning with the FY 2027 payment determination (88 FR 59161 through 59168) which corresponds to the performance period of July 1, 2024 through June 30, 2025. We subsequently made the submission of CCDE and linking variable requirements for this reporting period voluntary per the CY 2025 OPPS/ASC final rule (89 FR 94499). We expanded the measure cohort to include MA patients because MA beneficiary enrollment has been rapidly increasing as a share of overall beneficiaries. As of March 2025, 51 percent of Medicare beneficiaries—or 35.1 million people—were enrolled in MA plans.359 The Congressional Budget Office estimates that by 2034, 64 percent of beneficiaries will be covered by MA plans. MA coverage also varies across counties and states with lower enrollment in rural states.360 Including MA beneficiaries in hospital outcome measures will help ensure that hospital quality is measured across all Medicare beneficiaries.361 362 As July 1, 2024 through June 30, 2025 is the first performance period in which MA patients were included, we will examine the data submitted by hospitals and evaluate the need for measure adjustments to ensure successful submission of MBIs. In addition, we wil ce period in which MA patients were included, we will examine the data submitted by hospitals and evaluate the need for measure adjustments to ensure successful submission of MBIs. In addition, we will include MA data in the feedback reports for admissions July 1, 2024 through June 30, 2025 performance period to allow hospitals to address any reporting issues. Comment: Several commenters highlighted technical and operational barriers to meeting the reporting requirements for hybrid measures. A few commenters noted challenges with capturing specific clinical data elements, such as vital signs and lab values, due to variability in EHR systems and coding standards. Commenters highlighted specific 359 Centers for Medicare & Medicaid Services. (2025). Medicare Enrollment Dashboard. Available at: https://data.cms.gov/tools/medicare-enrollment- dashboard. Accessed: July 11, 2025. 360 Freed M, Biniek JF, Damico A, Neuman T. Medicare Advantage in 2024: Enrollment Update and Key Trends. Kaiser Family Foundation. Accessed July 11, 2025. Available at: https:// www.kff.org/medicare/issue-brief/medicare- advantage-in-2024-enrollment-update-and-key- trends/. 361 Ochieng N and Biniek JF. Beneficia amily Foundation. Accessed July 11, 2025. Available at: https:// www.kff.org/medicare/issue-brief/medicare- advantage-in-2024-enrollment-update-and-key- trends/. 361 Ochieng N and Biniek JF. Beneficiary Experience, Affordability, Utilization, and Quality in Medicare Advantage and Traditional Medicare: A Review of the Literature. Accessed July 11, 2025. 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/. 362 Medicare Payment Advisory Commission. The Medicare Advantage program: Status Report and mandated report on dual-eligible special needs plans. Accessed July 11, 2025. Available at: https:// www.medpac.gov/wp-content/uploads/2022/03/ Mar22_MedPAC_ReportToCongress_Ch12_SEC.pdf. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00490 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37025 examples such as ‘‘first heart rate’’ being marked as missing due to hospitals recording the first measu h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37025 examples such as ‘‘first heart rate’’ being marked as missing due to hospitals recording the first measurement as a ‘‘pulse’’ and the inability to submit platelets due to a different unit (femtoliter) being used. A few commenters emphasized the complexity and specificity required of the linking variables, and stated it leaves no margin for error. A few commenters also noted that the narrow 24-hour lookback period for CCDE collection may exclude relevant clinical data, particularly for transfer patients and patients with extended emergency department or observation stays as these tests are often performed at the originating facility or during the ED/observation period and may not be repeated within the 24-hour window. A commenter expressed their desire for patients under observation status to have their lab values extracted within 24 hours before inpatient status to avoid redundant labs being drawn when a patient is transferred. Another commenter proposed extending the lookback period to 48 hours prior to admission. Response: We thank the commenters for their feedback regarding technical drawn when a patient is transferred. Another commenter proposed extending the lookback period to 48 hours prior to admission. Response: We thank the commenters for their feedback regarding technical and operational barriers to meeting reporting requirements for the hybrid measures. We refer readers to the CY 2025 OPPS/ASC final rule (89 FR 94495 through 94499) in which many of these issues were raised by commenters and discussed in more detail. We recognize that variability in EHR systems and coding standards, such as the documentation of heart rate, present challenges with capturing CCDEs. However, our approach to CCDEs allows hospitals to map codes and is not specific to any particular EHR system, meaning that all hospitals should be able to successfully capture and submit CCDEs. Additionally, by lowering the reporting thresholds, particularly the allowance of up to two missing lab values and two missing vital signs, we provide hospitals with more flexibility regarding these potential technical challenges. Specific to concerns that platelets counted as ‘‘missing’’ in performance reports, we note that beginning with July 1, 2023, through June 20, 2024 performance period data, ass al technical challenges. Specific to concerns that platelets counted as ‘‘missing’’ in performance reports, we note that beginning with July 1, 2023, through June 20, 2024 performance period data, associated with FY 2026 payment determination, platelet laboratory test values with the unit of femtoliter (fL) were accepted. Regarding concerns about the current timing requirements for CCDEs, we have made updates to address these points. Specifically, we extended the anchor timestamp requirement for CCDEs to increase flexibility regarding data collection. We refer readers to the eCQI Resource Center for more details on the measure specifications.363 364 We will continue to work with stakeholders and monitor hospital feedback to address any technical and operational issues with reporting on the hybrid measures. Comment: A few commenters raised broader concerns about the validity and impact of the hybrid measures. A few commenters questioned whether the measures accurately reflect patient care and outcomes, particularly given challenges with data completeness and linking variables. Response: The hybrid measures are designed to provide a more comprehensive assessment of patient care and o re and outcomes, particularly given challenges with data completeness and linking variables. Response: The hybrid measures are designed to provide a more comprehensive assessment of patient care and outcomes by combining administrative claims data with clinical data extracted from EHRs, allowing us to account for important clinical variables that are not available in claims data alone. By incorporating these additional data points, hybrid measures aim to improve risk adjustment and provide a more detailed understanding of hospital performance, ultimately supporting efforts to improve patient care. We will continue working with stakeholders and monitoring hospitals’ experiences with reporting on these measures. Comment: A few commenters raised concerns about the potential unintended consequences of readmission measures as a whole, such as increased mortality rates and disproportionate penalties for hospitals serving low-income populations. Response: We acknowledge commenters’ concerns about readmission measures. The Hybrid HWM measure was developed as a balancing measure to the Hybrid HWR measure to decrease the potential unintended consequence of increasing mortality due to reducin bout readmission measures. The Hybrid HWM measure was developed as a balancing measure to the Hybrid HWR measure to decrease the potential unintended consequence of increasing mortality due to reducing readmissions. We note that since the implementation of the condition-specific mortality and readmission measures, there has been a reduction in readmission rates, without an accompanying increase in mortality.365 Additionally, the hybrid 363 eCQI Resource Center. May 2025. Core Clinical Data Elements for the Hybrid Hospital- Wide Readmission Measure with Claims and Electronic Health Record Data—HWR. Available at: https://ecqi.healthit.gov/ecqm/hosp-inpt/2026/ cms0529v6?qt-tabs_measure=specifications-and- data-elements. 364 eCQI Resource Center. May 2025. Core Clinical Data Elements for the Hybrid Hospital- Wide All-Condition All-Procedure Risk- Standardized Mortality Measure—HWM. Available at: https://ecqi.healthit.gov/ecqm/hosp-inpt/2026/ cms0844v6?qt-tabs_measure=specifications-and- data-elements. 365 Ko, D., Khera, R., Lau, G. et al. Readmission and Mortality After Hospitalization for Myocardial Infarction and Heart Failure. JACC. 2020 Feb, 75 (7) 736–746. https://doi.org/10.1016/ ta-elements. 365 Ko, D., Khera, R., Lau, G. et al. Readmission and Mortality After Hospitalization for Myocardial Infarction and Heart Failure. JACC. 2020 Feb, 75 (7) 736–746. https://doi.org/10.1016/j.jacc.2019.12.026. measures aim to improve upon existing readmission measures by incorporating clinical data that better accounts for patient complexity and social risk factors. This enhanced risk adjustment aims to ensure a more comprehensive evaluation of hospital performance, particularly for hospitals serving low- income populations. Comment: A commenter urged CMS to remove the hybrid measures altogether until standardized EHR interoperability and infrastructure are universally available, and they shared that these measures present a disproportionate burden on hospitals with little clinical value due to costly manual abstraction of certain data elements and unfairly penalize smaller resource-constrained hospitals. Another commenter emphasized the burden of reporting this measure and urged CMS to simplify the measure requirements due to the complexity and labor costs associated with implementation that take away from direct patient care, especially during ongoing workforce shortage rged CMS to simplify the measure requirements due to the complexity and labor costs associated with implementation that take away from direct patient care, especially during ongoing workforce shortages. Response: We thank the commenters for their input. While we recognize that standardized EHR interoperability is not yet universally available, the hybrid measures are an important step toward leveraging clinical data to improve quality measurement. The hybrid measures utilize EHR data for risk adjustment, based on stakeholder feedback that the claims-only measures did not adequately account for clinical risk factors. We acknowledge the concerns about the reporting burden associated with hybrid measures, particularly with ongoing workforce shortages. The hybrid measures are designed to leverage data that hospitals are already collecting as part of routine clinical care, which should help minimize additional workload. We have already taken steps to reduce manual abstraction by promoting the use of automated data extraction from EHRs and will continue working with stakeholders to refine the measures as necessary. After consideration of the public comments we received, we are finalizing he use of automated data extraction from EHRs and will continue working with stakeholders to refine the measures as necessary. After consideration of the public comments we received, we are finalizing our proposal to decrease the hybrid measures CCDE and linking variable submission thresholds beginning with the FY 2028 payment determination. 8. Hospital IQR Program Extraordinary Circumstances Exception (ECE) Policy a. Background Under our current Extraordinary Circumstances Exception (ECE) VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00491 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37026 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations regulations, we have granted exceptions with respect to quality data reporting requirements in the event of extraordinary circumstances beyond the control of a hospital (42 CFR 412.140(c)(2)). An exception may be granted for extraordinary circumstances including, but not limited to, natural disasters or systemic problems with data collection systems.366 We refer readers to 42 CFR 412.140(c)(2) for our current ECE regulations, as w nary circumstances including, but not limited to, natural disasters or systemic problems with data collection systems.366 We refer readers to 42 CFR 412.140(c)(2) for our current ECE regulations, as well as the FY 2012 IPPS/LTCH PPS final rule (76 FR 51651), FY 2014 IPPS/LTCH PPS final rule (78 FR 50836), and FY 2015 IPPS/ LTCH PPS final rule (79 FR 50277) for further background and details of our ECE policy. We also refer readers to the QualityNet website for the specific requirements for submission of an ECE request in the Hospital IQR Program.367 Our ECE policy provides flexibility for Hospital IQR Program participants to ensure continuity of quality care delivery and measure reporting in the event of an extraordinary circumstance. For instance, we recognize that, in circumstances where a full exception is not applicable, it is beneficial for a hospital to report data later than the reporting deadline. Delayed reporting authorized under our ECE policy allows temporary relief for a hospital experiencing an extraordinary circumstance while preserving the benefits of data reporting, such as transparency and informed decision- making for beneficiaries and providers alike. Accordingl ospital experiencing an extraordinary circumstance while preserving the benefits of data reporting, such as transparency and informed decision- making for beneficiaries and providers alike. Accordingly, we proposed to update our regulations to specify that an ECE could take the form of an extension of time for a hospital to comply with a data reporting requirement if CMS determines that this type of relief would be appropriate under the circumstances. b. Update to the Extraordinary Circumstances Exception (ECE) Policy for the Hospital IQR Program In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18344), we proposed to update the current ECE policy codified at 42 CFR 412.140(c)(2) to include extensions of time as a form of relief and to further clarify the policy. Specifically, at proposed § 412.140(c)(2)(i), we proposed that CMS may grant an ECE with respect to reporting requirements in the event of an extraordinary circumstance—defined 366 Centers for Medicare & Medicaid Services (CMS) Quality Program Extraordinary Circumstances Exceptions (ECE) Request Form. (2025). QualityNet. Available at: https:// qualitynet.cms.gov/files/ 677e843f50ed8df7419f60e1?filename=HQR_ECE_ Req_Form_CY ) Quality Program Extraordinary Circumstances Exceptions (ECE) Request Form. (2025). QualityNet. Available at: https:// qualitynet.cms.gov/files/ 677e843f50ed8df7419f60e1?filename=HQR_ECE_ Req_Form_CY_2025.pdf. as an event beyond the control of a hospital (for example a natural or man- made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing)—that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year. We proposed (90 FR 18344) that the steps for requesting or granting an ECE would remain the same as the current ECE process, detailed by CMS at the QualityNet website or a successor website.368 At proposed § 412.140(c)(2)(ii)(A), we proposed that a hospital may request an ECE within 30 calendar days of the date that the extraordinary circumstance occurred. Our current policy allows a request within 90 days; however, this change would align the Hospital IQR policy with CMS systems implementation requirements across all quality reporting programs. Under this proposed codified policy, we clarified that CMS retains the authority to grant an ECE as a form of relief at any time after the ex tation requirements across all quality reporting programs. Under this proposed codified policy, we clarified that CMS retains the authority to grant an ECE as a form of relief at any time after the extraordinary circumstance has occurred. At proposed § 412.140(c)(2)(ii)(B), we proposed that CMS would notify the requestor with a decision in writing. In the event that CMS grants an ECE to the hospital, the written decision will specify whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements. Additionally, at § 412.140(c)(2)(iii), we proposed that CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that: a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale. As is the case under our current policy, any ECE granted will specify whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hosp or locale. As is the case under our current policy, any ECE granted will specify whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. This updated ECE policy would provide further reporting flexibility for hospitals and clarify the ECE process. We invited public comment on our proposals. Comment: Many commenters expressed support for CMS’ proposal to update and codify the ECE policy across hospital quality reporting programs. Commenters appreciated CMS’ efforts to codify its authority to grant reporting deadline extensions or exceptions in response to extraordinary circumstances, recognizing this flexibility as critical for hospitals facing natural disasters or other emergencies. Commenters also noted that codifying updates to the ECE policy would provide hospitals with greater clarity and consistency in navigating quality reporting requirements during extraordinary events. A few commenters specifically supported the proposal to update and codify CMS’ ability to grant ECEs to hospitals even if those hospitals have not requested an exception s during extraordinary events. A few commenters specifically supported the proposal to update and codify CMS’ ability to grant ECEs to hospitals even if those hospitals have not requested an exception. A commenter supported the proposal to allow hospitals 30 days to submit an ECE request. Response: We thank the commenters for their support. Comment: Several commenters urged CMS to explicitly include cyberattacks as qualifying extraordinary circumstances under the ECE policy. Commenters emphasized that cyberattacks are increasingly frequent in the healthcare industry and can debilitate data systems for extended periods, disrupting hospitals’ data collection and reporting. A few commenters highlighted the burden associated with reverting to manual documentation practices during cyberattacks and the challenges of later integrating this data into electronic systems. A commenter urged CMS to provide additional clarification on its process for approving ECE requests related to cyberattacks, including publicly posting any supplemental documentation that would aid in requesting an ECE. Response: We thank commenters for their recommendations. We note that extraordinary circumstances are not including publicly posting any supplemental documentation that would aid in requesting an ECE. Response: We thank commenters for their recommendations. We note that extraordinary circumstances are not limited to the examples provided in § 412.140(c)(2). We have received and accepted multiple ECE requests due to cyberattacks across reporting programs. We recommend that hospitals submit an ECE request anytime an event beyond the control of a hospital affects the ability of the hospital to comply with one or more reporting requirements with respect to a fiscal year, regardless of whether it was included in the examples provided in the CFR language. We note that QualityNet provides the ECE Request Form, ECE Information and Resources document, and ECE Quick Reference document, all of which are updated as necessary. We will continue to update these documents to provide updated information, resources, and references.369 367 https://qualitynet.cms.gov/inpatient/iqr/ 368 https://qualitynet.cms.gov/inpatient/iqr/ 369 We refer readers to the Hospital IQR Program participation#tab3. participation#tab3. ECE web page, available at: https:// VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 gov/inpatient/iqr/ 369 We refer readers to the Hospital IQR Program participation#tab3. participation#tab3. ECE web page, available at: https:// VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00492 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37027 Comment: Several commenters, while supporting this proposal, cautioned CMS to avoid defaulting to extensions in cases where broader relief is warranted, and ensure reporting extensions are not disproportionately utilized in place of exceptions. Commenters also urged CMS to recognize that a mere extension is not always sufficient, as the reliability and integrity of data collected during extraordinary events may be compromised. A few commenters urged CMS to provide details on how the determination of an exception versus an extension will be made to ensure transparency. A commenter noted this transparency will allow hospitals to better prepare for response times and required resources based on whether they are likely to receive an exemption or an extension. Response: We appre er noted this transparency will allow hospitals to better prepare for response times and required resources based on whether they are likely to receive an exemption or an extension. Response: We appreciate commenters’ concerns regarding the use of extensions for ECE requests. We note that we do not intend to replace exemptions with extensions and acknowledge that extensions are not always appropriate or technically possible. The determination of an exception versus an extension will be approved on a case-by-case basis based on the specifics of the circumstance affecting the hospital. Comment: A commenter supported the inclusion of the Severe Sepsis and Septic Shock Management Bundle (SEP–1) measure within the ECE process and recommended that newly mandated measures, such as the Hospital-Level Total Hip Arthroplasty/Total Knee Arthroplasty Patient-Reported Outcome- Based Performance measure (THA/TKA PRO–PM), be incorporated into the ECE policy annually. Response: We note that this policy is inclusive of any measures within the program, regardless of when the measure was adopted. Comment: Several commenters did not support the reduced timeframe for hospitals to request an ECE from th y is inclusive of any measures within the program, regardless of when the measure was adopted. Comment: Several commenters did not support the reduced timeframe for hospitals to request an ECE from the current 90-day period to 30 days following an extraordinary circumstance. Commenters stated that the proposed 30-day window is insufficient for hospitals to respond to a crisis, assess the impact on data collection and systems, and submit a request for an exception. Commenters highlighted examples, such as severe flooding and ransomware attacks, where hospitals were fully engaged in patient care and operational recovery, leaving little capacity to prioritize administrative tasks like ECE requests. A few commenters expressed concern qualitynet.cms.gov/inpatient/iqr/participation#tab3 for reference materials. that the reduced timeframe encourages hospitals to divert critical staff at a time they are needed most and would force them to prioritize paperwork over patient care, undermining the goals of the CMS quality reporting and value programs. A commenter requested that CMS review past ECE submissions to assess the feasibility for hospitals to meet a 30-day response deadline and disclo goals of the CMS quality reporting and value programs. A commenter requested that CMS review past ECE submissions to assess the feasibility for hospitals to meet a 30-day response deadline and disclose its justification for the readjustment. Several commenters urged CMS to retain the current 90-day window, which they stated provides a more reasonable timeframe for hospitals to recover and assess the impact of extraordinary events. A commenter suggested a compromise of 60 days to provide hospitals with more flexibility while still encouraging timely notification to CMS. The commenter also urged CMS to retain discretion to accept late requests in extraordinary circumstances, such as if communication lines are down for an extended period, to ensure that hospitals are not unfairly punished for failing to report data during a crisis. Response: We appreciate commenters’ concern regarding the reduced timeframe for hospitals to submit an ECE request. We recognize that hospitals may not have the ability to assess the impact on quality data submissions and complete the necessary paperwork within 30 days of the extraordinary circumstance. Due to concerns regarding hospitals’ ability to compl he ability to assess the impact on quality data submissions and complete the necessary paperwork within 30 days of the extraordinary circumstance. Due to concerns regarding hospitals’ ability to complete the ECE request within 30 days of the extraordinary circumstance, we are modifying the timeframe to allow for 60 days to submit an ECE request. We believe this timeframe will provide sufficient time for hospitals to assess the impact on quality reporting without disrupting operational and care needs. After consideration of the public comments, we will finalize our ECE proposals as proposed, except for the proposed 30-day deadline. In lieu of the 30-day deadline, we will finalize an ECE deadline of 60 days following an extraordinary circumstance. We are making conforming amendments to our regulation text (at § 412.140(c)(2)(ii)(A)) to reflect this policy change. D. Changes to the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program 1. Background The PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program, authorized by section 1866(k) of the Act, applies to hospitals described in section 1886(d)(1)(B)(v) of the Act (referred to as ‘‘PPS-Exempt Cancer Hospitals’’ or ‘‘PC ality Reporting (PCHQR) Program, authorized by section 1866(k) of the Act, applies to hospitals described in section 1886(d)(1)(B)(v) of the Act (referred to as ‘‘PPS-Exempt Cancer Hospitals’’ or ‘‘PCHs’’). We refer readers to the FY 2013 IPPS/LTCH PPS final rule (77 FR 53555 through 53567) for a general overview of the PCHQR Program. We also refer readers to 42 CFR 412.24 for codified PCHQR Program requirements. 2. PCHQR Program Measures a. Removal of the Hospital Commitment to Health Equity Measure Beginning With CY 2024 Reporting Period/FY 2026 Program Year and for Subsequent Years We refer readers to the FY 2024 IPPS/ LTCH PPS final rule (88 FR 59204 through 59210) where we adopted the Hospital Commitment to Health Equity (hereinafter referred to as HCHE) measure into the PCHQR Program. In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18344 through 18345), we proposed to remove the HCHE measure beginning with the CY 2024 reporting period/FY 2026 program year 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 mea iated 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. Removal of this measure would alleviate an estimated annual burden of approximately 2 hours, at a cost of $90, across all PCHs (88 FR 59317). One of the goals of the PCHQR 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 PCHQR 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 topi ts. Removing this measure from the PCHQR 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 and well-being. It may be costly for hospitals to continue reporting on the HCHE measure, and removal of this measure would make room in the program’s measure set to enhance the program’s focus on measurable clinical outcomes. We acknowledge that some hospitals may have expended resources to implement some or all of the activities described in the HCHE measure VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00493 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37028 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 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. We stated that if the proposed removal is finalized, any HCHE measure data received ivities prior to adoption of the measure would have been able to attest ‘‘yes’’ without expending similar resources. We stated that if the proposed removal is finalized, any HCHE measure data received by CMS would not be used for public reporting purposes. We invited public comments on our proposal to remove the HCHE measure from the PCHQR Program beginning with the CY 2024 reporting period/FY 2026 program year. We received many general comments regarding our proposed removal of the HCHE measure. We focus here on comments specific to removing this measure from the PCHQR Program. For our responses to general comments, we refer readers to our responses in the Hospital IQR Program section of this final rule (section X.C.4.a.). Comment: A commenter expressed concern regarding removal of the HCHE measure, stating that public reporting on hospital performance fosters transparency and helps patients make informed decisions about where to seek care, which is especially important for patients with complex conditions such as cancer. Response: We thank the commenter for sharing this concern. We are removing these measures from the PCHQR Program to reduce the burden incurred by patients and pr ith complex conditions such as cancer. Response: We thank the commenter for sharing this concern. We are removing these measures from the PCHQR Program to reduce the burden incurred by patients and providers for screening, data storage, and data reporting. We note that the other quality measures in the PCHQR Program continue to be publicly reported to allow patients to make informed decisions about their care. Comment: A commenter recommended that CMS consider ways that health equity can be integrated into cancer-specific outcome, patient experience, or quality-of-life measures. Response: We thank this commenter for this recommendation and will consider this input in future measure development. PCHs may use a range of strategies to ensure positive outcomes for their patients and we encourage PCHs to pursue strategies that support efficient and high-quality care for all patients. After consideration of the public comments we received, we are finalizing the removal of the HCHE measure as proposed. b. Removal of Two Social Drivers of Health Measures Beginning With CY 2024 Reporting Period/FY 2026 Program Year and for Subsequent Years In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 1 proposed. b. Removal of Two Social Drivers of Health Measures Beginning With CY 2024 Reporting Period/FY 2026 Program Year and for Subsequent Years In the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18345), we proposed to remove two social drivers of health (SDOH) process measures from the PCHQR Program beginning with the CY 2024 reporting period/FY 2026 program year: • Screening for Social Drivers of Health measure (adopted in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59210 through 59219)); and • Screen Positive Rate for Social Drivers of Health measure (adopted in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59219 through 59222)). We proposed to remove the SDOH measures beginning with the CY 2024 reporting period/FY 2026 program year under removal Factor 8, the costs associated with the measure outweigh the benefit of its continued use in the program (90 FR 18345). 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.5.d of the proposed rule, removal of Screening for Soc via manual processes, manually storing such data, training hospital staff, and altering workflows for these measures. As stated in section XIII.B.5.d of the proposed rule, removal of Screening for Social Drivers of Health measure would alleviate an estimated annual burden for hospitals and patients of 29 hours, at a cost of $773 for 6 PCHs for the FY 2026 program year and 103 hours, at a cost of $2,699, across all PCHs for the FY 2027 program year (90 FR 18411). Also, as stated in section XIII.B.5.e. of the proposed rule, removal of Screen Positive Rate for Social Drivers of Health measure would alleviate an estimated annual burden of 1 hour, at a cost of $55 for 6 PCHs for the FY 2026 program year and 2 hours, at a cost of $111, across all PCHs for the FY 2027 program year (90 FR 18411).370 Further, we noted that these measures document an administrative process and report aggregate level results, and do not shed light on the extent to which providers are ultimately connecting patients with resources or services and whether patients are benefiting from these 370 We note that in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18345) we state that ‘‘In the FY 2023 and FY 2024 IPPS/LT s with resources or services and whether patients are benefiting from these 370 We note that in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18345) we state that ‘‘In the FY 2023 and FY 2024 IPPS/LTCH PPS final rules, we estimated a total annual burden of 101 hours across all PCHs at a cost of $2,092 to screen all patients in accordance with measure specifications for Screening for Social Drivers of Health measure (88 FR 59317 through 59318). . For Screen Positive Rate for Social Drivers of Health measure, we estimated a total annual burden of 2 hours across all PCHs at a cost of $90 (88 FR 59318).’’ We have updated the burden in this final rule to more accurately reflect the estimated impact. screenings (90 FR 18345). We stated that the costs of the use of these measures in the PCHQR Program outweigh the benefits to beneficiaries and providers at this time. 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. g 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 PCHQR 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 18345), that, if finalized, any SDOH measure data received by CMS would not be used for public reporting purposes. We invited public comment on our proposal to remove the SDOH measures from the PCHQR Program beginning with the CY 2024 reporting period/FY 2026 program year. We received many general comments regarding our proposed removal of the SDOH measures. We focus here on comments specific to removing these measures from the PCHQR Program. For our responses to general comments we refer readers to our responses in the Hospital I al of the SDOH measures. We focus here on comments specific to removing these measures from the PCHQR Program. For our responses to general comments we refer readers to our responses in the Hospital IQR Program section of this final rule (section X.C.4.c.). Comment: A few commenters recommended that CMS consider how social risk factors can be integrated into future outcome, patient experience, or quality-of-life measures specific to cancer treatment. A commenter stated that patients with cancer are at increased risk for financial distress, which can impact their quality of life, mental health, and satisfaction with social activities and relationships. The commenter emphasized the importance of addressing social needs as part of broader efforts to improve health and well-being, particularly for vulnerable populations like cancer patients. Response: We appreciate commenters’ concerns regarding the role SDOH can have on patient outcomes and will consider this risk in development of future measures. We expect PCHQR Program participants to continue to provide appropriate, high-quality care to all their patients. We agree that VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 0 measures. We expect PCHQR Program participants to continue to provide appropriate, high-quality care to all their patients. We agree that VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00494 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37029 addressing social needs is an important effort in improving health and well- being for patients, particularly for vulnerable populations like patients with cancer, and that healthcare outcomes may be different for those experiencing financial distress. Hospitals may find ways to address these concerns in their workflow, including connecting patients with community resources that would address patients’ needs and provide appropriate referrals, because they recognize the importance of these items. The removal of this requirement should not preclude hospitals from collecting and using this information. Hospitals will still be able to screen patients for SDOH related concerns, but they will not be required to report on these screenings or results. After consideration of the public co his information. Hospitals will still be able to screen patients for SDOH related concerns, but they will not be required to report on these screenings or results. After consideration of the public comments we received, we are finalizing the removal of the two SDOH measures as proposed. c. Summary of Adopted PCHQR Program Measures for the CY 2026 Reporting Period/FY 2028 Program Year and Subsequent Years Table X.D.–01 summarizes the finalized measures for the PCHQR Program measure set beginning with the CY 2026 reporting period/FY 2028 program year. BILLING CODE 4120–01–P 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00495 Fmt 4701 Sfmt 4725 E:\FR\FM\04AUR2.SGM 04AUR2 / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00496 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00497 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37032 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regula Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37032 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations applicable reporting requirements with respect to a fiscal year. We proposed that the process for requesting or granting an ECE would remain the same as the current ECE process, detailed by CMS at the QualityNet website or a successor website.373 At § 412.24(e)(2)(i), we proposed that a PCH may request an ECE within 30 calendar days of the date that the extraordinary circumstance occurred. Our current policy allows a request within 90 days; however, this proposed change would align the PCHQR policy with CMS systems implementation requirements across all quality reporting programs. Under this proposed codified policy, we clarify that CMS retains the authority to grant an ECE as a form of relief at any time after the extraordinary circumstance has occurred. At § 412.24(e)(2)(ii), we proposed that CMS notify the requestor with a decision in writing, via email. In the event that CMS grants an ECE to the PCH, the written decision will specify whether the PCH is exempted from one or mo oposed that CMS notify the requestor with a decision in writing, via email. In the event that CMS grants an ECE to the PCH, the written decision will specify whether the PCH is exempted from one or more reporting requirements or whether CMS has granted the PCH an extension of time to comply with one or more reporting requirements. Additionally, at § 412.24(e)(3), we proposed that CMS may grant an ECE to one or more PCHs that have not requested an ECE if CMS determines that: a systemic problem with CMS data collection systems directly impacted the ability of the PCH to comply with a data submission; or that an extraordinary circumstance has affected an entire region or locale. As is the case under our current policy, any ECE granted will specify whether the affected PCHs are exempted from one or more reporting requirements or whether CMS has granted the PCHs an extension of time to comply with one or more reporting requirements. At § 412.24(e)(4), we proposed that CMS may grant or deny an ECE based on the evaluation of the extraordinary circumstance including, but not limited to, whether the extraordinary circumstance occurred beyond the control of the PCH and affected the PCH’s abi an ECE based on the evaluation of the extraordinary circumstance including, but not limited to, whether the extraordinary circumstance occurred beyond the control of the PCH and affected the PCH’s ability to meet data reporting requirements by the specified deadlines. We proposed that CMS will notify the PCH of a denial of an ECE in writing via email to be codified at § 412.24(e)(5). This proposed ECE policy would provide further reporting flexibility for PCHs and clarify the ECE process. We invited public comment on our proposal to update the ECE policy for 373 https://qualitynet.cms.gov/inpatient/iqr/ participation#tab3. the PCHQR Program with corresponding updates to regulatory text at § 412.24(e). We received many general comments regarding our ECE-related proposals. We did not receive any comments specific to these updates for the PCHQR Program. For our responses to general comments we refer readers to our responses in the Hospital IQR Program section of this final rule (section X.C.8.). As discussed in section X.C.8 of this final rule in response to commenter concerns, we recognize that hospitals may not have the ability to assess the impact on quality data submissions and co .C.8.). As discussed in section X.C.8 of this final rule in response to commenter concerns, we recognize that hospitals may not have the ability to assess the impact on quality data submissions and complete the necessary paperwork within 30 days of the extraordinary circumstance. Due to concerns regarding PCHs’ ability to complete the ECE request within 30 days of the extraordinary circumstance and a commenter suggestion to increase to a 60-day deadline, we are modifying the timeframe to allow for 60 days to submit an ECE request. We believe this timeframe will provide sufficient time for PCHs to assess the impact on quality reporting without disrupting operational and care needs. After consideration of the public comments, we will finalize our ECE proposals as proposed, except for the proposed 30-day deadline. In lieu of the 30-day deadline, we will finalize an ECE deadline of 60 days following an extraordinary circumstance. We are making conforming amendments to our regulation text (at § 412.24(e)) to reflect this policy change. E. Changes to the Long-Term Care Hospital Quality Reporting Program (LTCH QRP) 1. Background and Statutory Authority The Long-Term Care Hospital Quality at § 412.24(e)) to reflect this policy change. E. Changes to the Long-Term Care Hospital Quality Reporting Program (LTCH QRP) 1. Background and Statutory Authority The Long-Term Care Hospital Quality Reporting Program (LTCH QRP) is authorized by section 1886(m)(5) of the Act, and it applies to all hospitals certified by Medicare as Long-Term Care Hospitals (LTCHs). Section 1886(m)(5)(C) of the Act requires LTCHs to submit to the Secretary quality measure data specified under section 1886(m)(5)(D) in a form and manner, and at a time, specified by the Secretary. In addition, section 1886(m)(5)(F) of the Act requires LTCHs to submit data on quality measures under section 1899B(c)(1) of the Act, resource use or other measures under section 1899B(d)(1) of the Act, and standardized patient assessment data required under section 1899B(b)(1) of the Act. LTCHs must submit the data required under section 1886(m)(5)(F) of the Act in the form and manner, and at the time, specified by the Secretary. Section 1886(m)(5)(A) of the Act requires the Secretary to reduce by 2 percentage points the annual update to the LTCH PPS standard Federal rate for discharges for an LTCH during a fiscal year (FY)— . Section 1886(m)(5)(A) of the Act requires the Secretary to reduce by 2 percentage points the annual update to the LTCH PPS standard Federal rate for discharges for an LTCH during a fiscal year (FY)— if the LTCH has not submitted data to the Secretary in accordance with the LTCH QRP requirements specified for that FY. Section 1890A of the Act requires that the Secretary establish and follow a pre-rulemaking process, in coordination with the consensus-based entity (CBE) with a contract under section 1890(a) of the Act, to solicit input from certain groups regarding the selection of quality and efficiency measures for the LTCH QRP. We have codified our program requirements in our regulations at 42 CFR 412.560. In this final rule, we finalize our proposal to modify reporting requirements for the COVID–19 Vaccine: Percent of Patients/Residents Who Are Up to Date measure to exclude patients who have expired in the LTCH by removing an item on the LTCH Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS) as described in section X.E.3. of this final rule. We also finalize our proposal to remove four items previously adopted as standardized patient assessment data elements un tion (CARE) Data Set (LCDS) as described in section X.E.3. of this final rule. We also finalize our proposal to remove four items previously adopted as standardized patient assessment data elements under the social determinants of health (SDOH) category beginning with the FY 2028 LTCH QRP: one item for Living Situation, two items for Food, and one item for Utilities. Next, we finalize our proposal to amend our reconsideration policy and process as described in section X.E.4. of this final rule. Finally, we provide summaries of the public comments received in response to several requests for information (RFIs), specifically on: (1) future measure concepts for the LTCH QRP as described in section X.E.5 of this final rule; (2) revisions to the data submission deadlines for assessment data collected for the LTCH QRP as described in section X.E.6. of this final rule; and (3) advancing digital quality measurement (dQM) in the LTCH QRP as described in section X.E.7. of this final rule. 2. General Considerations Used for the Selection of Measures for the LTCH QRP—Quality Measures Currently Adopted for the LTCH QRP For a detailed discussion of the considerations we use for the selection of eral Considerations Used for the Selection of Measures for the LTCH QRP—Quality Measures Currently Adopted for the LTCH QRP For a detailed discussion of the considerations we use for the selection of LTCH QRP quality, resource use, and other measures, we refer readers to the FY 2016 Inpatient Prospective Payment System (IPPS)/LTCH PPS final rule (80 FR 49728). The LTCH QRP currently has 18 adopted measures, which are set out in Table X.E.-01. We did not propose to adopt any new measures for the LTCH QRP. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00498 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37033 For a discussion of the factors we use to evaluate whether a measure should be removed from the LTCH QRP, we refer readers to the FY 2019 IPPS/LTCH PPS final rule (83 FR 41624 through 41634) and to the regulations at § 412.560(b)(3). BILLING CODE 4120–01–P BILLING CODE 4120–01–C 3. Modification of Reporting Requirements for COVID–19 Vaccine: Percent of Patients/Residents Who Are Up to Date Measure Beginning With the 412.560(b)(3). BILLING CODE 4120–01–P BILLING CODE 4120–01–C 3. Modification of Reporting Requirements for COVID–19 Vaccine: Percent of Patients/Residents Who Are Up to Date Measure Beginning With the FY 2028 LTCH QRP In the FY 2024 IPPS/LTCH PPS Final Rule (88 FR 59243 through 59250), we finalized the COVID–19 Vaccine: Percent of Patients/Residents Who Are Up to Date (Patient/Resident COVID–19 Vaccine) measure for the LTCH QRP beginning with the FY 2026 LTCH QRP. LTCHs collect and report data for this measure on the LTCH Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS), the LTCH patient assessment instrument (88 FR 59247 and 59253). We added the Patient/Resident COVID–19 Vaccine item (O0350) on the LCDS discharge assessments (Planned Discharge, Unplanned Discharge, and Expired) for LTCHs to collect data on this measure for patients being discharged from the LTCH and who expire during their stay (88 FR 59253). We finalized that LTCHs must begin collecting data using the LCDS for this measure with patients discharged on October 1, 2024, for the FY 2026 LTCH QRP (88 FR 59247 and 59253). Since the Patient/Resident COVID–19 Vaccine measure was adopted for the LTCH QRP he LCDS for this measure with patients discharged on October 1, 2024, for the FY 2026 LTCH QRP (88 FR 59247 and 59253). Since the Patient/Resident COVID–19 Vaccine measure was adopted for the LTCH QRP and LTCHs began collecting data for this measure on October 1, 2024, LTCHs and other interested parties have expressed concerns about challenges and increased provider burden in collecting immunization data.374 They have specifically noted 374 Standing Technical Expert Panel for the Development, Evaluation, and Maintenance of Post- Acute Care (PAC) and Hospice Quality Reporting Program (QRP) Measurement Sets Summary Report Continued VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00499 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00500 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37035 necessary to meet LTCH QRP requirements to avoid a 2 percent payment reduction beginning with the FY 2028 LTCH QR ral Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37035 necessary to meet LTCH QRP requirements to avoid a 2 percent payment reduction beginning with the FY 2028 LTCH QRP. In the proposed rule, we calculated that removing these items from the data collection for the FY 2028 LTCH QRP would keep the 330 LTCHs from incurring 2,601 hours of administrative burden at a cost of $182,330.10 (or $552.52 per LTCH) at this time (90 FR 18350). We refer readers to section XIII.B.6. of this final rule for more details on this estimated burden reduction. We invited public comment on our proposal to remove these four standardized patient assessment data elements collected under the SDOH category from the LTCH QRP beginning with the FY 2028 LTCH QRP. A summary of comments received and our responses follow. Comment: Several commenters supported our proposal, citing the burden of data collection. These commenters stated that the items can be time-consuming and detract from direct patient care. A few commenters state that removal of these items will help providers focus their resources on other areas of importance, address quality issues that matter most to patients, and direct patient care. A few commenters state that removal of these items will help providers focus their resources on other areas of importance, address quality issues that matter most to patients, and allow LTCH staff to spend more time caring for patients. Two commenters acknowledged that CMS must work towards a balance of provider burden and data collection efforts for quality, ensuring data adds value to its program and advances health care. Another commenter stated support for the removal of the four SDOH items, stating that this will not impact quality of care in LTCHs while noting that the items overlap with existing assessments or other health initiatives. Response: We thank commenters for their support for our proposal to remove these four SDOH items from the standardized patient assessment data elements collected and submitted using the LCDS. We continue to monitor the LTCH QRP data collection requirements to look for ways to reduce administrative burden, where appropriate, while maintaining a high standard of quality care. We agree that removing these items at this time will alleviate some of the burden on LTCH providers associated with LTCH QRP data collection and submis ile maintaining a high standard of quality care. We agree that removing these items at this time will alleviate some of the burden on LTCH providers associated with LTCH QRP data collection and submission requirements. We intend to align the LTCH QRP more closely with CMS’s overarching goal for improved health care delivery through health IT advances and low-burden interoperable electronic systems. As we stated in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18350), we plan to refocus efforts on how data elements can improve care coordination, efficiency, reduction in errors, and patient experience. We appreciate commenters’ recognition of having an appropriate balance of burden and value in quality measurement programs, such as the LTCH QRP. By streamlining the number of data elements required for reporting, LTCHs and their staff can focus efforts and resources to address the quality issues that matter most to their patients. As stated in section X.E.6 of this rule, we solicited comment on measurement concepts that address resident well- being while more appropriately reflecting factors that are within practitioners’ and facilities’ scope of care or where practitioners can provi ment on measurement concepts that address resident well- being while more appropriately reflecting factors that are within practitioners’ and facilities’ scope of care or where practitioners can provide actionable advice that will help reduce the prevalence of chronic diseases, including nutrition, increased adherence to expected daily thresholds for physical activity, minimization of chronic stressors, and improvements in mental health. Comment: A commenter supported these items becoming voluntary beginning October 1, 2025, and phased out of the LTCH QRP altogether by FY 2028. Response: We wish to clarify that these items were finalized to be collected beginning with patients discharged on or after October 1, 2026, and were never intended to be voluntary. They do not appear on the current version of the LTCH Care Data Set (LCDS, Version 5.1). We did not propose to modify these four SDOH items to be optional items on the LCDS that LTCHs could voluntarily report. Because we are finalizing our proposal to remove these items as proposed, they will not be added to the next version of the LCDS. Comment: Many commenters were opposed to CMS’s proposal to remove the four SDOH items from th ng our proposal to remove these items as proposed, they will not be added to the next version of the LCDS. Comment: Many commenters were opposed to CMS’s proposal to remove the four SDOH items from the LCDS and urged CMS to reconsider the proposal. These commenters stated that this data adds value to LTCHs, who serve some of the most vulnerable patients in the health care continuum. The commenters stated certain literature on how screening for SDOH improves health outcomes and how this information results in a more holistic approach to patient care and discharge planning which facilitates proactive approaches to reduce risks. A few of these commenters stated that removal of these items would leave remaining measures to focus too exclusively on diagnosed conditions at the expense of whole- person care. A few commenters stated these SDOH items were particularly important in caring for patients with complex or chronic conditions including geriatric patients. These commenters also stated that identification and subsequent support of patients’ social needs decreased healthcare expenditures, readmissions, inpatient stays, and emergency department visits resulting in both health and finan hat identification and subsequent support of patients’ social needs decreased healthcare expenditures, readmissions, inpatient stays, and emergency department visits resulting in both health and financial benefits. Response: We appreciate commenters’ concerns and feedback regarding the importance of collecting these SDOH items from LTCH patients and acknowledge the value that commenters ascribe to the collection of this information for discharge planning and patient care, especially for the LTCH patient population. We also acknowledge feedback from commenters that healthcare outcomes may be different for those experiencing unstable housing, food insecurity or challenges paying utilities. However, in reviewing the data collection and reporting requirements for the FY 2027 LTCH QRP, we determined that these SDOH items should be removed from the LCDS prior to the start of data collection and submission. We have re-evaluated the value of adding these SDOH items to the LCDS for the purposes of the LTCH QRP against their burden at this time. We considered that LTCHs have not yet begun to report these data, we do not currently have a use for these items in the LTCH QRP, and, these SDOH it of the LTCH QRP against their burden at this time. We considered that LTCHs have not yet begun to report these data, we do not currently have a use for these items in the LTCH QRP, and, these SDOH items are not clinical items related to direct patient care. We also have refocused our efforts on modernization of health care and health care systems. We continuously review and reassess the balance of data collection and LTCH provider burden for the LTCH QRP, and at this time, determined these SDOH items should be removed prior to implementation. The objectives of the LTCH QRP continue to be the improvement of care and health outcomes for all patients through transparency and quality measurement, while balancing burden on LTCHs and their staff. As outlined in our request for information in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18353 and 18354), we are refocusing our efforts to advance the digital quality measurement transition to include ways for data elements, such as those related to SDOH, to be collected as part of a low-burden interoperable electronic system. Given these administrative goals and efforts to reduce burden for LTCHs, we do not believe that the collection of ted to SDOH, to be collected as part of a low-burden interoperable electronic system. Given these administrative goals and efforts to reduce burden for LTCHs, we do not believe that the collection of these SDOH items via the LCDS assessment outweighs the cost and burden of collecting them at this time. At this time, we believe that halting the implementation of the four SDOH items prior to their being added to the LCDS on October 1, 2026 removes the VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00501 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37036 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations burden these data collection requirements and submission would impose on LTCHs before most training activities, data collection, reviews of the guidance manuals, and other implementation tasks have occurred. Comment: A few commenters noted standardized items on the LCDS improve consistency and the exchangeability of information and further support LTCH providers in administering a comprehensive plan of care in accordance with CMS’s regulation. A commenter urged CMS to re ove consistency and the exchangeability of information and further support LTCH providers in administering a comprehensive plan of care in accordance with CMS’s regulation. A commenter urged CMS to retain the SDOH items until a more efficient electronic health record (EHR) data collection framework was in place. A few commenters stated that the cost and burden does not meaningfully outweigh the value of collecting this information, which includes being able to more accurately measure the quality of care in LTCHs by determining whether the influence of poor outcomes is through factors outside the influence of the facility. These commenters added that assessing SDOH for patients improves coordination between facilities and community care providers ensuring that Medicare dollars are spent efficiently and facilitating high quality care across settings. Response: We acknowledge the value that commenters ascribe to the collection of this information for discharge planning and care coordination, and commenters’ experiences with improving outcomes and facilitating high quality care through improved coordination between providers. We agree with the commenters that the exchangeability of inf on, and commenters’ experiences with improving outcomes and facilitating high quality care through improved coordination between providers. We agree with the commenters that the exchangeability of information is important for a comprehensive plan of care. CMS intends to work towards the workflow and data exchange for items being part of a less burdensome interoperable electronic system. We appreciate the commenter’s suggestion to retain the items until a more efficient health IT infrastructure and data collection framework is in place. However, all data collection requirements have inherent burden associated with collection and we strive to balance that burden with the value of measuring the quality of care that patients receive. Data collection for these four SDOH items would be burdensome on LTCHs and there is no current or planned use for the data in the LTCH QRP at this time. As we have stated, LTCHs can continue to collect this information to inform discharge planning but, for the purposes of the LTCH QRP, we are finalizing our proposal to remove these four items from the LCDS before implementation begins. This means that LTCHs would not need to submit this information to meet purposes of the LTCH QRP, we are finalizing our proposal to remove these four items from the LCDS before implementation begins. This means that LTCHs would not need to submit this information to meet requirements of the LTCH QRP. With the alleviation of this data collection requirement, LTCHs could redistribute their resources toward efforts to improve or enhance clinical care, health IT, or other areas as determined by the LTCH. Comment: A commenter stated CMS provided extensive support and rationale for adopting these four items in the FY 2025 IPPS/LTCH PPS final rule, developing a policy that was well- vetted and examined in detail. This commenter stated that CMS has not provided any reasoning or explanation in our proposal in the FY 2026 IPPS/ LTCH PPS proposed rule as to why these are no longer important or how circumstances have changed to necessitate their removal. Response: We reiterate that, in the proposed rule, we explained that the removal of these items is a result of CMS’s focus on balancing the need for data collections regarding quality care and the burden of these data collection on LTCHs and their staff (90 FR 18350). We would also like to reiterate that LTCHs an ’s focus on balancing the need for data collections regarding quality care and the burden of these data collection on LTCHs and their staff (90 FR 18350). We would also like to reiterate that LTCHs and their staff independently may determine to screen their patients for factors that may affect their clinical decision-making, even in the absence of a reporting requirement. We did not intend to suggest with our proposal to remove these items from LTCH QRP requirements that LTCHs should cease collecting this or similar information for other purposes, such as the LTCH’s patient-specific assessment of needs in developing a discharge plan as required by 42 CFR 483.43. Rather, we are removing these four SDOH items from the LCDS to reduce the burden of data collection and submission for the LTCH QRP. Reducing the burden of LTCH QRP requirements would enable LTCHs and their staff to focus their efforts on clinical decision making by preserving clinicians’ flexibility to address social risk factors in other ways that are tailored to the needs of and make the most sense for their patient populations. We understand implementation efforts to collect and submit any data elements for the purposes ors in other ways that are tailored to the needs of and make the most sense for their patient populations. We understand implementation efforts to collect and submit any data elements for the purposes of meeting LTCH QRP requirements is inherently burdensome for LTCHs and their staff, particularly adopting and implementing new data elements since they involve adjustments to health IT systems and EHRs, workflows, and staff trainings. We are always reviewing and reassessing this balance of data collection and LTCH provider burden for the LTCH QRP. For these four SDOH items, we reconsidered the value of their collection and submission to CMS for the purposes of the LTCH QRP against their burden at this time. We specifically considered that these items are not clinical in nature. While they reflect certain aspects of a patient’s health that may inform clinical decisions, they are not factors within the scope of care an LTCH and its staff provides. Furthermore, if maintained on the LCDS, there is currently no use for these items in risk adjustment models, reporting of LTCH measure results, or the development of new quality measures. We proposed removal of these four SDOH items from the ere is currently no use for these items in risk adjustment models, reporting of LTCH measure results, or the development of new quality measures. We proposed removal of these four SDOH items from the LCDS because LTCHs have not started data collection for these items yet, we are not utilizing the information for any purpose at this time, and there is an agency-wide refocusing on modernization of health care and health care systems and on engaging LTCHs and their staff with these health IT efforts. We are working towards developing less burdensome data collection methods as we believe leveraging technological advances and data modernizations can streamline standardization of the LCDS in ways that support interoperable patient data and reduce time spent collecting this data by LTCHs and their staff. We strive to collaborate with LTCH providers in these efforts as exhibited in our request for information on advancing digital quality measurement (dQM) in the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18353 and 18354). This collaboration includes reducing the burden of paperwork for participating in the LTCH QRP, where possible, to support LTCH providers in moving towards health data te rule (90 FR 18353 and 18354). This collaboration includes reducing the burden of paperwork for participating in the LTCH QRP, where possible, to support LTCH providers in moving towards health data technology and interoperability that promotes spending more time with patients. LTCHs are welcome to continue collecting this information to inform care coordination and discharge planning. Comment: Many commenters stated that the SDOH items provide important insights into housing, food, and utility insecurity, which affect patient outcomes and that removing these SDOH items is counter to national efforts aimed at improving health outcomes, including current CMS agency goals related to the development of patient nutrition, physical activity, and well-being measures. The commenters stated that the SDOH items could be utilized to support the Make America Healthy Again initiative’s core mission of a more efficient, prevention- focused health care system through the treatment of expensive complications that could be prevented through early identification of risks. A few commenters encouraged CMS to specifically retain the items related to nutrition. These commenters stated that VerDate Sep 2 cations that could be prevented through early identification of risks. A few commenters encouraged CMS to specifically retain the items related to nutrition. These commenters stated that VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00502 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37037 nutritional risk is often linked to readmissions and overall health outcomes, especially for patients in rural and underserved areas. They also felt addressing food insecurity can reduce preventable healthcare cost, adding an estimated $53 billion annually, and disproportionately affects individuals with or at risk for diet- related diseases, such as patients with diabetes. Response: We disagree but understand why LTCH providers believe that removal of these items is counter to our national efforts aimed at improving health outcomes. In response to comments about the agency’s goals related to nutrition and well-being, we do not believe these four SDOH items are the only foundational items needed for future measure development relate response to comments about the agency’s goals related to nutrition and well-being, we do not believe these four SDOH items are the only foundational items needed for future measure development related to nutrition. As we finalized in the FY 2025 IPPS final rule (89 FR 69585 and 69586), the two Food items (R0320A and R0320B) assess one particular aspect of nutrition: food availability and food security. These items do not encompass other relevant, meaningful information to improve patients’ health outcomes, including healthy nutrition, sleep, and physical activity levels. In addition, there are other existing data elements on the LCDS that could support the development of measure concepts we are considering in the future. For example, the LCDS includes other nutrition items in Section I and K. To reiterate, at this time, we are removing these SDOH items to refocus efforts and resources towards a less burdensome interoperable system for LTCHs participating in the LTCH QRP and existing LCDS items, such as the standardized patient assessment data elements in Section K that were finalized in the FY 2020 IPPS final rule (84 FR 42564 through 42568), provide a foundation for building out CDS items, such as the standardized patient assessment data elements in Section K that were finalized in the FY 2020 IPPS final rule (84 FR 42564 through 42568), provide a foundation for building out nutrition measures. We would also like to note that CMS is currently considering other ways to measure nutrition in our RFI on potential future measures in the LTCH QRP. In the proposed rule (90 FR 18352 and 18353), we stated that preventable care, including assessment of an individual’s nutritional status, plays a vital role by proactively addressing factors that may lead to poor nutritional status or related health issues. These efforts not only support optimal nutrition but also work to prevent conditions that could otherwise hinder an individual’s health and nutritional needs. With regard to well-being, we are soliciting comment on ways to improve patient well-being across the Medicare programs and we remain committed to identifying the needs of patients and supporting LTCHs in addressing those risks in a way that best accounts for patients’ clinical circumstances with minimal burden. We also remain committed to supporting LTCHs and their staff in addressing health risks and needs ing those risks in a way that best accounts for patients’ clinical circumstances with minimal burden. We also remain committed to supporting LTCHs and their staff in addressing health risks and needs of at-risk populations such as those experiencing challenges with maintaining healthy nutrition and physical activity levels and managing or improving chronic stressors, mental health concerns, and chronic diseases. Comment: A few commenters were concerned that many healthcare facilities across the country have already made substantial investments to incorporate the screening of these SDOH items into setting up systems, electronic health records, and workflows. These commenters stated that this would amount to more than ongoing implementation costs, and that hospitals and other settings expecting to report these items have already expended the necessary resources to set up their systems and referral programs. These commenters stated that removing these SDOH items does not reduce their prior investments and may result in additional resources to rework their systems. A few other commenters stated that many healthcare organizations have already invested in incorporating SDOH screening int r investments and may result in additional resources to rework their systems. A few other commenters stated that many healthcare organizations have already invested in incorporating SDOH screening into their admissions processes and care coordination workflows. Response: We acknowledge the commenters’ concerns and understand the time and resources that LTCHs may have spent anticipating the requirement to collect these items as part of the LTCH QRP. Since the inception and initial development of the LTCH QRP, interested parties have requested we provide draft specifications for the upcoming release of the revised LCDS as early as possible. We have been responsive to this request and aim to provide as much information as possible when that information is available. However, we would like to emphasize that the information released consists of draft LCDS data specifications, not final specifications, and that the LCDS data specifications cannot be finalized until CMS policies are finalized after the final rule is released. We also note that the time and resources spent to build technical infrastructure accounts for only a portion of the overall cost we considered, which also includes t after the final rule is released. We also note that the time and resources spent to build technical infrastructure accounts for only a portion of the overall cost we considered, which also includes training activities, continuous data collection, reviews of the guidance manuals, and other implementation tasks. Collecting these SDOH items is not a one-time task but an ongoing requirement for every LTCH patient admitted to the facility. As a result, we believe removing these items before data collection begins will still save LTCHs and their staff time, money, and resources. After consideration of the public comments, we are finalizing our proposal to remove four standardized patient assessment data elements collected under the SDOH category (one item for Living Situation (R0310); two items for Food (R0320A and R0320B); and one item for Utilities (R0330)) from the LTCH QRP beginning with the FY 2028 LTCH QRP without modification. 5. Proposals To Amend the Reconsideration Request Policy and Process a. Background In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50885 through 50887), we finalized the LTCH QRP reconsiderations policy and process whereby an LTCH may request reconsideration and Process a. Background In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50885 through 50887), we finalized the LTCH QRP reconsiderations policy and process whereby an LTCH may request reconsideration of an initial determination that the LTCH did not comply with the LTCH QRP reporting requirements, warranting CMS reducing the LTCH’s annual payment update by 2 percent for the applicable fiscal year as required by section 1886(m)(5)(A) of the Act. In that rule, we stated that the LTCH may file a request for reconsideration if they believe that the finding of non-compliance is erroneous, or if they were non-compliant, they have a valid and justifiable excuse for this non-compliance (78 FR 50886). We further stated that, after we review the request for reconsideration, we may reverse our initial finding of non- compliance if: (1) the LTCH provides proof of compliance with all requirements during the reporting period; or (2) the LTCH provides adequate proof of a valid or justifiable excuse for non-compliance if the LTCH was not able to comply with requirements during the reporting period (78 FR 50886). Finally, we stated that we will uphold an initial finding of non-compliance if the LT for non-compliance if the LTCH was not able to comply with requirements during the reporting period (78 FR 50886). Finally, we stated that we will uphold an initial finding of non-compliance if the LTCH cannot show any justification for non- compliance (78 FR 50886). In the FY 2015 IPPS/LTCH PPS final rule (79 FR 50317 and 50318), we finalized amendments to the LTCH QRP reconsideration policy and process. Specifically, we stated that each LTCH would receive a notification of noncompliance with LTCH QRP requirements if we determine it had not correctly submitted data with respect to the applicable fiscal year (79 FR 50317). Then, the LTCH would have 30 days from the date of our initial notification of noncompliance to submit a request for reconsideration via email. We also VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00503 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37038 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations provided that, in very limited circumstances, we may grant a request by an LTCH to extend the deadline to submit its reconsideration request, so l 147 / Monday, August 4, 2025 / Rules and Regulations provided that, in very limited circumstances, we may grant a request by an LTCH to extend the deadline to submit its reconsideration request, so long as the LTCH requested the extension and demonstrated that extenuating circumstances existed that prevented it filing a reconsideration request by the 30-day deadline (79 FR 50317). Finally, we provided that, as part of its reconsideration request, the LTCH must submit all supporting documentation and evidence demonstrating: (1) full compliance with all LTCH QRP reporting requirements during the reporting period; or (2) extenuating circumstances that affected noncompliance if the LTCH was not able to comply with the requirements during the reporting period (79 FR 50317). We stated that we would not review any reconsideration request that fails to provide the necessary documentation and evidence along with the request (79 FR 50317). In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49755 and 49770), we codified the reconsideration policy and process for the LTCH QRP at § 412.560(d). In subsequent rulemakings, we have amended our reconsideration policy and process at § 412.560(d) for min d 49770), we codified the reconsideration policy and process for the LTCH QRP at § 412.560(d). In subsequent rulemakings, we have amended our reconsideration policy and process at § 412.560(d) for minor clarifications and technical updates (FY 2017 IPPS/LTCH PPS final rule (81 FR 57230 and 57231); FY 2019 IPPS/LTCH PPS final rule (83 FR 41633 and 41634; 83 FR 41705); and FY 2020 IPPS/LTCH PPS final rule (84 FR 42588 and 42615)). As codified, our regulation at § 412.560(d) addresses how we send our written notification of noncompliance to an LTCH, the process for an LTCH to request reconsideration, what information an LTCH must include with its reconsideration request (for example, documentation that demonstrates the LTCH’s compliance with LTCH QRP requirements), and how we notify the LTCH of our final decision regarding its reconsideration request. We have become aware there are inconsistencies in our preamble and regulation text regarding LTCH requests for reconsideration. On this basis, in this final rule, we seek to clarify these areas. b. Proposal To Allow LTCHs To Request an Extension To File a Request for Reconsideration As noted previously, in the FY 2015 IPPS/LTCH PPS final is, in this final rule, we seek to clarify these areas. b. Proposal To Allow LTCHs To Request an Extension To File a Request for Reconsideration As noted previously, in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50317 and 50318), we provided that, in very limited circumstances, we may grant a request by an LTCH to extend the deadline to submit its reconsideration request, so long as the LTCH requested the extension and demonstrated that extenuating circumstances existed that prevented it filing a reconsideration request by the 30-day deadline (79 FR 50317). We did not codify this policy— permitting LTCHs to request an extension to file their reconsideration request—in our regulation text at § 412.560(d). In implementing this finalized policy, we have noted two areas where further clarity would be beneficial to LTCHs. First, we have not clearly defined or explained the term ‘‘extenuating circumstances,’’ as used in our reconsideration policy. In contrast, we use the term ‘‘extraordinary circumstances’’ in our Extraordinary Circumstance Exception and Extension (ECE) policy, as codified at § 412.560(c). We did explain ‘‘extraordinary circumstances’’ in detail when we originally final y circumstances’’ in our Extraordinary Circumstance Exception and Extension (ECE) policy, as codified at § 412.560(c). We did explain ‘‘extraordinary circumstances’’ in detail when we originally finalized this ECE policy in FY 2014 IPPS/LTCH PPS final rule (78 FR 50883). On this basis, we proposed to remove the term ‘‘extenuating circumstances’’ as used currently in our reconsideration policy and replace it with ‘‘extraordinary circumstances.’’ Specifically, we proposed that an LTCH may request, and CMS may grant, an extension to file a reconsideration request if the LTCH was affected by extraordinary circumstances beyond the control of the LTCH (for example, a natural or man-made disaster). By modifying the basis by which an LTCH may request an extension to file a reconsideration request in this manner, we also proposed to incorporate our prior explanation regarding the meaning of the term extraordinary circumstances, as set forth in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50883 through 50885) as part of our Extraordinary Circumstance Exception and Extension (ECE) Policy. Second, we have noted some areas in our policy where LTCHs may benefit from clearly demarcated deadlines. hrough 50885) as part of our Extraordinary Circumstance Exception and Extension (ECE) Policy. Second, we have noted some areas in our policy where LTCHs may benefit from clearly demarcated deadlines. Although we believe an LTCH would have an interest in asking for an extension to file a reconsideration request prior to the deadline, our policy currently does not specify a deadline for an LTCH to submit its request for such extension (79 FR 50317). Our policy also provides that, to support such request, the LTCH must demonstrate that extenuating circumstances existed that prevented filing the reconsideration request by the 30-day deadline (79 FR 50317). However, we have not specified a temporal relationship between when the extenuating circumstances occurred and the reconsideration request deadline. We believe LTCHs may benefit from further specificity regarding these requirements for submitting a request to extend the deadline to file a reconsideration request. On this basis, we proposed to amend our reconsideration policy as codified at § 412.560(d) to permit LTCHs to request, and CMS to grant, an extension to file a request for reconsideration of a noncompliance determination if, ed to amend our reconsideration policy as codified at § 412.560(d) to permit LTCHs to request, and CMS to grant, an extension to file a request for reconsideration of a noncompliance determination if, during the period to request a reconsideration as set forth in § 412.560(d)(2), the LTCH was affected by an extraordinary circumstance beyond the control of the LTCH (for example, a natural or man- made disaster). We proposed that the LTCH must submit its request for an extension to file a reconsideration request to CMS via email no later than 30 calendar days from the date of the written notification of noncompliance. We proposed that the LTCH’s extension request, submitted to CMS, must contain the following information: (1) the CCN for the LTCH; (2) the business name of the LTCH; (3) the business address of the LTCH; (4) certain contact information for the LTCH’s chief executive officer or designated personnel; (5) a statement of the reason for the request for the extension; and (6) evidence of the impact of the extraordinary circumstances, including, for example, photographs, newspaper articles, and other media. We proposed to codify this process at § 412.560(d)(4). We further prop dence of the impact of the extraordinary circumstances, including, for example, photographs, newspaper articles, and other media. We proposed to codify this process at § 412.560(d)(4). We further proposed that CMS will notify the LTCH in writing of its final decision regarding its request for an extension to file a reconsideration of noncompliance request via an email from CMS. We proposed to notify the LTCH in writing via email because this will allow for more expedient correspondence with the LTCH, given the 30-day reconsideration timeframe. We proposed to codify this process at § 412.560(d)(5). We note that we proposed similar modifications across all post-acute care setting quality reporting programs to more closely align the reconsideration processes. We invited comment on these proposals to amend the LTCH QRP reconsideration policy to permit LTCHs to requests an extension to file a reconsideration request and to codify this proposed policy and process at § 412.560(d)(4) and (5). The following is a summary of the public comments received and our responses: Comment: Several commenters supported the proposed revisions, particularly the efforts to address inconsistencies in the r The following is a summary of the public comments received and our responses: Comment: Several commenters supported the proposed revisions, particularly the efforts to address inconsistencies in the reconsideration policy. Several of these commenters appreciated CMS’s recognition that extraordinary circumstances, such as disasters, can prevent timely filing of VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00504 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations 37039 reconsideration requests. A commenter encouraged CMS to consider adopting similar policies across its other quality and value-based programs. Response: We thank commenters for their support. Comment: A commenter supported CMS’s proposal to allow an extension of time to submit a request for reconsideration but opposed shortening the timeframe for submitting an ECE request from 90 days to 30 days following an extraordinary event, stating that a 30-day window is simply too short for hospitals that are in the midst of responding to a disaster. Response: We appreci request from 90 days to 30 days following an extraordinary event, stating that a 30-day window is simply too short for hospitals that are in the midst of responding to a disaster. Response: We appreciate the commenter’s concerns and recommendations, though we find aspects of the comments to be unclear. We interpret the commenter to mean that they believed our proposed 30-day deadline would apply to the exception and extension (ECE) process for data submission, rather than the ability to request an extension due to extraordinary circumstances during the reconsideration process following a determination of noncompliance. We wish to clarify the proposed policies do not modify either the deadline for submitting an ECE request during the reporting period, or the deadline for submitting a reconsideration request, but specifically address an LTCH’s ability to submit a request for an extension to submit the reconsideration request. This policy establishes that providers impacted by an extraordinary circumstance within the reconsideration time frame will have 30 days to request an extension to file their reconsideration request after receipt of the CMS initial notice of noncompliance for a inary circumstance within the reconsideration time frame will have 30 days to request an extension to file their reconsideration request after receipt of the CMS initial notice of noncompliance for a given fiscal year annual payment update. LTCHs still have 90 days to submit an exception and extension request from the time of an extraordinary event, and 30 days from the initial notification of noncompliance to submit a request for reconsideration. Because our current policy does not specify a deadline for an LTCH to submit its request for such an extension (79 FR 50317) during the reconsideration period, we are providing a clear timeframe of 30 days for this process. Comment: Several commenters opposed CMS’s proposal to remove the ‘‘extenuating circumstances’’ standard from the LTCH QRP reconsideration policy. They stated that this standard was established in the FY 2015 IPPS/ LTCH PPS Final Rule and has been upheld by federal courts (79 FR 50317). Commenters urged CMS to reaffirm and codify this standard in regulation as a valid and independent basis for reversing a payment penalty, separate from demonstrating full compliance. Another commenter emphasized that ‘‘extenuating’’ and codify this standard in regulation as a valid and independent basis for reversing a payment penalty, separate from demonstrating full compliance. Another commenter emphasized that ‘‘extenuating’’ and ‘‘extraordinary’’ circumstances are not synonymous. Response: We appreciate commenters’ feedback and recognize the historical use of the term ‘‘extenuating circumstances’’ in prior rulemaking and administrative decisions. However, as noted in the proposed rule, CMS identified inconsistencies between regulatory text and preamble language and is using this rulemaking to clarify and align the LTCH QRP reconsideration policy with other post- acute care quality reporting programs. The intent of this clarification is to promote consistency, not to reduce flexibility. Moving forward, CMS will use the single term ‘‘extraordinary circumstances,’’ defined as circumstances beyond the LTCH’s control, to standardize the basis for reconsideration. We believe this approach enhances transparency and improves alignment across quality reporting programs. In response to the commenter who stated that ‘‘extenuating’’ and ‘‘extraordinary’’ circumstances are not synonymous, we agree with this distinction and ves alignment across quality reporting programs. In response to the commenter who stated that ‘‘extenuating’’ and ‘‘extraordinary’’ circumstances are not synonymous, we agree with this distinction and proposed using ‘‘extraordinary circumstances’’ to establish a clear, program-wide definition that reflects events beyond a provider’s control. This approach aligns with policies used in other CMS quality reporting programs. CMS remains committed to reviewing documentation requesting an extension to file a reconsideration request on a case-by- case basis and will continue to consider all relevant evidence demonstrating that circumstances outside of the LTCH’s control impacted their ability to file a reconsideration request within the 30- day deadline. After consideration of the public comments, we are finalizing our proposal to amend the LTCH QRP reconsideration policy to permit LTCHs to requests an extension to file a reconsideration request and to codify this proposed policy and process at § 412.560(d)(4) and (d)(5). c. Update to the Bases on Which CMS Can Grant a Reconsideration Request As discussed previously, in the FY 2014 IPPS/LTCH PPS final rule, we stated that, after we review at § 412.560(d)(4) and (d)(5). c. Update to the Bases on Which CMS Can Grant a Reconsideration Request As discussed previously, in the FY 2014 IPPS/LTCH PPS final rule, we stated that, after we review an LTCH’s request for reconsideration, we may reverse our initial finding of non- compliance if: (1) the LTCH provides proof of compliance with all requirements during the reporting period; or (2) the LTCH provides adequate proof of a valid or justifiable excuse for non-compliance if the LTCH was not able to comply with requirements during the reporting period (78 FR 50886). We also stated that we will uphold an initial finding of non-compliance if the LTCH cannot show any justification for non- compliance (78 FR 50886). In the FY 2015 IPPS/LTCH PPS final rule (79 FR 50317 and 50318), we reiterated this position, and provided that, as part of its reconsideration request, the LTCH must submit all supporting documentation and evidence demonstrating: (1) full compliance with all LTCH QRP reporting requirements during the reporting period; or (2) extenuating circumstances that affected noncompliance if the LTCH was not able to comply with the requirements during the reporting period (79 F orting requirements during the reporting period; or (2) extenuating circumstances that affected noncompliance if the LTCH was not able to comply with the requirements during the reporting period (79 FR 50317). We stated that we would not review any reconsideration request that fails to provide the necessary documentation and evidence along with the request (79 FR 50317). As previously discussed, we codified our reconsideration policy at § 412.560(d) in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49755 and 49770). Our regulation at § 412.560(d)(2)(vii) requires that an LTCH’s request for reconsideration include accompanying documentation that demonstrates the LTCH’s compliance with the LTCH QRP requirements. Then, we will notify the LTCH in writing regarding our final decision on its reconsideration request (§ 412.560(d)(3)). We believe it would be beneficial for LTCHs if we codify our specific bases for granting a reconsideration request in our regulation at § 412.560(d). On these bases, we proposed to modify our reconsideration policy to provide that we will grant a timely request for reconsideration, and reverse an initial finding of non-compliance, only if CMS determines that th s, we proposed to modify our reconsideration policy to provide that we will grant a timely request for reconsideration, and reverse an initial finding of non-compliance, only if CMS determines that the long- term care hospital was in full compliance with the LTCH QRP requirements for the applicable program year. We would consider full compliance with the LTCH QRP requirements to include CMS granting an exception or extension to LTCH QRP reporting requirements under our ECE policy at § 412.560(c). However, to demonstrate full compliance with our ECE policy, the LTCH would need to comply with our ECE policy’s requirements, including the specific scope of the exception or extension as granted by CMS. We proposed to revise § 412.560(d)(3) to codify this modified policy in our regulation. The remainder of the text at § 412.560(d)(3) would remain the same, subject to minor technical amendments. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00505 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37040 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations We noted that we considered R2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37040 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations We noted that we considered proposing similar modifications across all post-acute care setting quality reporting programs to more closely align the reconsideration processes. We invited comment on these proposals to amend the bases by which we grant a reconsideration request under the LTCH QRP reconsideration policy and to codify this proposed policy at § 412.560(d)(3). The following is a summary of the public comments received and our responses: Comment: Commenters requested that CMS continue to allow LTCHs to raise extraordinary circumstances during the reconsideration appeal process. These commenters also requested that CMS reverse a payment penalty during the reconsideration process if an LTCH provides evidence of extraordinary circumstances that prevented timely submission of data, even if the LTCH did not previously submit an exception request to CMS. Response: We appreciate commenters’ input on the reconsideration process. We clarify that LTCHs will be considered compliant if an exception or extension req iously submit an exception request to CMS. Response: We appreciate commenters’ input on the reconsideration process. We clarify that LTCHs will be considered compliant if an exception or extension request (ECE) was submitted and approved under § 412.560(c). However, in order to be considered compliant, the ECE must have been both submitted and approved prior to the reconsideration request. LTCHs may not submit an ECE as a basis for requesting reconsideration in response to a notice of noncompliance. The ECE process requires that requests be submitted within 90 calendar days of the extraordinary circumstance event, as outlined in the current policy. During the 30-day reconsideration period, providers may also request an extension to file the reconsideration if they experienced extraordinary circumstances that prevented timely submission of the reconsideration request. Comment: Commenters had concerns about the change in terminology from ‘‘extraordinary’’ to ‘‘extenuating’’ and circumstances. They cited legal definitions to demonstrate that extenuating circumstances involve a reduction in culpability, whereas extraordinary circumstances imply highly unusual events. They expressed con nces. They cited legal definitions to demonstrate that extenuating circumstances involve a reduction in culpability, whereas extraordinary circumstances imply highly unusual events. They expressed concern that removing ‘‘extenuating circumstances’’ narrows the scope of acceptable reasons for reconsideration and removes an avenue for more subjective, contextual review. Response: We interpret these comments to mean that commenters are opposed to the use of ‘‘extraordinary circumstances’’ as a basis for reconsideration of a notice of noncompliance. We wish to clarify that we are proposing to permit LTCHs to request extensions to file reconsideration requests based on extraordinary circumstances in section E.5.b. We are also proposing in section E.5.c to update the bases by which we grant a reconsideration request. Specifically, we would only reverse an initial finding of non-compliance if CMS determines that the LTCH was in full compliance with the LTCH QRP requirements for the applicable program year. We would not consider an LTCH’s assertion of ‘‘extraordinary circumstances’’ as a new basis for overturning a noncompliance finding during the reconsideration process. While full compli program year. We would not consider an LTCH’s assertion of ‘‘extraordinary circumstances’’ as a new basis for overturning a noncompliance finding during the reconsideration process. While full compliance with the LTCH QRP requirements may include CMS granting an exception or extension to LTCH QRP reporting requirements under our ECE policy at § 412.560(c), we wish to reiterate that the LTCH would need to comply with our ECE policy’s requirements, including compliance with the specific scope of the exception or extension as granted by CMS. After consideration of the public comments, we are finalizing our proposal to amend the bases by which we grant a reconsideration request under the LTCH QRP reconsideration policy and to codify this proposed policy. 6. LTCH QRP Measure Concepts Under Consideration for Future Years— Request for Information (RFI): Interoperability, Well-Being, Nutrition & Delirium In the proposed rule, we sought input on the importance, relevance, appropriateness, and applicability of each of the quality measure concepts under consideration listed in Table X.E.–02 for future years in the LTCH QRP. In the FY 2025 LTCH PPS proposed rule (89 FR 36350 through 36351), w applicability of each of the quality measure concepts under consideration listed in Table X.E.–02 for future years in the LTCH QRP. In the FY 2025 LTCH PPS proposed rule (89 FR 36350 through 36351), we included a request for information (RFI) on a set of principles for selecting and prioritizing LTCH QRP measures, identifying measurement gaps, and suitable measures for filling these gaps. We refer readers to the FY 2025 LTCH PPS final rule (89 FR 69594 and 69596) for a summary of the public comments we received in response to the RFI. We sought input on four concepts for future measures for the LTCH QRP. We refer readers to the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18352 and 18353) for a description of each of the quality measure concepts under consideration for this RFI. We received several public comments with feedback on these measure concepts. The following is a summary of the comments we received. a. Interoperability Comment: A few commenters supported the interoperability measure. A commenter recommended CMS to consider a phased approach with financial incentives. Another commenter stated that they would be supportive of the interoperability measure in the LTCH QRP if CM asure. A commenter recommended CMS to consider a phased approach with financial incentives. Another commenter stated that they would be supportive of the interoperability measure in the LTCH QRP if CMS provided funding for implementation upgrades that are needed to achieve interoperability. A commenter opposed the measure, saying that LTCH staff responsible for quality reporting are not trained to evaluate the level of readiness for interoperable data exchange. The commenter also noted that CMS has not financially supported information technology systems. VerDate Sep 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00506 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 00:36 Aug 02, 2025 Jkt 265001 PO 00000 Frm 00507 Fmt 4701 Sfmt 4700 E:\FR\FM\04AUR2.SGM 04AUR2 2 S E L U R h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 37042 Federal Register / Vol. 90, No. 147 / Monday, August 4, 2025 / Rules and Regulations A commenter had concerns that current LTCH systems and workflows would not be able to sustain the change, especially with limited staffing and limited capacity of LTCH IT systems. This comm egulations A commenter had concerns that current LTCH systems and workflows would not be able to sustain the change, especially with limited staffing and limited capacity of LTCH IT systems. This commenter noted that few LTCHs have fully automated, real-time reporting pipelines and urged CMS to take a more gradual approach to reducing the data submission timeline. A few commenters stated that CMS should not reduce the data submission timeframe to less than 90 days, stating that the change to 45 days is drastic in scope. Response: We appreciate the input provided by commenters. While we will not be responding to specific comments submitted in response to this RFI in this final rule, we intend to use this input to inform our program improvement efforts. 8. Advancing Digital Quality Measurement in the LTCH QRP— Request for Information As part of our effort to advance the digital quality measurement (dQM) transition, in the proposed rule, we issued an RFI to gather broad public input on the dQM transition in LTCHs. We also issued an RFI and sought input on the use of Health Level Seven® (HL7® ) Fast Healthcare Interoperability Resources® quality reporting and value-based purchasing pro e dQM transition in LTCHs. We also issued an RFI and sought input on the use of Health Level Seven® (HL7® ) Fast Healthcare Interoperability Resources® quality reporting and value-based purchasing programs. We refer readers to the FY 2026 IPPS/LTCH PPS proposed rule (90 FR 18354 and 18355). (FHIR® ) in certain CMS a. Background We are committed to improving healthcare quality through measurement, transparency, and public reporting of quality data, and to enhancing healthcare data exchange by promoting the adoption of interoperable health IT that enables information exchange using FHIR® standards. We refer readers to the FY 2026 IPPS/LTCH PPS (90 FR 18354 and 18355) for additional background on the dQM transition. We also sought input on future measures under consideration including applicability of interoperability as a future measure concept in post-acute care settings, including the LTCH QRP. Refer to section X.E.5. of this final rule for more information. Any updates specific to the LTCH QRP program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice-and-comment rulemaking, as necessary. b. Solicitation for C LTCH QRP program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice-and-comment rulemaking, as necessary. b. Solicitation for Comment We sought feedback on the current state of health IT use, including electronic health records (EHRs), in LTCH facilities: • To what extent does your LTCH use health IT systems to maintain and exchange patient records? If your facility has transitioned to using electronic records, in part or in whole, what types of health IT does your LTCH use to maintain patient records? Are these health IT systems certified by the Office of the National Coordinator for Health Information Technology (ONC Health IT) Certification Program? If your facility uses health IT products or systems that are not certified under the ONC Health IT Certification Program, please specify. Does your facility use EHRs or other health IT products or systems that are not certified under the ONC Health IT Certification Program? If no, what is the reason for not doing so? Do these other systems exchange data using standards and implementation specifications adopted by HHS? Does your facility maintain any patient reco Program? If no, what is the reason for not doing so? Do these other systems exchange data using standards and implementation specifications adopted by HHS? Does your facility maintain any patient records outside of these electronic systems? If so, are the data organized in a structured format, using codes and recognized standards, that can be exchanged with other systems and providers? • Does your LTCH submit patient assessment data to CMS directly from your health IT system without the assistance of a third-party intermediary? If a third-party intermediary is used to report data, what type of intermediary service is used? How does your facility currently exchange health information with other healthcare providers or systems, specifically between LTCHs and other provider types? What about health information exchange with other entities, such as public health agencies? What challenges do you face with electronic exchange of health information? • Are there any challenges with your current electronic devices (for example, tablets, smartphones, computers) that hinder your ability to easily exchange information across systems? Please describe any specific issues you encounter. Does limi t electronic devices (for example, tablets, smartphones, computers) that hinder your ability to easily exchange information across systems? Please describe any specific issues you encounter. Does limited internet or lack of internet connectivity impact your ability to exchange data with other healthcare providers, including community-based care services, or your ability to submit patient assessment data to CMS? Please specify. • What steps does your LTCH take with respect to the implementation of health IT systems to ensure compliance with applicable security and patient privacy laws, such as HIPAA and its implementing regulations (the HIPAA Privacy, Security, and Breach Notification Rules)? • Does your LTCH refer to the Safety Assurance Factors for EHR Resilience (SAFER) Guides (see newly revised versions published in January 2025 at https://www.healthit.gov/topic/safety/ safer-guides) to self-assess EHR safety practices? • What challenges or barriers does your facility encounter when submitting quality measure data to CMS as part of the LTCH QRP? What opportunities or factors could improve your facility’s successful data submission to CMS? • What types of technical assistance, gu submitting quality measure data to CMS as part of the LTCH QRP? What opportunities or factors could improve your facility’s successful data submission to CMS? • What types of technical assistance, guidance, workforce trainings, and/or other resources would be most beneficial for the implementation of FHIR® -based technology in your facility for the submission of the LCDS to CMS and other existing systems such as CDC’s National Healthcare Safety Network (NHSN) for which LTCHs have current CMS reporting requirements? What strategies can CMS, HHS or other Federal partners take to ensure that technical assistance is both comprehensive and user-friendly? How could Quality Improvement Organizations (QIOs) or other entities enhance this support? • Is your facility using technology that utilizes APIs based on the FHIR® standard to enable electronic data sharing? If so, with whom are you sharing data using the FHIR® standard and for what purpose(s)? For example, have you used FHIR® APIs to share data with public health agencies? Does your facility use any Substitutable Medical Applications and Reusable Technologies (SMART) on FHIR® applications? If so, are the SMART on FHIR® applications i