Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency n and the Median Time for Discharged ED Patients measures as discussed in section XV.B.2. of this proposed rule; and add the Emergency Care Access & Timeliness eCQM as discussed in section XV.B.1. of this proposed rule. BILLING CODE 4120–01–P 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00288 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33763 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00289 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00290 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00291 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00292 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00293 Fmt 4701 Sfmt 4702 E:\FR\F t 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00293 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33768 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules when applicable, to all HCPCS codes to which we have proposed status indicator assignments of ‘‘J1,’’ ‘‘J2,’’ ‘‘P,’’ ‘‘Q1,’’ ‘‘Q2,’’ ‘‘Q3,’’ ‘‘R,’’ ‘‘S,’’ ‘‘T,’’ ‘‘V,’’ and ‘‘U’’ (other than New Technology APCs to which we have proposed status indicator assignments of ‘‘S’’ and ‘‘T’’). We propose to continue to exclude services paid under New Technology APCs. We propose to continue to apply the reporting ratio to the national unadjusted payment rates and the minimum unadjusted and national unadjusted copayment rates of all applicable services for those hospitals that fail to meet the Hospital OQR Program reporting requirements. We also propose to continue to apply all other applicable standard adjustments to the OPPS national unadjusted payment rates for hospitals that fail to meet the requirements of the Ho ng requirements. We also propose to continue to apply all other applicable standard adjustments to the OPPS national unadjusted payment rates for hospitals that fail to meet the requirements of the Hospital OQR Program. Similarly, we propose to continue to calculate OPPS outlier eligibility and outlier payment based on the reduced payment rates for those hospitals that fail to meet the reporting requirements. In addition to our proposal to implement the policy through the use of a reporting ratio, we propose to continue to calculate the reporting ratio to four decimals. For CY 2026, the proposed reporting ratio is 0.9805, which, when multiplied by the proposed full conversion factor of $91.747, equals a proposed conversion factor for hospitals that fail to meet the requirements of the Hospital OQR Program (that is, the reduced conversion factor) of $89.958. XVI. Rural Emergency Hospital Quality Reporting (REHQR) Program A. Background and History of the REHQR Program The Rural Emergency Hospital Quality Reporting (REHQR) Program is intended to ensure transparency and quality for rural emergency hospitals (REHs), defined at section 1861(kkk)(2) of the Act. Section 1861(kkk)(7)(A) aut Hospital Quality Reporting (REHQR) Program is intended to ensure transparency and quality for rural emergency hospitals (REHs), defined at section 1861(kkk)(2) of the Act. Section 1861(kkk)(7)(A) authorizes the Secretary to implement a quality reporting program requiring REHs to submit data on measures in accordance with the Secretary’s requirements in section 1861(kkk)(7). Section 1861(kkk)(7)(B)(ii) requires REHs to submit quality measure data to the Secretary ‘‘in a form and manner, and at a time, specified by the Secretary.’’ The Act does not require the Secretary to provide incentives for submitting this data under the REHQR Program, nor does it require the Secretary to impose penalties for failing to comply with this requirement under the REHQR Program. We refer readers to the CY 2024 OPPS/ASC final rule with comment period (88 FR 82046 through 82047) for a detailed discussion of the history of the REHQR Program. The REHQR Program requirements are codified at 42 CFR 419.95. We also refer readers to the CMS QualityNet REHQR Program website at https:// qualitynet.cms.gov/reh/rehqr for current program requirements and measure specifications.188 B. Proposed Changes to the REHQR lso refer readers to the CMS QualityNet REHQR Program website at https:// qualitynet.cms.gov/reh/rehqr for current program requirements and measure specifications.188 B. Proposed Changes to the REHQR Program Measure Set We propose to adopt the Emergency Care Access & Timeliness electronic clinical quality measure (eCQM) beginning with the CY 2027 reporting period/CY 2029 program determination as an alternative to reporting the Median Time from Emergency Department (ED) Arrival to ED Departure for Discharged ED Patients measure. We also refer readers to section XIV.C. of this proposed rule where we discuss the following proposed measure removals: (1) Hospital Commitment to Health Equity (HCHE) measure, beginning with the CY 2025 reporting period/CY 2027 program determination; (2) Screening for Social Drivers of Health (SDOH) measure, beginning with the CY 2025 reporting period; and (3) Screen Positive Rate for SDOH measure, beginning with the CY 2025 reporting period. 1. Proposed Adoption of the Emergency Care Access & Timeliness eCQM Beginning With Optional Reporting for the CY 2027 Reporting Period/CY 2029 Program Determination a. Background Occupancy and boarding rates in United on of the Emergency Care Access & Timeliness eCQM Beginning With Optional Reporting for the CY 2027 Reporting Period/CY 2029 Program Determination a. Background Occupancy and boarding rates in United States (U.S.) emergency departments (EDs) continue to worsen and exceed pre-pandemic levels.189 ED boarding, defined as holding a patient in the ED when there are no available inpatient beds, often occurs due to shortages of inpatient beds and staff. ED boarding time contributes to ED crowding which heightens safety risks for patients and can lead to stressful working conditions for healthcare personnel.190 A recent report from the 188 For additional information on REHs, we refer readers to a CMS Fact Sheet on REHs (Sept. 2024). Available at https://www.cms.gov/files/document/ rural-emergency-hospitals-factsheet-september- 2024.pdf. 189 Moore, C. & Heckmann R. (2025). Hospital Boarding In The ED: Federal, State, And Other Approaches. Health Affairs Forefront. Available at https://www.healthaffairs.org/content/forefront/ hospital-boarding-ed-federal-state-and-other- approaches. Accessed: April 30, 2025. 190 Moore, C. & Heckmann R. (2025). Hospital Boarding In The ED: Federal, State, And haffairs.org/content/forefront/ hospital-boarding-ed-federal-state-and-other- approaches. Accessed: April 30, 2025. 190 Moore, C. & Heckmann R. (2025). Hospital Boarding In The ED: Federal, State, And Other Approaches. Health Affairs Forefront. Available at https://www.healthaffairs.org/content/forefront/ hospital-boarding-ed-federal-state-and-other- approaches. Accessed: April 30, 2025. Agency for Healthcare Research and Quality (AHRQ) characterized patient ED boarding as a growing public health crisis and engaged interested parties to address the strain on the U.S. healthcare system.191 Recent studies indicate that delays in the timeliness of ED care are associated with patient harm.192 193 Long ED wait times are also one of the most cited reasons for patients leaving an ED without being evaluated by a clinician.194 One recent study indicated that ED crowding can harm sepsis patients by delaying administration of lifesaving intravenous (IV) fluids and antibiotics.195 ED boarding time can lead to an increased length of stay (LOS) which is also a strong predictor of poor timeliness of care. One study found that for every patient boarded, the median ED LOS for all admitted patients can lead to an increased length of stay (LOS) which is also a strong predictor of poor timeliness of care. One study found that for every patient boarded, the median ED LOS for all admitted patients increased by at least 12 minutes.196 While less studied than inpatient boarding, transfer boarding (defined as keeping the patient in the ED after the decision to transfer has been made), can have similar impacts as inpatient boarding, with greater impacts on patients receiving care in rural 191 Agency for Healthcare Research and Quality. (2025). Technical Report: AHQR Summit To Address Emergency Department Boarding. Available at https://www.ahrq.gov/sites/default/ files/wysiwyg/topics/ed-boarding-summit- report.pdf. Accessed: April 30, 2025. 192 Gaieski, D.F., Agarwal, A.K., Mikkelsen, M.E., Drumheller, B., Cham Sante, S., Shofer, F.S., Goyal, M., & Pines, J.M. (2017). The impact of ED crowding on early interventions and mortality in patients with severe sepsis. The American Journal of Emergency Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 193 Laam L.A., Wary A.A., Strony R.S., Fitzpatrick M.H., & Kraus C.K. (2021). Quant ergency Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 193 Laam L.A., Wary A.A., Strony R.S., Fitzpatrick M.H., & Kraus C.K. (2021). Quantifying the impact of patient boarding on emergency department length of stay: All admitted patients are negatively affected by boarding. Journal of American College Emergency Physicians, 2(2):e12401. Available at https://doi.org/10.1002/emp2.12401. Accessed: April 30, 2025. 194 Janke, A.T., Melnick, E.R., & Venkatesh, A.K. (2022). Monthly Rates of Patients Who Left Before Accessing Care in US Emergency Departments, 2017–2021. JAMA, 5(9), e2233708. Available at https://doi.org/10.1001/ jamanetworkopen.2022.33708. Accessed: April 30, 2025. 195 Gaieski, D.F., Agarwal, A.K., Mikkelsen, M.E., Drumheller, B., Cham Sante, S., Shofer, F.S., Goyal, M., & Pines, J.M. (2017). The impact of ED crowding on early interventions and mortality in patients with severe sepsis. The American Journal of Emergency Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 196 Laam L.A., Wary A.A., Strony R.S., Fitzpatrick M.H., & Kraus C.K. (2021). Quantifyin cy Medicine, 35(7), 953–960. Available at https://doi.org/10.1016/j.ajem.2017.01.061. Accessed: April 30, 2025. 196 Laam L.A., Wary A.A., Strony R.S., Fitzpatrick M.H., & Kraus C.K. (2021). Quantifying the impact of patient boarding on emergency department length of stay: All admitted patients are negatively affected by boarding. Journal of American College Emergency Physicians, 2(2):e12401. Available at https://doi.org/10.1002/emp2.12401. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00294 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33769 settings.197 198 The timeliness of care provided at REHs may be further impacted by transfer boarding due to lack of inpatient beds and resources required to coordinate transfers.199 Due to growing concerns about the quality and timeliness of care in the ED as well as the burden associated with manually abstracting the chart- abstracted ED measure adopted in the REHQR Program measure set, the Median Time from ED Arrival to ED Departure for Discharged ED as well as the burden associated with manually abstracting the chart- abstracted ED measure adopted in the REHQR Program measure set, the Median Time from ED Arrival to ED Departure for Discharged ED Patients (Median Time for Discharged ED Patients) measure, CMS is assessing additional ways to support efforts that reduce patient harm and improve outcomes for patients requiring emergency care while also providing flexibility for REHs. We previously sought comment on eCQM reporting under the REHQR Program in the CY 2024 OPPS/ASC proposed rule (88 FR 49840 through 49841). Our proposal to adopt the Emergency Care Access & Timeliness eCQM as an optional measure into the REHQR Program measure set, as discussed in section XVI.C.2.c. of this proposed rule, is in response to public comment recommending that CMS add eCQMs as optional measures initially (88 FR 82070). We refer readers to section XVI.C.2. of this proposed rule for proposed eCQM reporting and submission policies and requirements for the REHQR Program. b. Measure Overview An intermediate outcome measure, the Emergency Care Access & Timeliness eCQM 200 as specified for the 197 Mohr, N.M., Wu,C., Ward, M.J., McNaughton, C.D., Fai or the REHQR Program. b. Measure Overview An intermediate outcome measure, the Emergency Care Access & Timeliness eCQM 200 as specified for the 197 Mohr, N.M., Wu,C., Ward, M.J., McNaughton, C.D., Faine, B., Pomeranz, K., Richardson, K., & Kaboli, P.J. (2022). Transfer boarding delays care more in low-volume rural emergency departments: A cohort study.The Journal of Rural Health: Official Journal of the American Rural Health Association and the National Rural Health Care Association, 38(1), 282–292. Available at https://doi.org/ 10.1111/jrh.12559. Accessed: April 30, 2025. 198 Usher, M., Sahni, N., Herrigel, D., Simon, G., Melton, G.B., Joseph, A., & Olson, A. (2018). Diagnostic Discordance, Health Information Exchange, and Inter-Hospital Transfer Outcomes: A Population Study. Journal of General Internal Medicine, 33(9): 1447–53. Available at https:// doi.org/10.1007/s11606-018-4491-x. Accessed: April 30, 2025. 199 McNaughton, C.D., Bonnet, K., Schlundt, D., Mohr, N.M., Chung, S., Kaboli, P.J., & Ward, M.J. (2020). Rural Interfacility Emergency Department Transfers: Framework and Qualitative Analysis. The Western Journal of Emergency Medicine, 21(4), 858–865. Available at https://d li, P.J., & Ward, M.J. (2020). Rural Interfacility Emergency Department Transfers: Framework and Qualitative Analysis. The Western Journal of Emergency Medicine, 21(4), 858–865. Available at https://doi.org/10.5811/ westjem.2020.3.46059. Accessed: April 30, 2025. 200 The Emergency Care Access & Timeliness eCQM was previously named the Emergency Care Capacity and Quality (ECCQ) eCQM. The name of the measure has been updated to better reflect the purpose of the measure based on feedback from the Pre-Rulemaking Measure Review (PRMR) Hospital Recommendation Group Meeting on January 16, 2025. Available at https://p4qm.org/sites/default/ REH setting calculates the proportion of four outcome metrics that quantify access to and the timeliness of care in an ED setting against specified thresholds, including: (1) patient wait time; (2) whether the patient left the ED without being evaluated; (3) patient transfer boarding time in the ED; and (4) patient ED LOS. The numerator components for the Emergency Care Access & Timeliness eCQM are described in detail in section XVI.B.1.c. of this proposed rule. We note that the population and measure specifications for the Median Time for Discharged ED ergency Care Access & Timeliness eCQM are described in detail in section XVI.B.1.c. of this proposed rule. We note that the population and measure specifications for the Median Time for Discharged ED Patients measure overlaps with the Emergency Care Access & Timeliness eCQM for the numerator outcome metric (4), but that the scope of the proposed Emergency Care Access & Timeliness eCQM is broader than the Median Time for Discharged ED Patients measure.201 The Median Time for Discharged ED Patients measure assesses one component, the time patients spent in the ED before being sent home, also known as ED throughput. The Emergency Care Access & Timeliness eCQM measures four different ED components in a single measure and provides REHs with separate data for each individual component. Additionally, the eCQM measures transfer boarding time in the ED and time from arrival to placement in a treatment room, which is not measured by the Median Time for Discharged ED Patients measure, or any other measure currently in the REHQR Program measure set.202 As discussed later in section XVI.C.2.c. of this proposed rule, to provide flexibility for REHs, we propose that REHs could elect to report eit r measure currently in the REHQR Program measure set.202 As discussed later in section XVI.C.2.c. of this proposed rule, to provide flexibility for REHs, we propose that REHs could elect to report either the Emergency Care Access & Timeliness eCQM or the Median Time for Discharged ED Patients measure beginning with the CY 2027 reporting period/CY 2029 program determination. While CMS proposes that the Emergency Care Access & Timeliness eCQM would not be required to be reported by REHs, REHs must nonetheless elect to report either the Emergency Care Access & Timeliness eCQM or the Median Time for Discharged ED Patient measure to meet program requirements, beginning with the CY 2027 reporting period/CY 2029 program determination. We believe this files/2025-02/PRMR-Hospital-Recommendation- Group-Meeting-Summary.pdf. 201 The Median Time for Discharged ED Patients was adopted in the REHQR Program in the CY 2024 OPPS/ASC final rule with comment period (88 FR 49832). 202 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. timeline would provide REHs sufficient time to test and integrate the Emerg ty Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. timeline would provide REHs sufficient time to test and integrate the Emergency Care Access & Timeliness eCQM into existing clinical workflows. For more information about the testing, feasibility, scientific acceptability, meaningfulness, and validity of the Emergency Care Access & Timeliness eCQM, we refer readers to the ‘‘Feasibility’’ and ‘‘Scientific Acceptability’’ sections of the Emergency Care Access & Timeliness eCQM listing on the Partnership for Quality Measurement website at https:// p4qm.org/measures/4625e. c. Measure Calculation The measure denominator includes all ED encounters by patients of all ages, for all-payers, during a 12-month period of performance. Patients can have multiple encounters during a period of performance and each encounter is eligible to contribute to the calculation of the measure.203 The measure numerator includes any ED encounter in the denominator where the patient experiences any one of the following: (1) the patient waited longer than 1 hour after arrival to the ED to be placed in a treatment room or dedicated treatme unter in the denominator where the patient experiences any one of the following: (1) the patient waited longer than 1 hour after arrival to the ED to be placed in a treatment room or dedicated treatment area that allows for audiovisual privacy during history- taking and physical examination; (2) the patient left the ED without being evaluated; (3) the patient, if transferred, boarded in the ED for longer than 4 hours; 204 or (4) the patient had an ED LOS of longer than 8 hours. An encounter is included in the numerator if any one of the four numerator events occurred with events not being mutually exclusive and each contributing only once to the numerator. ED encounters with ED observation stays 205 are excluded from components (3) and (4). These four outcomes were selected based on published literature demonstrating that each numerator component is associated with patient harm,206 as well as clinical (including 203 For proposed measure specifications, we refer readers to the CMS QualityNet REHQR Program website at https://qualitynet.cms.gov/reh/rehqr. 204 This measure component is calculated at the encounter level by subtracting ‘‘Decision to Transfer’’ order time from ‘‘ED Depart tyNet REHQR Program website at https://qualitynet.cms.gov/reh/rehqr. 204 This measure component is calculated at the encounter level by subtracting ‘‘Decision to Transfer’’ order time from ‘‘ED Departure Time’’ for visits with the ED disposition of ‘‘Transferred’’ (to an acute care hospital), and then flagging as a numerator event if >240 minutes. 205 ED observations stays are defined as an observation encounter where the patient remains physically in an area under control of the ED and under the care of an ED clinician inclusive of observation in a hospital bed. Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/ measures/4625e. Accessed: April 30, 2025. 206 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at Continued VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00295 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33770 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules ED), statistical, and methodological expert input. Additionally, a Technical Expert Panel (TEP) was convened a h k 33770 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules ED), statistical, and methodological expert input. Additionally, a Technical Expert Panel (TEP) was convened by the measure developer.207 The Patient and Family Engagement (PFE) Work Group provided feedback on emergency care experiences such as long wait times to be seen by a provider, long wait times to be transferred, and gaps in discharge processes.208 The numerator thresholds were developed according to evidence and consensus-based clinical guidelines for ED time thresholds from a TEP and environmental scans. For example, the four-hour threshold for numerator component (3), transfer boarding time, was developed per recommendations from The Joint Commission (TJC) and the American College of Emergency Physicians (ACEP).209 If this proposal to adopt the Emergency Care Access & Timeliness eCQM for the REHQR Program is finalized, CMS would closely monitor the effect of this measure in REHs and may revise thresholds as appropriate. Measure testing for the Emergency Care Access & Timeliness eCQM was conducted by the measure developer across 32 hospital-based EDs, representing a diverse mix of ge revise thresholds as appropriate. Measure testing for the Emergency Care Access & Timeliness eCQM was conducted by the measure developer across 32 hospital-based EDs, representing a diverse mix of geographic regions, rurality, hospital size, teaching status, trauma level, and electronic health record (EHR) vendors, demonstrating that the measure is reliable, valid, and feasible for all required data elements.210 Measure testing results had a wide range in overall scores, and across all strata, indicating variation in performance and implying room for quality improvement.211 Although data element feasibility testing was performed at only one REH, the measure was also tested at a few rural hospital-based EDs with similar characteristics of pre-conversion https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 207 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 208 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 209 Yale New Haven Health Services Corporation. (2024). Technical Expert Pane Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 209 Yale New Haven Health Services Corporation. (2024). Technical Expert Panel (TEP) Evaluation of Measure Emergency Care Capacity and Quality Electronic Clinical Quality Measure (eCQM). Available at https://mmshub.cms.gov/sites/default/ files/ECCQ-TEP-Summary-Report-081624.pdf. Accessed: April 30, 2025. 210 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 211 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. REHs (for example, average bed range of under 25).212 Based on this, we believe these measure testing results are applicable to REHs. The measure score is calculated at the individual ED level as the proportion of ED encounters where any one of the four outcomes occurred, divided by the number of encounters in a performance period. For CMS Certification Numbers (CCNs) with more than one ED, individual ED scores are then combined as a weighted average for that CCN.213 , divided by the number of encounters in a performance period. For CMS Certification Numbers (CCNs) with more than one ED, individual ED scores are then combined as a weighted average for that CCN.213 The results of the Emergency Care Access & Timeliness eCQM are stratified into four groups, two by age (18 and older, and under 18) and two by mental health diagnoses (with, and without).214 We note that the approach to stratification by age and mental health diagnosis is sufficient to account for differences between REHs without further need for risk adjustment. For additional details regarding the proposed measure specifications, we refer readers to the CMS QualityNet REHQR Program website at https:// qualitynet.cms.gov/reh/rehqrhttps:// qualitynet.cms.gov/outpatient. d. Pre-Rulemaking Measure Review (PRMR) As required under section 1890A of the Act, the Secretary must establish and follow a pre-rulemaking process for selection of quality and efficiency measures, including for the REHQR Program. The pre-rulemaking process, which we refer to as the Pre-Rulemaking Measure Review (PRMR), includes a review of measures published on the publicly available list of Measures Under Considerat Program. The pre-rulemaking process, which we refer to as the Pre-Rulemaking Measure Review (PRMR), includes a review of measures published on the publicly available list of Measures Under Consideration (MUC List) by one of several committees convened by the consensus-based entity (CBE), with which we contract in accordance with section 1890 of the Act, for the purpose of providing interested parties input to the Secretary on the selection of quality and efficiency measures under consideration for use in certain Medicare quality programs, including 212 Partnership for Quality Measurement. 7.1 Supplemental Attachment. Available at https:// p4qm.org/sites/default/files/2024-10/4625e-section- 7.1-supplemental-attachment.pdf. Accessed: April 30, 2025. 213 Because REHs are typically a low volume setting, volume standardization is not applied to calculate the Emergency Care Access & Timeliness eCQM, unlike the version of the Emergency Care Access & Timeliness eCQM proposed for the Hospital OQR Program in section XV.B.1. this proposed rule. 214 The principal diagnosis (first listed diagnosis at ED discharge) will be used to define strata inclusion. For this measure’s purpose, mental heal OQR Program in section XV.B.1. this proposed rule. 214 The principal diagnosis (first listed diagnosis at ED discharge) will be used to define strata inclusion. For this measure’s purpose, mental health diagnoses do not include substance use disorder diagnoses. Mental health refers to mental health diagnoses, life stressors and crises, and stress-related physical symptoms. the REHQR Program. We refer readers to the CY 2025 OPPS/ASC final rule with comment period (89 FR 94372) for details on the PRMR process, including the voting procedures used to reach consensus on measure recommendations. The PRMR Hospital Recommendation Group met on January 15 and 16, 2025, to review measures included by the Secretary on the publicly available ‘‘2024 Measures Under Consideration List’’ (MUC List), including the Emergency Care Access & Timeliness eCQM (MUC2024–095), and provided additional recommendations on the potential use of this measure.215 The voting results of the PRMR Hospital Recommendation Group for the proposed Emergency Care Access & Timeliness eCQM within the REHQR Program were: 9 members recommended adopting the measure into the REHQR Program; 6 members recommended adoption with con Group for the proposed Emergency Care Access & Timeliness eCQM within the REHQR Program were: 9 members recommended adopting the measure into the REHQR Program; 6 members recommended adoption with conditions; 11 members voted not to recommend the measure for adoption. No voting category reached 75 percent or greater, including the combination of the recommend and the recommend with conditions categories and thus, the Hospital Recommendation Group did not reach consensus.216 The PRMR Hospital Recommendation Group noted in their deliberations that the measure will provide important insights into ED wait times which impact experience of care. The Group expressed concern that this measure may cause an increase in cost of care due to patients being transferred from the ED to observation.217 While we acknowledge that patients transferred from the ED to observation may result in increased short-term costs due to additional monitoring and extended stays, the measure is designed to address significant issues surrounding the access to timely care which have been proven to reduce long-term 215 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommen ificant issues surrounding the access to timely care which have been proven to reduce long-term 215 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 216 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 217 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00296 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal 025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00296 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33771 costs.218 Hospital Recommendation Group members also expressed concern about the lack of CBE endorsement. We note that we submitted the Emergency Care Access & Timeliness eCQM for CBE endorsement for review in the Fall 2024 cycle and the CBE endorsed the measure with conditions for use in the REHQR Program on February 12, 2025.219 220 We refer readers to section XVI.B.1.e. of this proposed rule for additional details on CBE endorsement. The Hospital Recommendation Group discussed a few conditions specific to the REHQR Program, including changing the name of the measure to better reflect the measure’s focus.221 We agree with this feedback and have changed the name of the measure from the Emergency Care Capacity and Quality eCQM to Emergency Care Access & Timeliness. Additionally, Group members recommended stratifying the measure by factors such as care type as well as by region and trauma level designation. We d Quality eCQM to Emergency Care Access & Timeliness. Additionally, Group members recommended stratifying the measure by factors such as care type as well as by region and trauma level designation. We emphasize that the approach to stratification by age and mental health diagnosis is sufficient to account for differences between REHs without further need for additional stratification.222 The Hospital Recommendation Group recommended revising the measure specifications to create separate measure components with the encouragement to explore additional measures for patient transfer boarding time and ED LOS as well as conducting further testing to expand the measure’s applicability to REHs. We acknowledge the Hospital 218 Dyas, S.R., Greenfield, E., Messimer, S., Thotakura, S., Gholston, S., Doughty, T., Hays, M., Ivey, R., Spalding, J., & Phillips, R. (2015). Process- Improvement Cost Model for the Emergency Department. Journal of Healthcare Management, 60(6): 442–57. Available at https://doi.org/10.1097/ 00115514-201511000-00011. Accessed: April 30, 2025. 219 Partnership for Quality Measurement. (2024). 2024 Pre-Rulemaking Measure Review Preliminary Assessment. Available at: https:// /doi.org/10.1097/ 00115514-201511000-00011. Accessed: April 30, 2025. 219 Partnership for Quality Measurement. (2024). 2024 Pre-Rulemaking Measure Review Preliminary Assessment. Available at: https://p4qm.org/sites/ default/files/2024-12/PRMR-PA-MUC2024-075.pdf. Accessed: April 30, 2025. 220 Partnership for Quality Measurement. (2025). Fall 2024 Cycle Endorsement and Maintenance (E&M) Technical Report. Available at https:// p4qm.org/sites/default/files/Initial%20 Recognition%20and%20Management/material/EM- Fall-2024-Initial-Recognition-Final-Project- Report.pdf. Accessed: April 30, 2025. 221 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. 222 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. endation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 30, 2025. Recommendation Group’s concerns and note that multiple TEPs and interested parties supported the inclusion of more than one numerator component as a strategy for internally balancing the measure and that time thresholds are based on more than a decade of consensus work.223 224 225 If the proposal to adopt the Emergency Care Access & Timeliness eCQM for the REHQR Program is finalized, CMS will closely monitor the effect of this measure in REHs and revise thresholds as appropriate. We note that out of the 32 hospital-based EDs that were tested for reliability, validity, and feasibility, approximately 20 percent were rural EDs, although not in the REHQR Program. Finally, Group members recommended implementing the Emergency Care Access & Timeliness eCQM with a phased approach with 2 years of voluntary reporting. We note that we propose adoption of the Emergency Care Access & Timeliness eCQM as an optional measure in lieu of the Median Time for Discharged ED Patients measure to provide add voluntary reporting. We note that we propose adoption of the Emergency Care Access & Timeliness eCQM as an optional measure in lieu of the Median Time for Discharged ED Patients measure to provide additional flexibility for REHs given the anticipated implementation burden of this measure. e. Measure Endorsement and Consideration of Low Case Volumes Section 1861(kkk)(7)(C)(i) of the Act generally provides that any measure specified by the Secretary for use in the REHQR Program be endorsed by the entity with a contract under section 1890(a) of the Act, also known as the consensus-based entity (CBE). The Emergency Care Access & Timeliness eCQM was submitted to the CBE for endorsement review in the Fall 2024 cycle (CBE #4625e), and the CBE endorsed the measure for use in the REHQR Program with conditions on February 12, 2025.226 The conditions 223 Partnership for Quality Measurement. Emergency Care Capacity and Quality. Available at https://p4qm.org/measures/4625e. Accessed: April 30, 2025. 224 Yale New Haven Health Services Corporation. (April 2024). Technical Expert Panel (TEP) Evaluation of Measure Emergency Care Capacity and Quality Electronic Clinical Quality Measure (eCQM). Avail . 224 Yale New Haven Health Services Corporation. (April 2024). Technical Expert Panel (TEP) Evaluation of Measure Emergency Care Capacity and Quality Electronic Clinical Quality Measure (eCQM). Available at https://mmshub.cms.gov/ sites/default/files/ECCQ-TEP-2-Summary- Report.pdf. Accessed: April 30, 2025. 225 Yale New Haven Health Services Corporation. (September 2024). Technical Expert Panel (TEP) Evaluation of Measure Emergency Care Capacity and Quality Electronic Clinical Quality Measure (eCQM). Available at https://mmshub.cms.gov/ sites/default/files/ECCQ-TEP-Summary-Report- 081624.pdf. Accessed: April 30, 2025. 226 Partnership for Quality Measurement. (2025). Fall 2024 Cycle Endorsement and Maintenance (E&M) Technical Report. Available at https:// p4qm.org/sites/default/files/Initial%20 Recognition%20and%20Management/material/EM- Fall-2024-Initial-Recognition-Final-Project- Report.pdf. Accessed: April 30, 2025. include that the measure developer explore: (1) the unintended consequences to patients and providers by engaging with the patient community and accountable entities; and (2) the data elements to identify and address where challenges may persist. If our proposal to a equences to patients and providers by engaging with the patient community and accountable entities; and (2) the data elements to identify and address where challenges may persist. If our proposal to adopt the Emergency Care Access & Timeliness eCQM for the REHQR Program is finalized, CMS would closely monitor the effects of this measure in REHs and data as part of the standard measure maintenance. We believe this measure is appropriate for measuring quality of care under the REHQR Program because ED care is the primary focus of REHs. Furthermore, we believe that this measure meets the selection criteria under section 1861(kkk)(7)(C)(i) of the Act because it is endorsed by the CBE. The REHQR Program’s statute also includes a requirement at section 1861(kkk)(7)(C)(iii) of the Act to consider ways to account for rural emergency hospitals that lack sufficient case volumes when selecting measures to ensure that the performance rates for such measures are reliable. We note that the target population for this measure is comprised of patients of all ages, for all payers, that visit an REH during a 1-year measurement period. As such, we anticipate that the overall number of patients that vi pulation for this measure is comprised of patients of all ages, for all payers, that visit an REH during a 1-year measurement period. As such, we anticipate that the overall number of patients that visit an REH within a given year would be high enough so that there would not be any issues with low case volumes that could undermine the reliability of this measure when used in the REH context. We therefore do not believe the Emergency Care Access & Timeliness eCQM would suffer from low case volumes, and we further believe that we have appropriately considered low case volumes as required by the REHQR statute when selecting this measure. f. Data Collection, Submission, and Reporting The Emergency Care Access & Timeliness eCQM is specified in a standard electronic format, utilizing data extracted electronically from EHRs, with all data coming from defined fields in electronic sources. We note that eCQMs allowing for the retrieval of data directly from the EHR will minimize errors due to manual abstraction of data.227 As discussed in section XVI.C.2.c. of this proposed rule, we propose that REHs would be required to 227 Centers for Medicare & Medicaid Services. (2023). Electronic Clinic nual abstraction of data.227 As discussed in section XVI.C.2.c. of this proposed rule, we propose that REHs would be required to 227 Centers for Medicare & Medicaid Services. (2023). Electronic Clinical Quality Measures (eCQMs) Specification, Testing, Standards, Tools, and Community. Available at https:// mmshub.cms.gov/sites/default/files/eCQM- Specifications-Testing-Standards-Tools- Community.pdf. Accessed: April 30, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00297 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33772 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules report either the Emergency Care Access & Timeliness eCQM or the Median Time for Discharged Patients measure. We refer readers to section XVI.C.2.c. of this proposed rule for a discussion of proposed eCQM form, manner, and timing of data submission and reporting requirements. If an REH chooses to report the Emergency Care Access & Timeliness eCQM, the REH would report the data using the proposed methods and standards specified in section XVI.C.2. of this proposed rule. We propose to adopt the report the Emergency Care Access & Timeliness eCQM, the REH would report the data using the proposed methods and standards specified in section XVI.C.2. of this proposed rule. We propose to adopt the Emergency Care Access & Timeliness eCQM into the REHQR Program measure set beginning with the CY 2027 reporting period/CY 2029 program determination. However, as discussed later in section XVI.C.2.c. of this proposed rule, we also propose that the Emergency Care Access & Timeliness eCQM would not be a required measure under the REHQR Program, and that REHs could thus elect to report either the Emergency Care Access & Timeliness eCQM or the Median Time for Discharged ED Patients measure for a given reporting period/ program determination. Providing REHs with the option to report either of these measures would provide greater flexibility for REHs to implement EHR infrastructure that meets their individual needs while still prioritizing measurement of the variation in access to and the timeliness of emergency care, the goal of promoting interoperability, and reducing burden for REHs in the long term. We note that adoption of this measure does not change the number of mandatory quality mea ness of emergency care, the goal of promoting interoperability, and reducing burden for REHs in the long term. We note that adoption of this measure does not change the number of mandatory quality measures required to be reported in the REHQR measure set. The Median Time for Discharged ED Patients measure assesses the time patients spent in the ED before being sent home, also known as ED throughput. We note that this measure is reported quarterly, compared to the Emergency Care Access & Timeliness eCQM, which is less burdensome as it is reported annually. We further emphasize that the Emergency Care Access & Timeliness eCQM measures four different ED metric components in a single measure and is more comprehensive than the Median Time for Discharged ED Patients measure which measures one ED metric component.228 Additionally, the eCQM measures transfer boarding time in the ED and time from arrival to placement in a treatment room, which are not currently captured by the Median Time for Discharged ED Patients measure, or any other measure currently in the REHQR Program measure set.229 We refer readers to section XV.B.1. of this proposed rule where we propose adoption of a similar vers ischarged ED Patients measure, or any other measure currently in the REHQR Program measure set.229 We refer readers to section XV.B.1. of this proposed rule where we propose adoption of a similar version of this eCQM for the Hospital Outpatient Quality Reporting Program. If CMS finalizes that proposal, adoption of this eCQM in the REHQR Program would also provide greater alignment with HOPD metrics. We refer readers to the CY 2024 OPPS/ASC final rule with comment 228 The Median Time for Discharged ED Patients was adopted in the REHQR Program in the CY 2024 OPPS/ASC final rule with comment period (88 FR 49832). period (88 FR 49832) for more information on the Median Time for Discharged ED Patients measure.230 We intend to publicly report data submitted on the Emergency Care Access & Timeliness eCQM and the Median Time for Discharged ED Patients measure on our Compare tool on Medicare.gov (https:// www.medicare.gov/care-compare/) or their successor websites after a 30-day preview period. Public reporting for both measures help to provide similar data on timeliness and encourage REHs to implement process improvements and reduce inefficiencies in ED operations, resulting in better qual Public reporting for both measures help to provide similar data on timeliness and encourage REHs to implement process improvements and reduce inefficiencies in ED operations, resulting in better quality of care. We invite public comment on this proposal. 2. Summary of Previously Finalized and Newly Proposed REHQR Program Measure Set for CY 2026 to CY 2031 Program Determinations Table 85 summarizes the previously finalized and newly proposed REHQR Program measure set for the CY 2026 to CY 2031 program determinations, which would remove the Hospital Commitment to Health Equity (HCHE), Screening for SDOH, and Screen Positive Rate for SDOH measures as discussed in section XIV.C. of this proposed rule and add the Emergency Care Access & Timeliness eCQM as discussed in section XVI.B.1. of this proposed rule. 229 Partnership for Quality Measurement. 230 Partnership for Quality Measurement. Median Emergency care capacity and quality. Available at: https://p4qm.org/measures/4625e. Accessed: April 30, 2025. Time from ED Arrival to ED Departure for Discharged ED Patients. Available at: https:// p4qm.org/measures/0496. Accessed: April 30, 2025. 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W ril 30, 2025. Time from ED Arrival to ED Departure for Discharged ED Patients. Available at: https:// p4qm.org/measures/0496. Accessed: April 30, 2025. 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00298 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33773 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00299 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00300 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33775 eCQMs specifications are updated to a more recent version. Requiring EHRs to be certified to all available eCQMs under the REHQR Program would produce greater certainty for REHs that their EHR systems are capable of accurately calculating the eCQMs under the REHQR Program because the EHR technology would be up to d er the REHQR Program would produce greater certainty for REHs that their EHR systems are capable of accurately calculating the eCQMs under the REHQR Program because the EHR technology would be up to date and tested on each eCQM. We believe this would reduce burden on REHs by minimizing the need to consult with their EHR and other health information technology vendors each time they report on a new or different eCQM. Finally, we also propose to codify at § 419.95(h)(4) that the requirements set forth in paragraphs (h)(1) through (3) apply only where an REH opts to report an eCQM. We invite public comment on these proposals. (2) File Format for EHR Data, Zero Denominator Declarations, and Case Threshold Exemptions (a) File Format for EHR Data Data can be collected in EHRs and health information technology systems using standardized formats to promote consistent representation, interpretation, and allowance for systems to compute data without needing human interpretation. As described in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49701), these standards are referred to as content exchange standards because the standard details how data should be represented and the relationships betw the FY 2016 IPPS/LTCH PPS final rule (80 FR 49701), these standards are referred to as content exchange standards because the standard details how data should be represented and the relationships between data elements. This allows the data to be exchanged across EHRs and health IT systems while retaining their meaning. Commonly used content exchange standards include the Quality Reporting Document Architecture (QRDA). The QRDA standard provides a document format and standard structure to electronically report quality measure data. We believe electronically reporting data elements formatted according to the QRDA standard can promote consistent representation and more efficient calculation of eCQM measure results. To utilize the same file format requirements currently applied in the Hospital IQR, OQR, and Medicare Promoting Interoperability Programs (85 FR 58940, 86 FR 42262, and 80 FR 49706, respectively), we propose the file format requirements for the REHQR Program beginning with the CY 2027 reporting period/CY 2029 program determination. Specifically, we propose that REHs: (1) must submit eCQM data via the QRDA Category I (QRDA I) file format; 231 (2) may use third parties to sub CY 2027 reporting period/CY 2029 program determination. Specifically, we propose that REHs: (1) must submit eCQM data via the QRDA Category I (QRDA I) file format; 231 (2) may use third parties to submit QRDA I files on their behalf; and (3) may either use abstraction or pull the data from non-certified sources in order to then input these data into CEHRT for capture and reporting QRDA I. REHs could meet the reporting requirements by submitting data via QRDA I files, zero denominator declaration, or case threshold exemptions. We discuss the zero-denominator declaration and case threshold exemptions in the subsequent sections. We also refer readers to section XVI.C.1. of this proposed rule where we outline the maintenance of technical specifications including those for eCQMs. Under this proposal, we expect QRDA I files to reflect data for one patient per file per quarter with five key elements necessary to identify the file: (1) CCN; (2) CMS Program Name; (3) EHR Patient ID; (4) Reporting period specified in the Reporting Parameters Section; and (5) EHR Submitter ID. (b) Zero Denominator Declarations We understand there may be situations in which an REH does not have data to report ng period specified in the Reporting Parameters Section; and (5) EHR Submitter ID. (b) Zero Denominator Declarations We understand there may be situations in which an REH does not have data to report on a particular eCQM. Therefore, we propose if the REH’s EHR is certified to an eCQM, but the REH does not have patients that meet the denominator criteria of that eCQM, the REH could submit a zero in the denominator for that eCQM; submission of a zero in the denominator for an eCQM would qualify as a successful submission for that eCQM. (c) Case Threshold Exemptions As a general matter, we understand that in some cases, particularly for REHs, an REH may not meet the applicable case threshold of encounters or discharges for a particular eCQM to reliably calculate performance on the measure. We propose to align with the case threshold exemption from the Medicare Promoting Interoperability Program (77 FR 54080), the Hospital IQR Program (79 FR 50324), and the Hospital OQR Program (86 FR 63869). As stated for the Hospital IQR Program, the case threshold exemption means that for each quality measure where the minimum number of patients that meet the patient population denominator criteria 9). As stated for the Hospital IQR Program, the case threshold exemption means that for each quality measure where the minimum number of patients that meet the patient population denominator criteria for the relevant reporting period is not met, REHs could declare a ‘‘case threshold exemption.’’ Specifically, for the REHQR Program, we propose that beginning with the CY 2027 reporting period/CY 2029 program determination, if an REH’s EHR system is certified to report an eCQM and the REH has 5 or fewer outpatient encounters or discharges per quarter or 20 or fewer outpatient encounters or discharges per year (Medicare and non-Medicare combined), as defined by an eCQM’s denominator population, that REH would be exempt from reporting on that eCQM. Case threshold exemptions would be able to be entered on the Denominator Declaration screen within the Hospital Quality Reporting (HQR) System (formerly referred to as the QualityNet Secure Portal) available during the submission period.232 The exemption would not have to be used; REHs could report those individual cases if they would like to. We invite public comment on these proposals. (3) Proposed Submission Deadlines for eCQM Data To alig xemption would not have to be used; REHs could report those individual cases if they would like to. We invite public comment on these proposals. (3) Proposed Submission Deadlines for eCQM Data To align with the Hospital OQR Program, we propose to adopt a policy to require eCQM data submission by May 15 of the following year for the applicable CY reporting period, beginning with the CY 2027 reporting period/CY 2029 program determination. For example, if an REH elects to report the Emergency Care Access & Timeliness eCQM, the first proposed reporting period would run from January 1, 2027 through December 31, 2027, with a submission deadline of May 15, 2028. We note that the submission deadline may be moved to a subsequent day if it falls on a non- working day for federal employees such as weekends or Federal holidays. We invite public comment on this proposal. c. Proposed Data Submission and Reporting Requirements for the Emergency Care Access & Timeliness eCQM Beginning With the CY 2027 Reporting Period/CY 2029 Program Determination In section XVI.B.1. of this proposed rule, we discuss the proposed adoption of the Emergency Care Access & Timeliness eCQM into the REHQR Program beginn Reporting Period/CY 2029 Program Determination In section XVI.B.1. of this proposed rule, we discuss the proposed adoption of the Emergency Care Access & Timeliness eCQM into the REHQR Program beginning with the CY 2027 reporting period/CY 2029 program 231 QRDA I is an individual patient-level quality report that contains quality data for one patient for one or more eCQMs. QRDA creates a standard method to report quality measure results in a structured, consistent format and can be used to exchange eCQM data between systems. For further detail on QRDA I, the most recently available QRDA I specifications and Implementation Guides (IGs) can be found at: https://ecqi.healthit.gov/qrda?qt- tabs_qrda=versions. 232 The Hospital Quality Reporting (HQR) System (formerly referred to as the QualityNet Secure Portal) is the only CMS-approved website for secure communications and healthcare quality data exchange to and within various CMS quality reporting programs. For more information regarding the HQR System, we refer readers to the CMS eCQI Resource Center (https://ecqi.healthit.gov/tool/ hospital-quality-reporting-hqr-system). VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00 the HQR System, we refer readers to the CMS eCQI Resource Center (https://ecqi.healthit.gov/tool/ hospital-quality-reporting-hqr-system). VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00301 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33776 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules determination as an option for REHs to report instead of the Median Time for Discharged ED Patients measure. In addition to the general data submission and reporting requirements proposed for eCQMs in section XVI.C.2. of this proposed rule, we also propose requirements for reporting the Emergency Care Access & Timeliness eCQM under the REHQR Program. Specifically, we propose that the Emergency Care Access & Timeliness eCQM would not be required to be reported by REHs under the REHQR Program, but that REHs must elect to report either the Emergency Care Access & Timeliness eCQM or the Median Time for Discharged ED Patients measure to meet program requirements, beginning with the CY 2027 reporting period/CY 2029 program determination. We believe our proposed approach would provide Median Time for Discharged ED Patients measure to meet program requirements, beginning with the CY 2027 reporting period/CY 2029 program determination. We believe our proposed approach would provide REHs with more flexibility, including the time to plan and budget for the type of EHR infrastructure that meets their needs. Additionally, we believe this approach could contribute to successful participation in the REHQR Program, while still requiring REHs to report timeliness of ED care metrics. We note that the Median Time for Discharged ED Patients measure is reported quarterly through the HQR system, compared to the Emergency Care Access & Timeliness eCQM, which is reported annually. Sources of the relevant data for the Median Time for Discharged ED Patients measure may include claims forms, electronic health care data, EHRs, or paper records. We refer readers to the CY 2024 OPPS/ASC final rule with comment period (88 FR 82059 through 82062; 88 FR 82074 through 82075) for additional information on reporting the chart- abstracted Median Time for Discharged ED Patients measure.233 We propose to report data from the REHQR Program as soon as it is feasible on CMS websites such as the nformation on reporting the chart- abstracted Median Time for Discharged ED Patients measure.233 We propose to report data from the REHQR Program as soon as it is feasible on CMS websites such as the Compare tool on Medicare.gov (https:// www.medicare.gov/care-compare/) or their successor websites after a 30-day preview period. We invite public comment on these proposals. 3. Review and Corrections Period for Measure Data Submitted to the REHQR Program In the CY 2024 OPPS/ASC final rule with comment period (88 FR 82075 through 82076), we finalized and codified at § 419.95(c)(3) a review and 233 For additional information on the Median Time for Discharged ED Patients measure, we refer readers to the specifications manuals for the REHQR Program, located at: https:// qualitynet.cms.gov/reh/specifications-manuals. corrections period for all measure data submitted to the REHQR Program, which runs concurrently with the data submission period. During the review and corrections period, REHs can review, correct, and change these data up until the close of each submission deadline. However, after the submission deadline, REHs are not allowed to change these data. This policy applies to all me review, correct, and change these data up until the close of each submission deadline. However, after the submission deadline, REHs are not allowed to change these data. This policy applies to all measure data submitted to the REHQR Program, so this would include eCQM data. The review and corrections period is from the time the submission period opens to the submission deadline. In the HQR System, REHs can submit QRDA Category I test and production data files and can correct QRDA Category I test and production data files before production data is submitted for final reporting. We encourage early testing and the use of pre-submission testing tools to reduce errors and inaccurate data submissions in eCQM reporting. We refer readers to the HQR System website (available at https:// hqr.cms.gov/hqrng/login) and the CMS eCQI Resource Center (available at https://ecqi.healthit.gov/tool/hospital- quality-reporting-hqr-system) for more resources on eCQM reporting. 4. REHQR Program Extraordinary Circumstances Exceptions (ECE) Policy We refer readers to section XIV.D. of this proposed rule for our cross-program proposal to codify updates to the Extraordinary Circumstances Exceptions (ECE) po y Circumstances Exceptions (ECE) Policy We refer readers to section XIV.D. of this proposed rule for our cross-program proposal to codify updates to the Extraordinary Circumstances Exceptions (ECE) policy for the REHQR Program. XVII. Ambulatory Surgical Center Quality Reporting (ASCQR) Program A. Background and History of the ASCQR Program The Ambulatory Surgical Center Quality Reporting (ASCQR) Program is a pay-for-reporting program intended to ensure transparency for quality of care provided at ambulatory surgical centers (ASCs). Section 1833(i)(7)(A) of the Act authorizes the Secretary to reduce any annual increase under the revised ambulatory surgical center (ASC) payment system by 2.0-percentage points for such year that an ASC fails to submit required data on quality measures specified by the Secretary in accordance with section 1833(i)(7)(B) of the Act. Section 1833(i)(7)(B) of the Act states that, except as the Secretary may otherwise provide, several of the statutory provisions governing the Hospital Outpatient Quality Reporting (OQR) Program, specifically sections 1833(t)(17)(B) through (E) of the Act, also apply to the services of ASCs under the ASCQR Program in a simila s governing the Hospital Outpatient Quality Reporting (OQR) Program, specifically sections 1833(t)(17)(B) through (E) of the Act, also apply to the services of ASCs under the ASCQR Program in a similar manner to the manner in which they apply to the services of hospital outpatient departments under the Hospital OQR Program. We refer readers to the CY 2012 OPPS/ASC final rule with comment period (76 FR 74492 through 74494) for a detailed discussion of the statutory authority of the ASCQR Program. The ASCQR Program requirements are codified at 42 CFR part 416, subpart H (§§ 416.300 through 416.330). We refer readers to the CMS website at https:// www.cms.gov/medicare/quality/ initiatives/asc-quality-reporting for general background on the ASCQR Program, as well as the CMS QualityNet ASCQR website at https:// qualitynet.cms.gov/asc for current program requirements and measure specifications. B. Proposed Changes to the ASCQR Program Measure Set We propose to adopt the Patient Understanding of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure (Information Transfer PRO–PM) beginning with volunta of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure (Information Transfer PRO–PM) beginning with voluntary reporting for the CY 2027 and CY 2028 reporting periods followed by mandatory reporting beginning with the CY 2029 reporting period/CY 2031 payment determination. We refer readers to section XIV.C. of this proposed rule for a discussion of the following proposed measure removals: (1) the COVID–19 Vaccination Coverage Among Healthcare Personnel (HCP) measure, beginning with the CY 2024 reporting period/CY 2026 payment determination; (2) the Facility Commitment to Health Equity (FCHE) measure, beginning with the CY 2025 reporting period/CY 2027 payment determination; (3) the Screening for Social Drivers of Health (SDOH) measure, beginning with the CY 2025 reporting period; and (4) the Screen Positive Rate for SDOH measure, beginning with the CY 2025 reporting period. 1. Proposed Adoption of the Information Transfer PRO–PM Beginning With Voluntary Reporting for the CY 2027 and CY 2028 Reporting Periods Followed by Mandatory Reporting Beginning With the CY 2029 Reporting Period/CY 2031 of the Information Transfer PRO–PM Beginning With Voluntary Reporting for the CY 2027 and CY 2028 Reporting Periods Followed by Mandatory Reporting Beginning With the CY 2029 Reporting Period/CY 2031 Payment Determination a. Background The volume and complexity of surgical procedures performed in outpatient settings, including ASCs, have steadily increased for over a VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00302 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33777 decade.234 235 236 As patients can benefit from having a clear understanding of their discharge information to support recovery from such procedures, the communication of discharge information is an important quality of care area for assessing facilities, and this information should be publicly available. A patient’s lack of understanding of clinical care instructions provided after a procedure and other aspects of health literacy have been linked to poor adherence to treatment, decreased patient safety, increased return to the emergency department, a instructions provided after a procedure and other aspects of health literacy have been linked to poor adherence to treatment, decreased patient safety, increased return to the emergency department, and lower levels of patient satisfaction; disproportionately increased rates of such adverse effects occur to patients with limited English proficiency and patients over age 65.237 238 Research in the hospital setting indicates that information provided to patients that is simpler and more complete is associated with fewer follow-up calls to an associated trauma center and less frequent hospital readmissions.239 240 A study comparing discharge instructions provided to patients who had procedures performed in inpatient and ambulatory settings found that discharge instructions from the inpatient setting contained more complete medication lists and pending 234 DelSole, E.M., Makanji, H.S., & Kurd, M.F. (2019). Current trends in ambulatory spine surgery: a systematic review. J Spine Surg. 5(Suppl 2):S124– S132. https://doi.org/10.21037/jss.2019.04.12. Accessed: April 29, 2025. 235 Kondamuri, N.S., Miller, A.L., Rathi, V.K., et al. (2020). Trends in Ambulatory Surgery Center Utilization for pl 2):S124– S132. https://doi.org/10.21037/jss.2019.04.12. Accessed: April 29, 2025. 235 Kondamuri, N.S., Miller, A.L., Rathi, V.K., et al. (2020). Trends in Ambulatory Surgery Center Utilization for Otolaryngologic Procedures among Medicare Beneficiaries, 2010–2017. Otolaryngol Head Neck Surg. 162(6):873–880 https://doi.org/ 10.1177/0194599820914298. Accessed: April 29, 2025. 236 Shariq, O.A., Bews, K.A., Etzioni, D.A., et al. (2023). Performance of General Surgical Procedures in Outpatient Settings Before and After Onset of the COVID–19 Pandemic. JAMA Netw Open.; 6(3):e231198. Doi:10.1001/jamanetworkopen. 2023.1198. Accessed: April 29, 2025. 237 DeSai, C., Janowiak, K., Secheli, B., et al. (2021). Empowering patients: simplifying discharge instructions. BMJ Open Quality;10(3)001419. http:// doi.org/10.1136/bmjoq-2021-001419. Accessed: April 8, 2025. 238 Malevanchik, L., Wheeler, M., Gagliardi, K., Karliner L., & Shah, S. J. (2021). Disparities After Discharge: The Association of Limited English Proficiency and Postdischarge Patient-Reported Issues, The Joint Commission Journal on Quality and Patient Safety, 47(12):775–782. https://doi.org/ 10.1016/j.jcjq.2021.08.013. Accessed: Ap ted English Proficiency and Postdischarge Patient-Reported Issues, The Joint Commission Journal on Quality and Patient Safety, 47(12):775–782. https://doi.org/ 10.1016/j.jcjq.2021.08.013. Accessed: April 8, 2025. 239 Choudhry, A.J., Younis, M., Ray-Zack, M.D., et al. (2019). Enhanced readability of discharge summaries decreases provider telephone calls and patient readmissions in the posthospital setting. Surgery. 165(4):789–794. https://doi.org/10.1016/ j.surg.2018.10.014. Accessed: April 8, 2025. 240 Becker, C., Zumbrunn, S., Beck, K., et al. (2021). Interventions to Improve Communication at Hospital Discharge and Rates of Readmission: A Systematic Review and Meta-analysis. JAMA Netw Open. 4(8):e2119346. https://doi.org/10.1001/ jamanetworkopen.2021.19346. Accessed: April 8, 2025. diagnostic result elements compared to discharge instructions provided by the hospital ambulatory setting.241 b. Measure Overview The Information Transfer PRO–PM assesses patient understanding of provided discharge information for patients aged 18 years or older who had a procedure (surgical or non-surgical) at an ASC via a 9-item survey.242 The survey evaluates patient reported understanding of informa ischarge information for patients aged 18 years or older who had a procedure (surgical or non-surgical) at an ASC via a 9-item survey.242 The survey evaluates patient reported understanding of information received across three domains: applicability to patient needs, medication, and daily activities. Survey results provide patient reported outcome (PRO) data measuring ASCs’ communication efforts regarding discharge instructions and enable ASCs to reduce future risk of patient harm related to patients not fully understanding their recovery information. The survey was tested and deemed reliable in both English and Spanish versions; for ease of administration, the survey can be completed using a translator, proxy, or caregiver. The measure’s testing results are based on data from the hospital outpatient department (HOPD) setting; however, it is reasonably expected that the instrument and methodology apply to the ASC setting regarding patients receiving surgical procedures as both are outpatient surgical settings providing similar services with the supply of discharge instructions. We note that the measure specifications for the Information Transfer PRO–PM require that the survey be ad atient surgical settings providing similar services with the supply of discharge instructions. We note that the measure specifications for the Information Transfer PRO–PM require that the survey be administered anonymously to patients, and that the survey instrument does not collect any identifiable patient information. In monitoring implementation of this measure for the Hospital OQR Program, we discovered that the anonymous administration requirement could potentially limit the hospitals’ ability to collect data for their patients without working with a third-party vendor. If the survey is required to be fully anonymous, hospitals fielding the survey themselves would not be able to conduct any targeted follow-up with patients during the 65-day response window or use the information provided to develop more targeted quality improvement efforts. While anonymous surveys can be valuable for gathering candid feedback, 241 Downey, E., & Olds, D.M. (2021). Comparison of Documentation on Inpatient Discharge and Ambulatory End-of-Visit Summaries. J Healthc Qual. 43(3):e43–e52. https://doi.org/10.1097/ JHQ.0000000000000269. Accessed: April 8, 2025. 242 A copy of the survey instrument is av atient Discharge and Ambulatory End-of-Visit Summaries. J Healthc Qual. 43(3):e43–e52. https://doi.org/10.1097/ JHQ.0000000000000269. Accessed: April 8, 2025. 242 A copy of the survey instrument is available at https://www.cms.gov/files/document/patient- understanding-key-information-related-recovery- after-facility-based-outpatient-procedure-or.pdf. these issues of preventing follow-up, targeted action plans, and deeper investigation of specific issues, as well as leading to less serious or misleading responses have been documented.243 We invite public comment on the proposal to utilize this measure as specified with anonymous administration as well as potential data collection options to address the anonymity requirement in both the Hospital OQR and ASCQR Programs, where this measure was previously adopted and is currently proposed for adoption, respectively. The measure developer conducted pilot testing for this measure in 26 HOPDs in five states and demonstrated that the measure is reliable and meaningful.244 Reliability of the measure was assessed with the Cronbach alpha score 245 to determine whether the nine survey questions reliably measured the same underlying characterist reliable and meaningful.244 Reliability of the measure was assessed with the Cronbach alpha score 245 to determine whether the nine survey questions reliably measured the same underlying characteristic; that is, patient’s assessment of the clarity and applicability of recovery instructions. The Cronbach alpha score indicated that the survey items are reliable.246 The measure developer also found the performance scores among facilities in the pilot study to be moderately reliable using a signal-to-noise ratio, which estimated variance among facilities and measured facility-specific standard errors to determine the extent to which variance in facility scores can be attributed to variance in actual performance.247 More information about 243 Murdoch, M., et. Al. (2014). Impact of different privacy conditions and incentives on survey response rate, participant representativeness, and disclosure of sensitive information: a randomized controlled trial. BMC Med Res Methodol. Jul 16:14–90. 244 Centers for Medicare & Medicaid Services. (April 2024). Patient Understanding of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Reported Outcome- Centers for Medicare & Medicaid Services. (April 2024). Patient Understanding of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure. Available at https://www.cms.gov/files/document/ patient-understanding-key-information-related- recovery-after-facility-based-outpatient-procedure- or.pdf. Accessed: April 29, 2025. 245 For more information on what the Cronbach alpha score determines and how it is used, we refer readers to: Tavakol, M., & Dennick, R. (2011). Making sense of Cronbach’s alpha. Int J Med Educ. 27;2: 53–55. https://www.ijme.net/archive/2/ cronbachs-alpha.pdf. Accessed: April 30, 2025. 246 Centers for Medicare & Medicaid Services. (April 2024). Patient Understanding of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure. Available at https://www.cms.gov/files/document/ patient-understanding-key-information-related- recovery-after-facility-based-outpatient-procedure- or.pdf. Accessed: April 29, 2025. 247 Centers for Medicare & Medicaid Services. (April 2024). Patient Understanding of Key Inf -information-related- recovery-after-facility-based-outpatient-procedure- or.pdf. Accessed: April 29, 2025. 247 Centers for Medicare & Medicaid Services. (April 2024). Patient Understanding of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Continued VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00303 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33778 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules the testing, feasibility, scientific acceptability, meaningfulness, and validity of the Information Transfer PRO–PM for the HOPD setting is available at https://p4qm.org/measures/ 4210. c. Measure Calculation The measure numerator is the sum of all the individual scores an ASC receives from eligible respondents, which could be patients or their caregivers. Individual scores are calculated for each respondent by taking the sum of items for which the respondent gave the most positive response (either, ‘‘Yes’’ or ‘‘Very Clear’’) and dividing by the number of items the respondent deemed applicable to their procedure or he sum of items for which the respondent gave the most positive response (either, ‘‘Yes’’ or ‘‘Very Clear’’) and dividing by the number of items the respondent deemed applicable to their procedure or surgery. Applicable items are calculated by subtracting the sum of items for which the respondent selected ‘‘Does not apply’’ from the total number of survey items (nine).248 The measure denominator is the total number of patients 18 years or older who had a procedure or surgery in an ASC, left the ASC alive, and responded to the survey. The cohort of patients for the Information Transfer PRO–PM is standardized with the OAS CAHPS cohort to minimize provider burden and to harmonize between the two surveys. Only fully completed surveys are included in the measure calculation. For additional details regarding the proposed measure specifications, we refer readers to the CMS QualityNet website.249 d. Pre-Rulemaking Measure Review (PRMR) As required under section 1890A of the Act, the Secretary must establish and follow a pre-rulemaking process for the selection of quality and efficiency measures, including for the ASCQR Program. The pre-rulemaking process, which we refer to as the Pre-Rulem must establish and follow a pre-rulemaking process for the selection of quality and efficiency measures, including for the ASCQR Program. The pre-rulemaking process, which we refer to as the Pre-Rulemaking Measure Review (PRMR), includes a review of measures published on the publicly available list of Measures Under Consideration (MUC List) by one of several committees convened by the consensus-based entity (CBE), with which we contract in accordance with section 1890 of the Act, for the purpose of providing interested parties’ input to Reported Outcome-Based Performance Measure. Available at https://www.cms.gov/files/document/ patient-understanding-key-information-related- recovery-after-facility-based-outpatient-procedure- or.pdf. Accessed: April 29, 2025. 248 Partnership for Quality Measurement. Submission Tool and Repository Measure Database. https://p4qm.org/measures/4210. Accessed: April 8, 2025. 249 The proposed ASCQR Program measure specifications can be found at https:// qualitynet.cms.gov/asc. the Secretary on the selection of quality and efficiency measures under consideration for use in certain Medicare quality programs, including the ASCQR Program. We refer readers to tynet.cms.gov/asc. the Secretary on the selection of quality and efficiency measures under consideration for use in certain Medicare quality programs, including the ASCQR Program. We refer readers to the CY 2025 OPPS/ASC final rule with comment period (89 FR 94372) for details on the PRMR process, including the voting procedures used to reach consensus on measure recommendations. The PRMR Hospital Recommendation Group met on January 15 and 16, 2025 to review measures included by the Secretary on the publicly available ‘‘2024 Measures Under Consideration List’’ (MUC List), including the Information Transfer PRO–PM, for potential use.250 251 The voting results of the PRMR Hospital Recommendation Group for the proposed Information Transfer PRO–PM for the ASCQR Program were: 5 members recommended adopting the measure; 14 members recommended adoption with conditions; and 8 members voted not to recommend the measure for adoption. No voting category reached 75 percent or greater, including the combination of the recommend and the recommend with conditions categories. Thus, the PRMR Hospital Recommendation Group did not reach consensus and did not recommend including this measure in the AS e combination of the recommend and the recommend with conditions categories. Thus, the PRMR Hospital Recommendation Group did not reach consensus and did not recommend including this measure in the ASCQR Program either with or without conditions. The PRMR Hospital Recommendation Group noted in their deliberations the importance of measuring patient experience and delivering personalized and clear discharge instructions to prevent unnecessary hospital readmissions. However, the PRMR Hospital Recommendation Group members expressed concerns about lack of testing in the ASC setting given differences between HOPDs as a hospital setting (where testing of the Information Transfer PRO–PM was conducted) and ASCs. This group also highlighted concerns related to patient survey fatigue; potential overlap with the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) survey sample population and content; and the risk of low response rates— particularly in small or rural facilities, which could impact scoring. 250 The Information Transfer PRO–PM is identified on the MUC List as MUC2024–073. 251 Partnership for Quality Measurement. (2025). 2024–2025 y in small or rural facilities, which could impact scoring. 250 The Information Transfer PRO–PM is identified on the MUC List as MUC2024–073. 251 Partnership for Quality Measurement. (2025). 2024–2025 Pre-Rulemaking Measure Review (PRMR) Recommendation Group Final Meeting Summary: Hospital Committee. Available at https:// p4qm.org/sites/default/files/2025-02/PRMR- Hospital-Recommendation-Group-Meeting- Summary.pdf. Accessed: April 29, 2025. Although the measure was not pilot tested in the ASC setting with facilities citing resource constraints, we believe that the instrument and methodology reasonably apply to the ASC setting as the measure concept was designed for use in both HOPDs and ASCs and many of the same surgical procedures are performed in both settings.252 Measure harmonization across the Hospital OQR and ASCQR Programs enables meaningful comparisons of care for patients to assess quality between settings that offer similar services. Regarding the PRMR Hospital Recommendation Group’s concern about potential overlap between the Information Transfer PRO–PM and OAS CAHPS content and target population, the OAS CAHPS survey addresses overall quality of healthcare facility comm Group’s concern about potential overlap between the Information Transfer PRO–PM and OAS CAHPS content and target population, the OAS CAHPS survey addresses overall quality of healthcare facility communication but does not assess patient understanding of discharge information related to medication, activity, and applicability/ personalization. We believe that both surveys provide valuable insights into different aspects of a patient’s experience related to discharge instructions. Additionally, to minimize duplication of patient sampling, resources are available to help facilities align administration of OAS CAHPS with other surveys.253 In consideration of potential population overlap, we selected a timeframe of 2 to 7 days post- procedure for administration of the Information Transfer PRO–PM’s survey to strike a balance between patient recovery and mitigated overlap with the initial administration of OAS CAHPS. Regarding concerns about patient survey fatigue and risk of low response rates, the 9-item survey is concise, presenting a low burden for completion. Further, ASCs would not be penalized for patients’ decisions to not complete the survey. Payment implications under the ASCQR tes, the 9-item survey is concise, presenting a low burden for completion. Further, ASCs would not be penalized for patients’ decisions to not complete the survey. Payment implications under the ASCQR Program are tied to the successful and timely reporting of required quality measure data, and an ASC that submits data to CMS in the form, manner, and timing specified, regardless of the number of surveys completed by the ASC’s patient population, would be considered 252 Centers for Medicare & Medicaid Services. (April 2024). Patient Understanding of Key Information Related to Recovery After a Facility- Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance Measure. Available at https://www.cms.gov/files/document/ patient-understanding-key-information-related- recovery-after-facility-based-outpatient-procedure- or.pdf. Accessed: April 29, 2025. 253 OAS CAHPS. (2024). 2024 Introduction to the OAS CAHPS Survey, Self-Paced Training. Available at https://oascahps.org/Training/Training- Materials. Accessed: April 29, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00304 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D g/Training/Training- Materials. Accessed: April 29, 2025. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00304 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33779 compliant with the measure requirements. To review the Hospital Recommendation Group’s voting summary, recommendations, and conditions for the Information Transfer PRO–PM please visit https://p4qm.org/ PRMR/Resources. e. Measure Endorsement Under section 1833(i)(7)(B) of the Act, requirements for the development of outpatient measures for the Hospital OQR Program at section 1833(t)(17)(C) of the Act apply to the ASCQR Program, except as the Secretary may otherwise provide. Section 1833(t)(17)(C)(i) of the Act requires measures developed to reflect consensus among affected parties and, to the extent feasible and practicable, shall include measures set forth by one or more national consensus-based entities (not necessarily the contracted CBE). As we have noted in previous rulemaking, consensus among affected parties can be reflected in ways other than CBE end ne or more national consensus-based entities (not necessarily the contracted CBE). As we have noted in previous rulemaking, consensus among affected parties can be reflected in ways other than CBE endorsement, including through the measure development process, through broad acceptance and use of the measure(s), and through public comment (76 FR 74494). We have also noted that section 1833(t)(17) of the Act does not require that each measure we adopt for the ASCQR Program be CBE- endorsed (76 FR 74494). A Technical Expert Panel consisting of interested parties, experts, and consumer advocates contributed to the development of the Information Transfer PRO–PM measure’s survey design, measure cohort, and survey implementation, demonstrating a consensus-based approach to the measure’s development.254 254 Centers for Medicare & Medicaid Services. (March 22). Methodology Report For Public Comment: Patient Understanding of Key Information Related to Recovery From an Outpatient Surgery or Procedure. Available at https://www.cms.gov/files/document/methodology- report-public-comment.pdf. Accessed: April 29, 2025. While we recognize the value of measures undergoing CBE endorsement review and p dure. Available at https://www.cms.gov/files/document/methodology- report-public-comment.pdf. Accessed: April 29, 2025. While we recognize the value of measures undergoing CBE endorsement review and prefer to use endorsed measures, at this time, we find no other CBE-endorsed measures for the ASC setting that address the topic of patients’ understanding of clinical information related to their recovery for an outpatient procedure or surgery. We note that we submitted the Information Transfer PRO–PM to the CBE for endorsement review in the Fall 2023 cycle (CBE #4210) for the Hospital OQR Program, and the CBE endorsed the measure on January 29, 2024.255 The ASC-specific version of the Information Transfer PRO–PM is designed to use the same specifications as the Hospital OQR Program CBE-endorsed measure. We plan to pursue CBE endorsement for the measure’s implementation in the ASC setting in a future measure endorsement cycle, and we will continue to monitor implementation of the measure as part of the standard measure maintenance process. f. Data Collection, Submission, and Reporting We propose that the Information Transfer PRO–PM would be calculated based on PRO data collected by ASC s part of the standard measure maintenance process. f. Data Collection, Submission, and Reporting We propose that the Information Transfer PRO–PM would be calculated based on PRO data collected by ASCs directly or through their authorized third-party vendors through the Information Transfer PRO–PM survey instrument 256 distributed to patients or their caregivers by electronic mail or text. We note that the Information Transfer PRO–PM survey is nonproprietary and free to use. We propose that the survey be distributed within 2 to 7 days post-procedure or 255 Partnership for Quality Measurement. (2024). Fall 2023 Management of Acute and Chronic Events Meeting Summary. Available at https://p4qm.org/ sites/default/files/Management%20of %20Acute%20Events%2C%20Chronic%20D isease%2C%20Surgery%2C%20and%20Behavioral %20Health/material/EM-Acute-Chronic-Events- Fall2023-Endorsement-Meeting-Summary.pdf. Accessed: April 8, 2025. 256 A copy of the survey instrument is available at https://www.cms.gov/files/document/patient- understanding-key-information-related-recovery- after-facility-based-outpatient-procedure-or.pdf. surgery. This timeframe minimizes the influence of variables related to the s /files/document/patient- understanding-key-information-related-recovery- after-facility-based-outpatient-procedure-or.pdf. surgery. This timeframe minimizes the influence of variables related to the surgery or procedure, such as medications that could affect comprehension, fatigue, or acute pain, while ensuring timely reporting of patient experience related to recovery information. In the pilot testing conducted by the measure developer using a third-party vendor, patients were sent a reminder to complete the survey 7 days after receipt. The survey remained open until pilot testing was completed; the mean length of time between the procedure date to the survey response date was 65 days. Based on these findings, we propose a 65-day window for patient response to the survey. We propose to adopt the Information Transfer PRO–PM as a voluntary measure for the CY 2027 and CY 2028 reporting periods followed by mandatory reporting beginning with the CY 2029 reporting period/CY 2031 payment determination. We would utilize the voluntary period to monitor the implementation and operationalization of the measure. We refer readers to section XVII.C. of this proposed rule for a discussion of the ermination. We would utilize the voluntary period to monitor the implementation and operationalization of the measure. We refer readers to section XVII.C. of this proposed rule for a discussion of the Information Transfer PRO–PM form, manner, and timing of data submission and reporting requirements. We invite public comment on this proposal. 2. Summary of Previously Finalized and Newly Proposed ASCQR Program Measure Set for CY 2026 to CY 2031 Payment Determinations Table 86 summarizes the previously finalized and newly proposed ASCQR Program measure set for the CY 2026 to CY 2031 payment determinations. Table 86 reflects our proposals to remove the FCHE, Screening for SDOH, Screen Positive Rate for SDOH, and the COVID–19 Vaccination Coverage Among HCP measures as discussed in section XIV.C. and add the Information Transfer PRO–PM as discussed in section XVII.B.1. of this proposed rule. 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00305 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 33780 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 2 S L A S O P O R P h t i w l 16, 2025 Jkt 265001 PO 00000 Frm 00305 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 33780 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00306 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00307 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00308 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33783 2. Policy Regarding Reduction to the ASC Payment Rates for ASCs That Fail to Meet the ASCQR Program Requirements for a Payment Determination Year The national unadjusted payment rates for many services paid under the ASC payment system are equal to the product of the ASC conversion factor and the scaled relative payment weight for the APC to which the service is assigned. For CY 2026, the ASC conversion factor is equal to the conversion factor calculated t of the ASC conversion factor and the scaled relative payment weight for the APC to which the service is assigned. For CY 2026, the ASC conversion factor is equal to the conversion factor calculated for the previous year updated by the productivity-adjusted hospital market basket update factor. The productivity adjustment is set forth in section 1833(i)(2)(D)(v) of the Act. The productivity-adjusted hospital market basket update was the annual update for the ASC payment system for a 5-year period (CY 2019 through CY 2023), which was extended an additional 2 years (through CY 2025) in the CY 2024 OPPS/ASC final rule with comment period (88 FR 81960). As discussed in section XIII of this proposed rule, we propose to continue using the productivity-adjusted hospital market basket update as the update factor for the ASC payment system for CY 2026. Under the ASCQR Program, in accordance with section 1833(i)(7)(A) of the Act and as discussed in the CY 2013 OPPS/ASC final rule with comment period (77 FR 68499), any annual increase in certain payment rates under the ASC payment system shall be reduced by 2.0-percentage points for ASCs that fail to meet the reporting requirements of the AS eriod (77 FR 68499), any annual increase in certain payment rates under the ASC payment system shall be reduced by 2.0-percentage points for ASCs that fail to meet the reporting requirements of the ASCQR Program. This reduction applied beginning with the CY 2014 payment rates (77 FR 68500). For a complete discussion of the calculation of the ASC conversion factor and our finalized proposal to update the ASC payment rates using the inpatient hospital market basket update for CYs 2019 through 2023, we refer readers to the CY 2019 OPPS/ASC final rule with comment period (83 FR 59073 through 59080). In the CY 2013 OPPS/ASC final rule with comment period (77 FR 68499 through 68500), in order to implement the requirement to reduce the annual update for ASCs that fail to meet the ASCQR Program requirements, we finalized the following policies: (1) to calculate a full update conversion factor and an ASCQR Program reduced update conversion factor; (2) to calculate reduced national unadjusted payment rates using the ASCQR Program reduced update conversion factor that would apply to ASCs that fail to meet their quality reporting requirements for that calendar year payment determination; and ( yment rates using the ASCQR Program reduced update conversion factor that would apply to ASCs that fail to meet their quality reporting requirements for that calendar year payment determination; and (3) that application of the 2.0- percentage point reduction to the annual update may result in the update to the ASC payment system being less than zero prior to the application of the productivity adjustment. The ASC conversion factor is used to calculate the ASC payment rate for services with the following payment indicators (listed in Addenda AA and BB to this proposed rule, which are available via the internet on the CMS website): ‘‘A2,’’ ‘‘D2,’’ ‘‘G2,’’ ‘‘P2,’’ ‘‘R2’’, and ‘‘Z2,’’ as well as the service portion of device-intensive procedures identified by ‘‘J8’’ (77 FR 68500). We finalized our proposal that payment for all services assigned the payment indicators listed would be subject to the reduction of the national unadjusted payment rates for applicable ASCs using the ASCQR Program reduced update conversion factor (77 FR 68500). The conversion factor is not used to calculate the ASC payment rates for separately payable services that are assigned status indicators other than pa m reduced update conversion factor (77 FR 68500). The conversion factor is not used to calculate the ASC payment rates for separately payable services that are assigned status indicators other than payment indicators ‘‘A2’’, ‘‘D2’’, ‘‘G2,’’ ‘‘J8’’, ‘‘P2’’, ‘‘R2’’, and ‘‘Z2.’’ These services include separately payable drugs and biologicals, pass-through devices that are contractor-priced, brachytherapy sources that are paid based on the OPPS payment rates, and certain office-based procedures, radiology services, and diagnostic tests where payment is based on the PFS nonfacility PE RVU-based amount, and a few other specific services that receive cost-based payment (77 FR 68500). As a result, we also finalized our proposal that the ASC payment rates for these services would not be reduced for failure to meet the ASCQR Program requirements because the payment rates for these services are not calculated using the ASC conversion factor and, therefore, are not affected by reductions to the annual update (77 FR 68500). Office-based surgical procedures (generally those performed more than 50 percent of the time in physicians’ offices) and separately paid radiology services (excluding covere nual update (77 FR 68500). Office-based surgical procedures (generally those performed more than 50 percent of the time in physicians’ offices) and separately paid radiology services (excluding covered ancillary radiology services involving certain nuclear medicine procedures or involving the use of contrast agents) are paid at the lesser of the PFS nonfacility PE RVU-based amounts or the amount calculated under the standard ASC ratesetting methodology. Similarly, in the CY 2015 OPPS/ASC final rule with comment period (79 FR 66933 through 66934), we finalized our proposal that payment for certain diagnostic test codes within the medical range of CPT codes for which separate payment is allowed under the OPPS will be at the lower of the PFS nonfacility PE RVU- based (or technical component) amount or the rate calculated according to the standard ASC ratesetting methodology when provided integral to covered ASC surgical procedures. In the CY 2013 OPPS/ASC final rule with comment period (77 FR 68500), we finalized our proposal that the standard ASC ratesetting methodology for this type of comparison would use the ASC conversion factor that has been calculated using the full ASC update 7 FR 68500), we finalized our proposal that the standard ASC ratesetting methodology for this type of comparison would use the ASC conversion factor that has been calculated using the full ASC update adjusted for productivity. This is necessary so that the resulting ASC payment indicator, based on the comparison, assigned to these procedures or services is consistent for each HCPCS code, regardless of whether payment is based on the full update conversion factor or the reduced update conversion factor. For ASCs that receive the reduced ASC payment for failure to meet the ASCQR Program requirements, we have noted our belief that it is both equitable and appropriate that a reduction in the payment for a service should result in proportionately reduced coinsurance liability for beneficiaries (77 FR 68500). Therefore, in the CY 2013 OPPS/ASC final rule with comment period (77 FR 68500), we finalized our proposal that the Medicare beneficiary’s national unadjusted coinsurance for a service to which a reduced national unadjusted payment rate applies will be based on the reduced national unadjusted payment rate. In the CY 2013 OPPS/ASC final rule with comment period, we finalized our prop to which a reduced national unadjusted payment rate applies will be based on the reduced national unadjusted payment rate. In the CY 2013 OPPS/ASC final rule with comment period, we finalized our proposal that all other applicable adjustments to the ASC national unadjusted payment rates would apply in those cases when the annual update is reduced for ASCs that fail to meet the requirements of the ASCQR Program (77 FR 68500). For example, the following standard adjustments would apply to the reduced national unadjusted payment rates: the wage index adjustment; the multiple procedure adjustment; the interrupted procedure adjustment; and the adjustment for devices furnished with full or partial credit or without cost (77 FR 68500). We believe that these adjustments continue to be equally applicable to payment for ASCs that do not meet the ASCQR Program requirements (77 FR 68500). In the CY 2015 through CY 2025 OPPS/ASC final rules with comment period, we did not make any other changes to these policies. We propose to continue applying these policies for the CY 2026 reporting period/CY 2028 payment determination and for subsequent years. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 P these policies. We propose to continue applying these policies for the CY 2026 reporting period/CY 2028 payment determination and for subsequent years. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00309 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33784 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules XVIII. Overall Hospital Quality Star Rating Modification To Emphasize the Safety of Care Measure Group A. Summary In the CY 2025 OPPS/ASC final rule with comment period (89 FR 94514 through 94521), we summarized broad public input received on a Request for Information (RFI) discussing potential methodologic modifications to the Safety of Care measure group within the Overall Hospital Quality Star Rating that is published on the provider comparison tool on Medicare.gov (https://www.medicare.gov/care- compare/). The potential modifications discussed in that RFI aimed to emphasize the contribution of the Safety of Care measure group to the Overall Hospital Quality Star Rating. In that RFI, we also noted our intention to potentially issue additional RFIs or undertake r emphasize the contribution of the Safety of Care measure group to the Overall Hospital Quality Star Rating. In that RFI, we also noted our intention to potentially issue additional RFIs or undertake rulemaking on this topic in the future. Patient safety constitutes a fundamental component of the CMS National Quality Strategy, representing a sustained commitment to fostering optimal health outcomes and ensuring the safest possible care for all patients.259 As we noted in the CY 2025 OPPS/ASC final rule with comment period (89 FR 94514 through 94521), we believe that increasing the influence of the Safety of Care measure group is a necessary and appropriate methodological change. Patient safety is cornerstone to healthcare delivery and the foundational principle of professional oaths is to ‘‘do no harm.’’ Prioritizing safety for both patients and healthcare workers align with this fundamental commitment. Considering the public input received and further internal analyses conducted, we propose to make the following modifications to the Overall Hospital Quality Star Rating methodology: (1) implement a 4-star cap for hospitals in the lowest-performing quartile of the Safety of Care meas opose to make the following modifications to the Overall Hospital Quality Star Rating methodology: (1) implement a 4-star cap for hospitals in the lowest-performing quartile of the Safety of Care measure group) for the 2026 Overall Hospital Quality Star Rating, and (2) implement a blanket 1- star reduction for hospitals in the lowest-performing quartile of the Safety of Care measure group for the 2027 Overall Hospital Quality Star Rating and thereafter. B. Background The Overall Hospital Quality Star Rating provides a summary of certain existing hospital quality information on Medicare.gov 260 based on publicly available quality measure results reported through CMS’ hospital quality measurement programs, by assigning hospitals between 1 and 5 stars, a way that is simple and easy for patients to understand (85 FR 86193). The Overall Hospital Quality Star Rating methodology was developed and is maintained according to the guiding principles of scientific validity, maximizing inclusion of hospitals and measure information, accounting for heterogeneity of available measures and hospital reporting, accommodating changes in the underlying measures, aligning with CMS hospital quality meas hospitals and measure information, accounting for heterogeneity of available measures and hospital reporting, accommodating changes in the underlying measures, aligning with CMS hospital quality measure programs to the extent feasible, transparency of the methodology, and responsiveness to input from stakeholders. The Overall Hospital Quality Star Rating was first introduced and reported on our Hospital Compare website in July 2016 (now reported on Care Compare on Medicare.gov) and has been refreshed multiple times. In the CY 2021 OPPS/ASC final rule with comment period (85 FR 86193), we codified the Overall Hospital Quality Star Rating methodology, including several methodology refinements, intended to improve the simplicity and predictability of measure emphasis within the methodology over time, and comparability of ratings among hospitals. We also finalized the inclusion of Veterans Health Administration (VHA) hospitals and Critical Access Hospitals (CAHs) in the Overall Hospital Quality Star Rating. In the CY 2023 OPPS/ASC final rule with comment period (87 FR 72233), we provided additional information on the previously finalized policy to incorporate VHA hospitals and finaliz uality Star Rating. In the CY 2023 OPPS/ASC final rule with comment period (87 FR 72233), we provided additional information on the previously finalized policy to incorporate VHA hospitals and finalized a proposal to amend 42 CFR 412.190 to revise how we would refresh the Overall Hospital Quality Star Rating annually. In the CY 2025 OPPS/ASC final rule with comment period (89 FR 94514 through 94521) we summarized public input received on the following potential methodological updates to greater emphasize patient safety in the Overall Hospital Quality Star Rating: (1) Reweighting the Safety of Care Measure Group, (2) Policy-based 1-Star Reduction for Poor Performance on Safety of Care, and (3) Reweighting the Safety of Care measure group combined with a Policy-based Star Rating Cap. We refer readers to section XXIV. (Overall Hospital Quality Star Rating Modification to Emphasize the Safety of Care Measure Group: Request for Information (RFI)) of the CY 2025 OPPS/ ASC final rule with comment period (89 FR 94514 through 94521) for additional information. C. Current Overall Hospital Quality Star Rating Methodology (§ 412.190) Measures reported on the provider comparison tool on Medicar ment period (89 FR 94514 through 94521) for additional information. C. Current Overall Hospital Quality Star Rating Methodology (§ 412.190) Measures reported on the provider comparison tool on Medicare.gov 261 that meet the criteria for inclusion in the Overall Hospital Quality Star Rating are organized into five conceptually coherent measure groups: Safety of Care, Mortality, Readmission, Patient Experience (all of which include outcome measures), and Timely and Effective Care (which includes a selection of process measures). The current Overall Hospital Quality Star Rating methodology includes eight general steps. First, measures are selected from those publicly reported on Care Compare on Medicare.gov through certain CMS hospital inpatient and outpatient quality programs. Second, the direction of all included measures that indicate better performance with a lower score are reversed to uniformly reflect that a higher score indicates better performance for all the measures, and all measure scores are standardized to a single, common scale to account for differences in measure score units. Third, measures are arranged into measure groups. Each measure group contains several publicl asure scores are standardized to a single, common scale to account for differences in measure score units. Third, measures are arranged into measure groups. Each measure group contains several publicly reported measures to produce a robust measure group score, which is reflective of differences in hospital quality. Fourth, the measure group scores are calculated as a simple average of the measure scores. Measure group scores are then standardized to a common scale, making varying scores comparable. Fifth, the hospital summary score is calculated as a weighted average of the standardized measure group scores. Specifically, each measure group score is multiplied by the assigned weight for that measure group. The weighted measure group scores are then summed up to generate the hospital summary score. If a hospital has no measure scores in a measure group (for example, by not achieving sufficient sample size in any of the measures), the weight is redistributed proportionally across the remaining measure groups. Sixth, minimum reporting thresholds are applied. To receive an Overall Hospital Quality Star Rating, hospitals must report at least three measures in each of at least three meas aining measure groups. Sixth, minimum reporting thresholds are applied. To receive an Overall Hospital Quality Star Rating, hospitals must report at least three measures in each of at least three measure groups, one of which must be either the Mortality or Safety of Care measure groups. Seventh, peer grouping is applied. Hospitals are grouped into one of three peer groups based on the number of measure groups for which 259 https://www.cms.gov/files/document/cms- 260 https://www.medicare.gov/care-compare/ national-quality-strategy-handout.pdf. resources/hospital/overall-star-rating. 261 https://www.medicare.gov/care-compare/. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00310 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33785 they report at least three measures: a three-measure group peer group, a four- measure group peer group, and a five- measure group peer group. Eighth, a clustering algorithm is applied within each peer group to assign hospital summary scores to Overall Hospital Quality Star Ratings so that 1 s eer group, and a five- measure group peer group. Eighth, a clustering algorithm is applied within each peer group to assign hospital summary scores to Overall Hospital Quality Star Ratings so that 1 star is the lowest and 5 stars is the highest. For additional details regarding the current methodology, we refer readers to § 412.190(d) and the Overall Hospital Quality Star Rating Methodology Reports, available at https:// qualitynet.cms.gov/inpatient/public- reporting/overall-ratings/resources. D. Proposed Modification to the Overall Hospital Quality Star Rating Methodology In the CY 2025 OPPS/ASC final rule with comment period (89 FR 94514 through 94521), we presented three options and analyses (utilizing data from the July 2023 refresh of the Overall Hospital Quality Star Rating) for potential methodological updates to emphasize Safety of Care in the Overall Hospital Quality Star Rating and summarized the public comments received. The majority of commenters did not support updating the methodology at that time. While some commenters expressed support for potential changes, there was no consensus on a preferred option (reweighting, the policy-based 1-star reduction, or reweighting e methodology at that time. While some commenters expressed support for potential changes, there was no consensus on a preferred option (reweighting, the policy-based 1-star reduction, or reweighting combined with the 4-star cap). We refer readers to the CY 2025 OPPS/ASC RFI (89 FR 94514 through 94521), where we detailed the importance of prioritizing Safety of Care within the Overall Hospital Quality Star Rating. Following the publication of the final rule, we conducted further internal analyses utilizing updated data from the July 2024 refresh of the Overall Hospital Quality Star Rating (the most recent publicly released results as of the writing of this proposal) to reassess the correlation between the Safety of Care measure group and performance in the Overall Hospital Quality Star Rating. To receive an Overall Hospital Quality Star Rating, hospitals must have at least three measures in each of at least three measure groups, one of which must be Mortality or Safety of Care. However, because the application of minimum reporting thresholds and peer grouping assignment occur strictly after the calculation of measure group scores and overall summary scores, any hospital with at lea , because the application of minimum reporting thresholds and peer grouping assignment occur strictly after the calculation of measure group scores and overall summary scores, any hospital with at least one measure in any group will have a measure group score for that group—that is, once a hospital meets the Overall Hospital Quality Star Rating reporting threshold, all measure groups for which it has any measure scores are included in its rating. In other words, a hospital with one or two Safety of Care measures can still receive an Overall Hospital Quality Star Rating if it still has at least three measures in Mortality and in two of the other measure groups; in this case, the hospital would still receive a Safety of Care measure group score based on the one or two measures it does have. Only a hospital qualifying for an Overall Hospital Quality Star Rating with zero Safety of Care measures would not have a Safety of Care measure group score. There were 2,847 hospitals that met the criteria to receive an Overall Hospital Quality Star Rating in 2024. Among the 2,847 rated hospitals, 2,803 (99 percent) had at least one Safety of Care measure and therefore received a Safety of Care m iteria to receive an Overall Hospital Quality Star Rating in 2024. Among the 2,847 rated hospitals, 2,803 (99 percent) had at least one Safety of Care measure and therefore received a Safety of Care measure group score, while 2,475 (87 percent) had at least three Safety of Care measures. Our analysis showed that hospitals in the lowest-performing quartile of the Safety of Care measure group tended to receive lower Overall Hospital Quality Star Ratings (being more likely to receive 1 or 2 stars and less likely to receive 4 or 5 stars than other hospitals) (Table 87). However, some hospitals performed in the lowest quartile (lowest-performing 25 percent, indicating poor Safety of Care performance relative to other hospitals) of the Safety of Care measure group and still received a 5-star rating. Of the 2,847 hospitals that received an Overall Hospital Quality Star Rating, 695 hospitals scored in the lowest quartile of the Safety of Care measure group, of which 595 hospitals had at least three Safety of Care measures. Of these 595 hospitals, 14 received a 5-star rating, representing 0.5 percent of all rated hospitals (Table 87). These 14 hospitals attained a 5-star rating despite havi three Safety of Care measures. Of these 595 hospitals, 14 received a 5-star rating, representing 0.5 percent of all rated hospitals (Table 87). These 14 hospitals attained a 5-star rating despite having the lowest quartile Safety of Care measure group performance by achieving high scores across the other measure groups. 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00311 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00312 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33787 Using the data of the July 2024 Overall Hospital Quality Star Rating, we evaluated the proportion of hospitals that would be impacted by the proposed methodological changes, stratified by various hospital characteristics (Table 88). As previously noted, a larger proportion of hospitals would be impacted by the blanket 1-star reduction (Stage 2 proposed methodological change) compared to the targeted 4-star cap (Stag s (Table 88). As previously noted, a larger proportion of hospitals would be impacted by the blanket 1-star reduction (Stage 2 proposed methodological change) compared to the targeted 4-star cap (Stage 1 proposed methodological change). Our simulation revealed that teaching hospitals, non-safety-net hospitals, VHA hospitals, non-CAHs, large hospitals (100+ beds), urban hospitals, and non-specialty hospitals could be somewhat more likely to observe a change in Overall Hospital Quality Star Rating by both Stage 1 and Stage 2 proposed methodological changes than their counterparts. We recognize that with only 14 hospitals experiencing a change in Overall Hospital Quality Star Rating by the Stage 1 proposed methodological change, the generalizability of this observation is limited. In part, this is because these hospitals are more likely to receive an Overall Hospital Quality Star Rating and have three or more Safety of Care measures than their non- teaching, safety-net, non-VHA, CAH, small, rural, and specialty counterparts (Table 88). However, these differences in hospital characteristics are not strongly determinative of a hospital’s overall rating, with hospitals of any characteris l, rural, and specialty counterparts (Table 88). However, these differences in hospital characteristics are not strongly determinative of a hospital’s overall rating, with hospitals of any characteristic being capable of receiving either high or low ratings. 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00313 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 33788 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00314 Fmt 4701 Sfmt 4725 E:\FR\FM\17JYP2.SGM 17JYP2 / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00315 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33790 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules MRF that the hospital has, to the best of its knowledge and belief, included all applicable standard charge information in accordance with the requirements of 45 CFR part 180 and that the information displayed the hospital has, to the best of its knowledge and belief, included all applicable standard charge information in accordance with the requirements of 45 CFR part 180 and that the information displayed is true, accurate, and complete as of the date indicated in the file. As described in the summary of proposals below, we propose to strengthen this requirement, beginning January 1, 2026, by replacing it with an attestation in the MRF, and that attestation would also contain new specifications (relative to existing affirmation requirements). These specifications would include that the hospital has: (1) included all applicable payer-specific negotiated charges in dollars that can be expressed as a dollar amount and for payer-specific negotiated charges that are not knowable in advance or cannot be expressed as a dollar amount, the hospital has provided in the MRF all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to the specific fee schedule or components referenced in such percentage, algorithm, or formula, and (2) included the name of the hospital’s chief executive officer, president, or senior officia mited to the specific fee schedule or components referenced in such percentage, algorithm, or formula, and (2) included the name of the hospital’s chief executive officer, president, or senior official designated to oversee the encoding of true, accurate, and complete data. In addition, pursuant to section 2718(b)(3) of the PHS Act, we previously have established regulations for enforcing the provisions of this section, including appropriate penalties. We propose an additional change to encourage faster resolution of HPT civil monetary penalties (CMPs) and to reduce the amount of a CMP, under certain conditions, when the hospital waives its right to an administrative law judge (ALJ) hearing. 2. Summary of Proposals We propose amendments to the HPT regulations to enhance clarity and standardization in hospital disclosure of standard charges. Specifically, we propose revisions to § 180.20 to add definitions for ‘‘tenth (10th) percentile allowed amount,’’ ‘‘median allowed amount,’’ and ‘‘ninetieth (90th percentile allowed amount,’’ which are values a hospital would encode when a payer-specific negotiated charge is based on a percentage or algorithm, to more accurately reflect the dist ninetieth (90th percentile allowed amount,’’ which are values a hospital would encode when a payer-specific negotiated charge is based on a percentage or algorithm, to more accurately reflect the distribution of actual amounts that a hospital has received for an item or service. In tandem with that, we propose revisions to § 180.50 to remove the requirement for hospitals to disclose the estimated allowed amount, and, instead, require hospitals, beginning January 1, 2026, to disclose the 10th percentile, median, and 90th percentile allowed amounts, as well as the count of allowed amounts, in MRFs when payer-specific negotiated charges are based on percentages or algorithms. We also propose to require that hospitals use electronic data interchange (EDI) 835 electronic remittance advice (ERA) transaction data to calculate and encode these values, and we propose to require that hospitals comply with specific instructions regarding the methodology, including the lookback period, that must be used to calculate those amounts. We propose revisions to § 180.50 to require hospitals, beginning January 1, 2026, to attest that in the MRF, the hospital has included all applicable standard charge e used to calculate those amounts. We propose revisions to § 180.50 to require hospitals, beginning January 1, 2026, to attest that in the MRF, the hospital has included all applicable standard charge information in accordance with the requirements of this section and the information encoded is true, accurate, and complete as of the date in the file. We further propose that hospitals attest in the MRF that the hospital has included all applicable payer-specific negotiated charges as dollars that can be expressed as a dollar amount, and for payer-specific negotiated charges that are not knowable in advance or cannot be expressed as a dollar amount, the hospital has provided in the MRF all necessary information available to the hospital for the public to be able to derive a dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm, or formula. We also propose that hospitals encode in the MRF the name of the hospital chief executive officer, president, or senior official designated to oversee the encoding of true, accurate, and complete data. In addition, to advance the comparability of HPT data with other healthcare ef executive officer, president, or senior official designated to oversee the encoding of true, accurate, and complete data. In addition, to advance the comparability of HPT data with other healthcare data, we propose to require that hospitals encode their National Provider Identifier(s) (NPIs) in the MRFs. Finally, to encourage faster resolution and payment of CMPs, and in exchange for a hospital’s admission of having violated HPT requirements, we propose to update § 180.90 to reduce the amount of a CMP by 35 percent, under certain conditions, when a hospital waives its right to an ALJ hearing. These proposed changes aim to improve transparency in hospital pricing, facilitate efficient enforcement of the HPT requirements, and empower consumers with actionable pricing information. B. Proposal To Modify the Requirements for Making Public Hospital Standard Charges at 45 CFR 180.50 1. Background a. CY 2024 OPPS/ASC Final Rule With Comment Period This section of the background recites relevant history from the CY 2024 OPPS/ASC final rule with comment period, and all references pertain to it. In the CY 2024 OPPS/ASC final rule with comment period (88 FR 82083, 82097, 82184), we indicate vant history from the CY 2024 OPPS/ASC final rule with comment period, and all references pertain to it. In the CY 2024 OPPS/ASC final rule with comment period (88 FR 82083, 82097, 82184), we indicated we understand that hospitals establish payer-specific negotiated charges in many ways, ranging from basic fee schedules (in which dollar amounts for specific items and services are known) to grouper methodologies (in which a base rate in dollars has been established but may then be modified depending on other factors like transfers or outliers), to ‘‘percent of billed charges’’ schemes (in which the dollar amount varies from person to person and is not known until the services are performed). We demonstrated in Figure A in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82098) the components of an MS–DRG algorithm. An example of how Figure A may translate into an algorithm encoded in the MRF may be: base rate multiplied by the MS–DRG weight; outlier payment of $4303 per diem when length of stay is greater than 2 times the average length of stay. Based on our experiences reviewing MRFs since the finalization of the CY 2024 OPPS/ASC rule, we have observed factors included in hen length of stay is greater than 2 times the average length of stay. Based on our experiences reviewing MRFs since the finalization of the CY 2024 OPPS/ASC rule, we have observed factors included in algorithms such as, but not limited to: weights based on resources required, mix of services provided within an episode of care, and thresholds or caps on the overall price of services billed within an episode of care. Therefore, we reiterate our stance outlined in the CY 2024 OPPS/ASC final rule that not all hospitals can produce a payer-specific negotiated charge in dollars that meets the definition of a ‘standard charge’. As indicated in the CY 2024 OPPS/ ASC final rule with comment period, we finalized a requirement for hospitals to display an estimated allowed amount which would provide needed context, in dollars, for instances where the hospital’s standard charge is based on a percentage or algorithm for a specified payer’s plan. We defined a new data element, the ‘‘estimated allowed amount,’’ at § 180.20, as the average dollar amount that the hospital has historically received from a third party payer for an item or service. We noted that we had heard from interested parties th d amount,’’ at § 180.20, as the average dollar amount that the hospital has historically received from a third party payer for an item or service. We noted that we had heard from interested parties that, when a hospital VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00316 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33791 has negotiated a payer-specific negotiated charge that is based on an algorithm, an estimate displayed in dollars within the MRF is useful, particularly for making comparisons across hospitals (88 FR 82099). We stated, for example, that an estimate displayed in dollars would permit users to make price comparisons across hospitals when, regarding the same procedure and payer/plan, one hospital has established a payer-specific negotiated charge as an algorithm and a second has established a payer-specific negotiated charge as a dollar amount. After considering what additional data could be required in the MRF to provide further needed context for a payer- specific negotiated charge that is expressed c negotiated charge as a dollar amount. After considering what additional data could be required in the MRF to provide further needed context for a payer- specific negotiated charge that is expressed as an algorithm or a percentage, we finalized the estimated allowed amount as a new data element at § 180.20. We also required at § 180.50(b)(2)(ii)(C) that hospitals calculate and encode an estimated allowed amount, in dollars, when hospitals have established a payer- specific negotiated charge that is based on a percentage or an algorithm. We stated that the estimated allowed amount is the average reimbursement in dollars that the hospital has received from the payer in the past. We further stated that the estimated allowed amount is therefore not prospective and is also not based on the hospital’s chargemaster, which, as we understand it, contains only gross charges for itemized items and services, or claims submitted to the payer. As we explained (88 FR 82099 through 82100), because the estimated allowed amount data element is meant to provide an estimate of what the algorithm produces in dollars, across the universe covered by a particular payer’s plan, such an amount should refle e estimated allowed amount data element is meant to provide an estimate of what the algorithm produces in dollars, across the universe covered by a particular payer’s plan, such an amount should reflect the amount the hospital expects to be reimbursed for the item or service (or service package), on average. As such, it is not the final exact amount in dollars that an individual would pay for an item or service. Even so, we stated that we believe this information provides context to the public that is necessary to compare payer-specific negotiated charges across hospitals and is a valuable benchmark that innovators can use to develop price estimator tools to estimate an individual’s personalized out-of-pocket costs. We stated that we believed this information, when paired with the algorithm encoded in the MRF, would promote greater transparency of hospital standard charges that can be useful to MRF users. b. Background Subsequent to the CY2024 OPPS/ASC Final Rule With Comment Period Since the CY2024 OPPS/ASC final rule with comment period was finalized, we have continued to gain experience with the implementation of the estimated allowed amount data element and received public feed nce the CY2024 OPPS/ASC final rule with comment period was finalized, we have continued to gain experience with the implementation of the estimated allowed amount data element and received public feedback and questions requesting that we further clarify its calculation. Based on our observations through comprehensive audits and feedback from users of the data, and consistent with Executive Order 14221, we propose to revise the HPT regulations to recast the estimated allowed amount data element to better require, through new data elements, disclosure of dollar amounts for items and services in hospital MRFs, which we believe would enhance transparency and comparability of payer-specific negotiated charges across hospitals. Specifically, and as further discussed later in this section, we propose to require hospitals to report four new data elements when a standard charge is based on a percentage or algorithm—the median allowed amount (which would replace the estimated allowed amount data element), the 10th percentile and 90th percentile allowed amounts, and the count of allowed amounts used to calculate the median, 10th, and 90th percentile allowed amounts. 2. Definitions At § 180.20 element), the 10th percentile and 90th percentile allowed amounts, and the count of allowed amounts used to calculate the median, 10th, and 90th percentile allowed amounts. 2. Definitions At § 180.20, we propose to add definitions for three new data elements, the ‘‘median allowed amount,’’ the ‘‘tenth (10th) percentile allowed amount,’’ and the ‘‘ninetieth (90th) percentile allowed amount.’’ These data elements would be defined as follows: • ‘‘Median allowed amount’’ would be defined as the median of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated median fall between two observed allowed amounts, the median allowed amount is the next highest observed value. • ‘‘Tenth (10th) percentile allowed amount’’ would be defined as the 10th percentile of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated percentile fall between two observed allo om a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated percentile fall between two observed allowed amounts, the 10th percentile allowed amount is the next highest observed value. • ‘‘Ninetieth (90th) percentile allowed amount’’ would be defined as the 90th percentile of total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the machine-readable file. Should the calculated percentile fall between two observed allowed amounts, the 90th percentile allowed amount is the next highest observed value. We discuss these proposed definitions in more detail in the following sections. 3. Proposal To Replace the Estimated Allowed Amount With the Allowed Amounts Data Elements and the Count of Allowed Amounts Data Element a. Background on Encoding Payer- Specific Negotiated Charges as Dollar Amounts 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00317 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM as Dollar Amounts 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00317 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 33792 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules As noted in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82099), we have learned that most commercial contracting methods allow a hospital to identify and display as a dollar figure the payer-specific negotiated charges they have established with third party payers. Accordingly, we expect that, for most contracting scenarios, a hospital’s payer-specific negotiated charges can also be expressed as a dollar amount. Hospitals and MRF users have indicated in inquiries to CMS that they are confused about our current requirements for encoding payer- specific negotiated charges, so we are clarifying our current policy. If a dollar amount can be derived from a hospital’s payer-specific negotiated charge, it must be encoded as a dollar value in the MRF. For items and services encoded in the MRF with a ‘‘standard charge methodology’’ of ‘‘case rate,’’ ‘‘per diem,’’ or a known ‘‘fee schedule, ted charge, it must be encoded as a dollar value in the MRF. For items and services encoded in the MRF with a ‘‘standard charge methodology’’ of ‘‘case rate,’’ ‘‘per diem,’’ or a known ‘‘fee schedule,’’ we expect that hospitals will be able to encode a ‘‘payer-specific negotiated charge: dollar amount.’’ We recognize that there may be situations where the payer-specific negotiated charge is a percentage of a fee schedule that is not available to the hospital. In such instances, under our existing policies, the hospital must encode a ‘‘payer- specific negotiated charge: percentage’’ and an estimated allowed amount (which would be replaced with the median allowed amount should our proposal be finalized) and may indicate in the additional notes data element the type of fee schedule. We note that hospitals encoding a case rate or per diem as the standard charge methodology must encode the dollar amount for the service package base rate, which may be coupled with a ‘‘payer-specific negotiated charge: algorithm’’ and an estimated allowed amount (which would be replaced with the median allowed amount should our proposal be finalized) if necessary. We encourage readers to review the scenar ed charge: algorithm’’ and an estimated allowed amount (which would be replaced with the median allowed amount should our proposal be finalized) if necessary. We encourage readers to review the scenarios and examples on the CMS Hospital Price Transparency—Data Dictionary GitHub Repository website for examples of how to encode standard charge data,269 and additional guidance on CMS’ HPT website.270 269 CMS, (2024, June), Hospital-Price- Transparency Examples, Hospital Price Transparency, GitHub. https://github.com/CMSgov/ hospital-price-transparency/tree/master/examples. 270 CMS, (2025, May), Resources, Hospital Price Transparency website https://www.cms.gov/ priorities/key-initiatives/hospital-price- transparency/resources. b. Replacing the Estimated Allowed Amount With the Median Allowed Amount We propose to revise § 180.50(b)(2)(ii)(C) to require, at new § 180.50(b)(2)(ii)(C)(2), that, beginning January 1, 2026, if a payer-specific negotiated charge is based on a percentage or algorithm, the hospital must calculate and encode the median allowed amount in dollars for that item or service. As noted above, we propose to define ‘‘median allowed amount’’ in § 180.20 as the median of t thm, the hospital must calculate and encode the median allowed amount in dollars for that item or service. As noted above, we propose to define ‘‘median allowed amount’’ in § 180.20 as the median of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the MRF. Should the calculated median fall between two observed allowed amounts (in other words, where the total count, n, is an even number), we propose that the median allowed amount would be the next highest observed value. As discussed in more detail below, we believe that requiring hospitals to encode the median allowed amount in the circumstances described in proposed § 180.50(b)(2)(ii)(C), rather than the estimated allowed amount, would improve the public’s ability to better understand, and, therefore, more meaningfully use, payer-specific negotiated charges, and would make such charges more comparable across hospitals. Currently, § 180.50(b)(2)(ii)(C) states that if the payer-specific negotiated charge is based on a percentage or algorithm, the MRF must also describe the percentage or algorithm that deter hospitals. Currently, § 180.50(b)(2)(ii)(C) states that if the payer-specific negotiated charge is based on a percentage or algorithm, the MRF must also describe the percentage or algorithm that determines the dollar amount for the item or service and calculate and encode an estimated allowed amount in dollars for that item or service. This data element is intended to improve the public’s ability to understand the actual price of care, particularly when making comparisons across hospitals. In § 180.20, we define ‘‘estimated allowed amount’’ as the average dollar amount that the hospital has historically received from a third party payer for an item or service. Since finalizing the CY 2024 OPPS/ASC final rule with comment period, we have received feedback from interested parties requesting clarity on how, and the appropriate data source and lookback period from which, to calculate this additional contextual data element. As indicated in the CY 2024 OPPS/ ASC final rule with comment period, we believe that having a contextual data element displayed in dollars would improve users’ ability to make price comparisons across hospitals when, with respect to the same procedure and payer/pla od, we believe that having a contextual data element displayed in dollars would improve users’ ability to make price comparisons across hospitals when, with respect to the same procedure and payer/plan, one hospital has established a payer-specific negotiated charge as an algorithm and a second as a dollar amount. In addition, we agree with interested parties that have noted that data points with dollar amounts are necessary to support a better understanding of the costs of care, especially given the complexities of hospital contractual arrangements with third party payers. On February 25, 2025, the President issued Executive Order 14221 requiring that HHS act to require disclosure of actual prices and ensure pricing information is easily comparable across hospitals. Consistent with the Executive Order and the feedback we have received from interested parties, we have considered ways to improve the requirement for hospitals to make public actual dollar amounts in the MRF to further transparency and comparability of hospital pricing information. Specifically, we have further considered the usefulness of the estimated allowed amount, as defined at § 180.20, in providing necessary con nsparency and comparability of hospital pricing information. Specifically, we have further considered the usefulness of the estimated allowed amount, as defined at § 180.20, in providing necessary context for the payer-specific negotiated charge and in facilitating comparisons across hospitals. We now believe that the payer-specific negotiated charge should be better contextualized and more precisely encoded to improve the MRF users’ ability to understand and use hospital standard charges. As set forth in § 180.20, the ‘‘estimated allowed amount’’ means the average dollar amount that the hospital has historically received from a third party payer for an item or service. While we believe that the estimated allowed amount provides useful additional context and enhances transparency and comparability of hospital standard charges, we acknowledge, as indicated in the CY 2024 OPPS/ASC final rule with comment period, that these average dollar amounts do not necessarily represent the actual dollar amount an individual would pay for an item or service. Thus, we propose to revise § 180.50(b)(2)(ii)(C) to require hospitals to encode, beginning January 1, 2026, the median allowed amount, rathe llar amount an individual would pay for an item or service. Thus, we propose to revise § 180.50(b)(2)(ii)(C) to require hospitals to encode, beginning January 1, 2026, the median allowed amount, rather than the estimated allowed amount, if a payer-specific negotiated charge is based on an algorithm or percentage. As noted above, we propose to define the median allowed amount as the median of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the MRF. Should the calculated median fall between two observed allowed amounts, VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00318 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33793 the median allowed amount is the next highest observed value. For example, in the scenario detailed in Table 89 the mean of the claim remittances amounts is $35,000, which exceeds all the other values except for the $200,000 outlier and would not reasonably reflect the allo in the scenario detailed in Table 89 the mean of the claim remittances amounts is $35,000, which exceeds all the other values except for the $200,000 outlier and would not reasonably reflect the allowed amount for most patients. By contrast, the $20,000 median would be a more accurate reflection of the allowed amount for many patients and the amount a hospital typically would be reimbursed for an item or service. Requiring the median rather than the average is consistent with generally accepted statistical principles for assessing the central point of a distribution when there are outliers.271 We recognize there are different methodologies that can be used to calculate a specific percentile when there is no single value. In this context, however, we believe that the need to identify an actual dollar value instead of an average of the two amounts outweighs the use of this accepted methodology and justifies the deviation. This methodology would only be applicable in cases, as we stated, when the percentile falls between two different integers. MRF users would be able to identify cases in which the methodology has been applied by looking at the ‘count of allowed amounts’ data element when the percentile falls between two different integers. MRF users would be able to identify cases in which the methodology has been applied by looking at the ‘count of allowed amounts’ data element, which is described below. We believe that requiring the median allowed amount would provide greater context and clarity with respect to the 271 Cooksey RW. Descriptive Statistics for Summarising Data. Illustrating Statistical Procedures: Finding Meaning in Quantitative Data. 2020 May 15:61–139. payer-specific negotiated charge and would better enable price estimator tools to develop and estimate an individual’s personalized out-of-pocket cost, enabling MRF users to more easily compare such standard charges across hospitals. c. Proposal To Add the 10th and 90th Percentile Allowed Amounts We propose to revise § 180.50(b)(2)(ii)(C) to require at new § 180.50(b)(2)(ii)(C)(2) that, beginning January 1, 2026, if a payer-specific negotiated charge is based on a percentage or algorithm, the hospital must calculate and encode a 10th and a 90th percentile allowed amount in dollars for that item or service. We propose to define ‘‘tenth (10th) percentile allowed amount’’ in § 180.20 as the 10th ital must calculate and encode a 10th and a 90th percentile allowed amount in dollars for that item or service. We propose to define ‘‘tenth (10th) percentile allowed amount’’ in § 180.20 as the 10th percentile of the total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the MRF. If the calculated percentile falls between two observed allowed amounts, the 10th percentile allowed amount is the next highest observed value. We propose to define ‘‘ninetieth (90th) percentile allowed amount’’ in § 180.20 as the 90th percentile of total allowed amounts the hospital has historically received from a third party payer for an item or service for a time period no longer than the 12 months prior to posting the MRF. Should the calculated percentile fall between two observed allowed amounts, the 90th percentile allowed amount is the next highest observed value. Research demonstrates that healthcare prices for a service can vary widely even within one insurer, and are not uniformly distributed.272 However, requiring a hospital to post every possible value and the frequency of tho that healthcare prices for a service can vary widely even within one insurer, and are not uniformly distributed.272 However, requiring a hospital to post every possible value and the frequency of those values would be highly burdensome to hospitals and would produce unmanageably large data files that are difficult to access and interpret. Therefore, our proposals for hospitals to encode 10th and 90th percentile allowed amounts, if a payer-specific negotiated charge is based on a percentage or algorithm, is to provide MRF users with useful information about the distribution of allowed amounts as simply and directly as possible. We considered removing outlier allowed amounts to provide MRF users a range of expected allowed amounts that are not distorted by unusually low or high claims, which are common in healthcare data (for example, we considered the 1st, 5th, and 99th percentile). Along with the median (which is the 50th percentile), the 10th and 90th percentiles convey information about the likelihood, based on the distribution, of the allowed amounts that the hospital has actually received for an item or service as, by definition, 80 percent of observations fall between the 10t bout the likelihood, based on the distribution, of the allowed amounts that the hospital has actually received for an item or service as, by definition, 80 percent of observations fall between the 10th and 90th percentile values. We believe that requiring the display of the 10th and 272 Whaley C., Radhakrishnan, N., Richards, M., Simon, K., Chartock, B. (2025) Understanding health care price variation: evidence from Transparency-in-Coverage data. Health Affairs Scholar, 3(2). https://pmc.ncbi.nlm.nih.gov/articles/ PMC11798183/. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00319 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00320 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33795 In the scenario detailed in Table 90, the hospital would calculate the median allowed amount to be $21,000 and then would select the next highest observed value, $22,000, to encode in the median allowed amou scenario detailed in Table 90, the hospital would calculate the median allowed amount to be $21,000 and then would select the next highest observed value, $22,000, to encode in the median allowed amount data element. Similarly, the hospital would calculate the 10th percentile to be $11,100 and select the next highest observed value, $12,000, to encode in the 10th percentile allowed amount data element. Finally, the hospital would calculate the 90th percentile to be $47,600 and select the next highest observed value, $50,000, to encode in the 90th percentile allowed amount data element. We solicit comment on our proposed revision to § 180.50(b)(2)(ii)(C) requiring hospitals to calculate and encode the 10th percentile, median (50th percentile), and 90th percentile allowed amounts in dollars when the payer- specific negotiated charge is based on a percentage or algorithm, as well as our proposed definition at § 180.20 of ‘‘tenth (10th) percentile allowed amount,’’ ‘‘median allowed amount,’’ and ‘‘ninetieth (90th) percentile allowed amount.’’ d. Calculation of Allowed Amounts (1) Determining the ‘‘Total Allowed Amount’’ We note that, under the proposed definition of ‘‘median allowed am ’’ and ‘‘ninetieth (90th) percentile allowed amount.’’ d. Calculation of Allowed Amounts (1) Determining the ‘‘Total Allowed Amount’’ We note that, under the proposed definition of ‘‘median allowed amount,’’ ‘‘10th percentile allowed amount,’’ and ‘‘90th percentile allowed amount’’ at § 180.20, hospitals would calculate the allowed amount considering the ‘‘total allowed amount’’ for an item or service. The ‘‘total allowed amount’’ dollar figure would be derived from the gross charge minus contractual adjustments and consist of the portion billed to a payer for a particular plan and the portion, if any, billed to the patient. As with the estimated allowed amount in the current rule, and as we explained in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82101), the amount should reflect the total amount the hospital was reimbursed for the item or service (or service package). We believe defining the ‘‘total allowed amount’’ this way would help to enhance consistency in how hospitals calculate this contextual data element, increasing comparability across hospitals. As described in more detail later in this section, hospitals would determine the ‘‘total allowed amount’’ from pitals calculate this contextual data element, increasing comparability across hospitals. As described in more detail later in this section, hospitals would determine the ‘‘total allowed amount’’ from EDI 835 ERA transaction data, which includes information about what the hospital was reimbursed by the plan, any secondary or other payer payment, and the patient’s cost sharing responsibility for an item or service. (2) Data Source for Calculating the Allowed Amounts In the CY 2024 OPPS/ASC final rule with comment period, we stated our belief at the time that hospitals should retain flexibility, in the interest of reducing burden, to determine the best data source(s) for calculating the estimated allowed amount data element, though we agreed with commenters that using information from EDI 835 ERA transaction data would appear to meet our requirements (88 FR 82101). To enhance the consistency of hospital standard charge information and the comparability of the median allowed amount, and the 10th percentile and the 90th percentile allowed amounts, and in accord with what commenters had earlier suggested, we propose to require that hospitals only use EDI 835 ERA transaction data to calc he 10th percentile and the 90th percentile allowed amounts, and in accord with what commenters had earlier suggested, we propose to require that hospitals only use EDI 835 ERA transaction data to calculate and encode the allowed amounts. As we had indicated, EDI 835 ERA transaction data, the electronic transaction data that provides claim payment information that hospitals use to track and analyze their claims and reimbursement patterns, including any adjustments made to the claim such as denials, reductions, or increases to the amount charged, and expected patient co-pays, co-insurance or secondary coverage, would meet the requirement to calculate an allowed amount (88 FR 82100 through 82101). We seek comment on the proposal to require that hospitals only use EDI 835 ERA transaction data to calculate and encode the allowed amounts. We also seek comment on whether there are instances where a hospital would not have access to EDI 835 ERA transaction data and whether there are alternative data sources we should consider requiring hospitals to use to calculate the allowed amounts and count of allowed amounts. (3) Lookback Period for Calculating the Allowed Amounts In the CY 2024 OPPS/ e data sources we should consider requiring hospitals to use to calculate the allowed amounts and count of allowed amounts. (3) Lookback Period for Calculating the Allowed Amounts In the CY 2024 OPPS/ASC final rule with comment period, we also declined to specify a lookback period for hospitals when calculating the estimated allowed amount. This flexibility was intended to reflect the variations in frequency and timing with which hospitals negotiate contracts with payers. The estimated allowed amount was intended to reflect the average reimbursement in dollars a hospital received. Our expectation was that hospitals would calculate the historical amount they received from a payer for an item or service based on the most VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00321 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k / > H P G 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00322 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33797 data sources E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33797 data sources we should consider requiring hospitals to use to calculate the allowed amounts and count of allowed amounts. Finally, we solicit comment on our proposal to require that the lookback period for the median allowed amount, the 10th and 90th percentile allowed amounts (and count of allowed amounts) be based on EDI 835 ERA transaction data from no longer than 12 months prior to posting the MRF. 4. Proposal for Hospitals To Encode the Count of Allowed Amounts Because the percentage or algorithm reported by a hospital is based on the contract a hospital has with a particular payer for a particular plan, the median allowed amount would be calculated as the median of the total allowed amounts (after all adjustments and payments on the claim) for an item or service under a particular plan, and the 10th and 90th percentile allowed amounts would be calculated as the 10th percentile and the 90th percentile of the total allowed amounts (after all adjustments and payments on the claim) for an item o 10th and 90th percentile allowed amounts would be calculated as the 10th percentile and the 90th percentile of the total allowed amounts (after all adjustments and payments on the claim) for an item or service under a particular plan. As part of our proposal to require hospitals to encode the median, 10th percentile, and 90th percentile allowed amounts if a hospital’s payer-specific negotiated charge is based on an algorithm or percentage, we also propose to require hospitals to encode the count of allowed amounts that were used to calculate the median, 10th percentile, and 90th percentile allowed amounts when the standard charge is based on a percentage or algorithm. We propose that the same count of allowed amounts would be used to calculate the median, 10th percentile, and 90th percentile allowed amounts. By providing additional context regarding the number of values used to calculate the median, 10th, and 90th percentile allowed amounts— because more price volatility might reasonably be anticipated with respect to a less frequently performed service— the count of allowed amounts in the EDI 835 ERA transaction data would help MRF users determine whether those are reasonably good ly be anticipated with respect to a less frequently performed service— the count of allowed amounts in the EDI 835 ERA transaction data would help MRF users determine whether those are reasonably good approximations of what typically would be generated by the payer-specific negotiated charge percentage or algorithm. Knowing the number of claims used to derive the allowed amounts allows the MRF user to assess how representative the median, 10th and 90th percentile allowed amounts are of the overall price distribution for the item or service. For example an MRF user may question the reliability of the encoded median, 10th and 90th percentile allowed amounts for a smaller sample of allowed amounts and may feel greater reassurance that these values are more statistically valid if a large number of allowed amounts was used to derive them. We believe this data element would also help drive understanding of the accuracy and completeness of the file as, where applicable, we also propose that hospitals would be required to disclose why they are unable to calculate a median allowed amount based on a lack of EDI 835 ERA transaction data. We propose requiring hospitals to encode this data elem ospitals would be required to disclose why they are unable to calculate a median allowed amount based on a lack of EDI 835 ERA transaction data. We propose requiring hospitals to encode this data element based on the actual number of allowed amounts within the EDI 835 ERA transaction data utilized to calculate the allowed amount data elements, except that we also propose that hospitals exclude zero- dollar claims from the count of allowed amounts. Zero-dollar claims are healthcare claims submitted by the hospital to a payer organization where the payment amount is zero, and they arise because of payer contractual situations where a service is not reimbursed for reasons including, but not limited to: when provided with a mix of other services, if the service was performed more than a specified number of times within a specified time period, lack of prior authorization for services, pre-existing condition exclusions, services deemed not medically necessary, and patients not having yet met their deductibles. Hospitals submit claims that result in no payment for some items and services because they provide information for the payer to calculate and process payment for the mix of servic t their deductibles. Hospitals submit claims that result in no payment for some items and services because they provide information for the payer to calculate and process payment for the mix of services furnished, not because it results in a separate payment for that item or service. We propose to exclude them because they would result in misleading and skewed calculation of the median, 10th, and 90th percentile allowed amounts. The count of allowed amounts should be based on the number of allowed amounts used to calculate the allowed amounts. For example, if 184 allowed amounts were used to derive the median, 10th, and 90th percentile allowed amounts for a particular item or service, the hospital would encode ‘‘184’’ as the value for the count of allowed amounts. If a hospital only had 1 allowed amount within the EDI 835 ERA transaction data for an item or service, the hospital would encode a ‘‘1’’ as the value for the count of allowed amounts. We also acknowledge that, in certain situations (for example, in the case of a new hospital, or a hospital contracting with a new payer organization or a newly renegotiated contract), a hospital may have no historical claim remittance histo uations (for example, in the case of a new hospital, or a hospital contracting with a new payer organization or a newly renegotiated contract), a hospital may have no historical claim remittance history from which to derive a median, 10th, or 90th percentile allowed amount for a payer and plan. Should a hospital have a ‘‘0’’ count of allowed amounts from the most recent 12-month time period from which to derive the allowed amounts for a particular item or service, we propose that it would encode ‘‘0’’ as the value for the count of allowed amounts for a specific payer and plan and may leave the median, 10th, and 90th percentile allowed amounts in the MRF blank. In such cases, we propose to require hospitals to encode information to explain the hospital’s insufficient claim remittance history in the additional notes data element. In particular, should a hospital have no claims with the payer because it is a new or revised payer contract, we propose that a hospital should encode ‘‘new or recently revised payer contract’’ in the additional notes data element. We also note that nothing would preclude a hospital from updating its MRF when it has one or more remittances for an item or ser recently revised payer contract’’ in the additional notes data element. We also note that nothing would preclude a hospital from updating its MRF when it has one or more remittances for an item or service. We considered proposing an alternative approach of requiring hospitals to provide the range, or categories, of the count of allowed amounts, for example less than 10, 10– 49, 50–99, 100–149, 150–199, 200–499, and 500 and over. Requiring hospitals to report ranges for the count of allowed amounts would have similarly met the objective of providing the needed context to the allowed amounts and helped inform users of the volatility of the price, and providing standard ranges could have improved the ability to compare across MRFs without the variability of individual counts. Although we believe the policy that we elected to propose offers greater precision and information value, we nevertheless believe that such an alternative approach still would have achieved our goal of providing clarity and context about the encoded price, as well as providing standard range values that can be used for comparison across MRFs. We seek comment on whether knowing a precise count of allowed amounts i ity and context about the encoded price, as well as providing standard range values that can be used for comparison across MRFs. We seek comment on whether knowing a precise count of allowed amounts is helpful to determine the volatility of the price encoded in allowed amount data elements, or if knowing that allowed counts fell within a particular range is sufficient. We also seek comment on particular range criteria, and, were we to finalize this alternative approach as opposed to our proposed approach, we might incorporate commenter feedback to provide more guidance on how the ranges would be encoded and the valid values required in the CMS Hospital Price Transparency—Data Dictionary GitHub Repository website. For example, were a hospital to base the VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00323 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33798 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules allowed amount data elements on 184 allowed amounts within the EDI 835 ERA transaction data, the hospital would select a predetermined range, such as 150–199 allow sday, July 17, 2025 / Proposed Rules allowed amount data elements on 184 allowed amounts within the EDI 835 ERA transaction data, the hospital would select a predetermined range, such as 150–199 allowed amounts. We solicit comment on our proposed revision to § 180.50(b)(2)(ii)(C) to require hospitals to calculate and encode the count of allowed amounts used to calculate the median, 10th, and 90th percentile allowed amounts, as well as on our proposal that hospitals encode this data element with the actual number of allowed amounts used within the EDI 835 ERA transaction data. We also solicit comment on the alternative we considered of encoding the count of allowed amounts using a standardized range of the number of allowed amounts used within the EDI 835 ERA transaction data, rather than the actual number of allowed amounts, and seek comment on standardized range values of counts of allowed amounts that would be useful. 5. Proposal To Modify the MRF Affirmation Statement We propose to supplant the existing affirmation requirement by, instead, specifying at new § 180.50(a)(3)(iii) that, beginning January 1, 2026, hospitals would be required to attest in their MRFs to the following s supplant the existing affirmation requirement by, instead, specifying at new § 180.50(a)(3)(iii) that, beginning January 1, 2026, hospitals would be required to attest in their MRFs to the following statement: ‘‘The hospital has included all applicable standard charge information in accordance with the requirements of § 180.50, and the information encoded is true, accurate, and complete as of the date in the file. The hospital has included all payer-specific negotiated charges in dollars that can be expressed as a dollar amount. For payer-specific negotiated charges that cannot be expressed as a dollar amount in the machine-readable file or not knowable in advance, the hospital attests that the payer-specific negotiated charge is based on a contractual algorithm, percentage or formula that precludes the provision of a dollar amount and has provided all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula.’’ We also propose at new § 180.50(a)(3)(iv) that, beginning January 1, 2026, the hospital must encode within he specific fee schedule or components referenced in such percentage, algorithm or formula.’’ We also propose at new § 180.50(a)(3)(iv) that, beginning January 1, 2026, the hospital must encode within the MRF the name of the hospital chief executive officer, president, or senior official designated to oversee the encoding of true, accurate and complete data as directed in § 180.50(a)(3)(iii). We propose to adopt this attestation to make clear to hospitals, MRF users, and to the public our expectations that the hospital should accurately and completely encode all available standard charge information, and if the hospital established a standard charge as a dollar amount, the hospital would display the standard charge as a dollar amount, and if the hospital is unable to display standard charges as a dollar, the hospital would be required to provide all information necessary to derive a dollar amount. We intend this public declaration to establish for MRF users and for CMS actionable certainty on the accuracy and completeness of the standard charge information displayed. We also intend that this public declaration would increase hospital accountability to the MRF users that the data is inty on the accuracy and completeness of the standard charge information displayed. We also intend that this public declaration would increase hospital accountability to the MRF users that the data is complete as of the date indicated in the file. We believe demonstrating our strengthened expectations will result in the public display by hospitals of more meaningful data for MRF users. Since the proposed new attestation requirements at § 180.50(a)(3)(iii)–(iv) would supplant, with significantly stronger provisions, certain existing requirements, we believe those particular existing requirements would become superfluous and propose to remove them. Provisions that we propose to remove, effective December 31, 2025, include the affirmation requirement now at § 180.50(a)(3)(ii) and the requirement at § 180.50(a)(3)(i), which states, beginning January 1, 2024, that each hospital must make a good faith effort to ensure that the standard charge information encoded in the MRF is true, accurate, and complete as of the date indicated in the MRF. Specifically, we believe the attestation requirement that we propose would not only incorporate those concepts, but, in fact, would mandate significa and complete as of the date indicated in the MRF. Specifically, we believe the attestation requirement that we propose would not only incorporate those concepts, but, in fact, would mandate significantly heightened hospital recognition of their responsibilities than what we presently require. We believe that our proposed attestation requirements, if finalized as proposed, would reduce public confusion related to whether all standard charges for hospital items and services, where possible, are included within the MRF as dollar amounts. Additionally, should our proposal be finalized as proposed, it would establish that the hospital has provided all available information to enable the public to derive a dollar amount, including, but not limited to, the specific fee schedule or components referenced in a percentage, algorithm or formula. We believe this would provide the necessary reassurance that hospitals have provided in their MRFs meaningful, accurate information to MRF users about their standard charges for health care items and services in order for those users to fully realize the intended use of the MRFs as expressed in the CY 2020 HPT final rule—that is, for enhancing the pub eir standard charges for health care items and services in order for those users to fully realize the intended use of the MRFs as expressed in the CY 2020 HPT final rule—that is, for enhancing the public’s ability to use the data in, for example, innovator developed consumer tools and in EHRs at the point of care for value-based referrals, or to aggregate and use the data to increase competition. We stated in the CY 2024 OPPS/ASC final rule with comment period that we believed an affirmation in the hospital’s MRF, which we finalized in that rulemaking, would lessen public confusion related to the accuracy and completeness of the data in the file and improve CMS’ ability to assess both the completeness and accuracy of the MRF, and that by improving assessment of compliance, CMS would improve its enforcement capabilities. Through rulemaking and during subsequent public engagement and outreach, CMS has received numerous comments and inquiries from the public and interested parties leading us to question the sufficiency of the current affirmation requirement. For example, we have heard from MRF users that they were unsure whether the absence of standard charge information meant that th us to question the sufficiency of the current affirmation requirement. For example, we have heard from MRF users that they were unsure whether the absence of standard charge information meant that the hospital had not established a standard charge or if the hospital had not complied with the requirement to disclose those charges in the MRF. We have heard from MRF users that they questioned whether hospitals have included all items and services they offer or if they included all payer and plan combinations for the payer-specific standard charges they have established. We have received complaints that hospitals are obfuscating standard charge dollar amounts and instead only encoding payer-specific standard charges as percentages and algorithms. We have also received questions regarding our assessment of the accuracy and completeness of the standard charge information displayed by hospitals in their MRFs. We also noted in the 2024 OPPS/ASC final rule with comment period that, while we believe enforcement of HPT requirements is CMS’s role, the law places responsibility on hospitals to establish and make public complete and accurate standard charge information. We also have received co lieve enforcement of HPT requirements is CMS’s role, the law places responsibility on hospitals to establish and make public complete and accurate standard charge information. We also have received comments from MRF users since the effective date of the 2024 OPPS/ASC final rule with comment period indicating that requiring hospitals to make a good faith effort did not go far enough to convey CMS’ intent that all standard charge information available must be encoded in the MRF, with commenters suggesting our requirement to allow a good faith estimate may actually deter VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00324 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33799 hospitals from providing fully complete and accurate standard charge data in their MRF. MRF users have also questioned hospitals’ inability to encode dollar amounts for the payer-specific negotiated charge data elements, and, relatedly, whether the notion that hospitals and payers use complex contracting methodologies really means the amount for an i llar amounts for the payer-specific negotiated charge data elements, and, relatedly, whether the notion that hospitals and payers use complex contracting methodologies really means the amount for an item or service could only be expressed as an algorithm or formula and not a dollar amount. Similarly, MRF users have questioned why specific contract methodologies, when coupled with an algorithm, preclude a hospital from specifying a dollar amount, with these MRF users also indicating they were unsure that all the hospital standard charge data was, in fact, fully encoded in the MRF. We do not find it surprising that MRF users, upon finding only a consumer- unfriendly algorithm, may be unable to easily compare pricing information across hospitals; efforts to rectify that give rise to some of our proposals here. We also provided clarification in the 2024 OPPS/ASC final rule with comment period, (88 FR 82096) and reiterated in recently issued guidance, that if a hospital can derive a dollar amount for a hospital’s payer-specific negotiated charge, it must encode that dollar value in the MRF’s ‘‘payer- specific negotiated charge: dollar amount’’ data element.290 Nevertheless, we acknowled amount for a hospital’s payer-specific negotiated charge, it must encode that dollar value in the MRF’s ‘‘payer- specific negotiated charge: dollar amount’’ data element.290 Nevertheless, we acknowledge that we do not believe that all hospitals, in all instances, can produce a payer-specific negotiated charge in dollars that meets the definition of a ‘‘standard charge.’’ Thus, we clarify that a hospital may display a payer-specific negotiated charge as a standard algorithm to the extent a standard algorithm is the manner by which the hospital establishes its standard charges with third party payers, and in such instances, as provided at § 180.50(b)(2)(ii)(C), the MRF must also describe the percentage or algorithm that determines the dollar amount for the item or service. In the 2024 OPPS/ASC final rule with comment period (88 FR 82098), we provided direction for hospitals on how to encode standard charges as an algorithm, stating that descriptions for algorithms could include, for example, a link to the algorithm used, a descriptor of a commonly understood algorithm, or a list of factors that would be used to 290 Updated Hospital Price Transparency Guidance Implementing the Preside ple, a link to the algorithm used, a descriptor of a commonly understood algorithm, or a list of factors that would be used to 290 Updated Hospital Price Transparency Guidance Implementing the President’s Executive Order ‘‘Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information,’’ May 22, 2025, https://www.cms.gov/files/document/ updated-hpt-guidance-encoding-allowed- amounts.pdf. determine the individualized allowed amount in dollars. Our expectation is that hospitals will encode the necessary information to enable MRF users to have all the factors of the algorithm required to be able to derive a price. To provide CMS actionable and enforceable certainty, and MRF users additional assurance, including in situations where the hospital’s payer- specific negotiated charge is based on a contractual algorithm, percentage, or formula by which a hospital genuinely cannot specify a dollar amount, we propose at § 180.50(a)(3)(iii) to require that a hospital attest in its MRF to the accuracy and completeness of the data, and at § 180.50(a)(3)(iv) to require that a hospital include the name of the hospital chief executive, presid to require that a hospital attest in its MRF to the accuracy and completeness of the data, and at § 180.50(a)(3)(iv) to require that a hospital include the name of the hospital chief executive, president, or other senior official designated by the hospital’s leadership to maintain true, accurate, and complete MRF data, to establish that the data was reviewed and verified by the hospital’s leadership. Requiring an individual’s name be specified would also, we believe, expedite our ability to quickly identify an individual at the hospital to obtain, where necessary, further clarity regarding the MRF data. In connection with this proposed requirement, we propose to add a new general data element, attester name, and should the proposal be finalized as proposed, we would provide, on the CMS Hospital Price Transparency—Data Dictionary GitHub Repository website, instruction on how to encode this data element. We acknowledge that, at § 180.50(d)(6)(i)(D), we already require hospitals to include in their .txt files a hospital point of contact. But, that existing requirement was added as part of our efforts to improve the automated accessibility of MRFs (88 FR 82111). This point of contact w e in their .txt files a hospital point of contact. But, that existing requirement was added as part of our efforts to improve the automated accessibility of MRFs (88 FR 82111). This point of contact was generally intended to identify for the MRF users who used the .txt requirement to retrieve hospitals MRF urls an individual capable of answering technical questions about a hospital’s MRF. We noted in the CY 2024 OPPS/ ASC final rule with comment period that the designation of a primary point of contact to address technical questions regarding the MRF per that requirement would not in itself assure accuracy or completeness of an MRF (88 FR 82116). Thus, we believe that existing requirement is distinct from our proposed requirement here that a hospital specifically encode within the MRF file itself the name of a senior official designated by the hospital’s leadership to maintain true, accurate, and complete MRF data, but we seek comment on whether our current requirement at § 180.50(d)(6)(i)(D) adequately assures all MRF users of the accuracy and completeness of the data encoded within the hospitals’ MRF. We appreciate the need the public has expressed, as conveyed by their feedback )(i)(D) adequately assures all MRF users of the accuracy and completeness of the data encoded within the hospitals’ MRF. We appreciate the need the public has expressed, as conveyed by their feedback to us, for greater assurance that MRF standard charge information is true, accurate, and complete, which is, in part, why we propose that hospitals include this revised attestation statement in the MRF. We believe that strengthening this attestation about the veracity of the MRF data, in lieu of the existing good faith effort requirement, would better assure us and MRF users that the data encoded is accurate and complete. Such greater assurance would not, however, diminish CMS’s role as the hospital price transparency enforcer or alter our view that the False Claims Act is outside the scope of this proposed rule just as we expressed at 88 FR 82086 that it was outside the scope of that final rule with comment period, and attestations will not alter our use of the regulatory alternatives outlined at § 180.70 to monitor and enforce hospital compliance with our requirements. In the 2024 OPPS/ASC final rule with comment period, at § 180.70(a)(2)(iv), we extended our compliance authority to lined at § 180.70 to monitor and enforce hospital compliance with our requirements. In the 2024 OPPS/ASC final rule with comment period, at § 180.70(a)(2)(iv), we extended our compliance authority to require, upon our request, an authorized hospital official to submit to CMS a certification as to the accuracy and completeness of the standard charge information posted in the MRF. Independent of our proposal here, we continue to believe that it is necessary for CMS to have the authority, as part of our monitoring processes, to require a formal certification by an authorized hospital official to resolve any specific questions related to the standard charges displayed by a hospital and the items and services for which the hospital has established a standard charge. As part of that existing authority, we may also require further assurance that within the hospital’s MRF, any payer-specific negotiated standard charges that cannot be expressed as a dollar amount in the MRF are based on a contractual algorithm, percentage, or formula that precludes the provision of a dollar amount. We expect that the authorized hospital official who is named as the Attester in the MRF is the same authorized actual algorithm, percentage, or formula that precludes the provision of a dollar amount. We expect that the authorized hospital official who is named as the Attester in the MRF is the same authorized hospital official who would submit to CMS a certification to the accuracy and completeness of the MRF data. In the 2024 OPPS/ASC final rule with comment period, we also finalized at § 180.70(a)(2)(v) that we will require hospitals to submit to us, upon our request, additional documentation as may be necessary to make a determination of hospital compliance. In response to a request from CMS, a VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00325 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k 33800 Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules hospital must supply sufficient source documentation to satisfy CMS that the hospital has met the regulatory requirements. We believe our attestation proposal here complements the authority finalized in the 2024 OPPS/ ASC final rule with comment period to provide CMS with adequate documentation to determine the accuracy and comp eve our attestation proposal here complements the authority finalized in the 2024 OPPS/ ASC final rule with comment period to provide CMS with adequate documentation to determine the accuracy and completeness of a hospital’s price transparency files. We considered several alternatives to altering the required affirmation within the MRF. First, we considered proposing that hospitals would be required to submit their MRF attestation directly to CMS, using a CMS-developed template that would provide evidence of the accuracy and completeness of the MRF. We did not propose such an alternative because we believe that the attestation statement and the name of the authorized hospital official should remain within the MRF to streamline our compliance process and reassure users of the MRF about the accuracy and completeness of the information. This alternative would also, we believe, be duplicative of the CMS’s existing authority at § 180.70(a)(2)(iv). In the 2024 OPPS/ASC final rule with comment period, we noted that many other CMS programs require the submission of an attestation; for brevity we do not repeat them here, but refer the reader to that discussion at 88 FR 82085. Though we did t period, we noted that many other CMS programs require the submission of an attestation; for brevity we do not repeat them here, but refer the reader to that discussion at 88 FR 82085. Though we did not mention it there, we note that the CMS–1500, the standard claim form used by non- institutional providers and suppliers to bill Medicare and other payers, and CMS–1450, the standard claim form used by institutional healthcare providers to bill for services, also both contain certification provisions. We seek comment on whether CMS should require hospitals to post, on their publicly available websites that host the hospital MRF, a standalone attestation document that would be signed by a hospital senior official. We viewed such an alternative as less useful than what we have proposed because MRF users, innovators, researchers, employers, other policy makers, and CMS, frequently access hospitals’ MRFs from hospital websites in an automated fashion, and where an attestation would consist of a separate standalone document it would not ‘‘travel’’ inside the MRF like the current affirmation statement, potentially hindering effective automated retrieval. Moreover, we stated in the CY 2024 of a separate standalone document it would not ‘‘travel’’ inside the MRF like the current affirmation statement, potentially hindering effective automated retrieval. Moreover, we stated in the CY 2024 OPPS/ASC proposed rule that requiring hospitals to add the then-proposed affirmation directly in their MRF would make it clear to the public that it relates directly to that MRF and would mitigate the potential for confusion if we only required that the affirmation appear on a website that links to the hospital’s MRF, especially if that website also links to other hospital MRFs. In short, we believe that separating the attestation from the MRF could add complexity to existing automation processes, introduce more public confusion about the intent of the attestation, and defeat one of our primary objectives of having hospitals better assure the public of the accuracy and completeness of hospitals’ MRFs. However, we acknowledge that MRFs are not necessarily particularly healthcare consumer friendly and frequently are very large files, so there may be merit to requiring a separate, easily retrieved attestation document. We seek comment on this alternative. We seek comment on our proposal riendly and frequently are very large files, so there may be merit to requiring a separate, easily retrieved attestation document. We seek comment on this alternative. We seek comment on our proposal to add § 180.50(a)(3)(iii) which, beginning January 1, 2026, would require hospitals to include in their MRFs the following attestation: ‘‘The hospital has included all applicable standard charge information in accordance with the requirements of § 180.50, and the information encoded is true, accurate, and complete as of the date in the file. The hospital has included all payer- specific negotiated charges in dollars that can be expressed as a dollar amount. For payer-specific negotiated charges that cannot be expressed as a dollar amount in the MRF or not knowable in advance, the hospital attests that the payer-specific negotiated charge is based on a contractual algorithm, percentage or formula that precludes the provision of a dollar amount and has provided all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula ilable to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula.’’ We also seek comment on our proposal, in § 180.50(a)(3)(iv), to require, beginning January 1, 2026, that hospitals include a data element in the MRF to encode the name of the hospital chief executive officer, president, or senior official designated to oversee the encoding of true, accurate, and complete data as directed in § 180.50(a)(3)(iii). Finally, we seek comment on our proposal to remove, as superseded and rendered unnecessary by virtue of these stronger proposed requirements, effective January 1, 2026, § 180.50(a)(3)(i), which states that beginning January 1, 2024, a hospital must make a good faith effort to ensure that the standard charge information encoded in the MRF is true, accurate, and complete as of the date indicated in the MRF, and the affirmation statement at § 180.50(a)(3)(ii). 6. Proposal To Report Hospital National Provider Identifier (NPI) Information in the Machine Readable File We propose to revise § 180.50(b)(2)(i)(A) to require hospitals, beginning Januar 0(a)(3)(ii). 6. Proposal To Report Hospital National Provider Identifier (NPI) Information in the Machine Readable File We propose to revise § 180.50(b)(2)(i)(A) to require hospitals, beginning January 1, 2026, to report a unique identifier, specifically their NPI(s), in their MRFs. We believe that having hospitals add their NPI(s) to the MRF would improve the comparability of HPT and other healthcare data, including health plan transparency data from the Transparency in Coverage (TiC) MRFs. Below, we explain the details of this proposal, including how we propose that hospitals would encode their NPI(s) in their MRFs. An NPI is a unique 10-digit number used to identify healthcare providers and organizations, including hospitals.291 All healthcare providers that are Health Insurance Portability and Accountability Act (HIPAA)-covered entities must obtain an NPI.292 Healthcare providers who are individuals are assigned a Type 1 NPI and healthcare providers that are organizations are assigned a Type 2 NPI (69 FR 3440). Type 2 NPIs are also known as organizational NPIs. ‘‘Subparts’’ of organizations—which are components of the same organization that may be separately licensed or identif ned a Type 2 NPI (69 FR 3440). Type 2 NPIs are also known as organizational NPIs. ‘‘Subparts’’ of organizations—which are components of the same organization that may be separately licensed or identified 293—may also obtain a Type 2 NPI (69 FR 3441) if they conduct HIPAA standard transactions separately 294 from the main organization (45 CFR 162.410(a)(1)). Entities and individuals maintain NPIs unless they are deactivated upon request, death, or dissolution (45 CFR 162.408(c)), and NPIs do not change if provider name, EIN, or state licensure changes (69 FR 3441). There are several internet-based NPI lookup tools available online, including CMS’s National Plan & Provider Enumeration System (NPPES) NPI registry.295 NPIs are commonly used in other CMS systems for financial transactions, and for other health care 291 https://www.cms.gov/regulations-and- guidance/administrative-simplification/ nationalprovidentstand. 292 Ibid. 293 Guidance on NPI Enumeration; 45 CFR 162.412(b). https://www.cms.gov/files/document/ guidance-national-provider-identifier-npi- enumeration-pdf.pdf. 294 https://www.cms.gov/regulations-and- guidance/administrative-simplification/ nationalprovidentstand/downloa .cms.gov/files/document/ guidance-national-provider-identifier-npi- enumeration-pdf.pdf. 294 https://www.cms.gov/regulations-and- guidance/administrative-simplification/ nationalprovidentstand/downloads/ medsubparts01252006.pdf. 295 CMS’s NPPES registry is available online at the following website address: https:// npiregistry.cms.hhs.gov/. VerDate Sep 2014 22:23 Jul 16, 2025 Jkt 265001 PO 00000 Frm 00326 Fmt 4701 Sfmt 4702 E:\FR\FM\17JYP2.SGM 17JYP2 2 S L A S O P O R P h t i w D O R P 4 4 1 S 7 W 9 K S D n o d n o m m a h k Federal Register / Vol. 90, No. 135 / Thursday, July 17, 2025 / Proposed Rules 33801 data sets, including claims, utilization, and quality data sets. In the CY 2020 HPT final rule (84 FR 65555), we stated that, by ensuring accessibility to all hospital standard charge data for all items and services, these data would be available for use by the public in price transparency tools, to be integrated into electronic health records (EHRs) for purposes of clinical decision making and referrals, or to be used by researchers and policy officials to help bring more value to healthcare. Similarly, in the TiC final rule (85 FR 72160), we indicated that the release of stan on making and referrals, or to be used by researchers and policy officials to help bring more value to healthcare. Similarly, in the TiC final rule (85 FR 72160), we indicated that the release of standard charge data would strengthen America’s health care system by giving health care consumers, researchers, regulators, lawmakers, health innovators, and other interested parties in health care the information they need to make or assist others in making informed decisions about health care purchases. In the CY 2024 OPPS/ASC final rule with comment period (88 FR 82027), we further advanced standardization of the MRF to reduce data coding inconsistencies that hindered the machine-readability of the data in the files, which at the time presented a barrier to the intended use of the data and reinforced our goal to advance the utility of the MRF data. With this proposal, we take additional steps to remove barriers to effective use of this data. Under the current HPT regulations at § 180.50, hospitals must provide identifying information, including hospital name, address, license number, and the Employer Identification Number (EIN) either in the MRF file name or the file itself. While thes ospitals must provide identifying information, including hospital name, address, license number, and the Employer Identification Number (EIN) either in the MRF file name or the file itself. While these elements help to identify the hospital, interested parties have told us that they are inadequate to facilitate comparing hospital MRF data with other datasets that include hospital-related information and that a standard identifier would bolster these efforts. In particular, we are told that the MRF’s lack of a standard identifier hinders efforts to compare standard charge data across MRFs and limits opportunities to automate the comparison and analysis of HPT and TiC MRF data. Innovators, researchers and other MRF users have stressed to us the importance of including standard identifiers to streamline data and reduce the complexity of analyzing numerous and different disclosures. The currently required hospital license number is useful to help crosswalk the name of the hospital with the state license number, but because it differs from the identifier required in the TiC files, innovators and researchers have noted that they find it difficult to compare across files. We also note tha state license number, but because it differs from the identifier required in the TiC files, innovators and researchers have noted that they find it difficult to compare across files. We also note that EINs, while required as part of the naming convention for the hospital MRF and included in the TiC MRF, are generally not included in CMS datasets or other public financial and claims datasets. Therefore, we believe it is important to propose to require hospitals to report a standard identifier, specifically the NPI, which is used in other CMS systems such as the Provider Enrollment, Chain, and Ownership System (PECOS), and the TiC MRFs, to maximize comparability across data and files. Moreover, Executive Order 14221 requires HHS to ensure that pricing information is standardized and easily comparable across hospitals and health plans.296 To this end, we believe it is important to align the HPT MRF and the TiC identifier data element. Under the TiC final rule (85 FR 72158), and as described in the TiC GitHub schemas for the ‘‘In-Network File,’’ ‘‘Out-Of-Network Allowed Amount File,’’ and the optional ‘‘Provider Reference File,’’ most group health plans and health insurance issuers mu