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

In section VI.K. of the preamble of this final rule, we discuss updates to the Hospital Readmissions Reduction Program. Specifically, in this final rule, we are (1) modifying the six readmission measures in the program to include Medicare Advantage (MA) beneficiaries into the patient cohorts, and (2) modifying the applicable performance period from a 3-year period to a 2-year period. All six of the current Hospital Readmissions Reduction Program's measures are claims-based measures, therefore these policies will not impact information collection burden. We believe that continuing to use these claims-based measures will not create or reduce any information collection burden for hospitals because they will continue to be collected using Medicare FFS claims that hospitals are already submitting to the Medicare program for payment purposes under OMB control number 0938-1197 (expiration date October 31, 2027). 2. ICRs for the Hospital Value-Based Purchasing (VBP) Program

In section VI.L. of the preamble of this final rule, we discuss updates to the Hospital VBP Program. Specifically, we are modifying the Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty/Total Knee Arthroplasty (THA/ TKA) measure in alignment with the Hospital IQR Program, beginning with the April 1, 2029-March 31, 2031, performance period/FY 2033 payment determination. The finalized modifications will include adding Medicare Advantage (MA) beneficiaries into the patient cohorts and modifying the applicable performance period from a 3-year period to a 2-year period.

The Hospital-Level RSCR Following Elective Primary THA/TKA measure currently uses data that are collected using Medicare FFS claims that hospitals are already submitting to the Medicare program for payment purposes; therefore, there is no additional information collection burden associated with this measure regarding the modification of the applicable performance period. We also do not assume any change in burden associated with the finalized modification to add MA beneficiaries into the patient cohorts. As finalized, the measure will use MA encounter data already collected by CMS to determine cohort inclusion criteria, complications outcomes, and present on admission (POA) comorbidities. We discuss the burden associated with the similar policy to modify the Hospital-Level RSCR Following Elective Primary THA/TKA measure under the Hospital IQR Program in section X.C.3.b. of the preamble of this final rule.

We also finalized removal of the Health Equity Adjustment (HEA) that rewards top performing hospitals that serve higher proportions of patients with dual eligibility status. Because the HEA affects the scoring methodology and does not require hospitals to submit any additional information, there is no change in burden associated with the policy. 3. ICRs for the Hospital-Acquired Condition (HAC) Reduction Program

OMB has currently approved 28,840 hours of burden and approximately $1.5 million under OMB control number 0938-1352 (expiration date November 30, 2027), accounting for information collection burden experienced by 400 subsection (d) hospitals selected for validation each year in the HAC Reduction Program.

In section VI.M. of the preamble of this final rule, we discuss updates to the HAC Reduction Program. Specifically, we are updating the Centers for Disease Control and Prevention's (CDC's) National Healthcare Safety Network (NHSN) Hospital-Acquired Infection (HAI) chart-abstracted measures to a more recent baseline year to better reflect current HAI diagnostic practices to improve patient safety outcomes and quality of care. This update does not affect the amount of data hospitals are required to submit for these measures; therefore, we do not assume any change in information collection burden. Information collection burden associated with collection of data for these measures is accounted for by CDC under OMB control number 0920-0666 (expiration date December 31, 2027). 4. ICRs for the Hospital Inpatient Quality Reporting (IQR) Program a. Background

Data collections for the Hospital IQR Program are associated with OMB control number 0938-1022 (expiration date January 31, 2026), under which OMB has currently approved 2,283,878 hours of burden at a cost of approximately $92.1 million, accounting for information collection burden experienced by approximately 3,050 IPPS hospitals and 1,500 non- IPPS hospitals for the FY 2027 payment determination. In this final rule, we describe the burden changes regarding collection of information, under OMB control number 0938-1022.

For more detailed information on our finalized policies for the Hospital IQR Program, we refer readers to sections X.C.3., X.C.4., and X.C.7. of the preamble of this final rule. We are modifying two measures: (1) the Hospital-Level, Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) measure (herein after referred to as the COMP-HIP-KNEE measure) beginning with the FY 2027 payment determination, associated with the April 1, 2023-March 31, 2025 performance period; (2) the Hospital 30-Day, All-Cause, Risk- Standardized Mortality Rate (RSMR) Following Acute Ischemic Stroke Hospitalization (hereinafter referred to as the MORT-30-STK) measure, beginning with the FY 2027 payment determination, associated with a July 1, 2023-June 30, 2025 performance period. We are also modifying the reporting requirements of

the Hybrid Hospital-Wide Readmission (HWR) measure beginning with the FY 2028 payment determination, associated with a July 1, 2025-June 30, 2026, performance period; and the Hybrid Hospital-Wide Mortality (HWM) measure beginning with the FY 2028 payment determination, associated with a July 1, 2025-June 30, 2026, performance period. These policies will not affect information collection burden.

We are removing four measures beginning with the CY 2024 reporting period/FY 2026 payment determination: (1) the Hospital Commitment to Health Equity measure; (2) the COVID-19 Vaccination Coverage among Healthcare Personnel (HCP) measure; (3) the Screening for Social Drivers of Health measure; and (4) the Screen Positive Rate for Social Drivers of Health Measure. We discuss the impacts on information collection burden associated with these policies later in this section.

Using the most recent data from the BLS for medical records specialists (SOC 29-2072), entitled, the May 2023 National Occupational Employment and Wage Estimates (OEWS), we are finalizing the use of the mean hourly wage for medical records specialists for the industry, “general medical and surgical hospitals,” which is $27.69.\500\ We believe the industry of “general medical and surgical hospitals” is more specific to this program compared to other industries under medical records specialists, such as “office of physicians” or “nursing care facilities.” We calculated the cost of overhead, including fringe benefits, at 100 percent of the mean hourly wage, consistent with previous years. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly by employer and methods of estimating these costs vary widely in the literature. Nonetheless, we believe that doubling the hourly wage rate ($27.69 x 2 = $55.38) to estimate total cost is a reasonably accurate estimation method. Unless otherwise specified, we will calculate cost burden to hospitals using a wage plus benefits estimate of $55.38 per hour throughout the discussion in this section of this final rule for the Hospital IQR Program.

\500\ U.S. Bureau of Labor Statistics. Occupational Outlook Handbook, Medical Records Specialists. Accessed November 27, 2024. Available at: https://www.bls.gov/oes/current/oes292072.htm.

In the FY 2025 IPPS/LTCH PPS final rule (89 FR 69894), our burden estimates were based on an assumption of approximately 3,050 IPPS hospitals. For this final rule, based on data from the FY 2025 Hospital IQR Program payment determination, we are maintaining that assumption and estimate that approximately 3,050 IPPS hospitals will report data to the Hospital IQR Program for the CY 2026 reporting period. b. Information Collection Burden Estimate for the Modifications to the Hospital-Level, RSCR Following Elective Primary THA/TKA Measure and Hospital 30-Day, All-Cause, RSMR Following Acute Ischemic Stroke Hospitalization Measure Beginning With the FY 2027 Payment Determination

In sections X.C.3.a. and X.C.3.b. of the preamble of this final rule, we discuss the modification of the COMP-HIP-KNEE measure beginning with the FY 2027 payment determination, associated with the April 1, 2023-March 31, 2025 performance period and the MORT-30-STK measure beginning with the FY 2027 payment determination, associated with the July 1, 2023-June 30, 2025 performance period. These modifications will include adding MA patients to the current cohort of patients and shortening the performance period from 3 years to 2 years. Because these measures will be calculated using MA encounter data and Medicare FFS claims that are already reported to the Medicare program for payment purposes, modifying these measures does not result in a change in burden associated with OMB control number 0938-1022. c. Information Collection Burden Estimate for the Modification of the Hybrid HWR and HWM Measures Beginning With the FY 2028 Payment Determination

In section X.C.7.c. of the preamble of this final rule, we are modifying the Hybrid HWR and HWM measure reporting requirements beginning with the FY 2028 payment determination, associated with a July 1, 2025-June 30, 2026, performance period. This modification will lower the submission thresholds for both the Hybrid HWR and HWM measures to allow for up to two missing laboratory results and up to two missing vital signs, reduce the core clinical data elements (CCDEs) submission requirement to 70 percent or more of discharges, and reduce the submission requirement of linking variables to 70 percent or more of discharges.

In the CY 2025 OPPS/ASC final rule (89 FR 94495 through 94499), we finalized that submission of CCDEs and linking variables associated with the Hybrid HWR and Hybrid HWM measures will remain voluntary. In the FY 2020 IPPS/LTCH PPS and FY 2022 IPPS/LTCH PPS final rules, respectively, we estimated the burden for voluntary reporting for the Hybrid HWR (84 FR 42603 and 42604) and Hybrid HWM measures (86 FR 45508) and stated that we encourage all hospitals to submit data for the Hybrid HWR and Hybrid HWM measures during the voluntary reporting period. As a result, our previously finalized reporting burden estimates assume that all hospitals will participate in order to not underestimate the burden on participating hospitals and account for the submission of CCDEs and linking variables. Therefore, while these modifications are designed to reduce the administrative burden associated with reporting these measures, they will not affect information collection burden as neither the amount of data collected nor frequency of data submission are impacted. d. Information Collection Burden Estimate for the Removal of the Hospital Commitment to Health Equity Measure Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination

In section X.C.4.a. of the preamble of this final rule, we are removing the Hospital Commitment to Health Equity (HCHE) measure beginning with the CY 2024 reporting period/FY 2026 payment determination. Reporting on the HCHE measure involves each hospital being required to provide responses and attest “yes” or “no” in response to as many as five questions one time per year for a given reporting period through CMS' HQR System. We estimate each hospital requires 10 minutes (0.167 hours) annually to report this measure.

The current burden estimate approved under OMB control number 0938- 1022 is 509 hours annually across all 3,050 IPPS hospitals (0.167 hours x 3,050 IPPS hospitals). Therefore, we estimated the removal of this measure will decrease the burden for all 3,050 IPPS hospitals by 509 hours annually at a savings of $28,188 (509 hours x $55.38). e. Information Collection Burden Estimate for the Removal of the COVID- 19 Vaccination Coverage Among HCP Measure Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination

In section X.C.4.b. of the preamble of this final rule, we are removing the COVID-19 Vaccination Coverage among HCP measure beginning with the CY 2024 reporting period/FY 2026 payment determination. This measure was previously finalized in the FY 2022 IPPS/LTCH PPS final rule (86 FR 45374 through 45382), and the associated

information collection is approved under OMB control number 0920-1317 \501\ (expiration date January 31, 2028).

\501\ Available at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202501-0920-003. Accessed February 26, 2025.

Hospitals have the option to manually enter data directly into the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) web-based application or by uploading a CSV file. CDC estimates that each hospital requires between 40 minutes (0.67 hours) to upload a CSV file and 45 minutes (0.75 hours) monthly to enter the data manually. CDC assumes that manual data entry is completed by a Microbiologist with a wage rate of $58.60/hour and uploading of a CSV file is completed by an Information Technologist with a wage rate of $56.50/hour. Therefore, we estimate that this policy will result in a decrease in burden of between 24,400 hours (0.67 hours x 12 months x 3,050 IPPS hospitals) at a cost of $1,378,600 (24,400 hours x $56.50) and 27,450 hours (0.75 hours x 12 months x 3,050 IPPS hospitals) at a cost of $1,608,570 (27,450 hours x $58.60) annually across all 3,050 IPPS hospitals under OMB control number 0920- 1317. f. Information Collection Burden Estimate for the Removal of the Screening for Social Drivers of Health Measure Beginning with the CY 2024 Reporting Period/FY 2026 Payment Determination

In section X.C.4.c. of the preamble of this final rule, we are removing the Screening for Social Drivers of Health measure beginning with the CY 2024 reporting period/FY 2026 payment determination. There are two components to this measure: patient screening for five health related social needs domains and hospital submission of aggregated hospital-level measure data. We estimate each patient requires 2 minutes (0.033 hours) to complete the screening and each hospital requires 10 minutes (0.167 hours) annually to report this measure.

With regard to patient screening, the currently approved burden estimate under OMB control number 0938-1022 is 625,500 hours annually for 18,765,000 patients (0.033 hours x 18,765,000 patients). With regard to measure reporting, the currently approved burden estimate is 509 hours annually across all 3,050 IPPS hospitals (0.167 hours x 3,050 IPPS hospitals).

We determine the cost for patients (or their representative) undertaking administrative and other tasks, such as filling out a survey or intake form, using a post-tax wage of $25.63/hour based on the report “Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices,” which identifies the approach for valuing time when individuals undertake activities on their own time.\502\ To derive the costs for patients (or their representatives), a measurement of the usual weekly earnings of wage and salary workers of $1,192 is divided by 40 hours to calculate an hourly pre-tax wage rate of $29.80/ hour.\503\ This rate is adjusted downwards by an estimate of the effective tax rate for median income households of about 14 percent calculated by comparing pre- and post-tax income,\504\ resulting in the post-tax hourly wage rate of $25.63/hour. Unlike our state and private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs because the individuals' activities, if any, will occur outside the scope of their employment.

\502\ Office of the Assistant Secretary for Planning and Evaluation, Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices, September 17, 2017. Available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework.

\503\ Bureau of Labor and Statistics, Usual Weekly Earnings of Wage and Salary Workers, First Quarter 2024. Available at https://www.bls.gov/news.release/pdf/wkyeng.pdf. Accessed March 3, 2025.

\504\ U.S. Census Bureau, Income in the United States: 2023, p. 43, September 2024. Available at https://www2.census.gov/library/publications/2024/demo/p60-282.pdf.

Therefore, we estimate the removal of this measure will decrease the burden for all 3,050 IPPS hospitals by 626,009 hours (625,500 + 509) annually at a savings of $16,059,753 (625,500 hours x $25.63 + 509 hours x $55.38). g. Information Collection Burden Estimate for the Removal of the Screen Positive Rate for Social Drivers of Health Measure Beginning With the CY 2024 Reporting Period/FY 2026 Payment Determination

In section X.C.4.c. of the preamble of this final rule, we are removing the Screen Positive Rate for Social Drivers of Health measure beginning with the CY 2024 reporting period/FY 2026 payment determination. For this measure, hospitals are required to report on an annual basis the number of patients who screen positive for one or more of the five Social Drivers of Health domains divided by the total number of patients screened (reported as five separate rates). We estimate each hospital requires 10 minutes (0.167 hours) annually to report this measure.

The current burden estimate approved under OMB control number 0938- 1022 is 509 hours annually across all 3,050 IPPS hospitals (0.167 hours x 3,050 IPPS hospitals). Therefore, we estimated the removal of this measure will decrease the burden for all 3,050 IPPS hospitals by 509 hours annually at a savings of $28,188 (509 hours x $55.38/hour).

We invited public comments on the proposed information collection requirements and whether our estimated burden reduction of 0.033 hours per patient and an annual decrease of 509 hours in burden per hospitals at admission is an accurate estimate. We received no comments regarding these information collection requirements or the associated burden estimates and therefore, are finalizing without modification. h. Summary of Information Collection Burden Estimates for the Hospital IQR Program

In summary, under OMB control number 0938-1022 (expiration date January 31, 2026), we estimate that the policies finalized in this final rule will result in a decrease in information collection burden of 627,027 hours at a savings of $16,116,129. We also estimate that the policies finalized in this final rule will result in a decrease in information collection burden of between 24,400 hours at a savings of $1,378,600 and 27,450 hours at a savings of $1,608,570 under OMB control number 0920-1317. We will submit the revised information collection estimates to OMB for approval under OMB control number 0938- 1022. With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis (section I.K. of Appendix A of this final rule). BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C 5. ICRs for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program

OMB has currently approved 109 hours of burden at a cost of $2,844 under OMB control number 0938-1175 (expiration date November 30, 2027), accounting for the annual information collection requirements for 11 PCHs for the PCHQR Program. In this final rule, we describe the burden changes regarding collection of information under OMB control number 0938-1175 for PCHs.

For more detailed information on our finalized policies for the PCHQR Program, we refer readers to section X.D. of the preamble of this final rule. We are removing three measures beginning with the FY 2026 program year: (1) the Hospital Commitment to Health Equity measure; (2) the Screening for Social Drivers of Health measure; and (3) the Screen Positive Rate for Social Drivers of Health Measure. We discuss the impacts on information collection burden associated with these policies later in this section.

We are also modifying the public reporting requirements to allow for public reporting of the PCHQR Program on the Care Compare tool on Medicare.gov or a successor website in addition to current publication in the Provider Data Catalog. This policy will not affect information collection burden as neither the amount of data collected nor frequency of data submission are impacted.

Using the most recent data from the BLS for medical records specialists (SOC 29-2072), entitled, the May 2023 National Occupational Employment and Wage Estimates (OEWS), we are finalizing to use the mean hourly wage for medical records specialists for the industry, “general medical and surgical hospitals,” which is $27.69. We believe the industry of “general medical and surgical hospitals” is more specific to this program compared to other industries under medical records specialists, such as “office of physicians” or “nursing care facilities.” We calculated the cost of overhead, including fringe benefits, at 100 percent of the mean hourly wage, consistent with previous years. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly by employer and methods of estimating these costs vary widely in the literature. Nonetheless, we believe that doubling the hourly wage rate ($27.69 x 2 = $55.38) to estimate total cost is a reasonably accurate estimation method. Unless otherwise specified, we will calculate cost burden to hospitals using a wage plus benefits estimate of $55.38 per hour throughout the discussion in this section of this final rule for the PCHQR Program. b. Information Collection Burden Estimate for the Removal of the Hospital Commitment to Health Equity Measure Beginning With the FY 2026 Program Year

In section X.D.2.a. of the preamble of this final rule, we are removing the Hospital Commitment to Health Equity (HCHE) measure beginning with the FY 2026 program year. Reporting on the HCHE measure involves each PCH being

required to provide responses and attest “yes” or “no” in response to as many as five questions one time per year for a given program year through CMS' HQR System.

The current burden estimate approved under OMB control number 0938- 1175 is 2 hours annually across all 11 PCHs (0.167 hours x 11 PCHs). Therefore, we estimate the removal of this measure will decrease the burden for all 11 PCHs by 2 hours annually at a savings of $111 (2 hours x $55.38). c. Information Collection Burden Estimate for the Removal of the Screening for Social Drivers of Health Measure Beginning With the FY 2026 Program Year

In section X.D.2.b. of this final rule, we are removing the Screening for Social Drivers of Health measure beginning with the 2026 program year. There are two components to this measure: patient screening for five health related social needs domains and PCH submission of aggregated PCH-level measure data. In the FY 2024 IPPS/ LTCH PPS final rule, the Screening for Social Drivers of Health and Screen Positive Rate for Social Drivers of Health measures were adopted with voluntary reporting in the FY 2026 program year followed by mandatory reporting on an annual basis beginning with the FY 2027 program year (88 FR 59317 and 59318). We estimate each patient requires 2 minutes (0.033 hours) to complete the screening and each PCH requires 10 minutes (0.167 hours) annually to report this measure.

With regard to patient screening, the currently approved burden estimate under OMB control number 0938-1175 is 28 hours for 828 patients (0.033 hours x 828 patients) for the FY 2026 program year and 101 hours annually for 3,025 patients (0.033 hours x 3,025 patients) beginning with the FY 2027 program year. With regard to measure reporting, the currently approved burden estimate is 1 hour (0.167 hours x 6 PCHs) for the FY 2026 program year and 2 hours annually (0.167 hours x 11 PCHs) beginning with the FY 2027 program year. We invited public comments on the proposed information collection requirements and whether our estimated burden reduction of 0.033 hours per patient and an annual decrease of 2 hours in burden per PCH at admission is an accurate estimate. We received no comments regarding these information collection requirements or the associated burden estimates and therefore, are finalizing without modification.

We determine the cost for patients (or their representative) undertaking administrative and other tasks, such as filling out a survey or intake form, using a post-tax wage of $25.63/hour based on the report “Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices,” which identifies the approach for valuing time when individuals undertake activities on their own time.\505\ To derive the costs for patients (or their representatives), a measurement of the usual weekly earnings of wage and salary workers of $1,192 is divided by 40 hours to calculate an hourly pre-tax wage rate of $29.80/ hour.\506\ This rate is adjusted downwards by an estimate of the effective tax rate for median income households of about 14 percent calculated by comparing pre- and post-tax income,\507\ resulting in the post-tax hourly wage rate of $25.63/hour. Unlike our state and private sector wage adjustments, we are not adjusting beneficiary wages for fringe benefits and other indirect costs because the individuals' activities, if any, will occur outside the scope of their employment.

\505\ Office of the Assistant Secretary for Planning and Evaluation, Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices, September 17, 2017. Available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework.

\506\ Bureau of Labor and Statistics, Usual Weekly Earnings of Wage and Salary Workers, First Quarter 2024. Available at https://www.bls.gov/news.release/pdf/wkyeng.pdf. Accessed March 3, 2025.

\507\ U.S. Census Bureau, Income in the United States: 2023, p. 43, September 2024. Available at https://www2.census.gov/library/publications/2024/demo/p60-282.pdf.

Therefore, we estimate the removal of this measure will decrease the burden by 29 hours (1 hour + 28 hours) at a savings of $773 (28 hours x $25.63 + 1 hour x $55.38) for 6 PCHs for the FY 2026 program year and 103 hours (2 hour + 101 hours) at a savings of $2,699 (101 hours x $25.63/hour + 2 hours x $55.38/hour) for 11 PCHs for the FY 2027 program year. d. Information Collection Burden Estimate for the Removal of the Screen Positive Rate for Social Drivers of Health Measure Beginning With the FY 2026 Program Year

In section X.D.2.b. of the preamble of this final rule, we are removing the Screen Positive Rate for Social Drivers of Health measure beginning with the FY 2026 program year. For this measure, PCHs are required to report on an annual basis the number of patients who screen positive for one or more of the five Social Drivers of Health domains divided by the total number of patients screened (reported as five separate rates). We estimate each PCH requires 10 minutes (0.167 hours) annually to report this measure.

The current burden estimate approved under OMB control number 0938- 1175 is 1 hour (0.167 hours x 6 PCHs) for the FY 2026 program year and 2 hours annually (0.167 hours x 11 PCHs) beginning with the FY 2027 program year. Therefore, we estimated the removal of this measure will decrease the burden by 1 hours at a savings of $55 (1 hour x $55.38) for the FY 2026 program year and 2 hours at a savings of $111 (2 hours x $55.38) beginning with the FY 2027 program year. e. Summary of Information Collection Burden Estimates for the PCHQR Program

In summary, under OMB control number 0938-1175 (expiration November 30, 2027), we estimate that the policies finalized in this final rule will result in a decrease in burden of 107 hours and $2,921. We will submit the revised information collection estimates to OMB for approval under OMB control number 0938-1175. With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis (section I.L. of Appendix A of this final rule). BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C 6. ICRs for the Long-Term Care Hospital Quality Reporting Program (LTCH QRP)

As required by section 1886(m)(5)(A)(i) of the Act, an LTCH that does not meet the requirements of the LTCH QRP for a fiscal year will receive a 2-percentage point reduction to its otherwise applicable annual update for that fiscal year. We estimated that the burden associated with the LTCH QRP is the time and effort associated with complying with the requirements of the LTCH QRP. In section X.E.5. of this final rule, we are finalizing our proposal to amend the LTCH QRP reconsideration request policy and process. As we noted in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49755), we believe the reconsideration requirements, and the associated burden would be incurred subsequent to an administrative action. In accordance with the implementing regulations for the PRA (5 CFR 1320.4(a)(2) and (c)), the burden associated with any information collected subsequent to the administrative action is exempt from the requirements of the PRA. However, we have provided detailed cost burden estimates in section I.M. of Appendix A of this final rule. We did not receive any public comments on the accuracy of the cost estimate assigned to this administrative burden. a. Information Collection Burden Estimate for the Modification of Reporting Requirements for the COVID-19 Vaccine: Percent of Patients/ Residents Who Are Up to Date Measure Beginning With the FY 2028 LTCH QRP

In section X.E.3. of this final rule, we are finalizing our proposal to modify reporting requirements for the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date (Patient/Resident COVID-19 Vaccine) measure to exclude patients who have expired in the LTCH beginning with the FY 2028 LTCH QRP. Version 5.1 of the LCDS, which includes the Patient/Resident COVID-19 Vaccine item (O0350) for purposes of reporting the Patient/Resident COVID-19 Vaccine measure, has been approved under OMB control number 0938-1163 (Expiration date: 12/31/2027). To implement these modifications to this measure, we also are finalizing our proposal to remove the related Patient/Resident COVID-19 Vaccine Status item (O0350) from the LTCH Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS) form used for patients who have expired. The remaining LCDS forms used for Planned Discharge and Unplanned Discharge would continue to include the Patient/Resident COVID-19 Vaccine Status item (O0350) for purposes of collecting and reporting data on the COVID-19 Vaccine: Percent of Patients/Residents Who Are Up to Date measure. The following is a

discussion of this information collection.

In estimating the change in information collection burden, we noted in the proposed rule (90 FR 18413) that LTCHs would no longer be required to collect information and report the Patient COVID-19 Vaccination Status item on the LCDS form used for patients who have expired in the LTCH. We estimated that our proposal would result in a decrease of 0.005 hours (0.3 minutes/60 minutes) of clinical staff time on the LCDS form used for expired patients. We identified the staff type based on past LTCH burden calculations, and our assumptions are based on the staff type generally necessary to perform an assessment.

Using data collected for FY 2024, we estimated 130,050 total admissions and 6,503 expired assessments from 330 LTCHs annually. This equates to a decrease of 33 hours for all LTCHs (6,503 x 0.005 hours) and 0.10 hours per LTCH.

We estimated that the item on the LCDS would be completed equally by a Registered Nurse (RN) and a Licensed Practical and Licensed Vocational Nurse (LPN/LVN). However, LTCHs determine the staffing resources necessary. For the purposes of calculating the costs associated with the collection of information requirements, we obtained median hourly wages for these staff from the U.S. Bureau of Labor Statistics' (BLS) May 2023 National Occupational Employment and Wage Estimates. To account for other indirect costs and fringe benefits, we doubled the hourly wage. These amounts are detailed in Table XIII.B-05. We established a composite cost estimate using our adjusted wage estimates. The composite estimate of $70.10/hour was calculated by weighting each adjusted hourly wage equally (that is, 50 percent) [($82.76 x 0.5) + ($57.44 x 0.5) = $70.10]. [GRAPHIC] [TIFF OMITTED] TR04AU25.325

We estimated that the burden and cost for LTCHs for complying with data collection and reporting requirements for the FY 2028 LTCH QRP would decrease under this proposal. Using FY 2024 data, we estimate a total of 6,503 expired assessments from 330 LTCHs annually for a decrease of 33 hours for all LTCHs (6,503 x 0.005 hour) and 0.10 hours per LTCH. Given 33 hours at $70.10 per hour, we estimate the total cost will be decreased by $2,313.30 (33 hours x $70.10 per hour) for all LTCHs annually, or $7.01 per LTCH (2,279.13 / 330 LTCHs) annually.

We have summarized the comments we received about modifying reporting requirements for the Patient/Resident COVID-19 Vaccination Measure in section X.E.3. of the preamble of this final rule and provided responses. We received public comments on the accuracy of the cost estimate assigned to this administrative burden, and provide a summary of those comments:

Comment: A few commenters stated that the burden estimate for this measure is not accurate, citing that it does not account for costs associated with the education/training of clinicians, reconciling patient vaccination status among the various sources, administering vaccinations, or providing payment for technological solutions to obtain a patient's COVID-19 vaccination status.

Response: We appreciate the commenters' feedback. Our current burden estimates do not include the cost of individual provider education and training needs, or those related to technological updates to software and hardware. Our burden estimates are doubled to provide for overhead and fringe benefits, which we believe accounts for the time it takes for staff to report items that are assessed as part of routine clinical care and medical charting in an LTCH.

After consideration of the public comments, we are finalizing our proposal to modify reporting requirements for the Patient/Resident COVID-19 Vaccine measure in the LTCH QRP to exclude patients who have expired in the LTCH beginning with the FY 2028 LTCH QRP. b. Information Collection Burden Estimate for the Removal of Four Standardized Patient Assessment Data Elements Beginning With the FY 2028 LTCH QRP

In section X.E.4. of this final rule, we are finalizing our proposal to remove four standardized patient assessment data elements from the LCDS, with respect to admission, effective October 1, 2026.

We identified the staff type based on past LTCH burden calculations, and our assumptions are based on the categories generally necessary to perform an assessment. We believed that the items would be completed equally by a Registered Nurse (RN) and a Licensed Practical and Licensed Vocational Nurse (LPN/LVN). However, LTCHs determine the staffing resources necessary.

For the purposes of calculating the costs associated with the collection of information requirements, we obtained median hourly wages for these staff from the U.S. Bureau of Labor Statistics' (BLS) May 2023 National Occupational Employment and Wage Estimates.\508\ To account for other indirect costs and fringe benefits, we doubled the hourly wage. These amounts are detailed in Table XIII.B-06. We established a composite cost estimate using our adjusted wage estimates. The composite estimate of $70.10/hr was calculated by weighting each adjusted hourly wage equally (that is, 50 percent) [($82.76 x 0.5) + ($57.44 x 0.5) = $70.10].

\508\ U.S. Bureau of Labor Statistics' (BLS) May 2023 National Occupational Employment and Wage Estimates. https://www.bls.gov/oes/current/oes_nat.htm.

[GRAPHIC] [TIFF OMITTED] TR04AU25.326

We estimated that the burden and cost for LTCHs for complying with requirements of the FY 2028 LTCH QRP would decrease under this proposal. We estimate that the removal of these four standardized patient assessment data elements will result in a decrease of 1.2 minutes (0.3 minutes x 4), or 0.02 hours (1.2 / 60). Using FY 2024 data, we estimate a total of 130,050 admissions from 330 LTCHs annually for a decrease of 2,601 hours in burden for all LTCHs (130,050 x 0.02 hour), or a decrease of 7.88 hours per LTCH (2,601 / 330 LTCHs). Given 7.88 hours at $70.10 per hour, we estimate the total cost will be decreased by $552.39 (7.88 x $70.10) annually, or $182,330.100 ($552.39 x 330 LTCHs) for all LTCHs annually.

We have summarized the comments we received about removing four standardized patient assessment data elements collected under the SDOH category in section X.E.4 of this final rule and provided responses. We did not receive any comments about these specific estimates. c. Summary of Information Collection Burden Estimates for the LTCH QRP Program

As described in Table XIII.B-07, under OMB control number 0938- 1163, we estimate that our proposals set forth in this final rule for the LTCH QRP, if finalized, would result in an overall decrease of 7.98 hours per LTCH, or 2,633.51 hours annually for 330 LTCHs. The total cost decrease related to this information collection is estimated at approximately -$180,016.80, or $545.51 per LTCH. The decrease in burden would be accounted for in a revised information collection request under OMB control number 0938-1163. [GRAPHIC] [TIFF OMITTED] TR04AU25.327

We invited public comments on the modification to information collection requirements for LTCH QRP beginning with the FY 2028 LTCH QRP.

We have summarized the comments we received about modifying reporting requirements for the Patient/Resident COVID-19 Vaccination Measure in section X.E.3. of this final rule, removing four standardized patient assessment data elements collected under the SDOH category in section X.E.4. of this final rule and amending the reconsideration policy and process in X.E.5. of this final rule and provided responses. After consideration of the public comments, we are finalizing these proposals as proposed. 7. ICRs for the Medicare Promoting Interoperability Program a. Background

OMB has currently approved 30,151 hours of burden at a cost of $1,571,474 under OMB control number 0938-1278 (expiration date April 30, 2027), accounting for information collection burden experienced by approximately 3,150 eligible hospitals and 1,400 CAHs for the electronic health record (EHR) reporting period in CY 2025. The collection of information burden analysis in this final rule focuses on all eligible hospitals and CAHs that could participate in the Medicare Promoting Interoperability Program and report the objectives and measures, and report electronic Clinical Quality Measures (eCQMs), under the Medicare Promoting Interoperability Program for the EHR reporting periods in CY 2026 through CY 2027.

For more detailed information on our finalized policies for the Medicare Promoting Interoperability Program, we refer readers to section X.F. of the preamble of this final rule. For the Medicare Promoting Interoperability Program, we are adopting a new optional bonus measure under the Public Health and Clinical Data Exchange objective for health information exchange with a public health agency (PHA) that occurs using the Trusted Exchange Framework and Common Agreement (TEFCA), and where the eligible hospital or CAH meets certain additional requirements, beginning with the EHR reporting period in CY 2026. We are modifying two measures: (1) the Safety Assurance Factors for Electronic Health Record Resilience (SAFER) Guides measure,

requiring eligible hospitals and CAHs to attest “yes” to completing an annual self-assessment using the SAFER Guides published in January 2025 beginning with the EHR reporting period in CY 2026; and (2) the Security Risk Analysis measure, requiring eligible hospitals and CAHs to attest “yes” to having conducted security risk management as required by the HIPAA Security Rule beginning with the EHR reporting period in CY 2026. We also finalized the definition of the EHR reporting period in CY 2026 and subsequent years as a minimum of any continuous 180-day period within that CY for eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program.

Using the most recent data, the May 2023 National Occupational Employment and Wage Estimates (OEWS) from the BLS, we are finalizing to use the mean hourly wage for medical records specialists (SOC 29-2072) for the industry, “general medical and surgical hospitals,” which is $27.69.\509\ We believe the industry of “general medical and surgical hospitals” is more specific to this program compared to other industries under medical records specialists, such as “office of physicians” or “nursing care facilities.” We calculated the cost of overhead, including fringe benefits, at 100 percent of the mean hourly wage, consistent with previous years. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly by employer and methods of estimating these costs vary widely in the literature. Nonetheless, we believe that doubling the hourly wage rate ($27.69 x 2 = $55.38) to estimate total cost is a reasonably accurate estimation method. Accordingly, unless otherwise specified, we calculate the cost burden to eligible hospitals and CAHs using a wage plus benefits estimate of $55.38 per hour throughout the discussion in this section of the preamble of this final rule for the Medicare Promoting Interoperability Program.

\509\ U.S. Bureau of Labor Statistics. Occupational Outlook Handbook, Medical Records Specialists. Accessed November 27, 2024. Available at: https://www.bls.gov/oes/current/oes292072.htm.

In the FY 2025 IPPS/LTCH PPS final rule (89 FR 69903), our burden estimates were based on an assumption of 4,550 eligible hospitals and CAHs. For this FY 2026 final rule, based on data from the EHR reporting period in CY 2023, we continue to estimate approximately 3,150 eligible hospitals and 1,400 CAHs will report data to the Medicare Promoting Interoperability Program for the EHR reporting period in CY 2026, for a total number of 4,550 respondents. b. Information Collection Burden for the Adoption of a New Optional Bonus Measure Under the Public Health and Clinical Data Exchange Objective Beginning With the EHR Reporting Period in CY 2026

In section X.F.5. of the preamble of this final rule, we are adopting a new optional bonus measure under the Public Health and Clinical Data Exchange objective for reporting data to a PHA using TEFCA, and where the eligible hospital or CAH meets certain additional requirements, beginning with the EHR reporting period in CY 2026.

As part of the Public Health and Clinical Data Exchange objective, eligible hospitals and CAHs can receive credit for attesting to up to one optional bonus measure. While eligible hospitals and CAHs can attest to more than one optional bonus measure, we assumed they will not attest to more than one because they cannot receive any additional credit for doing so. Under OMB control number 0938-1278, our currently approved burden estimates include 0.5 minutes for eligible hospitals and CAHs to attest to one of the previously finalized optional bonus measures (the Public Health Registry measure and the Clinical Data Registry Reporting measure) under this objective. As a result, we estimate no additional burden for eligible hospitals and CAHs that elect to instead attest to this new optional bonus measure. c. Information Collection Burden for the Modification of the SAFER Guides Measure Beginning With the EHR Reporting Period in CY 2026

In section [X.F.4.] of the preamble of this final rule, we are modifying the SAFER Guides measure by requiring eligible hospitals and CAHs to attest “yes” to completing an annual self-assessment using the SAFER Guides published in January 2025 beginning with the EHR reporting period in CY 2026.

In the FY 2022 IPPS/LTCH PPS final rule, we adopted the SAFER Guides measure and required eligible hospitals and CAHs to attest “yes” or “no” as to whether they completed an annual self- assessment on each of the nine SAFER Guides at any point during the CY in which their EHR reporting period occurs (86 FR 45479 through 45481). In the FY 2024 IPPS/LTCH PPS final rule, we finalized a requirement for eligible hospitals and CAHs to attest “yes” to fulfill the measure and discussed the associated costs for eligible hospitals and CAHs to conduct a SAFER Guides self-assessment (88 FR 59262 through 59265 and 59432 and 59433). In this final rule, because we are not finalizing an additional attestation, but instead modifying one that was previously finalized, this policy will not result in any changes to the information collection burden currently approved under OMB control number 0938-1278. d. Information Collection Burden for the Modification of the Security Risk Analysis Measure Beginning With the EHR Reporting Period in CY 2026

In section X.F.3. of the preamble of this final rule, we are modifying the Security Risk Analysis measure by adding a requirement for eligible hospitals and CAHs to attest “yes” to having conducted security risk management as required by the HIPAA Security Rule at 45 CFR 164.308(a)(1)(ii)(B) beginning with the EHR reporting period in CY 2026.

The currently approved burden estimate under OMB control number 0938-1278 for eligible hospitals and CAHs to conduct or review a security risk analysis, including addressing the security (to include encryption) of data created or maintained by CEHRT, implementing security updates as necessary, and correcting identified security deficiencies as part of the eligible hospital's or CAH's risk management process is approximately 6 hours annually as currently approved under OMB control number 0938-1278. Given the negligible additional effort associated with this policy compared to the currently approved burden estimate, we assume the currently approved burden estimate is sufficient to include the attestation and are not finalizing any changes to the information collection burden currently approved under OMB control number 0938-1278. e. Information Collection Burden for the Policy to Define the EHR Reporting Period in CY 2026 and Subsequent Years as a Minimum of Any Continuous 180-Day Period Within That Calendar Year

In section X.F.2. of the preamble of this final rule, we are defining the EHR reporting period in CY 2026 and subsequent years as a minimum of any continuous 180-day period within that CY for eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program. As this is the current requirement for the EHR reporting period in CY 2025 as finalized in the FY 2024 IPPS/LTCH PPS final rule (88 FR 59259 through 59260), this policy will not result in any changes to the information collection burden

currently approved under OMB control number 0938-1278. f. Summary of Estimates Used To Calculate the Collection of Information Burden

In summary, under OMB control number 0938-1278 (expiration date April 30, 2027), we estimate that the policies in this final rule will not result in a change in information collection burden. With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis (section I.N. of Appendix A of this final rule). 8. ICRs for the Transforming Episode Accountability Model

In section XI.A. of the preamble of this final rule, we discuss testing the Transforming Episode Accountability Model (TEAM), finalized in the FY 2025 IPPS/LTCH PPS final rule (89 FR 68986), and finalized updates to the model under the authority of the CMS Innovation Center. Section 1115A of the Act authorizes the CMS Innovation Center to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. As stated in section 1115A(d)(3) of the Act, chapter 35 of title 44, United States Code, shall not apply to the testing and evaluation of models under section 1115A of the Act. As a result, the information collection requirements contained in this final rule for TEAM need not be reviewed by the Office of Management and Budget.

Dr Mehmet Oz, Administrator of the Centers for Medicare & Medicaid Services, approved this document on July 30, 2025.

42 CFR Part 412

Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.

42 CFR Part 495

Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Health professions, Health records, Medicaid, Medicare, Penalties, Privacy, and Reporting and recordkeeping requirements.

42 CFR Part 512

Administrative practice and procedure, Health care, Health facilities, Health insurance, Intergovernmental relations, Medicare, Penalties, Reporting and recordkeeping requirements.

45 CFR Part 170

Computer technology, Electronic health record, Electronic information system, Electronic transactions, Health, Healthcare, Health information technology, Health insurance, Health records, Hospitals, Incorporation by reference, Laboratories, Medicaid, Medicare, Privacy, Reporting and record keeping requirements, Public health, Security.

For the reasons set out in the preamble, 42 CFR parts 412, 495, and 512 and 45 CFR part 170 are amended as follows:

Title 42--Public Health

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES

0 1. The authority citation for part 412 continues to read as follows:

Authority : 42 U.S.C. 1302 and 1395hh.

0 2. Section 412.24 is amended by revising paragraphs (e) and (f) to read as follows:

Sec. 412.24 Requirements under the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program.

* * * * *

(e) Extraordinary circumstances exceptions (ECEs)--(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the PCH. For purposes of this paragraph (e), an extraordinary circumstance is an event beyond the control of a PCH (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the PCH to comply with one or more applicable reporting requirements with respect to a fiscal year.

(2) Process for requesting an ECE. (i) A PCH may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website.

(ii) CMS notifies the PCH of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the PCH, the written decision specifies whether the PCH is exempted from one or more reporting requirements or whether CMS has granted the PCH an extension of time to comply with one or more reporting requirements.

(3) Authority to grant an ECE. (i) CMS may grant an ECE to one or more PCHs that have not requested an ECE if CMS determines that--

(A) A systemic problem with a CMS data collection system directly impacted the ability of the PCH to comply with a quality data reporting requirement; or

(B) An extraordinary circumstance has affected an entire region or locale.

(ii) Any ECE granted under this paragraph (e)(3) specifies whether the affected PCHs are exempted from one or more reporting requirements or whether CMS has granted the PCHs an extension of time to comply with one or more reporting requirements.

(f) Public reporting of PCHQR Program data. CMS makes data submitted by PCHs under the PCHQR Program available to the public on CMS websites. Prior to making any such data submitted by a PCH available to the public, CMS gives the PCH an opportunity to review the data via the Hospital Quality Reporting (HQR) system and announces the timeline for review on the QualityNet website and applicable listservs.

0 4. Section 412.85 is amended by revising the section heading and paragraphs (b) and (c) to read as follows:

Sec. 412.85 Payment adjustment for certain immunotherapy cases.

* * * * *

(b) Discharges subject to payment adjustment. Payment is adjusted in accordance with paragraph (c) of this section for discharges assigned to MS-DRG 018 involving expanded access use of immunotherapy or that are part of an applicable clinical trial as determined by CMS based on the reporting of a diagnosis code indicating the encounter is part of a clinical research program on the claim for the discharge or, for discharges occurring on or after October 1, 2025, other cases where the immunotherapy product is not purchased in the usual manner, such as provided at no cost.

(c) Adjustment. The DRG weighting factor determined under Sec. 412.60(b) is adjusted by a factor that reflects the average cost for cases assigned to MS-DRG 018 that involve expanded access use of immunotherapy, are part of an applicable clinical trial, or where the immunotherapy product is not purchased in the usual manner, such as provided at no cost, to the average cost for all other cases assigned to MS-DRG 018.

Sec. 412.90 [Amended]

0 5. Section 412.90(j) is amended in by removing the date “January 1, 2025”

and adding in its place the date “October 1, 2025”.

Sec. 412.101 [Amended]

0 6. Section 412.101 is amended by-- 0 a. In paragraph (b)(2)(i), removing the phrase “FY 2010, the portion of FY 2025 beginning on January 1, 2025 and subsequent fiscal years,” and adding in its place the phrase “FY 2010 and FY 2026 and subsequent years,”; 0 b. In paragraph (b)(2)(iii), removing the phrase “FY 2024 and the portion of FY 2025 beginning on October 1, 2024, and ending on December 31, 2024,” and adding in its place the phrase “FY 2025,”; 0 c. In paragraph (c)(1), removing the phrase “FY 2010, the portion of FY 2025 beginning on January 1, 2025, and subsequent fiscal years,” and adding in its place the phrase ” FY 2010 and FY 2026 and subsequent years,”; and 0 d. In paragraph (c)(3) introductory text, removing the phrase “FY 2024 and the portion of FY 2025 beginning on October 1, 2024, and ending on December 31, 2024,” and adding in its place “FY 2025,”.

Sec. 412.108 [Amended]

0 7. Section 412.108 is amended by-- 0 a. In paragraph (a)(1) introductory text, removing the date “January 1, 2025” and adding in its place the date “October 1, 2025”; and 0 b. In paragraph (c)(2)(iii) introductory text, removing the date “January 1, 2025” and adding in its place the date “October 1, 2025”.

0 8. Section 412.140 is amended by revising paragraph (c)(2) to read as follows:

Sec. 412.140 Participation, data submission, and validation requirements under the Hospital Inpatient Quality Reporting (IQR) Program.

* * * * *

(c) * * *

(2) Extraordinary circumstance exception (ECE)--(i) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c)(2), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year.

(ii) Process for requesting an ECE. (A) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website.

(B) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements.

(iii) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that--

(A) A systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement; or

(B) An extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (c)(2)(iii) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * * * * *

0 9. Section 412.152 is amended by-- 0 a. Revising and republishing the definition of “Applicable period”; and 0 b. In the definition of “Applicable period for dual eligibility,” removing the phrase “3-year data period” and adding in its place the phrase “2-year or 3-year data period”.

The revision reads as follows:

Sec. 412.152 Definitions for the Hospital Readmissions Reduction Program.

* * * * *

Applicable period is, with respect to a fiscal year, the 2-year or 3-year period (specified by the Secretary) from which data are collected in order to calculate excess readmission ratios and adjustments under the Hospital Readmissions Reduction Program.

(1) The applicable period for FY 2022 is the 3-year period from July 1, 2017 through June 30, 2020;

(2) Beginning with the FY 2023 program year, the applicable period is the 3-year period advanced by 1-year from the prior year's period from which data are collected in order to calculate excess readmission rations and adjustments under the Hospital Readmissions Reduction Program, unless otherwise specified by the Secretary; and

(3) Beginning with the FY 2027 program year, the applicable period is the 2-year period advanced by 1-year from the prior year's period from which data are collected in order to calculate excess readmission ratios and adjustments under the Hospital Readmissions Reduction Program, unless otherwise specified by the Secretary. * * * * *

0 10. Section 412.154 is amended by adding paragraph (d) to read as follows:

Sec. 412.154 Payment adjustments under the Hospital Readmissions Reduction Program.

* * * * *

(d) Extraordinary circumstance exception (ECE)--(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (d), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year.

(2) Process for requesting an ECE. (i) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website.

(ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements.

(3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (d)(3) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * * * * *

Sec. 412.160 [Amended]

0 11. Section 412.160 is amended by removing the definition of “Health equity adjustment bonus points.”

0 12. Section 412.165 is amended by-- 0 a. Removing paragraph (b)(5); 0 b. Redesignating paragraph (b)(6) as paragraph (b)(5); 0 c. Revising newly redesignated paragraph (b)(5) and paragraph (c).

The revisions read as follows:

Sec. 412.165 Performance scoring under the Hospital Value-Based Purchasing (VBP) Program.

* * * * *

(b) * * *

(5) The hospital's Total Performance Score for the fiscal year is the sum of the weighted domain scores up to a maximum score of 100.

(c) Extraordinary circumstance exception (ECE)--(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year.

(2) Process for requesting an ECE. (i) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website.

(ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision will specify whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements.

(3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement or that an extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (c)(3) specifies whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements.

0 13. Section 412.172 is amended by adding paragraph (c) to read as follows:

Sec. 412.172 Payment adjustments under the Hospital-Acquired Condition Reduction Program.

* * * * *

(c) Extraordinary circumstance exception (ECE)--(1) General rule. CMS may grant an ECE with respect to the reporting requirements under this section in the event of extraordinary circumstances beyond the control of the hospital. For purposes of this paragraph (c), an extraordinary circumstance is an event beyond the control of a hospital (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the hospital to comply with one or more applicable reporting requirements with respect to a fiscal year.

(2) Process for requesting an ECE. (i) A hospital may request an ECE within 60 calendar days of the date that the extraordinary circumstance occurred by submitting the information specified by CMS at QualityNet or a successor website.

(ii) CMS notifies the hospital of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the hospital, the written decision specifies whether the hospital is exempted from one or more reporting requirements or whether CMS has granted the hospital an extension of time to comply with one or more reporting requirements.

(3) Authority to grant an ECE. CMS may grant an ECE to one or more hospitals that have not requested an ECE if CMS determines that a systemic problem with a CMS data collection system directly impacted the ability of the hospital to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (c)(3) will specify whether the affected hospitals are exempted from one or more reporting requirements or whether CMS has granted the hospitals an extension of time to comply with one or more reporting requirements. * * * * *

0 14. Section 412.273 is amended by-- 0 a. Revising the section heading, the definitions of “Termination” and “Withdrawal” in paragraph (a), and paragraphs (c)(1), (d), and (e)(2); and 0 b. Adding paragraph (e)(3).

The revisions and addition read as follows:

Sec. 412.273 Withdrawing an application, terminating an approved 3- year reclassification, or reinstating a previous termination.

(a) * * *

Termination refers to the termination of an approved 3-year MGCRB reclassification. A termination is effective only for the full fiscal year(s) remaining in the 3-year period at the time the request is received. Requests for terminations for part of a fiscal year are not considered.

Withdrawal refers to the withdrawal of a 3-year MGCRB reclassification where the MGCRB has not yet issued a decision on the application. * * * * *

(c) * * *

(1) A request for withdrawal must be received by the MGCRB at any time before the MGCRB issues a decision on the application. * * * * *

(d) Reapplication within the approved 3-year period, reinstatement of terminations, and prohibition on overlapping reclassification approvals--(1) Reinstatement of terminations. Subject to the provisions of this section, a hospital (or group of hospitals) may cancel a termination, effective for the subsequent year, and request the MGCRB to reinstate the wage index reclassification for the remaining fiscal year(s) of the 3-year period.

(2) Timing and process of reinstatement request. Reinstatement requests must be submitted in writing to the MGCRB according to the method prescribed by the MGCRB no later than the deadline for submitting reclassification applications for the following fiscal year, as specified in Sec. 412.256(a)(2).

(3) Reapplications. A hospital may apply for reclassification to a different area (that is, an area different from the one to which it was originally reclassified for the 3-year period). If the application is approved, the reclassification will be effective for 3 years. Once a 3- year reclassification becomes effective, a hospital may no longer reinstate a termination of another 3-year reclassification, regardless of whether the termination request is made within 3 years from the date of the withdrawal or termination.

(4) Termination of existing 3-year reclassification. In a case in which a hospital with an existing 3-year wage index reclassification applies to be reclassified to another area, its existing 3-year reclassification will be terminated when a second 3-year wage index reclassification goes into effect for payments for discharges on or after the

following October 1. The terminated reclassification in such a case is not eligible for reinstatement.

(e) * * *

(2) A request to terminate or reinstate an approved individual reclassification must be submitted in writing to the MGCRB according to the method prescribed by the MGCRB.

(3) A request to terminate or reinstate an approved group reclassification must be submitted in writing to the MGCRB according to the method prescribed by the MGCRB.

(i) A request to terminate or reinstate an approved group reclassification that has not yet gone into effect must include all hospitals party to the reclassification.

(ii) Termination requests for group reclassification for the second or third year of the 3-year wage index reclassification and reinstatement requests for a group reclassification effective for the third year of the 3-year wage index reclassification may be submitted by an individual hospital that is party to the reclassification. * * * * *

0 14. Section 412.312 is amended by revising paragraph (f) to read as follows:

Sec. 412.312 Payment based on the Federal rate.

* * * * *

(f) Payment adjustment for certain immunotherapy cases. For discharges occurring on or after October 1, 2020, in determining the payment amount under this section for certain clinical trial or expanded access use immunotherapy cases, or, for discharges occurring on or after October 1, 2025, other cases where the immunotherapy product is not purchased in the usual manner, such as provided at no cost, as described in Sec. 412.85(b), the DRG weighting factor described in paragraph (b)(1) of this section is adjusted as described in Sec. 412.85(c).

0 15. Section 412.560 is amended by-- 0 a. Revising paragraph (d)(3); and 0 b. Adding paragraphs (d)(4) and (5).

The revision and additions read as follows:

Sec. 412.560 Requirements under the Long-Term Care Hospital Quality Reporting Program (LTCH QRP).

* * * * *

(d) * * *

(3) CMS decision on reconsideration request. (i) CMS notifies the LTCH, in writing, of its final decision regarding any reconsideration request through at least one of the following methods:

(A) CMS designated data submission system.

(B) The United States Postal Service.

(C) Via email from the CMS Medicare Administrative Contractor (MAC).

(ii) CMS grants a timely request for reconsideration, and reverses an initial finding of non-compliance, only if CMS determines that the long-term care hospital was in full compliance with the LTCH QRP requirements for the applicable program year.

(4) Request for an extension to file a reconsideration of noncompliance request. A long-term care hospital may request, and CMS may grant, an extension to file a reconsideration request if, during the period to request a reconsideration as set forth in paragraph (d)(2) of this section, the long-term care hospital was affected by an extraordinary circumstance beyond the control of the LTCH (for example, a natural or man-made disaster).

(i) The long-term care hospital must submit its request for an extension to file a reconsideration request no later than 30 calendar days from the date of the written notification of noncompliance.

(ii) The long-term care hospital must submit its request for an extension to CMS via email to [email protected], and it must contain the following information:

(A) The CCN for the long-term care hospital.

(B) The business name of the long-term care hospital.

(C) The business address of the long-term care hospital.

(D) Contact information for the long-term care hospital's chief executive officer or designated personnel, including the name, telephone number, title, email address, and physical mailing address, which may not be a post office box.

(E) A statement of the reason for the request for the extension.

(F) Evidence of the impact of the extraordinary circumstances, including, for example, photographs, newspaper articles, and other media.

(5) CMS decision on extension to file a reconsideration of noncompliance request. CMS notifies the long-term care hospital in writing of its final decision regarding its request for an extension to file a reconsideration of noncompliance request via an email from CMS. * * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM

0 16. The authority citation for part 495 continues to read as follows:

Authority: 42 U.S.C. 1302 and 1395hh.

0 17. Section 495.4 is amended in the definition of “EHR reporting period for a payment adjustment year” by adding paragraphs (2)(x) and (3)(x) to read as follows:

Sec. 495.4 Definitions.

* * * * *

EHR reporting period for a payment adjustment year. * * *

(2) * * *

(x) For an eligible hospital in CY 2026 and subsequent years, the EHR reporting period is any continuous 180-day period within that calendar year and applies for the fiscal year payment adjustment year that is 2 years after the calendar year of the EHR reporting period.

(3) * * *

(x) For a CAH in CY 2026 and subsequent years, the EHR reporting period is any continuous 180-day period within that calendar year and applies for the fiscal year payment adjustment year for the calendar year of the EHR reporting period. * * * * *

PART 512--STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR CERTAIN MODELS

0 18. The authority citation for part 512 continues to read as follows:

Authority: 42 U.S.C. 1302, 1315a, and 1395hh.

0 19. The heading for part 512 is revised to read as set forth above.

Sec. 512.500 [Amended]

0 20. Section 512.500 is amended by removing and reserving paragraph (b)(18).

0 21. Section 512.505 is amended by-- 0 a. Removing the definition for “ADI”; 0 b. Adding definitions for “APC” and “CDI” in alphabetical order; 0 c. Removing the definition for “Decarbonization and Resilience Initiative”; 0 d. Revising the definition for “Final normalization factor”; 0 e. Removing the definitions for “Health equity goal”, “Health equity plan”, “Health equity plan intervention strategy”, and “Health equity plan performance measure”; 0 f. Revising the definition for “High-cost outlier cap”; 0 g. Adding definitions for “Medicare ID” and “PECOS” in alphabetical order; 0 h. Revising the definitions for “Prospective normalization factor” and “Region”; 0 i. Adding a definition for “Scaling factor” in alphabetical order; 0 j. Revising the definition for “TEAM participant”; 0 k. Adding a definition for “Trend year” in alphabetical order; and

0 l. Removing the definition for “Underserved community”.

The additions and revisions read as follows:

Sec. 512.505 Definitions.

* * * * *

APC stands for Ambulatory Payment Classification. * * * * *

CDI stands for the Community Deprivation Index. * * * * *

Final normalization factor refers to the mean of the benchmark price for each MS-DRG/HCPCS episode type and region divided by the mean of the risk-adjusted benchmark price for the same MS-DRG/HCPCS episode type and region. * * * * *

High-cost outlier cap refers to the 99th percentile of regional spending for a given MS-DRG/HCPCS episode type, region, and baseline year, which is the amount at which episode spending would be capped for purposes of determining baseline and performance year episode spending. * * * * *

Medicare ID means the hospital CCN in the PECOS. * * * * *

PECOS stands for the Provider Enrollment, Chain, and Ownership System. * * * * *

Prospective normalization factor refers to the multiplier incorporated into the preliminary target price to ensure that the average of the total risk-adjusted benchmark price does not exceed the average of the total non-risk adjusted benchmark price, calculated as set forth in Sec. 512.540(b)(6). * * * * *

Region means one of the nine U.S. census divisions, as defined by the U.S. Census Bureau, with the U.S. territories included in Census Division 9. * * * * *

Scaling factor means the ratio of the remapped MS-DRG or HCPCS/APC relative weight in the performance year, as applicable, to the original MS-DRG or HCPCS/APC relative weight in the baseline period. * * * * *

TEAM participant means an acute care hospital that either--

(1) Initiates episodes and is paid under the IPPS and OPPS with a CCN primary address located in one of the mandatory CBSAs selected for participation in TEAM in accordance with Sec. 512.515; or

(2) Makes a voluntary opt-in participation election to participate in TEAM in accordance with Sec. 512.510 and is accepted to participate in TEAM by CMS. * * * * *

Trend year means either of the 2 years immediately prior to the 3- year baseline period used in combination with the baseline period to calculate the prospective trend factor. * * * * *

0 22. Section 512.508 is added, under undesignated center heading “TEAM Participation,” to read as follows:

Sec. 512.508 Mandatory participation.

(a) General. TEAM participants, as defined in Sec. 512.505, must participate in TEAM for the full duration of the model performance period, unless CMS terminates TEAM or the TEAM participant receives notice of termination from TEAM in accordance with Sec. 512.596.

(b) New hospital exception. New hospitals with a Medicare ID with an initial effective date after December 31, 2024, within the PECOS that initiate episodes and are paid under the IPPS and OPPS with a CCN primary address located in one of the mandatory CBSAs selected for participation in TEAM in accordance with Sec. 512.515, must participate in TEAM at the beginning of the performance year that follows one full performance year since their Medicare ID initial effective date.

(1) As described in Sec. 512.550(b)(2)(ii), CMS performs reconciliation calculations for any new or surviving TEAM participant that results from a TEAM participant's reorganization event, as defined in Sec. 512.505, for episodes where the anchor hospitalization admission or anchor procedure occurred on or after the effective date of the reorganization event. Therefore, new hospitals that result from a TEAM participant's reorganization event begin participation in TEAM on the effective date of the reorganization event.

(2) [Reserved]

(c) Newly qualifying hospital exception. (1) Hospitals that begin to satisfy the definition of TEAM participant, as described in Sec. 512.505, must participate in TEAM at the beginning of the performance year that follows one full performance year since the date on which they began to satisfy the definition of TEAM participant.

(2) Hospitals that no longer satisfy the definition of TEAM participant, as described in Sec. 512.505, end TEAM participation on the date they no longer satisfy the definition.

(i) CMS notifies hospitals identified in this paragraph (c)(2) within 30 days of the hospital no longer satisfying the TEAM participant definition or as soon as is reasonably practicable.

(ii) [Reserved]

(d) Monitoring. CMS may monitor specifically for the potential shifting of patients with 0 high anticipated treatment costs from TEAM participants to new non- participant hospitals, including hospitals in the participation deferment period in accordance with Sec. 512.505(b) and (c).

23. Section 512.520 is amended by revising paragraph (b)(4)(i) to read as follows:

Sec. 512.520 Participation tracks.

* * * * *

(b) * * *

(4) * * *

(i) Medicare-dependent hospital (as defined in Sec. 512.505) and the Medicare Dependent Hospital program, as authorized by statute, is not expired at the time Track 2 selections are due, as described in paragraph (b)(2) of this section. * * * * *

0 24. Section 512.540 is amended by revising paragraphs (a)(2) and (3), (b)(1) introductory text, and (b)(2) through (8) to read as follows:

Sec. 512.540 Determination of preliminary target prices.

(a) * * *

(2) Applicable time period for preliminary target prices. CMS calculates preliminary target prices for each MS-DRG/HCPCS episode type and region for each performance year and applies the preliminary target price to each episode based on the episode's date of discharge from the anchor hospitalization or the date of the anchor procedure, as applicable. CMS also does all of the following:

(i) Accounts for MS-DRG and HCPCS/APC code changes between the baseline period and performance year by identifying diagnosis or procedure codes that are being moved from one MS-DRG or HCPCS/APC to another for the relevant performance year and mapping the new or revised MS-DRG or HCPCS/APC codes to the original codes that were used in the baseline period.

(ii) Constructs preliminary target prices using the remapped MS-DRG or HCPCS/APC codes in the same manner described in paragraph (b) of this section, with target prices for each MS-DRG/HCPCS episode type, inclusive of episodes initiated by anchor hospitalizations and anchor procedures that would be related to the remapped MS-DRG or HCPCS/APC codes.

(iii) Adjusts the preliminary target price by calculating and applying the scaling factor to the standardized episode spending of the MS-DRG portion for the anchor hospitalization or standardized episode spending of the HCPCS/APC portion of the anchor procedure.

(3) Episodes that begin in one performance year and end in the subsequent performance year. CMS applies the preliminary target price to the episode based on the date of discharge from the anchor hospitalization or the date of the anchor procedure, as applicable, and reconciles the episode based on the date of discharge from the anchor hospitalization or the date of the anchor procedure.

(b) * * *

(1) Calculation of the preliminary target price. CMS calculates preliminary target prices based on average baseline episode spending for the region where the TEAM participant is located. * * * * *

(2) Baseline periods and associated performance years. CMS uses the following baseline periods to determine baseline episode spending:

(i) Performance Year 1: Episodes with anchor hospitalization start dates or anchor procedure dates beginning on or after January 1, 2022, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2022, and December 31, 2024.

(ii) Performance Year 2: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2023, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2023, and December 31, 2025.

(iii) Performance Year 3: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2024, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2024, and December 31, 2026.

(iv) Performance Year 4: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2025, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2025, and December 31, 2027.

(v) Performance Year 5: Episodes with anchor hospitalization or anchor procedure start dates beginning on or after January 1, 2026, and anchor hospitalization discharge dates or anchor procedure dates between January 1, 2026, and December 31, 2028.

(3) Baseline episode spending weights. CMS calculates the benchmark price as the weighted average of baseline episode spending, applying the following weights:

(i) Baseline episode spending from baseline year 1 is weighted at 17 percent.

(ii) Baseline episode spending from baseline year 2 is weighted at 33 percent.

(iii) Baseline episode spending from baseline year 3 is weighted at 50 percent.

(4) Exclusion for high episode spending. CMS applies a high-cost outlier cap to baseline episode spending at the 99th percentile of regional spending for each of the MS-DRG/HCPCS episode types specified in paragraph (a)(1)(ii) of this section for each baseline year individually.

(5) Exclusion of incentive programs and add-on payments under existing Medicare payment systems. Certain Medicare incentive programs and add-on payments are excluded from baseline episode spending by using, with certain modifications, the CMS Price (Payment) Standardization Detailed Methodology used for the Medicare spending per beneficiary measure in the Hospital Value-Based Purchasing Program.

(6) Prospective normalization factor. Based on the episodes in the most recent calendar year of the baseline period, CMS calculates a prospective normalization factor at the MS-DRG/HCPCS region level, which is a multiplier that ensures that the average of the total risk- adjusted benchmark price does not exceed the average of the total non- risk adjusted benchmark price, by doing the following:

(i) CMS applies risk adjustment multipliers, as specified in Sec. 512.545(a)(1) through (3), to the most recent baseline year episodes to calculate the estimated risk-adjusted target price for all performance year episodes.

(ii) CMS divides the mean of the preliminary target price for each episode across all hospitals and regions by the mean of the estimated risk-adjusted target price calculated in Sec. 512.540(b)(6)(i) for the same episode types across all hospitals and regions.

(7) Prospective trend factor. CMS calculates a multiplier for each MS-DRG/HCPCS episode type and region which is applied to the most recent calendar year of the applicable baseline period. The multiplier is calculated using linear regression on the logarithmically transformed average regional spending for each MS-DRG/HCPCS episode type in the baseline years and trend years at both the regional and national level. CMS exponentiates the coefficient from this regression to calculate the estimated annual change (where an exponentiated coefficient of 1 signifies no change) in average regional spending for each MS-DRG/HCPCS episode type from year to year. CMS then squares this value to calculate the 2-year prospective trend factor. The prospective trend factor for each MS-DRG/HCPCS episode type and region is the average (arithmetic mean) of the multiplier for that MS-DRG/HCPCS episode type and region and the national average for that MS-DRG/HCPCS episode type.

(8) Communication of preliminary target prices. CMS communicates the preliminary target prices for each MS-DRG/HCPCS episode type for each region, and the preliminary target prices for each MS-DRG/HCPCS episode type specific to the TEAM participant before the performance year in which they apply. * * * * *

0 25. Section 512.545 is amended by revising paragraphs (a), (e)(1)(i), and (f) introductory text to read as follows:

Sec. 512.545 Determination of reconciliation target prices.

* * * * *

(a) CMS risk adjusts the preliminary episode target prices computed under Sec. 512.540 at the beneficiary level using a TEAM Hierarchical Condition Category (HCC) count risk adjustment factor, an age bracket risk adjustment factor, a beneficiary economic risk adjustment factor, and at the hospital level using a hospital bed size risk adjustment factor and a safety net hospital risk adjustment factor, and at the episode category-specific beneficiary level using factors specified in paragraphs (a)(6)(i) through (v) of this section.

(1) The TEAM HCC count risk adjustment factor uses five variables, representing beneficiaries with zero, one, two, three, or four or more CMS-HCC conditions based on a 180-day lookback period that ends on the day prior to the anchor hospitalization or anchor procedure.

(2) The age bracket risk adjustment factor uses four variables, representing beneficiaries in the following age groups as of the first day of the episode:

(i) Less than 65 years.

(ii) 65 to less than 75 years.

(iii) 75 years to less than 85 years.

(iv) 85 years or more.

(3) The beneficiary economic risk adjustment factor uses two variables, representing beneficiaries that, as of the first day of the episode--

(i) Meet one or more of the following economic measures:

(A) [Reserved]

(B) National CDI above the 80th percentile.

(C) Eligibility for the low-income subsidy.

(D) Eligibility for full Medicaid benefits.

(ii) Do not meet any of the three economic measures in paragraph (a)(3)(i) of this section.

(4) The hospital bed size risk adjustment factor uses four variables based on the TEAM participant's characteristics:

(i) 250 beds or fewer.

(ii) 251-500 beds.

(iii) 501-850 beds.

(iv) 850 beds or more.

(5) The safety net hospital risk adjustment factor is based on the TEAM participant meeting the definition of safety net hospital, as defined in Sec. 512.505.

(6) Episode category-specific beneficiary level risk adjustment factors represent the presence or absence in beneficiaries, based on a 180-day lookback period that ends on the day prior to the anchor hospitalization or anchor procedure, of each of the following conditions:

(i) CABG episode category.

(A) Prior post-acute care use.

(B) HCC 37: Diabetes with Chronic Complications.

(C) HCC 48: Morbid Obesity.

(D) HCC 125: Dementia, Severe.

(E) HCC 126: Dementia, Moderate.

(F) HCC 127: Dementia, Mild or Unspecified.

(G) HCC 155: Major Depression, Moderate or Severe, without Psychosis.

(H) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia.

(I) HCC 213: Cardio-Respiratory Failure and Shock.

(J) HCC 224: Acute on Chronic Heart Failure.

(K) HCC 226: Heart Failure, Except End-Stage and Acute.

(L) HCC 228: Acute Myocardial Infarction.

(M) HCC 229: Unstable Angina and Other Acute Ischemic Heart Disease.

(N) HCC 238: Specified Heart Arrhythmias.

(O) HCC 249: Ischemic or Unspecified Stroke.

(P) HCC 253: Hemiplegia/Hemiparesis.

(Q) HCC 263: Atherosclerosis of Arteries of the Extremities with Ulceration or Gangrene.

(R) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders.

(S) HCC 298: Severe Diabetic Eye Disease, Retinal Vein Occlusion, and Vitreous Hemorrhage.

(T) HCC 326: Chronic Kidney Disease, Stage 5.

(U) HCC 327: Chronic Kidney Disease, Severe (Stage 4).

(V) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle.

(W) [Reserved]

(X) HCC 409: Amputation Status, Lower Limb/Amputation Complications.

(ii) LEJR episode category.

(A) Ankle procedure or reattachment, partial hip procedure, partial knee arthroplasty, total hip arthroplasty or hip resurfacing procedure, and total knee arthroplasty.

(B) Disability as the original reason for Medicare enrollment.

(C) Prior post-acute care use.

(D) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; Acute Myeloid Leukemia Except Promyelocytic.

(E) HCC 36: Diabetes with Severe Acute Complications.

(F) HCC 37: Diabetes with Chronic Complications.

(G) HCC 48: Morbid Obesity.

(H) HCC 125: Dementia, Severe.

(I) HCC 126: Dementia, Moderate.

(J) HCC 127: Dementia, Mild or Unspecified.

(K) HCC 151: Schizophrenia.

(L) HCC 155: Major Depression, Moderate or Severe, without Psychosis.

(M) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia.

(N) HCC 224: Acute on Chronic Heart Failure.

(O) HCC 225: Acute Heart Failure (Excludes Acute on Chronic).

(P) HCC 226: Heart Failure, Except End-Stage and Acute.

(Q) HCC 238: Specified Heart Arrhythmias.

(R) HCC 253: Hemiplegia/Hemiparesis.

(S) HCC 267: Deep Vein Thrombosis and Pulmonary Embolism.

(T) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders.

(U) [Reserved]

(V) HCC 326: Chronic Kidney Disease, Stage 5.

(W) HCC 327: Chronic Kidney Disease, Severe (Stage 4).

(X) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle.

(Y) HCC402: Hip Fracture/Dislocation.

(iii) Major Bowel Procedure episode category.

(A) Long-term institutional care use.

(B) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; Acute Myeloid Leukemia Except Promyelocytic.

(C) HCC 22: Bladder, Colorectal, and Other Cancers.

(D) HCC 37: Diabetes with Chronic Complications.

(E) HCC 48: Morbid Obesity.

(F) HCC 78: Intestinal Obstruction/Perforation.

(G) HCC 125: Dementia, Severe.

(H) HCC 126: Dementia, Moderate.

(I) HCC 127: Dementia, Mild or Unspecified.

(J) HCC 151: Schizophrenia.

(K) HCC 155: Major Depression, Moderate or Severe, without Psychosis.

(L) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia.

(M) HCC 201: Seizure Disorders and Convulsions.

(N) HCC 211: Respirator Dependence/Tracheostomy Status/ Complications.

(O) HCC 213: Cardio-Respiratory Failure and Shock.

(P) HCC 224: Acute on Chronic Heart Failure.

(Q) HCC 226: Heart Failure, Except End-Stage and Acute.

(R) HCC 238: Specified Heart Arrhythmias.

(S) HCC 253: Hemiplegia/Hemiparesis.

(T) HCC 267: Deep Vein Thrombosis and Pulmonary Embolism.

(U) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders.

(V) HCC 326: Chronic Kidney Disease, Stage 5.

(W) HCC 327: Chronic Kidney Disease, Severe (Stage 4).

(X) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle.

(Y) HCC 463: Artificial Openings for Feeding or Elimination.

(iv) SHFFT episode category.

(A) HCC 36: Diabetes with Severe Acute Complications.

(B) HCC 37: Diabetes with Chronic Complications.

(C) HCC 38: Diabetes with Glycemic, Unspecified, or No Complications.

(D) HCC 48: Morbid Obesity.

(E) HCC 63: Chronic Liver Failure/End-Stage Liver Disorders.

(F) HCC 93: Rheumatoid Arthritis and Other Specified Inflammatory Rheumatic Disorders.

(G) HCC 109: Acquired Hemolytic, Aplastic, and Sideroblastic Anemias.

(H) HCC 125: Dementia, Severe.

(I) HCC 126: Dementia, Moderate.

(J) HCC 127: Dementia, Mild or Unspecified.

(K) HCC 180: Quadriplegia.

(L) HCC 181: Paraplegia.

(M) HCC 191: Quadriplegic Cerebral Palsy.

(N) HCC 198: Multiple Sclerosis.

(O) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia.

(P) HCC 211: Respirator Dependence/Tracheostomy Status/ Complications.

(Q) HCC 213: Cardio-Respiratory Failure and Shock.

(R) HCC 226: Heart Failure, Except End-Stage and Acute.

(S) HCC 238: Specified Heart Arrhythmias.

(T) HCC 249: Ischemic or Unspecified Stroke.

(U) HCC 253: Hemiplegia/Hemiparesis.

(V) HCC 280: Chronic Obstructive Pulmonary Disease, Interstitial Lung Disorders, and Other Chronic Lung Disorders.

(W) HCC 326: Chronic Kidney Disease, Stage 5.

(X) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle.

(Y) HCC 402: Hip Fracture/Dislocation.

(v) Spinal Fusion episode category.

(A) Prior post-acute care use.

(B) HCC 17: Cancer Metastatic to Lung, Liver, Brain, and Other Organs; Acute Myeloid Leukemia Except Promyelocytic.

(C) HCC 18: Cancer Metastatic to Bone, Other and Unspecified Metastatic Cancer; Acute Leukemia Except Myeloid.

(D) HCC 37: Diabetes with Chronic Complications.

(E) HCC 48: Morbid Obesity.

(F) HCC 93: Rheumatoid Arthritis and Other Specified Inflammatory Rheumatic Disorders.

(G) HCC 125: Dementia, Severe.

(H) HCC 126: Dementia, Moderate.

(I) HCC 127: Dementia, Mild or Unspecified.

(J) HCC 155: Major Depression, Moderate or Severe, without Psychosis.

(K) HCC 180: Quadriplegia.

(L) HCC 181: Paraplegia.

(M) HCC 182: Spinal Cord Disorders/Injuries.

(N) HCC 192: Cerebral Palsy, Except Quadriplegic.

(O) HCC 193: Chronic Inflammatory Demyelinating Polyneuritis and Multifocal Motor Neuropathy.

(P) HCC 199: Parkinson and Other Degenerative Disease of Basal Ganglia.

(Q) HCC 224: Acute on Chronic Heart Failure.

(R) HCC 226: Heart Failure, Except End-Stage and Acute.

(S) HCC 238: Specified Heart Arrhythmias.

(T) HCC 249: Ischemic or Unspecified Stroke.

(U) HCC 253: Hemiplegia/Hemiparesis.

(V) HCC 254: Monoplegia, Other Paralytic Syndromes.

(W) HCC 267: Deep Vein Thrombosis and Pulmonary Embolism.

(X) HCC 326: Chronic Kidney Disease, Stage 5.

(Y) HCC 383: Chronic Ulcer of Skin, Except Pressure, Not Specified as Through to Bone or Muscle.

(Z) HCC 401: Vertebral Fractures without Spinal Cord Injury. * * * * *

(e) * * *

(1) * * *

(i) Is the mean benchmark price for each MS-DRG/HCPCS episode type and region divided by the mean risk-adjusted benchmark price for the same MS-DRG/HCPCS episode type and region. * * * * *

(f) CMS calculates a multiplier for each MS-DRG/HCPCS episode type and region which is applied during reconciliation to the most recent calendar year of the applicable baseline period. The multiplier is calculated as the average regional capped performance year episode spending for each MS-DRG/HCPCS episode type divided by the average regional capped baseline period episode spending for each MS-DRG/HCPCS episode type. * * * * *

0 26. Section 512.547 is amended by-- 0 a. In paragraph (a) introductory text, removing the phrase “Hospital Inpatient Quality Reporting Program and the Hospital-Acquired Condition Reduction Program” and adding in its place “Hospital Inpatient Quality Reporting Program, the Hospital-Acquired Condition Reduction Program, and the Hospital Outpatient Quality Reporting Program”; 0 b. In paragraph (a)(2) introductory text, removing the phrase “years 2 through 5” and adding in its place “year 2”; 0 c. Adding paragraph (a)(3); and 0 d. Revising paragraphs (b)(1)(i)(B) introductory text and (b)(1)(i)(D).

The addition and revisions read as follows:

Sec. 512.547 Quality measures, composite quality score, and display of quality measures.

(a) * * *

(3) For performance years 3 through 5:

(i) For all episode categories: Hybrid Hospital-Wide All-Cause Readmission Measure with Claims and Electronic Health Record Data (CMIT ID #356) with a CY 2025 CQS baseline period.

(ii) For all episode categories: Hospital Harm--Falls with Injury (CMIT ID #1518) with a CY 2026 CQS baseline period.

(iii) For all episode categories: Hospital Harm--Postoperative Respiratory Failure (CMIT ID #1788) with a CY 2026 CQS baseline period.

(iv) For all episode categories: Thirty-day Risk-Standardized Death Rate among Surgical Inpatients with Complications (Failure-to-Rescue) (CMIT ID #134) with a CY 2026 CQS baseline period.

(v) For LEJR episodes: Hospital-Level Total Hip and/or Total Knee Arthroplasty (THA/TKA) Patient-Reported Outcome-Based Performance Measure (PRO-PM) (CMIT ID #1618) with a CY 2025 CQS baseline period.

(vi) For LEJR and Spinal Fusion episodes: Information Transfer PRO- PM (CMIT ID #1797) with a CY 2027 CQS baseline period. * * * * *

(b) * * *

(1) * * *

(i) * * *

(B) For the Hospital-Level Total Hip and/or Total Knee Arthroplasty (THA/TKA) Patient-Reported Outcome-Based Performance Measure (PRO-PM) (CMIT ID #1618) and the Information Transfer PRO-PM (CMIT ID # 1797): * * * * *

(D) CMS assigns a scaled quality measure of 50 if the TEAM participant has no or an incomplete raw quality measure score for a given quality measure. * * * * *

0 27. Section 512.550 is amended by revising paragraph (c) to read as follows:

Sec. 512.550 Reconciliation process and determination of the reconciliation payment or repayment amount.

* * * * *

(c) Calculation of the reconciliation amount. CMS compares the reconciliation target prices described in Sec. 512.545 and the TEAM participant's performance year spending to establish a reconciliation amount for the TEAM participant for each performance year as follows:

(1) CMS determines the performance year spending for each episode included in the performance year (other than episodes that have been canceled in accordance with Sec. 512.537(b)) for each MS-DRG/HCPCS episode type using claims data that is available 6 months after the end of the performance year.

(2) CMS calculates and applies the high-cost outlier cap for performance year episode spending by applying the calculation described in Sec. 512.540(b)(4) to performance year episode spending for each MS-DRG/HCPCS episode type.

(3) CMS applies the adjustments specified in Sec. 512.545 to the preliminary

target prices computed in accordance with Sec. 512.540 to calculate the reconciliation target prices for each MS-DRG/HCPCS episode type.

(4) CMS aggregates the reconciliation target prices computed in accordance with paragraph (c)(3) of this section for all episodes included in the performance year (other than episodes that have been canceled in accordance with Sec. 512.537(b)) for each MS-DRG/HCPCS episode type.

(5) CMS subtracts the performance year spending amount determined under paragraphs (c)(1) and (2) of this section from the reconciliation target price amount determined under paragraph (c)(4) of this section for each MS-DRG/HCPCS episode type.

(6) CMS sums the values calculated under paragraph (c)(5) of this section across all MS-DRG/HCPCS episode types to determine the reconciliation amount.

(7) Exception for low volume hospitals: CMS caps the performance year spending amount for each MS-DRG/HCPCS episode type determined under paragraphs (c)(1) and (2) of this section to equal the reconciliation target price computed in accordance with paragraph (c)(3) of this section for episode categories where the TEAM participant did not meet the low volume threshold of at least 31 episodes during the 3-year baseline period. Low volume hospital episodes, including episode categories where CMS caps performance year spending, are included in the CQS, as calculated in Sec. 512.547(b), and stop-loss/stop-gain thresholds, as applied at paragraph (e) of this section, * * * * *

0 28. Section 512.562 is amended by revising paragraph (c)(3) to read as follows:

Sec. 512.562 Data sharing with TEAM participants.

* * * * *

(c) * * *

(3) Sex. * * * * *

0 29. Section 512.563 is amended by: 0 a. Revising the section heading; and 0 b. Removing and reserving paragraphs (a) and (b).

The revision read as follows:

Sec. 512.563 Health data reporting.

* * * * *

0 30. Section 512.564 is amended by revising paragraph (a) to read as follows:

Sec. 512.564 Referral to primary care services.

(a) A TEAM participant must include in hospital discharge planning a referral to an established supplier of primary care services, as recorded on admission to the hospital or hospital outpatient department, for a TEAM beneficiary, on or prior to discharge from an anchor hospitalization or anchor procedure. In the event an established supplier of primary care services is not recorded on admission to the hospital or hospital outpatient department, the TEAM participant must include in hospital discharge planning a referral to a supplier of primary care services for a TEAM beneficiary, on or prior to discharge from an anchor hospitalization or anchor procedure. * * * * *

0 31. Section 512.580 is amended by revising the section heading and paragraph (b)(3) to read as follows:

Sec. 512.580 TEAM Medicare Program Waivers.

* * * * *

(b) * * *

(3) Determination of qualified SNFs. CMS determines the qualified SNFs for each calendar quarter based on a review of the most recent rolling 12 months of overall star ratings on the Five-Star Quality Rating System for SNFs on the Nursing Home Compare website.

(i) Qualified SNFs are rated an overall of 3 stars or better for at least 7 of the 12 months. (ii) Qualified SNFs include providers furnishing SNF services under swing bed agreements, which will not be subject to the star ratings requirement. * * * * *

Sec. 512.598 [Removed]

0 32. Section 512.598 is removed.

Title 45--Public Welfare

PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY

0 33. The authority citation for part 170 continues to read as follows:

Authority: 42 U.S.C. 300jj-11; 42 U.S.C 300jj-14; 5 U.S.C. 552.

0 34. Section 170.102 is amended by--revising and republishing the definition of “Base EHR” to read as follows:

Sec. 170.102 Definitions.

* * * * *

Base EHR means an electronic record of health-related information on an individual that--

(1) Includes patient demographic and clinical health information, such as medical history and problem lists;

(2) Has the capacity--

(i) To provide clinical decision support;

(ii) To support physician order entry;

(iii) To capture and query information relevant to healthcare quality;

(iv) To exchange electronic health information with, and integrate such information from other sources; and

(3) Has been certified to the certification criteria adopted by the Secretary in all of the following:

(i) Section 170.315(a)(1), (2), or (3); (a)(5) and (14), (b)(1), (c)(1), and (g)(7), (9), (10); and (h)(1) or (2).

(ii) Section 170.315(a)(9) or (b)(11) for the period up to and including December 31, 2024.

(iii) Section 170.315(b)(11) on and after January 1, 2025.

(iv) Section 170.315(b)(4) on and after January 1, 2028. * * * * *

0 35. Section 170.207 is amended by revising paragraph (d) to read as follows:

Sec. 170.207 Vocabulary standards for representing electronic health information.

* * * * *

(d) Medications--(1) Clinical drugs--(i) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, December 4, 2023, Full Update Release (incorporated by reference in Sec. 170.299).

(ii) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, Full Update Release, July 5, 2022 (incorporated by reference, see Sec. 170.299).

(iii) Standard. RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, September 8, 2015, Full Release Update (incorporated by reference in Sec. 170.299).

(2) Standard. National Drug Codes. The code set specified at 45 CFR 162.1002(b)(2) as referenced in 45 CFR 162.1002(c)(1) for the time period on or after October 1, 2015.

(3)-(4) [Reserved] * * * * *

0 36. Section 170.215 is revised and republished to read as follows:

Sec. 170.215 Application Programming Interface Standards.

The Secretary adopts the following standards and associated implementation specifications as the available standards for application programming interfaces (API):

(a) API base standard. The following are applicable for purposes of standards-based APIs.

(1) Standard. HL7[supreg] Fast Healthcare Interoperability Resources (FHIR[supreg]) Release 4.0.1 (incorporated by reference, see Sec. 170.299).

(2) [Reserved]

(b) API constraints and profiles. The following are applicable for purposes of constraining and profiling data standards.

(1) United States Core Data Implementation Guides--(i) Implementation specification. HL7[supreg] FHIR[supreg] US Core Implementation Guide STU 3.1.1 (incorporated by reference in Sec. 170.299). The adoption of this standard expires on January 1, 2026.

(ii) Implementation Specification. HL7[supreg] FHIR[supreg] US Core Implementation Guide STU 6.1.0 (incorporated by reference, see Sec. 170.299).

(2) [Reserved]

(c) Application access and launch. The following are applicable for purposes of enabling client applications to access and integrate with data systems.

(1) Implementation specification. HL7[supreg] SMART Application Launch Framework Implementation Guide Release 1.0.0, including mandatory support for the “SMART Core Capabilities” (incorporated by reference, see Sec. 170.299). The adoption of this standard expires on January 1, 2026.

(2) Implementation specification. HL7[supreg] SMART App Launch Implementation Guide Release 2.0.0, including mandatory support for the “Capability Sets” of “Patient Access for Standalone Apps” and “Clinician Access for EHR Launch”; all “Capabilities” as defined in “8.1.2 Capabilities,” excepting the “permission-online” capability; “Token Introspection” as defined in “7 Token Introspection” (incorporated by reference, see Sec. 170.299).

(d) Bulk export and data transfer standards. The following are applicable for purposes of enabling access to large volumes of information on a group of individuals.

(1) Implementation specification. FHIR[supreg] Bulk Data Access (Flat FHIR[supreg]) (v1.0.0: STU 1), including mandatory support for the “group-export” “OperationDefinition” (incorporated by reference, see Sec. 170.299).

(2) [Reserved]

(e) API authentication, security, and privacy. The following are applicable for purposes of authorizing and authenticating client applications.

(1) Standard. OpenID Connect Core 1.0, incorporating errata set 1 (incorporated by reference, see Sec. 170.299).

(2) [Reserved]

(f) API-based workflow triggers. The following are applicable for purposes of initiating calls to decision support services or initiating interactions that can be presented to users synchronously in their workflows.

(1) Implementation specification. HL7 FHIR[supreg] CDS Hooks Implementation Guide, Version 2.0.1--STU 2 Release 2 (incorporated by reference in Sec. 170.299).

(2) [Reserved]

(g) [Reserved]

(h) API-based event notifications. The following are applicable for the purposes of supporting proactive notifications from a server to a client when new information has been added or existing information has been updated.

(1) FHIR Subscriptions: Implementation specification. HL7[supreg] FHIR[supreg] Subscriptions R5 Backport Implementation Guide, Version 1.1.0--Standard for Trial Use (incorporated by reference in Sec. 170.299).

(2) [Reserved]

(i) [Reserved]

(j) Prior authorization--(1) Coverage requirements discovery--(i) Implementation specification. HL7 FHIR[supreg] Da Vinci--Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.0.1--STU 2 (incorporated by reference in Sec. 170.299).

(ii) [Reserved]

(2) Prior authorization documentation--(i) Implementation specification. HL7 FHIR[supreg] Da Vinci--Documentation Templates and Rules (DTR) Implementation Guide, Version 2.0.1--STU 2 (incorporated by reference in Sec. 170.299).

(ii) [Reserved]

(3) Prior authorization submission--(i) Implementation specification. HL7 FHIR Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1--STU 2 (incorporated by reference in Sec. 170.299).

(ii) [Reserved]

(k) Payer data exchange--(1) Blue button--(i) Implementation specification. HL7 FHIR[supreg] CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button[supreg]) Implementation Guide, Version 2.0.0--STU 2 US (incorporated by reference in Sec. 170.299).

(ii) [Reserved]

(2) Payer data exchange--(i) Implementation specification. HL7 FHIR[supreg] Da Vinci Payer Data Exchange (PDex) Implementation Guide, Version 2.1.0--STU 2.1 (incorporated by reference in Sec. 170.299).

(ii) [Reserved]

(l) [Reserved]

(m) Drug formulary--(1) Implementation specification. HL7 FHIR[supreg] Da Vinci Payer Data Exchange (PDex) US Drug Formulary Implementation Guide, Version 2.0.1--STU 2 (incorporated by reference in Sec. 170.299).

(2) [Reserved]

(n) Directory information--(1) Implementation specification. HL7 FHIR[supreg] Da Vinci Payer Data Exchange (PDex) Plan Net Implementation Guide, Version 1.1.0--STU 1.1 US (incorporated by reference in Sec. 170.299).

(2) [Reserved]

0 37. Section 170.299 is amended by adding paragraphs (g)(41) through (49) and (r)(10) to read as follows:

Sec. 170.299 Incorporation by reference.

* * * * *

(g) * * *

(41) HL7 FHIR[supreg] Da Vinci--Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.0.1--STU 2, January 8, 2024, IBR approved for Sec. 170.215(j).

(42) HL7 FHIR[supreg] Da Vinci--Documentation Templates and Rules (DTR) Implementation Guide, Version 2.0.1--STU 2, January 11, 2024, IBR approved for Sec. 170.215(j).

(43) HL7 FHIR[supreg] Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1--STU 2, December 1, 2023, IBR approved for Sec. 170.215(j).

(44) HL7 FHIR[supreg] CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button[supreg]) Implementation Guide, Version 2.0.0--STU 2 US, November 28, 2022, IBR approved for Sec. 170.215(k).

(45) HL7 FHIR[supreg] Da Vinci Payer Data Exchange (PDex) Implementation Guide, Version 2.1.0--STU 2.1, June 18, 2025, IBR approved for Sec. 170.215(k).

(46) HL7 FHIR[supreg] Da Vinci Payer Data Exchange (PDex) US Drug Formulary Implementation Guide, Version 2.0.1--STU 2, December 1, 2023, IBR approved for Sec. 170.215(m).

(47) HL7 FHIR[supreg] Da Vinci Payer Data Exchange (PDex) Plan Net Implementation Guide, Version 1.1.0--STU 1.1 US, April 4, 2022, IBR approved for Sec. 170.215(n).

(48) HL7 FHIR[supreg] Subscriptions R5 Backport Implementation Guide, Version 1.1.0--Standard for Trial Use, draft as of January 11, 2023, IBR approved for Sec. 170.215(h).

(49) HL7 FHIR[supreg] CDS Hooks Implementation Guide, Version 2.0.1--STU 2 Release 2, March 12, 2025, IBR approved for Sec. 170.215(f). * * * * *

(r) * * *

(10) RxNorm, December 4, 2023, Full Update Release, IBR approved for Sec. 170.207(d). * * * * *

0 38. Section 170.315 is amended by-- 0 a. Revising and republishing paragraph (b)(3); 0 b. Revising paragraph (b)(4); 0 c. Adding paragraph (g)(2); 0 d. Removing and reserving paragraph (g)(8); 0 e. Adding and reserving paragraphs (g)(11) through (30); 0 f. Adding paragraphs (g)(31) through (33); 0 g. Adding and reserving paragraph (i); and 0 h. Adding paragraph (j).

The revisions and additions read as follows:

Sec. 170.315 ONC Certification Criteria for Health IT.

* * * * *

(b) * * *

(3) Electronic prescribing. (i) [Reserved]

(ii) For technology certified subsequent to June 30, 2020:

(A)(1) For the time period up to and including December 31, 2027, enable a user to perform the prescription-related electronic transactions specified in paragraph (b)(3)(ii)(A)(3) of this section in accordance with the standards specified in Sec. 170.205(b)(1) or (2).

(i) At a minimum, at least one of the versions of the standard adopted in Sec. 170.207(d)(1).

(ii) The standard in Sec. 170.207(d)(2) if using the standard in Sec. 170.205(b)(2).

(2) On and after January 1, 2028, enable a user to perform the prescription-related electronic transactions specified in paragraph (b)(3)(ii)(A)(3) of this section in accordance with the standard specified in Sec. 170.205(b)(2).

(i) At a minimum, at least one of the versions of the standard adopted in Sec. 170.207(d)(1).

(ii) The standard in Sec. 170.207(d)(2).

(3) The prescription-related electronic transactions are as follows:

(i) New prescriptions (NewRx).

(ii) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse).

(iii) Request and respond to cancel prescriptions (CancelRx, CancelRxResponse).

(iv) Request and respond to renew prescriptions (RxRenewalRequest, RxRenewalResponse).

(v) Receive fill status notifications (RxFill).

(vi) Request and receive medication history (RxHistoryRequest, RxHistoryResponse).

(vii) Relay acceptance of a transaction back to the sender (Status).

(viii) Respond that there was a problem with the transaction (Error).

(ix) Respond that a transaction requesting a return receipt has been received (Verify).

(x) Electronic prior authorization transactions (PAInitiationRequest, PAInitiationResponse, PARequest, PAResponse, PAAppealRequest, PAAppealResponse, PACancelRequest, PACancelResponse, and PANotification). These transactions are required if using the standard in Sec. 170.205(b)(2).

(B) Enable a user to exchange race and ethnicity information when performing the following prescription-related electronic transactions, if using the standard in Sec. 170.205(b)(2):

(1) Receive fill status notifications (RxFill).

(2) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse).

(3) Request to cancel prescriptions (CancelRx).

(4) Request and respond to renew prescriptions (RxRenewalRequest, RxRenewalResponse).

(C) For the following prescription-related transactions, the technology must be able to receive and transmit the diagnosis or diagnoses that are the reason for prescription:

(1) Required transactions:

(i) New prescriptions (NewRx).

(ii) Request and respond to change prescriptions (RxChangeRequest, RxChangeResponse).

(iii) Cancel prescriptions (CancelRx).

(iv) Request and respond to renew prescriptions (RxRenewalRequest, RxRenewalResponse).

(v) Receive fill status notifications (RxFill).

(vi) [Reserved]

(vii) Electronic prior authorization transactions (PAInitiationRequest, PAInitiationResponse, PARequest, PAResponse, PAAppealRequest, PAAppealResponse and PACancelRequest, PACancelResponse, PANotification). These transactions are required if using the standard in Sec. 170.205(b)(2).

(2) [Reserved]

(D) [Reserved]

(E) Limit a user's ability to prescribe all oral liquid medications in only metric standard units of mL (that is, not cc).

(F) Always insert leading zeroes before the decimal point for amounts less than one and must not allow trailing zeroes after a decimal point when a user prescribes medications.

(4) Real-time prescription benefit--(i) Send and receive information. Enable a user to perform the following transactions using the XML format in accordance with at least one of the versions of the standards adopted in Sec. 170.205(c); at a minimum, a standard adopted in Sec. 170.207(d)(1); and the standard in Sec. 170.207(d)(2), as follows:

(A) Request patient-specific prescription benefit information, estimated cost information, and alternative products, in accordance with the RTPBRequest transaction.

(B) Receive patient-specific prescription benefit information, estimated cost information, and alternative products in response to a request, in accordance with the RTPBResponse transaction.

(ii) Display. Display to a user in human readable format patient- specific prescription benefit information, estimated cost information, and alternative products, in accordance with at least one of the versions of the standard adopted in Sec. 170.205(c). * * * * *

(g) * * *

(2) Automated measure calculation. For each Promoting Interoperability Programs percentage-based measure that is supported by a capability included in a technology, record the numerator and denominator and create a report including the numerator, denominator, and resulting percentage associated with each applicable measure. * * * * *

(8) [Reserved] * * * * *

(11)-(30) [Reserved]

(31) Provider prior authorization API--coverage requirements discovery. Support the following capabilities to enable users to request and receive coverage requirements.

(i) Coverage discovery. Support the capability to initiate and exchange information as a “CRD Client” to enable the identification of coverage requirements according to at least one of the versions of the implementation specification adopted in Sec. 170.215(j)(1), including the following:

(A) Registration. Support registration capabilities applicable to “CRD Clients”.

(B) CDS Hooks support. Support the capabilities in paragraph (j)(20) of this section to enable workflow triggers to call decision support services including support for the “order-sign” CDS Hook.

(C) CRD Client capabilities. Support all requirements and required capabilities applicable to a “CRD Client.”

(ii) Documentation. Supported API server capabilities of “CRD Clients” from an implementation specification

adopted in Sec. 170.215(j)(1) must include complete accompanying technical documentation.

(32) Provider prior authorization API--documentation templates and rules. Support the capability for users to request and populate prior authorization documentation using templates and rules as a “Full DTR EHR” according to at least one of the versions of the implementation specification adopted in Sec. 170.215(j)(2), including:

(i) Registration. Support registration capabilities applicable to a “Full DTR EHR.”

(ii) Authentication and authorization. Support system authentication and authorization as a client in accordance with the “Backend Services” section of at least one of the versions of the implementation specification adopted in Sec. 170.215(c).

(iii) Full DTR EHR capabilities. Support all requirements and required capabilities applicable to a “Full DTR EHR.”

(33) Provider prior authorization API--prior authorization support. Support the following capabilities to enable users to submit prior authorization requests.

(i) Prior authorization submission. Support submitting a prior authorization request as a client in accordance with at least one of the versions of the implementation specification adopted in Sec. 170.215(j)(3) including the following:

(A) Registration. Support registration capabilities applicable to a client system.

(B) Authentication and authorization. Support system authentication and authorization as a client in accordance with the “Backend Services” section of at least one of the versions of the implementation specification adopted in Sec. 170.215(c).

(C) Prior authorization transactions. Support the ability to submit a prior authorization request as a client system including the following:

(1) Support the capabilities in the “EHR PAS Capabilities” Capability Statement.

(2) Support the ability to consume and process a “ClaimResponse.”

(3) Support subscriptions as a client according to the requirements in paragraph (j)(21) of this section in order to support “pended authorization responses.”

(ii) Documentation. Supported subscriptions client endpoint capabilities for the “REST-Hook” channel from implementation specifications adopted in Sec. 170.215(j)(3) must include complete accompanying technical documentation. * * * * *

(i) [Reserved]

(j) Modular API capabilities. The following technical outcomes and conditions must be met through the demonstration of application programming interface technology.

(1)-(19) [Reserved]

(20) Workflow triggers for decision support interventions--clients. Support the requirements applicable to a “CDS Client” according to at least one of the implementation specifications in Sec. 170.215(f) including the following:

(i) Registration. Support registration capabilities applicable to “CDS Clients”.

(ii) Authentication and authorization. Support authentication and authorization, including the following:

(A) Support for client authentication using JSON web tokens (JWT).

(B) Support for data access authorization of a “CDS Service” using access tokens.

(iii) Workflow triggers. Support the execution of decision support workflow triggers.

(iv) Information exchange. Send a decision support request to a “CDS Service,” including support for the following:

(A) Resource access via API. Support access to HL7 FHIR Resources via a RESTful API to support decision support intervention workflows according to the “FHIR Resource Access” section.

(B) Receive and display response. Support the receipt of a decision support response, including support for the display of the contents of a decision support response to an end-user.

(21) Subscriptions--client. Support subscriptions as a client according to at least one of the implementation specifications in Sec. 170.215(h), including the following:

(i) Support the requirements in section “Topic-Based Subscriptions--FHIR R4.”

(ii) Support the “R4/B Topic-Based Subscription” profile.

(iii) Support the accompanying client capabilities for the minimum requirements included in the “R4 Topic-Based Subscription Server Capability Statement,” including support for “create,” “update,” and “delete” interactions for Subscription Resources.

(iv) Receive subscription notifications according to section “Topic-Based Subscriptions--FHIR R4,” including support for consuming notifications via the “REST-Hook” channel as specified in the “Channels” section.

0 39. Section 170.404 is amended by-- 0 a. Revising the introductory text; 0 b. Revising paragraph (b)(1); and 0 c. Revising definitions for “Certified API Developer” and “Certified API technology” in paragraph (c).

The revisions read as follows:

Sec. 170.404 Application programming interfaces.

The following Condition and Maintenance of Certification requirements apply to developers of Health IT Modules certified to any of the certification criteria adopted in Sec. 170.315(g)(7) through (10), and (31) through (g)(33) unless otherwise specified in this section. * * * * *

(b) * * *

(1) Authenticity verification and registration for production use. The following apply to a Certified API Developer with a Health IT Module certified to one or more of Sec. 170.315(g)(10), (31), and (33):

(i) Authenticity verification. A Certified API Developer is permitted to institute a process to verify the authenticity of API Users so long as such process is objective and the same for all API Users and completed within ten business days of receipt of an API User's request to register their software application for use with the Certified API Developer's Health IT Module certified to Sec. 170.315(g)(10), (g)(31), and (g)(33).

(ii) Registration for production use. A Certified API Developer must register and enable all applications for production use within five business days of completing its verification of an API User's authenticity, pursuant to paragraph (b)(1)(i) of this section. * * * * *

(c) * * *

Certified API Developer means a health IT developer that creates “certified API technology.”

Certified API technology means the capabilities of Health IT Modules that are certified to any of the API-focused certification criteria adopted in Sec. 170.315(g)(7) through (10), and (31) through (33).

Sec. 170.405 [Amended]

0 40. Section[thinsp]170.405 is amended in paragraph (a), by removing the phrase “(g)(7) through (10), and (h) must” and adding in its place the phrase “(g)(7) through (10), (g)(31) through (33), (h), and (j)(20) and (21) must”.

0 41. Section 170.550 is amended by-- 0 a. Adding paragraph (g)(6); and 0 b. Removing paragraph (m).

The addition reads as follows:

Sec. 170.550 Health IT Module certification.

* * * * *

(g) * * *

(6) Section 170.315(b)(4) if the Health IT Module is presented for certification to the certification criteria in Sec. 170.315(b)(3). * * * * *

Robert J. Kennedy, Jr. Secretary, Department of Health and Human Services.

Note: The following addendum and appendices will not appear in the Code of Federal Regulations.

Addendum--Schedule of Standardized Amounts, Update Factors, Rate-of- Increase Percentages Effective With Cost Reporting Periods Beginning On or After October 1, 2025, and Payment Rates for LTCHs Effective for Discharges Occurring On or After October 1, 2025