Documents › Agency rules › 2025-20907 › Text 27 of 29
Health and Human Services Department, Centers for Medicare & Medicaid Services, Office of the Secretary
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots
The text of the rule, page 27 of 29. 19 headings, 19,664 words, quoted as the Federal Register prints them.
← C. Improved and Enhanced Enforcement to B. Definition of “Approved Medical Residency Programs”ContentsA. Statement of Need to XXVII. Waiver of 60-Day Delay of Effective Date →
A. Background
Section 5506 of the Patient Protection and Affordable Care Act (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, “Affordable Care Act”), authorizes the Secretary to redistribute residency slots after a hospital that trained residents in an approved medical residency program closes. Section 5506 of the Affordable Care Act instructs the Secretary to establish a process by regulation that redistributes slots from teaching hospitals that close to hospitals that meet certain criteria, with priority given to certain hospitals including those located in the same Core Based Statistical Area (CBSA), in a contiguous CBSA or in the same state as the closed hospital.
Specifically, section 5506 of the Affordable Care Act amended the Act by adding subsection (vi) to section 1886(h)(4)(H) of the Act and modifying language at section 1886(d)(5)(B)(v) of the Act, to instruct the Secretary to establish a process to increase the full-time equivalent (FTE) resident caps for other hospitals based upon the FTE resident caps in teaching hospitals that closed on or after a date that is 2 years before the date of enactment (that is, March 23, 2008). In the CY 2011 Outpatient Prospective Payment System (OPPS) final rule with comment period (75 FR 72264), we established regulations at 42 CFR 413.79(o) and an application process for qualifying hospitals to apply to CMS to receive direct GME and IME FTE resident cap slots from the hospital that closed. We made certain additional modifications to Sec. 413.79 in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53434), and we made changes to the section 5506 application process in the FY 2015 IPPS/LTCH PPS final rule (79 FR 50122 through 50134). The procedures we established apply both to teaching hospitals that closed on or after March 23, 2008, and on or before August 3, 2010, and to teaching hospitals that close after August 3, 2010 (75 FR 72215).
B. Notice of Closure of Pontiac General Hospital Located in Pontiac, MI, and the Application Process--Round 26
We have learned of the closure of Pontiac General Hospital, located in Pontiac, MI (CCN 230013). Accordingly, this notice serves to notify the public of the closure of this teaching hospital and initiate another round (“Round 26”) of the application and selection process. This round will be the 26th round (“Round 26”) of the application and selection process. Table 145 contains the identifying information and IME and direct GME FTE resident caps for the closed teaching hospital, which are part of the Round 26 application process under section 5506 of the Affordable Care Act. [GRAPHIC] [TIFF OMITTED] TR25NO25.235
C. Application Process for Available Resident Slots
The application period for hospitals to apply for slots under section 5506 of the Affordable Care Act is 90 days following notice to the public of a hospital closure (77 FR 53436). Therefore, hospitals that wish to apply for and receive slots from the previously noted hospital's FTE resident caps must submit applications using the electronic application intake system, Medicare Electronic Application Request Information System (MEARIS\TM\), with application submissions for Round 26 due no later than February 19, 2026. The section 5506 application can be accessed at https://mearis.cms.gov/public/home.
CMS will only accept Round 26 applications submitted via MEARIS\TM\. Applications submitted through any other method will not be considered. Within MEARIS\TM\, we have built in several resources to support applicants:
Please refer to the “Resources” section for guidance regarding the application submission process at https://mearis.cms.gov/public/resources.
Technical support is available under “Useful Links” at the bottom of the MEARIS\TM\ web page.
Application related questions can be submitted to CMS using the form available under “Contact” at https://mearis.cms.gov/public/resources.
Application submission through MEARIS\TM\ will not only help CMS track applications and streamline the review process, but it will also create efficiencies for applicants when
compared to a paper submission process.
We have not established a deadline by when CMS will issue the final determinations to hospitals that receive slots under section 5506 of the Affordable Care Act. However, we review all applications received by the application deadline and notify applicants of our determinations as soon as possible.
We refer readers to the CMS Direct Graduate Medical Education (DGME) website at https://www.cms.gov/medicare/payment/prospective-payment-systems/acute-inpatient-pps/direct-graduate-medical-education-dgme. Hospitals should access this website for a list of additional section 5506 guidelines for the policy and procedures for applying for slots, and the redistribution of the slots under sections 1886(h)(4)(H)(vi) and 1886(d)(5)(B)(v) of the Act.
XXIII. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501- 3520, we are required to provide notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection should be approved by OMB, 44 U.S.C. 3506(c)(2)(A) requires that we solicit comment on the following issues:
The need for the information collection and its usefulness in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection burden.
The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We solicited public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
A. ICRs for the Hospital Outpatient Quality Reporting (OQR) Program
1. Background
In sections XIV. and XV. of this final rule with comment period, we discuss the finalized requirements for the Hospital OQR Program. The Hospital OQR Program is generally aligned with the CMS quality reporting program for hospital inpatient services known as the Hospital Inpatient Quality Reporting (IQR) Program. We refer readers to the CY 2025 OPPS/ASC final rule with comment period (89 FR 94522 through 94530) for detailed discussions of the previously finalized Hospital OQR Program ICRs which are currently approved under OMB control number 0938-1109 (expiration date January 31, 2026).
We are: (1) removing the COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) measure beginning with the CY 2024 reporting period/CY 2026 payment determination; (2) removing the Hospital Commitment to Health Equity (HCHE) measure beginning with the CY 2025 reporting period/CY 2027 payment determination; (3) removing the Screening for Social Drivers of Health (SDOH) measure beginning with the CY 2025 reporting period; (4) removing the Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period; (5) modifying the Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults (Hospital Level--Outpatient) eCQM (Excessive Radiation eCQM) from mandatory reporting beginning with the CY 2027 reporting period to continue voluntary reporting in the CY 2027 reporting period and subsequent years; (6) adopting the Emergency Care Access & Timeliness electronic clinical quality measure (eCQM) with voluntary reporting for the CY 2027 reporting period, followed by mandatory reporting beginning with the CY 2028 reporting period/CY 2030 payment determination; (7) removing the Median Time from Emergency Department (ED) Arrival to ED Departure for Discharged ED Patients measure beginning with the CY 2028 reporting period/CY 2030 payment determination; and (8) removing the Left Without Being Seen (LWBS) measure beginning with the CY 2028 reporting period/CY 2030 payment determination.
In section XIV.D. of this final rule with comment period, we are also updating our Extraordinary Circumstances Exception (ECE) Policy for the Hospital OQR Program. This update will explicitly include extensions as a type of extraordinary circumstances relief option, in addition to exceptions. Because the process for requesting or granting an ECE will remain the same as the current ECE process, these updates will not affect burden associated with the submission of the ECE form.
In the CY 2025 OPPS/ASC final rule with comment period, we calculated reporting burden estimates for the Hospital OQR Program by utilizing the Bureau of Labor Statistics (BLS) mean hourly wage rate for Medical Records Specialists (89 FR 94522 through 94523). Specifically, we used the industry-specific wage for Medical Records Specialists working in “general medical and surgical hospitals”, as this categorization aligns the closest with the Hospital OQR Program care setting. The most recent data from BLS' May 2024 National Occupational Employment and Wage Estimates reflects a median hourly wage of $27.53 per hour for Medical Records Specialists working in “general medical and surgical hospitals” (SOC 29-2072).\514\ We calculated the cost of overhead, including fringe benefits, at 100 percent of the median hourly wage, consistent with previous years. This is 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 ($27.53 x 2 = $55.06) to estimate total cost burden is reasonably accurate. Accordingly, unless otherwise specified, we calculate cost burden to hospitals using a wage plus benefits estimate of $55.06 per hour throughout the discussion in this section of this final rule with comment period for the Hospital OQR Program.
\514\ U.S. Bureau of Labor Statistics. (2025). Occupational Outlook Handbook, Medical Records Specialists. Available at: https://data.bls.gov/oes/#/industry/622100. Accessed: April 8, 2025.
In the CY 2025 OPPS/ASC final rule with comment period, our burden estimates assumed that approximately 3,200 hospital outpatient departments (HOPDs) will report data to the Hospital OQR Program (89 FR 94523). For this final rule with comment period, based on the most recent available data from the CY 2024 Hospital OQR Program payment determination, we estimate that 3,200 HOPDs will report data to the Hospital OQR Program for the CY 2026 reporting period/CY 2028 payment determination and future years. 2. Information Collection Burden Estimate for the Removal of the COVID- 19 Vaccination Coverage Among HCP Measure Beginning With CY 2024 Reporting Period/CY 2026 Payment Determination
As discussed in section XIV.C.1. of this final rule with comment period, we are removing the COVID-19 Vaccination Coverage Among HCP measure beginning with the CY 2024 reporting period/CY 2026 payment determination. The information collection burden associated with this measure is currently approved under OMB control number 0920-1317. To report this measure, HOPDs 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 HOPD 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 will be completed by a Microbiologist with a wage rate of $58.60/hour and uploading of a CSV file will be 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 25,600 hours (0.67 hours x 12 months x 3,200 HOPDs) at a savings of $1,446,400 (25,600 hours x $56.50/hour) and 28,800 hours (0.75 hours x 12 months x 3,200 HOPDs) at a savings of $1,687,680 (28,800 hours x $58.60/hour) annually across all 3,200 HOPDs under OMB control number 0920-1317.
We did not receive public comments on this burden estimate. 3. Information Collection Burden Estimate for the Removal of the HCHE Measure Beginning With the CY 2025 Reporting Period/CY 2027 Payment Determination
As discussed in section XIV.C.2. of this final rule with comment period, we are removing the HCHE measure beginning with the CY 2025 reporting period/CY 2027 payment determination. The information collection burden associated with this measure is currently approved under OMB control number 0938-1109. The currently approved information collection burden estimate for this measure assumes HOPDs spend approximately 10 minutes (0.167 hours) annually to report measure data. Therefore, for all participating HOPDs, we estimate removal of this measure will decrease burden by approximately 533 hours (0.167 hours x 3,200 HOPDs) at a savings of $29,347 (533 hours x $55.06/hour).
We did not receive public comments on this burden estimate. 4. Information Collection Burden Estimate for the Removal of the Screening for SDOH Measure Beginning With the CY 2025 Reporting Period
In section XIV.C.3. of this final rule with comment period, we are removing the Screening for SDOH measure beginning with the CY 2025 reporting period. 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 have previously estimated 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.
We determine the cost for patients (or their representative) to complete the screening using a post-tax wage of $25.63/hour based on assumptions from the report “Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices”, which identifies an approach for valuing time when individuals undertake administrative and other tasks on their own time.\515\ 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.\516\ 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,\517\ 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.
\515\ Office of the Assistant Secretary for Planning and Evaluation. (2017). Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices. Available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework. Accessed: June 24, 2025.
\516\ Bureau of Labor and Statistics. (2025). Usual Weekly Earnings of Wage and Salary Workers, Fourth Quarter 2025. Available at https://www.bls.gov/news.release/pdf/wkyeng.pdf. Accessed: March 3, 2025.
\517\ Guzman, G. & Kollatr, M. (2024). Income in the United States: 2023. Available at https://www2.census.gov/library/publications/2024/demo/p60-282.pdf. Accessed: June 24, 2025.
Under OMB control number 0938-1109, we estimated 206,325,645 HOPD visits annually that would have resulted in screening once the measure became mandatory. Therefore, for all participating HOPDs, we estimate removal of this measure will decrease burden for voluntary reporting for the CY 2025 reporting period by approximately 1,719,380 hours for 51,581,411 patients (0.033 hours x 206,325,645 patients x 50 percent response rate x 50 percent of HOPDs) at a savings of $44,067,709 (1,719,380 hours x $25.63/hour). For mandatory reporting beginning with the CY 2026 reporting period, we estimate a decrease in burden of 6,877,522 hours (206,325,645 patients x 0.033 hours per patient) at a savings of $176,270,889 (6,877,522 hours x $25.63/hour). With regard to measure reporting, we estimate a decrease in burden of 267 hours (3,200 HOPDs x 50 percent of HOPDs x 0.167 hours per HOPD) at a savings of $14,701 (267 hours x $55.06/hour) for voluntary reporting for the CY 2025 reporting period and 533 hours annually (0.167 hours x 3,200 HOPDs) at a savings of $29,347 (533 hours x $55.06/hour) for mandatory reporting beginning with the CY 2026 reporting period.
We did not receive public comments on this burden estimate. 5. Information Collection Burden Estimate for the Removal of the Screen Positive Rate for SDOH Measure Beginning With the CY 2025 Reporting Period
In section XIV.C.3. of this final rule with comment period, we are removing the Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period. For this measure, HOPDs are required to report on an annual basis the number of patients who screen positive for one or more of the five SDOH domains divided by the total number of patients screened (reported as five separate rates). We previously estimated each HOPD requires 10 minutes (0.167 hours) annually to report this measure. Therefore, we estimate removal of this measure will decrease burden by 267 hours (3,200 HOPDs x 50 percent of HOPDs x 0.167 hours per HOPD) at a savings of $14,701 (267 hours x $55.06/hour) for voluntary reporting for the CY 2025 reporting period and 533 hours annually (0.167 hours x 3,200 HOPDs) at a savings of $29,347 (533 hours x $55.06/hour) for mandatory reporting beginning with the CY 2026 reporting period.
We did not receive public comments on this burden estimate. 6. Information Collection Burden Estimate for the Adoption of the Emergency Care Access & Timeliness eCQM With Voluntary Reporting for the CY 2027 Reporting Period, Followed by Mandatory Reporting Beginning With the CY 2028 Reporting Period/CY 2030 Payment Determination
As discussed in section XV.B.1. of this final rule with comment period, we are adopting the Emergency Care Access & Timeliness eCQM beginning with voluntary reporting for the CY 2027 reporting period, followed by mandatory reporting beginning with the CY 2028 reporting period/CY 2030 payment determination. Similar to the information collection burden for the Appropriate Treatment for ST-Segment
Elevation Myocardial Infarction (STEMI) and Excessive Radiation Dose or Inadequate Image Quality for Diagnostic CT in Adults eCQMs currently approved under OMB control number 0938-1109, we assume a Medical Records Specialist will require 10 minutes (0.167 hours) to submit the data required per quarter for each HOPD or 40 minutes (0.67 hours; 10 minutes x 4 quarters) annually. For voluntary reporting for the CY 2027 reporting period, HOPDs will be able to voluntarily submit at least one quarter and up to four quarters of data. For estimation purposes, similar to the assumptions previously used for the STEMI and Excessive Radiation Dose or Inadequate Image Quality for Diagnostic CT in Adults eCQMs, we estimate 20 percent of HOPDs will voluntarily report one quarter of data for the measure in the CY 2027 reporting period, with 100 percent of HOPDs reporting the measure as required in subsequent years (86 FR 63962 and 63963, and 88 FR 82134). For voluntary reporting for the CY 2027 reporting period, we estimate an annual burden for voluntarily participating HOPDs of 107 hours (3,200 HOPDs x 20 percent x 0.167 hours x 1 quarter) at a cost of $5,891 (107 hours x $55.06/ hour). Beginning with the CY 2028 reporting period, we estimate the annual burden for all participating HOPDs to be 2,133 hours (0.67 hours x 3,200 HOPDs) at a cost of $117,443 (2,133 hours x $55.06/hour). With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis in section XXVI. of this final rule with comment period.
We received public comments on these burden estimates. The following is a summary of the comments we received and our responses.
Comment: A commenter asserted that the burden estimate associated with the Emergency Care Access & Timeliness eCQM, and eCQMs in general, includes only the burden associated with the submission of data and does not include the cost or effort associated with other activities such as: education to providers and staff on the impact of the measure on their workflow; modifications to documentation as appropriate; evaluation of measure report details against EHR documentation, especially on fallouts and exclusions to identify opportunities for improved discrete documentation; time needed for review of ONC Project Tracking for ongoing issues identified with the eCQM measures; development of trending and benchmark reports for awareness of reported outcomes prior to submission of data; reprocessing of data when errors have been identified and corrected; and meetings with vendors and IT, quality, leadership, and other staff to assure an understanding of what is reported on Medicare.gov/Care Compare, its impact on public reporting, star reporting, and use by other reporting agencies.
Response: Because we assume the collection of data for eCQMs is already being collected in each HOPD's electronic health record (EHR) system as part of the HOPD's patient workflow, the burden estimates provided in this final rule with comment period include only the time associated with submission of data to CMS. However, as noted in the Regulatory Impact Analysis in section XXVI.C.3.b. of this final rule with comment period, we agree with the commenter that there are additional recurring and non-recurring activities associated with the adoption of new eCQM measures.
After consideration of public comments, we are declining to update our burden estimate. 7. Information Collection Burden Estimate for the Removal of the Median Time From ED Arrival to ED Departure for Discharged ED Patients Measure Beginning With the CY 2028 Reporting Period/CY 2030 Payment Determination
As discussed in section XV.B.2. of this final rule with comment period, we are removing the Median Time from ED Arrival to ED Departure for Discharged ED Patients measure beginning with the CY 2028 reporting period/CY 2030 payment determination, when reporting for the Emergency Care Access & Timeliness eCQM becomes mandatory. The information collection burden associated with this measure is currently approved under OMB control number 0938-1109. The currently approved information collection burden estimate for this measure assumes an average of 289 cases are reported annually per HOPD, and HOPDs require approximately 2.9 minutes (0.049 hours) per case to perform the necessary chart abstraction and report measure data. Therefore, we estimate removal of this measure will decrease burden by approximately 14.2 hours (0.049 hours x 289 cases) at a savings of $782 per HOPD (14.2 hours x $55.06/ hour). Therefore, for all participating HOPDs, we estimate a decrease in annual burden of 45,440 hours (14.2 hours per HOPD x 3,200 HOPDs) at a savings of $2,501,926 (45,440 hours x $55.06/hour).
We did not receive public comments on this burden estimate. 8. Information Collection Burden Estimate for the Removal of the Left Without Being Seen Measure Beginning With the CY 2028 Reporting Period/ CY 2030 Payment Determination
As discussed in section XV.B.2. of this final rule with comment period, we are removing the Left Without Being Seen measure beginning with the CY 2028 reporting period/CY 2030 payment determination, when reporting for the Emergency Care Access & Timeliness eCQM becomes mandatory. The information collection burden associated with this measure is currently approved under OMB control number 0938-1109. The currently approved information collection burden estimate for this measure assumes HOPDs spend approximately 10 minutes (0.167 hours) annually to report measure data. Therefore, for all participating HOPDs, we estimate removal of this measure will decrease burden by approximately 533 hours (0.167 hours x 3,200 HOPDs) at a savings of $29,347 (533 hours x $55.06/hour).
We did not receive public comments on this burden estimate. 9. Information Collection Burden Estimate To Modify the Excessive Radiation eCQM From Mandatory Reporting Beginning With the CY 2027 Reporting Period To Continue Voluntary Reporting in the CY 2027 Reporting Period and Subsequent Years
As discussed in section XV.B.3. of this final rule with comment period, we are modifying the reporting requirements for the Excessive Radiation eCQM by maintaining voluntary reporting instead of mandatory reporting of the measure, beginning with the CY 2027 reporting period. The information collection burden associated with this measure is currently approved under OMB control number 0938-1109 and estimates HOPDs spend approximately 10 minutes (0.167 hours) per quarter annually to report measure data. In the CY 2024 OPPS/ASC final rule with comment period, where we adopted the Excessive Radiation eCQM beginning with voluntary reporting in the CY 2026 reporting period, we estimated that 20 percent of hospitals will voluntarily report one quarter of data for the measure and 100 percent of hospitals would report data for the measure once mandatory reporting began with the CY 2027 reporting period/CY 2029 payment determination. We also finalized to gradually increase the number of quarters of data hospitals would be required to report on the measure
starting with two self-selected quarters for the CY 2027 reporting period/CY 2029 payment determination, and all four quarters for the CY 2028 reporting period/CY 2030 payment determination (88 FR 82134).
Because HOPDs will no longer be required to report this measure under the modification to extend voluntary reporting beginning with the CY 2027 reporting period, we estimate the revised data submission burden, reflecting 20 percent of hospitals voluntarily reporting, will be 107 hours (3,200 HOPDs x 20 percent x 0.167 hours x 1 quarter) at a cost of $5,891 (107 hours x $55.06/hour) annually. This updated burden estimate is a decrease of 960 hours [(3,200 HOPDs x 0.167 hours x 2 quarters)-(3,200 HOPDs x 20 percent x 0.167 hours x 1 quarter)] at a savings of $52,858 (960 hours x $55.06) for the CY 2027 reporting period, and a decrease of 2,027 hours [(3,200 HOPDs x 20 percent x 0.167 hours x 3 quarters) + (3,200 HOPDs x 80 percent x 0.167 hours x 4 quarters)] at a savings of $111,607 (2,027 hours x $55.06/hour) annually beginning with the CY 2028 reporting period.
In addition, for this measure as described under OMB control number 0938-1109, participating HOPDs must follow the process for running their chosen vendor's translation software prior to sending data to its EHR for measure calculation and reporting. We estimate participating HOPDs spend approximately 15 minutes (0.25 hours) annually to conduct these activities prior to data submission. Therefore, for all participating HOPDs, we estimate modification of this measure from mandatory to voluntary reporting will decrease annual burden associated with these activities by approximately 640 hours (0.25 hours x 80 percent x 3,200 HOPDs) at a savings of $35,238 (640 hours x $55.06/ hour) beginning with the CY 2027 reporting period.
We received public comments on these burden estimates. The following is a summary of the comments we received and our responses.
Comment: A commenter stated their opinion that the burden estimate associated with the Excessive Radiation eCQM includes only the burden associated with the submission of data and does not include the cost or effort associated with other activities such as: contracted physicist time for scanner reconfiguration and validation; health information system, radiology information system, and EHR modifications to create separate low-, routine-, and high-dose orderable exams; radiologist and technologist labor for workflow redesign and training; IT integration across picture archiving and communication systems, dose monitoring systems, and reporting vendors; and scanner manufacturer support to ensure redesigned protocols remain consistent with each scanner's technology and capability. The commenter further noted that first-year costs associated with these activities range between $20,000 and $50,000 with additional annual expenses incurred thereafter.
Response: Reporting on this measure will continue to be voluntary, and as such HOPDs can determine their readiness to implement any changes necessary if they elect to report on this measure. Because we assume the collection of data for eCQMs is already being collected in each HOPD's EHR system as part of the HOPD's patient workflow, the burden estimates provided in this final rule with comment period include only the time associated with submission of data to CMS. However, as noted in the Regulatory Impact Analysis in section XXVI.C.3.b. of this final rule with comment period, we agree with the commenter that there are additional recurring and non-recurring activities associated with adoption of new eCQM measures.
After consideration of public comments, we are declining to update our burden estimate. 10. Summary of Information Collection Burden Estimates for the Hospital OQR Program
Tables 146 through 150 summarizes the information collection burden changes under OMB control number 0938-1109 (expiration date January 1, 2026). We estimate that removal of the COVID-19 Vaccination Coverage Among HCP measure in this final rule with comment period will result in a decrease in information collection burden of between 25,600 hours at a savings of $1,446,400 and 28,800 hours at a savings of $1,687,680 under OMB control number 0920-1317. We also estimate that the remaining measure removals, adoptions, and modifications in this final rule with comment period will result in a decrease in information collection burden of 6,924,988 hours at a savings of $178,884,367 annually for all 3,200 program-eligible HOPDs from the CY 2025 reporting period/CY 2027 payment determination through the CY 2028 reporting period/CY 2030 payment determination. We submitted the revised information collection estimates to OMB for approval under OMB control number 0938-1109. With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis in section XXVI.C.3 of this final rule with comment period.
We invited public comments on the information collection requirements and whether our estimated burden is a reasonable estimate but did not receive any comments other than those previously discussed. BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
B. ICRs for the Rural Emergency Hospital Quality Reporting (REHQR) Program
1. Background
In sections XIV. and XVI. of this final rule with comment period, we discuss the finalized changes to requirements for the REHQR Program. The REHQR Program is generally aligned with the CMS quality reporting program for HOPDs, known as the Hospital OQR Program. We refer readers to the CY 2025 OPPS/ASC final rule with comment period (89 FR 94530 through 94533) for detailed discussions of the previously finalized REHQR Program ICRs, which have been submitted for OMB approval under OMB control number 0938-1454 (expiration date April 30, 2027).
We are: (1) removing the HCHE measure beginning with the CY 2025 reporting period/CY 2027 program determination; (2) removing the Screening for SDOH measure beginning with the CY 2025 reporting period; (3) removing the Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period; and (4) adopting the Emergency Care Access & Timeliness eCQM beginning with the CY 2027 reporting period/CY 2029 program determination as an optional measure. In section XIV.D. of this final rule with comment period, we are also updating our Extraordinary Circumstances Exception (ECE) Policy for the REHQR Program. This update will explicitly include extensions as a type of extraordinary circumstances relief option, in addition to exceptions. Because the process for requesting or granting an ECE will remain the same as the current ECE process, these updates will not affect burden associated with the submission of the ECE form.
In the CY 2025 OPPS/ASC final rule with comment period, we calculated reporting burden estimates for the REHQR Program by utilizing the BLS mean hourly wage rate for Medical Records Specialists (89 FR 94530). Specifically, we used the industry-specific wage for Medical Records Specialists working in “general medical and surgical hospitals,” as this categorization aligns the closest with the REHQR Program care setting. The most recent data from BLS' May 2024 National Occupational Employment and Wage Estimates reflects a median hourly wage of $27.53 per hour for Medical Records Specialists working in “general medical and surgical hospitals” (SOC 29-2072).\518\ We calculated the cost of overhead, including fringe benefits, at 100 percent of the median 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 ($27.53 x 2 = $55.06) to estimate total cost is a reasonably accurate estimation method. Accordingly, unless otherwise specified, we will calculate cost burden to REHs using a wage plus benefits estimate of $55.06 per hour throughout the discussion in this section of this rule for the REHQR Program.
\518\ U.S. Bureau of Labor Statistics. (2025). Occupational Outlook Handbook, Medical Records Specialists. Available at https://data.bls.gov/oes/#/industry/622100. Accessed: June 24, 2025.
In the CY 2025 OPPS/ASC final rule with comment period, our burden estimates were based on the 33 acute care and critical access hospital conversions to REH status as of September 27, 2024 (89 FR 94530). For this final rule with comment period, based on the actual number of acute care and critical access hospital conversions to REH status as of April 11, 2025, we estimate that 38 REHs will report data to the REHQR Program during the CY 2026 reporting period unless otherwise noted. While the exact number of REHs required to submit data may vary due to status changes to and from an REH, as reiterated in section XVI. of this final rule with comment period, REHs are required by statute to submit quality data. Therefore, for purposes of estimating burden, we assume that all 38 REHs will submit data under the REHQR Program for the CY 2026 reporting period and future years. 2. Information Collection Burden Estimate for the Removal of the HCHE Measure Beginning With the CY 2025 Reporting Period/CY 2027 Program Determination
As discussed in section XIV.C.2. of this final rule with comment period, we are removing the HCHE measure beginning with the CY 2025 reporting
period/CY 2027 program determination. The information collection burden associated with this measure is currently approved under OMB control number 0938-1454. The currently approved information collection burden estimate for this measure assumes REHs spend approximately 10 minutes (0.167 hours) annually to report measure data. Therefore, for all participating REHs, we estimate removal of this measure will decrease burden by approximately 6 hours (0.167 hours x 38 REHs) at a savings of $349 (6 hours x $55.06/hour).
We did not receive public comments on this burden estimate. 3. Information Collection Burden Estimate for the Removal of the Screening for SDOH Measure Beginning With the CY 2025 Reporting Period
In section XIV.C.3. of this final rule with comment period, we are removing the Screening for SDOH measure beginning with the CY 2025 reporting period. 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 have previously estimated 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.
We determine the cost for patients (or their representative) to complete the screening using a post-tax wage of $25.63/hour based on assumptions from the report “Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices,” which identifies an approach for valuing time when individuals undertake administrative and other tasks on their own time.\519\ 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.\520\ 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,\521\ 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.
\519\ Office of the Assistant Secretary for Planning and Evaluation. (2017). Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices. Available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework. Accessed: June 24, 2025.
\520\ Bureau of Labor and Statistics. (2025). Usual Weekly Earnings of Wage and Salary Workers, Fourth Quarter 2025. Available at https://www.bls.gov/news.release/pdf/wkyeng.pdf. Accessed: March 3, 2025.
\521\ Guzman, G. & Kollatr, M. (2024). Income in the United States: 2023. Available at https://www2.census.gov/library/publications/2024/demo/p60-282.pdf. Accessed: June 24, 2025.
Under OMB control number 0938-1454, we estimated 11,798 patients annually would have been screened per REH when reporting on the measure became mandatory. For voluntary reporting in the CY 2025 reporting period, we estimate that 50 percent of REHs will survey 50 percent of patients. Therefore, for all participating REHs with regard to patient screening, we estimate removal of this measure will decrease burden for voluntary reporting for the CY 2025 reporting period by 3,699 hours for 112,081 patients (0.033 hours x 11,798 patients x 50 percent response rate x 19 REHs) at a savings of $94,797 (3,699 hours x $25.63/hour). For mandatory reporting beginning with the CY 2026 reporting period, we estimate a decrease in burden of 14,795 hours (448,324 patients x 0.033 hours per patient) at a savings of $379,188 (14,795 hours x $25.63/ hour). With regard to measure reporting, we estimate a decrease in burden of 3 hours (38 REHs x 50 percent of REHs x 0.167 hours per REH) at a savings of $175 (3 hours x $55.06/hour) for voluntary reporting for the CY 2025 reporting period and 6 hours annually (38 REHs x 0.167 hours) at a savings of $349 (6 hours x $55.06/hour) for mandatory reporting beginning with the CY 2026 reporting period.
We did not receive public comments on this burden estimate. 4. Information Collection Burden Estimate for the Removal of the Screen Positive Rate for SDOH Measure Beginning With the CY 2025 Reporting Period
In section XIV.C.3. of this final rule with comment period, we are removing the Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period. For this measure, REHs are required to report on an annual basis the number of patients who screen positive for one or more of the five SDOH domains divided by the total number of patients screened (reported as five separate rates). We previously estimated each REH requires 10 minutes (0.167 hours) annually to report this measure. Therefore, we estimate the removal of this measure will decrease burden by 3 hours (38 REHs x 50 percent of REHs x 0.167 hours) at a savings of $175 (3 hours x $55.06/hour) for voluntary reporting for the CY 2025reporting period and 6 hours (38 REHs x 0.167 hours) at a savings of $349 (6 hours x $55.06/hour) annually for mandatory reporting beginning with the CY 2026 reporting period.
We did not receive public comments on this burden estimate. 5. Information Collection Burden Estimate for the Adoption of the Emergency Care Access & Timeliness eCQM Beginning With the CY 2027 Reporting Period/CY 2029 Program Determination
As discussed in section XVI.B.1. of this final rule with comment period, we are adopting the Emergency Care Access & Timeliness eCQM beginning with the CY 2027 reporting period/CY 2029 program determination. We refer readers to the discussion of information collection burden associated with the proposal to adopt a similar measure for the Hospital OQR Program in section XXIII.A.6. of this final rule with comment period. Because this will be the first eCQM adopted in the REHQR Program, we are also finalizing that REHs will be provided with the option of reporting either the Median Time for Discharged ED Patients measure or the Emergency Care Access & Timeliness eCQM to meet program requirements. We assume a Medical Records Specialist will require 10 minutes (0.167 hours) to submit the data required per quarter for each REH, therefore, for each REH that elects to report the Emergency Care Access & Timeliness eCQM, we estimate an annual burden of 40 minutes (0.67 hours; 10 minutes x 4 quarters) annually at a cost of $36.92 (0.67 hours x $55.06/hour). Because we are currently unable to estimate the number of REHs that will elect to report the Emergency Care Access & Timeliness eCQM instead of the Median Time for Discharged ED Patients measure, we base our estimate of total burden for the REHQR Program solely on the time to report the Median Time for Discharged ED Patients measure. For reporting the Median Time for Discharged ED Patients measure, we have previously estimated that a Medical Records Specialist would require 12.2 hours per REH annually or 464 hours (12.2 hours x 38 REHs) at a cost of $25,526 (464 hours x $55.06/hour) across all REHs.
We received public comments on this burden estimate. The following is a summary of the comments we received and our responses.
Comment: A commenter stated their opinion that the burden estimate associated with the Emergency Care Access & Timeliness eCQM and eCQMs in general includes only the burden associated with the submission of data and does not include the cost or effort associated with other activities such as: education to impacted providers and staff on the impact of the measure on their workflow; modifications to documentation as appropriate; evaluation of measure report details against EHR documentation, especially on fallouts and exclusions to identify opportunities for improved discrete documentation; time needed for review of ONC Project Tracking for ongoing issues identified with the eCQM measures; development of trending and benchmark reports for awareness of reported outcomes prior to submission of data; reprocessing of data when errors have been identified and corrected; and meetings with vendors and IT, quality, leadership, and other staff to assure an understanding of what is reported on Medicare.gov/Care Compare, its impact on public reporting, star reporting, and use by other reporting agencies.
Response: Because we assume the collection of data for eCQMs is already being collected in each REH's EHR system as part of the REH's patient workflow, the burden estimates provided in this final rule include only the time associated with submission of data to CMS. However, as noted in the Regulatory Impact Analysis in section XXVI.C.4.b. of this final rule with comment period, we agree with the commenter that there are additional recurring and non-recurring activities associated with adoption of new eCQM measures.
After consideration of public comments, we are declining to update our burden estimate. 6. Summary of Information Collection Burden Estimates for the REHQR Program
Tables 151 through 153 summarizes the information collection burden changes for the REHQR Program. We estimate that the measure adoptions and removals in this final rule with comment period will result in a decrease of 14,813 hours at a savings of $380,235 for 38 REHs annually from the CY 2025 reporting period through the CY 2027 reporting period. We submitted these information collection estimates to OMB for approval under OMB control number 0938-1454. With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis in section XXVI.C.4. of this final rule with comment period.
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C. ICRs for the Ambulatory Surgical Center Quality Reporting (ASCQR) Program
1. Background
In sections XIV. and XVII. of this final rule with comment period, we discuss the finalized requirements for the ASCQR Program. We refer readers to the CY 2025 OPPS/ASC final rule with comment period (89 FR 94533 through 94537) for detail regarding the previously finalized ASCQR Program ICRs which are currently approved under OMB control number 0938-1270 (expiration date July 31, 2027).
We are: (1) removing the COVID-19 Vaccination Coverage Among HCP measure beginning with the CY 2024 reporting period/CY 2026 payment determination; (2) removing the Facility Commitment to Health Equity (FCHE) measure beginning with the CY 2025 reporting period/CY 2027 payment determination; (3) removing the Screening for SDOH measure beginning with the CY 2025 reporting period; and (4) removing the Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period. We are not finalizing the Patient Understanding of Key Information Related to Recovery After a Facility-Based Outpatient Procedure or Surgery, Patient Reported Outcome-Based Performance measure (Information Transfer PRO-PM).
In section XIV.D. of this final rule with comment period, we are also updating our Extraordinary Circumstances Exception (ECE) Policy for the ASCQR Program. This update will explicitly include extensions as a type of extraordinary circumstances relief option, in addition to exceptions. Because the process for requesting or granting an ECE will remain the same as the current ECE process, these updates will not affect burden associated with the submission of the ECE form.
In the CY 2025 OPPS/ASC final rule with comment period, we calculated reporting burden estimates for the ASCQR Program by utilizing the BLS mean hourly wage rate for Medical Records Specialists (89 FR 94534). Specifically, we used the industry-specific wage for Medical Records Specialists working in the “general medical and surgical hospitals”
industry, as this categorization aligns the closest with the ASCQR Program care setting. The most recent data from BLS' May 2024 National Occupational Employment and Wage Estimates reflects a median hourly wage of $27.53 per hour for Medical Records Specialists working in “general medical and surgical hospitals” (SOC 29-2072).\522\ We calculated the cost of overhead, including fringe benefits, at 100 percent of the median 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, doubling the hourly wage rate ($27.53 x 2 = $55.06) to estimate total cost is a reasonably accurate estimation method. Accordingly, unless otherwise specified, we will calculate cost burden to ASCs using a wage plus benefits estimate of $55.06 per hour throughout the discussion in this section of this rule for the ASCQR Program.
\522\ U.S. Bureau of Labor Statistics. (2025). Occupational Outlook Handbook, Medical Records Specialists. Available at: https://data.bls.gov/oes/#/industry/622100. Accessed: April 8, 2025.
Based on the most recent analysis of the CY 2025 payment determination data, we found that, of the 6,012 ASCs that were actively billing Medicare, 4,271 were required to participate in the ASCQR Program. Of the 1,741 ASCs not required to participate in the program, 319 ASCs did so and met full requirements. On this basis, we estimate that 4,590 ASCs (4,271 + 319) will submit data for the ASCQR Program for the CY 2026 reporting period/CY 2028 payment determination and future years.
We received public comments on these burden estimates. The following is a summary of the comments we received and our responses.
Comment: A commenter stated their opinion that CMS' estimate of the costs associated with implementing the Information Transfer PRO-PM are too low and does not believe the utility of the measure is outweighed by the burden.
Response: We thank the commenter for its comment and note that we are not finalizing the Information Transfer PRO-PM measure. 2. Information Collection Burden Estimate for the Removal of the COVID- 19 Vaccination Coverage Among HCP Measure Beginning With CY 2024 Reporting Period/CY 2026 Payment Determination
As discussed in section XIV.C.1. of this final rule with comment period, we are removing the COVID-19 Vaccination Coverage Among HCP measure beginning with the CY 2024 reporting period/CY 2026 payment determination. The information collection burden associated with this measure is currently approved under OMB control number 0920-1317.
To report this measure, ASCs have the option to manually enter data directly into CDC's NHSN web-based application or to upload a CSV file. CDC estimates that each ASC 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 will be completed by a Microbiologist with a wage rate of $58.60/hour and uploading of a CSV file would be completed by an Information Technologist with a wage rate of $56.50/hour. Therefore, we estimate that this proposal will result in a decrease in burden of between 36,720 hours (0.67 hours x 12 months x 4,590 ASCs) at a savings of $2,074,680 (36,720 hours x $56.50/hour) and 41,310 hours (0.75 hours x 12 months x 4,590 ASCs) at a savings of $2,420,766 (41,310 hours x $58.60/hour) annually across all 4,590 ASCs under OMB control number 0920-1317.
We did not receive public comments on this burden estimate. 3. Information Collection Burden Estimate for the Removal of the FCHE Measure Beginning With the CY 2025 Reporting Period/CY 2027 Payment Determination
As discussed in section XIV.C.2. of this final rule with comment period, we are removing the FCHE measure beginning with the CY 2025 reporting period/CY 2027 payment determination. The information collection burden associated with this measure is currently approved under OMB control number 0938-1270.
The currently approved information collection burden estimate for this measure assumes ASCs spend approximately 10 minutes (0.167 hours) annually to report measure data. Therefore, for all participating ASCs, we estimate removal of this measure will decrease burden by approximately 765 hours (0.167 hours x 4,590 ASCs) at a savings of $42,121 (765 hours x $55.06/hour).
We did not receive public comments on this burden estimate. 4. Information Collection Burden Estimate for the Removal of the Screening for SDOH Measure Beginning With the CY 2025 Reporting Period
In section XIV.C.3. of this final rule with comment period, we are removing the Screening for SDOH measure beginning with the CY 2025 reporting period. There are two components to this measure's burden calculation: patient screening for five health related social needs domains and ASC submission of aggregated ASC-level measure data. We previously estimated each patient requires 2 minutes (0.033 hours) to complete the screening and each ASC requires 10 minutes (0.167 hours) annually to report this measure. We determine the cost for patients (or their representative) to complete the screening using a post-tax wage of $25.63/hour based on assumptions from 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 administrative and other tasks on their own time.\523\ 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.\524\ 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,\525\ 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.
\523\ Office of the Assistant Secretary for Planning and Evaluation. (2017). Valuing Time in U.S. Department of Health and Human Services Regulatory Impact Analyses: Conceptual Framework and Best Practices. Available at https://aspe.hhs.gov/reports/valuing-time-us-department-health-human-services-regulatory-impact-analyses-conceptual-framework. Accessed: June 24, 2025.
\524\ Bureau of Labor and Statistics. (2025). Usual Weekly Earnings of Wage and Salary Workers, Fourth Quarter 2025. Available at https://www.bls.gov/news.release/pdf/wkyeng.pdf. Accessed: March 3, 2025.
\525\ Guzman, G. & Kollatr, M. (2024). Income in the United States: 2023. Available at https://www2.census.gov/library/publications/2024/demo/p60-282.pdf. Accessed: June 24, 2025.
Under OMB control number 0938-1270, we estimated an average of 4,765 patients per ASC annually would have been screened once the measure became mandatory. Therefore, consistent with
the burden estimates for this measure under OMB control number 0938- 1270, for all participating ASCs with regard to patient screening, we estimate removal of this measure will decrease burden for voluntary reporting for the CY 2025 reporting period by approximately 182,262 hours for 5,467,838 patients (0.033 hours x 4,765 patients x 50 percent response rate x 4,590 ASCs x 50 percent of ASCs) at a savings of $4,671,375 (182,262 hours x $25.63/hour). Beginning with the mandatory reporting for the CY 2026 reporting period, we estimate a decrease in burden of approximately 729,045 hours for 21,871,350 patients (4,765 patients x 4,590 ASCs x 0.033 hours per patient) at a savings of $18,685,423 (729,045 hours x $25.63/hour). With regard to measure reporting, we estimate the removal of this measure will decrease burden for voluntary reporting for the CY 2025 reporting period by 383 hours (4,590 ASCs x 50 percent of ASCs x 0.167 hours per ASC) at a savings of $21,088 (383 hours x $55.06/hour) and 765 hours annually (0.167 hours x 4,590 ASCs) at a savings of $42,121 (765 hours x $55.06/hour) for mandatory reporting beginning with the CY 2026 reporting period.
We did not receive public comments on this burden estimate. 5. Information Collection Burden Estimate for the Removal of the Screen Positive Rate for SDOH Measure Beginning With the CY 2025 Reporting Period
In section XIV.C.3. of this final rule with comment period, we are removing the Screen Positive Rate for SDOH measure beginning with the CY 2025 reporting period. For this measure, ASCs are required to report on an annual basis the number of patients who screen positive for one or more of the five SDOH domains divided by the total number of patients screened (reported as five separate rates). We previously estimated each ASC requires 10 minutes (0.167 hours) annually to report this measure. Therefore, consistent with the burden estimates for this measure under OMB control number 0938-1270, we estimate the removal of this measure will decrease burden for voluntary reporting for the CY 2025 reporting period by 383 hours (4,590 ASCs x 50 percent of ASCs x 0.167 hours per ASC) at a savings of $21,088 (383 hours x $55.06/hour) and 765 hours annually (0.167 hours x 4,590 ASCs) at a savings of $42,121 (765 hours x $55.06/hour) for mandatory reporting beginning with the CY 2026 reporting period.
We did not receive public comments on this burden estimate. 6. Summary of Information Collection Burden Estimates for the ASCQR Program
Tables 154 through 158 summarizes the information collection burden changes for OMB control number 0938-1270 (expiration date July 31, 2027). We estimate that the removal of the COVID-19 Vaccination Coverage Among HCP Measure in this final rule with comment period will result in a decrease in information collection burden of between 36,720 hours at a savings of $2,074,680 and 41,310 hours at a savings of $2,420,766 under OMB control number 0920-1317. We also estimate that the remaining measure removals and adoptions in this final rule with comment period will result in an overall decrease in information collection burden of 731,340 hours at a savings of $18,811,786 annually for all 4,590 program-eligible ASCs from the CY 2025 reporting period/ CY 2027 payment determination through the CY 2029 reporting period/CY 2031 payment determination. We submitted the revised information collection estimates to OMB for approval under OMB control number 0938- 1270. With respect to any costs/burdens unrelated to data submission, we refer readers to the Regulatory Impact Analysis in section XXVI.C.5. of this final rule with comment period.
We invited public comments on the information collection requirements and whether our estimated burden is a reasonable estimate but did not receive any comments other than those previously discussed. BILLING CODE 4120-01-P
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D. Summary of Information Collection Burden Estimates for the Overall Hospital Quality Star Rating
The Overall Hospital Quality Star Rating uses measures that are publicly reported on Hospital Compare or its successor websites under the public reporting authority of each individual hospital program furnishing measure data. The burden associated with measures included in the Overall Hospital Quality Star Rating, including requesting withholding of measures from public reporting, is already captured in the respective hospital programs' ICRs and represents no increased information collection burden to hospitals.
Therefore, as the Overall Hospital Quality Star Rating utilizes output data from CMS hospital quality and payment programs, there is no additional information collection burden. The burden is accounted for under OMB control numbers 0938-1109, 0938-1022, 0938-1352, 0920-0666, 0938-0981, 0938-1240 and 0938-1197.
E. ICRs for Payer-Specific Negotiated Charges Data Collection
Section XX. of this final rule with comment period discusses the collection of market-based payment rate information by MS-DRG on the Medicare cost report for cost reporting periods ending on or after January 1, 2026. Hospitals would report the median payer-specific negotiated charge by MS-DRG for payers that are Medicare Advantage Organization (MAOs). We proposed to collect this market-based information on new worksheet Supplemental to Form CMS-2552-10, Weighted Median MAO Payer-Specific Negotiated Charge Data Worksheet. This new information collection request will be submitted to OMB for review under control number 0938-1486 (CMS-10935). The OMB control number will not be valid until formally approved by OMB.
As described further in section XX.C.3. of this final rule with comment period, for the purposes of reporting the data on the cost report, we proposed and are finalizing that hospitals would report the median of the payer-specific negotiated charges for an MS-DRG that the hospital has disclosed for all of its MAOs on the most recent version of the MRF that the hospital is required to disclose under the hospital price transparency regulations. We believe reporting this market-based information would result in less burden for hospitals given that hospitals are required to make public their payer-specific negotiated charges for the same service packages under the requirements we finalized in the Hospital Price Transparency final rule, which became effective January 1, 2021. We refer readers to the Hospital Price Transparency final rule for the full burden assessment analysis for the requirements set forth within that final rule (84 FR 65524). We also refer readers to section XIX. of this final rule with comment period, where we discuss our proposal to amend the hospital price transparency regulations at 45 CFR 180 to require that, beginning January 1, 2026, hospitals would report a new data element, the “median allowed amount”, instead of the “estimated allowed amount” reported at present, and that the median allowed amount would be defined as the median of the total allowed amounts that the hospital has historically received from a third-party payer (including MAOs) for an item or service. For purposes of the market-based rate information we proposed to collect on the Medicare cost report, in determining the median of the payer-specific negotiated charges to report on its cost report, we proposed that if the proposal to amend the regulations at 45 CFR 180 was finalized, the “median allowed amount” would be used for instances in which the payer-specific negotiated charge reported on the MRF is based on a percentage or algorithm. Otherwise, we proposed that the “estimated allowed amount” (as defined under current regulations) would be used in determining the median of the payer-specific negotiated charges for instances in which the payer-specific negotiated charge is based on a percentage or algorithm. We note that in section XIX. of this final rule with comment period, CMS is finalizing, that beginning January 1, 2026, if a hospital's payer specific negotiated amount is based on an algorithm or percentage, the hospital would be required to describe the percentage or algorithm and report a new data element, the “median allowed amount”, instead of the “estimated allowed amount”, and that the “median allowed amount” is defined as the median of the total allowed amounts the hospital has historically received from a third-party payer for an item or service for a time period no less than 12 months and no longer than 15 months prior to the date the MRF is posted. Should the calculated median fall between two observed allowed amounts, the median allowed amount is the next highest observed value. In section XIX. of this final rule with comment period, CMS is finalizing as proposed that if a payer-specific negotiated charge is based on a percentage or algorithm, the hospital must describe the algorithm or percentage and calculate and encode the median allowed amount in dollars for that item or service. Finally, in section XIX. of this final rule with comment period, CMS is finalizing, with modification, that hospitals must use EDI 835 ERA transaction data or an alternative equivalent source of remittance data that includes the same information as EDI 835 ERA transaction data would include, to calculate and encode the allowed amounts for items and services based on a percentage or algorithm in the MRF. We refer readers to section XIX. of this final rule with comment period for more information regarding the specific final policy. In the CY 2026 OPPS/ASC proposed rule we stated that we believed that because hospitals would already be required to publicly report the payer-specific negotiated charge information that they would use to calculate these medians, the additional calculation and reporting of the median payer-specific negotiated charge would result in less burden for hospitals than if hospitals did not already have this information compiled to disclose on the MRF under the hospital price transparency requirements. For additional details on hospital price transparency requirements, including MRF requirements and the final modifications to the hospital price transparency requirements, we refer readers to section XIX. of this final rule with comment period and https://www.cms.gov/priorities/key-initiatives/hospital-price-transparency/hospitals.
Burden hours estimate the time (number of hours) required for each IPPS hospital to complete ongoing data gathering and recordkeeping tasks, search existing data resources, review instructions, and complete the Supplemental to Form CMS-2552-10, Weighted Median MAO Payer-Specific Negotiated Charge Data Worksheet. In the CY 2026 OPPS/ ASC proposed rule we stated that the most recent data from the System for Tracking Audit and Reimbursement, an internal CMS data system maintained by the Office of Financial Management (OFM), reported that 3,038 hospitals, the current number of Medicare certified IPPS hospitals, file Form CMS-2552-10 annually.
As discussed in section XX.C.2. of this final rule with comment period, we proposed that subsection (d) hospitals in the 50 states and DC, as defined at section 1886(d)(1)(B) of the Act, and subsection (d) Puerto Rico hospitals, as defined under section 1886(d)(9)(A) of the Act, would be required to report the median payer-specific negotiated charge
information. We proposed that hospitals that do not negotiate payment rates and only receive non-negotiated payments for service would be exempted from this definition. We noted that this proposed data collection requirement would apply to a smaller subset of hospitals as compared to the public reporting requirements under the hospital price transparency regulations. Under our proposal, hospitals that would be exempted from this policy included, Critical Access Hospitals (CAHs), hospitals in Maryland, which are currently paid under the Maryland Total Cost of Care Model, during the performance period of that Model, hospitals operated by an Indian Health Program as defined in section 4(12) of the Indian Health Care Improvement Act, and Federally owned and operated facilities, and non-subsection (d) hospitals. In the CY 2026 OPPS/ASC proposed rule, we also noted that rural emergency hospitals would not be subject to this data collection requirement given that they do not provide inpatient services. Based on this proposal, we estimated that 3,038 hospitals (which excludes hospitals described earlier as being exempted from this proposal) would be required to comply with this market-based data collection requirement.
Based on our understanding of the resources necessary to report this information, in the CY 2026 OPPS/ASC proposed rule we estimated an average annual burden per hospital of 20 hours (5 hours for recordkeeping and 15 hours for reporting) for the Supplemental to Form CMS-2552-10: Weighted Median MAO Payer-Specific Negotiated Charge Data Worksheet. This estimate included effort that would be necessary to crosswalk inpatient discharges to an MS-DRG, specifically if a hospital is not familiar with the MS-DRG classification system, for use in calculating the median payer-specific negotiated charges. In the CY 2026 OPPS/ASC proposed rule we stated that the burden was minimized because the median payer-specific negotiated charge data that we proposed to collect on the Supplemental to Form CMS-2552-10: Weighted Median MAO Payer-Specific Negotiated Charge Data Worksheet is based on payer-specific data that would already be maintained by the hospital, the data from the MRF that hospitals are required to disclose under the hospital price transparency regulations at 45 CFR part 180. In the CY 2026 OPPS/ASC proposed rule we stated we believed that since hospitals assign the underlying ICD-10-CM principal diagnosis, and any other secondary diagnosis codes and ICD-10-PCS procedure codes, which determine how patients are assigned to an MS-DRG, hospitals are able to associate those items and services to MS-DRGs for each discharge. Additionally, hospitals that are not as familiar with MS-DRGs have access to the most current publicly available version of the CMS Grouper used to group ICD-10 codes to MS-DRGs, and are able to use this software to uniformly group inpatient items and services to MS-DRGs, either initially by proactively using the same Grouper version used by CMS, or retrospectively after an inpatient hospital stay, but prior to submitting this information on the hospital cost report.
In the CY 2026 OPPS/ASC proposed rule, we estimated the total annual burden hours as follows: 3,038 hospitals times 20 hours per hospital equals 60,760 annual burden hours.
The 5 hours for recordkeeping include hours for bookkeeping, accounting and auditing clerks; the 15 hours for reporting include accounting and audit professionals' activities. In the CY 2026 OPPS/ASC proposed rule we stated that we believed the basic median calculation would be captured within the recordkeeping portion of this assessment.
Based on the most recent Bureau of Labor Statistics (BLS) in its 2024 Occupation Outlook Handbook, the mean hourly wage for Category 43- 3031 (bookkeeping, accounting and auditing clerks) is $25.01 (https://www.bls.gov/oes/current/oes433031.htm). We added 100 percent of the mean hourly wage to account for fringe and overhead benefits, which calculates to $50.02 ($25.01 + $25.01) and multiplied it by 5 hours, to determine the annual recordkeeping costs per hospital to be $250.10 ($50.02 x 5 hours).
The mean hourly wage for Category 13-2011 (accounting and audit professionals) is $44.96 (www.bls.gov/oes/current/oes132011.htm). We added 100 percent of the mean hourly wage to account for fringe and overhead benefits, which calculates to $89.92 ($44.96 + $44.96) and multiplied it by 15 hours, to determine the annual reporting costs per hospital to be $1,348.80 ($89.92 x 15 hours). We calculated the total annual cost per hospital of $1,598.90 by adding the recordkeeping costs of $250.10 plus the reporting costs of $1,348.80 (Table 157). We estimated the total annual cost to be $4,857,458.20 ($1,598.90 x 3,038 IPPS hospitals) (Table 158). [GRAPHIC] [TIFF OMITTED] TR25NO25.247
[GRAPHIC] [TIFF OMITTED] TR25NO25.248
Comment: Some commenters expressed concern that CMS underestimated the amount of time and burden it will take hospitals to collect, organize, properly format, calculate, update and report the median payer-specific negotiated charges by MS-DRG. According to commenters, the proposal's newly added burden is at odds with the Administration's goal of reducing administrative burden in healthcare. Commenters stated that hospitals cannot complete the task of implementing the reporting requirements themselves, nor have they been able to find vendors capable of accomplishing the task. Commenters noted that a health system operating in numerous States will have multiple contracts for each individual hospital, within each State, and with each payer. Commenters stated that this could result in the system needing to arrange the payer-specific negotiated charges for hundreds of discharges for a given MS-DRG across hundreds of different payer contracts in order to determine the median. Additionally, commenters stated that some MA organizations do not pay based on MS-DRGs and as a result, hospitals will need to calculate an MS-DRG based on the same or similar package of services. Commenters noted that this process becomes even more complicated if MAOs do not pay the hospital based on FFS rates.
According to commenters, the task of tabulating the data required for complying with this proposed policy could encompass reviewing data from thousands of patients from a single hospital taking well over the estimated 20 hours. According to a commenter, even if CMS moved to market-based weights, it would still need cost data for other purposes (outlier payments, new technology add-on payments, etc.) and thus, hospitals would shoulder additional reporting duties rather than any offsetting reduction. According to the commenter, this would create a dual system: cost reports still collecting traditional cost/charge info (for outliers and transparency enforcement) plus this new, additive median price reporting. The commenter stated that this duplication further undermines any claim of burden reduction or simplification.
According to a commenter, each hospital would be required to ensure its chargemaster team, contracting department, and finance staff coordinate to correctly identify all negotiated rates for each MS-DRG across potentially dozens of contracts, then calculate medians (with volume-weighting for each payer's discharges). For hospitals with complex contracts (per diems, etc.), the commenter stated that this means analyzing internal claims data to derive the “allowed amounts” per case and then the median, which it described as an extremely labor- intensive task. According to the commenter, this is an example of new regulation requirements that will divert critically needed resources to administrative tasks that do not benefit patients. The commenter stated that every hour staff spend on this reporting is an hour not spent on patient care improvement, revenue cycle for actual claims, or compliance with existing requirements. The commenter stated that this burden is especially onerous for smaller and rural hospitals that have fewer staff and already face compliance challenges and limited resources and it is precisely those hospitals that often have less sophisticated contracting (or more capitated arrangements) and will struggle to compute medians from messy data.
One commenter stated that they simply do not have the manpower to perform this collection and would need to contract this out to a third- party vendor leading to a cost of $32,000 a year. The commenter also stated that this would cause an increase in employee time for coordinating data capture and ensuring quality data and that the cost would continue to increase as well because of the complexity of the requirements and the resources to create the data.
Some commenters recommended CMS collect MA negotiated data from hospital or payor websites via MRFs or gather it directly since CMS already contracts with MAO plans, rather than requiring hospitals to extract and re-report the same information on the cost report, to avoid unnecessary administrative burden.
Response: We continue to note as discussed in the CY 2026 OPPS/ASC proposed rule that under the Hospital Price Transparency requirements hospitals are already required to publicly report the payer-specific negotiated charge information that they will use to calculate median payer-specific negotiated charges by MS-DRG for payers that are MA organizations. We therefore continue to believe that the additional calculation and reporting requirements in this final rule with comment period for this policy would result in less burden overall for hospitals absent those price transparency requirements since hospitals will already have the initial data compiled and the incremental additional burden of reporting medians by MS-DRG would be limited.
In the CY 2026 OPPS/ASC proposed rule (90 FR 33831), we estimated a total annual burden to hospitals of 20 hours per hospital: 5 hours for recordkeeping, including hours for bookkeeping, accounting and auditing clerks; and 15 hours for reporting, including accounting and audit professionals' activities. We acknowledge that different hospitals may face more or less
burden and do not assert that the total annual burden for every hospital will be precisely 20 hours, but we continue to believe that the 20 hour estimate per hospital for this data collection is reasonable given that hospitals will already be required to disclose the data used to calculate the median payer-specific negotiated charges under the Hospital Price Transparency requirements. We estimated an initial annual burden of 60,760 annual burden hours for 3,038 hospitals, at cost of $1,598.90 per hospital, or $4,857,458.20 across all hospitals. Although commenters did not agree with our proposed burden estimate for cost and hours, they did not provide additional information, to include a breakdown of tasks and hours estimates across hospitals, to support a burden estimate revision. In addition, we note that in response to comments in the FY 2021 IPPS/LTCH PPS final rule (85 FR 59015 through 59016), we increased the burden estimate from 15 hours to 20 hours after consideration of comments stating that additional effort would be necessary to crosswalk discharges to an MS- DRG, specifically if a hospital is not familiar with the MS-DRG classification system, for use in calculating the median payer-specific negotiated charges. In light of this prior burden estimate revision to account for the additional effort that commenters stated would be necessary to crosswalk discharges to an MS-DRG, and since hospitals are already required to publicly report the payer-specific negotiated charge information which they will use to calculate these medians, in accordance with the Hospital Price Transparency requirements in effect at the time that this data collection requirement goes into effect, we continue to believe that the burden estimate is reasonable. As noted earlier, we continue to believe that the additional calculation and reporting of the median payer-specific negotiated charge will result in less administrative burden overall for hospitals than in the absence of the Hospital Price Transparency requirements since hospitals are already required to have this information compiled and the burden associated with that compilation is already assumed.
In response to the comments recommending CMS collect MA negotiated data from hospital or payor websites via MRFs or gather it directly, we believe hospitals are more familiar with their own data and are best positioned to calculate the medians across payers.
In summary, for the reasons discussed we are maintaining our estimate for the hours associated with recordkeeping at 5 and our estimate of hours associated with reporting at 15, which equals 20 hours of annual burden per hospital and 60,760 hours of estimated annual burden across all 3,038 hospitals. This equals a cost of $1,598.90 per hospital, or $4,857,458.20 across all hospitals.
F. ICRs for Medicare OPPS Drug Acquisition Cost Survey
a. Background
In section V.C. of this final rule with comment period, we discuss our intent to conduct a survey of hospitals' drug acquisition costs. Section 1833(t)(14)(A)(iii) of the Act required the Secretary to set payment rates for specified covered outpatient drugs (SCODs) \526\ beginning in 2006 at the amount the Secretary determined to be the average acquisition cost for the drug for that year, at least when certain hospital acquisition cost survey data is available. To collect the cost survey data for the Secretary to use for 2006 payment rates, section 1833(t)(14)(D)(i)(I) of the Act required the Comptroller General of the U.S. to conduct a survey in each of 2004 and 2005 to determine the hospital acquisition cost for each SCOD. To inform payment rates in later years, section 1833(t)(14)(D)(ii) of the Act requires the Secretary periodically to conduct surveys of hospital acquisition costs for each SCOD.
\526\ For the definition of a SCOD, see section 1833(t)(14)(B) of the Act at https://www.ssa.gov/OP_Home/ssact/title18/1833.htm.
The GAO conducted the required surveys in 2004 and 2005, and, in reporting the results in 2006, recommended that the Secretary thereafter validate, “on an occasional basis--possibly every 5 or 10 years--average sales price (ASP) data that manufacturers report to CMS for developing SCOD payment rates.” \527\ CMS has not, however, conducted its own survey of the acquisition costs for each SCOD for all hospitals paid under the OPPS. Accordingly, under section 1833(t)(14)(D)(ii) of the Act, we intend to conduct a survey, with the survey submission window opening by early CY 2026, of the acquisition costs for each separately payable drug acquired by all hospitals paid under the OPPS. We intend for the survey to be completed in time for the survey results to be used to inform policy making beginning with the CY 2027 OPPS/ASC proposed rule.
\527\ https://www.gao.gov/assets/gao-06-372.pdf.
Additionally, on April 18, 2025, President Trump signed Executive Order (E.O.) 14273, “Lowering Drug Prices by Once Again Putting Americans First.” \528\ Section 5 of the E.O., “Appropriately Accounting for Acquisition Costs of Drugs in Medicare,” directs the Secretary of HHS to publish in the Federal Register a plan to conduct a survey under section 1833(t)(14)(D)(ii) of the Act so he can determine the hospital acquisition cost for covered outpatient drugs at hospital outpatient departments.
\528\ https://www.govinfo.gov/content/pkg/FR-2025-04-18/pdf/2025-06837.pdf.
b. OPPS Drug Acquisition Cost Survey Description and Burden Calculation
From January 1, 2026, through March 31, 2026, we intend to survey hospitals paid under the OPPS for their drug acquisition costs, including for SCODs, and drugs and biologicals CMS historically treats as SCODs. The survey is designed to impose the least amount of burden on hospitals as possible while ensuring we capture the required data to inform payment rates as required by statute. As part of this data collection, we will survey hospitals only about drugs that are separately paid under the OPPS and will ask hospitals to report the total acquisition cost, net of all rebates and discounts, of each drug by National Drug Code (NDC) purchased during the 1-year timeframe of July 1, 2024 through June 30, 2025. We are asking hospitals to incorporate all rebates and discounts in their acquisition cost for each NDC, including discounts directly applicable to an individual NDC, but also those discounts that are not necessarily linked to a single NDC, but could be a discount linked to a certain invoice, or discounts linked to purchases made over a certain time period, such as prompt pay discounts, wholesaler discounts, or other discounts. We understand that certain discounts may depend on whether an eligible patient receives the drug. That is true, for example, for drugs acquired through the 340B program. We are therefore asking for hospitals to separately list their acquisition costs for drug NDCs acquired through the 340B program and those drug NDCs acquired outside of the 340B program to ensure that all discounts are accurately captured and represent the hospital's acquisition costs. In the CY 2026 OPPS/ASC proposed rule, we welcomed comments on whether other common drug discount programs have a similar structure or should otherwise also be separately noted.
There are approximately 700 drug HCPCS codes that will be subject to the survey, with most HCPCS codes having multiple NDCs per HCPCS code. During
the CY 2026 OPPS/ASC proposed rule stage, we published a draft list of the NDCs that would be included in the survey, if finalized, so hospitals would have ample opportunity to review and prepare to report their acquisition costs for those NDCs. We noted there may be slight adjustments to this NDC list, but we expected the final list would be similar to the draft list. We recognized that hospitals may not have acquired all drugs on this list, and hospitals are not expected to provide data for NDCs for which they do not have acquisition cost data. We are collecting acquisition cost data by NDC as we understand most hospitals acquire drugs from wholesalers and manufacturers based on NDCs rather than other identifiers, such as HCPCS billing codes. We expect this method will likely reduce hospital burden, as hospitals can simply report the cost at which they acquired the drug without significant calculations. Additionally, we have designed the survey so that only the total cost and the total units of the drug acquired need to be reported. This means that only two fields of information are required per NDC: total net acquisition cost--non-340B and total units purchased--non-340B. If the same drug NDC is purchased multiple times throughout the given timeframe, only the total cost of all of the drug acquired during the given timeframe plus the total number of units purchased is needed. As we previously discussed, for each NDC, we are asking hospitals to report the total acquisition cost, net of all rebates and discounts, which includes all discounts attributable to each specific NDC as well as those discounts attributable to multiple NDCs. For those discounts received for drugs acquired through the 340B Program, since those discounts may be dependent on whether a 340B eligible patient receives the drug, we are asking for hospitals to separately list their acquisition costs for those drug NDCs acquired through the 340B program and those drug NDCs acquired outside of the 340B program. This means for 340B covered entity hospitals that acquire NDCs through the 340B program, they are to submit up to four fields of information for each NDC depending on their acquisition patterns: total net acquisition cost--non-340B, total units purchased--non-340B, total net acquisition cost 340B, total units purchased 340B.
We will assume the burden of performing any additional calculations. We believe this collection of information is based on common information that the hospital already has in its records from its drug purchase history.
This survey will apply to all hospitals paid under the OPPS, which for purposes of our burden calculations we estimated to be 3,500 hospitals in the CY 2026 OPPS/ASC proposed rule. Based on our understanding of hospital practices, in the CY 2026 OPPS/ASC proposed rule we estimated the total time for each hospital to respond to the survey to be 73.5 hours, which includes time required to review instructions, gather data (including potentially from hospital wholesalers), perform basic addition calculations, and enter data. As previously mentioned, we will take every practical step to streamline the data collection for each hospital.
We estimated 73.5 hours to complete the survey by aggregating time from the four roles that are most likely to be responsible. These roles are described below:
A Top Executive (11-1000) will likely review the survey request and designate a Submitter prior to survey distribution.
A Lawyer (23-1011) will likely review the survey request, the survey, and requirements for compliance.
A Pharmacy Technician (29-1051) will likely register for the module and apply to fill out the survey. Once the survey is distributed, the Pharmacy Technician will review the survey. Then, the Pharmacy Technician will request data from suppliers, and/or pull data from internal systems, ensure data are in the appropriate format, manually enter data OR upload data into system, review data, make corrections as needed, and certify data.
A Pharmacist (29-2052) will likely review the survey request and data that are pulled by the Pharmacy Technician. [GRAPHIC] [TIFF OMITTED] TR25NO25.249
As described in Table 159, we estimated the total burden hours as follows: 3,500 hospitals times 73.5 hours per hospital equals 257,250 hours. We used data from the Occupational Employment and Wage Statistics (Hospital-Specific Wages) \529\ for all
salary estimates. In this regard, the previous table presents the mean hourly wage, the cost of fringe benefits, and the adjusted hourly wage for providers that are responsible for completing the survey. We added 100 percent of the mean hourly wage to account for fringe and overhead benefits.
\529\ https://data.bls.gov/oes/#/industry/622000.
We received public comments on these proposals. We refer readers to section V.C. of this final rule with comment period for the summary of comments and our responses to them. We reiterate below one comment especially relevant to the calculation of burden discussed in this section.
Comment: Many commenters alleged that, given the complexity and scale of the required data collection and analysis, conducting the survey will impose a significant burden on hospitals and that CMS's estimate of that burden grossly underestimates the cost, time and resources that will be necessary to complete the survey. Commenters also stated that CMS is wrong to assume that the reporting will be done by pharmacy technicians and that the survey will actually be completed by pharmacists, which will cost more. One commenter opined that completing the survey would demand the concerted effort of multi- disciplinary teams, including pharmacy, supply chain, finance, legal, and reimbursement professionals, far beyond what pharmacy technicians alone could provide. The commenter stated that CMS's own Information Collection Review document “acknowledges the breadth of the undertaking, but fails to account for the extensive coordination needed with vendors and suppliers, from whom much of the requested data must be sourced. The time and resources required to collect, clean, analyze, and accurately report thousands of distinct drug prices would divert critical personnel from patient care and other essential hospital functions”. Many other commenters also emphasized the point that the cost of completing the survey would come at the expense of the hospital's ability to provide essential care to patients and quoted the GAO's 2006 report to the Congress in which the GAO concluded that the surveys it conducted “created a considerable burden for hospitals” and that to submit the required price data hospitals “had to divert staff from their normal duties, thereby incurring additional costs.” Many commenters stated that the financial burden of completing the survey would be exacerbated by upcoming Medicaid and Medicare reductions under the Inflation Reduction Act.
Response: We have taken the burdens on hospitals of completing the survey and the GAO's conclusions relating to that burden very seriously in the design and implementation of the survey. We have created a survey instrument and survey process that we think will minimize, to the greatest extent possible, the staffing and financial burden on hospitals of collecting and reporting the necessary information to CMS. The survey instrument consists of a streamlined online portal, where hospitals can either directly enter acquisition costs or download and reupload an excel template of acquisition costs. There will be technical assistance available for those with any issues that arise during the submission process. We have taken the feedback from commenters into careful consideration when finalizing the survey tool. We believe future surveys will be periodic in nature, as to limit the burden that hospitals face on a reoccurring basis.
We were persuaded that the role of the pharmacist in the data collection effort may be greater than 1 hour. Therefore, based on comments, we are now estimating 1 working day of 8 hours, for a pharmacist to assist in completing the survey. This is reflected in Table 160. Additionally, reflected in Table 160 is an updated number of total hospitals expected to respond to the survey. This number was determined by assessing which CCNs were paid under the OPPS during the survey period for a drug or biological under the OPPS. Additionally, in the rare event that a hospital is paid under the OPPS, but does not have any acquisition costs for the entire year period that is being surveyed, we'd still expect a submission by the hospital. During the CY 2026 OPPS/ASC proposed rule stage, we published a draft list of the NDCs that would be included in the survey, if finalized, so hospitals would have ample opportunity to review and prepare to report their acquisition costs for those NDCs. We noted there may be slight adjustments to this NDC list, but we expected the final list would be similar to the draft list. We have refined this list by removing certain NDCs that were not separately payable under the OPPS to ensure that we are only surveying necessary drugs.
[GRAPHIC] [TIFF OMITTED] TR25NO25.250
After consideration of public comments as discussed in section V.C. of this final rule with comment period, we are finalizing our intent to conduct a survey of OPPS drug acquisition costs, subject to the clarifications and modifications discussed in this final rule with comment period and outlined in the final package approved by OMB. Based on the updates to the burden calculations in response to commenters, we now estimate the cost per response to be $5,047.15 and the total estimated cost across all survey respondents to be $22,712,175.
This new information collection request will be submitted to OMB for review under control number 0938-1487 (CMS-10931). The OMB control number will not be valid until formally approved by OMB.
G. ICRs for Hospital Price Transparency
In a final rule published in November 2019 (84 FR 65524) (herein referred to as the CY 2020 HPT final rule), we adopted requirements for hospitals to make public their standard charges in two ways: (1) as a comprehensive machine-readable file (MRF); and (2) in a consumer- friendly format. We codified these requirements at 45 CFR 180.50 and 180.60, respectively.
The proposed changes to the information collection request were submitted to OMB for review under control number 0938-1369 (CMS-10707). The previously approved requirements and burden associated with 0938- 1369 lapsed due to administrative oversight. Specifically, CMS failed to submit the revisions to 0938-1369 that pertained to the 2024 hospital price transparency requirements in the CY 2024 OPPS/ASC final rule with comment period (88 FR 81540). Therefore, we included the finalized burden mentioned in the CY 2024 OPPS/ASC final rule with comment period and the new burden associated with the CY 2026 OPPS proposed rule in the request for reinstatement.
In the CY 2020 HPT final rule, we originally estimated the number of hospitals subject to the HPT requirements to be 6,002. We finalized an initial one-time burden of 150 hours and cost of $11,898.60 per hospital, resulting in a total national burden of 900,300 hours (150 hours x 6,002 hospitals) and $71,415,397 ($11,898.60 x 6,002 hospitals) for hospitals to build processes and make required system updates to make their standard charge information publicly available: (1) as a comprehensive MRF and (2) in a consumer-friendly format. Additionally, we estimated an ongoing annual burden of 46 hours per hospital with a cost of $3,610.88 per hospital, resulting in a total national burden of 276,092 hours (46 hours x 6,002 hospitals) and total cost of $21,672,502 ($3,610.88 x 6,002 hospitals), to make required annual updates to the hospitals' standard charge information. For a detailed discussion of the cost estimates for the requirements related to hospitals making their standard charge information publicly available, we refer readers to our discussion in the collection of information section in the CY 2020 HPT final rule (84 FR 65591 through 65596).
In the CY 2024 OPPS/ASC final rule with comment period (88 FR 82080 through 82114), we finalized revisions to the regulations at 45 CFR 180.50 related to making public hospital standard charges in an MRF. First, we finalized adding data elements to be included in the hospital's MRF and to require hospitals to conform to a CMS template layout. Second, to enhance automated access to the MRF, we finalized that hospitals include a .txt file in the root folder of the public website it selects to host its MRF in the form and manner specified by CMS that includes a standardized set of fields, and a link in the footer on its website that is labeled “Hospital Price Transparency” and links directly to the publicly available web page that hosts the link to the MRF.
As explained in the CY 2024 OPPS/ASC final rule with comment period, we increased the number of hospitals that we believed to be subject to these requirements from 6,002 to 7,098, which, in turn, increased the estimated national burden. The reason for this increase was because in the CY 2020 HPT final rule (84 FR 65591), we relied on data from the American Hospital Association (AHA).\530\ For the collection of information estimates in the CY 2024 OPPS/ASC final rule with comment period we used updated hospital numbers based on the publicly available dataset from the Homeland Infrastructure Foundation- Level Data (HIFLD) hospital dataset.\531\ The HIFLD dataset compiles a directory of hospital facilities based on data acquired directly from State hospital licensure information and Federal sources and validates this data annually. Thus, we stated our belief that the HIFLD dataset is more comprehensive than the AHA Directory. To estimate the number of hospitals subject to these requirements in the CY 2024 OPPS/ASC proposed rule with comment period, we leveraged the HIFLD hospital dataset to identify 8,013 total hospitals. We then subtracted 379 hospitals HIFLD identified as “closed” as well as hospitals that are deemed under the regulation to have met requirements (see 45 CFR 180.30) which included 339 Federally owned non-military and military hospitals, and 197 State, local, and district run forensic hospitals. We therefore estimated that the CY 2024 OPPS/ASC final rule with comment period would apply to 7,098 hospitals operating within the U.S that meet the HPT regulation's definition of “hospital” at 45 CFR 180.20.
\530\ American Hospital Association. Fast Facts on U.S. Hospitals, 2019. Available at https://www.aha.org/statistics/fast-facts-us-hospitals.
\531\ Homeland Infrastructure Foundation-Level Data (HIFLD) hospital dataset accessed on May 3, 2023, located at https://hifld-geoplatform.hub.arcgis.com/maps/9e318142490c4884bf74932af437c6c2/about. Note: All HIFLD open datasets, including the hospital dataset, have been discontinued as of September 30, 2025, and are no longer publicly available online.
In the CY 2024 OPPS/ASC final rule with comment period (88 FR 82151), we estimated the total initial one-time burden to implement the CMS standard template and conform to the data dictionary to be 120 hours (5 hours for a Lawyer + 5 hours for a General and Operations Manager + 80 hours for a Business Operations Specialist + 30 hours for a Network and Computer System Administrator) per hospital with a cost of $10,587.10 ($787.40 for a Lawyer + $590.70 for a General and Operations Manager + $6,406.40 for a Business Operations Specialist + $2,802.60 for a Network and Computer System Administrator) per hospital. The initial one-time national burden was calculated to be $75,147,235.80 dollars ($10,587.10 per hospital x 7,098 hospitals). As we indicated in the CY 2026 OPPS/ASC proposed rule, we still believe this estimate to be an accurate estimate of the one-time burden for a new hospital to implement the CMS standard template and conform to the data dictionary. However, CMS is not presently aware of any new hospitals that are beginning operations. We find it challenging to determine the number of new hospitals that are opened each year because distinguishing brand-new hospitals from expansions, new locations, or mergers is inherently arduous. Many hospitals open satellite facilities or rebrand existing ones under similar names, creating ambiguity in identifying independent entities. Additionally, there is no standardized or centralized database that categorizes hospitals based on their origin, and regulatory processes often overlap for new openings, expansions, and mergers, making it difficult to rely on licensing data alone. Complex ownership structures within healthcare systems further blur the lines between new hospitals and extensions of existing networks. Marketing strategies and naming conventions can also mislead public perception, as hospitals often promote new locations as “new” regardless of their operational independence. Finally, data inconsistencies and delays in reporting further complicate efforts to verify whether a hospital is truly new. Because we find it difficult to determine a new hospital, we will still account for the original one- time burden to implement the CMS standard template that we calculated in the CY 2024 OPPS/ASC final rule with comment period, but we will no longer account for this one-time burden moving forward.
Additionally, we finalized in the CY 2024 OPPS/ASC final rule with comment period an estimated ongoing annual national burden of 383,292 hours (54 hours x 7,098 hospitals) and an annual national cost of $32,370,571 dollars ($4,560.52 per respondent x 7,098 hospitals), which represented a $10,698,069 ($32,370,571-$21,672,502) increase over our previous estimated ongoing national annual burden for subsequent years for hospitals to update their standard charge information in the CMS standard template and conform to the data dictionary.
As we discuss in more detail below, in addition to providing updated one-time estimates for hospitals to implement new MRF data elements, updating wage rates for the ongoing annual estimates, and adding an additional labor category for Chief Executives, we are also updating the number of hospitals estimated to be subject to the HPT requirements, in this final rule with comment period.
For this final rule with comment period, we updated the number of hospitals estimated to be subject to the HPT requirements using the same methodology as we did in the CY 2024 OPPS/ASC final rule with comment period. There were 8,340 hospitals most recently identified in the HIFLD hospital dataset.\532\ We subtracted 374 hospitals HIFLD identified as “closed” as well as hospitals that are deemed under the regulation to have met requirements which included 352 Federally owned non-military and military hospitals, and 198 State, local, and district run forensic hospitals. We therefore estimate that, for this final rule with comment period, 7,416 hospitals would meet the HPT regulation's definition of “hospital” at 45 CFR 180.20.
\532\ Homeland Infrastructure Foundation-Level Data (HIFLD) hospital dataset accessed on April 2, 2025, located at https://hifld-geoplatform.hub.arcgis.com/maps/9e318142490c4884bf74932af437c6c2/about. Note: All HIFLD open datasets, including the hospital dataset, have been discontinued as of September 30, 2025, and are no longer publicly available online.
We estimated the hourly cost for each labor category used in this analysis by referencing the Bureau of Labor Statistics report on Occupational Employment and Wages (May 2024).\533\ We included labor categories for General and Operations Managers, Business Operations Specialists, and Network and Computer Systems Administrators for this final rule with comment period as we still believe these labor categories are associated with the one-time and annual burden related to the implementation of HPT requirements. As discussed below, we have also added a labor category for Chief Executives in response to comments on the CY 2026 OPPS/ASC proposed rule (that are addressed in section XIX. of this final rule with comment period), that suggested we failed to account for the burden for the hospital chief executive officer, president, or senior official designated to oversee the encoding of true, accurate, and complete data in the MRF
to review and attest to the information (See Table 161.)
\533\ U.S. Bureau of Labor Statistics, May 2024 National Occupational Employment and Wage Estimates United States, Occupational Employment and Wage Statistics. Accessed at https://www.bls.gov/oes/tables.htm. [GRAPHIC] [TIFF OMITTED] TR25NO25.251
As discussed in section XIX. of this final rule with comment period, while we believe the “estimated allowed amount” (defined at Sec. 180.20 as the average dollar amount that the hospital has historically received from a third party payer for an item or service) provides useful additional context and enhances transparency and comparability of hospital standard charges, we acknowledge that these average dollar amounts do not necessarily apply to any particular individual, nor do they necessarily represent the actual dollar amount an individual would pay for an item or service. Therefore, we proposed to require hospitals to report four new data elements when the payer- specific negotiated charge is based on a percentage or algorithm--the median allowed amount (which would replace the estimated allowed amount data element), the 10th percentile allowed amount, the 90th percentile allowed amount, and the count of allowed amounts. We also proposed to require that hospitals abide by specific instructions regarding the data source and methodology, including the lookback period, that should be used to calculate the median, 10th and 90th percentile allowed amounts. As we indicated in the CY 2026 OPPS/ASC proposed rule, we believe that the median, 10th and 90th percentile allowed amounts would provide greater context and clarity with respect to the payer-specific negotiated charge, would be a better consumer benchmark than the estimated allowed amount, and better enable price estimator tools to develop and estimate an individual's personalized out-of-pocket cost, enabling MRF users to more easily compare such standard charges across hospitals. After consideration of public comments, discussed in an earlier section of this final rule with comment period, we are finalizing with modification our proposals to replace the estimated allowed amount with the median allowed amount and to add the 10th and 90th percentile allowed amounts, including our proposed methodology for calculating the allowed amounts should the calculated percentile fall between two observed allowed amounts, effective January 1, 2026. We are finalizing with modification our proposal that a hospital must calculate and encode the total number of allowed amount remittances that were used to calculate the median, 10th and 90th percentile allowed amounts, using the valid values and instructions that will be detailed in the CMS Hospital Price Transparency--Data Dictionary GitHub Repository website. We are also finalizing with modification our proposals to require that hospitals abide by specific instructions regarding the data source and methodology, including the lookback period, that should be used to calculate the median, 10th and 90th percentile allowed amounts effective January 1, 2026.
We also proposed that beginning January 1, 2026, hospitals must attest in their MRF that they have included all applicable standard charge information in accordance with the requirements of 45 CFR 180.50, and the information encoded is true, accurate, and complete as of the date in the file, and the hospital has included all payer- specific negotiated charges in dollars that can be expressed as a dollar amount. For payer-specific negotiated charges that cannot be expressed as a dollar amount in the MRF, or are not knowable in advance, the hospital would attest that the payer-specific negotiated charge is based on a contractual algorithm, percentage or formula that precludes the provision of a dollar amount and has provided all necessary information available to the hospital for the public to be able to derive the dollar amount, including, but not limited to, the specific fee schedule or components referenced in such percentage, algorithm or formula. Additionally, we proposed that, beginning January 1, 2026, the hospital must encode within the MRF the name of the chief executive officer, president, or senior official designated to oversee the encoding of true, accurate and complete data in the MRF. As we indicated in the CY 2026 OPPS/ASC proposed rule, we believe these proposed requirements would provide the necessary reassurance that hospitals have provided in their MRFs meaningful, accurate information to users of the MRF about their standard charges for health care items and services. However, after consideration of public comments, discussed in an earlier section of this final rule with comment period, we are finalizing, effective January 1, 2026, our proposal to supplant the existing affirmation requirement with the proposed attestation statement at new
Sec. 180.50(3)(iii), with a modification to add to the following phrase to the beginning of the attestation: “To the best of its knowledge and belief,”. In addition, we are finalizing, as proposed, new Sec. 180.50(a)(3)(iv) to require that, beginning January 1, 2026, the hospital must encode within the MRF the name of the hospital chief executive officer, president, or senior official designated to oversee the encoding of true, accurate and complete data as directed in Sec. 180.50(a)(3)(iii).
We also proposed in the CY 2026 OPPS/ASC proposed rule adding a standard identifier, specifically the hospital's National Provider Identifiers (NPIs) to the MRFs. As we indicated in the CY 2026 OPPS/ASC proposed rule, we believe that adding a standard identifier to the file would advance the comparability of the HPT data with other healthcare data, including health plan transparency data from the Transparency in Coverage (TiC) MRFs. After consideration of public comments, discussed in an earlier section of this final rule with comment period, we are finalizing, as proposed, the requirement that, beginning January 1, 2026, hospitals must report, in a newly created general data element in the MRF, any Type 2 NPI(s) that are associated with a primary taxonomy code starting with `28' (indicating hospital) or `27' (indicating hospital unit) and that is active as of the date of the most recent update to the standard charge information.
As we indicated in the CY 2026 OPPS/ASC proposed rule, we still believe that, by now, hospitals have largely developed standardized processes and procedures for encoding the existing estimated allowed amount and general data elements, like hospital license number, in the MRF and that modifying their existing processes to include the four new data elements related to the proposed allowed amounts and hospital NPI would not entail a significant amount of additional work for hospitals. Furthermore, hospitals are required to encode the affirmation statement in the MRF currently, therefore we still believe the additional burden related to the proposed attestation statement is the requirement for hospitals to encode the name of the senior official making the attestation. However, as discussed in more detail below, after consideration of public comments, we are increasing both the one-time and annual burden hours estimates associated with the information collections in this final rule with comment period.
We indicated in the CY 2026 OPPS/ASC proposed rule, we believed hospitals would incur an initial one-time cost to update their processes and systems to (1) identify and collect the newly proposed data elements, and (2) encode the standard charge information for the newly proposed data elements in the CMS standard template. To implement the proposed requirements, we estimated that it would take a Business Operations Specialist (BLS 13-1000), on average, 4 hours (at a cost of $87.52 per hour) to develop and update the necessary processes and procedures and develop the requirements to implement the proposed data elements and a General and Operations Managers (BLS 11-1021), on average, 1 hours (at a cost of $128.00 per hour) to review the updates.
Therefore, we believed the one-time burden estimate to be 37,080 hours for all hospitals (5 hours x 7,416 hospitals) at a cost of $3,545,441.28 (7,416 hospitals x [($87.52 x 4 hours) + ($128.00 x 1 hours)]); see Table 162. As we indicated in the CY 2026 OPPS/ASC proposed rule, we believe the benefits to users of the MRF of having this additional information would justify the initial one-time burden to hospitals to update their processes and systems to identify and collect the newly proposed data elements and encode the standard charge information for the newly proposed data elements in the CMS standard template. [GRAPHIC] [TIFF OMITTED] TR25NO25.252
For the annual burden estimate we relied on our previous assumptions related to labor categories and number of hours as we did in the CY 2024 OPPS/ASC final rule with comment period (88 FR 82153). We estimated it would take a General and Operations Manager 2 hours per hospital, to review and determine updates in compliance with requirements. We estimated the ongoing time for a Business Operations Specialist to be 40 hours per hospital, to identify and gather the required data elements on an annual basis. We estimated that it would take a Computer System Administrator 12 hours to maintain and post the MRF in a manner that conforms to the CMS standard template, which brings the total burden per hospital to 54 hours. Therefore, we estimated a total annual burden of 400,464 hours for all hospitals (7,416 hospitals x 54 hours) at a cost of $36,519,350.40 (7,416 hospitals x [($128/hour x 2 hours) + ($87.52/hour x 40 hours) + ($97.30/hour x 12 hours)]); see Table 163.
[GRAPHIC] [TIFF OMITTED] TR25NO25.253
We received public comments on these information collections. The following is a summary of the comments we received and our responses.
Comment: While many commenters indicated that our proposed changes to the HPT requirements outlined in the CY 2026 OPPS/ASC proposed rule and/or the HPT requirements in general are burdensome, as discussed in prior sections of this final rule with comment period, only several commenters commented on our specific burden estimates for these information collections. Several commenters stated that CMS's projected annual burden estimate was underestimated, noting an undefined, but “significantly higher” burden and cost to implement the proposed policies. A few commenters stated that hospitals that contract with outside vendors or consultants to update their MRFs on an annual basis, do so at a cost of $10,000 to $30,000 per hospital and those without vendor support report needing 5 to 30 full-time-equivalents (FTEs) to update their MRFs on an annual basis. One commenter indicated that they recently updated their MRF to meet the annual update requirement and it required 5 times the amount of hours CMS estimated for the annual burden estimates. One commenter indicated that hospitals incur annual vendor fees of up to $250,000 to update their MRFs and that even with vendor support, hospitals may have three FTEs spend an entire month developing and validating their MRFs.
Similarly, several commenters indicated that CMS' one-time burden estimate to encode the new data elements in the MRF as proposed in the CY 2026 OPPS/ASC proposed rule was underestimated. A few commenters maintained that they expect to spend $20,000-$30,000 to elicit vendor support to encode the new data elements in the MRF by the January 1, 2026, effective date proposed in the CY 2026 OPPS/ASC proposed rule. One commenter indicated they believe they will need to spend thousands of dollars per hospital to hire a third-party vendor or devote an internal “project management team” to support the encoding of the new data elements. One commenter incorrectly stated that we estimated a one-time burden estimate of 20 hours to implement the new HPT requirements, at a cost of $1,598.90, and that this estimate significantly understated the real cost of implementing the proposals. One commenter indicated they had already spent more than the cost of the entire one-time burden estimate in just reviewing the proposed rule.
Response: We appreciate commenters' concerns and the varying range of estimates provided by commenters suggests that hospitals have different operational and administrative processes and systems that impact the projected burden of encoding the new data elements and meeting the requirement to update the MRF annually. To address this variability, we allow hospitals to choose which CMS MRF template format they use, providing hospitals some flexibility to select the least burdensome format and layout to develop and update their MRF. We expect that, as indicated in the CY 2026 OPPS/ASC proposed rule, more than a year after the implementation of the CMS MRF standard template, some hospitals have well developed automated processes in place that they leverage to minimize the burden associated with making hospital standard charge information public in their current MRFs. Additionally, as discussed in more detail in prior sections of this final rule with comment period and as with previous HPT rulemaking, we will provide technical guidance and examples of how to encode the new data elements we are finalizing in this rule on the CMS Hospital Price Transparency-- Data Dictionary GitHub Repository, as well as guidance on the HPT resources page on the CMS website to further minimize the burden to hospitals.
Moreover, in order to further reduce burden, as discussed in more detail in prior sections of this final rule with comment period, we are delaying enforcement of our requirements to encode the new data elements in the MRF. Specially, we are finalizing at Sec. 180.50, the removal of the estimated allowed amount, disclosure of the 10th percentile, median, 90th percentile allowed amounts and the count of allowed amounts, the attestation requirements, and the requirement to encode hospital NPIs effective January 1, 2026. However, we will delay enforcement of these finalized revisions until April 1, 2026. We believe this 3-month enforcement delay will provide hospitals with sufficient additional time to encode the new data elements and review their MRFs prior to making them public online.
We continue to believe that increased standardization and comparability of the MRFs benefit consumers of the MRF, and that this benefit outweighs the burden imposed by these requirements. However, we are swayed by commenters that suggested we underestimated the one-time burden of encoding the new data elements in the MRF. Therefore, we have increased the one-time burden estimate for the General and Operations Manager and Business Operations Specialist labor categories by doubling those estimates in this final rule with comment period. Additionally, we have also added one-time and annual burden estimates for Chief Executives in response to comments on the “Modification to the MRF Affirmation Statement” section of the CY 2026 OPPS/ASC proposed rule, addressed in an earlier section of this final rule with comment period, that suggested we failed to account for the burden for the hospital chief executive officer, president, or senior official designated to oversee the encoding of true, accurate, and complete data in the MRF to review and attest to the information. However, we have retained our existing annual burden estimates for the General and Operations Manager and Business Operations Specialist labor categories as we believe it is reasonable to assume that the burden to
hospitals for encoding the new data elements finalized in this rule will lessen with subsequent annual updates to the MRF once hospitals have developed standardized processes and procedures for doing so such that increasing the annual burden estimates for these labor categories is unnecessary.
Final Action: After consideration of public comments, we are increasing both our one-time and annual burden estimates. To implement the encoding of the new data elements we are finalizing in this final rule with comment period, we now estimate that it will take a Business Operations Specialist (BLS 13-1000), on average, 8 hours (at a cost of $87.52 per hour) to develop and update the necessary processes and procedures and develop the requirements to implement the new data elements and a General and Operations Managers (BLS 11-1021), on average, 2 hours (at a cost of $128.00 per hour) to review the updates, and a Chief Executive (BLS 11-1011) 2 hours (at a cost of $252.82) to review and attest to the accuracy and completeness of the data in the MRF. Therefore, we believe the one-time burden estimate to be 88,992 hours for all hospitals (12 hours x 7,416 hospitals) at a cost of $10,840,708.80 (7,416 hospitals x [($87.52 x 8 hours) + ($128.00 x 2 hours) + ($252.82 x 2 hours]); see Table 164. [GRAPHIC] [TIFF OMITTED] TR25NO25.254
Additionally, we still estimate it will take a General and Operations Manager (BLS 11-1021), 2 hours (at a cost of $128.00 per hour) per hospital to review and determine updates in compliance with the annual update requirement. We still estimate the ongoing time for a Business Operations Specialist (BLS 13-1000), to be 40 hours (at a cost of $87.52 per hour) per hospital, to identify and gather the required data elements on an annual basis. We still estimate that it will take a Computer System Administrator (BLS 15-1244) 12 hours (at a cost of $97.30 per hour) to maintain and post the MRF in a manner that conforms to the CMS standard template. However, we now estimate it will take a Chief Executive (BLS 11-1011) 2 hours (at a cost of $252.82) to review and attest to the accuracy and completeness of the data in the MRF each year prior to posting the MRF online, which now brings the total ongoing annual burden per hospital to 56 hours. Therefore, we estimate a total ongoing annual burden of 415,296 hours for all hospitals (7,416 hospitals x 56 hours) at a cost of $40,269,176.60 (7,416 hospitals x [($128/hour x 2 hours) + ($87.52/hour x 40 hours) + ($97.30/hour x 12 hours) + ($252.82/hour x 2 hours]); see Table 165. The annual burden is increased by 2 hours from 54 hours to 56 hours per hospital as compared to the CY 2024 OPPS/ASC final rule with comment period, which reflects the additional burden annually associated with the new requirements finalized in this final rule with comment period. [GRAPHIC] [TIFF OMITTED] TR25NO25.255
If you comment on these information collection, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget,
Attention: CMS Desk Officer, CMS-1834-FC Fax: (202) 395-6974; or Email: [email protected]
XXIV. Files Available to the Public via the Internet
The Addenda to the OPPS/ASC proposed rules and final rules with comment period are published and available via the internet on the CMS website. In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59154), for CY 2019, we changed the format of the OPPS Addenda A, B, and C by adding a column titled “Copayment Capped at the Inpatient Deductible of $1,364.00” where we flag, through use of an asterisk, those items and services with a copayment that is equal to or greater than the inpatient hospital deductible amount for any given year (the copayment amount for a
procedure performed in a year cannot exceed the amount of the inpatient hospital deductible established under section 1813(b) of the Act for that year). In the CY 2022 OPPS/ASC final rule with comment period (85 FR 86266), we updated the format of the OPPS Addenda A, B, and C by adding a column titled “Drug Pass-Through Expiration during Calendar Year” where we flagged, through the use of an asterisk, each drug for which pass-through payment was expiring during the calendar year on a date other than December 31. For CY 2026 and subsequent years, we proposed to retain these columns that are updated to reflect the drug codes for which pass-through payment is expiring in the applicable year.
In the CY 2023 OPPS/ASC final rule with comment period (87 FR 72250) for CY 2023, we changed the format of the OPPS Addenda A, B, and C by adding a column titled “Drug Pass-Through Expiration during Calendar Year” to include devices, so that the column reads: “Drug and Device Pass-Through Expiration during Calendar Year” where we flagged, through the use of an asterisk, each drug and device for which pass-through payment was expiring during the calendar year on a date other than December 31.
For CY 2024, we deleted the column titled “Copayment Capped at the Inpatient Deductible” and instead added a new column for “Adjusted Beneficiary Copayment” to identify any copayment adjustment due to either the inpatient deductible amount copayment cap or the inflation- adjusted copayment of a Part B rebatable drug per section 1833(t)(8)(F) and section 1833(i)(9) of the Act, as added by section 11101 of the Inflation Reduction Act (IRA). We also added another column for notes. The “Note” column contains multiple messages including, but not limited to, inflation-adjusted copayment of a Part B rebatable drug, the copayment for a code capped at the inpatient deductible, or 8 percent of the reference product add-on applied for a biosimilar.
In addition, for CY 2024, we updated the format of the OPPS Addenda A, B, and C by adding another column for “IRA Coinsurance Percentage” to identify the percentage for the inflation-adjusted copayment of a Part B rebatable drug per section 1833(t)(8)(F) and section 1833(i)(9) of the Act, as added by section 11101 of the Inflation Reduction Act (IRA).
For CY 2026 and subsequent years, we proposed to keep the same format for the addenda A, B, and C, and we did not propose any additional changes for CY 2026.
We did not receive any public comments related to the format of the OPPS Addenda A, B, and C and are adopting the addenda format as proposed.
To view the Addenda to this final rule with comment period pertaining to CY 2026 payments under the OPPS, we refer readers to the CMS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices; select “CMS- 1834-FC” from the list of regulations. All OPPS Addenda to this final rule with comment period are contained in the zipped folder titled “2026 NFRM OPPS Addenda” in the related links section at the bottom of the page. To view the Addenda to this final rule with comment period pertaining to CY 2026 payments under the ASC payment system, we refer readers to the CMS website at https://www.cms.gov/medicare/payment/prospective-payment-systems/ambulatory-surgical-center-asc/asc-regulations-and-notices; select “CMS-1834-FC” from the list of regulations. The ASC Addenda to this final rule with comment period are contained in a zipped folder titled “2026 NFRM Addendum AA, BB, DD1, DD2, EE, and FF” in the related links section at the bottom of the page.
XXV. Response to Comments
Because of the large number of public comments, we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble; and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
XXVI. Economic Analyses
← C. Improved and Enhanced Enforcement to B. Definition of “Approved Medical Residency Programs”ContentsA. Statement of Need to XXVII. Waiver of 60-Day Delay of Effective Date →
- The rule itself
Health and Human Services Department, Centers for Medicare & Medicaid Services, Office of the Secretary, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots,” 90 FR 53448 (November 25, 2025). Effective January 1, 2026.
https://www.federalregister.gov/documents/2025/11/25/2025-20907/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment - This page
“Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots,” the text from “A. Background” to “XXVI. Economic Analyses.” Read the Mandate, https://readthemandate.org/rules/rule-2025-20907/text-27/ (retrieved August 27, 2026).
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