CMS-10210 (HIQR)_Supporting Statement A_clean (5-10-2022)

CMS-10210 (HIQR)_Supporting Statement A_clean (5-10-2022).docx

Hospital Reporting Initiative--Hospital Quality Measures (CMS-10210)

OMB: 0938-1022

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Supporting Statement – Part A

Quality Measures and Procedures for the Hospital Inpatient Quality Reporting Program for the FY 2025 IPPS Annual Payment Updates (OMB Control No. 0938-1022)

FY 2023 IPPS/LTCH PPS Proposed Rule (RIN 0938-AU84, CMS-1771-P)


A. Background


The Centers for Medicare & Medicaid Services (CMS) seeks to empower consumers to make more informed decisions about their healthcare and to promote higher quality of care through its quality reporting programs. To begin participation in the Hospital Inpatient Quality Reporting (IQR) Program, all hospitals paid under the Inpatient Prospective Payment System (IPPS) must complete a Hospital IQR Notice of Participation. The Notice of Participation explains the participation and reporting requirements for the program. The form explains that in order to receive the full market basket update (or Annual Payment Update (APU)), the hospitals are agreeing to submit data on selected measures and allowing CMS to publish their data for public viewing according to section 1886(b)(3)(B)(viii) of the Social Security Act. Other hospitals not paid under the IPPS, such as critical access hospitals (CAHs), may also wish to voluntarily submit data and have their data published for public viewing. In order to accommodate these hospitals, a separate section of the participation form, referred to as the Optional Public Reporting Notice of Participation, is available for these hospitals to give CMS permission to collect and publish data that are voluntarily submitted by a hospital. These hospitals may choose to suppress a measure or measures prior to their posting on the Compare tool hosted by HHS, currently available at: https://www.medicare.gov/care-compare, or its successor website(s).


Hospitals that indicated their intent to participate will be considered active Hospital IQR Program participants until they submit a withdrawal to CMS. Hospitals that no longer wish to participate in the Hospital IQR Program or those that no longer wish to submit data for publishing on the Compare tool hosted by HHS or its successor website(s) can notify CMS of their decision using the same form discussed above.


Annually, hospitals participating in hospital quality reporting use the Hospital Quality Reporting Data Accuracy and Completeness Acknowledgement (DACA) form after the end of each reporting year. This requirement was added based on a U.S. Government Accountability Office report from 2006 that recommended that CMS require hospitals to “formally attest to the completeness of the quality data that they submit.” This form, completed annually, is an acknowledgement that the data a hospital has submitted are complete and accurate.


Hospitals that voluntarily participate in quality reporting but are not paid under the IPPS may elect to have those data withheld from public reporting by completing the Request Form for Withholding/Footnoting Data from Public Reporting. Once the form is submitted, data can be withheld for the quarter in which the form is submitted. However, the data will be released on the Compare tool hosted by HHS or its successor website(s) for subsequent releases unless the hospital submits a new Request Form for Withholding/Footnoting Data from Public Reporting indicating the measure(s) the hospital would like to withhold from public reporting for the period.


Hospitals that do not treat specified conditions or that do not have treatment locations defined for certain of the National Healthcare Safety Network’s healthcare-associated infection (HAI) measures (Central Line-Associated Bloodstream Infections (CLABSI), Catheter-associated Urinary Tract Infections (CAUTI), and Surgical Site Infection) have the option to either complete the enrollment process with National Healthcare Safety Network (NHSN) and indicate that they do not have patients who meet the measure requirements, or submit a CMS IPPS Quality Reporting Programs Measure Exception Form for PC and HAI Data Submission. Hospitals that do not have an Obstetrics Department and do not deliver babies may also use this form for the PC-01: Elective Delivery measure. This Measure Exception Form will reduce the burden of completing the entire NHSN enrollment process or entering zero denominator information for inapplicable measures for the hospitals that meet the exception requirements.


CMS selects up to 400 subsection (d) hospitals participating in the Hospital IQR Program on an annual basis for validation (85 FR 58946 and 58948). Specifically, CMS randomly selects up to 200 hospitals for validation and up to 200 hospitals selected using the targeting criteria, applied across electronic clinical quality measures (eCQMs) and chart-abstracted measures.


When CMS determines that a hospital did not meet one or more of the Hospital IQR Program requirement(s), the hospital may submit a request for reconsideration to CMS using the CMS Quality Reporting Program APU Reconsideration Request Form, by the deadline identified on the Hospital IQR Program APU Notification Letter it received. For reconsideration requests related specifically to the validation requirements, hospitals must use the CMS Hospital IQR Program Validation Review for Reconsideration Request Form.


Hospitals may use the educational review process to correct disputed chart-abstracted measure or eCQM validation results. To submit a formal request, hospitals can utilize the CMS Quality Reporting Validation Educational Review Form. We note that should the results of an educational review not be favorable to a hospital, a hospital may still also request reconsideration of those results using the CMS Hospital IQR Program Validation Review for Reconsideration Request Form.


CMS offers a process for hospitals to request exceptions to the reporting of required quality data, including eCQM data, for one or more quarters when a hospital experiences an extraordinary circumstance beyond the hospital’s control. The CMS Quality Program Extraordinary Circumstances Exceptions Request Form indicates that for non-eCQM circumstances, the request must be submitted within 90 calendar days of an extraordinary circumstance event for all programs. In addition, the form indicates that for eCQM reporting circumstances under the Hospital IQR Program, the request must be submitted by April 1st following the end of a reporting period calendar year.


We may only select measures for the Hospital Value-Based Purchasing (VBP) Program from the measures (other than measures of readmissions) specified under the Hospital IQR Program. Hospitals may appeal the calculation of their performance assessment with respect to the performance standards, as well as their Total Performance Score (TPS), for the Hospital VBP Program. Hospitals may review and request recalculation of their hospital’s performance scores on each condition, domain, and TPS using the Hospital VBP Program Review and Corrections Request Form within 30 calendar days of the posting date of the Value-Based Percentage Payment Summary Report. Hospitals may submit an appeal using the Hospital VBP Program Appeal Request Form within 30 calendar days of the date of receiving an adverse determination from CMS on their review and corrections request. Hospitals may submit a Hospital VBP Program Independent CMS Review Request Form within 30 days after they receive an adverse determination from CMS on their appeal.


1. Hospital IQR Program Quality Measures


The FY 2025 APU determination will be based on Hospital IQR Program data reported and supporting forms submitted by hospitals on chart-abstracted measures, patient surveys, and eCQMs for calendar year (CY) 2023 discharges. In an effort to reduce burden, a variety of different data collection mechanisms are employed, with every consideration taken to employ data and data collection systems already in place.


In the FY 2023 IPPS/Long-Term Care Hospital (LTCH) PPS proposed rule, we are proposing a modification to our eCQM reporting and submission requirements whereby we would increase the total number of eCQMs to be reported from four to six eCQMs beginning with the CY 2024 reporting period/FY 2026 payment determination, which would increase our collection of information burden.


In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing to add 10 new measures as well as refinements for 2 existing measures. Proposed changes are discussed below.


a. Proposed Measure Adoptions in the FY 2023 IPPS/LTCH PPS Proposed Rule Which Affect the Burden for the Hospital IQR Program

In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing to add 4 new measures which will increase burden for the Hospital IQR Program, which is discussed in more detail in section 12.


We are proposing adoption of the following measures: (1) the Hospital Commitment to Health Equity structural measure, beginning with the CY 2023 reporting period/FY 2025 payment determination; (2) the Screening for Social Drivers of Health measure, beginning with voluntary reporting for the CY 2023 reporting period and mandatory reporting beginning with the CY 2024 reporting period/FY 2026 payment determination; (3) the Screen Positive Rate for Social Drivers of Health process measure, beginning with voluntary reporting for the CY 2023 reporting period and mandatory reporting beginning with the CY 2024 reporting period/FY 2026 payment determination; and (4) the Hospital-Level, Risk-Standardized Patient-Reported Outcomes Following Elective Primary Total Hip and/or Total Knee Arthroplasty (THA/TKA) performance measure (THA/TKA PRO–PM), beginning with voluntary reporting across two periods (July 1, 2023 through June 30, 2024 and July 1, 2024 through June 30, 2025), followed by mandatory reporting of the measure for the reporting period which runs from July 1, 2025 through June 30, 2026, impacting the FY 2028 payment determination.


b. Proposed Updates in the FY 2023 IPPS/LTCH PPS Proposed Rule Which Do Not Affect the Burden for the Hospital IQR Program


In the FY 2023 IPPS/LTCH PPS proposed rule, there are a number of proposed policies which do not affect our information collection burden estimates. We are proposing to adopt four eCQMs: (1) Cesarean Birth electronic clinical quality measure (eCQM), beginning with the CY 2023 reporting period/FY 2025 payment determination, followed by mandatory reporting beginning with the CY 2024 reporting period/FY 2026 payment determination; (2) Severe Obstetric Complications eCQM, beginning with the CY 2023 reporting period/FY 2025 payment determination, followed by mandatory reporting beginning with the CY 2024 reporting period/FY 2026 payment determination; (3) Hospital-Harm—Opioid-Related Adverse Events eCQM, beginning with the CY 2024 reporting period/FY 2026 payment determination; and (4) Global Malnutrition Composite Score eCQM, beginning with the CY 2024 reporting period/FY 2026 payment determination. We are also proposing the adoption of two claims-based measures beginning with the FY 2024 payment determination: (1) Medicare Spending Per Beneficiary (MSPB) Hospital; and (2) the Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary THA/TKA. We are proposing refinements to current Hospital IQR Program claims-based measures beginning with the FY 2024 payment determination: (1) Hospital-Level, Risk-Standardized Payment Associated with an Episode of Care for Primary Elective THA/TKA; and (2) The Acute Myocardial Infarction (AMI) Excess Days in Acute Care (EDAC). Lastly, we are proposing to: (1) Establish a publicly-reported hospital designation to capture the quality and safety of maternity care in advancing maternal health equity on a public-facing website beginning in Fall 2023; (2) modify our case threshold exemptions and zero denominator declaration policies for hybrid measures as we believe they are not applicable for this measure type beginning with the FY 2026 payment determination; and (3) modify our eCQM validation policy to increase the reporting of medical requests from 75 percent of records to 100 of records, beginning with the validation of CY 2022 eCQM data affecting the FY 2025 payment determination.


B. Justification


1. Need and Legal Basis


The Hospital IQR Program was first established to implement Section 501(b) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173), which authorized CMS to pay hospitals that successfully reported quality measures a higher annual update to their payment rates. It builds on a voluntary Inpatient Quality Reporting Program, which remains in effect. Section 5001(a) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) revised the mechanism used to update the standardized amount for payment for hospital inpatient operating costs. This is reflected in sections 1886(b)(3)(B)(viii)(I) and (II) of the Social Security Act, which provide that the APU will be reduced for any “subsection (d) hospital” that does not submit certain quality data in a form and manner, and at a time, specified by the Secretary.


Section 1886(o) of the Social Security Act mandates CMS’ transition from a passive supplier of health care to an active purchaser of quality care.  Pursuant to section 1886(o)(2)(A) of the Social Security Act, CMS must select measures for the Hospital VBP Program from the measures (other than measures of readmissions) specified under the Hospital IQR Program. Consistent with this legislation, CMS established a Hospital VBP Program, beginning effective with payment adjustments on FY 2013 discharges, which qualifies hospitals for financial incentives based on their performance on a defined set of quality measures selected for the Hospital VBP Program from the measures specified under the Hospital IQR Program.


2. Information Users


The information from the Hospital IQR Program is made available to hospitals for their use in internal quality improvement initiatives. CMS provides confidential feedback reports that hospitals may use to assess their performance and operationalize quality improvement activities throughout the quality reporting period. These reports include the data that CMS has collected from the hospital and the hospital’s claims, and some also include information about how the hospital’s data look relative to the performance of other hospitals. For example, the Facility, State and National (FSN) Report allows hospitals to compare their performance related to a specific measure during a specific timeframe, to the average performance of other hospitals at the state and national levels.


CMS will use the information collected from hospital quality reporting to set payment adjustments for value-based purchasing. For example, the Hospital VBP Program Baseline Measures Report allows hospitals to compare their performance for each measure to the program’s benchmarks and achievement thresholds, which are obtained from the scores of all hospitals. These reports allow hospitals time to assess how their current performance in each measure could be scored in the upcoming Hospital VBP payment determinations while there is still time to target improvement activities related to specific measures so that their performance and scores can be maximized.


Hospital measure information is also used by CMS to direct its contractors to focus on particular areas of improvement and to develop quality improvement initiatives. Medicare beneficiaries experience a high rate of preventable readmissions, which are burdensome to patients and families, as well as costly. Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs), under contract with CMS, use readmissions data from CMS to assist communities to reduce avoidable readmissions. For example, the QIN-QIO program helps communities with high readmission rates form local coalitions, identify the factors driving avoidable hospital readmissions in their area, and find ways to better coordinate care and to encourage patients to manage their health more actively.


Most importantly, this information is available to beneficiaries, as well as to the public, to provide hospital information to assist them in making decisions in choosing their health care providers. CMS sometimes conducts focus groups or market testing prior to publicly reporting hospital quality data on the Compare tool hosted by HHS or its successor website(s) in order to get feedback on ways to make the website more user-friendly. Feedback from these focus groups have helped CMS understand how beneficiaries and consumers use the Compare tool hosted by HHS or its successor website(s). Under emergency circumstances, consumers choose hospitals based on proximity, reputation, prior experience, or their doctor’s recommendation. For childbirth or elective hospital admissions, when patients and their family members may have the time and motivation to consider options and engage in informed decision making, they have expressed interest in information such as the provider’s track record in treating their condition, safety and infection rates, and a hospital’s recognized areas of expertise, as well as to take into consideration their doctor’s recommendation.


3. Use of Information Technology


To assist hospitals in standardizing data collection initiatives across the industry, CMS continues to improve data collection tools in order to make data submission easier for hospitals (e.g., the automated collection of electronic patient data in electronic health records (EHRs) for eCQMs and hybrid measures, the collection of data from paper or electronic medical records for chart-abstracted measures, or the collection of data from federal registries like the NHSN), as well as to increase the utility of the data provided by the hospitals.


For the claims-based measures or measures which collect data from claims in part, this section is not applicable, because these measures can be fully or partially calculated based on data that are already reported to the Medicare program for payment purposes. Therefore, no additional information technology will be required of hospitals to collect this data for these measures.


4. Duplication of Similar Information


The information to be collected is not duplicative of similar information collected by CMS. We prioritize efforts to reduce reporting burden for the collection of quality of care information by utilizing electronic data that hospitals already report to The Joint Commission for accreditation, as well as aligning eCQMs and related reporting requirements with the Medicare Promoting Interoperability Program for Eligible Hospitals and CAHs.


5. Small Business


Information collection requirements were designed to allow maximum flexibility specifically to small hospitals wishing to participate in hospital reporting. This effort will assist small hospitals in gathering information for their own quality improvement efforts. We define a “small hospital” as one with 1-99 inpatient beds. The Hospital IQR Program included approximately 1,135 participating IPPS small hospitals in the FY 2023 program year.


6. Less Frequent Collection


We have designed the collection of quality measure data to be the minimum necessary for data validation and for calculation of summary figures to be used as reliable estimates of hospital performance. Frequency of data collection may vary (monthly, quarterly, annually, etc.) based on how a quality measure is specified. The following table details the frequency of data submission to CMS by measure type.


Measure Type

Frequency of Data Submission

Chart-abstracted clinical process of care

Quarterly

Online reporting of structural and process measures

Annually

EHR-based clinical process of care (i.e., eCQMs)

Annually

EHR data for hybrid measures

Annually

Online reporting of PRO-PM measures

Semi-annually

7. Special Circumstances


Although participation in the Hospital IQR Program is voluntary on the part of subsection (d) hospitals, all eligible hospitals must submit these data and meet all other Hospital IQR Program requirements in order to receive their full APU for the given fiscal year. If a hospital does not submit the required data and meet all other Hospital IQR Program requirements, it would be subject to a reduced APU for a given fiscal year.


8. Federal Register Notice/Outside Consultation


A 60-day Federal Register notice of the FY 2023 IPPS/LTCH PPS proposed rule (RIN 0938-AU84, CMS-1771-P) was published on May 10, 2022 (87 FR 28108).


CMS is supported in this initiative by The Joint Commission, National Quality Forum (NQF), Measure Applications Partnership (MAP), Centers for Disease Control and Prevention (CDC), and Agency for Healthcare Research and Quality (AHRQ). These organizations collaborate with CMS on an ongoing basis, providing technical assistance in developing and/or identifying quality measures, and assisting in making the information accessible, understandable, and relevant to the public.


9. Payment/Gift to Respondent


No payments or gifts will be given to respondents for participation.


10. Confidentiality


All information collected under this initiative will be maintained in strict accordance with statutes and regulations governing confidentiality requirements for Quality Improvement Organizations, which can be found at 42 CFR Part 480. In addition, the tools used for transmission of data are considered confidential forms of communication, and there are safeguards in place in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules to protect the submission of patient information, at 45 CFR Part 160 and 164, Subparts A, C and E. The CMS clinical data warehouse also voluntarily meets or exceeds the HIPAA standards.


11. Sensitive Questions


Case-specific clinical data elements will be collected and are necessary to calculate statistical measures. These statistical measures are the basis of all subsequent improvement initiatives derived from this collection and cannot be calculated without the case-specific data. These sensitive data will not, however, be released to the public. Only hospital-specific data will be released to the public after consent has been received from the hospital for the release. The patient-specific data remaining in the CMS clinical data warehouse after the data are aggregated for release for public reporting will continue to be subject to the strict confidentiality regulations in 42 CFR Part 480.


12. Burden Estimate (Total Hours & Wages)


a. Background

Our currently approved burden estimates are based on an assumption of approximately 3,300 IPPS hospitals and 1,100 non-IPPS hospitals. For this proposed rule, we are updating our assumption to 3,150 IPPS hospitals and 1,350 non-IPPS hospitals based on recent data from the FY 2022 Hospital IQR Program payment determination which reflects a closer approximation of the total number of hospitals reporting data to the Hospital IQR Program.


For the purposes of burden estimation, we assume all of the activities associated with the Hospital IQR Program for 3,150 IPPS hospitals and 1,350 non-IPPS hospitals will be completed by Medical Records and Health Information Technicians, with the exception of survey completion which will be completed by patients. These staff are qualified to complete the tasks associated with the chart-abstraction of patient data from medical records, the submission of electronic data from EHRs, the submission of data to clinical registries, and the completion of any of the other applicable forms associated with activities related to the Hospital IQR Program.


As shown in Table 1, OMB has currently approved 1,579,010 hours at a cost of approximately $67.0 million (adjusted for updated wage rates) under OMB control number 0938-1022, accounting for information collection burden experienced by approximately 3,300 IPPS hospitals and 1,100 non-IPPS hospitals for the FY 2024 payment determination. Our burden estimates exclude burden associated with the NHSN under OMB control number 0920-0666, the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey under OMB control number 0938-0981, and the Health Insurance Common Claims Form and Supporting Regulations under OMB control number 0938-1197.


With the exception of updating the number of hospitals, we are not proposing any changes to the currently approved burden estimates for chart-abstracted measures (sepsis and perinatal care), the Hybrid Hospital-Wide All-Cause Readmission (Hybrid HWR) and Hospital-Wide Mortality (Hybrid HWM) measures, the Maternal Morbidity Structural Measure, population and sampling for ongoing measure sets, reviewing of reports for claims-based measure sets, and completion of all other forms used in the data collection process for the FY 2025 through FY 2028 payment determination years.


Table 1. Currently Approved Burden Estimates for the Hospital IQR Program Measure Set and Other Activities for the FY 2024 Payment Determination

Measure Set

Estimated time per record (minutes) -
FY 2024 payment determination

Number reporting quarters per year -
FY 2024 payment determination

Number of hospitals reporting

Average number records per hospital per quarter

Annual burden (hours) per hospital

Calculation for FY 2024 payment determination

CHART ABSTRACTION

IPPS Hospitals (3,300)

Sepsis Measure

60

4

3,300

100

400

1,320,000

Perinatal care (PC)

10

4

3,300

76

51

167,200

Subtotal IPPS chart-based

 

 

 

 

451

1,487,200


Non-IPPS Hospitals (1,100)

Sepsis measure

60

4

362

25

100

36,200

Perinatal care (PC)

10

4

334

21

14

4,676

Subtotal Non-IPPS chart-based

 

 

 

 

 114

40,876


Subtotal IPPS and Non-IPPS chart-based

 

 

 

 

 

1,528,076



HYBRID MEASURES

IPPS Hospitals (3,300)

Hybrid HWR Measure

10

4

3,300

1

0.67

2,200

Hybrid HWM Measure

10

2

3,300

1

0.33

1,100

Non-IPPS Hospitals (1,100)

Hybrid HWR Measure

10

4

1,100

1

0.67

733

Hybrid HWM Measure

10

2

1,100

1

0.33

367

Hybrid Measure Subtotal (IPPS and Non-IPPS)

4,400


Maternal Morbidity Structural Measure

IPPS Hospitals (3,300)

5

1

3,300

1

0.08

275

Non-IPPS Hospitals (1,100)

5

1

1,100

1

0.08

92

Maternal Morbidity Structural Measure Subtotal (IPPS and Non-IPPS)

367


REPORTING eCQMs

IPPS Hospitals (3,300)

Reporting 4 eCQMs

40

3

3,300

1

1.33

6,600

Non-IPPS Hospitals (1,100)

Reporting 4 eCQMs

40

3

1,100

1

1.33

2,200

eCQM Subtotal (IPPS and Non-IPPS)

-

8,800


OTHER ACTIVITIES
All Hospitals (3,300 IPPS + 1,100 non-IPPS)

Population and sampling for the ongoing measure sets

15

4

4,400

4

4

17,600

Review reports for claims-based measure sets

60

4

4,400

1

4

17,600

eCQM Validation

10

2

400

8

2.67

1,067

All other forms used in the data collection process and structural measures

15

1

4,400

1

0.25

1,100

Subtotal other activities

10.92

37,367

Total Burden Hours

 

 

 

 

 

1,579,010

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$66,950,024


Table 2 provides a summary of burden estimates for the measures and activities in Table 1 updated to account for the change in the estimated number of IPPS hospitals from 3,300 to 3,150 and the number of non-IPPS hospitals from 1,100 to 1,350. This adjustment results in a decrease of 66,467 hours and $2,818,201.


Table 2. Updated Burden Estimates for the Hospital IQR Program Measure Set and Other Activities for the FY 2024 Payment Determination

Measure Set

Estimated time per record (minutes) -
FY 2024 payment determination

Number reporting quarters per year -
FY 2024 payment determination

Number of hospitals reporting

Average number records per hospital per quarter

Annual burden (hours) per hospital

Calculation for FY 2024 payment determination

CHART ABSTRACTION

IPPS Hospitals (3,150)

Sepsis Measure

60

4

3,150

100

400

1,260,000

Perinatal care (PC)

10

4

3,150

76

51

159,600

Subtotal IPPS chart-based

 

 

 

 

451

1,419,600


Non-IPPS Hospitals (1,350)

Sepsis measure

60

4

362

25

100

36,200

Perinatal care (PC)

10

4

334

21

14

4,676

Subtotal Non-IPPS chart-based

 

 

 

 

 114

40,876


Subtotal IPPS and Non-IPPS chart-based

 

 

 

 

 

1,460,476



HYBRID MEASURES

IPPS Hospitals (3,150)

Hybrid HWR Measure

10

4

3,150

1

0.67

2,100

Hybrid HWM Measure

10

2

3,150

1

0.33

1,050

Non-IPPS Hospitals (1,350)

Hybrid HWR Measure

10

4

1,350

1

0.67

900

Hybrid HWM Measure

10

2

1,350

1

0.33

450

Hybrid Measure Subtotal (IPPS and Non-IPPS)

4,500


Maternal Morbidity Structural Measure

IPPS Hospitals (3,150)

5

1

3,150

1

0.08

263

Non-IPPS Hospitals (1,350)

5

1

1,350

1

0.08

112

Maternal Morbidity Structural Measure Subtotal (IPPS and Non-IPPS)

375


REPORTING eCQMs

IPPS Hospitals (3,150)

Reporting 4 eCQMs

40

3

3,150

1

2

6,300

Non-IPPS Hospitals (1,350)

Reporting 4 eCQMs

40

3

1,350

1

2

2,700

eCQM Subtotal (IPPS and Non-IPPS)

-

9,000


OTHER ACTIVITIES
All Hospitals (3,150 IPPS + 1,350 non-IPPS)

Population and sampling for the ongoing measure sets

15

4

4,500

4

4

18,000

Review reports for claims-based measure sets

60

4

4,500

1

4

18,000

eCQM Validation

10

2

400

8

2.67

1,067

All other forms used in the data collection process and structural measures

15

1

4,500

1

0.25

1,125

Subtotal other activities

10.92

38,192

Total Burden Hours

 

 

 

 

 

1,512,543

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$64,131,823


Changes to currently approved burden estimates due to proposed policies in the FY 2023 IPPS/LTCH PPS proposed rule are discussed below.


b. Updated Hourly Wage Rate


In the FY 2022 IPPS/LTCH PPS final rule (86 FR 45508), we estimated that the labor performed could be accomplished by Medical Records and Health Information Technician staff based on a mean hourly wage in general medical and surgical hospitals of $20.50 per hour. We note that since then, more recent wage data from the Bureau of Labor Statistics have become available, reflecting a median hourly wage of $21.20 per hour.1 We calculated the cost of overhead, including fringe benefits, at 100% of the mean hourly wage, consistent with previous years. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly between employers, and because methods of estimating these costs vary widely in the literature. Nonetheless, we believe that doubling the hourly wage ($21.20 × 2 = $42.40) to estimate total cost is a reasonably accurate estimation method. As a result of the availability of this more recent wage data, we have updated the wage rate used in these calculations in the FY 2023 IPPS/LTCH PPS proposed rule and this corresponding PRA package to $42.40.


c. Chart-Abstracted Measure Reporting and Submission Requirements for the CY 2023 Reporting Period/FY 2025 Payment Determination and Subsequent Years


We are not proposing any changes to the reporting or submission requirements for chart-abstracted measures in the FY 2023 IPPS/LTCH PPS proposed rule. As shown in Table 1, we continue to estimate the information collection burden associated with the reporting of chart-abstracted measures to be 60 minutes or 1 hour per record for the sepsis measure and 10 minutes or 0.167 hours per record for the perinatal care measure. We continue to assume that each IPPS hospital will report 100 and 76 records quarterly for the sepsis measure and perinatal care measure, respectively. We estimate a total annual burden of 400 hours (1 hour/record x 100 records x 4 quarters) per IPPS hospital for the sepsis measure and 51 hours (0.167 hours/record x 76 records x 4 quarters) per IPPS hospital for the perinatal care measure. We estimate an annual burden of 1,419,600 hours (451 hours/hospital x 3,150 IPPS hospitals) at a cost of $60,191,040 (1,419,600 hours x $42.40).


d. eCQM Reporting and Submission Requirements for the CY 2023 Reporting Period/FY 2025 Payment Determination, and the CY 2024 Reporting Period/FY 2026 Payment Determination and Subsequent Years


In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58974 through 58975), we finalized a policy requiring hospitals to report four quarters of data beginning with the CY 2023 reporting period/FY 2025 payment determination and for subsequent years, while continuing to require hospitals to report three self-selected eCQMs and the Safe Use of Opioids—Concurrent Prescribing eCQM (for a total of four eCQMs). In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing a modification to our eCQM reporting and submission requirements whereby we are increasing the total number of eCQMs to be reported from four to six eCQMs beginning with the CY 2024 reporting period/FY 2026 payment determination.


As previously stated, in the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing to adopt two perinatal eCQMs—Cesarean Birth and Severe Obstetric Complications—beginning with the CY 2023 reporting period/FY 2025 payment determination, followed by mandatory reporting beginning with the CY 2024 reporting period/FY 2026 payment determination and for subsequent years. For the CY 2023 reporting period/FY 2025 payment determination, these two measures are being proposed for inclusion in the Hospital IQR Program measure set, for which hospitals can self-select to report. Beginning with the CY 2024 reporting period/FY 2026 payment determination, these two eCQMs represent the two additional measures hospitals will be required to report.


For the CY 2023 reporting period/FY 2025 payment determination, we estimate the information collection burden associated with the eCQM reporting and submission requirements to be 40 minutes or 0.67 hours per hospital per quarter (10 minutes x 4 eCQMs x = 40 minutes/0.67 hours) with a total burden estimate of 2,100 hours across all IPPS hospitals (0.67 hours × 3,150 IPPS hospitals) for each quarter of eCQM data. As shown in Table 2, using the updated wage estimate described above, we estimate this to represent a total cost of $89,040 ($42.40 hourly wage × 2,100 annual hours) across all IPPS hospitals per each quarter of data. For the CY 2024 reporting period/FY 2026 payment determination and subsequent years, we estimate the information collection burden associated with the eCQM reporting and submission requirements to be 60 minutes or 1 hour per hospital per quarter (10 minutes x 6 eCQMs = 1 hour) with a total burden estimate of 3,150 hours across all IPPS hospitals (1 hour × 3,150 IPPS hospitals) for each quarter of eCQM data. We therefore estimate a total burden of 12,600 burden hours (3,150 hours/quarter x 4 quarters) at a cost of $534,240 (12,600 hours x $42.40/) for reporting four quarters of eCQM data.


We are also proposing to adopt the Hospital-Harm—Opioid-Related Adverse Events eCQM and the Global Malnutrition Composite Score eCQM beginning with the CY 2024 reporting period/FY 2026 payment determination and for subsequent years. We do not believe that our proposed provisions to add these two eCQMs to the eCQM measure set will affect the information collection burden of submitting eCQMs under the Hospital IQR Program. While these provisions result in new eCQMs being added to the Hospital IQR Program measure set, hospitals will not be required to report more than a total of four eCQMs for the CY 2023 reporting period/FY 2025 payment determination and six eCQMs for the CY 2024 reporting period/FY 2026 payment determination and subsequent years.


Table 2. Estimated Burden for the eCQM Reporting and Submission Requirements for the FY 2025 through FY 2028 Payment Determination Years

eCQM Measure Reporting

Estimated time per record (minutes)

Number reporting quarters per year

Number of hospitals reporting

Average number records per hospital per quarter

Annual burden (hours) per hospital

Total Annual Hours for all hospitals

FY 2025 Payment Determination

Reporting 4 eCQMs (IPPS Hospitals)

40

4

3,150

1

2.67

8,400

Reporting 4 eCQMs (Non-IPPS Hospitals)

40

4

1,350

1

2.67

3,600

Total Burden Hours


12,000

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$508,800



FY 2026 through FY 2028 Payment Determination Years


Reporting 6 eCQMs (IPPS Hospitals)

60

4

3,150

1

4

12,600

Reporting 6 eCQMs (Non-IPPS Hospitals)

60

4

1,350

1

4

5,400

Total Burden Hours

18,000

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$763,200


e. Structural Measure Reporting and Submission Requirements for the CY 2023 Reporting Period/FY 2025 Payment Determination and Subsequent Years


We are not proposing any changes to the reporting or submission requirements for the Maternal Morbidity Structural Measure in the FY 2023 IPPS/LTCH PPS proposed rule. In the FY 2022 IPPS/LTCH PPS final rule, we finalized to adopt the Maternal Morbidity Structural Measure beginning with the CY 2021 reporting period/FY 2023 payment determination and for subsequent years. Reporting on the Maternal Morbidity Structural Measure involves each hospital responding to a single question using a web-based tool available via Hospital Quality Reporting (HQR) System (formerly referred to as the QualityNet Secure Portal) with one of the following response options: (A) “Yes”; (B) “No”; or (C) “N/A (our hospital does not provide inpatient labor/delivery care).” Hospitals are required to submit responses for this structural measure on an annual basis during the submission period.  As shown in Table 3, using the estimate of five minutes (or 0.083 hours) per hospital per year, and the updated wage estimate as described previously, we estimate a total annual burden of 263 hours across all IPPS hospitals (0.083 hours × 3,150 IPPS hospitals) at a cost of $11,130 (263 hours × $42.40).


In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing the adoption of the Hospital Commitment to Health Equity structural measure beginning with the CY 2023 reporting period/FY 2025 payment determination and for subsequent years. Hospitals would report data via the HQR System. We are proposing to require hospitals to submit the response on an annual basis during the submission period. We estimate the information collection burden associated with this proposed structural measure to be, on average across all 3,150 IPPS hospitals, no more than 10 minutes per hospital per year, as it involves attesting to as many as five questions one time per year for a given reporting period. While we understand some hospitals may require more than 10 minutes to research the information needed to respond, we believe that the majority of hospitals will have the information readily available to respond to the questions and will require less than 10 minutes. In addition, we believe that many hospitals would be able to submit similar responses in future years, thereby reducing the actual time to respond in subsequent reporting periods. Using the estimate of 10 minutes (or 0.167 hours) per hospital per year, and the updated wage estimate as described previously, we estimate that this proposed policy would result in a total annual burden increase of 525 hours across all participating IPPS hospitals (0.167 hours × 3,150 IPPS hospitals) at a cost of $22,260 (525 hours × $42.40).



Table 3. Estimated Burden for Structural Measure Reporting for the FY 2025 through FY 2028 Payment Determination Years

Structural Measure Reporting

Estimated time per record (minutes)

Number reporting quarters per year

Number of hospitals reporting

Average number records per hospital per quarter

Annual burden (hours) per hospital

Total Annual Hours for all hospitals

FY 2025 through FY 2028 Payment Determination Years

Maternal Morbidity Measure (IPPS Hospitals)

5

1

3,150

1

0.083

263

Maternal Morbidity Measure (Non-IPPS Hospitals)

5

1

1,350

1

0.083

112

Total Burden Hours

375

Hospital Commitment to Health Equity Measure (IPPS Hospitals)

10

1

3,150

1

0.167

525

Hospital Commitment to Health Equity Measure (Non-IPPS Hospitals)

10

1

1,350

1

0.167

225

Total Burden Hours

750

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$47,700


f. Hybrid Measure Reporting and Submission Requirements for the CY 2023 Reporting Period/FY 2025 Payment Determination and Subsequent Years


We are not proposing any changes to the reporting or submission requirements for the Hybrid HWR and Hybrid HWM measures in the FY 2023 IPPS/LTCH PPS proposed rule. In the FY 2020 IPPS/LTCH PPS final rule, we finalized the adoption of the Hybrid HWR measure (84 FR 42505 through 42508). In the FY 2022 IPPS/LTCH PPS final rule, we finalized the adoption of the Hybrid HWM measure. As shown in Table 4, we continue to estimate the information collection burden associated with these measures will be 10 minutes per measure per quarter for each hospital. The total annual burden estimate beginning with the CY 2023 reporting period/FY 2025 payment determination is 1.33 hours per hospital (10 minutes/quarter x 2 measures x 4 quarters) at a cost of $56.53 (1.33 hours x $42.40) for each hospital. The total annual burden for all 3,150 IPPS hospitals is estimated to be 4,200 hours (1.33 hours/hospital x 3,150 hospitals) at a cost of $178,080 (4,200 hours x $42.40).


The Hybrid HWR and Hybrid HWM measures use both claims-based data and EHR data, specifically, a set of core clinical data elements consisting of vital signs and laboratory test information and patient linking variables collected from hospitals’ EHR systems. We do not expect any additional burden to hospitals to report the claims-based portion of these measures because these data are already reported to the Medicare program for payment purposes. However, we do expect that hospitals will experience burden in reporting the EHR data.


Table 4. Estimated Burden for Hybrid Measure Reporting and Submission Requirements for the FY 2025 through FY 2028 Payment Determination Years

Hybrid Measure Reporting

Estimated time per record (minutes)

Number reporting quarters per year

Number of hospitals reporting

Average number records per hospital per quarter

Annual burden (hours) per hospital

Total Annual Hours for all hospitals

FY 2025 through FY 2028 Payment Determination Years


Hybrid HWR Measure (IPPS Hospitals)

10

4

3,150

1

0.67

2,100

Hybrid HWR Measure (Non-IPPS Hospitals)

10

4

1,350

1

0.67

900

Total Burden Hours

3,000

Hybrid HWM Measure (IPPS Hospitals)

10

4

3,150

1

0.67

2,100

Hybrid HWM Measure (Non-IPPS Hospitals)

10

4

1,350

1

0.67

900

Total Burden Hours

3,000

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$254,400


g. Process Measure Reporting and Submission Requirements for the CY 2023 Reporting Period/FY 2025 Payment Determination and Subsequent Years


In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing to adopt the Screening for Social Drivers of Health and the Screen Positive Rate for Social Drivers of Health process measures beginning with voluntary reporting in the CY 2023 reporting period and mandatory reporting beginning with the CY 2024 Reporting Period/FY 2026 payment determination. Hospitals would report data through the HQR System.


For the Screening for Social Drivers of Health measure, hospitals would be able to collect data and report the measure via multiple methods. We believe the Outcome and Assessment Information Set (OASIS), which is currently used in the Home Health Quality Reporting Program, is a reasonable comparison for estimating the information collection burden for the Screening for Social Drivers of Health measure due to analogous assessment of patient-level need. OASIS is a core standard data assessment data set home health agencies integrate into their own patient-specific, comprehensive assessment to identify each patient’s need for home care that meets the patient’s medical, nursing, rehabilitative, social, and discharge planning needs. For OASIS, the currently approved information collection burden under OMB 0938-1279 is estimated to be 0.3 minutes per data element (18 seconds). For the five HRSN domains screened for by the Social Drivers of Health measure, we estimate a total of 2 minutes (0.033 hours) per patient to conduct this screening. The most recent data from the Bureau of Labor Statistics reflects an Average Hourly Earnings of $31.31.2 Based on information collected by the American Hospital Association,3 we estimate approximately 21,000,000 patients (34,251,159 total admissions in U.S. community hospitals x 3,150 IPPS hospitals ÷ 5,198 total U.S. community hospitals) will be screened annually across all participating IPPS hospitals. We estimate that during the voluntary period, 50 percent of hospitals will survey 50 percent of patients. We estimate that during the mandatory period, hospitals would submit for 100 percent of patients. For the CY 2023 voluntary reporting period, we estimate a total burden of 175,000 hours (21,000,000 respondents x 50 percent of patients x 50 hospitals of hospitals x 0.033 hours) at a cost of $5,479,250 (175,000 hours x $31.31) across all participating IPPS hospitals. For the CY 2024 reporting period and subsequent years, we estimate a total annual burden of 700,000 hours (21,000,000 respondents x 0.033 hours) at a cost of $21,917,000 (700,000 hours x $31.31) across all participating IPPS hospitals.


Measure data would be submitted via the HQR System annually. Similar to the currently approved data submission and reporting burden estimate for eCQMs in the Hospital IQR Program reported via the HQR System, we estimate a burden of 10 minutes per hospital response to transmit the measure data. We estimate that during the voluntary period, 50 percent of hospitals will submit data. For the CY 2023 voluntary reporting period, we estimate a total burden of 263 hours (0.1667 hours x 3,150 hospitals x 50 percent of hospitals) at a cost of $11,130 (263 hours x $42.40) across all participating IPPS hospitals. For the CY 2024 reporting period and subsequent years, we estimate a total annual burden for all IPPS hospitals of 525 hours (0.1667 hours x 3,150 hospitals) at a cost of $22,260 (525 hours x $42.40).


For the Screening Positive Rate for Social Drivers of Health measure, hospitals would be required to report on an annual basis the number of patients who screen positive for one or more of the five domains (reported as five separate rates) divided by the total number of patients screened. For this measure, we estimate only the additional burden for a hospital reporting this measure via the HQR System since patients would not need to provide any additional information for this measure. We estimate that during the voluntary period, 50 percent of hospitals would submit data. For the CY 2023 voluntary reporting period, we estimate a total burden of 263 hours (0.1667 hours x 3,150 hospitals x 50 percent of hospitals) at a cost of $11,130 (263 hours x $42.40) across all participating IPPS hospitals. For the CY 2024 reporting period and subsequent years, we estimate a total annual burden estimate for all participating IPPS hospitals of 525 hours (0.1667 hours/measure x 3,150 hospitals) at a cost of $22,260 (525 hours x $42.40).


Table 5. Estimated Burden for the Process Measures Reporting and Submission Requirements for the FY 2026 through FY 2028 Payment Determination Years

Process Measure Reporting

Estimated time per record (minutes)

Number reporting quarters per year

Number of respondents

Average number records per respondent per quarter

Annual burden (hours) per hospital

Total Annual Hours for all respondents

FY 2025 Payment Determination Year


Screening for Social Drivers of Health Measure (Survey) (IPPS Hospitals)

0.033

1

5,250,000

1

111.11

175,000

Screening for Social Drivers of Health Measure (Reporting) (IPPS Hospitals)

10

1

1,575

1

0.167

263

Screening for Social Drivers of Health Measure (Survey) (Non-IPPS Hospitals)

0.033

1

2,250,000

1

111.11

75,000

Screening for Social Drivers of Health Measure (Reporting) (Non-IPPS Hospitals)

10

1

675

1

0.167

112

Total Burden Hours

250,375

Total Burden @ Average Individual labor rate ($31.31/hr)

$7,827,500

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$15,900

Screen Positive Rate for Social Drivers of Health Measure (IPPS Hospitals)

10

1

1,575

1

0.167

263

Screen Positive Rate for Social Drivers of Health Measure (Non-IPPS Hospitals)

10

1

675

1

0.167

112

Total Burden Hours

375

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$15,900


FY 2026 through FY 2028 Payment Determination Years


Screening for Social Drivers of Health Measure (Survey) (IPPS Hospitals)

0.033

1

21,000,000

1

222.2

700,000

Screening for Social Drivers of Health Measure (Reporting) (IPPS Hospitals)

10

1

3,150

1

0.167

525

Screening for Social Drivers of Health Measure (Survey) (Non-IPPS Hospitals)

0.033

1

9,000,000

1

222.2

300,000

Screening for Social Drivers of Health Measure (Reporting) (Non-IPPS Hospitals)

10

1

1,350

1

0.167

225

Total Burden Hours

1,000,750

Total Burden @ Average Individual labor rate ($31.31/hr)

$31,310,000

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$31,800

Screen Positive Rate for Social Drivers of Health Measure (IPPS Hospitals)

10

1

3,150

1

0.167

525

Screen Positive Rate for Social Drivers of Health Measure (Non-IPPS Hospitals)

10

1

1,350

1

0.167

225

Total Burden Hours

750

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$31,800



h. Patient-Reported Outcomes-Based Performance Measure (PRO-PM) Reporting and Submission Requirements for the CY 2024 Reporting Period/FY 2026 Payment Determination and Subsequent Years


In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing to adopt the Hospital-Level THA/TKA PRO-PM measure beginning with voluntary reporting across two periods (July 1, 2023 through June 30, 2024 and July 1, 2024 through June 30, 2025), followed by mandatory reporting of the measure beginning with the reporting period which runs from July 1, 2025 through June 30, 2026, impacting the FY 2028 payment determination, and for subsequent years.


The Hospital-Level THA/TKA PRO-PM uses four sources of data for the calculation of the measure: (1) Patient-reported outcome (PRO) data; (2) claims data; (3) Medicare enrollment and beneficiary data; and (4) U.S. Census Bureau survey data. We estimate no additional burden associated with claims data, Medicare enrollment and beneficiary data, and U.S. Census Bureau survey data as these data are already collected via other mechanisms.


Many hospitals have already incorporated PRO data collection into their workflows. Hospitals new to collecting PRO data have multiple options for when and how they would collect this data so they can best determine the mode and timing of collection that works best for their patient population. The possible patient touchpoints for pre-operative PRO data collection include the doctor’s office, pre-surgical steps such as education classes, or medical evaluations that can occur in an office or at the hospital. The modes of PRO data collection can include completion of the pre-operative surveys using electronic devices (such as an iPad or tablet), pen and paper, mail, phone call, or through the patient’s portal. Post-operative PRO data collection modes are similar to pre-operative modes. The possible patient touchpoints for post-operative data collection can occur before the follow-up appointment, at the doctor’s office, or after the follow-up appointment. The potential modes of PRO data collection for post-operative data are the same as for pre-operative data. If the patient does not or cannot attend a follow-up appointment, the modes of collection can include completion of the post-operative survey using email, mail, phone, or through the patient portal. Use of multiple modes would increase response rates as it allows for different patient preferences.


For the Hospital-Level THA/TKA PRO-PM data, we are proposing that hospitals would be able to submit data during two voluntary periods, followed by a mandatory period for eligible elective procedures occurring July 1, 2025 through June 30, 2026, impacting the FY 2028 payment determination and for subsequent years. Hospitals would need to submit data twice (pre-operative data and post-operative data). For the purposes of calculating collection of information-related burden, we estimate that during the voluntary periods, 50 percent of hospitals would submit data, and would do so for 50 percent of THA/TKA patients. We estimate during the mandatory period, hospitals would submit for 100 percent of patients. While we are proposing that hospitals would be required to submit, at minimum, 50 percent of eligible, complete pre-operative data with matching eligible, complete post-operative data, we are conservative in our estimate for the mandatory period in case hospitals exceed this currently proposed threshold.


Under OMB control number 0938-0981 (expiration date September 30, 2024), the currently approved burden per respondent to complete the HCAHPS Survey is 7.25 minutes (0.120833 hours). We estimate that the time to complete both the pre-operative and post-operative surveys is analogous to completing the HCAHPS Survey once. The most recent data from the Bureau of Labor Statistics reflects an Average Hourly Earnings of $31.31.4 For burden estimation purposes, we assume that most hospitals will likely undertake PRO data collection through a screening tool incorporated into their EHR or other patient intake process. We estimate that approximately 330,000 THA/TKA procedures occur in the inpatient setting each year, and that many patients could complete both the pre-operative and post-operative questionnaires, although from our experience with using this measure in the Comprehensive Joint Replacement model, we are also aware that not all patients who complete the pre-operative questionnaire would complete the post-operative questionnaire. Due to the performance period for the first voluntary reporting period being 6 months, we assume 41,250 patients will complete the survey (165,000 patients x 50 percent x 50 percent of hospitals) for a total of 4,984 hours annually (41,250 respondents x 0.120833 hours) at a cost of $156,061 (4,984 hours x $31.31) across all IPPS hospitals. For the second voluntary reporting period, we assume 82,500 patients will complete the survey (330,000 patients x 50 percent x 50 percent of hospitals) for a total of 9,969 hours annually (82,500 respondents x 0.120833 hours) at a cost of $312,122 (9,969 hours x $31.31) across all participating IPPS hospitals. Beginning with mandatory reporting for the FY 2028 payment determination, we estimate a total of 39,875 hours (330,000 patients x 0.120833 hours) at a cost of $1,248,486 (39,875 hours x $31.31) across all IPPS hospitals. Due to the voluntary and mandatory performance periods occurring across reporting periods, we have included Table 6 below to allow for easier understanding of how many procedures (and therefore how many surveys) are estimated to be conducted during each reporting period.


Table 6. Estimated Number of THA/TKA PRO-PM Surveys Conducted in the CY 2023 through CY 2026 Reporting Periods


Reporting Period

Performance Period

Number of Procedures

Minutes per Survey

Burden Hours

Total Burden

CY2023

1st Voluntary Period

20,625

7.25

2,492

2,492

CY2024

1st Voluntary Period

20,625

7.25

2,492

7,477

CY2024

2nd Voluntary Period

41,250

7.25

4,984

CY2025

2nd Voluntary Period

41,250

7.25

4,984

24,922

CY2025

Mandatory Period

165,000

7.25

19,938

CY2026

Mandatory Period

330,000

7.25

39,875

39,875


For the data submission, which would be reported via the HQR System, we estimate a burden of 10 minutes per response. For each of the two voluntary reporting periods, we estimate that each hospital will spend 20 minutes (0.33 hours) annually (10 minutes x 2 surveys) to collect and submit the data via this tool. We estimate a resulting burden for all participating IPPS hospitals of 525 hours (0.33 hours x 3,150 hospitals x 50 percent) at a cost of $22,260 (525 hours x $42.40). Beginning with mandatory reporting for the FY 2028 payment determination, we estimate a total of 1,050 hours (0.33 hours x 3,150 hospitals) at a cost of $44,520 (1,050 hours x $42.40).


We are not able to accurately distinguish the number of procedures that take place in IPPS hospitals from those conducted in non-IPPS hospitals. As a result, we combine the burden associated with completion of the pre-operative and post-operative surveys in Table 7.


Table 7. Estimated Burden for PRO-PM Measure Reporting and Submission Requirements for the FY 2025 through FY 2028 Payment Determination Years

PRO-PM Measure Reporting

Estimated time per record (minutes)

Number reporting quarters per year

Number of respondents

Average number records per respondent per quarter

Annual burden (hours) per hospital

Total Annual Hours for all respondents

FY 2025 Payment Determination


IPPS and Non-IPPS Hospitals (Survey)

7.25

N/A

20,625

N/A

1.11

2,492

IPPS Hospitals (Reporting)

10

2

1,575

1

0.33

525

Non-IPPS Hospitals (Reporting)

10

2

675

1

0.33

225

Total Burden Hours

3,242

Total Burden @ Average Individual labor rate ($31.31/hr)

$78,030

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$31,800


FY 2026 Payment Determination


IPPS and Non-IPPS Hospitals (Survey)

7.25

N/A

61,875

N/A

3.32

7,477

IPPS Hospitals (Reporting)

10

2

1,575

1

0.33

525

Non-IPPS Hospitals (Reporting)

10

2

675

1

0.33

225

Total Burden Hours

8,227

Total Burden @ Average Individual labor rate ($31.31/hr)

$234,091

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$31,800


FY 2027 Payment Determination


IPPS and Non-IPPS Hospitals (Survey; Voluntary)

7.25

N/A

41,250

N/A

2.22

4,984

IPPS and Non-IPPS Hospitals (Survey; Mandatory)

7.25

N/A

165,000

N/A

4.43

19,938

IPPS Hospitals (Voluntary Reporting)

10

1

1,575

1

0.167

263

IPPS Hospitals (Mandatory Reporting)

10

1

3,150

1

0.167

525

Non-IPPS Hospitals (Voluntary Reporting)

10

1

675

1

0.167

112

Non-IPPS Hospitals (Mandatory Reporting)

10

1

1,350

1

0167

225

Total Burden Hours

26,047

Total Burden @ Average Individual labor rate ($31.31/hr)

$780,304

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$47,700


FY 2028 Payment Determination


IPPS and Non-IPPS Hospitals (Survey)

7.25

N/A

330,000

N/A

8.86

39,875

IPPS Hospitals (Reporting)

10

2

3,150

1

0.33

1,050

Non-IPPS Hospitals (Reporting)

10

2

1,350

1

0.33

450

Total Burden Hours

41,375

Total Burden @ Average Individual labor rate ($31.31/hr)

$1,248,486

Total Burden @ Medical Records and Health Information Technician labor rate ($42.40/hr)

$63,600



i. Validation of Hospital IQR Program Measure Data, Population and Sampling for Ongoing Measure Sets, and Reviewing Reports for Claims-Based Measure Sets


We continue to estimate the information collection burden associated with eCQM validation beginning with the CY 2023 reporting period/FY 2025 payment determination to be 10 minutes per record for the pool of 400 hospitals selected. In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing modify our eCQM validation policy to increase the reporting of medical requests from at least 75 percent of records to 100 percent of records beginning with the CY 2023 reporting period/FY 2025 payment determination and for subsequent years. In the FY 2017 IPPS/LTCH PPS final rule, we finalized to require submission of at least 75 percent of sampled eCQM medical records in a timely and complete manner (81 FR 57181). We estimate the burden associated with this finalized policy with the assumption that hospitals would submit 100 percent of sampled eCQM medical records (81 FR 57261). Based on this assumption, we believe the currently approved burden already includes any additional burden associated with this proposed policy and are therefore making no changes to our burden estimate.


As shown in Tables 8 and 9, for eCQM validation of CY 2022 data impacting the FY 2025 payment determination, we estimate a total burden of 1,600 hours across 400 IPPS hospitals selected for eCQM validation (0.167 hours × 3 quarters × 8 cases × 400 IPPS hospitals) at a cost of $67,840 ($42.40 × 1,600 annual hours). For eCQM validation of CY 2023 data impacting the FY 2026 payment determination and for subsequent years, we estimate a total burden of 2,133 hours across 400 IPPS hospitals selected for eCQM validation (0.167 hours × 4 quarters × 8 cases × 400 IPPS hospitals) at a cost of $90,439 ($42.40 × 2,133 annual hours).


As shown in Table 1, we continue to estimate the information collection burden associated with population and sampling of ongoing measure sets to be 15 minutes per record per quarter and assume each hospital will report four records for four quarters each year. The total annual burden estimate per hospital is 4 hours (15 minutes/record/quarter x 4 records x 4 quarters) at a cost of $164 ($42.40 x 4 hours). For all 4,500 IPPS and non-IPPS hospitals, we estimate a total annual burden of 18,000 hours (4 hours x 4,500 hospitals) at a cost of $763,200 ($42.40 x 18,000 hours).


Also as shown in Table 1, we continue to estimate the information collection burden associated with reviewing reports for claims-based measure sets to be 60 minutes per record per quarter and assume each hospital will report one record for four quarters each year. The total annual burden estimate per hospital is 4 hours (60 minutes/quarter x 4 quarters) at a cost of $170 ($42.40 x 4 hours). For all 4,500 hospital (IPPS and non-IPPS), we estimate a total annual burden of 18,000 hours (4 hours x 4,500 hospitals) at a cost of $763,200 ($42.40 x 18,000 hours).


j. Additional Information on Burden Estimates


Time estimates for activities other than chart-abstraction, including completion of the forms listed below, routine reporting of population and sampling numbers for ongoing chart-abstracted measures, and review of reports were made in consultation with our Hospital IQR Program support contractor, which is responsible for routine interface with hospitals and Quality Improvement Organizations regarding Hospital IQR Program requirements. We define “all other forms used in the data collection process” as the forms listed below. Consistent with estimates in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49762), we estimate a burden of 15 minutes per hospital to complete all applicable forms.


Other than the DACA form, the forms listed in section B.12.l. would not be filled out by hospitals on a regular basis. Because the CMS Quality Reporting Program Extraordinary Circumstances Exceptions (ECE) Request Form would be used across ten quality programs (Hospital IQR Program, Hospital Outpatient Quality Reporting Program, Inpatient Psychiatric Facility Quality Reporting Program, PPS-Exempt Cancer Hospital Quality Reporting Program, Ambulatory Surgical Center Quality Reporting Program, Hospital VBP Program, Hospital-Acquired Condition Reduction Program, Hospital Readmissions Reduction Program, End Stage Renal Disease Quality Incentive Program, and Skilled Nursing Facility Value-Based Purchasing Program), we have included a burden calculation using this form as an example of “all other forms” within this PRA package. This form is intended to be submitted by participants only in the event of an extraordinary circumstance or disaster if they seek an exception from data reporting requirements due to such extraordinary circumstance. For example, in CY 2018, 89 ECE requests were submitted by hospitals for an exception from reporting requirements in the Hospital IQR Program. Based on our estimation of 15 minutes per record to submit the ECE Request Form, the total burden calculation for the submission of 89 ECE Request Forms was 1,335 minutes (or 22.25 hours) across 3,150 IPPS hospitals. Note that non-IPPS hospitals do not need this form because they participate in quality data reporting on a voluntary basis. We were conservative in our estimate (provided in Table 1 above) of 1,350 hours across all IPPS and non-IPPS hospitals, thus this 22.25 hours ECE Request Form burden estimation is accounted for in that figure.


As shown in Table 1, we estimate the information collection burden per hospital associated with completing all other forms used in the data collection process to be 15 minutes (0.25 hours) per year at a cost of $10.60 ($42.40 x 0.25 hours). For all 4,500 IPPS and non-IPPS hospitals, we estimate a total annual burden of 1,125 hours (0.25 hours x 4,500 hospitals) at a cost of $47,700 ($42.40 x 1,125 hours).


k. Burden Estimate Summary


As shown in Tables 8 and 9, in summary, under OMB control number 0938-1022, we estimate a total annual information collection burden increase for 4,500 hospitals (IPPS and non-IPPS) of 983,258 hours associated with our proposed policies and updated burden estimates described above and a total cost increase related to this information collection of approximately $30,157,925 (which also reflects use of an updated hourly wage rate as previously discussed), from the CY 2023 reporting period/FY 2025 payment determination through the CY 2026 reporting period/FY 2028 payment determination, compared to our currently approved information collection burden estimates. The tables below summarizes the total burden changes for each respective FY payment determination compared to our currently approved information collection burden estimates (the columns in each table for the FY 2028 payment determination reflects the cumulative burden changes).


Table 8. Summary of Annual Burden Hour Estimates for the FY 2024 through FY 2028

Payment Determination Years


ANNUAL BURDEN HOURS

Information Collection

FY2024

Difference from Currently Approved

FY2025

Difference from Currently Approved

FY2026

Difference from Currently Approved

FY2027

Difference from Currently Approved

FY2028

Difference from Currently Approved

Chart Abstraction











IPPS

1,419,600

-67,600

1,419,600

-67,600

1,419,600

-67,600

1,419,600

-67,600

1,419,600

-67,600

Non-IPPS

40,876

0

40,876

0

40,876

0

40,876

0

40,876

0

Hybrid Measures











IPPS

3,150

-150

4,200

-200

4,200

-200

4,200

-200

4,200

-200

Non-IPPS

1,350

+250

1,800

+333

1,800

+333

1,800

+333

1,800

+333

Structural Measures











IPPS

263

-12

788

+513

788

+513

788

+513

788

+513

Non-IPPS

112

+20

337

+245

337

+245

337

+245

337

+245

Reporting eCQMs











IPPS

6,300

-300

8,400

-400

12,600

+3,800

12,600

+3,800

12,600

+3,800

Non-IPPS

2,700

+500

3,600

+667

5,400

+2,467

5,400

+2,467

5,400

+2,467

Process Measures











IPPS

0

0

175,525

+175,525

701,050

+701,050

701,050

+701,050

701,050

+701,050

Non-IPPS

0

0

75,225

+75,225

300,450

+300,450

300,450

+300,450

300,450

+300,450

PRO-PM Measures











IPPS

0

0

3,017

+3,017

8,002

+8,002

25,710

+25,710

40,925

+40,925

Non-IPPS

0

0

225

+225

225

+225

337

+337

450

+450

Population and sampling for the ongoing measure sets

18,000

+400

18,000

+400

18,000

+400

18,000

+400

18,000

+400

Review reports for claims-based measure sets

18,000

+400

18,000

+400

18,000

+400

18,000

+400

18,000

+400

eCQM Validation

1,067

0

1,600

0

2,133

0

2,133

0

2,133

0

All other forms used in the data collection process

1,125

+25

1,125

+25

1,125

+25

1,125

+25

1,125

+25

TOTAL

1,512,543

-66,467

1,772,318

+188,375

2,534,586

+950,110

2,552,406

+967,930

2,567,734

+983,258





Table 9. Summary of Annual Burden Cost Estimates for the FY 2024 through FY 2028 Payment Determination Years*


ANNUAL BURDEN COST

Information Collection

FY2024

Difference from Currently Approved

FY2025

Difference from Currently Approved

FY2026

Difference from Currently Approved

FY2027

Difference from Currently Approved

FY2028

Difference from Currently Approved

Chart Abstraction











IPPS

$60,191,040

-$2,866,240

$60,191,040

-$2,866,240

$60,191,040

-$2,866,240

$60,191,040

-$2,866,240

$60,191,040

-$2,866,240

Non-IPPS

$1,733,142

0

$1,733,142

0

$1,733,142

0

$1,733,142

0

$1,733,142

0

Hybrid Measures











IPPS

$133,560

-$6,360

$178,080

-$8,480

$178,080

-$8,480

$178,080

-$8,480

$178,080

-$8,480

Non-IPPS

$57,240

+$10,600

$76,320

+$14,119

$76,320

+$14,119

$76,320

+$14,119

$76,320

+$14,119

Structural Measures











IPPS

$11,151

-$509

$33,411

+$21,751

$33,411

+$21,751

$33,411

+$21,751

$33,411

+$21,751

Non-IPPS

$4,749

+$848

$14,289

+$10,388

$14,289

+$10,388

$14,289

+$10,388

$14,289

+$10,388

Reporting eCQMs











IPPS

$267,120

-$12,720

$356,160

-$16,960

$534,240

+$161,120

$534,240

+$161,120

$534,240

+$161,120

Non-IPPS

$114,480

+$21,200

$152,640

+$28,281

$228,960

+$104,601

$228,960

+$104,601

$228,960

+$104,601

Process Measures











IPPS

0

0

$5,501,510

+$5,501,510

$21,961,520

+$21,961,520

$21,961,520

+$21,961,520

$21,961,520

+$21,961,520

Non-IPPS

0

0

$2,357,790

+$2,357,790

$9,412,080

+$9,412,080

$9,412,080

+$9,412,080

$9,412,080

+$9,412,080

PRO-PM Measures











IPPS**

0

0

$100,290

+$100,290

$256,351

+$256,351

$813,715

+$813,715

$1,293,006

+$1,293,006

Non-IPPS

0

0

$9,540

+$9,540

$9,540

+$9,540

$14,289

+$14,289

$19,080

+$19,080

Population and sampling for the ongoing measure sets

$763,200

+$16,960

$763,200

+$16,960

$763,200

+$16,960

$763,200

+$16,960

$763,200

+$16,960

Review reports for claims-based measure sets

$763,200

+$16,960

$763,200

+$16,960

$763,200

+$16,960

$763,200

+$16,960

$763,200

+$16,960

eCQM Validation

$45,241

0

$67,840

0

$90,439

0

$90,439

0

$90,439

0

All other forms used in the data collection process

$47,700

$1,060

$47,700

$1,060

$47,700

$1,060

$47,700

$1,060

$47,700

$1,060

TOTAL

$64,131,823

-$2,818,201

$72,346,153

+$5,186,970

$96,293,513

+$29,111,730

$96,855,626

+$29,673,843

$97,339,708

+$30,157,925

* Cost estimates are based on updated wage rate of $42.40. Differences from currently approved burden account for updating estimates of currently approved hours to the new wage rate.

** Includes burden associated with surveys completed by patients receiving care at Non-IPPS hospitals (see Section 12.h)


l. Information Collection Instruments/Instructions


  • The Hospital Inpatient Quality Reporting Notice of Participation is being resubmitted for updates made to the instructions to reflect changes to the Notice of Participation application process in the new Hospital Quality Reporting (HQR) System.

  • The Hospital Quality Reporting Data Accuracy and Completeness Acknowledgement form is being resubmitted to reflect updates to remove the individual measures to make it more general, e.g. removed “Sepsis” from the chart-abstracted measure. This will make it easier if new measures are added.

  • The Hospital Compare Request Form for Withholding/Footnoting Data for Public Reporting is being resubmitted to add new measures.

  • The CMS IPPS Quality Reporting Programs Measure Exception Form for PC and HAI Data Submission is being resubmitted to make minor updates to instructions.

  • The CMS Quality Reporting Program APU Reconsideration Request Form is being resubmitted to update instructions to encourage the use of Managed File Transfer.

  • The CMS Quality Program Extraordinary Circumstances Exceptions (ECE) Request Form is being resubmitted to (1) add the COVID-19 HCP Vaccination measure (2) add non-measure and other options for SNF VBP.

  • The Hospital Value-Based Purchasing (VBP) Program Review and Corrections Request Form, Appeal Request Form, and Independent CMS Review Request Form are being resubmitted but have no updates.

  • The Hospital IQR Program Maternal Morbidity Structural measure web-based form is being add to this package. This form replicates the web-based screen within the Hospital Quality Reporting (HQR) System that hospitals use to submit data for the Maternal Morbidity Structural measure.

  • The Hospital IQR PC-01 measure web-based form replicates the web-based screen within the HQR System that hospitals use to submit data for the PC-01 measure.

  • The Hospital IQR Population and Sampling web-based form replicates the web-based screen within the HQR System that hospitals use to submit population and sampling data.


The following information collection forms will continue to be used without any modifications and are not being revised with this PRA package:

  • CMS Quality Reporting Validation Educational Review Form

  • The CMS Hospital IQR Program Validation Review for Reconsideration Request Form

  • Hospital Value-Based Purchasing (VBP) Program Review and Corrections Request Form

  • Hospital VBP Appeal Request Form

  • Hospital VBP Independent CMS Review Request Form

  • CMS Quality Reporting Validation Educational Review Form

.


13. Capital Costs (Maintenance of Capital Costs)


In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing the Hospital Commitment to Health Equity structural measure. In order for hospitals to receive a point for each of the five domains in the measure, affirmative attestations are required for each of the elements within a domain. For hospitals that are unable to attest affirmatively for an element, there are likely to be additional costs associated with activities such as updating hospital policies, engaging senior leadership, participating in new quality improvement activities, performing additional data analysis, and training staff. The extent of these costs will vary from hospital to hospital depending on what activities the hospital is already performing, hospital size, and the individual choices each hospital makes in order to meet the criteria necessary to attest affirmatively.


We are also proposing the Screening for Social Drivers of Health measure. For hospitals that are not currently administering some screening mechanism and elect to begin doing so as a result of this policy, there would be some non-recurring costs associated with changes in workflow and information systems to collect the data. The extent of these costs is difficult to quantify as different hospitals may utilize different modes of data collection (for example paper-based, electronically patient-directed, clinician-facilitated, etc.).


Lastly, we are proposing the Hospital-Level THA/TKA PRO-PM. For hospitals that are not currently collecting this data and elect to begin doing so as a result of this policy, there would be some non-recurring costs associated with changes in workflow and information systems to collect the data. The extent of these costs is difficult to quantify as different hospitals may utilize different modes of data collection (for example paper-based, electronically patient-directed, clinician-facilitated, etc.). While we assume the majority of hospitals will report data for this measure via the HQR System, we assume some hospitals may elect to submit measure data via a third-party CMS-approved survey vendor, for which there are associated costs. Under OMB control number 0938-0981 for the HCAHPS Survey measure (expiration date September 30, 2024), an estimate of approximately $4,000 per hospital is used to account for these costs. This estimate originates from 2012, therefore, to account for inflation (assuming end of CY 2012 to end of CY 2021), we adjust the price using the Bureau of Labor Statistics Consumer Price Index and estimate an updated cost of approximately $4,856 ($4,000 x 121.4 percent).5


14. Cost to Federal Government


The cost to the Federal Government includes costs associated with the collection and validation of the data. These costs are estimated at $10,050,000 annually for the validation and quality reporting contracts. Additionally, this program takes three CMS staff at a GS-13 level with approximate annual salaries of $106,823 per staff member to operate for an additional cost of $320,469.


For the claims-based measures, the cost to the Federal Government is minimal. CMS uses data from the CMS National Claims History system that are already being collected for provider reimbursement; therefore, no additional data will need to be submitted by hospitals for claims-based measures.


15. Program or Burden Changes


We previously requested and received approval for total annual burden estimates under this OMB control number for the CY 2022 reporting period/FY 2024 payment determination of 1,579,010 hours at a total cost of approximately $64.7 million (accounting for updated wage rates) as a result of policies finalized in the FY 2022 IPPS/LTCH PPS final rule. The updated wage rate from $41.00/hour to $42.40/hour results in a total increase of approximately $2.2 million. We have also adjusted our estimates of the number of IPPS hospitals from 3,300 to 3,150 and non-IPPS hospitals from 1,100 to 1,350. This adjustment results in a total decrease of 66,634 hours and $2,825,282 (66,634 hours x $42.40).


The proposed policy in the FY 2023 IPPS/LTCH PPS proposed rule to adopt the Hospital Commitment to Health Equity structural measure for the FY 2023 payment determination results in an annual burden increase of 750 hours and $31,800. The proposed policy to adopt the Screening for Social Drivers of Health process measure beginning in the CY 2023 reporting period/FY 2025 payment determination results in an annual burden increase of 1,000,750 hours and $31,341,800. The proposed policy to adopt the Screen Positive Rate for Social Drivers of Health process measure beginning in the CY 2023 reporting period/FY 2025 payment determination results in an annual burden increase of 750 hours and $31,800. The proposed policy to adopt the Hospital-Level THA/TKA PRO-PM beginning in the CY 2023 reporting period/FY 2025 payment determination results in an annual burden increase of 41,375 hours and $1,312,086. The proposed policy to require hospitals to report six eCQMs beginning in the CY 2024 reporting period/FY 2026 payment determination results in an annual burden increase of 6,267 hours and $265,721.


The aggregate increase due to these proposals and adjustments is 977,158 hours (-66,467 + 750 + 1,000,750 + 750 + 41,375 + 6,267) and $29,899,285 (-$2,818,201 + $31,800 + 31,341,800 + $31,800 + $1,312,086 + 265,721) as shown in Tables 8 and 9.


16. Publication/Tabulation Data


The goal of the data collection is to tabulate and publish hospital-specific data. We will continue to display hospital quality information for public viewing as required by Social Security Act sections 1886(b)(3)(B)(viii)(VII) for the Hospital IQR Program, 1886(o)(10) for the Hospital VBP Program, 1886(p)(6) for the HAC Reduction Program, and 1886(q)(6) for the Hospital Readmissions Reduction Program. Hospital data from these initiatives are currently used to populate the Compare tool hosted by HHS, available at: https://www.medicare.gov/care-compare/, or its successor website(s). Data are presented on the Compare tool hosted by HHS in a format mainly aimed towards consumers, patients, and the general public, providing access to hospital-specific quality measure performance rates along with state and national performance rates. For certain outcome and cost measures, data are presented on the Compare tool hosted by HHS in performance categories of Better, No Different, or Worse than the National Rate. More detailed measure data, including the data used for the Compare tool hosted by HHS, are also available to the public as downloadable files at https://data.medicare.gov. Hospital quality data on the Compare tool hosted by HHS are currently updated on a quarterly basis.


17. Expiration Date


We will display the approved expiration date on each of the forms included as appendices to this PRA, which would become available on the QualityNet website (https://qualitynet.cms.gov). We will also display the approved expiration date prominently on the QualityNet website’s Hospital IQR Program pages used to document our measure specifications and reporting guidance.


18. Certification Statement


We are not claiming any exceptions to the Certification for Paperwork Reduction Act Submissions Statement.

1 U.S. Bureau of Labor Statistics. Occupational Outlook Handbook, Medical Dosimetrists, Medical Records Specialists, and Health Technologists and Technicians, All Other. Accessed 13 January 2022. Available at: https://www.bls.gov/oes/current/oes292098.htm.

2 U.S. Bureau of Labor Statistics. Economy at a Glance, Average Hourly Earnings. Accessed on January 24, 2022; available at: https://www.bls.gov/eag/eag.us.htm.

3 https://www.aha.org/system/files/media/file/2020/01/2020-aha-hospital-fast-facts-new-Jan-2020.pdf

4 U.S. Bureau of Labor Statistics. Economy at a Glance, Average Hourly Earnings. Accessed on January 24, 2022; available at: https://www.bls.gov/eag/eag.us.htm.

5 U.S. Bureau of Labor Statistics. Historical CPI-U data. Accessed on March 10, 2022. Available at: https://www.bls.gov/cpi/tables/supplemental-files/historical-cpi-u-202112.pdf.

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