Supporting Statement—Part A
Quality Measures and Administrative Procedures for the Hospital-Acquired Condition Reduction Program (CMS-10668)
The Centers for Medicare & Medicaid Services (CMS) is committed to promoting higher quality healthcare and improving outcomes for Medicare beneficiaries. The Hospital-Acquired Condition (HAC) Reduction Program is established by section 1886(p) of the Social Security Act, as added by Section 3008 of the Affordable Care Act (Pub. L. 111-148), and requires the Secretary to reduce payments to subsection (d) hospitals in the worst-performing quartile of all subsection (d) hospitals by 1 percent effective beginning on October 1, 2014 and subsequent years. For the FY 2025 program year we are proposing in the Fiscal Year (FY) 2023 Inpatient Prospective Payment System (IPPS)/Long-Term Care Hospital (LTCH) PPS proposed rule to suppress all six measures in the HAC Reduction Program and not calculate measure scores or Total HAC Scores for any hospital such that no hospital will receive a payment reduction due to the significant impacts of the COVID-19 pandemic on the quality measures. We are not proposing any policies in the FY 2023 IPPS/LTCH PPS proposed rule which result in a change to our estimated burden.
To administer its requirements, the HAC Reduction Program relies on data collection established through the Centers for Disease Control and Prevention’s (CDC) OMB control number, 0920-0666, and validation processes established through the Hospital Inpatient Quality Reporting (IQR) Program’s OMB control number, 0938-1022. However, in the FY 2019 IPPS/LTCH PPS final rule, the Hospital IQR Program finalized the removal of the CDC National Healthcare Safety Network (NHSN) Healthcare-associated Infection (HAI) measures and NHSN HAI validation processes beginning on January 1, 2020. To continue validation of these measures, the HAC Reduction Program adopted validation templates similar to the ones previously used under the Hospital IQR Program. These templates, continue the HAC Reduction Program’s use and validation of NHSN HAI data.
The HAC Reduction Program identifies the worst-performing quartile of hospitals by calculating a Total HAC Score derived from the CMS Patient Safety and Adverse Events Composite (CMS PSI 90) and NHSN HAI measures, which require that we collect claims-based and chart-abstracted measures data, respectively. The HAC Reduction Program validates NHSN HAI data reported by subsection (d) hospitals to ensure that hospitals report correct NHSH HAI measure data, and the Total HAC Score is calculated using accurate data. The HAC Reduction Program may penalize any hospitals that fail validation by assigning the maximum Winsorized
z-score for the set of measures that fail validation, for use in the Total HAC Score calculation. The collection of information for validation is necessary to ensure that the HAC Reduction Program and Total HAC Score are administered fairly.
The HAC Reduction Program will continue to receive NHSN HAI data for hospitals from CDC. Because the burden associated with submitting data for the HAI measures (CDI, CAUTI, CLABSI, MRSA, and SSI) is captured under a separate OMB control number, 0920-0666, we do not provide an independent estimate of the burden associated with collecting data for these
measures for the HAC Reduction Program. We also do not provide an estimate of burden for the claims-based PSI 90 measure, because this measure is collected using Medicare FFS claims that hospitals are already submitting to the Medicare program for payment purposes. We also do not provide an estimate of burden for validation of data submitted for the PSI 90 measure, because Medicare claims are audited under the Medicare Fee for Service (FFS) Recovery Audit Program.
1 HAC Reduction Program Quality Measures
The FY 2025 program year for the HAC Reduction Program will be based on data for the CMS PSI 90 measure using the 24-month period from July 1, 2021 through June 30, 2023, and data for NHSN HAI measures using the 24-month period from January 1, 2022 through December 31, 2023, which are consistent with the applicable periods specified at 42 CFR §
412.170. Because the HAC Reduction Program is a payment program, it must ensure proper exceptions are available to hospitals that do not meet NHSN HAI data requirements and to ensure the accuracy of the NHSN HAI data submissions. The HAC Reduction Program must collect information to verify hospital exceptions and data submissions. 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.
We note that in the FY 2023 IPPS/LTCH PPS proposed rule, we are not proposing the addition or removal of any measures for the FY 2025 program year or subsequent years. The HAC Reduction Program currently has adopted six measures, which were finalized in previous rulemaking. The program uses five Centers for Disease Control and Prevention measures (Catheter-Associated Urinary Tract Infection (CAUTI), NHSN Facility-wide Inpatient Hospital- onset Clostridium difficile Infection (CDI), NHSN Central Line-Associated Bloodstream Infection (CLABSI), American College of Surgeons – Centers for Disease Control and Prevention (ACS-CDC) Harmonized Procedure Specific Surgical Site Infection (Colon and Abdominal Hysterectomy SSI), and NHSN Facility-wide Inpatient Hospital-onset Methicillin- resistant Staphylococcus aureus Bacteremia (MRSA)). The Program also uses Patient Safety and Adverse Events Composite (CMS PSI 90 Composite) as its sixth measure.
To facilitate the HAC Reduction Program, validation templates to ensure data accuracy are necessary. There are validation templates for each of the following measures:
Central line-associated bloodstream infection (CLABSI);
Catheter-associated urinary tract infection (CAUTI);
Methicillin-resistant Staphylococcus aureus (MRSA); and
Clostridium difficile infection (CDI).
The validation templates are dependent upon a hospital’s selection for validation and may not be required by any particular hospital in any given year.
Annual updates are made to the validation templates for the CLABSI, CAUTI, MRSA, and CDI measures to reflect changes in fiscal year and beginning reporting quarter, as well as new CDC pathogen lists, with each new selection of hospitals for validation.
Additionally, we note that the burden associated with completing and submitting the following forms is already accounted for under OMB Control Number 0938-1022.
Hospital Inpatient Quality Reporting (IQR) Program Data Accuracy and Completeness Acknowledgement (DACA)
Centers for Medicare & Medicaid Services (CMS) Inpatient Prospective Payment System (IPPS) Quality Reporting Programs Measure Exception Form for PC, ED, and HAI Data Submission
Hospital Inpatient Quality Reporting (IQR) Program Validation Educational Review Form
Centers for Medicare & Medicaid Services (CMS) Quality Reporting Program Extraordinary Circumstances Exceptions (ECE) Request Form
Only the Data Accuracy and Completeness Acknowledgement (DACA) form must be completed by all hospitals each year. This form only requires a hospital to check a box affirming the accuracy and completeness of the data reported. The remainder of the forms are exceptions or one time only forms, and hospitals may not need to complete any of these forms in any given year.
Annually, subsection (d) hospitals paid under the IPPS must complete a Data Accuracy and Completeness Acknowledgement (DACA) form at 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 is an acknowledgement that the data a hospital has submitted are complete and accurate. The burden associated with the DACA form is accounted for under OMB control number 0938-1022.
In addition to the DACA form, the HAC Reduction Program has adopted a number of ad hoc processes for situations that may impact specific hospitals. These processes include an Extraordinary Circumstances Exceptions policy, an NHSN HAI measure exception policy for hospitals with certain data considerations, and an Educational Review Process for hospitals that have questions regarding the validation process or its results. In order for hospitals to engage these processes, hospitals must submit forms that are currently and will be subsequently associated with the Hospital IQR Program’s PRA Package. In the FY 2023 IPPS/LTCH PPS proposed rule, we are proposing to clarify the removal of the No Mapped Locations (NML) policy beginning in FY 2023. Hospitals will be required to appropriately submit data to the NHSN or, if hospitals do not have the applicable locations for the CLABSI and CAUTI measures, the hospital must submit an IPPS Measure Exception Form to be exempt from CLABSI and CAUTI reporting for CMS programs. If the hospitals do not submit an IPPS
Measure Exception Form and continue to not submit data to the NHSN, these hospitals would receive the maximum measure score (that is, Winsorized z-score) under the HAC Reduction Program for not reporting data. The burden associated with each of the forms hospitals might use to avail themselves to the appropriate process is accounted for under OMB control number 0938-1022.
The HAC Reduction Program is a payment program that assesses hospital performance with respect to healthcare safety of all subsection (d) hospitals using claims-based and NHSN HAI measures. While all claims-based data are submitted through claims processing systems that have validation methods to accept accurate Medicare claims into the claims database, the NHSN HAI data are not validated through other CMS processes. For the HAC Reduction Program to assess hospitals fairly, it must be able to ensure the accuracy of the data it collects. Validation is necessary to ensure the data used by the program are both correct and useful.
As finalized in the FY 2021 IPPS/LTCH PPS final rule, to validate NHSN HAI data, CMS performs a random selection of up to 200 subsection (d) hospitals and selecting up to 200 additional hospitals using targeting criteria in the HAC Reduction Program on an annual basis for validation of chart-abstracted measures (85 FR 58864). Each hospital selected for validation is required to produce a list of patients or lab results associated with the measure being validated. All hospitals selected for validation will have their SSI measure data validated, but hospitals do not need to submit a template for this measure for CMS to select cases for validation. This process includes the use of validation templates for each of the CLABSI, CAUTI, MRSA, and CDI measures. Approximately 200 hospitals will be required to produce the CLABSI and CAUTI templates and the other approximately 200 hospitals will be required to produce only the MRSA and CDI templates.
Hospitals that do not treat these conditions or do not have treatment locations defined for the NHSN’s HAI measures used in the HAC Reduction Program (CLABSI, CAUTI, and Surgical Site Infection) have the option to either complete the enrollment process with NHSN and indicate that they do not have patients who meet the measures requirements or submit a CMS Inpatient Prospective Payment System (IPPS) Quality Reporting Programs Measure Exception Form for NHSN HAI Data Submission. This form is accounted for under OMB Control Number 0938-1022.
The validation templates for the CLABSI, CAUTI, MRSA, and CDI measures are updated annually to reflect the annual changes in fiscal year and beginning reporting quarter, as well as new CDC pathogen lists, with each new selection of hospitals for validation. The templates for each year are only utilized by the hospitals that are selected for validation.
Hospitals may use the educational review process to correct disputed chart-abstracted HAI measure validation results for all quarters of validation. To submit a formal request, hospitals can utilize the Educational Review Request Form. This form is accounted for under OMB Control Number 0938-1022.
In the event of extraordinary circumstances not within the control of the hospital, a hospital may request an exception, as specified by CMS, for quality reporting and value-based purchasing program requirements. For the hospital to receive consideration for an extension or exemption, an Extraordinary Circumstances Exceptions (ECE) Request Form must be submitted within 90
calendar days of an extraordinary circumstance event. This form is accounted for under OMB Control Number 0938-1022.
CMS will use the information collected for the HAC Reduction Program to determine whether a hospital is within the penalty quartile of subsection (d) hospitals. As stated above, the HAC Reduction Program applies a 1-percent payment reduction or penalty to subsection (d) hospitals in the worst-performing quartile of all subsection (d) hospitals. To determine which hospitals are in the worst-performing quartile, the HAC Reduction Program uses CMS PSI 90 data and NHSN HAI measure data. For the FY 2025 program year, we are proposing in the FY 2023 IPPS/LTCH PPS proposed rule to suppress all six measures in the HAC Reduction Program, to not calculate measure scores or Total HAC Scores for any hospital such that no hospital will receive a payment reduction. The Program must collect chart-abstracted information to validate NHSN HAI data reported by subsection (d) hospitals to ensure that hospitals report correct NHSH HAI measure data, and the Total HAC Score is calculated using accurate data. For the FY 2025 program year, even though no Total HAC Scores are being calculated, the information will be made available publicly and confidentially for hospitals to use in internal quality improvement initiatives.
To assist hospitals in standardizing data collection initiatives across the industry, CMS continues to improve data collection tools to make data submission easier for hospitals (including the collection of data from paper medical records for chart-abstracted measures) and increase the utility of the data provided by the hospitals. The NHSN HAI measures are collected through the National Healthcare Safety Network, a federal registry. Chart-abstracted information may be submitted electronically, but for many hospitals there still is a manual component.
For the claims-based measures, this section is not applicable, because claims-based measures can be 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 for these measures.
The information to be collected is not duplicative of similar information collected by CMS. As required by statute, CMS maintains a set of quality measures which a hospital must report to be scored in the HAC Reduction Program.
Information collection requirements were designed to allow maximum flexibility specifically to small hospitals having 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 HAC Reduction Program includes 1,135 small hospitals in the FY 2022 program year. An additional 6 hospitals have not reported bed
size data; this could bring the "small hospital" total to as high as 1,141. We do not expect this number to change significantly by the FY 2025 program year.
No special processes or procedures are available to small hospitals to make the information collection less burdensome. We have previously finalized policies to make the processes under the HAC Reduction Program as similar as possible to the current Hospital IQR Program processes and anticipate that small hospitals participating in the Hospital IQR Program will continue to be familiar with the information collection request required for validation.
We have designed the collection of quality measure data to be as minimally burdensome as possible while collecting the information necessary for data validation and for calculation of summary figures to be used as reliable estimates of hospital performance. Data validation is expected to occur quarterly, but as noted above, only up to 400 hospitals will be selected for validation. Neither less frequent collection of data nor validation of fewer cases is practicable at this time. Less frequent data collection would strain the ability for CMS to validate the submitted validation template and associated NHSN HAI infection cases in a timely manner.
Under the current process, CMS Clinical Data Abstraction Center (CDAC) abstractors are able to review and validate hospital submissions as those submissions are made each quarter. If the hospitals submitted data less frequently, CDAC abstractors would not have time to complete the necessary reviews of each submission before the Total HAC Score is calculated. Similarly, if the HAC Reduction Program proposed to validate fewer cases, the statistical analysis would be altered, and the Program would be less likely to generate meaningful results from validation.
There are no special circumstances.
Federal Register/Outside Consultation
The 60-day Federal Register notice published on June 13, 2022 (87 FR 35784). There were no public comments received.
The 30-day Federal Register notice published on August 24, 2022 (87 FR 51985).
CMS is supported in this initiative by the CDC. The CDC collaborates with CMS on an ongoing basis, providing technical assistance in developing and/or identifying quality measures.
There will be no gifts given for participation.
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 are Health Insurance Portability and Accountability Act (HIPAA) compliant. The CMS clinical data warehouse also voluntarily meets or exceeds the HIPAA standards.
There are no sensitive questions.
Under Section 1886(p) of the Social Security Act, we are required to rank hospitals with respect to the national average in hospital-acquired conditions and reduce payment by 1 percent to the worst performing quartile. This PRA discusses policies addressed in the FY 2023 IPPS/ LTCH PPS proposed rule which will affect the FY 2025 program year and subsequent years. In the FY 2023 IPPS/LTCH PPS proposed rule, we are not proposing any new measures for the HAC Reduction Program. Further, for the FY 2025 program year we are proposing to suppress all six measures in the HAC Reduction Program, to not calculate measure scores or Total HAC Scores for any hospital such that no hospital will receive a payment reduction. This package excludes burden associated with the NHSN HAI data collection, which is captured under a separate OMB control number: 0920-0666.
For the purposes of burden estimation, we assume all activities associated with the HAC Reduction Program for 3,150 IPPS hospitals, of which up to 400 will be selected for validation of the data submitted for the NHSN measures associated with the FY 2025 HAC Reduction Program, will be completed by Medical Records and Health Information Technicians. 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 HAC Reduction Program. The labor performed can be accomplished by these staff with a median hourly wage in general medical and surgical hospitals of $21.20 per hour1; however, obtaining data on other overhead costs is challenging. Overhead costs vary greatly across industries and organization size. In addition, the precise cost elements assigned as “indirect” or “overhead” costs, as opposed to direct costs or employee wages, are subject to some interpretation at the organization level. Therefore, we have chosen to calculate the cost of overhead at 100% of the mean hourly wage. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. Therefore, using these assumptions, we estimate an hourly labor cost of $42.40 ($21.20 base salary + $21.20 fringe).
We estimate a total burden of 28,800 hours associated with our policies for the FY 2025 program year. Taken with our estimated wage rate of $42.40, we estimate a total cost of approximately $1,221,120 across all participating hospitals. The estimated total burden was calculated as follows:
1 Bureau of Labor Statistics, Occupational Employment and Wages. Accessed on March 7, 2022: https://www.bls.gov/oes/current/oes292098.htm.
Consistent with previous estimates, we have estimated a reporting burden of 80 hours (20 hours x 1 record per hospital per quarter x 4 quarters) per hospital selected for validation per year to submit the CLABSI and CAUTI templates, and 64 hours (16 hours x 1 record per hospital per quarter x 4 quarters) per hospital selected for validation per year to submit the MRSA and CDI templates. We estimate a total burden of 28,800 hours [(80 hours per hospital to submit CLABSI and CAUTI templates + 64 hours per hospital to submit MRSA and CDI templates) x 200 hospitals selected for validation] and approximately $1.22 million (28,800 hours x $42.40 per hour).
Table 1. Burden Calculations for the HAC Reduction Program Validation Program Validation for up to 400 IPPS Hospitals
Measure Set |
Number of hospitals reporting |
Annual burden (hours) per hospital |
Calculation for FY 2025 program year for all subsection (d) hospitals selected for validation |
Cost per Hour |
Total Cost |
HAI Validation Templates (CLABSI, CAUTI) |
200 |
80 |
16,000 hours |
$42.40 |
$678,400 |
HAI Validation Templates (MRSA, CDI) |
200 |
64 |
12,800 hours |
$42.40 |
$542,720 |
Total |
|
|
28,800 hours |
|
$1,221,120 |
There are no capital costs associated with the HAC Reduction Program’s policies.
The cost to the Federal Government includes costs associated with the collection and validation of the data. The cost is estimated at $7,500,000 annually for the validation contract. Additionally, this program takes one and one-half (1.5) CMS staff at a GS-13 level to operate. GS-13 Step 5 approximate annual salary is $121,065 (DC, M D, VA, WV, PA local) for an additional cost of $181,598. The total annual cost to the Federal Government is $7,681,598.
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.
We are not proposing any policies in the FY 2023 IPPS/LTCH PPS proposed rule which result in a change to our estimated burden. As a result, the only differences between the currently approved burden and our updated estimate are due to the updated wage rate from
$41.00/hour to $42.40/hour. The total increase associated with the difference in wage rate is
$40,320 ($1,221,120 - $1,180,800).
The goal of the data collection is to validate NHSN HAI data. We will continue to display quality information for public viewing on the Compare website maintained by HHS or its successor website as required for the HAC Reduction Program by Section 1886(p)(6) of the Social Security Act. Data are presented on the Compare website 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. Hospital quality data on the Compare website are updated on a quarterly basis. One of the goals of the HAC Reduction Program is to publicly display data on all measures adopted for the Program. We note, however, that in certain circumstances we may decide to delay public display as we evaluate the accuracy of the measure data.
We will display this expiration date on each of the forms listed above in section A.1.c, which would become available on our QualityNet website’s (www.qualitynet.org) HAC Reduction Program page. We will display the approved expiration date prominently on our QualityNet website’s HAC Reduction Program pages used to document our validation templates.
We are not claiming any exceptions to the Certification for Paperwork Reduction Act Submissions Statement.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | HACRP PRA Supporting Statement - Part A |
| Subject | Supporting Statement—Part AQuality Measures and Administrative Procedures for the Hospital-Acquired Condition Reduction Program |
| File Modified | 0000-00-00 |
| File Created | 2022-08-25 |