CMS-10530 ASCQR Supporting Statement A 9-13-21

Supporting Statement – Part A

Submission of Information for the Ambulatory Surgical Center Quality Reporting Program: CY 2022 OPPS/ASC Proposed Rule (CMS-10530)

1. Background

The Centers for Medicare and Medicaid Services’ (CMS’) quality reporting programs promote higher quality, more efficient health care for Medicare beneficiaries by increasing transparency through public reporting of quality of care metrics; this information is made available to inform consumers and to incentivize healthcare facilities to make continued improvements. CMS has implemented quality measure reporting programs for multiple settings, including for ambulatory surgical centers (ASCs).

The CMS quality reporting program established for the ASC setting is referred to as the Ambulatory Surgical Center Quality Reporting (ASCQR) Program. As required, CMS has adopted quality of care measures for the ASC setting; data collection under this program began calendar year 2012. As required by authorizing statute, these data have been made publicly available after providing ASCs the opportunity to review the data.

Based on program feedback received through our outreach and education activities, the identification of measure topics of interest and required data collection have raised awareness of quality improvement in the ASC community. As discussed in more detail below, ASCs can utilize program measures for their survey and certification required quality assessment and performance improvement (QAPI) programs. The information collection requirements for the CY 2014 through CY 2023 payment determinations are approved under OMB Control Number 0938-1270. This information collection request covers the existing measures to be collected for CYs 2024 through 2027 payment determinations and subsequent years.

CMS seeks to reduce regulatory burden on the healthcare industry, lower health costs, and enhance patient care through the Meaningful Measures Framework launched in October 2017. CMS is implementing broad efforts to reduce administrative burden on providers so they can focus on patients and provide high quality care. The Meaningful Measures Framework identifies core quality of care issues that advance CMS’ work to improve patient outcomes while reducing paperwork and reporting burden associated with quality measurement for clinicians and other providers: address high-impact measure areas that safeguard public health; patient-centered and meaningful to patients; outcome-based where possible; fulfill each program’s statutory requirements; minimize the level of burden for providers; significant opportunity for improvement; address measure needs for population-based payment through alternative payment models; and align across programs and/or with other payers.

The information collection requirements for the CY 2023 payment determination is currently approved under OMB Control Number 0938-1270.

In the CY 2022 OPPS/ASC proposed rule, we are proposing to: (1) adopt the COVID-19 Vaccination Coverage Among HCP measure, beginning with the CY 2022 reporting period/CY 2024 payment determination; (2) resume and require the following four patient safety outcome measures beginning with the CY 2023 reporting period/CY 2025 payment determination: (a) Patient Burn (ASC-1); (b) Patient Fall (ASC-2); (c) Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant (ASC-3); and (d) All-Cause Hospital Transfer/Admission (ASC-4); (3) require the Cataracts: Improvement in Patient's Visual Function within 90 Days Following Cataract Surgery (ASC-11) measure, beginning with the CY 2023 reporting period/CY 2025 payment determination; and (4) require the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey measures (ASC-15 a-e), with voluntary reporting beginning with the CY 2023 reporting period and mandatory reporting beginning with CY 2024 reporting period/CY 2026 payment determination and provide survey administration requirements.

B. Justification

1. Need and Legal Basis

A quality reporting program for ASCs was authorized by Section 109(b) of the Medicare Improvements and Extension Act of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) (Pub. L. 109-432) which amended section 1833(i) of the Social Security Act (the Act) by re-designating clause (iv) as clause (v) and adding new clause (iv) to paragraph (2)(D) and by adding new paragraph (7). Section 1833(i)(2)(D)(iv) of the Act states that the Secretary may provide that any Ambulatory Surgical Center (ASC) that does not submit quality measures to the Secretary in accordance with paragraph (7) may incur a 2.0 percentage point reduction to any annual increase provided under the revised ASC payment system for such year. This section specifies that a reduction for one year cannot be taken into account in computing any annual increase factor for a subsequent year.

Section 1833(i)(7)(B) of the Act provides that, ‘‘[e]xcept as the Secretary may otherwise provide,’’ the hospital outpatient quality data provisions of subparagraphs (B) through (E) of section 1833(t)(17) of the Act shall apply to ASCs in a similar manner to the manner in which they apply under these paragraphs to hospitals and any reference to a hospital, outpatient setting, or outpatient hospital services is deemed a reference to an ASC, the setting of an ASC, or services of an ASC, respectively. Section 1833(t)(17)(B) of the Act requires that hospitals submit quality data in a form, manner, and at a time that the Secretary specifies.

Section 1833(t)(17)(C)(i) of the Act requires the Secretary to develop measures appropriate for the measurement of the quality of care (including medication errors) furnished by hospitals in outpatient settings, that these measures reflect consensus among affected parties and, to the extent feasible and practicable, that these measures include measures set forth by one or more national consensus building entities. Section 1833(t)(17)(C)(ii) of the Act allows the Secretary to select measures that are the same as (or a subset of) the measures for which data are required to be submitted under the program developed for hospital outpatient departments.

Section 1833(t)(17)(D) of the Act gives the Secretary the authority to replace measures or indicators as appropriate, such as where all hospitals are effectively in compliance or the measures or indicators have been subsequently shown not to represent the best clinical practice. Section 1833(t)(17)(E) of the Act requires the Secretary to establish procedures for making data submitted under the program developed for ASCs available to the public. Such procedures include providing facilities with the opportunity to review their data prior to public release.

ASCQR Program Measures

The ASCQR Program seeks to collect and publicly report data on quality of care measures for the ambulatory outpatient setting. To utilize quality measures that are fully and specifically reflective of the quality of ambulatory outpatient services, the program utilizes the public comment process, solicit comment on proposed and recommended measures, has collaborated with and intends to continue collaborative efforts with the ASC organizations including the ASC Quality Collaboration and the Ambulatory Surgery Center Association (ASCA), and has consulted with professional organizations focused on procedures performed in ASCs to develop and implement such measures.

Measures where data are collected via Quality Data Codes (QDCs) are submitted on Part B Medicare claims submitted on the CMS-1500 form for payment; the CMS-1500 revised form received OMB approval on March 29, 2017 (OMB Control Number 0938-1197). Data collected in this manner require nominal additional effort for ASC facilities. We note that in the CY 2019 OPPS/ASC final rule (83 FR 58818) that we suspended data collection for these measures until further action in rulemaking due to concerns with this data submission method.

Web-based measures labeled as “CMS” require ASCs to submit non-patient level, aggregated data directly to CMS via a web-based tool located on a CMS website.

Measures labeled as having an information collection mode of “Claims” have information derived through analysis of administrative Medicare claims data and do not require additional effort or burden from ASCs.

Measures labeled as having an information collection mode of “Survey-based” have information derived through analysis of data submitted via the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey and do not require additional effort or burden from ASCs beyond administering the survey and submitting survey data to CMS. These survey administration burdens are captured under OMB Control Number 0938-1240.

TABLE 1. ASCQR PROGRAM MEASURES PREVIOUSLY FINALIZED AND PROPOSED FOR THE CY 2023 PAYMENT DETERMINATION AND SUBSEQUENT YEARS

NQF No.	Measure Name	Data Collection Mode
0263	ASC-1: Patient Burn	Web-based (CMS)
0266	ASC-2: Patient Fall	Web-based (CMS)
0267	ASC-3: Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant	Web-based (CMS)
0265	ASC-4: Hospital Transfer/Admission	Web-based (CMS)
0658	ASC-9: Endoscopy/Polyp Surveillance: Appropriate Follow-Up Interval for Normal Colonoscopy in Average Risk Patients	Web-based (CMS)
1536	ASC-11: Cataracts: Improvement in Patient’s Visual Function within 90 Days Following Cataract Surgery	Web-based (CMS)
2539	ASC-12: Facility Seven-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy	Claims
N/A	ASC-13: Normothermia Outcome	Web-based (CMS)
N/A	ASC-14: Unplanned Anterior Vitrectomy	Web-based (CMS)
N/A	ASC-15a: OAS CAHPS – About Facilities and Staff	Survey-based
N/A	ASC-15b: OAS CAHPS – Communication About Procedure	Survey-based
N/A	ASC-15c: OAS CAHPS – Preparation for Discharge and Recovery	Survey-based
N/A	ASC-15d: OAS CAHPS – Overall Rating of Facility	Survey-based
N/A	ASC-15e: OAS CAHPS – Recommendation of Facility	Survey-based
3470	ASC-17: Hospital Visits after Orthopedic Ambulatory Surgical Center Procedures	Claims
3366	ASC-18: Hospital Visits after Urology Ambulatory Surgical Center Procedures	Claims
3357	ASC-19: Facility-Level 7-Day Hospital Visits after General Surgery Procedures Performed at Ambulatory Surgical Centers*	Claims
	COVID-19 Vaccination Coverage Among HCP Measure	Web-based (NHSN)

* Finalized in the CY 2020 OPPS/ASC final rule (84 FR 61142), for implementation beginning with the CY 2024 payment determination and subsequent years.

Forms Used in ASCQR Program Procedures

Two administrative forms are utilized by the ASCQR Program: 1) Extraordinary Circumstances Exception Request form; and 2) Reconsideration Request form. Neither of these forms is completed on an annual basis; both are completed on a need-to-use, exception basis and most ASCs will not need to complete either of these forms in a given year.

In the event of extraordinary circumstances not within the control of an ASC, such as a natural disaster, an ASC can request a waiver or extension for meeting program requirements. For the ASC to receive consideration for an extension or waiver, an Extraordinary Circumstances Exception Request form must be submitted. CMS provides this form to ASCs online and facilities may submit the form electronically, by mail, or fax. We note that the burden associated with completing and submitting an Extraordinary Circumstances Exception request is already accounted for in a separate PRA package, OMB Control Number 0938-1022.¹ Therefore, the burden associated with completing and submitting and Extraordinary Circumstances Exception Request is not addressed in this PRA Package.

When an ASC is determined by CMS to not have fully met program requirements and has had a 2.0 percentage point reduction in their APU, the ASC may submit a completed Reconsideration Request form to CMS. An ASC must submit a Reconsideration Request to CMS by no later than the first business day on or after March 17 of the affected payment year. CMS provides this form to ASCs online and facilities may submit the form by mail or by fax. While there is burden associated with filing a reconsideration request, 5 CFR 1320.4 of the Paperwork Reduction Act of 1995 regulations exclude collection activities during the conduct of administrative actions such as redeterminations, reconsiderations, or appeals or all of these actions. Therefore, the burden associated with submitting a Reconsideration Request form is not accounted for in this PRA package.

2. Information Users

The ASCQR Program views an effective pay-for-reporting program as having a streamlined measure set that provides meaningful measurement that serves to differentiate facilities by quality of care while limiting burden to the fullest extent possible.

This information gathered by the program can be utilized by ASCs as metrics for required quality assessment and performance improvement (QAPI) programs under ASC conditions for coverage (CfCs). As described in 42 CFR 416.43, these programs must include, but not be limited to, an ongoing program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcome and by the identification and reduction of medical errors.

Most importantly, this information is available to Medicare beneficiaries, as well as to the general public, to provide information to assist them in making decisions about their health care. ASCQR Program data are published on the CMS data website located at https://data.cms.gov/provider-data/topics/hospitals/ambulatory-surgical-centers

in a form that allows reviewers to review both facility-level and national performance on quality measures selected for use in the ASCQR Program.

3. Use of Information Technology

To assist ASCs in this initiative, CMS provides a secure data warehouse via the CMS Hospital Quality Reporting (HQR) system secure portal for storage and transmittal of data prior to the release of data to the CMS website. ASCs also have the option of using vendors to transmit the data. CMS has engaged a national support contractor to provide technical assistance with the data collection tool, other program requirements, and to provide education.

This section is not applicable to claims-based measures as they are calculated from data from claims submitted by ASCs to Medicare for reimbursement. Therefore, no additional information technology will be required for ASCs for these measures.

4. Duplication of Efforts

The information to be collected is not duplicative of similar information collected by the CMS or other efforts to collect quality of care data for outpatient ASC care. As required by statute, CMS requires ASCs to submit quality measure data for services provided.

Once an ASC submits quality measure data to the ASCQR Program, it is considered to be participating in the program. To withdraw from the program after submitting quality measure data, an ASC must complete and submit an online withdrawal form requesting withdrawal from the program.

5. Small Business

For the CY 2021 payment determination, all 6,811 ASCs that met eligibility requirements for the ASCQR Program received the annual payment update due to data submission requirements being excepted under the ASCQR Program’s ECEs policy in consideration of the COVID-19 public health emergency (PHE); of these 3,957 would have been required to participate sans the PHE exception. Based on an analysis of the CY 2020 payment determination data, we found that 689 ASCs that were not required to participate, did so voluntarily. Therefore, we estimate that 3,957 plus 689, or 4,646 ASCs will submit data for the ASCQR Program for the CY 2022 payment determination and future years unless otherwise noted.

Based on industry survey, ASCs have an average of twenty employees, and many are considered small businesses. All of the program information collection requirements are designed to allow maximum flexibility to facilities as possible to encourage participation in the program. The program is designed with the goal that the collection of quality of care data be the minimum necessary for the calculation of summary figures that are reliable estimates of individual ASC performance. We have also incorporated measures that use data collected from Medicare Fee-for-Service claims to ease facility burden.

6. Less Frequent Collection

We have designed the collection of quality of care data to be the minimum necessary for calculation of summary figures to be reliable estimates of individual ASC performance. Under the ASCQR Program, ASCs are required to submit measure data via a web-based submission tool to CMS on an annual basis. In addition, for claims-based measures, measures are calculated from paid Medicare Fee-for-Service claims for encounters that occurred during designated data collection time periods. CMS collects the data submitted by participating ASCs for web-based measures and claims-based measures to make payment determinations on an annual basis. To collect the information less frequently would compromise the timeliness of any calculated estimates.

7. Special Circumstances

All ASCs reimbursed under the ASC Payment System are required to meet ASCQR Program requirements to receive the full annual increase provided under the revised ASC payment system for a given calendar year. Failure to meet all requirements may result is a 2.0 percentage point reduction in the APU. Under program requirements, ASCs with fewer than 240 Medicare claims in a calendar year are not required to participate.

8. Federal Register Notice/Outside Consultation

The 60-day Federal Register notice for this data collection was published on August 4, 2021 (86 FR 42018). The CY 2022 Outpatient Prospective Payment System and Ambulatory Surgical Center (OPPS/ASC) proposed rule is available on the Federal Register and CMS Web sites.

Measures adopted for the ASCQR Program are required by statute to undergo a recognized consensus process. To this end, CMS engages the Measure Applications Partnership as well as industry stakeholders such as the ASC Quality Collaboration and individual technical experts through Technical Expert Panels.

9. Payment/Gift to Respondent

ASCs are required to submit these data to receive the full annual increase provided under the revised ASC payment system for a given calendar year. No other payments or gifts will be given to respondents for participation.

10. Confidentiality

All information collected under the ASCQR Program will be maintained in strict accordance with statutes and regulations governing confidentiality requirements for CMS data, including the Privacy Act of 1974 (5 U.S.C. 552a), the Health Insurance Portability and Accountability Act (HIPAA), and the Quality Improvement Organizations confidentiality requirements, which can be found at 42 CFR Part 480. CMS maintains this information in the CMS data warehouse, which contains all information collected under this and other quality data reporting programs. In addition, the tools used for transmission and storage of data are considered confidential forms of communication and are HIPAA-compliant.

11. Sensitive Questions

This program does not collect information on “sexual behavior and attitudes, religious beliefs, etc.,” but it does collect health information, which could be considered “matters that we commonly considered private.” This includes clinical data elements that will be collected and are necessary to calculate statistical measures. These statistical measures are the basis of subsequent improvement activities for ASC facilities and cannot be calculated without the case-specific data. Case-specific data will not be released to the public and is not releasable by requests under the Freedom of Information Act. Only ASC-specific data will be made publicly available as mandated by statute. In addition, the tools used for transmission of data are considered confidential forms of communication and are HIPAA-compliant.

12. Burden Estimate (Total Hours & Wages)

For the ASCQR Program, the burden associated with meeting program requirements includes the time and effort associated with completing administrative requirements and collecting and submitting data on the required measures.

As previously stated, we estimate that 4,646 ASCs will submit data for the ASCQR Program for the CY 2022 payment determination and future years unless otherwise noted. This is an increase of 1,152 from the previous assumption of 3,494 ASCs which was based on an analysis of CY 2020 payment determination data.

We estimate that it takes approximately 15 minutes for chart abstraction of a measure for collection. We reached this number based on an analysis of historical data from the Hospital Inpatient Quality Reporting Program’s data validation contractor. Based on this contractor’s validation activities, we believe that the average time required to chart-abstract data for each measure is approximately 15 minutes.

All burden hour and cost estimates have been rounded to the nearest whole number.

1. Calculation of Wage Rate

We estimate an hourly labor cost (wage plus fringe and overhead) of $42.40²/hour, in accordance with the Bureau of Labor Statistics, based upon the median wage for Medical Records and Health Information Technicians which is $21.20 per hour before inclusion of overhead and fringe benefits. BLS describes Medical Records and Health Information Technicians as those responsible for organizing and managing health information data; therefore, we believe it is reasonable to assume that these individuals would be tasked with abstracting clinical data for submission for the ASCQR Program.

We estimate the cost of overhead, including fringe benefits, at 100 percent of the median hourly wage, as is currently done in other CMS quality reporting programs. This is necessarily a rough adjustment, because fringe benefits and overhead costs vary significantly from employer to employer. Nonetheless, we believe that doubling the hourly wage rate ($21.20 x 2 = $42.40) to estimate total cost is a reasonably accurate estimation method. Accordingly, we will use an hourly labor cost estimate of $42.40 ($21.20 salary plus $21.20 fringe and overhead) for calculation of burden forthwith.

2. Estimated Burden for the Proposed COVID-19 Vaccination Coverage Among Health Care Personnel (HCP) Measure

In the CY 2022 OPPS/ASC proposed rule, we are proposing to adopt the COVID-19 Vaccination Coverage Among HCP measure, beginning with the CY 2022 reporting period/CY 2024 payment determination. ASCs would submit data through the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN). The NHSN is a secure, Internet-based surveillance system maintained by the CDC and provided free. Currently the CDC does not estimate burden for COVID-19 vaccination reporting under the CDC PRA (OMB control number 0920-1317) because the agency has been granted a waiver under Section 321 of the National Childhood Vaccine Injury Act (NCVIA).³ As such, the burden associated with the COVID-19 Vaccination Coverage Among HCP measure is not accounted for under the CDC PRA 0920-1317 or 0920-0666 due to the NCVIA waiver. When the waiver expires, we will work with CDC to ensure that the burden is accounted for in an updated PRA under OMB control number 0920-1317.

3. Estimated Burden for Claims-Based Measures Not Using QDCs

For the ASC-12 measure, which is calculated by CMS based on Medicare claims and does not require ASCs to use QDCs, we estimated that any burden would be nominal for the CY 2022 payment determination and subsequent years.

In the CY 2018 OPPS/ASC final rule with comment period, CMS added two measures collected via Part A and Part B Medicare administrative claims and Medicare enrollment data to the ASCQR Program measure set beginning with the CY 2022 payment determination: (1) ASC-17: Hospital Visits after Orthopedic Ambulatory Surgical Center Procedures; and (2) ASC-18: Hospital Visits after Urology Ambulatory Surgical Center Procedures. Because data for these measures are collected via claims, ASCs are already submitting claims data for the purposes of payment and do not require any additional data collection. Therefore, we estimate that any burden resulting from the data collection for ASC-17 and ASC-18 would be nominal for the CY 2022 payment determination and subsequent years.

4. Estimated Burden for Web-Based Submission of Measures ASC-1, ASC-2, ASC-3, ASC-4, ASC-9, ASC-11, ASC-13, and ASC-14
   
   

In the CY 2022 OPPS/ASC proposed rule, we are proposing to require four patient safety outcome measures beginning with the CY 2023 reporting period/CY 2025 payment determination: (1) Patient Burn (ASC-1); (2) Patient Fall (ASC-2); (3) Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant (ASC-3); and (4) All-Cause Hospital Transfer/Admission (ASC-4). Based on our data for CY 2014 payment determinations for the ASC-1, ASC-2, ASC-3, and ASC-4 claims-based measures (approximately one case per month per ASC). As not all web-based measures are also chart-abstracted, our estimate is based on the chart-abstraction for these four measures being complete by the hospital at the time of web-based entry. Measure data for these measures would be submitted via the CMS Hospital Quality Reporting (HQR) system secure portal (also known as the CMS QualityNet Secure Portal). Consistent with prior years (78 FR 75171 through 75172), we estimate that each participating hospital will spend 10 minutes per measure per year to collect and submit the data via a CMS web-based tool. As a result of this proposal, we estimate a total annual burden estimate for all ASCs of 3,098 hours (0.1667 hours/measure x 4 measures x 4,646 ASCs) at a cost of $131,355 (3,098 hours x $42.40).

ASCs will incur a financial burden associated with ASC-9, ASC-13, and ASC-14 for their chart abstraction and for submitting the measures to the web-based tool. For the web-based submission, we estimate that each participating ASC would spend 10 minutes per measure to submit the data. Therefore, we estimate the reporting burden for each measure to be 0.1667 hours (10 minutes/60 minutes) and $7.08 (0.1667 hours x $42.40/hour). We further estimate a total burden of 774 hours (4,646 ASCs x 0.1667 hours) and $32,818 (774 hours x $42.40/hour) each for ASC-9, ASC-13, and ASC-14.

In the CY 2022 OPPS/ASC proposed rule, we are proposing to require the Cataracts: Improvement in Patient's Visual Function within 90 Days Following Cataract Surgery (ASC-11) measure beginning with the CY 2023 reporting period/CY 2025 payment determination. We estimate that each ASC would spend 10 minutes per measure to submit the data for this measure. We estimate a total annual burden estimate for all ASCs of 774 hours (4,646 ASCs x 0.1667 hours) at a cost of $32,818 (774 hours x $42.40).

Table 2. Summary of Data Submission Burden Estimates for ASC-1 to ASC-4, ASC-9, ASC-11, ASC-13 & ASC-14

Measure	# Responses	Hours per Facility	Total Hours	Hourly Rate	Total Burden
ASC-1 to 4	18,584	0.1667	3,098	$42.40	$131,355
ASC-9	4,646	0.1667	774	$42.40	$32,818
ASC-11	4,646	0.1667	774	$42.40	$32,818
ASC-13	4,646	0.1667	774	$42.40	$32,818
ASC-14	4,646	0.1667	774	$42.40	$32,818

Total

37,168

1.3336

6,194

$262,627

5. Estimated Burden for Chart-Abstracted Measures ASC-9, ASC-11, ASC-13, and ASC-14

ASCs will incur a financial burden associated with ASC-9, ASC-13, and ASC-14 for their chart abstraction in addition to submitting the measures to the web-based tool. For the chart-abstracted aspect of the measures, we estimate that each participating ASC would spend 15 minutes per case to collect and submit the data for the minimum required yearly sample size of 63 as designated in the Ambulatory Surgical Center Quality Reporting Specifications Manual. We, therefore, estimate the reporting burden for an ASC with 63 cases would be approximately 16 hours (0.25 hours x 63 cases = 16 hours) and $678 (16 hours x $42.40/hour). We further estimate a total burden of 74,336 hours (4,646 ASCs x 16 hours) and $3,151,846 (4,646 ASCs x 16 hours x $42.40/hour) each for ASC-9, ASC-13, and ASC-14.

In the CY 2022 OPPS/ASC proposed rule, we are proposing to require the Cataracts: Improvement in Patient's Visual Function within 90 Days Following Cataract Surgery (ASC-11) measure beginning with the CY 2023 reporting period/CY 2025 payment determination. We, therefore, estimate the reporting burden for an ASC with 63 cases would be 16 hours (0.25 hours x 63 cases = 16 hours) and $678 (16 hours x $42.40/hour). We further estimate a total burden of 74,336 hours (4,646 ASCs x 16 hours) and $3,151,846 (4,646 ASCs x 16 hours x $42.40/hour) for ASC-11.

Table 3. Summary of Chart-Abstracted Burden Estimates for ASC-9, ASC-11, ASC-13 & ASC-14 for Obtaining Required Data for Submission

Measure	# Facilities	Hours per Response	Sample	# Cases	Total Hours	Hourly Rate	Burden
ASC-9	4,646	0.25	63	292,698	74,336	$42.40	$3,151,846
ASC-11	4,646	0.25	63	292,698	74,336	$42.40	$3,151,846
ASC-13	4,646	0.25	63	292,698	74,336	$42.40	$3,151,846
ASC-14	4,646	0.25	63	292,698	74,336	$42.40	$3,151,846

Total

1.00

252

1,170,792

297,344

$12,607,384

6. Estimated Burden for Survey-Based Measures

In the CY 2017 OPPS/ASC final rule (81 FR 79562), CMS finalized five survey-based measures: (1) ASC-15a: OAS CAHPS – About Facilities and Staff; (2) ASC-15b: OAS CAHPS – Communication About Procedure; (3) ASC-15c: OAS CAHPS – Preparation for Discharge and Recovery; (4) ASC-15d: OAS CAHPS – Overall Rating of Facility; and (5) ASC-15e: OAS CAHPS – Recommendation of Facility in the ASCQR Program. In the CY 2018 OPPS/ASC final rule (82 FR 59216), CMS delayed implementation of the five OAS CAHPS survey-based measures until further action in rulemaking. In the CY 2022 OPPS/ASC proposed rule, we are proposing to require all five OAS CAHPS Survey-based measures with voluntary reporting beginning with the CY 2023 reporting period and mandatory reporting beginning with CY 2024 reporting period/CY 2026 payment determination and for subsequent years, and adding related administration methods. The information collection requirements associated with measures ASC-15a–e are currently approved under OMB Control Number 0938-1240; for this reason, we are not providing an independent estimate of the burden associated with the OAS CAHPS Survey administration for the ASCQR Program.

7. Summary

The following table summarizes the adjusted burden estimates for the CY 2024 payment determinations and subsequent years (note that the burden for ASC-17 and ASC-18 is estimated to be nominal because they are claims-based measures and do not influence burden estimates as described above):

Table 4. Summary of Adjusted Burden Estimates for the CY 2024 Payment Determinations and Subsequent Years

Total Burden for CY 2024 and Subsequent Years
	CY 2024 Payment Determination		CY 2025 Payment Determination & Subsequent Years
Measure	Hour Burden	Total Cost	Hour Burden	Total Cost
ASC-1 to 4			3,098	$131,355
ASC-9	75,110	$3,184,664	75,110	$3,184,664
ASC-11*	15,022	$636,933	75,110	$3,184,664
ASC-13	75,110	$3,184,664	75,110	$3,184,664
ASC-14	75,110	$3,184,664	75,110	$3,184,664
Total	240,352	$10,190,925	303,538	$12,870,011

* We continue to assume that 20% of ASCs will voluntarily report ASC-11 in the CY 2024 payment determination until reporting become mandatory in the CY 2025 payment determination.

13. Capital Costs (Maintenance of Capital Costs)

There are no capital costs being placed on the ASCs. In fact, successful submission will result in an ASC receiving the full payment update, while having to expend no capital costs for participation. CMS is providing a data collection tool and method for submission of data to the participants. There are no additional data submission requirements placing additional cost burdens on ASCs.

14. Cost to Federal Government

The cost to the Federal Government for maintaining program activities is for Federal staff, supporting data system architecture, data storage, maintenance and updating of information technology infrastructure on My QualityNet, providing ongoing technical assistance to ASCs and data vendors, calculation of claims-based measures, measure development and maintenance, the provision of ASCs with feedback and preview reports as well as costs associated with public reporting on Hospital Compare. Estimated annual costs are $9,500,000 for data and infrastructure plus $3,000,000 for contracted support.

There is one FTE assigned full-time in a lead position to this program. Using a GS-14 step 5 salary, that provides a rough estimate of $142,950 plus benefits (30%) or $42,885 or $185,835 for the federal government labor cost for this program year and subsequent years. Estimated annual information technology costs are $9,500,000 for data collection and infrastructure. Estimated annual costs based on existing contracts for program support, measure development and maintenance, and public reporting activities are $3,000,000.

ASCs will be reporting outpatient quality data directly to CMS through the HQR system secure portal. An abstraction tool is under development that is based upon the current tool for collecting ASC data. The tools will be revised as needed and updates will be incorporated.

15. Program or Burden Changes

Accounting for the increase of 1,152 in ASCs from 3,494 to 4646, the proposal to resume and require data collection for the ASC-1, ASC-2, ASC-3, and ASC-4 measures increases burden from 176,096 hours to 179,194 hours; an increase of 3,098 hours (0.1667 hours/measure x 4 measures x 4,646 ASCs) at a cost of $131,355 (3,098 hours x $42.40). Also, the proposal to require data collection for the ASC-11 measure will result in the remaining 80% of ASCs we previously assumed were not reporting voluntarily to report beginning with the CY 2025 payment determination. Therefore, this proposal increases burden by 60,088 hours (75,110 hours x 80%) at a cost of $2,547,731 ($3,184,664 x 80%).

The total number of responses for ASC-1 to 4, ASC-9, ASC-11, ASC-13, and 14 will be (From Tables 2 and 3) 1,189,376 (18,584 + 1,170,792).

16. Publication/Tabulation Dates

The goal of the data collection is to tabulate and publish ASC-specific data. We will continue to display information on the quality of care provided in the ASC setting for public viewing as specified by authorizing statute. Data from this program are currently publicly displayed and are available for download on CMS’ Hospital Compare Web site, https://www.medicare.gov/care-compare/.

17. Expiration Date

CMS will display the expiration date on the manual and data collection tool.

18. Certification Statement

There are no exceptions to the certification statement.

19. Collections of Information Employing Statistical Methods

This information collection does not require the use of statistical methods. However, to reduce burden, facilities may sample using their method of choice to reduce the number of cases for which to submit data.

1 This burden is captured under another package for 10 quality reporting and value-based purchasing programs that use a single request form. Accounting for this burden under a single package ensures that all programs are using the same form, process, and burden estimates and avoids the risk of inconsistency or misalignment in CMS policies on this issue, as well as reducing inefficiencies in form updates and request processing.

2 The most recent data from the Bureau of Labor Statistics reflects a median hourly wage of $21.20 per hour for a Medical Records and Health Information Technician professional. Occupational Employment and Wages. Available at: https://www.bls.gov/ooh/healthcare/medical-records-and-health-information-technicians.htm (accessed April 13, 2021)

3 Section 321 of the National Childhood Vaccine Injury Act (NCVIA) provides the PRA waiver for activities that come under the NCVIA, including those in the NCVIA at section 2102 of the Public Health Service Act (42 U.S.C. 300aa-2).  Section 321 is not codified in the U.S. Code, but can be found in a note at 42 U.S.C. 300aa-1.

12