U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
OFFICE OF MANAGEMENT AND BUDGET
PAPERWORK REDUCTION ACT
CLEARANCE PACKAGE
SUPPORTING STATEMENT-PART A
REVISIONS TO THE LTCH CARE DATA SET
FOR THE COLLECTION OF DATA
PERTAINING TO
LONG-TERM CARE HOSPITAL QUALITY REPORTING PROGRAM
SUPPORTING STATEMENT-PART A
LTCH CARE DATA SET
FOR THE COLLECTION OF DATA PERTAINING TO
THE LONG-TERM CARE HOSPITAL QUALITY REPORTING PROGRAM
TABLE OF CONTENTS
A. Background 1
B. Justification 1
1. Need and Legal Basis 1
2. Information Users 3
3. Use of Information Technology 3
4. Duplication of Efforts 3
5. Small Businesses 3
6. Less Frequent Collection 4
7. Special Circumstances 4
8. Federal Register/Outside Consultation 4
9. Payment/Gifts to Respondents 4
10. Confidentiality 4
11. Sensitive Questions 4
12. Burden Estimates (Hours & Wages) 4
13. Capital Costs 7
14. Cost to Federal Government 7
15. Changes to Burden 8
16. Publication/Tabulation Dates 8
17. Expiration Date 8
18. Certification Statement 8
Appendices: 9
Appendix A – LTCH CARE Data Set V 5.00 Item Mockups and Change Table 9
Supporting Statement Part A
LTCH
CARE Data Set For the Collection of Data Pertaining
to the
Long-Term Care Hospital Quality Reporting Program
We are requesting approval for revisions to the Long-Term Care Hospital Continuity Assessment Record and Evaluation Data Set (LTCH CARE Data Set or LCDS). The current PRA approval expiration date is December 31, 2021. The LTCH CARE Data Set is used to collect, submit, and report quality data to CMS for compliance with the Long-Term Care Hospital Quality Reporting Program (LTCH QRP).
Regarding the LTCH QRP, Table 1 lists the quality measures collected via the LTCH CARE Data Set.
Table 1. Quality Measures Currently Collected via the LTCH CARE Data Set
NQF Number |
Measure Name |
Data Collection Start Date |
Application of NQF #0674 |
Application of Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay) |
April 1, 2016 |
NQF #2631 |
Percent of Long-Term Care Hospital Patients with an Admission and Discharge Functional Assessment and a Care Plan That Addresses Function |
April 1, 2016 |
Application of NQF #2631 |
Application of Percent of Long-Term Care Hospital Patients with an Admission and Discharge Functional Assessment and a Care Plan That Addresses Function |
April 1, 2016 |
NQF #2632 |
Functional Outcome Measure: Change in Mobility among Long-Term Care Hospital Patients Requiring Ventilator Support |
April 1, 2016 |
Not endorsed |
Drug Regimen Review Conducted With Follow-Up for Identified Issues- Post Acute Care (PAC) Long-Term Care Hospital (LTCH) Quality Reporting Program (QRP) |
July 1, 2018 |
Not endorsed |
Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/Injury |
July 1, 2018 |
Not endorsed |
Compliance with Spontaneous Breathing Trial (SBT) by Day 2 of the LTCH Stay |
July 1, 2018 |
Not endorsed |
Ventilator Liberation Rate |
July 1, 2018 |
The burden associated with this requirement is staff time required to complete the LTCH CARE Data Set. The burden associated with transmitting the data is unaffected by the proposed revisions to the assessment instrument.
Section 3004 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) authorizes the establishment of the LTCH QRP. The LTCH QRP was implemented in section VII.C. of the FY 2012 IPPS/LTCH PPS final rule (76 FR 51743 through 51756)1 pursuant to Section 3004 of the Affordable Care Act.2 Beginning in FY 2014, LTCHs that fail to submit quality data to CMS were subject to a 2 percentage point reduction in their annual payment update.
Section 2(a) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185, enacted on Oct. 6, 2014), requires that the Secretary specify not later than the applicable specified application date, as defined in section 1899B(a)(2)(E), quality measures on which LTCH providers are required to submit standardized patient assessment data described in section 1899B(b)(1) and other necessary data specified by the Secretary. Section 1899B(c)(2)(A) requires, to the extent possible, the submission of the such quality measure data through the use of a PAC assessment instrument and the modification of such instrument as necessary to enable such use; for LTCHs, this requirement refers to the LTCH CARE Data Set.
Proposed Transfer of Health Information Measures
Transfer of Health Information from LTCH to another Provider–Post-Acute Care (PAC)
Transfer of Health Information from LTCH to the Patient–Post-Acute Care (PAC)
In the FY 2020 IPPS/LTCH PPS proposed rule, we are proposing to adopt two Transfer of Health Information measures as well as standardized patient assessment data elements (SPADEs) beginning with the FY 2022 LTCH QRP. We estimate the data elements for the proposed Transfer of Health Information quality measures will take 1.2 minutes of clinical staff time to report data on discharge. We believe that the additional LTCH CARE Data Set data elements will be completed by registered nurses and licensed vocational nurses. Individual LTCHs determine the staffing resources necessary. We estimate 102,468 discharges from 415 LTCHs annually. This equates to an increase of 2,049 hours in burden for all LTCHs (0.02 hours × 102,468 discharges). Given 0.7 minutes of registered nurse time at $70.72 per hour and 0.5 minutes of licensed vocational nurse time at $43.96 per hour to complete an average of 247 sets of LTCH CARE Data Set assessments per provider per year, we estimated the total cost will be increased by $289.76 per LTCH annually, or $120,252 for all LTCHs annually.
Proposed Standardized Patient Assessment Data Elements
Brief Interview for Mental Status (BIMS)
Confusion Assessment Method (CAM)
Patient Health Questionnaire-2 to 9
Pain Interference (Pain Effect on Sleep, Pain Interference with Therapy Activities, and Pain Interference with Day-to-Day Activities)
Ability to Hear
Ability to See
Nutritional Approaches: Parenteral/IV Feeding, Feeding Tube, Mechanically Altered Diet, Therapeutic Diet
Cancer Treatments: Chemotherapy, Radiation
Respiratory Treatments: Oxygen Therapy, Suctioning, Tracheostomy Care, Invasive Mechanical Ventilator, Non-invasive Mechanical Ventilator
Other Treatments: IV Medications, Transfusions, Dialysis, IV Access
High-Risk Drug Classes and Indications
Mobility [Car transfer, Walking 10 feet on uneven surfaces, 1 step (curb), 4 steps,12 steps, Picking up object]
Transportation
Preferred Language and Interpreter Services
Health Literacy
Social Isolation
Race
Ethnicity
We estimate the proposed SPADEs will take 11.6 minutes of clinical staff time to report data on admission and 10.2 minutes of clinical staff time to report data on discharge, for a total of 21.8 minutes. We believe that the additional LTCH CARE Data Set data elements will be completed by registered nurses and licensed vocational nurses. Individual LTCHs determine the staffing resources necessary. We estimate 102,468 discharges from 415 LTCHs annually. This equates to an increase of 37,195 hours in burden for all LTCHs (0.363 hours × 102,468 discharges). Given 11.6 minutes of registered nurse time at $70.72 per hour and 10.2 minutes of licensed vocational nurse time at $43.96 per hour to complete an average of 247 sets of LTCH CARE Data Set assessments per provider per year, we estimated the total cost will be increased by $5,209.86 per LTCH annually, or $2,162,093 for all LTCHs annually.
See Appendix A for the LTCH CARE Data Set V5.00 Item Mockups and Change Table (effective October 1, 2020).
The LTCH CARE Data Set is used to collect data for the LTCH QRP. The LTCH QRP is authorized by section 1886(m)(5) of the Social Security Act, and it applies to all hospitals certified by Medicare as LTCHs. Under the LTCH QRP, the Secretary reduces the annual update to the LTCH PPS standard Federal rate for discharges for an LTCH during a fiscal year by 2 percentage points if the LTCH has not complied with the LTCH QRP requirements specified for that fiscal year. The IMPACT Act enacted new data reporting requirements for LTCHs. All of the data that must be reported in accordance with section 1899B(a)(1)(A) must be standardized and interoperable so as to allow for the exchange of the information among PAC providers and other providers and the use of such data in order to enable access to longitudinal information and to facilitate coordinated care.
In addition, the public/consumer is a data user, as CMS is required to make LTCH QRP data available to the public after ensuring that an LTCH has the opportunity to review its data prior to public display. Measure data is currently displayed on Long-Term Care Hospital Compare (LTCH Compare): https://www.medicare.gov/longtermcarehospitalcompare/
LTCHs have the option of recording the required data on a printed form and later transferring the data to electronic format or they can choose to directly enter the required data electronically. The LTCHs currently transmit the submission to the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system. CMS is currently transitioning from the QIES ASAP system to the Internet Quality Improvement and Evaluation System (iQIES), which is a modernized, cloud-based solution that was developed through user-centered design.
This information collection does not duplicate any other effort and the standardized information cannot be obtained from any other source. There are no other data sets that will provide comparable information on patients admitted to LTCHs.
As part of our PRA analysis for an update of our existing approval, we considered whether the change impacts a significant number of small entities. Out of a total of 415 LTCHs, approximately 89 are considered small LTCHs. The average number of assessment sets completed yearly is 247, and is the same across all respondents based on the number of actual assessment sets completed by LTCHs in fiscal year 2018.
CMS requests authorization for LTCHs to use the updated LTCH CARE Data Set for the submission of quality measure and standardized patient assessment data information. Provider participation in the submission of quality measure and standardized patient assessment data is mandated by Section 3004 of the Affordable Care Act and Section 1899B(c)(2)(A) of the IMPACT Act. Small business providers viewing the data collection as a burden can elect not to participate. However, if an LTCH does not submit the required data, this provider shall be subject to a 2 percentage point reduction in their annual payment update.
Standardized patient assessment data and quality measure data will be collected for every patient at admission and upon discharge. According to the LTCH QRP requirements, LTCHs are required to submit this data to CMS on a quarterly basis so that data can be updated more frequently in their confidential feedback reports and on the LTCH Compare website.
There are no special circumstances.
We will solicit comments on the proposed modifications to the LTCH CARE Data Set through the FY 2020 IPPS/LTCH PPS proposed rule, which published on May 3, 2019 (84 FR 19158).
There will be no payments/gifts to respondents for the use of the LTCH CARE Data Set.
The data collected using the updated LTCH CARE Data Set will be kept confidential by CMS. Data will be stored in a secure format meeting all federal privacy guidelines. Data will be collected using a secure platform for electronic data entry and secure data transmission. The electronic system will be password protected with access limited to CMS and project staff. To protect beneficiary confidentiality, the subject’s name will not be linked to his/her individual data. For identification purposes, a unique identifier will be assigned to each sample member.
All patient-level data is protected from public dissemination in accordance with the Privacy Act of 1974, as amended. The information collected is protected and held confidential in accordance with 20 CFR 401.3. Data will be treated in a confidential manner, unless otherwise compelled by law.
The information collected in the LTCH CARE Data Set is still considered to be confidential personal health information. Some patient level data is considered sensitive and all necessary protections will be employed to keep the data secure and confidential. Though this information is considered to be personal health information, similar information is currently collected through the use of other CMS instruments in other post-acute care settings. The items on the updated LTCH CARE Data Set are being collected for the LTCH QRP, which has been established pursuant to Section 3004 of the Affordable Care Act.
Current Burden Estimate
Estimate Number of Yearly LTCH Discharges and LTCH CARE Data Sets (LCDS) Submissions
Total Number of LTCHs in U.S. = 415
Total Number of Discharges from all LTCHs per year: 102,468
Estimate Number of Discharges from each LTCH per year = 247
(102,468 D/Cs from all LTCHs / 415 LTCHs in U.S. = 247)
Estimated Number of LCDS’s submitted by all LTCHs per year = 204,936
(247 estimated # of D/C’s in each LTCH per year x 415 LTCHs in U.S. ≈ 102,468 D/C’s per all LTCHs per year
102,468 D/C’S per all LTCHs per year x 2 LCDS forms per patient = 204,936 LCDS per all LTCHs per year)
Estimated Average Number of LCDS’s submitted by each LTCH per year = 494
(204,936 LCDS per all LTCHs in U.S. / 415 LTCHs in U.S. = 494 LCDS per each LTCH)
OR
(102,468 D/C’S per all LTCHs per year x 2 LCDS forms per patient = 204,936 per all LTCHs per year
204,936 LCDS per all LTCHs per year / 415 LTCHs in U.S. = 494 LCDS per each LTCH)
Estimate of Financial (Wage) Burdens for Submission of LTCH CARE Data Set
Time Required to Complete Each LTCH CARE Data Set Assessment = 85.3 minutes
39.2 minutes for Admission assessment – clinical staff time to collect clinical data;
36.1 minutes for Discharge assessment – clinical staff time to collect clinical data;
10 minutes administrative data entry time to aggregate and submit data to CMS
85.3 minutes – Total time burden to complete LTCH CARE Data Set per patient
Estimated Annual Time Burden per each LTCH = 351 hours/each LTCH/year
Estimated Annual Time Burden all LTCHs = 145,665 hours/all LTCHs/year
29.252 hours per LTCH per month x 12 months/year = 351 hours per each LTCH/year
351 hours/each LTCH/year x 415 LTCHs in U.S. = 145,665 hours/all LTCHs/year
Cost/Wage Calculation for Completion of the LTCH CARE Data Set
Wages for Clinical Staff Completing the LTCH CARE Data Set
Registered nurses: 61.3 minutes for Admission & Discharge assessment at $70.72/hour3
Licensed vocational nurses: 13.1 minutes for Admission & Discharge assessment at $43.96/hour4
Respiratory therapists: 0.9 minutes for Admission & Discharge assessment at $59.44/hour5
Average wages for clinical staff based on completion time: $65.94/hour
75.3 minutes x 247 LCDS forms6 / each LTCH / year ≈ 18,592.3 minutes / each LTCH / year
18,592.3 minutes per LTCH per year / 60 minutes ≈ 309.7 hours per year
309.7 hours per year x $65.94 per hour ≈ $20,420.80 clinical staff wages /per each LTCH / year
$20,420.80 x 415 LTCHs ≈ $ 8,474,633 per all LTCHs / year
Wages for Admin Assistant/ Clerical Staff who gather and transmit LTCH CARE Data Set
(NOTE: Administrative data entry time calculated at an hourly wage of $34.50/hour7)
10 minutes x 247 LCDS forms8 /per LTCH/year = 2,470 minutes/LTCH/year
2,470 minutes per LTCH per year / 60 minutes = 41.15 hours per year
41.15 hours per year x $34.50 per hour ≈ 1,419.73 admin assistant wages/per LTCH/year
$1,419.73 x 415 LTCHs ≈ $589,191 per all LTCHs/year
Combined Calculations
$20,420.80 – Clinical staff wages/per LTCH /year (LTCH CARE Data Set)
$1,419.73 – Admin assistant wages/per LTCH /year (LTCH CARE Data Set)
$21,840.53 – Total Annualized Cost to Each LTCH
$8,474,633 – Clinical staff wages/per all LTCHs /year (LTCH CARE Data Set)
$589,191 – Admin assistant wages/per all LTCHs /year (LTCH CARE Data Set)
$9,063,824 – Total Annualized Cost For All LTCHs
Additional Calculations
Total Yearly Cost to All LTCHs for Reporting Quality Data = $9,063,824
$21,840.53 x 415 LTCHs in U.S. = $9,063,824)
Total Yearly Cost to Each LTCHs for Reporting Quality Data = $21,840.53
($9,063,824 yearly cost for all LTCHs / 415 LTCHs in U.S. = $21,840.53)
Estimated Average Cost per each LCDS Submission = $88.46
($9,063,824 yearly cost of LCDS submissions for all LTCHs / 102,468 LCDS submissions per all LTCHs/year ≈ $88.46)
OR
($21,840.53 yearly cost of LCDS submissions per each LTCH / 247 LCDS submissions per LTCHs/year ≈ $88.46)
Itemized Time and Wage/Cost Burden Estimate for the LTCH CARE Data Set Assessments
The LTCH CARE Data Set consists of 4 different assessment forms in which 2 (an admission and discharge assessment) are required per stay.
All of these forms consist of required items (questions) that contribute to the assessment completion time, and required items if information is available.
Some of these items have subitems. These subitems are not counted towards the assessment completion time since the time to complete the subitems is included in the time to complete the parent item.
An LTCH is required to perform an admission assessment within 3 days after the patient is admitted.
An LTCH must also perform a discharge assessment on each patient.
There are 3 different types of Discharge Assessment forms:
Planned Discharge Assessment
Unplanned Discharge Assessment
Expired (Death) Assessment
The type of discharge assessment used is based on the circumstances of the discharge.
Admission Assessment
Number of Required Questions (including subitems): 205
Number of Required Questions for Assessment Completion Time: 118
Planned Discharge Assessment
Number of Required Questions (including subitems): 128
Number of Required Questions for Assessment Completion Time: 114
Unplanned Discharge Assessment
Number of Required Questions (including subitems): 64
Number of Required Questions for Assessment Completion Time: 46
Expired Assessment
Number of Required Questions (including subitems): 46
Number of Required Questions for Assessment Completion Time: 15
There are no additional capital costs to respondents or to record keepers. LTCHs do not need to acquire any additional equipment to collect data. LTCHs can use the free software to collect and submit the LTCH CARE Data Set. Information regarding the free software, including instructions for installing and using the software, is located at: https://www.qtso.com/providers/long-term-care-hospital-ltch-providers.
The Department of Health & Human Services (DHHS) will incur costs associated with the administration of the LTCH QRP including costs associated with the IT system used to process LTCH CARE Data Set submissions to CMS and analysis of the data received.
CMS engaged the services of an in-house CMS contractor to create and manage an online reporting/IT platform for the LTCH CARE Data Set. This contractor works with the CMS Center for Clinical Standards and Quality, Division of Post-Acute and Chronic Care (DCPAC) in order to support the IT needs of multiple quality reporting programs. When LTCHs transmit the data contained within the LTCH CARE Data Set to CMS it is received by this contractor. Upon receipt of all data sets for each quarter the contractor performs some basic analysis which helps to determine each provider’s compliance with the reporting requirements of the LTCH QRP. The findings are communicated to the LTCH QRP lead in a report. Contractor costs include the development, testing, roll-out, and maintenance of the software that is made available to LTCHs free of charge providing a means by which LTCHs can submit the required data to CMS.
DCPAC retains the services of a separate contractor for the purpose of performing a more in-depth analysis of the LTCH data, as well as the calculation of the quality measures, and for future public reporting of the LTCH data. Said contractor is responsible for obtaining the LTCH quality reporting data from the in-house CMS contractor. They perform statistical analysis on this data and prepare reports of their findings, which will be submitted to the LTCH QRP lead.
DCPAC retains the services of a third contractor to assist with provider training and help desk support services related to the LTCH QRP.
In addition to the contractor costs, the total includes the cost of the following Federal employees:
GS-13 (locality pay area of Washington-Baltimore-Northern Virginia) at 100% effort for 3 years, or $290,910.
GS-14 (locality pay area of Washington-Baltimore-Northern Virginia) at 33% effort for 3 years, or $114,590.
The estimated cost to the federal government for the contractor is as follows:
CMS in-house contractor – Maintenance and support of IT platform that
Supports the LTCH CARE Data Set $750,000
Data analysis contractor $1,000,000
Provider training & help desk contractor $1,000,000
GS-13 Federal Employee (100% X 3 years) $290,910
GS-14 Federal Employee (33% X 3 years) $114,590
Total cost to Federal Government $3,155,500
This section compares the burden of the previously approved PRA package for LTCH CARE Data Set V4.00 and the revised PRA package submission for LTCH CARE Data Set V5.00 because of LTCH QRP proposals in the FY 2020 IPPS/LTCH PPS proposed rule.
We have updated information regarding the current number of Medicare-certified LTCHs in the U.S., as well as the total number of yearly LTCH discharges. The number of Medicare-certified LTCHs has declined from 420 to 415 and discharges declined from 136,476 to 102,468. The total annual burden hours increased from 121,674 to 145,655. We have increased our time estimate from 23.4 to 39.2 minutes for completing the admission assessment and increased our time estimate from 20.1 to 36.1 minutes for completing the discharge assessment. Overall, the combined time estimate increased from 43.5 to 75.3 minutes for the revised LTCH CARE Data Set.
The wages for a registered nurse and administrative assistant remained the same. In addition, we have added wages for licensed vocational nurses ($43.96 per hour; $21.98 without fringe benefits) and respiratory therapists ($59.44 per hour; $29.72 without fringe benefits) since they have been assigned to some of the new items added to the LTCH CARE Data Set. Overall, the average wage based on time to complete the assessment for each clinical staff decreased from $69.22 to $65.94.
The estimated average cost per each LTCH CARE Data Set V5.00 submission increased from $50.18 to $88.46. Subsequently, the total yearly cost to each LTCH for reporting quality data increased from $18,174.35 to $21,840.54, and the total yearly cost to all LTCHs for reporting data using the LTCH CARE Data Set increased from $7,633,226 to $9,063,824.
CMS is mandated to publish quality measure data collected pursuant to Section 3004 of the Affordable Care Act. Measure data is currently displayed on the LTCH Compare website, which is an interactive web tool that assists individuals by providing information on LTCH quality of care including those who need to select an LTCH. The IMPACT Act mandates that measures that are standardized across post-acute care settings be published within two years from the implementation date. The information on the LTCH Compare website is refreshed quarterly. For more information on LTCH Compare, we refer readers to: https://www.medicare.gov/longtermcarehospitalcompare/.
The OMB expiration date will be displayed on all disseminated data collection materials.
There are no exceptions to the certifications statement.
See attached: Appendix A
1 U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals’ FTE Resident Caps for Graduate Medical Education Payment, Federal Register/Vol. 76, No. 160, August 18, 2011. http://www.gpo.gov/fdsys/pkg/FR-2011-08-18/pdf/2011-19719.pdf.
2 Patient Protection and Affordable Care Act. Pub. L. 111-148. Stat. 124-119. 23 March 2010. Web. http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf.
3 The mean hourly wage of $35.36 for a Registered Nurse was obtained from the U.S. Bureau of Labor Statistics, and the wage was multiplied by 2 to account for fringe benefits. See https://www.bls.gov/oes/current/oes291141.htm
4 The mean hourly wage of $21.98 for a Licensed Vocational Nurse was obtained from the U.S. Bureau of Labor Statistics, and the wage was multiplied by 2 to account for fringe benefits. See https://www.bls.gov/oes/current/oes292061.htm
5 The mean hourly wage of $29.72 for a Respiratory Therapist was obtained from the U.S. Bureau of Labor Statistics, and the wage was multiplied by 2 to account for fringe benefits. See https://www.bls.gov/oes/current/oes291126.htm
6 LCDS forms include 1 admission and 1 discharge assessment (2 total)
7 The mean hourly wage of $17.25 per hour for a Medical Secretary was obtained from the U.S. Bureau of Labor Statistics, and the wage was multiplied by 2 to account for fringe benefits. See https://www.bls.gov/oes/current/oes436013.htm
8 LCDS forms include 1 admission and 1 discharge assessment (2 total)
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