CMS-10409 Supporting Statement Part A _508C

CMS-10409 Supporting Statement Part A _508C.docx

(CMS-10409) Long Term Care Hospital (LCTH) Quality Reporting Program

OMB: 0938-1163

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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


EXTENSION TO THE LTCH CARE DATA SET V2.01

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


1. Background and Justification 1

2. Information Users 6

3. Use of Information Technology 6

4. Duplication of Efforts 6

5. Small Businesses 6

6. Less Frequent Collection 6

7. Special Circumstances 6

8. Federal Register/Outside Consultation 7

9. Payment/Gifts to Respondents 7

10. Confidentiality 7

11. Sensitive Questions 7

12. Burden Estimates (Hours & Wages) 7

13. Capital Costs 13

14. Cost to Federal Government 13

15. Changes to Burden 14

16. Publication/Tabulation Dates 14

17. Expiration Date 14

18. Certification Statement 14


Appendix A – Master List of LTCH CARE Data Set Version 3.00 Items 15

Appendix B – Master List of Changes from LTCH CARE Data Set Version 2.01 to LTCH CARE Data Set Version 3.00 15

Revised Supporting Statement for Paperwork Reduction Act Submissions

PART A


LTCH CARE Data Set For the Collection of Data Pertaining
to the Long-Term Care Hospital Quality Reporting Program

  1. Background and Justification


Section 3004 of The Affordable Care Act authorizes the establishment of a new quality reporting program for Long Term Care Hospitals (LTCHs). The LTCH Quality Reporting Program (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 Patient Protection and Affordable Care Act of 2010.2 Beginning in FY 2014, LTCHs that fail to submit quality measures data to CMS on three quality measures (NQF #0678, NQF #0138, NQF #0139), as listed in the Table 1-1, may be subject to a 2 percentage point reduction in their annual update to the standard Federal rate for discharges occurring during a rate year. In the FY 2013 IPPS/LTCH PPS final rule (76 FR 53614 through 53637 and 53667 through 53672), CMS retained three measures and adopted two new measures (NQF #0680 and NQF #0431) for the FY 2016 payment determination, as listed in the Table 1-13. In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50853 through 50887 and 50959 through 50964)4, CMS retained five measures and adopted two additional measures (NQF #1716 and NQF #1717) for the FY 2017 payment determination. In the FY 2015 IPPS/LTCH PPS final rule (79 FR 50286 through 50318 and 50348 through 50349)5, CMS retained seven measures and adopted one additional measure (NQF #2512) for the FY 2017 payment determination and four additional measures (application of NQF #0674, NQF #2631, NQF #2632, and non-NQF endorsed NHSN VAE) for the FY 2018 payment determination. In the FY2016 IPPS/LTCH PPS final rule (80 FR 49723 through 49756 and 49764 through 49766)6, CMS retained twelve measures and adopted 3 measures to meet the requirements of the IMPACT Act (NQF #0678, application of NQF #2631, and application of NQF #0674) for FY 2018 payment determination and 1 measure (NQF #2512) to reflect NQF endorsement status for FY 2018 payment determination.


Implementation of the LTCH CARE Data Set V 3.00 does not require approval of this information collection request extension. According to the FY 2016 IPPS/LTCH PPS final rule (80 FR 49766),6 the LTCH CARE Data Set V 3.00 falls under the PRA provision in section 1899B(m) of the Social Security Act, which was added by the IMPACT Act of 2014. The provision states that the PRA requirements do not apply to section 1899B of the Act and the sections referenced in subsection 1899B(a)(2)(B) of the Act that require modifications in order to achieve the standardization of patient assessment data.


Table 1-1. Quality Measures for Fiscal Years 2014, 2015, 2016, 2017, and 2018 Payment Update Determination

NQF Number

Measure Name

Fiscal Year Payment Update Determination

Data Collection Start Date

NQF #0678

Percent of Residents or Patients with Pressure Ulcers That Are New or Worsened (Short Stay)

Starting FY 2014

October 1, 2012

NQF #0138

National Healthcare Safety Network (NHSN) Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure

Starting FY 2014

October 1, 2012

NQF #0139

National Healthcare Safety Network (NHSN) Central line-associated Bloodstream Infection (CLABSI) Outcome Measure

Starting FY 2014

October 1, 2012

NQF #0680

Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay)

Starting FY 2016

October 1, 2014

NQF #0431

Influenza Vaccination Coverage among Healthcare Personnel

Starting FY 2016

October 1, 2014

NQF #1716

National Healthcare Safety Network (NHSN) Facility-Wide Inpatient Hospital-Onset Methicillin-Resistant Staphylococcus Aureus (MRSA) Bacteremia Outcome Measure

Starting FY 2017

January 1, 2015

NQF #1717

National Healthcare Safety Network (NHSN) Facility-Wide Inpatient Hospital-Onset Clostridium difficile Infection (CDI) Outcome Measure

Starting FY 2017

January 1, 2015

NQF #2512

All-Cause Unplanned Readmission Measure for 30 Days Post‑Discharge from Long-Term Care Hospitals

Starting FY 2018

N/A – Medicare FFS Claims Data

Application of NQF #0674

Application of Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay)

Starting FY 2018

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

Starting FY 2018

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

Starting FY 2018

April 1, 2016

NQF #2632

Functional Outcome Measure: Change in Mobility among Long-Term Care Hospital Patients Requiring Ventilator Support

Starting FY 2018

April 1, 2016

Not endorsed

National Healthcare Safety Network (NHSN) Ventilator-Associated Event (VAE) Outcome Measure

Starting FY 2018

January 1, 2016


The Long-Term Care Hospital (LTCH) Continuity Assessment Record & Evaluation (CARE) Data Set (LTCH CARE Data Set) was developed specifically for use in LTCHs for data collection of NQF #0678 Pressure Ulcer measure beginning October 1, 2012, with the understanding that the data set would expand in future rule-making years with the adoption of additional quality measures for the LTCH QRP. Relevant data elements contained in other well-known and clinically established data sets, including but not limited to the Minimum Data Set 3.0 (MDS 3.0) and Continuity Assessment Record and Evaluation (CARE), were incorporated into the LTCH CARE Data Set V1.01,7 V2.008 and V2.01, each of which has been approved by the Office of Management and Budget (OMB).


Implementation of the LTCH CARE Data Set V 3.00 does not require approval of this information collection request extension as the LTCH CARE Data Set falls under the PRA provision in section 1899B(m)of the Social Security Act, which was added by the IMPACT Act of 2014.


The following changes from the LTCH CARE Data Set V 2.01 were made to develop LTCH CARE Data Set V3.00 which will be implemented April 1, 2016:

  • The addition of Section J: Health Conditions to collect data for the application of NQF #0674: Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay).

  • The addition of section J in the LTCH CARE Data Set is necessary in order to allow CMS to collect LTCH quality measure data in compliance with Section 3004 of the Affordable Care Act. There are no other reasonable alternatives available to CMS for collecting falls with major injury data in LTCHs.

  • The addition of the following items, will allow CMS to assess and risk adjust the two function measures:

    • Section B:

      • BB0700. Expression of Ideas and Wants (3-day assessment period)

      • BB0800. Understanding Verbal Content (3-day assessment period)

    • Section C

      • C1610: Signs and Symptoms of Delirium

        • Acute Onset and Fluctuating Course

          • A. Is there evidence of an acute change in mental status from the patient's baseline?

          • B. Did the (abnormal) behavior fluctuate during the day, that is, tend to come and go or increase and decrease in severity?

        • Inattention

          • C. Did the patient have difficulty focusing attention, for example, being easily distractible or having difficulty keeping track of what was being said?

        • Disorganized Thinking

          • D. Was the patient's thinking disorganized or incoherent, such as rambling or irrelevant conversation, unclear or illogical flow of ideas, or unpredictable switching from subject to subject?

        • Altered Level of Consciousness

          • E1. Alert (Normal)

          • E2. Vigilant (hyperalert) or Lethargic (drowsy, easily aroused) or Stupor (difficult to arouse) or Coma (unarousable)

    • Section GG

      • GG0100: Prior Functioning

        • A. Indoor Mobility (Ambulation)

      • GG0105. Prior Device Use

        • A. Manual Wheelchair

        • B. Motorized wheelchair or scooter

        • C. Mechanical Lift

      • GG0130. Self-Care

        • A. Eating

        • B. Oral hygiene

        • C. Toileting hygiene

        • D. Wash upper body

      • GG0170. Functional Mobility

        • A. Roll left and right

        • B. Sit to lying

        • C. Lying to sitting on side of bed

        • D. Sit to stand

        • E. Chair/bed-to-chair transfer

        • F. Toilet transfer

        • H. Does the patient walk?

        • I. Walk 10 feet

        • J. Walk 50 feet with two turns

        • K. Walk 150 feet

        • Q. Does the patient use a wheelchair or scooter?

        • R. Wheel 50 feet with two turns

        • RR. Indicate the type of wheelchair/scooter used for this assessment.

        • S. Wheel 150 feet

        • SS. Indicate the type of wheelchair/scooter used for this assessment.

    • Section H.

      • H0350. Bladder Continence (3-day assessment period.)

    • Section I

      • I0101. Severe and Metastatic Cancers

      • I1501. Chronic Kidney Disease, Stage 5

      • I1502. Acute Renal Failure

      • I2101. Septicemia, Sepsis, Systemic Inflammatory Response Syndrome/Shock

      • I2600. Central Nervous System Infections, Opportunistic Infections, Bone/Joint/Muscle Infections/Necrosis

      • I4100. Lower Limb Amputation (e.g., above knee, below knee, above elbow, below elbow)

      • I4501. Stroke

      • I4801. Dementia

      • I4900. Hemiplegia or Hemiparesis

      • I5000. Paraplegia

      • I5102. Incomplete Tetraplegia

      • I5110. Other Spinal Cord Disorder/Injury (e.g., myelitis, cauda equina syndrome)

      • I5470. Severe Anoxic Brain Damage, Cerebral Edema, or Compression of Brain

      • I5101. Complete Tetraplegia

      • I5200. Multiple Sclerosis (MS)

      • I5250. Huntington's Disease

      • I5300. Parkinson's Disease

      • I5450. Amyotrophic Lateral Sclerosis

      • I5460. Locked-In State

      • I5601. Malnutrition (protein or calorie)

      • I5602. At risk for malnutrition

      • I7900. None of the Above

    • Section O

      • O0100. Special Treatments, Procedures, and Programs

        • F1. Ventilator: weaning

        • F2: Ventilator: non-weaning

        • G: Non-invasive ventilator (BIPAP, CPAP)

        • J. Dialysis

        • N. Total parenteral nutrition

  • The removal of I5600. At risk for malnutrition (protein or calorie), which has been replaced by two items, I5601 and I5602 above.

  1. Information Users


  • Data Submitters: All LTCHs

  • Data Users:

    • CMS: as required under Section 3004 of the Affordable Care Act and the IMPACT Act of 2014

    • Public: the measure calculated from the data obtained will be made available at a later date for public use on a CMS website


  1. Use of Information Technology


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 transmit the submission to the Quality Improvement Evaluation System (QIES) Assessment Submission and Processing (ASAP) system, which is currently used by Inpatient Rehabilitation Facilities (IRFs), Skilled Nursing Facilities (SNFs), and Home Health Agencies (HHAs). LTCHs also use the QIES ASAP system for transmitting other measure records, such as pressure ulcer and influenza measure records.


CMS requires that the collected data be transmitted to CMS electronically, in a manner similar to the process used by LTCHs submitting pressure ulcer data, and currently used by HHAs for the Outcome and Assessment Information Set, Version C (OASIS-C), SNFs for the Minimum Data Set (MDS 3.0), and IRFs for Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI). Attestation as to the accuracy of the data collected remains required of the provider upon completion of the LTCH CARE Data Set. However, if electronic signatures were to be required at a future date, CMS could accommodate this as well.


  1. Duplication of Efforts


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.


  1. Small Businesses


CMS requests authorization for LTCHs to use the updated LTCH CARE Data Set for the submission of quality measure information. Provider participation in the submission of quality data is mandated by Section 3004 of the Affordable Care 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 quality data, this provider shall be subject to a 2% reduction in their annual payment update.


  1. Less Frequent Collection


The updated LTCH CARE Data Set will be used in LTCHs to collect quality measure data about falls with major injury and functional status during the patient’s stay. Collection of falls with major injury data will be performed upon discharge of every patient; collection of functional status data will be performed upon admission and discharge of every patient. LTCHs will be required to submit this data to CMS on a quarterly basis.


  1. Special Circumstances


There are no special circumstances.

  1. Federal Register/Outside Consultation


The 60-day Federal Register notice published on March 11, 2016. There were no public comments received.


The updated LTCH CARE Data Set was developed in consultation with the CMS Division of Chronic and Post Acute Care measure development contractor, Research Triangle Institute, International (RTI), the CMS Division of Quality Systems for Assessments and Surveys and its contractors, Telligen and GDIT.


  1. Payment/Gifts to Respondents


There will be no payments/gifts to respondents for the use of the LTCH CARE Data Set.


  1. Confidentiality


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.


  1. Sensitive Questions


The information collected in the LTCH CARE Data Set is still considered to be confidential personal health information. This 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 Quality Reporting Program, which has been established pursuant to Section 3004(a) of the Affordable Care Act.


  1. Burden Estimates (Hours & Wages)


  1. Burden Estimate from Prior PRA Package

(Based on V2.00 approved on June 30, 2013. OMB Control Number: 0938-1163)


  1. Estimate Number of Yearly LTCH Discharges and LTCH CARE Data Sets (LCDS) Submissions

Total Number of LTCH in U.S. = 442

Total Number of Discharges from all LTCHs per year: 202,050

Estimate Number of Discharges from each LTCH per year = 457

(202,050 D/Cs from all LTCHs / 442 LTCHs in U.S. = 457)


Estimated Number of Discharges from each LTCH per month = 38

(202,050 D/Cs from all LTCHs / 442 LTCHs in U.S. / 12 months per year = 38)


Estimated Number of LCDS’s submitted by all LTCHs per year = 403,988

(457 estimated # of D/C’s in each LTCH per year x 442 LTCHs in US = 201,994 D/C’s per all LTCHs per year

201,994 D/C’S per all LTCH per year x 2 LCDS forms per patient = 403,988 LCDS per all LTCHs per year)


Estimated Average Number of LCDS’s submitted by each LTCH per year = 914

(403,988 LCDS per all LTCHs in U.S. / 442 LTCHs in US = 914 LCDS per each LTCH)

OR

(202,050 D/C’S per all LTCH per year x 2 LCDS forms per patient = 404,100 LCDS per all LTCHs per year

404,100 LCDS per all LTCHs per year / 442 LTCHs in U.S. = 914 LCDS per each LTCH)


Estimated Average Number of LCDS’s submitted by each LTCH per month = 76

(403,988 LCDS per all LTCHs in U.S. per mo. / 442 LTCHs in US = 914 LCDS per each LTCH per year

914 LCDS per each LTCH per year / 12 months per year = 76 LCDS per each LTCH per month)


Estimated Average Number of LCDS’s submitted by All LTCHs per month = 33,666

(403,988 LCDS per all LTCHs in U.S. per year / 12 months per year = 33,666)


  1. Estimate of Financial (Wage) Burdens for Submission of LTCH CARE Data Set


Time Required to Complete Each LTCH CARE Data Set Assessment = 32 minutes

11 minutes for Admission assessment – nursing/clinical staff time to collect clinical data;

11 minutes for Discharge assessment – nursing/clinical staff time to collect clinical data;

10 minutes administrative data entry time to aggregate and submit data to CMS

32 minutes9 – Total time burden to complete LTCH CARE Data Set per patient


Estimated Annual Time Burden per each LTCHs = 480 hours/each LTCH/year

Estimated Annual Time Burden all LTCHs = 212,160 hours/all LTCH’s/year

32 minutes/form x 76 forms/each LTCH/month = 2,432 minutes/each LTCH/month

2,432 minutes / 60 minutes/ hour = 40 hours per LTCH per month

40 hours per LTCH per month x 12 months/year = 480 hours per each LTCH/year

480 hours/each LTCH/year x 442 LTCHs in U.S. = 212,160 hours/all LTCH’s/year


  1. Cost/Wage Calculation for Completion of the LTCH CARE Data Set


  1. Wages for Clinical Staff Completing the LTCH CARE Data Set

11 minutes for Admission assessment – nursing time to collect clinical data at $33.23/hour10

11 minutes for Discharge assessment – nursing time to collect clinical data at $33.23/hour


22 minutes x 457 LCDS forms11/ each LTCH / year = 10,054 minutes /each LTCH / year

10,054 minutes per LTCH per year / 60 minutes = 167.57 hours per year


167.57 hours per year x $33.23 per hour = $5,568.35 nursing wages /per each LTCH / year

$5,568.35 x 442 LTCH providers = $2,461,211 per all LTCHs / year


  1. 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 $15.59/hour12)


10 minutes x 457 LCDS forms/ LTCH/year = 4,570 minutes/LTCH/year

4,570 minutes per LTCH per year / 60 minutes = 76.17 hours per year


76.17 hours per year x $15.59 per hour = $1,187.49 admin assistant wages/per LTCH/year

$1,187.49 x 442 LTCHs = $524,871 per all LTCH providers/year

  1. Combined Calculations


$5,568.35 – Nursing wages/per LTCH /year (LTCH CARE Data Set)

$1,187.49 – Admin assistant wages/per LTCH /year (LTCH CARE Data Set)

$6,755.84 – Total Annualized Cost to Each LTCH Provider


$2,461,211 – Nursing wages/per ALL LTCHs /year (LTCH CARE Data Set)

$524,871 – Admin assistant wages/per ALL LTCHs /year (LTCH CARE Data Set)

$2,986,082 – Total Annualized Cost For All LTCH Providers


  1. Additional Calculations


Total Yearly Cost to All LTCH Providers for Reporting Data using the LCDS = $2,986,082

($6,755.84 x 442 LTCHs in U.S. = $2,986,082)


Total Yearly Cost to Each LTCH Provider for Reporting Quality Data = $6,755.84

($2,986,082 yearly cost for all LTCHs / 442 LTCHs in U.S. = $6,755.84)


Estimated Average Monthly Cost to Each LTCH Provider for Reporting Quality Data = $562.99

($2,986,081 Total yearly cost for all LTCHs / 442 LTCHs in U.S. / 12 months per year = $562.99)


Estimated Average Cost per each LCDS Submission = $14.78

($2,986,081 yearly cost of LCDS submissions for ALL LTCHs / 201,994 LCDS submissions per all LTCHs/year = $14.78)

OR

($6,755.84 yearly cost of LCDS submissions per each LTCH / 457 LCDS submissions per LTCHs/year = $14.78)


  1. Current Burden Estimate

(Based on V3.00 for OMB Control Number: 0938-1163)


  1. Estimate Number of Yearly LTCH Discharges and LTCH CARE Data Sets (LCDS) Submissions

Total Number of LTCH in U.S. = 432

Total Number of Discharges from all LTCHs per year: 202,635

Estimate Number of Discharges from each LTCH per year = 469

(202,635 D/Cs from all LTCHs / 432 LTCHs in U.S. = 469)


Estimated Number of Discharges from each LTCH per month = 39

(202,635 D/Cs from all LTCHs / 432 LTCHs in U.S. / 12 months per year = 39)


Estimated Number of LCDS’s submitted by all LTCHs per year = 405,270

(469 estimated # of D/C’s in each LTCH per year x 432 LTCHs in US ≈ 202,635 D/C’s per all LTCHs per year

202,635 D/C’S per all LTCH per year x 2 LCDS forms per patient = 405,270 LCDS per all LTCHs per year)


Estimated Average Number of LCDS’s submitted by each LTCH per year = 938

(405,270 LCDS per all LTCHs in U.S. / 432 LTCHs in US = 938 LCDS per each LTCH)

OR

(202,635 D/C’S per all LTCH per year x 2 LCDS forms per patient = 405,270 LCDS per all LTCHs per year

405,270 LCDS per all LTCHs per year / 432 LTCHs in U.S. = 938 LCDS per each LTCH)


Estimated Average Number of LCDS’s submitted by each LTCH per month = 78

(405,270 LCDS per all LTCHs in U.S. per mo. / 432 LTCHs in US = 938 LCDS per each LTCH per year

938 LCDS per each LTCH per year / 12 months per year = 78 LCDS per each LTCH per month)


Estimated Average Number of LCDS’s submitted by All LTCHs per month = 33,773

(405,270 LCDS per all LTCHs in U.S. per year / 12 months per year = 33,773)


  1. Estimate of Financial (Wage) Burdens for Submission of LTCH CARE Data Set


Time Required to Complete Each LTCH CARE Data Set Assessment = 58.3 minutes

22.2 minutes for Admission assessment – nursing/clinical staff time to collect clinical data;

26.1 minutes for Discharge assessment – nursing/clinical staff time to collect clinical data;

10 minutes administrative data entry time to aggregate and submit data to CMS

58.3 minutes13 – Total time burden to complete LTCH CARE Data Set per patient


Estimated Annual Time Burden per each LTCH = 774.4 hours/each LTCH/year

Estimated Annual Time Burden all LTCHs = 335,836 hours/all LTCH’s/year

58.3 minutes/form x 78 forms/each LTCH/month = 4,547 minutes/each LTCH/month

4,547 minutes / 60 minutes / hour = 75.78 hours per LTCH per month

75.78 hours per LTCH per month x 12 months/year = 909.4 hours per each LTCH/year

909.4 hours/each LTCH/year x 432 LTCHs in U.S. = 392,861 hours/all LTCH’s/year


  1. Cost/Wage Calculation for Completion of the LTCH CARE Data Set


  1. Wages for Clinical Staff Completing the LTCH CARE Data Set

22.2 minutes for Admission assessment – nursing time to collect clinical data at $33.23/hour14

26.1 minutes for Discharge assessment – nursing time to collect clinical data at $33.23/hour


48.3 minutes x 469 LCDS forms15 / each LTCH / year = 22,653 minutes / each LTCH / year

22,653 minutes per LTCH per year / 60 minutes = 377.6 hours per year


377.6 hours per year x $33.55 per hour = $12,668.48 nursing wages /per each LTCH / year

$12,668.48 x 432 LTCH providers = $5,472,783 per all LTCHs / year


  1. 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 $15.59/hour16)


10 minutes x 469 LCDS forms / LTCH/year = 4,690 minutes/LTCH/year

4,690 minutes per LTCH per year / 60 minutes = 78.17 hours per year


78.17 hours per year x $16.12 per hour = $1,260.10 admin assistant wages/per LTCH/year

$1,260.10 x 432 LTCHs = $544,363 per all LTCH providers/year

  1. Combined Calculations


$12,668.48 – Nursing wages/per LTCH /year (LTCH CARE Data Set)

$1,260.10 – Admin assistant wages/per LTCH /year (LTCH CARE Data Set)

$13,928.58 – Total Annualized Cost to Each LTCH Provider


$5,472,783 – Nursing wages/per ALL LTCHs /year (LTCH CARE Data Set)

$544,363 – Admin assistant wages/per ALL LTCHs /year (LTCH CARE Data Set)

$6,017,146 – Total Annualized Cost For All LTCH Providers


  1. Additional Calculations


Total Yearly Cost to All LTCH Providers for Reporting Data using the LCDS = $6,017,146

$13,928.58 x 432 LTCHs in U.S. = $6,017,146)


Total Yearly Cost to Each LTCH Provider for Reporting Quality Data = $3,928.58

($6,017,146 yearly cost for all LTCHs / 432 LTCHs in U.S. = $13,928.58)


Estimated Average Monthly Cost to Each LTCH Provider for Reporting Quality Data = $1,160.71

($6,017,146 Total yearly cost for all LTCHs / 432 LTCHs in U.S. / 12 months per year = $1,160.71)


Estimated Average Cost per each LCDS Submission = $29.69

($6,017,146 yearly cost of LCDS submissions for ALL LTCHs / 202,635 LCDS submissions per all LTCHs/year = $29.69)

OR

($13,928.58 yearly cost of LCDS submissions per each LTCH / 469 LCDS submissions per LTCHs/year = $29.69)


  1. Itemized Time and Wage/Cost Burden Estimate for the LTCH CARE Data Set Assessments


  • The LTCH CARE Date Set consists of 4 different assessment forms.

  • All of these forms consist of some items (questions) that are required, and some that are voluntary (LTCH may choose not to answer the voluntary questions without affecting quality reporting compliance).

  • 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: 73 @ 0.3 minutes each = 21.9 minutes

Number of Voluntary Questions: 1 @ 0.3 minutes each = 0.3 minutes

Total Number of Questions: 74 @ 0.3 minutes each = 22.2 minutes


Planned Discharge Assessment

Number of Required Questions: 77 @ 0.3 minutes each = 23.1 minutes

Number of Voluntary Questions: 10 @ 0.3 minutes each = 3.0 minutes

Total Number of Questions: 87 @ 0.3 minutes each = 26.1 minutes


Unplanned Discharge Assessment

Number of Required Questions: 55 @ 0.3 minutes each = 16.5 minutes

Number of Voluntary Questions: 10 @ 0.3 minutes each = 3.0 minutes

Total Number of Questions: 65 @ 0.3 minutes each = 19.5 minutes


Expired Assessment

Number of Required Questions: 26 @ 0.3 minutes each = 7.8 minutes

Number of Voluntary Questions: 0 @ 0.3 minutes each = 0.0 minutes

Total Number of Questions: 26 @ 0.3 minutes each = 7.8 minutes


  1. Cost Estimates for Several Combinations of the LTCH CARE Data Set Admission and Discharge Forms


Planned Discharge Assessment / Required and Voluntary Data Given By Provider

Admission Assessment – Nursing Wages (Required) 21.9 minutes @ 33.55 per hour = $12.25

Admission Assessment – Nursing Wages (Voluntary) 0.3 minutes @ 33.55 per hour = $0.17

Admission Assessment – (Admin Assistant) 10.0 minutes @ 16.12 per hour = $2.69

Planned Discharge Assessment (Required) 23.1 minutes @ 33.55 per hour = $12.92

Planned Discharge Assessment (Voluntary) 3.0 minutes @ 33.55 per hour = $1.51

48.3 minutes @ 33.55 per hour = $27.00

10.0 minutes @ 16.12 per hour = $2.69

58.3 minutes = $29.69


Unplanned Discharge Assessment / Required and Voluntary Data Given By Provider

Admission Assessment – Nursing Wages (Required) 21.9 minutes @ 33.55 per hour = $12.25

Admission Assessment – Nursing Wages (Voluntary) 0.3 minutes @ 33.55 per hour = $0.17

Admission Assessment (Admin Assistant) 10.0 minutes @ 16.12 per hour = $2.69

Unplanned Discharge Assessment (Required) 16.5 minutes @ 33.55 per hour = $12.92

Unplanned Discharge Assessment (Voluntary) 3.0 minutes @ 33.55 per hour = $1.68

41.7 minutes @ 33.55 per hour = $23.32

10.0 minutes @ 16.12 per hour = $2.69

51.7 minutes = $26.01



Planned or Unplanned Discharge Assessment / Required Only Data Given By Provider

Admission Assessment – Nursing Wages (Required Data Only) 21.9 minutes @ 33.55 per hour = $12.25

Admission Assessment – (Admin Assistant) 10.0 minutes @ 16.12 per hour = $2.69

Planned Discharge Assessment (Required Data Only) 23.1 minutes @ 33.55 per hour = $12.92

45.0 minutes @ 33.55 per hour = $25.16

10 minutes @ 16.12 per hour = $2.69

55.0 minutes = $27.85


Expired Assessment / Required and Voluntary Data Given By Provider

Admission Assessment – Nursing Wages (Required) 21.9 minutes @ 33.55 per hour = $12.25

Admission Assessment – Nursing Wages (Voluntary) 0.3 minutes @ 33.55 per hour = $0.17

Admission Assessment (Admin Assistant) 10.0 minutes @ 16.12 per hour = $2.69

Expired Discharge Assessment (Required) 7.8 minutes @ 33.55 per hour = $4.36

Expired Discharge Assessment (Voluntary) 0.0 minutes @ 33.55 per hour = $0.00

32.7 minutes @ 33.55 per hour = $18.28

10.0 minutes @ 16.12 per hour = $2.69

42.7 minutes = $20.97


Expired Assessment / Required Only Data Given By Provider

Admission Assessment – Nursing Wages (Required) 21.9 minutes @ 33.55 per hour = $12.25

Admission Assessment (Admin Assistant) 10.0 minutes @ 16.12 per hour = $2.69

Expired Discharge Assessment (Required) 7.8 minutes @ 33.55 per hour = $4.36

29.7 minutes @ 33.55 per hour = $18.11

10.0 minutes @ 16.12 per hour = $2.69

39.7 minutes = $20.80


  1. Capital Costs


There are no additional capital costs to respondents or to record keepers.


  1. Cost to Federal Government


The Department of Health & Human Services (DHHS) will incur costs associated with the administration of the LTCH quality reporting program including costs associated with the IT system used to process LTCH 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 LTCH providers 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 LTCH Assessment Submission Entry and Reporting (LASER) software that is made available to LTCH providers free of charge providing a means by which LTCHs can submit the required quality measure data to CMS.


DCPAC retains the services of a separate contractor for the purpose of performing a more in-depth analysis of the LTCH quality data, as well as the calculation of the quality measures, and for future public reporting of the LTCH quality 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 helpdesk 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 $276,435.

  • GS-14 (locality pay area of Washington-Baltimore-Northern Virginia) at 33% effort for 3 years, or $108,887.


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 & helpdesk contractor $1,000,000

GS-13 Federal Employee (100% X 3 years) $276,435

GS-14 Federal Employee (33% X 3 years) $108,887

Total cost to Federal Government $3,135,322


  1. Changes to Burden


In section 12 above, we have provided the previous burden estimate that was submitted with our revised PRA package that was approved on June 10, 2013. We have also provided a new, updated burden estimate. A comparison of these two burden estimates will show that adjustments have been made to the time and cost estimates. First, 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 have declined from 442 to 432; however, discharges remained steady (202,050 vs. 202,635). The annual burden hours increased from 212,160 to 392,861. Second, the number of questions increased from V2.01 to V3.00 due to the addition of new measures. We have increased our time estimate to 22.2 minutes for the admission assessment and to 26.1 minutes for the discharge assessment from 11 minutes in V2.01 for both the admission and discharge assessment. Lastly, wages have been updated to the most recent figures. The wage for a registered nurse to complete the LTCH CARE Data Set assessment increased from $33.23 to $33.55 per hour, and the wage for an administrative assistant to aggregate and submit data to CMS increased from $15.59 to $16.12 per hour.


Overall, the estimated average cost per each LCDS V3.00 submission was $29.69 which is an increase from the cost of completing V2.01 ($14.78). Subsequently, the total yearly cost to each LTCH provider for reporting quality data increased from $6,755.84 for V2.01 to $13,928.58 for V3.00, and the total yearly cost to all LTCH providers for reporting data using the LCDS rose from $2,986,082 for V2.01 to $6,017,146 for V3.00.


All changes that have been made to the LTCH CARE Data Set are listed in Appendix B. The justification for each change is also included in Appendix B.


  1. Publication/Tabulation Dates


CMS is mandated to publish quality measure data collected pursuant to Section 3004 of the Affordable Care Act. The date and method for publication of this data has not yet been established. At this time, there are no publications or tabulations associated with data collection not associated with Section 3004 of the Affordable Care Act.


  1. Expiration Date


The OMB expiration date will be displayed on all disseminated data collection materials.


  1. Certification Statement


There are no exceptions to the certifications statement.



Appendix A – Master List of LTCH CARE Data Set Version 3.00 Items


See attached Excel: Appendix A - Master List of LTCH CARE Data Set Version 3.00 Items


Appendix B – Master List of Changes from LTCH CARE Data Set Version 2.01 to LTCH CARE Data Set Version 3.00


See attached PDF: Appendix B - LTCH CARE Data Set Change Table V2.01 to Final V3.00

1 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.

2 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.

3 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals’ Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers; Final Rule, Federal Register/Vol. 77, No. 170, August 31, 2011. http://www.gpo.gov/fdsys/pkg/FR-2012-08-31/pdf/2012-19079.pdf.

4 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 Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status; Final Rule, Federal Register/Vol. 78, No. 160, August 19, 2013. http://www.gpo.gov/fdsys/pkg/FR-2013-08-19/pdf/2013-18956.pdf.

5 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 Fiscal Year 2015 Rates; Quality Reporting Requirements for Specific Providers; Reasonable Compensation Equivalents for Physician Services in Excluded Hospitals and Certain Teaching Hospitals; Provider Administrative Appeals and Judicial Review; Enforcement Provisions for Organ Transplant Centers; and Electronic Health Record (EHR) Incentive Program; Final Rule, Federal Register/Vol. 79, No. 163, August 22, 2014 http://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-18545.pdf.

6 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 Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Extensions of the Medicare-Dependent, Small Rural Hospital Program and the Low-Volume Payment Adjustment for Hospitals; Final Rule, Federal Register/Vol. 80, No. 158, August 17, 2015 http://www.gpo.gov/fdsys/pkg/FR-2015-08-17/pdf/2015-19049.pdf.

7 The LTCH CARE Data Set V1.01 was approved on August 13, 2012 by the Office of Management and Budget in accordance with the Paperwork Reduction Act.  The OMB Control Number is 0938-1163.  Expiration Date April 30, 2013. 

8 The LTCH CARE Data Set V2.00 was approved on June 10, 2013 by the Office of Management and Budget in accordance with the Paperwork Reduction Act.  The OMB Control Number is 0938-1163.  Expiration Date June 30, 2016. 

9 This time estimate includes the time required to complete both the required and voluntary questions on the LTCH CARE Data Set.

10 The mean hourly wage of $33.23 for a Registered Nurse was obtained from the U.S. Bureau of Labor Statistics. See http://www.bls.gov/oes/current/oes291111.htm

11 LCDS forms include 1 admission and 1 discharge assessment (2 total)

12 The mean hourly wage of $15.59 per hour for a Medical Secretary was obtained from the U.S. Bureau of Labor Statistics. See http://www.bls.gov/oes/current/oes436013.htm

13 This time estimate includes the time required to complete both the required and voluntary questions on the LTCH CARE Data Set.

14 The mean hourly wage of $33.55 for a Registered Nurse was obtained from the U.S. Bureau of Labor Statistics. See http://www.bls.gov/oes/current/oes291111.htm

15 LCDS forms include 1 admission and 1 discharge assessment (2 total)

16 The mean hourly wage of $16.12 per hour for a Medical Secretary was obtained from the U.S. Bureau of Labor Statistics. See http://www.bls.gov/oes/current/oes436013.htm

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleSupporting Statement-Part A
SubjectSupporting Statement-Part A
AuthorRTI International and/or Centers for Medicaid & Medicare Service
File Modified0000-00-00
File Created2021-01-23

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