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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE AND MEDICAID SERVICES DATA COLLECTION FOR ADMINISTERING THE MEDICARE CONTINUITY ASSESSMENT RECORD AND EVALUATION (CARE) INSTRUMENT OFFICE OF MANAGEMENT AND BUDGET CLEARANCE PACKAGE SUPPORTING STATEMENT-PART A July 17, 2007 CONTENTS A. BACKGROUND ....................................................................................................................1 JUSTIFICATION ............................................................................................................................2 A.1 Need and Legal Basis.....................................................................................................2 A.2 Information Users ..........................................................................................................3 A.3 Use of Information Technology .....................................................................................3 A.4 Duplication of Efforts ....................................................................................................4 A.5 Small Businesses ............................................................................................................4 A.6 Less Frequent Collection ...............................................................................................4 A.7 Special Circumstances ...................................................................................................4 A.8 Federal Register/Outside Consultation ..........................................................................4 A.9 Payment/Gifts to Respondents .......................................................................................5 A.10 Confidentiality ...............................................................................................................5 A.11 Sensitive Questions ........................................................................................................6 A.12 Burden Estimates (Hours & Wages) ..............................................................................6 A.13 Capital Costs ..................................................................................................................8 A.14 Cost to Federal Government ..........................................................................................8 A.15 Changes to Burden .........................................................................................................8 A.16 Publication/Tabulation Dates .........................................................................................8 A.17 Expiration Date ..............................................................................................................8 A.18 Certification Statement ..................................................................................................8 Appendix A Master List of CARE Items .........................................................................................9 Appendix B CARE Instrument ......................................................................................................10 Appendix C Deficit Reduction Act Section 5008 ..........................................................................11 Page i Supporting Statement for Administering the Medicare Continuity Assessment Record and Evaluation (CARE) Instrument A. BACKGROUND The Medicare Continuity Assessment Record and Evaluation (CARE) is a uniform patient assessment instrument designed to measure differences in patient severity, resource utilization, and outcomes for patients in acute and post-acute care settings. This tool will be used to 1) standardize program information on Medicare beneficiaries’ acuity at discharge from acute hospitals, 2) document medical severity, functional status and other factors related to outcomes and resource utilization at admission, discharge, and interim times during post acute treatment, and 3) understand the relationship between severity of illness, functional status, social support factors, and resource utilization. The CARE instrument will be used in the Post-Acute Care (PAC) Payment Reform Demonstration program mandated by Section 5008 of the Deficit Reduction Act of 2005 to develop payment groups that reflect patient severity and related cost and resource use across post acute settings. The Centers for Medicare and Medicaid Services (CMS) awarded the contract for both the uniform patient assessment development and for the payment reform demonstration to RTI, International (RTI) who teamed with experts from each of the different levels of care, including acute, rehabilitation, and long term care hospitals; skilled nursing facilities, and home health care. The lack of a uniform post-acute assessment tool is one of the major limitations to understanding variations in post-acute outcomes, cost-effectiveness, and Medicare payments. The CARE instrument has been developed as a uniform assessment instrument and includes items measuring case mix at hospital discharge and explaining expected resource use and outcomes in each level of post-acute care, given the individual characteristics of the patient. The major items collected on the CARE instrument include those related to: Administrative information, such as provider, beneficiary, and payer data Admission Information, including prior use and pre-morbid status Current Medical items such as diagnoses, procedures, medications, allergies, skin integrity, and physiologic factors related to the current admission Cognitive Status and other interview-based items to measure risk of delirium, depression, and pain Physical Factors, including functional status and physical impairments Factors affecting outcomes, such as engagement levels and Frailty or Life Expectancy, and Discharge Items, including discharge and caregiver information that might affect these choices Page 1 The instrument includes a core set of items to measure basic acuity on all patients and screen for particular conditions. Most of these items are commonly collected in patient assessments in all settings. A longer version containing supplemental items will be used in postacute settings to measure variations in functional status, impairments, and skin integrity for patients having any of these problems. For cases with none of these deficits, the respondent will skip some of the medical items, and all the impairment and functional status items. Each of these sections have screening questions to determine whether the supplemental items are needed (see Appendix A – Master List of Items). The CARE tool is based on input from each of the different settings, including 4 clinical workgroups with experts from each setting to discuss 1) medical, 2) functional, 3) cognitive, and 4) social support issues. These experts were charged with identifying items that effect resource use, resource needs, or outcomes. The workgroups were also charged with building on the current scientific evidence from each field to develop a tool that would effectively measure resource needs and outcomes but still minimize the burden on providers. The workgroups began with an examination of current assessment tools, including a sample of those used by acute and long term acute hospitals, as well as the 3 Federally mandated assessment tools currently used in the Medicare program: the IRF Patient Assessment Instrument (IRF-PAI), the Minimum Data Set 2.0 used in skilled nursing facilities, and the Outcome and Assessment Information Set (OASIS) used in home health agencies. Input from those revising the current Federal tools was incorporated as well as recommendations from CMS based on other related efforts to measure quality of care, and input from two Technical Expert Panels, on-going discussions with the AHA, AMPRA, NALTH, ALTHA, AHCA, AANAC, AAHSA, VNAA, JCAHO, CARF, and other associations. The team has been presenting early drafts at many of these association meetings and inviting input to the demonstration website: [email protected]. This process has lead to constant revisions and updates to develop a tool that measures basic case-mix across the Medicare population, including types of conditions as well as severity of illness. The tool has been designed to limit provider reporting burden, both conceptually and electronically. The CARE tool will be an electronic, web-based tool that will allow providers to select the items that are appropriate for the type of case being treated. The technology builds on item response theory to develop an item bank for standardizing the types of items collected in the Medicare program while allowing respondents to “skip” items not relevant for the type of case being treated. Providers will be able to choose whether to submit their data electronically to CMS or to continue to use their current vendors. The system is being developed as an interoperable data system meeting CHI standards and allowing the limited CARE tool to later be merged with other components of a provider’s record system. It contains only a subset of the items currently in the IRFPAI, MDS, and OASIS but will be able, in the future, to merge with the remaining care planning items a provider may be using. JUSTIFICATION A.1 Need and Legal Basis CMS requires the use of standardized assessment instruments to collect and report specified data on Medicare patients receiving post-acute services in skilled nursing facilities (SNF), home health agencies (HHA) and inpatient rehabilitation facilities (IRF). There is no Page 2 required instrument for long term care hospitals (LTCH) or acute care hospitals. The current assessment instruments are used for payment purposes and contain many similar questions as well as setting specific questions. However, the item definitions and rating scales differ across settings, and instructions for data collection specify different time periods in each setting. These differences in the existing assessment instrument make it difficult to compare patient function and clinical characteristics across post-acute care settings. Medicare policy makers have sought a means to compare patients cared for in the different post-acute care settings. In 2005, Congress passed the Deficit Reduction Act (DRA) which charged CMS with the development of a single comprehensive assessment to be used across all post-acute settings. This instrument was also mandated for use in the Post-Acute Care (PAC) Payment Demonstration program (Section 5008 of the DRA). Congress requires that this single patient assessment instrument 1) detail the needs of the patient, 2) describe the clinical characteristics of the patient’s diagnosis that determine the appropriate post-acute care setting for treatment, and 3) be used across all post-acute care sites in order to measure functional status and other factors during treatment and at discharge from each site of care. Appendix C contains the legislative language for Section 5008 of the DRA. The Post-Acute Care (PAC) Payment Demonstration will take place for a 3-year period although data collection will be limited to the first 18 months. The purpose of the demonstration is to collect data that will enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care costs and resource use in the Medicare program. The demonstration includes the CARE instrument data collection which will be combined with cost/resource use data and Medicare claims data to develop a post-acute care payment reform model. CMS will deliver a Report to Congress on the demonstration including results and recommendations for legislation and administrative action as the Secretary determines to be appropriate. A.2 Information Users The data collected using the CARE instrument during the Post-Acute Care Payment Demonstration will be used by CMS to develop a setting neutral post-acute care payment model as mandated by Congress. The data will be used to characterize patient severity of illness and level of function in order to predict resource use, post-acute care discharge placement, and beneficiary outcomes. CMS will use the data from the CARE instrument to examine the degree to which the items on the instrument can be used to predict beneficiary resource use and outcomes. Internet-based software developed by CMS will be used to collect and transmit the CARE data electronically. A.3 Use of Information Technology The CARE data will be collected electronically using an internet-based platform developed through a CMS contract to Northrop Grumman. The goal of this data collection method is to reduce provider burden. The instrument will be available at a secure CMSaddressed website and data will be transferred to CMS via the website once the data in each CARE record has been finalized at the participating provider sites. All providers participating in the demonstration will enter their data electronically. Internet access will be provided to demonstration sites in areas without an internet connection. Page 3 The CARE instrument is a new data collection tool and will be solely electronic. The data collection does not require a signature from the respondent, but the electronic software will have a place for respondents to finalize the data prior to submission. A.4 Duplication of Efforts This information collection does not duplicate any other effort and the information cannot be obtained from any other source. There is no other assessment instrument that provides standardized comparable information on patients admitted to the full range of post-acute providers. Items on existing patient assessment instruments differ in their definitions and rating scales preventing comparison of patient populations across post-acute care settings. The CARE instrument is being designed to standardize the information collected across post-acute care settings. Though the current assessment will continue to be collected during the demonstration, the CARE instrument may eventually replace the current instruments and reduce provider burden. A.5 Small Businesses Providers participating in the demonstration will potentially include small home health agencies and skilled nursing facilities as well as larger hospitals and other post-acute providers. Provider participation in the demonstration is voluntary. Small providers viewing the data collection as a burden can refuse to participate. A.6 Less Frequent Collection This is a one-time data collection effort limited to the three-year study period of the PostAcute Care Payment Reform Demonstration as mandated by Congress under Section 5008 of the Deficit Reduction Act of 2005. Data collection will be limited to providers volunteering to participate in the demonstration. A.7 Special Circumstances The CARE instrument will be administered on all Medicare patients at discharge from acute care hospitals, at admission and discharge from other post-acute care providers, and at interim points during a patient admission for a nine month period during the Post-Acute Care Payment Reform Demonstration. Data coordinators at participating demonstration providers will review and finalize the CARE data for submission to CMS as patients are admitted to and discharged from each setting. Frequency of data reporting to CMS will depend on the volume of Medicare admissions and discharges at participating providers. A.8 Federal Register/Outside Consultation CMS developed the CARE tool in consultation with experts in patient assessment, item development, Medicare payment policy, as well as clinicians and provider association representatives. CMS held an Open Door Forum on the instrument development in December 2006 and invited input from the provider and beneficiary communities regarding issues they would like to see addressed Two technical expert panels were convened to solicit feedback on the feasibility of implementing this instrument in acute hospitals and the full range of post-acute care providers. The first technical expert panel included representatives from post acute Page 4 providers and provider associations and the second technical expert panel included clinicians and researchers in post-acute care, item and scale development, and Medicare payment policy. The panels were integral to item and scale development, and efforts to ensure that the tool is feasible and can be implemented with minimum burden to providers. CMS also established an email address inviting comments on the CARE instrument development and any other feedback from post-acute care researchers and providers. Following the publication of the Federal Register Notice, CMS will review and incorporate additional comments and feedback from the public. Members of the CARE instrument development team outside of CMS include: A.9 Barbara Gage, RTI International Shulamit Bernard, RTI International Roberta Constantine, RTI International Anne Deutsch, Rehabilitation Institute of Chicago Trudy Mallinson, Rehabilitation Institute of Chicago Margaret Stineman, University of Pennsylvania Christopher Murtaugh, Visiting Nurse Service of New York Debra Saliba, RAND Corporation Patrick Murray, Case Western Reserve University Payment/Gifts to Respondents There will be no payments/gifts to respondents to the CARE instrument. A.10 Confidentiality The data collected in the CARE instrument will be kept confidential by RTI and CMS. Only authorized staff at participating demonstration providers and project staff at CMS and RTI will have access to respondents’ data. Data will be stored in a secure format meeting all federal privacy guidelines. Data will be collected using a secure internet-based platform for electronic data entry and secure data transmission. The internet-based electronic system will be password protected with access limited to project staff. To protect beneficiary confidentiality, the subject’s name will not be linked to his/her individual data. For identification purposes, a unique ID number will be assigned to each sample member. All patient-level data are protected form 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. Page 5 A.11 Sensitive Questions The information collected in the CARE instrument is considered to be confidential personal health information. This individual 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 in other CMS instruments. The items on the CARE instrument are being collected for CMS operational purposes and the data will be used for analysis in the Post-Acute Care Payment Reform Demonstration. A.12 Burden Estimates (Hours & Wages) The estimated time to complete the CARE instrument varies by patient severity of illness. During limited pilot testing, CMS and RTI found that in took approximately 45 minutes to complete the form in home health agencies, long term care hospitals, and inpatient rehabilitation hospitals. In skilled nursing facilities, the time to complete the CARE instrument was closer to 60 minutes. The difference in time to complete across post-acute care settings is driven by differences in the patient populations. In acute care settings, the time to complete the form can be as short as 20 minutes for the two-thirds of patients discharged home, but time to complete is longer, approximately 45 minutes, for the one-third of patients discharged to post acute settings. Patients discharged home are less likely to have functional and cognitive impairments that require additional documentation in the CARE form and therefore the time to complete the CARE instrument for these patients is shorter. Across all settings, the time to complete the form varies significantly depending on a beneficiary’s severity of illness. The time to complete the instrument is shorter for beneficiaries who are very healthy and can skip sections of the instrument and the time to complete the instrument is longer for beneficiaries with some functional or cognitive limitations. A sample calculation of the time burden associated with the CARE instrument is shown in Table A-1. This table shows the estimated burden for each provider type participating in the demonstration. The total burden associated with the 94,292 CARE assessments we expect to collect for the purposes of the demonstration is 66,841 hours. The number of CARE assessments is based on estimates of the number of Medicare beneficiaries admitted to participating providers during the demonstration period. In addition to the providers that will be participating in the demonstration, we expect that there will be a number of other providers that will be interested in collecting data using the electronic CARE instrument. Based on inquiries to participate thus far, we estimate that an additional 238 providers may ask to test the system leading to the collection of an additional 150,000 assessments. We estimate that these 238 providers will include 25 acute hospitals, 17 long term care hospitals, 44 inpatient rehabilitation facilities, 76 skilled nursing facilities, and 76 home health agencies. Page 6 Table A-1. Estimated Response Burden for CARE Target Number of Participating Providers Expected Number of Admission & Discharge Assessment Patients Number of Admission & Discharge Assessments Number of Interim Assessments Total Number of Assessments Average Burden Hours Per Response Total Burden Hours Acute Hospitals (Excluding CAHs) 15 28,439 28,439 0 28,439 0.55 15,642 LTCHs 11 2,457 4,915 386 5,300 0.75 3,975 IRFs (Freestanding) 7 3,559 7,119 520 7,639 0.75 5,729 IRFs (Hospital Unit) 21 4,064 8,127 520 8,647 0.75 6,485 SNF (Freestanding) 42 3,002 6,004 504 6,509 1.00 6,509 SNF (Hospital Unit) 6 343 687 45 732 1.00 732 HHA (Freestanding) 39 14,632 29,263 2,245 31,508 0.75 23,631 HHA (Hospital-Based) 9 2,562 5,125 393 5,518 0.75 4,138 150 59,059 89,678 4,613 94,292 0.55-1.00 hours 66,841 150,000 0.75 112,500 Provider Type Page 7 Total Demonstration Providers Assessments from additional providers volunteering to collect data, but not part of the demonstration 238 93,750 142,662 7,338 NOTES: The expected number of CARE assessment patients is equal to the average number of Medicare discharges (episodes for HHAs), excluding the top and bottom deciles for each setting, multiplied by: the assumed fraction of each setting provider participating; the assumed fraction of the year for which CARE assessments will be collected on Medicare patients (nine of twelve months, or 0.75); and the number of participating providers of that setting type. Acute hospitals will only collect discharge assessments. HHAs will collect one interim assessment for each patient treated during each of three two-week periods coinciding with cost and resource use data collection in their market. A.13 Capital Costs There are no additional capital costs to respondents or to record keepers. A.14 Cost to Federal Government There is not additional cost burden to the federal government beyond what Congress has allocated for the demonstration. A.15 Changes to Burden There are no program changes or adjustments. A.16 Publication/Tabulation Dates There are no publications and tabulations associated with this collection. A.17 Expiration Date The OMB expiration date will be displayed on all disseminated data collection materials. A.18 Certification Statement There are no exceptions to the certifications statement. Page 8 APPENDIX A MASTER LIST OF CARE ITEMS Page 9 APPENDIX B CARE INSTRUMENT Page 10 APPENDIX C DEFICIT REDUCTION ACT SECTION 5008 Page 11 SEC. 5008. POST-ACUTE CARE PAYMENT REFORM DEMONSTRATION PROGRAM. (a) ESTABLISHMENT.— (1) IN GENERAL.—By not later than January 1, 2008, the Secretary of Health and Human Services (in this section referred to as the ‘‘Secretary’’) shall establish a demonstration program for purposes of understanding costs and outcomes across different postacute care sites. Under such program, with respect to diagnoses specified by the Secretary, an individual who receives treatment from a provider for such a diagnosis shall receive a single comprehensive assessment on the date of discharge from a subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act (42 U.S.C. 1395ww(d)(1)(B))) of the needs of the patient and the clinical characteristics of the diagnosis to determine the appropriate placement of such patient in a post-acute care site. The Secretary shall use a standardized patient assessment instrument across all post-acute care sites to measure functional status and other factors during the treatment and at discharge from each provider. Participants in the program shall provide information on the fixed and variable costs for each individual. An additional comprehensive assessment shall be provided at the end of the episode of care. (2) NUMBER OF SITES.—The Secretary shall conduct the demonstration program under this section with sufficient numbers to determine statistically reliable results. (3) DURATION.—The Secretary shall conduct the demonstration program under this section for a 3-year period. (b) WAIVER AUTHORITY.—The Secretary may waive such requirements of titles XI and XVIII of the Social Security Act (42 U.S.C. 1301 et seq.; 42 U.S.C. 1395 et seq.) as may be necessary for the purpose of carrying out the demonstration program under this section. (c) REPORT.—Not later than 6 months after the completion of the demonstration program under this section, the Secretary shall submit to Congress a report on such program, that includes the results of the program and recommendations for such legislation and administrative action as the Secretary determines to be appropriate. (d) FUNDING.—The Secretary shall provide for the transfer from the Federal Hospital Insurance Trust Fund established under section 1817 of the Social Security Act (42 U.S.C. 1395i), $6,000,000 for the costs of carrying out the demonstration program under this section. Page 12