CMS-2744.Supporting Statement-5-16-06

SUPPORTING STATEMENT

FOR THE PAPERWORK REDUCTION ACT SUBMISSION

CMS-2744, ESRD Facility Survey Form (OMB No. 0938-0447)

A. Background

The PMMIS Facility Certification/Survey Record (CERTDATA & SURVDATA) contains provider-specific and aggregate patient population data on beneficiaries treated by that provider obtained from the Annual Facility Survey form (CMS-2744). Each facility certification/survey record represents one provider. The Facility Certification portion of the record captures certification and other information about ESRD facilities approved by Medicare to provide kidney dialysis and transplant services. The Facility Survey portion of the record captures activities performed during the calendar year as well as aggregate year-end population counts for both Medicare beneficiaries and non-Medicare patients. The data elements include basic provider information such as provider certification and type of ownership; aggregated dialysis patient data such as the number of patients, number of deaths, and number of patients receiving different types of dialysis; dialysis treatment data; kidney transplant data such as number of transplants, type of transplants, and number of patients awaiting transplants; and the total number of each method used to obtain kidneys for transplants. The 2744 now includes the collection on hemodialysis patients dialyzing more than 4 times per week, vocational rehabilitation and staffing. The accuracy of the Facility Survey depends on complete reporting by each facility.

The ESRD Facility Survey File is created from the PMMIS SURVDATA and contains data collected annually by CMS from all facilities certified to provide Medicare-covered renal dialysis and transplantation. The survey, which includes the entire United States, uses CMS Form 2744 and encompasses the full calendar year. Geographical data are included to the level of ZIP Code for each facility. Each record contains information about the facility and aggregate information about the number of patients served, number of dialysis treatments provided, and number of kidney transplants performed. The data includes services rendered to both Medicare and non-Medicare patients.

B. Justification

1. Need and Legal Basis

This is a request to extend the currently approved collection form. Collection of the data contained in the CMS-2744, End Stage Renal Disease Facility Survey Form is necessary for the establishment and maintenance of the legislatively mandated single, nationwide database containing patient-medical, specific demographic and billing data, and provider-specific certification and patient population data, the End Stage Renal Disease (ESRD) Program Management and Medical Information System (PMMIS). It is the Agency’s responsibility to collect, maintain, disseminate, on a national basis, uniform data pertaining to ESRD patients and their treatment of care. All renal providers who are approved to participate in the ESRD program are required by P.L. 95-292 to supply data to the ESRD PMMIS. The conditions of coverage for participation in the Medicare program (section 405.2133 of CFR 42) states:

"ESRD facility, laboratory performing histocompatibility testing, and organ procurement agency furnishes data and information in the manner and at the intervals specified by the Secretary, pertaining to its ESRD patient care activities and costs, for inclusion in a national ESRD medical information system and in compilations relevant to program administration, including claims processing and reimbursement. Such information is treated as confidential when it pertains to individual patients and is not disclosed except as authorized by Department regulations on confidentiality and disclosure (see CFR Part 5, 5b, and 20 CFR Parts 401 and 422 (Subpart E))."

The ESRD Facility Survey (CMS-2744) is completed by all Medicare-approved ESRD facilities once a year. The CMS-2744 was designed to collect information concerning

treatment trends, utilization of services and patterns of practice in treating ESRD patients.

2. Information Users

The aggregate patient information is collected from each Medicare-approved provider of dialysis and kidney transplant services. The information is used to assess and evaluate the local, regional and national levels of medical and social impact of ESRD care and are used extensively by researchers and suppliers of services for trend analysis. The information is available on the CMS Dialysis Facility Compare website and will enable patients to make informed decisions about their care by comparing dialysis facilities in their area. The ESRD Facility Survey Public Use File is also posted at: http://www.cms.hhs.gov/ESRDGeneralInformation/02_Data.asp#TopOfPage

Reports generated by the collection of these data enables individual practitioners and providers to review, compare and improve ESRD patient treatment methods and permits local Medical Review Boards to more effectively monitor utilization and quality of medical care. National and regional data have been published in the ESRD Program Highlights. The data are used by CMS throughout the year to validate and monitor patient specific information and to determine the ESRD Network Coordinating Council’s annual budget from the reported number of treatments provided to dialysis patients (as required by Section 9335 of P.L. 99-509 of the Omnibus Reconciliation Act of 1986 (OBRA) which amended Section 1881© of the Social Security Act). The data are also provided to the United States Renal Data System (USRDS), through a contract with the National Institutes of Health, for use in studies relating to the ESRD program.

3. Improved Information Technology

The ESRD Medicare-approved facilities provide the survey data to their respective ESRD Network either via hardcopy form or electronically depending upon the technological capabilities of the provider. Data are transmitted electronically to CMS by the ESRD Networks. Therefore, we estimate the information technology to be about 5%. However, it is 100% electronically available.

4. Duplication of Similar Information

There is no other form that collects this information. CMS is the only agency that annually surveys all renal facilities for dialysis patient population and transplant data. Since the renal facilities are required to report on all activities that occurred during the year, CMS is able to obtain information on the Medicare and non-Medicare ESRD population, therefore providing a more comprehensive overview of renal disease occurrence in the United States.

5. Small Businesses

A small business would be described as a provider that is not a member of a chain organization and/or has a small dialysis patient population. These providers are legislatively required to maintain the same patient information and to report on this information in the same manner as all other providers of renal services. Therefore, there are no methods to minimize burden for these providers. However, this collection does not have a significant economic impact on small businesses.

6. Less Frequent Collection

If these data were not collected annually, CMS would be administering a program for which it would be impossible to identify characteristics of the relationship between patients and treatments. These data describe those approaches to and conditions under which treatment is administered so that morbidity and mortality are kept to minimum levels.

7. Special Circumstances

ESRD Facility Survey Data are collected on an annual basis and is not envisioned to be collected on a more frequent basis.

- There is no written response necessary in fewer than 30 days after receipt of the survey.

- Only the original/signed copy of the form is required.

- The form is required to be retained by the ESRD Network for 2 years.

- All data produced by respondents are validated by their respective ESRD Network. Only validated data is acceptable.

- There are no requirements for statistical data classification.

- No confidentiality rules apply. There is no patient-specific information gathered on this form.

- No trade secrets or confidential information is involved in this process.

8. Federal Register Notice/Outside Consultation

The 60-day Federal Register notice was published on May 26, 2006, attached.

The retention of the facility survey form and its process are necessary for the effective administration of Network functions. The process requires Medicare-approved providers to monitor their dialysis and transplant patients in the progress of their treatment. Instructions are revised annually to provide clarification of situations that arise each year during the survey process.

9. Payment/Gifts to Respondents

No payment or gifts are provided to respondents for compliance with the survey process.

10. Confidentiality

A confidentiality statement is provided on the form as it related to the Privacy Act regulations.

11. Sensitive Questions

There are no questions on the facility survey form that are of a sensitive nature. Only aggregate data on patients are collected.

12. Burden Estimates (Total Hours & Wages)

- The number of respondents – 4,800 renal providers.

- The frequency of response - once a year.

- The estimated hour burden - 8 hours.

Providers with larger patient populations may require a longer period of time to prepare the survey, estimated to 15 hours or more. However, the majority of providers should be able to respond within the annual burden hours. Completion time may also vary depending upon the electronic capabilities of respondents, e.g., some respondents may take as little as 1 hour to complete the form.

Cost to respondents: $19.25/hour x 8 hours for completion = $154.00

The person completing the survey form at one provider is not necessarily a person of equivalent position at another. For example, persons completing the survey form could be the renal provider Administrator, head nurse, data coordinator, or clinical supervisor. The cost to respondents is based on an average of these salaries.

13. Capital Costs

There is no estimate of a total annual cost burden to respondents to the survey. There is no capital or start up costs. The information respondents are required to report /reflect the general information they are required to maintain in patient records and as specified in Section 405.2133 of Subpart U of the Code of Federal Regulations.

14. Cost to the Federal Government

The following is the annual cost to the Federal Government for the ESRD Facility Survey process:

- Total hours - 1,040 (5 months from the start of process to end)

- Equipment - $24,268.00 (an increase of approximately 10% of what was reported before)

- Printing - $0 (forms are printed from a website by the Networks)

- Staffing - $28,600 (based on staff time of 1,500 hours)

- Mail - $0 (no forms are mailed-forms are printed off of CMS website by

Networks)

- TOTAL - $53,094.80

15. Program Changes/Adjustments

The increase in the total annual hours requested is due to the increase in the number of Medicare approved facilities filling out the annual facility survey.

16. Publication and Tabulation Dates

The results of the ESRD Facility Survey process are published annually. The time schedule for this annual process is as follows:

- Information is collected in January, February and March

- Preliminary data are provided to CMS in April

- Final data are provided to CMS in May

- Tables containing aggregate data are available in August

- Information is printed in the ESRD Program Highlights in August and made available on the Internet as a CMS Public Use File. Data is also included in the United States Renal Data System Annual Report.

17. Expiration Date

CMS would like to display the expiration date.

18. Certification Statement

There are no exceptions to the certification statement.

C. Collection of Information Employing Statistical Methods

No statistical methods are used for the ESRD Facility Survey process. Only aggregate information is requested.

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