CMS-2567 - Supporting Statement part A [revised.12-13-2012]

Supporting Statement for

Statement of Deficiencies and Plan of Correction (CMS-2567)

and Supporting Regulations contained in

42 CFR 488.18, 488.26, and 488.28

CMS-2567. OMB 0938-0391

Background

The CMS-2567 Statement of Deficiencies and Plan of Correction is the means by which State and CMS surveyors document findings of compliance or noncompliance (deficiencies) resulting from inspection of Medicare, Medicaid, and Clinical Laboratory Improvement Amendments (CLIA) laboratories. The CMS-2567 is the legal, documentary basis for CMS’s certification of a facility’s compliance or noncompliance with the Medicare/Medicaid Conditions of Participation or Coverage, and the requirements for Nursing Home participation and CLIA certification.

This form is used to state concisely and in a standard format whether or not any deficiencies were identified during the course of an inspection, and if so, what each deficiency was and the evidence for it. It also provides a uniform format for providers, suppliers and CLIA laboratories to describe required plans to correct each deficiency. This form facilitates analysis of deficiencies and plans of correction, and disclosure of information concerning deficiencies.

A. Justification

1. Need and Legal Basis

Section 1864(a) of the Social Security Act requires that the Secretary use State survey agencies to conduct surveys to determine whether health care facilities meet Medicare, and CLIA participation requirements. The CMS-2567 is the means by which the survey findings are documented. This section of the law further requires that compliance findings resulting from these surveys be made available to the public within 90 days of such surveys. The CMS-2567 is the vehicle for this disclosure. The regulations at 42 CFR 488.18 require that State survey agencies document all deficiency findings on a statement of deficiencies and plan of correction, which is the CMS-2567. 42 CFR 488.26 and 488.28 further delineate how compliance findings must be recorded and that CMS prescribed forms must be used.

2. Information Users

The information from the CMS-2567 is used by the States and CMS regional offices to document and certify compliance. It is also used by health care facilities to document their plan of correction. It is used by CMS, the States, facilities, purchasers, consumers, advocacy groups, and the public as a source of information about quality of care and facility compliance.

3. Improved Information Technology

This form is frequently produced in an automated fashion by the CMS Automated Survey Processing Environment (ASPEN) survey software. This automates the capture of survey data.

4. Duplication and Similar Information

This form elicits information not collected by any other means or form. There is no duplication of collection or information.

5. Small Business

These requirements do affect small businesses, however, the information collection is necessary for the businesses to participate and receive Medicare or Medicaid reimbursement, or CLIA certification. These paperwork requirements are minimal and are necessary to meet the documentation and disclosure requirements of the law.

6. Less Frequent Collection

This information must be collected in conjunction with a facility survey. Survey frequency is prescribed by law for some facility types and by agency policy in other cases, in order to ensure quality of care. This information collection complies with the general guidelines in 5 CFR 1320.6.

7. Special Circumstances for Information Collection

There are no special circumstances associated with this information collection.

8. Federal Register and Outside Consultation

The 60-day Federal Register notice published on July 18, 2012 (77 FR 42316). No comments were received.

There has been no outside consultation since the last approval.

9. Payments or Gifts

There are no payments or gifts associated with this collection.

10. Confidentiality

This information is publicly disclosable. Identifiable data subject to the Privacy Act is not incorporated into the CMS-2567.

11. Sensitive Questions

There are no questions of a sensitive nature associated with this paperwork package.

12. Estimation of Burden

Reporting burden is based on approximately 62,000 surveys annually that will identify deficiencies that require a health care facility complete a Plan of Correction on the CMS-2567 form.

We estimate that it will take approximately 110 minutes for each form to be completed. The cost for completion of this form has been calculated at the average national salary of $45.05 per hour. Based on a timeframe of 110 minutes to complete the form, the cost per facility will be $82.44. For the approximately 62,000 surveys annually, the national cost to complete the form will be $5,111,280.00.

Number of Respondents	62,000
Frequency of Responses Per Year	1
Annual Number of Responses	62,000
Estimated Time Per Response	110 min
Subtotal	113,667 hr

We estimate that it will take approximately 10 minutes for record keeping for each form. The cost for this has been calculated at the average national salary of $15.00 per hour. Based on a timeframe of 10 minutes for this task, the cost per facility will be $2.55 per form. For the approximately 62,000 surveys annually, the national cost for this task will be $158,100.

Number of Respondents	62,000
Frequency of Responses Per Year	1
Annual Number of Responses	62,000
Estimated Time Per Response	10 min
Subtotal	10,333 hr

We estimate that it will take approximately 10 minutes for third party disclosure for each form. The cost for this has been calculated at the average national salary of $15.00 per hour. Based on a timeframe of 10 minutes for this task, the cost per facility will be $2.50 per form. For the approximately 62,000 surveys annually, the national cost for this task will be $158,100.

Number of Respondents	62,000
Frequency of Responses Per Year	1
Annual Number of Responses	62,000
Estimated Time Per Response	10 min
Subtotal	10,333 hr

The total burden cost for the CMS-2567 is estimated to be $5,427,480.

Number of Respondents	62,000
Frequency of Responses Per Year	1
Annual Number of Responses	62,000
Estimated Time Per Response	130 min
Total Annual Hour Burden	134,333 hr

13. Annualized Cost of Burden

There are no annualized costs associated with this collection.

14. Cost to Federal Government

The estimated annual cost is less than $1,600.

15. Program Changes / Burden Changes

There are no program changes. In this package, the burden estimate has been adjusted to account for an increase in the number of respondents (60,000 in 2009 vs. 62,000 in 2012). This package also corrects the burden (Reporting, Recordkeeping, and Third Party Disclosure) that was submitted in the 2009 ICR. Specifically, in 2009, a total of two hours (per response) were allocated to Recordkeeping and Third Party Disclosure for a total of 120,000 hr (60,000 responses x 2 hr/response). However, the 2009 burden estimate should have set out 130,000 hr (60,000 responses x 130 min/response) consisting of 110 min for Reporting, 10 min for Recordkeeping, and 10 min for Third Party Disclosure. Within this 2012 package, we have increased the number of respondents and have corrected the 2009 burden estimates.

16. Publication and Tabulation Dates

There are no publication and tabulation dates associated with this collection.

17. OMB Expiration Date

CMS does not want to display the OMB expiration date, as it would involve the destruction of too many forms every three years; these forms are used on a continuing basis.

18. Certification Statement

There are no exceptions to the certification statement.

B. Collections of Information Employing Statistical Methods

There are no statistical methods employed in this information collection.

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