CMS-643 supporting statement

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SUPPORTING STATEMENT

FOR THE FORM CMS-643

HOSPICE SURVEY AND DEFICIENCIES REPORT FORM

AND SUPPORTING REGULATIONS IN 42 CFR 488.26(c) and 42 CFR 442.30(a)(4)

A. BACKGROUND

A hospice is a heath care entity that provides palliative care (relief of pain and uncomfortable symptoms), as opposed to curative care, to terminally ill individuals. In addition to meeting the patient’s medical needs, hospice care addresses the physical, psychosocial, and spiritual needs of the patient, as well as psychosocial needs of the patient’s family/caregiver related to the terminal illness. The emphasis of the hospice program is on keeping the hospice patient at home with family and friends as long as possible. All hospices must meet specific Conditions of Participation (conditions) and be separately certified and approved as such for Medicare participation.

When an entity expresses an interest in participating in the Medicare program as a hospice, it contacts the Medicare State survey agency, which forwards the Hospice Request for Certification in the Medicare Program form (CMS-417)(OMB# 0938-0313), to the hospice. The hospice completes the form and returns it to the State agency. If the hospice meets the preliminary requirements, a survey is conducted to determine if the hospice complies with the hospice conditions.

The Hospice Survey and Deficiencies Report form is primarily a coding worksheet designed to facilitate data collection and entry into the Online Survey, Certification, and Reporting (OSCAR) System in the State and at the central and regional offices of CMS. State agency surveyors who do not have access to the computerized data entry system while they are onsite at the hospice use this form to record data about a hospice’s noncompliance with the Federal conditions that they have identified during the survey. Only deficiencies are cited on this survey form. Surveyors also collect 14 data elements related to patient health and safety. They then sign the form, certifying their review of the Federal requirements, and report this information to the Federal Government.

This form was updated to reflect the current terminology for certification number. The term provider number is obsolete. There were three times that the provider number was mentioned on the form, in each instance it has been changed to certification. The changes were made at the top of the form and questions 12 and 14.

The other change that was made was to question #1 of the form. The reference to 418.100 is no longer current as it was redesignated. The correct citation is 418.110.

B. JUSTIFICATION

1. Need and Legal Basis

Section 1864 of the Social Security Act (the Act) requires the Secretary to enter into agreements with States to survey providers and certify compliance or

noncompliance with the Medicare conditions of participation. Section 1902(a)(33)(B) of the Act requires the State Medicaid Agency to contract with the State survey agency used by Medicare to determine whether providers meet the requirements for participation in the Medicaid program.

42 CFR 488.26(c) and 42 CFR 442.30(a)(4) require that State survey agencies must use the survey forms, methods and procedures prescribed by CMS.

2. Information Uses

CMS uses the information collected as the basis for certification decisions for hospices that wish to obtain or retain participation in the Medicare and Medicaid programs. The information is used by CMS regional offices, which have the delegated authority to certify Medicare facilities for participation, and by State Medicaid agencies, which have comparable authority under Medicaid. The information on the Hospice Survey and Deficiencies Report Form is coded for entry into the OSCAR system. These data are analyzed by the CMS regional offices and by the CMS central office components for program evaluation and monitoring purposes. This information is also available to the public upon request.

3. Improved Information Technology

The coded information on the Hospice Survey and Deficiencies Report Form provides essential data on a hospice’s performance. This improves the OSCAR database as a means of monitoring and evaluating the survey and certification activities.

4. Duplication of Similar Information

This form is to be used in all hospice surveys and does not duplicate any other collection instrument. This form is the only standardized mechanism available for the surveyor to record data on hospice compliance with the Federal regulatory requirements.

5. Small Business

These requirements do not affect small businesses.

6. Less Frequent Collection

State submission of the survey report form depends on the frequency of provider surveys. These submissions, in turn, depend on the frequency of surveys specified in regulations and the availability of survey funds. It is a basic contract requirement that State surveyors transmit their compliance findings for each survey they conduct.

7. Special Circumstances for Information Collection

There are no special circumstances for this information collection. These requirements comply with all general information collection guidelines in 5 CFR 1320.6.

8. Federal Register and Outside Consultations

A 60-day Federal Register notice soliciting comments on this information collection was published on March 13, 2009, attached.

We did not seek further outside consultation for this collection.

9. Payment or Gifts

There are no payments or gifts associated with this collection.

10. Confidentiality

We do not pledge confidentiality.

11. Sensitive Questions

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

12. Estimate of Burden

The Hospice Survey and Deficiencies Report Form is completed by the State agency or Federal surveyor based on the results of his/her investigation of each provider’s compliance with each individual hospice condition. The surveyor then records any deficiency (ies) found during the survey on this form, listing them by data tag number and a brief statement supporting the conclusion of noncompliance. Surveyors also collect 14 data elements related to patient health and safety. They then sign the form, certifying their review of the Federal Requirements.

Since the survey form is basically completed by recording data tag numbers supported by a few explanatory statements and by responses to questions asked of the hospice representative, we estimate that surveyors will be able to complete the survey form in approximately 1 hour. Hospice agencies are surveyed every 6 to 7 years. This estimate was derived from calculating the number of hospice surveys completed in the 3 previous years, divided by 3 to get an average then multiplied by 1 (estimated hours to complete survey).

1130 providers surveyed annually

x 1 estimated time to complete survey

1,130 hours of respondent burden

13. Capital Costs

There are no capital costs.

14. Cost to Federal Government

There are no direct costs to the Government, except for the cost of printing the forms.

15. Program/Burden Changes

There are no program changes. The decrease in burden is due to an updated estimate of how long it takes surveyors to complete the form. The estimate was obtained from the surveyors who actually complete the form.

16. Publication and Tabulation Dates

There are no publication and tabulation dates with this collection.

17. OMB Expiration Date

CMS would prefer not to display the expiration date. The form is used on a continuing basis, and to discard surplus every 3 years (or fewer), would not be economically sound.

18. Certification Statement

There are no exceptions to the certification statement.

B. Collection of Information Employing Statistical Methods

There are no statistical methods employed in this information collection.