2017 CMS-1572 supp stmt 01-05-18

SUPPORTING STATEMENT

HOME HEALTH AGENCY SURVEY AND DEFICIENCIES REPORT

AND SUPPORTING REGULATIONS (CMS-1572)

A. BACKGROUND

This is a request for a reinstatement for the form CMS-1572, “Home Health Agency Survey and Deficiencies Report” (OMB 0938-0355). The form has been in violation since its approval lapsed at the end of April 2017

This form is used by State Survey Agencies when surveying Home Health Agencies (HHAs). The form is used to collect information about an HHA’s compliance with Federal requirements, as promulgated by the Centers for Medicare and Medicaid Services (CMS). The Secretary established these requirements at 42 CFR Part 484 in Subparts A, B, and C, under the authority of sections 1861(o) and 1891 of the Act. These requirements are known as the conditions of participation (CoPs), and an HHA must meet them in order to participate in the Medicare program. HHAs participating in the Medicaid program must also meet the Medicare CoPs, per CMS regulations at 42 CFR 440.70(d).

Surveyors implementing these regulations and statutory requirements focus on the actual delivery of care and the results of that care when making certification decisions. The survey process and form CMS-1572 are intended to ensure and strengthen patient health and safety, to enhance quality of care by emphasizing outcomes rather than process, to implement the Omnibus Reconciliation Act of 1987 (OBRA 87), and to achieve more effective compliance with Federal requirements.

The survey form and survey process have been designed to ensure consistency in the review and enforcement of the Federal requirements. The survey form summarizes data relative to provider characteristics, the patient population, and special needs of the patient populations. The form also helps to ensure surveyor consistency in the application of the requirements and serve as coding documents to facilitate data reduction (i.e., keypunching) and input and retrieval into the Online Survey Certification and Reporting (OSCAR) System at the State and at the CMS central and regional offices. Finally, the form serves as an aid to help surveyors structure and record key observation data for subsequent reference and/or retrieval and are designed to result in an objective compliance decision. This form is used in conjunction with the regulation text, interpretive guidelines https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-14.pdf

and survey probes. The State agencies use the survey form to report the collected information to the Federal Government. In addition, Federal surveyors use this form when conducting periodic Federal monitoring surveys of HHAs.

In the Medicare and Medicaid programs, CMS is responsible for developing conditions of participation that facilities must meet to become eligible to receive Federal payments. State survey agencies conduct on-site surveys to ensure that facilities are in compliance with these requirements. The revised HHA conditions of participation and other requirements mandated by OBRA-87 represent a significant change in the survey and certification process by focusing on actual care as opposed to process-oriented requirements. The survey form reflects this fundamental change and directs surveyors to observe and monitor the provision of care in the home setting. Surveyors use the survey form to assist and direct them in evaluating important information relating to the quality of services provided in the home setting. Moreover, this form represents a deficiency-based approach to evaluating and reporting compliance.

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 Medicare conditions of participation. As such, it is the State survey agencies who most commonly use the CMS-1572 to collect the necessary information.

Section 1861(o) of the Act describes Home Health Care with respect to the Medicare program. 42 CFR Part 484, in Subparts A, B, and C, sets forth the health and safety conditions of participation (CoPs) that all Home Health Agencies must meet to participate in Medicare. State survey agencies, as well as accreditation agencies, are used by CMS to determine if the CoPs are met.

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.

Finally, sections 488.26 and 442.30 of Title 42 in the Code of Federal Regulations require State survey agencies to follow basic principles and procedures in their work to determine a provider’s compliance with the CoPs.

2. Information Users

CMS uses the information collected as the basis for certification decisions affecting the initial as well as the continued participation of HHAs 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 CMS-1572 is entered into the Survey and Certification technology system (currently the Automated Survey Processing Environment [ASPEN]). These data are analyzed by the 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.

At the time of survey, most of the form is completed by the home health agency and given to the surveyor, so that the necessary identification and operational data (such as the number and types of staff, types of services, and other information to assist the surveyors in selecting a sample of patients) may be revised in the event that there have been changes.

The HHA Survey and Deficiencies Report form (CMS-1572) has five parts. Each part has its own form designation. The first two parts of the form, CMS-1572(a) and (b) summarize the following: data relative to provider characteristics; description of the client population served; special needs represented by that population; and essential characteristics of the survey conducted. This part of the form provides comprehensive descriptive information about the provider, the clients served by the provider, and the survey team. The information is used by the State survey agency in the course of the survey process. Several data elements on this part of the form are also necessary to compare specific characteristics about HHAs and their clients with other Medicare and Medicaid providers.

The third part of the form, CMS-1572(c), contains instructions to the surveyor. The fourth part of the form, CMS-1572(d) provides the space for documentation for the items required in part three. Finally, the State surveyors sign the fifth part of the form, CMS-1572(e), certifying their review of the Federal requirements.

3. Improved Information Technology

The coded information on the HHA survey form provides essential data on HHAs and facility performance. This improves the OSCAR database as a means of monitoring and evaluating the survey and certification activities. Also, the standardized format provides for consistent reporting by State survey agencies, and the data are keyed on-site into laptop computers by the surveyors. At this time, the form itself is not submitted electronically.

4. Duplication

This form is used for surveying HHAs and do not duplicate any other collection instruments. The form addresses specific requirements for participation in the Medicare and Medicaid programs, and use of this form is required under the contracts with the State agencies.

5. Small Business

Home Health Agencies may be small businesses. The requirements in the Home Health Agency Conditions of Participation are the same for all home health care providers, regardless of the size of the business.

6. Less Frequent Collection

The 1996 budget bill amended Section 1819(c)(2)(A) of the Act in order to provide flexibility in the standard survey cycle for HHAs. The law now states that standard surveys will occur not later than 36 months after the previous standard survey, and that the Secretary shall establish a frequency for surveys within this 36-month interval commensurate with the need to assure the delivery of quality home health services.

7. Special Circumstances

There are no special circumstances.

8. Federal Register/Outside Consultation

The 60-day Federal Register notice published February 27, 2017 (82 FR 11921). There were no comments received.

The 30-day Federal Register notice published on June 2, 2017 (82 FR 25608). There were not public comments.

This form is modeled after related forms used for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICR-IIDs), Skilled Nursing Facilities, and for Nursing Facilities. We worked closely with a wide spectrum of public and private organizations in development of the forms and worksheets for Intermediate Care Facilities for the Mentally Retarded and Skilled Nursing Facilities and Nursing Facilities. The assessment instrument was developed under contract with a private consulting firm.

9. Payment/Gifts to Respondent

The completion of this form during a successfulcertification/recertification survey certifies that the HHA is compliant with the Conditions of Participation, thus enabling the HHA to bill CMS for services rendered.

10. Confidentiality

We do not pledge confidentiality.

11. Sensitive Questions

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

12. Burden Estimate (Total Hrs. & Wage)

At the time of survey, the form is completed by the home health agency at the direction of its Director of Operations. Then, the form is provided to the surveyor for signature.

We estimate the total hourly respondent burden of the CMS-1572 to be 849 hours per year. In the 2016 calendar year, the number of surveys of non-accredited HHAs completed was 3,395, with 2,401 standard surveys and approximately 994 complaint surveys. Form CMS-1572 must be completed at each survey.

We estimate that the hourly burden required for the completion of items 1 through 22 on form CMS-1572 will be no more than 15 minutes (0.25 hours) per survey. The total hours of respondent burden for the CMS-1572 equals 849 hours per year (3,395 HHAs surveys/year x 0.25 hours/survey).

We similarly estimate the total fiscal respondent burden of the CMS-1572 to be $86,598 per year. The CMS-1572 would typically be completed by an HHA’s Director of Operations, a position that falls under the U.S. Bureau of Labor Statistic’s Standard Occupational Code 11-9111, for Medical and Health Services Managers, with a mean hourly wage of $50.99/hour. Including overhead and benefits with the underlying wage, we estimate an hourly rate $102. We therefore estimate the total annual fiscal impact for all 3,395 HHA respondents would be $86,598 per year (849 hours/year x $102/hour).

13. Capital Costs

There are no capital costs associated with this collection.

14. Costs to Federal Government

All costs associated with this form are incurred by the Federal Government in the normal course of business; therefore, there are no additional costs to the Federal Government.

15. Changes in Burden/Program Changes

There are no program changes.

The slight change in annual hourly burden is due to a decrease in the estimated number of surveys per year, for which we look to the number of surveys in the prior calendar year. The new hourly burden is estimated to be 849 hours per year, compared to 958 in the currently approved package.

The currently approved package does not include a fiscal estimate, thus the newly estimated burden figures here are recorded as an increase even though there has been no change to practice in how the form is used. We estimate the respondents’ annual fiscal burden to be $86,598 per year.

16. Publication and Tabulation Dates

There are no publication and tabulation dates.

17. Expiration Date

CMS will display the expiration date.

18. Certification Statement

There are no exceptions to the certification statement.

C. Collections of Information Employing Statistical Methods

There are no statistical methods employed in the information collected.