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HHS/CMS RIN: 0938-AG81 Publication ID: Spring 1997 
Title: Home Health Agency (HHA) Conditions of Participation (BPD-819-P) 
Abstract: This proposed rule would revise home health agency conditions of participation to center on the patient, using outcome-oriented measures. Most of the current HHA conditions of participation have remained unchanged since home health services became a Medicare benefit in 1966. Some limited modifications have been made over the years to comply with legislative changes. As a result, most of the conditions of participation continue to be structure and process oriented. They do not effectively support the mandate of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) to develop a patient-centered, outcome-oriented survey process that focuses on the organization and delivery of quality care services. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 484   
Legal Authority: 42 USC 1302    42 USC 1395x    42 USC 1395cc(a)    42 USC 1395hh    42 USC 1395bbb   

Statement of Need: Because the existing survey process continues to focus on structure and process measures, the discrepancy between a Congressional mandate for outcome-oriented care and the authority for measuring the actual performance capabilities of HHAs in patient care services remains a problem. It presents difficulties for both providers and surveyors in areas of survey/certification, medical review, developing data based performance standards for HHA management and monitoring, and implementing a continuous quality improvement system for outcomes of care. ^PRegulations containing the Medicare HHA conditions of participation must be revised in order to provide a regulatory basis for a patient-centered, outcome-oriented system of home health quality assurance. The implementation of such a system will enhance Medicare's ability to ensure that high-quality care is furnished to the patients of Medicare-certified home health agencies. The Social Security Act authorizes us to regulate this area and no improvements in the survey process can be made without underlying regulatory authority. ^PThe Health Care Financing Administration has already met with a variety of provider and consumer representatives to discuss the development of revised standards. Representatives of consumers, providers, and States participated in this effort. Additional consultations are ongoing.

Alternatives: Congress has mandated the implementation of an outcome-oriented quality assurance system for home health. Therefore, the Medicare home health agency conditions of participation must be revised to provide the basis for implementation of such a system. Because of this mandate, no alternatives to this action have been considered.

Anticipated Costs and Benefits: The primary benefit of this rule will be the implementation of a more effective, efficient, and patient-centered system of quality assurance for HHAs. Costs and benefits associated with the implementation of the rule have not yet been estimated, but costs should not be significant.

Risks: This rule would have the potential for reducing risks to patient health and safety. No quantitative estimates are available yet.

Timetable:
Action Date FR Cite
NPRM  03/10/1997  62 FR 11005   
NPRM Comment Period End  06/09/1997    
Additional Information: BPD-819
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses, Organizations 
Included in the Regulatory Plan: Yes 
Agency Contact:
Susan Levy
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-08-27, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-9364