Dialysis Facilities:

Problems Remain in Ensuring Compliance with Medicare Quality Standards

GAO-04-63: Published: Oct 8, 2003. Publicly Released: Nov 7, 2003.

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Most patients with end-stage renal disease (ESRD) must rely on dialysis treatments to compensate for kidney failure. Currently, over 222,000 ESRD patients visit dialysis centers several times a week to have toxins removed from their bloodstreams. While dialysis care has improved overall, questions remain regarding the quality of care provided by some of the nation's roughly 4,000 ESRD facilities. We examined (1) the extent and nature of quality of care problems identified at dialysis facilities, (2) the effectiveness of state survey agencies in ensuring that quality issues are uncovered, corrected, and stay corrected, and (3) the extent to which the Centers for Medicare & Medicaid Services (CMS) funds, monitors, and assists state survey activities related to dialysis care.

A substantial number of ESRD facilities do not achieve minimum patient outcomes specified in clinical practice guidelines, with significant proportions of their patients receiving inadequate dialysis or treatment for anemia. Similarly, inspections of dialysis facilities by state survey agencies have uncovered numerous problems that put patient health at risk. Between fiscal years 1998 and 2002, these inspections, commonly called surveys, revealed that 15 percent of facilities surveyed had serious quality problems that, if left uncorrected, would warrant termination from the Medicare program. Serious deficiencies commonly found during surveys included medication errors, contamination of water used for dialysis, and insufficient physician involvement in patient care. Infrequent, poorly targeted, and inadequate inspections allow facilities' quality of care problems to go undetected or remain uncorrected. Although ESRD survey activity has increased in recent years, only nine state survey agencies consistently met CMS's goal to inspect 33 percent of ESRD facilities annually. A substantial number of facilities go many years between inspections. In fiscal year 2002, 216 facilities nationwide went 9 or more years without an inspection. Deficiencies may not have been detected during an inspection if the surveyors had little experience in assessing dialysis quality. Even when deficiencies are identified and facilities take corrective action, little incentive exists for these facilities to remain in compliance. Data show a pattern of repeated serious deficiencies in successive inspections of an individual facility. No effective sanctions are available to enforce compliance, short of terminating the facility from the Medicare program, which is rarely done. Federal monitoring of state agencies' performance of surveys and technical assistance provided is uneven across CMS regions. CMS substantially increased its funding for ESRD surveys from an estimated $3.1 million in fiscal year 1998 to $8.2 million in fiscal year 2002. At the same time, several CMS regional offices in our study did not actively oversee how the state agencies used these funds to improve survey activities. CMS has not taken steps needed to facilitate information sharing between federally funded ESRD networks and state agencies on the performance of individual dialysis facilities--information that could help states to target their inspection resources. In addition, CMS has not offered adequate training opportunities for surveyors inspecting ESRD facilities.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: CMS reports that steps have been taken to encourage better communication between Networks and state survey agencies (SSA). The agency noted that, in 2003, SSAs began receiving annual facility-specific data that can be used to better target facility oversight activities. GAO continues to believe that, while these data are useful to SSAs, information collected through Networks' quality improvement projects and patient complaint investigations can also help identify poor performing facilities and should, therefore, be made available to SSAs on a routine basis.

    Recommendation: To enhance the support and monitoring of state survey agencies, the administrator of CMS should amend its regulations to require that networks share facility-specific data with state agencies on a routine basis.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  2. Status: Closed - Implemented

    Comments: In FY 2004, CMS for the first time offered two sessions of its end-stage renal disease (ESRD) Basic course, one in May 2004 in Minneapolis and the second in August 2004 in Denver. Approximately 160 students attended, compared to the 100 ESRD Basic course slots offered in FY 1999 through FY 2003.

    Recommendation: To help surveyors identify and systematically document deficiencies, the Administrator of CMS should make ESRD training courses more available to state surveyors, which may nclude increasing the number of classes and slots available as well as varying class location.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  3. Status: Closed - Not Implemented

    Comments: CMS indicated that alternative action has been taken to address the intent of this recommendation. The agency has implemented the Surveyor Technical Assistant for Renal Disease (STAR) system for end-stage renal disease (ESRD) facility surveyors in selected states and has plans to expand its use nationwide. (An automated computer program for use on a tablet personal computer, STAR is designed to guide surveyors through the ESRD survey and certification process. It provides regulatory text, survey guidance, and reference material related to the ESRD survey process.)

    Recommendation: To help surveyors identify and systematically document deficiencies, the Administrator of CMS should strongly encourage states to assign ESRD inspections to a designated subset of surveyors who specialize in conducting ESRD surveys.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  4. Status: Closed - Not Implemented

    Comments: CMS reported that there are insufficient resources to accomplish this task. GAO maintains that public-reporting of dialysis facility performance indicators can provide a needed incentive to maintain compliance with quality of care standards.

    Recommendation: To create incentives for facilities to maintain compliance with Medicare quality standards, the Administrator of CMS should publish facilities' survey results on its Dialysis Facility Compare Web site.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  5. Status: Closed - Not Implemented

    Comments: CMS indicated that no action will be taken on this recommendation. It pointed out that, in 2002, its Budget Call Letter to State Agencies reduced the goal for the maximum time required between surveys from 6 years to 3 years. As of 2007, it planned to convert this frequency goal into a state performance standard. It also noted that any facility that is found to have condition level non-compliance receives at least one revisit and more if necessary.

    Recommendation: To create incentives for facilities to maintain compliance with Medicare quality standards, the Administrator of CMS should establish a goal for state agencies to reduce the time between surveys for facilities with condition-level deficiencies.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  6. Status: Closed - Not Implemented

    Comments: Although CMS reported adding specific state performance standards for end-stage renal disease (ESRD) surveys, it has not indicated any actions on the part of CMS Regional offices to enhance monitoring and assistance to state agencies.

    Recommendation: To enhance the support and monitoring of state survey agencies, the administrator of CMS should ensure that regional offices both adequately monitor state performance and provide state agencies ongoing assistance on policy and technical issues through regularly scheduled contacts with state surveyors.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

 

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