Medicare Home Health Agencies: Weaknesses in Federal and State Oversight Mask Potential Quality Issues

Although HHA surveys conducted nationwide since 1998 identified a small proportion of HHAs with serious, COP-level deficiencies, there is evidence suggesting that the extent of serious care problems may be understated and that situations endangering the health and well-being of home health patients may occur more often than documented. Over two-thirds of all HHAs nationwide with documented serious, COP-level deficiencies were located in just two states, which conducted 16 percent of the surveys nationwide. In 14 states, no COP-level deficiencies were identified during the approximately 40-month period we reviewed. In contrast with these state survey results, reports compiled from HHA data on adverse events situations that raise a flag about the quality of care provided showed little such variation in their occurrence across states. Adding uncertainty to the status of quality, states are not required to routinely survey branch offices, which constitute about one-quarter of all HHA service locations. Our analysis of a sample of HHA surveys showed that, when deficiencies were documented in quality-of-care COPs, surveyors identified serious care problems that harmed patients or had the potential to do so. For example, instances with the potential to harm patients included the failure to monitor the blood sugar levels of patients with diabetes, not informing the physician of abnormal vital signs, or not checking for potential adverse drug reactions or duplicate prescriptions. Instances in which we concluded that a patient was likely harmed included the lack of interventions to treat worsening pressure sores and failure to notify the physician of a circulation blockage that resulted in the loss of a patient's leg.

Shortcomings in the survey process and inconsistencies in how states conduct surveys make it difficult to assess the quality of care delivered and may mask potential problems. For example, although consistent with CMS requirements, surveys routinely exclude about half of the 15 COPs from review, including the COP for skilled nursing services, and rely on small samples of clinical records and patient visits that may be inadequate to make determinations about the quality of care provided or the prevalence of quality problems. Inconsistencies in how the surveys are conducted magnify survey process shortcomings and help explain some of the variability in survey findings. For example, states we reviewed did not consistently categorize problems of similar severity as COP-level deficiencies, thus underreporting severe quality problems. State surveyors generally lacked clear criteria and tools to help them decide when to cite a COP-level deficiency. Moreover, 20 states did not survey all COPs when at least one COP-level deficiency was identified; 20 percent of HHAs nationwide with COP-level deficiencies on recent surveys had not received on-site revisits as required; and about half of HHAs that are required to have annual surveys such as HHAs with less than 3 years in the Medicare program and those with documented COP-level deficiencies did not receive them with that frequency. The ability of states to survey all HHAs as required whether that means every 3 years or less often because of other considerations may be compromised by the recent reduction in federal funding for HHA surveys.

The complaint intake and investigation practices in the 14 states we reviewed frequently had weaknesses. The ability to lodge complaints about an HHA?whether by patients, family members, or the caregivers themselves?and to have them resolved in a timely manner is an important aspect of protecting patient health and safety, especially if an HHA is surveyed only once every 3 years or for patients served by branch offices that generally receive little scrutiny. However, states? complaint hotlines and filing procedures sometimes placed burdens on complainants that could discourage them from filing their complaints, such as hotlines that were not advertised, identified, or used exclusively as complaint hotlines or that did not enable callers to leave a message. In our opinion, based on the allegations presented, about one-fourth of the complaints we reviewed to determine if they were appropriately prioritized appear to have been assigned too low a priority, thus delaying a timely response to potentially serious care problems. In addition, 5 of the 14 states we reviewed had management information systems that were insufficient for the state and CMS to properly monitor complaint investigations during 2000. For example, the systems in several states did not include the assigned investigation's priority or a key date, such as the date a complaint was received or investigated, which is vital to determining the timeliness of the state's investigation. Two of the five states indicated that they have since improved their information systems to better track the timeliness of complaint investigations.

CMS oversight of HHAs has been too limited to identify the problems we found in the survey process and with state performance. CMS does not review state compliance with certain requirements for conducting HHA surveys, such as whether HHAs with COP-level deficiencies are surveyed annually rather than every 3 years or whether minimum patient visit and medical record review samples are adhered to. Moreover, CMS is not statutorily required to conduct federal monitoring surveys that would better enable it to evaluate state performance in conducting HHA surveys, as it is required to do for nursing homes; consequently, few are done. Although CMS plans to take some steps to improve oversight, regional offices told us that they lack the staff to devote to this effort. Shortcomings in the OSCAR data system also impair effective oversight, such as limited data on branch offices and inconsistent data entry by states. To enforce compliance with federal quality requirements, termination from the Medicare program remains the only sanction CMS uses. The Congress mandated implementation of alternative, intermediate sanctions for noncompliant HHAs by 1989?13 years ago; CMS has yet to implement such sanctions and has set no firm time frame for doing so. In our previous work, we found that the threat of termination often had little effect on HHAs' continuing compliance with quality requirements because it is rarely carried out. In practice, HHAs often are able to slip in and out of compliance repeatedly without any adverse effects on their participation in the Medicare program.

We are suggesting that the Congress consider providing CMS a new deadline to implement intermediate sanctions for HHAs that do not comply with federal quality requirements and requiring CMS to conduct federal monitoring surveys of state survey agencies in order to better assess state performance in ensuring that HHAs provide quality care to public beneficiaries. We are also making recommendations to the Administrator of CMS to (1) strengthen the survey process, (2) better ensure that the complaint process is accessible and responsive to allegations of serious quality problems, and (3) improve federal oversight of state compliance with statutory, regulatory, and other CMS requirements. CMS concurred with all of our recommendations.