Medicare’s home health benefit includes skilled nursing and home health aide services, physical and occupational therapy, speech pathology services, medical social services, and the provision of certain medical supplies and equipment. To qualify for services, beneficiaries must be confined to their homes; have a plan of care signed by a physician; and need intermittent skilled nursing care (other than solely venipuncture for the purpose of obtaining a blood sample), physical therapy, speech- language pathology services, or have a continuing need for occupational therapy services. Intermittent means that the skilled care is either provided or needed fewer than 7 days each week, or less than 8 hours of each day for periods of 21 days or less, with extensions in exceptional circumstances when the need for additional care is finite and predictable. HHAs may serve Medicare beneficiaries from a parent office or expand their coverage by delivering services from affiliated branches or subunits. Branch locations provide services in the same geographic area as the parent and share administration, supervision, and services with the parent. Subunits are semiautonomous entities and provide services in a geographic area different from the parent HHA. To participate in Medicare, parent offices as well as subunits must generally serve a minimum of 10 patients prior to undergoing an initial survey that certifies compliance with Medicare COPs. In other words, a subunit must meet the Medicare COPs independent of its parent office. In contrast, a branch location is not subject to an initial survey. In approving a branch location, CMS requires a parent HHA to demonstrate that it provides adequate day-to-day supervision to prove that the branch is not autonomous and should not independently meet Medicare COPs. As of mid-2001, there were approximately 6,900 HHAs and subunits and approximately 2,600 separate branch offices, for a total of about 9,500 service locations. Sixty-eight percent of HHAs were freestanding agencies (not associated with a hospital), and nearly 50 percent were for-profit. CMS and its 10 regional offices are responsible for overseeing the quality of care delivered by HHAs. CMS fulfills this responsibility by contracting with states to examine compliance with Medicare requirements, known as COPs, through periodic surveys generally conducted every 12 to 36 months, depending on an HHA’s compliance history. Focusing on care processes, Medicare’s 15 COPs cover broad areas such as patient rights, adherence to the physician-prescribed patient plan of care, the provision and supervision of skilled nursing and home health aide services, and the maintenance of medical records. All but two COPs are further subdivided into more detailed standards. For example, the “skilled nursing services” COP covers the duties of both a registered nurse and a licensed practical nurse as further defined by 15 specific standards. Two of the 15 COPs, added in 1999, cover patient assessments using the Outcome and Assessment Information Set (OASIS). OASIS is used to collect standardized information on patient conditions in order to monitor changes over time and help identify potential quality-of-care problems. In general, assessments are required no less frequently than at the start of care, every 60 days following admission, and when the patient is discharged by the HHA. HHAs were required to begin collecting and reporting OASIS data in July 1999. OASIS data are also an integral part of the new HHA prospective payment system implemented in October 2000, which provides HHAs a fixed, predetermined payment for each 60-day “episode of care.” The amount of the payment is adjusted for the severity of the patient’s condition using OASIS data. While encouraging efficiency, the new prospective payment system also provides HHAs an incentive to reduce services in order to increase net revenues. Prior to October 1997, HHAs were paid on the basis of their costs, up to preestablished per-visit limits. There were no incentives to control the volume of services delivered, and as a result, HHAs could enhance their revenues by providing more beneficiaries with more visits. According to CMS requirements, state surveyors must routinely conduct a “standard survey” to test compliance with about half of the 15 COPs (see app. II). CMS deems these COPs to be those most closely associated with the quality of care provided by HHAs. If an HHA is found to be out of compliance with at least one of these COPs, surveyors are required to extend the standard survey and review the remaining COPs. Typically, state surveyors are registered nurses. CMS offers a basic course that focuses on HHA regulations and survey methodology but it is not mandatory for HHA surveyors to take this course. However, every surveyor must complete one of the basic training courses, such as the course on surveying nursing homes, end-stage renal facilities, or hospitals. In addition to focusing on the regulations specific to a provider, each of these courses also covers generic skills such as observation, interviewing, and documentation. The core of the statutorily defined standard survey is the review of a case- mix stratified sample of patient medical records and visits to patients’ homes to validate the record review. The medical record review includes determining whether the HHA has a current and appropriate plan of care for each patient as ordered by the patient’s physician, whether the ordered care and services are provided and coordinated by the personnel who furnish them, and whether the patient’s physician is notified of changes in medical condition. The visit to the patient’s home is to ensure the patient is receiving the physician-ordered treatment in accordance with the plan of care and that the care is provided in accordance with Medicare health and safety standards. The number of records reviewed and patients visited is based on the number of unduplicated skilled care patients served by an HHA in the 12 months prior to the survey. For example, an HHA with fewer than 150 patients would have a minimum of 3 to 5 record reviews with patient home visits, while an HHA with 1,251 or more patients would have 25 or more. Because home health patients reside in their own homes and care delivery is not as readily observable, detecting quality-of-care deficiencies—both individual and systemic—is more challenging than it is for nursing home residents. For example, HHA surveyors are typically in each patient’s home for less than an hour to interview the patient and, if possible, to observe care delivery by HHA personnel; in contrast, a nursing home survey lasts several days, giving surveyors a significant opportunity to observe the delivery of care and identify the quality-of-care concerns of a number of residents over a longer period of time. When HHAs fail to meet Medicare quality requirements, surveyors are required to cite deficiencies of either COPs or standards or both. According to CMS’s guidance, COP-level deficiencies are more serious and reflect the existence of a significant problem that “adversely affects or has the potential to adversely affect patients”—that is, harms patients or has the potential to do so. CMS guidance does not specifically define a standard-level deficiency. When a deficiency is cited, HHAs must submit a plan of correction. CMS requires state surveyors to confirm that HHAs with a COP-level deficiency have returned to compliance by making on- site revisits. By statute, each HHA must be surveyed at least once every 36 months, with CMS requirements determining the exact survey frequency based on an HHA’s compliance history and other factors. Generally, CMS requires an HHA without COP-level deficiencies to be surveyed once every 3 years. In contrast, CMS requires annual surveys if HHAs have participated in Medicare for fewer than 3 years; have had a recent change in ownership; have had a COP-level deficiency within the last 24 months; have been reviewed by a state, regional, or national fraud and abuse initiative; or have had a complaint survey with any deficiency citations since the last standard survey. This variable 12- to 36-month survey schedule was implemented in 1996 to focus survey resources on HHAs with compliance problems. The results of HHA surveys are tracked in CMS’s OSCAR database, which permits federal monitoring of state survey activities. State survey agencies are required to conduct timely investigations of reported complaints, and to operate a home health hotline for individuals to register complaints against HHAs. For complaints that involve a possible immediate and serious threat, states must conduct complaint investigations within 2 working days. Additional time frames for investigating other complaints may be set at each state’s discretion. A complaint investigation can trigger a standard survey if surveyors find situations that warrant further review. HHAs that are out of compliance with one or more COPs can be terminated from the Medicare program and thus lose the right to serve Medicare beneficiaries. Termination is the only federal sanction available because CMS has not implemented other sanctions as directed by the Congress in 1987. When a COP-level deficiency poses an “immediate and serious threat” to a patient’s health and safety, HHAs are placed on an accelerated 23-day termination timetable; in less serious situations, CMS uses a 90-day termination timetable. HHAs can avoid termination by implementing plans of correction that bring them back into compliance with Medicare’s COPs. HHAs with one or more standard-level deficiencies—as opposed to having a COP-level deficiency—are not subject to termination but must submit an acceptable plan of correction. In states that license HHAs, other state-specific enforcement actions, including revoking an HHA’s operating license or assessing monetary penalties, may be available. Although the results of HHA surveys conducted since 1998 indicated that few agencies had serious quality problems, the prevalence of reported COP-level deficiencies varied dramatically across states, suggesting that such problems may be understated in many states. In contrast, analysis of adverse events recorded in OASIS data collected by HHAs—incidents that raise a flag about the quality of care delivered—showed they occurred with little variation across states. Thus, problems endangering the well- being of patients may be occurring with greater regularity than state surveys indicate. Moreover, CMS does not require states to routinely survey branch offices, which constitute about one-quarter of HHA service locations, adding to the uncertainty about the status of HHA quality. Our review of 80 surveys that cited quality-of-care related COP deficiencies, including 25 from the two states citing the majority of COP deficiencies, indicated that surveyors had documented serious care problems that either harmed patients or had the potential to do so. The deficiencies often represented a basic failure to follow the patient’s plan of care, notify the doctor of important changes in the patient’s condition, or take appropriate precautions with medications. The most recent HHA surveys showed that only about 6 percent of HHAs nationwide had COP-level deficiencies—situations that harm or have the potential to harm patients. However, the skewed findings of COP-level deficiencies in a small number of states, despite more consistent indications of potential care problems across all states, suggest that states may not be identifying all COP-level deficiencies, resulting in a likely understatement of serious care problems. Furthermore, the fact that branch offices are not required to be routinely surveyed limits knowledge about the quality of care they provide. Branches account for about one- quarter of HHA operating locations nationwide, and in five states branches are more numerous than parent HHAs. (App. III shows the number of branch offices as a percentage of all HHA operating locations for each state.) Moreover, the number of branches may be significantly greater than the number identified by CMS. In addition, states lack a way of separately recording the results of any branch office surveys because branches operate under their parents’ provider numbers. California and Texas accounted for over two-thirds of documented COP- level deficiencies nationwide, suggesting that states have disparate survey practices that may not consistently capture the actual status of quality. While these two states represented less than one-fifth of the nation’s HHAs with current surveys, they identified 261 of the 368 HHAs with COP-level deficiencies. The remaining 107 HHAs with COP-level deficiencies were spread across 35 states, states that accounted for almost 70 percent of HHAs with current surveys. Finally, as of August 2001, 14 states had cited no COP deficiencies since March 31, 1998. (App. IV shows the number of HHAs cited with COP-level deficiencies in each state.) In contrast with the variable citation of COP-level deficiencies nationwide, our analysis of OASIS adverse events reports showed significantly less interstate variation. While the range in the percentage of HHAs with COP- level deficiencies is wide—from none in Arkansas, Georgia, and Utah to at least 23 percent in California—the range of adverse events per 100 valid episodes is much narrower, from 7 to 11.1 percent. Figure 1 compares the percentage of surveys with COP-level deficiencies and adverse events per 100 valid episodes for our sample of 14 states (see app. IV for other states). California and Texas cited COP-level deficiencies at a significantly higher proportion of the HHAs they surveyed than did most other states, but for adverse events reports, both states were close to the national average of 8.5 adverse events per 100 valid episodes. Arkansas and Utah, which cited no COP-level deficiencies, were among the states with the highest number of adverse events per 100 valid episodes—10.9 and 11.1, respectively. To assess the severity of the problems identified during HHA surveys, we reviewed 80 surveys that documented at least one of five quality-of-care related COP deficiencies. (Table 1 describes the five COPs and associated standards.) These surveys—containing 132 quality-of-care related COP deficiencies—documented serious care delivery problems, the majority of which had the potential to harm patients. Our analysis showed that the examples provided to support 93 percent of the 132 COP-level deficiency citations demonstrated serious quality-of- care problems with either the potential for or likely patient harm. However, we found that the documentation for these COP-level deficiencies described relatively few instances of likely patient harm. On the basis of the information in the survey reports, we were usually unable to determine whether there was no harm or it was simply not documented. The deficiencies often represented a basic failure to follow the patient’s plan of care, notify the doctor of important changes in the patient’s condition, or take appropriate precautions with medications (see table 2). Consistent with the focus of surveys on care processes rather than outcomes, the potential for harm was frequently shown, but only a relatively small number of the COP deficiencies documented whether likely patient harm had resulted. Overall, the 132 COP deficiencies we reviewed in the 80 state survey reports demonstrated likely harm to 22 patients in 16 of the surveys. Appendix V contains abstracts of these 22 instances, including 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 leg. In 7 percent of the 132 COP-level deficiencies we reviewed, surveyors demonstrated that HHAs were not following the Medicare COPs, but the documentation for problems cited in those standards we examined did not indicate a potential for serious or immediate harm to patients. Most of these deficiencies involved the failure to meet medical record or patient assessment documentation requirements, and they were frequently systemic in nature. For example, surveyors in one state cited a new HHA for a COP-deficiency related to medical records because the HHA had not assigned numbers to the medical records of the 14 patients it had served up to that time or completed discharge summaries for any of its 7 discharged patients. Another state cited an HHA with this same deficiency because of an undated physician’s signature on care plans for four patients and the lack of a physician’s signature or date on the care plan for one other patient. Finally, two states cited HHAs for failing to meet the COP related to patient assessment because the HHAs consistently performed separate OASIS and patient assessments instead of integrating them as required. Shortcomings in the HHA survey process as well as inconsistencies in how states conduct surveys make it difficult to assess the quality of care provided. Although CMS now requires surveyors to use reports generated from OASIS data to help identify patients for whom quality of care may be a concern when selecting medical record and patient visit samples, this change is not sufficient to address more fundamental shortcomings in the survey process. For instance, standard surveys exclude about half of the 15 COPs and rely on very small samples of clinical records and patient visits to adequately assess quality of care. In addition, the surveyors lack clear criteria and tools to help them decide when to cite a COP-level deficiency, and guidance on when to survey branch offices is unclear. Inconsistencies in how states conduct surveys magnify these weaknesses and help explain some of the variability in survey findings. For example, states did not consistently categorize problems of similar severity as COP- level deficiencies, providing evidence that quality-of-care problems may be understated. Three of the states we assessed used nursing home surveyors for HHA surveys who were inexperienced with the HHA survey process. In addition, based on our analysis of OSCAR data, states did not always comply with federal survey requirements, such as reviewing the required number of medical records and visiting the minimum number of patients. Furthermore, HHAs new to the Medicare program and those with serious deficiencies frequently were not surveyed annually as required. The ability of states to survey these and other HHAs as required may be compromised by the reduction in federal funding for HHA surveys. Although CMS now requires surveyors to use reports generated from OASIS data to focus survey activities on patients for whom quality of care may be a concern, this change has not fundamentally altered the survey’s reliance on process requirements to evaluate HHA performance. CMS also has not addressed some of the serious weaknesses in the survey process we identified in our 1997 report, such as not surveying HHAs against all COPs and inadequate oversight of HHA branch offices. Consistent with provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA), CMS has taken incremental steps from 1991 through 2001 to broaden the focus of surveys beyond a test of compliance with process requirements by including an evaluation of the kind of care being provided and the effect of that care on the beneficiaries being served. In 1991, HCFA implemented a revised survey process using indicators of medical, nursing, and rehabilitative care to determine the quality and scope of patient care services provided by an HHA. Nevertheless, a 1994 study commissioned by HCFA to evaluate the 1991 changes concluded that HHA surveys continued to emphasize care processes over patient outcomes. While determining compliance with standard care processes is an important aspect of measuring quality of care, determining patient outcomes is also vital because it identifies the impact of poor care processes. However, the design of the HHA survey still allows surveyors to cite a deficiency without addressing the patient outcome because the COPs focus on care processes (see app. II, table 8). In contrast, the design of the nursing home survey process allows surveyors not only to examine compliance with care processes but also to identify the outcomes of care delivered. (See app. II, table 9, for examples of outcome measures used in nursing home surveys.) While HCFA had proposed revising the COPs against which HHAs are evaluated, it gave introduction of OASIS a higher priority. HCFA issued proposed rules in 1997 to revise the home health COPs and to require HHAs to begin collecting and reporting OASIS data. Revising the COPs was intended to eliminate unnecessary process requirements and focus on the health status impact of the treatment furnished by an HHA. For example, the proposed changes would likely require a review of skilled nursing services during standard surveys. Similarly, OASIS was intended to have HHAs collect standardized patient information that could be used to monitor changes in patients’ conditions and to link any changes to the care provided by an HHA. Although the issuance of revised COPs has been delayed until mid-2003, new OASIS COPs—requiring HHAs to collect and report OASIS data on most patients—were implemented during 1999. With the availability of OASIS data, HCFA began requiring state surveyors to access and review certain reports before conducting HHA surveys: (1) patient characteristics, (2) adverse events, (3) health care services utilization, and (4) improvement and stabilization of health status. These reports are intended to assist surveyors in targeting potential quality-of- care problems during the on-site survey and identifying individuals or types of patients to be included in the case-mix stratified sample. While worthwhile, the use of these reports has not fundamentally altered surveys, which continue to focus on care processes. Despite CMS’s focus on revising the home health COPs and adding OASIS, other shortcomings in the survey process have not been addressed, including (1) exclusion of some COPs during routine surveys, (2) insufficient sample sizes to adequately detect quality-of-care problems, (3) lack of clear criteria or tools to categorize the severity of deficiencies, and (4) lack of sufficiently detailed requirements regarding surveys of branch offices. HHAs Not Surveyed against All COPs. HHAs may participate in the Medicare program without ever undergoing a survey that examines their compliance with all COPs. During 2000, 92 percent of HHA surveys did not include a review of all 15 COPs. Without such a review, CMS has no assurance that an HHA is fully complying with Medicare health and safety requirements. In particular, the skilled nursing COP is not one of the COPs included in a standard survey, even though the need for skilled nursing care is one of the eligibility requirements for Medicare beneficiaries to receive home health services. According to CMS, initial surveys of HHAs—unlike surveys of nursing homes, critical access hospitals, intermediate care facilities for the mentally retarded, hospices, and kidney dialysis facilities—do not automatically assess compliance with all COPs. Moreover, HHAs are one of the few such providers for which surveyors do not automatically examine all COPs during subsequent surveys. In 1997, we recommended that HCFA establish targeting criteria for selecting HHAs to survey for compliance with all COPs—to periodically ensure that all HHAs fully comply with Medicare safety and health requirements. HCFA responded that its targeting criteria were adequate. We continue to believe that the agency should require states to periodically review HHAs’ compliance with all COPs, since over 40 percent of recently cited COP- level deficiencies involved conditions that are not routinely examined during a standard survey. Insufficient Sample Size. HCFA’s 1994 evaluation of the survey process concluded that the number of medical records reviewed with and without home visits was too small to detect the prevalence of quality-of-care problems at HHAs. A change in the sample selection procedure introduced since 1994, however, has generally further reduced home health survey sample sizes. Currently, survey sample sizes are based on the number of unduplicated skilled care admissions from all payer sources during the 12 months preceding a survey. Depending on the number of unduplicated skilled care admissions, surveyors must review a minimum of 11 to 40 records and interview a minimum of 3 to 25 patients in their homes. The nursing home survey sample size, on the other hand, is considerably larger. For example, a nursing home surveyor must review 30 records for 400 patients, while an HHA surveyor inspecting a similarly sized HHA would need to review a minimum of 15 records. Reviewing a valid and representative sample of medical records and conducting patient visits is important because these activities allow surveyors to identify the nature and prevalence of quality-of-care concerns, including whether treatment is consistent with the plan of care. Small sample sizes reduce the ability of surveyors to generalize their findings to other patients at an HHA or determine whether quality-of-care problems are isolated or widespread. Limited Criteria or Tools to Help Categorize the Severity of Deficiencies. Federal guidance to surveyors about when to cite a COP-level deficiency is limited, and surveyors lack tools to help categorize deficiencies when they are found. CMS guidance for surveyors states that an incident with little or no effect on the delivery of patient services does not warrant a deficiency citation. On the other hand, a COP-level deficiency may be cited if, in a surveyor’s judgment, the deficiency constitutes a significant or a serious problem that adversely affects, or has the potential to adversely affect, patients. Vague Requirements for Surveying Branch Offices. Despite the fact that branch offices represent about one-quarter of all HHA locations, CMS guidance on surveying branches is vague. In 1997, we recommended that HHA branch locations be “periodically surveyed.” CMS instructed states as of April 2001 that (1) branch locations should be periodically included in or replace the unannounced standard survey of a parent HHA, (2) standard surveys should be routinely conducted at a branch location when that location serves more patients than the parent, and (3) all locations of an HHA should be visited during the survey whenever possible. Officials in CMS regional offices told us that no additional guidance was provided to states for defining the terms “periodically,” “included in,” or “routinely.” Furthermore, according to CMS, some state surveyors currently lack a systematic way of determining the number of patients served by a parent HHA or its branch offices prior to the actual survey. Inconsistencies in how states conduct surveys may amplify shortcomings in the survey process and help explain some of the variability in survey findings we noted across states. Based on our work with the 14 sample states and analysis of national OSCAR data, we found that surveyors in certain states (1) inconsistently categorized quality-of-care deficiencies, (2) lacked appropriate training and experience, (3) failed to cite deficiencies because they viewed their role as advisory rather than as one of oversight of HHAs, and (4) did not consistently follow CMS requirements regarding significant elements of the survey process. Georgia and Massachusetts, 2 of our 14 sample states, reported no COP- level quality-of-care deficiencies in surveys conducted since December 31, 1999, and entered into OSCAR as of August 17, 2001. In reviewing documented standard-level deficiencies in these two states, we noted six examples in 5 of 16 surveys where patients were exposed to likely harm, but no COP-level deficiency was cited. (See app. VI.) In other states, we found that deficiencies of this severity were often cited at the COP level. (See app. V.) Such survey inconsistencies across states probably result in an understatement of quality problems. For example, Massachusetts cited standard-level deficiencies for a case in which a patient on a blood- thinning medication died after the HHA failed to ensure that the patient received regular tests to measure blood clotting time, as ordered by the physician. In commenting on a draft of this report, a Massachusetts official said that only standard-level deficiencies were cited in this case because, in the professional judgment of the surveyors, the HHA had implemented systemic changes to correct the problem prior to their arrival at the HHA. We continue to believe that the likely patient harm we identified in this and another Massachusetts survey warranted the citation of COP-level deficiency. Moreover, we found cases in other states where COP-level deficiencies were cited for outcomes of similar or lesser severity. For example, Nevada cited an HHA with a COP-level deficiency for waiting 9 days before informing the physician of a patient’s nausea, vomiting, and diarrhea. This patient was admitted to the hospital for weakness, inability to eat, and dehydration. In another case, Texas cited an HHA with a COP- level deficiency at the level of “immediate jeopardy” for failing to report the patient’s worsening pressure sore and pulmonary status to the physician, and failing to ensure that the physician’s orders for tests were fully implemented. As a result, this patient’s pressure sore worsened and became infected and the pneumonia was not treated for 2 months. (See app. V.) In Florida, Kansas, and Louisiana, we found that a substantial number of surveyors assigned to conduct HHA surveys during 2000 had neither (1) taken the basic HHA training course offered by CMS nor (2) acquired substantial on-the-job experience by conducting HHA surveys (see table 3). In contrast, surveyors in Arkansas, California’s Los Angeles county district office, and Texas have generally taken CMS’s HHA training course. According to a CMS official, attendance at a basic training course is mandatory for HHA surveyors, but the course does not have to be the basic HHA training course. In general, officials in Florida, Kansas, and Louisiana said that the limited number of surveyors who had graduated from the course was the result of the course being offered infrequently, the limited number of slots available to a state, surveyor turnover, and the amount of training resources. However, a Texas official told us that the state sent 30 new surveyors to basic HHA training in 2000 and 2001 because it sees national training as an investment that helps ensure consistency across surveys. Texas, we were told, pushed for more slots at each of these courses. Florida and Louisiana officials indicated that their respective CMS regional offices allocated fewer HHA training slots than were requested. According to a CMS headquarters training official, regional offices should be working with headquarters to accommodate state needs. A state official also emphasized that, like Texas, Louisiana valued national training. Finally, Florida, Kansas, and Louisiana all pointed out that they provide state-level training to HHA surveyors, which may include on-site mentoring by experienced staff. As shown in table 3, Florida, Kansas, and Louisiana gave little opportunity for surveyors to develop their HHA survey skills because they generally assigned a large number of surveyors relative to the number of HHAs being inspected, resulting in many surveyors conducting few surveys. For example, Louisiana assigned 74 surveyors to inspect 125 HHAs—a ratio of less than 2 HHAs per surveyor. From 18 percent to 32 percent of surveyors in these states conducted only one survey during 2000 and about half or more conducted no more than three. A Kansas official attributed the assignment of a large number of surveyors to having less experienced surveyors assist experienced surveyors and to providing less experienced surveyors on-the-job training before receiving more formal HHA training. In contrast, Arkansas, which had 36 percent more HHAs than Kansas, surveyed HHAs in 2000 with 6 surveyors compared with the 27 used by Kansas. Three of Arkansas’ six dedicated HHA surveyors inspected from 16 to 28 HHAs during 2000; the remaining three surveyors only conducted from 7 to 10 surveys each because they were only employed part of the year. According to a CMS official, surveyors who do a limited number of HHA surveys each year would lack a cohesive comprehension of the regulations. In addition, ensuring consistency across surveys is very difficult if surveyors have limited on-the-job experience. Although the objective of HHA surveys is to examine compliance with federal health and safety requirements, officials in several states acknowledged that surveyors previously considered or continued to view their roles as educating and consulting with rather than overseeing HHAs—practices that are contrary to CMS policy. For example, an official with Colorado’s survey agency explained the state’s small number of COP deficiencies by noting that both top management and two surveyors advocated educating providers about HHA regulations but not citing deficiencies when they were found. A June 2001 Colorado State Auditor’s report found additional problems with state HHA surveys including inconsistent and inadequate deficiency citations, poor documentation of survey results, and failure to follow federal guidance on sample sizes. According to the Colorado survey agency official, a change in top management in late 2000, along with surveyor retirement and retraining, has resulted in more deficiency and COP citations. Since July 2000, surveyors have found deficiencies at 78 percent of surveyed HHAs, compared with 15 percent of HHAs surveyed in 1999. Arkansas officials told us that until recently HHA surveyors did not cite deficiencies when the problem appeared to be inadequate documentation of services required by patients’ care plans because surveyors viewed their role as educational. From 1997 through 2000, Arkansas surveyors cited no COP-level deficiencies, and 93 percent of the state’s HHA surveys found no deficiencies of either COPs or standards. According to a state survey agency official, a change in management has resulted in a reversal of this practice and Arkansas HHA surveyors are now citing deficiencies when they find inadequate documentation of services. This official told us that 43 of 62 surveys conducted from October 2001 through May 2002 cited deficiencies, including two HHAs with COP-level deficiencies. We noted that other states do cite deficiencies for inadequate documentation. Thus, our review of 96 recent surveys from 34 states demonstrated that deficiencies were frequently cited because of the inadequate documentation of services (see app. V). Without such documentation, determining whether patients received physician-ordered services would depend on agency staff’s recall. Many states did not consistently follow CMS requirements when COP violations were found during surveys. Fifteen percent of surveys conducted nationally during 2000 that identified COP-level deficiencies did not include a review of all COPs, even though surveyors are required to expand a survey and examine all COPs when they find at least one COP- level deficiency. Specifically, 19 of 20 states did not extend 25 of the 85 surveys that had COP-level deficiencies, while Texas, the 20th state, did not extend 21 of 95. In addition, surveyors did not always conduct on-site revisits to ensure that the COP deficiencies identified had been corrected. We found that 20 percent of HHAs nationwide with at least one COP-level deficiency on surveys since January 2000 had not received on-site revisits as required. Based on our analysis of OSCAR data, states did not consistently review the minimum sample of medical records and patient visits, exacerbating the problem noted earlier of sample sizes that are already too small to adequately identify the prevalence of quality-of-care problems. Overall, six of the states we reviewed failed to meet minimum sampling requirements during 2000 for patient visits and record reviews 23 percent and 24 percent of the time, respectively (see table 4). Furthermore, while CMS requires sample sizes to fall within specified ranges, for example, a minimum of 5 to 7 patient visits for an HHA with 150 to 750 unduplicated admissions, state surveyors almost never chose to review the highest number in this range. In addition, because CMS’s April 2001 guidance for states to periodically include branch offices in their standard surveys is vague, state interpretations of the new requirement have varied. For example, 6 of the 14 states in our sample told us that the requirement could be satisfied by including patients served by branches in their clinical records review when conducting surveys at parent locations. Likewise, five states said the new guidance does not require them to physically visit the branch location during routine surveys, and half stated they do not plan to conduct standard surveys at branches. Texas, on the other hand, recently initiated agency surveys at branch offices instead of at parent locations. Having done so, the state found more serious deficiencies, including 13 COP violations, at the 13 branches surveyed than it did at the respective parent locations during previous surveys. CMS officials in the San Francisco and Seattle regions said that the new federal requirement to periodically survey branches does not change what the states in their regions have been doing because they have been surveying branch locations for many years. Finally, about half of the HHAs nationwide that are required to have annual surveys are actually surveyed less frequently. Such HHAs would include those in the Medicare program for fewer than 3 years, with a change of ownership since the previous survey, with a COP-level deficiency cited within 24 months of their most recent survey, or with a complaint deficiency citation since the previous survey (see table 5). By reviewing these providers more frequently, states can ensure that problematic HHAs and those lacking experience or a consistent quality-of- care track record will receive extra scrutiny. In addition, CMS requires that states survey 5 percent of their HHAs that qualify for surveys every 36 months within 16 to 20 months of their prior survey. Based on information entered into OSCAR, it appears that states are generally not conducting these surveys at all. According to CMS, the objective of this 16- to 20- month survey cycle is to reduce the predictability of 3-year surveys and to provide intermittent scrutiny of at least a small number of HHAs that fall into this category. Reduced funding for HHA surveys could undermine the statutory and other requirements to inspect all HHAs at least once every 3 years and certain HHAs more frequently. Although CMS requires HHAs with a good survey track record to be surveyed every 3 years, some must be surveyed annually, such as those with COP-level deficiencies and those with 3 or fewer years in the Medicare program and thus little practical experience in providing home health services. Because some states must survey more than one-third of their HHAs annually, they may be unable to survey the remaining HHAs at least once every 3 years. Moreover, states electing to periodically survey branch offices as well as the parent HHA face an increased survey workload. From fiscal years 2000 through 2002, federal funding of state HHA surveys has been reduced by 20 percent from $31.9 million to $25.4 million. While CMS estimated that the number of standard surveys would fall from about 5,000 in fiscal year 2001 to about 2,500 in fiscal year 2002, the new funding level would still be sufficient to survey each HHA on average once every 3 years rather than every 2 years, as provided for in earlier budgets. But basing funding of state HHA surveys on a 3-year average is inconsistent with the variable survey schedule implemented in 1996, in which certain HHAs are specifically required to be surveyed annually. Under that schedule, 11 states must survey more than one-third of their HHAs annually because of recent COP citations or other factors (see table 6). Four of the 11 states—California, Delaware, Maine, and Nevada—must survey over half of their HHAs annually. Despite the importance of the complaint process in responding to concerns and problems with patient health and safety, complaint investigation practices in the 14 states we reviewed frequently had weaknesses that undermined their effectiveness. An effective state complaint investigation process is important because state surveyors will not otherwise be aware of potentially harmful situations that arise between surveys, especially concerning complaints filed directly with an HHA, a practice encouraged by some states. Yet some states in our sample used practices that could discourage the filing of complaints with the state. In addition, we believe that roughly one-fourth of the complaints we analyzed to determine if they were appropriately prioritized were assigned a lower priority for investigation than the alleged problems appeared to warrant. Inappropriately delaying the investigation of complaints alleging serious quality problems may prolong a condition that places patients at risk of harm. Furthermore, 5 of the 14 states did not have management information systems capable of providing necessary information to adequately monitor complaint investigations in 2000, but 2 states indicated that they have since improved their systems. Our review of states’ procedures for handling HHA complaints found practices in some states that could discourage individuals from filing complaints. These practices included not publicizing the existence of the toll-free telephone numbers for filing complaints, limiting access to such toll-free telephone numbers to in-state residents, making it difficult to reach state hotline staff by telephone to file a complaint, and requiring complaints to be submitted in writing. Our prior work on nursing home complaints concluded that the process of filing a complaint should not place an unnecessary burden on a complainant. An easy-to-use complaint process should include a toll-free telephone number that is easy to access and use and that permits the complainant to leave a recorded message when state staff are unavailable. In addition, a user-friendly hotline would accept complaints verbally and not expect or require complaints to be submitted in writing. In 1987, federal legislation directed that each state establish a toll-free telephone number, or “hotline,” to provide the public information about HHAs in the state and to receive complaints against HHAs. According to CMS, the hotline requirement was added because home health patients are homebound, may have little contact with anyone except the HHA’s staff, and may therefore be vulnerable to poor care or abuse. Under such circumstances, a hotline gives patients a direct link to the state for filing complaints—a link that is also available to family members, neighbors, and even HHA personnel. While each of the 14 states we contacted maintains a hotline, as required, publicity about its availability is limited. The only CMS requirement with respect to publicizing the hotline is that an HHA inform each new patient that the state maintains a hotline for filing complaints and make the patient aware of the telephone number. There is no requirement for states to publicize the number to the general public, and officials from 3 of the 14 states we contacted indicated that they do not publicize the number at all. Officials from 6 of the 14 states indicated that they list the number in local telephone books or show it on their Web site. The hotlines in 5 of the 14 states contacted are toll-free only for calls made from within the state. To file a complaint from outside one of these states, a complainant must pay for the call. This could present a difficulty not only for family members who live in another state but also for patients who live in one state but are served by an HHA located in an adjacent state. Officials from two of the five states indicated that the states chose to limit the hotline to in-state calls because of cost. According to CMS, the toll-free hotlines in about half the states and territories do not accept out- of-state calls. Although hotlines should be easy to use, callers in some states may find using them confusing or may even find the hotlines unresponsive. When we called the hotlines in our 14 sample states, we identified situations that could frustrate complainants, especially patients who may be elderly and in poor health. The following are examples of such situations: Hotlines in eight states did not clearly indicate in their telephone messages that the caller had reached the number for filing a complaint against an HHA. For example, when we contacted the Florida hotline in September 2001, Florida’s message indicated that we had reached the state survey agency and then asked us to select from six menu options. If the correct option was selected, the next message provided three more options from which to select. At no time did Florida’s recorded message specifically indicate that any of the options were for filing a complaint or for using the complaint hotline. In commenting on a draft of this report, a state official indicated that in January 2002 the state changed the menu options and the message to provide up-front notice that the caller had reached the state’s HHA complaint hotline. While Massachusetts also used a menu system, it specifically identified the number for the caller to press to file a complaint. Six states use their hotlines for multiple purposes. Although this practice is not prohibited, it could confuse callers. Connecticut’s toll-free number, for example, is a referral line for all types of health care questions. Kansas uses its hotline for complaints against any state-licensed provider, while Indiana uses its hotline for providing HHA and hospice information. Ohio uses its toll-free number for information about all state health facilities, and the wide range of calls it receives on this number include calls about animal cruelty concerns. Where hotlines are used for multiple purposes, it is important that clear instructions are provided so that callers can be sure they have reached the proper number. Reaching state staff or leaving a voice message at the hotline was a problem in five states. For example, Florida and Kansas have no voice mail capability, requiring complainants to call only during business hours. A Kansas official noted that only 40 HHA complaints were received in all of 2000, suggesting that the lack of voice mail was not causing a problem. On the contrary, a voice mail capability that makes it easier to reach state officials could result in an increase in complaints. In three other states, it was difficult either to have a call returned or to leave a message. For example, we called the Pennsylvania hotline after business hours four times over several days in September 2001 and again in April 2002 and the voice mail activated only once. A Pennsylvania official expressed concern about our finding but indicated that system tests showed no equipment problems. As Florida noted, CMS does not require states to have a voice mail capability. Of the 14 states contacted, only Connecticut has a policy that “Complaints made to the Department must be in writing; however, staff must be flexible regarding the needs of some individuals.” Only one of eight complaints we reviewed from Connecticut did not include a written letter from the complainant. A Connecticut official indicated that the state “encourages” complaints in writing but never requires a letter if it is a hardship to the complainant. Similarly, Massachusetts encourages complainants to follow up their telephone call with a letter or a fax. As we noted in our prior work on nursing homes, requiring complaints to be put in writing may place an unnecessary burden on the complainant and limit the number of complaints received. Of 79 complaints we examined that states placed in low-priority investigation categories, about one-fourth, in our opinion, appeared to be inappropriately prioritized. Delaying the initiation of an investigation could delay the identification of serious problems at HHAs and postpone needed corrections. Furthermore, delayed investigations of complaints could prolong periods in which a patient’s health and safety are at risk. With some notable exceptions, the 14 states we contacted generally investigated their complaints within the time frames they assigned. Finally, since many complaints are filed directly with an HHA rather than the state, and the interval between standard surveys can be up to 3 years, there may be a gap in state oversight of complaints against HHAs. The state survey agency ascertains the potential seriousness of each complaint it receives in order to determine how quickly it should be investigated. CMS requires that complaints representing a potential immediate and serious threat to a patient be investigated within 2 workdays of receipt. For all other complaints, states are permitted to establish their own investigation time frames. Officials in 9 of the 14 states we contacted said they have a requirement that complaints alleging harm to a patient be investigated within 10 days of receipt. Complaint investigation categories for less serious complaints vary by state but often include 30-day, 60-day, and 90-day time frames as well as a category that does not require investigation until the HHA’s next scheduled survey. As demonstrated in table 7, states placed few of the complaints they received in 2000 in the 2-day or 10-day investigation time frames—with the exception of Florida, which placed 68 percent of the complaints it received in one of these two categories. Because the infrequent use of high-priority investigation time frames in some states raised a question as to whether complaints were appropriately categorized, we reviewed the 79 complaints in our sample that states placed in categories other than the 2-day or 10-day categories. In our opinion, 21 of the 79 complaints alleged potential serious care issues and should have been placed in a category requiring investigation within at least 10 days. Three examples follow. (App. VII includes other examples of these complaints.) A Colorado complaint alleged that the HHA was not providing proper wound care and indicated that the HHA aide’s failure to correctly change the patient’s bandage caused the patient to require surgery for the wound. The complaint also alleged that the HHA was not providing this patient with physical therapy services as required. The state categorized this complaint as a 60-day complaint. It contacted the HHA by telephone the day after receiving the complaint and requested the patient’s medical record, which the state received 19 days later. The state also requested medical records from the hospital but did not receive them for 78 days. A Kansas complaint alleged that an HHA nurse, while providing wound care for a patient who had recently had heart bypass surgery, failed to report signs of wound infection to the physician. It also alleged that at the patient’s scheduled 3-week checkup, the physician found that the wound was infected to the bone and that the patient was readmitted to the hospital where the entire chest incision had to be redone. The state categorized this complaint as a 60-day complaint and investigated it in 72 days. Kansas officials did not agree with our judgment that an earlier time frame was warranted, commenting that the state had a well-developed complaint policy and procedure that is utilized in complaint intake and investigations. We continue to believe that the seriousness of the allegation—including rehospitalization of the patient—warranted investigation within 10 days. An Ohio complaint alleged that by using the wrong syringe, an HHA nurse gave 4 times the amount of quick-acting insulin ordered by the physician to a diabetic patient whose blood sugar was severely elevated. The nurse was supposed to remain with the patient for 2 hours to monitor the patient’s response but left after 1 hour and 40 minutes. The patient then became ill, weak, and pale and called the physician, who told the patient to drink orange juice to reduce the insulin level. Ohio categorized this complaint as a 30-day complaint (30 working days) and investigated it in 16 working days (24 calendar days). In reviewing the 79 complaints, we also found that state agencies sometimes did not gather or document sufficient information from the complainant to determine the correct investigation time frame. For instance, one complaint in Georgia alleged that a patient was not given physical therapy as ordered. It added that a therapist from the HHA that came to the house to evaluate the patient for therapy was rude and told the family that they would have to provide the therapy themselves. There was no documentation in the complaint file to indicate that the state staff that received this complaint probed for further information about the condition or the needs of the patient. This complaint was placed in the next-on-site-investigation category and was not investigated for 182 days. A complaint in Indiana alleged that the HHA did not provide a substitute aide when the regular aide was on vacation and also did not keep a list of the patient’s medications. The complaint file did not indicate that the state employee who took the complaint information probed for other information, such as how long the patient went without services or whether the HHA’s failure to keep a list of the patient’s medications resulted in the patient’s not receiving necessary medications. The state placed this complaint in the 90-day investigation category but investigated it in 32 days. With some notable exceptions, most of the 14 states we contacted generally investigated complaints within the investigation time frames they assigned. Among the exceptions was California, which did not timely investigate 10 of the 29 complaints it placed in the 2-day category, and Texas, which as of April 2001 had not investigated 56 of the 118 complaints that it received in 2000 and placed in its 45-day investigation category. As discussed earlier, the interval between standard surveys of an HHA can be lengthy—often up to 3 years. This could present a gap in state oversight with respect to complaints, since they may be filed directly with an HHA rather than with the state. Colorado, for instance, encourages HHAs to ensure that patients and others direct complaints to the HHA before contacting the state. Furthermore, our review of one standard survey of a Connecticut HHA showed that the HHA received 23 complaints during a 6- month period in 2000, while the state agency received no complaints against this HHA for the entire year. Although states review HHA practices for investigating complaints during a standard survey, the state agency may be unaware of the volume, seriousness, and disposition of complaints filed directly with the HHA during the sometimes lengthy interval between standard surveys. Five of the 14 states we contacted lacked adequate information systems necessary to effectively manage and track complaint investigations. Two of these states, Florida and Georgia, told us that since 2000 they have improved their complaint tracking systems. An effective complaint reporting system is an important element of both state and CMS efforts to ensure the adequacy of complaint investigations, including the categorization and investigation status of each complaint. We asked each of the 14 states we contacted to identify all complaints filed against each Medicare-certified HHA during 2000. For each complaint, we asked the state to provide information identifying (1) the investigation category (for example, 2-day, 10-day, or 30-day) that the complaint was assigned, (2) the date each complaint was received, and (3) the date each complaint was investigated. Louisiana officials told us that information on either the date a complaint was received or the date it was investigated was not available in any state reports. Colorado’s system does not track the date an HHA was contacted to investigate a complaint but instead tracks the dates that a complaint investigation was started and completed. However, the start date may represent only the date some action was taken on the complaint, such as when the state recontacted the complainant for further information or clarification. Massachusetts’ system could not identify the investigation category, the dates of investigation, or the investigation results of the 29 complaints that the state categorized as off-site investigations. Since 2000, Florida and Georgia have made improvements to their systems that allow them to track the timeliness of complaint investigations. Thus, Florida now includes in its database the date a complaint investigation was initiated and Georgia assigns each complaint an investigation priority. CMS oversight of the HHA survey process has been too limited to identify and address the weaknesses and inconsistencies we identified in the survey process and in states’ performance of surveys. Although the home health prospective payment system introduced in October 2000 encourages HHAs to provide care more efficiently, it also provides the incentive to reduce services in order to increase net revenues. The potential associated adverse effect on the level and quality of care thus makes appropriate oversight even more important. CMS regional offices do not routinely review whether states are complying with key statutory, regulatory, or other requirements, such as performing annual surveys of HHAs with COP-level deficiencies and ensuring that sample sizes of clinical records and patients meet minimum federal standards. Although CMS intends to improve state accountability, its plans are limited, and officials in most CMS regional offices told us that they lacked sufficient staff to improve oversight. In addition, CMS is not required to conduct federal monitoring surveys, as it is statutorily required to do for nursing homes, which would help it to evaluate the effectiveness of states in fulfilling their contractual responsibility to oversee HHAs. Consequently, few are done. Even if oversight improved, shortcomings in OSCAR and inconsistent data entry by states would require attention in order to optimize federal monitoring. To enforce compliance with COPs, CMS uses just one sanction—termination from the Medicare program—which carries little deterrent effect for noncompliant HHAs. Our prior HHA work and this analysis showed that the threat of termination effects only temporary compliance, and HHAs may slip back into noncompliance until their next survey. Although the Congress mandated implementation of intermediate sanctions—short of termination—for HHAs by April 1, 1989, CMS has not established them and has no concrete time frame for doing so. CMS oversight of state HHA surveys has been too limited to identify and address the inconsistencies in the survey process we have cited. For example, CMS has not applied to HHA survey activities the types of oversight tools it uses to monitor state nursing home surveys. Periodic analysis of OSCAR data to monitor state survey activities is now routine for state nursing home inspections but not for HHA surveys. In 2000, the agency began requiring its 10 regional offices to prepare and review 18 reports to track state nursing home surveys. These reports, in standard format, allow comparisons within and across states and regions to help surface problems and identify the need for intervention. Because CMS does not use OSCAR to monitor state compliance with HHA survey requirements, it was unaware of significant issues and inconsistencies that we identified by analyzing OSCAR data. State survey weaknesses we found include the following: Surveyors used less than the minimum number of medical records and patient visits to determine the scope and nature of quality-of-care problems. Surveyors failed to expand standard surveys, when a COP-level deficiency was identified, beyond the COPs typically examined. Surveyors did not verify that COP-level deficiencies were corrected through required on-site HHA revisits. HHAs falling into categories requiring annual surveys did not receive them within that time period. CMS officials generally were unaware of the variability in the extent to which states cited deficiencies, as shown by OSCAR, and were unable to offer insights as to the underlying causes. Officials also did not know that six states had cited no COP-level deficiencies for 4 years in a row, or that Texas and California accounted for more than two-thirds of all COP-level deficiencies identified on current surveys nationwide over the approximately 40-month period we analyzed. To improve oversight, CMS officials told us they will begin to apply the concept of performance standards—adopted for nursing homes in 2000— to HHA surveys in fiscal year 2002. However, the three home health performance standards CMS chose to apply do not focus on critical issues that require more immediate attention, such as ensuring that HHAs with COP-level deficiencies are surveyed annually and that states do not assign an inappropriately low investigation category to complaints, resulting in investigations that are not timely. The three home health standards CMS selected require that (1) all HHAs are surveyed at least every 36 months, (2) the appropriate HHA termination time frames are followed, and (3) state survey expenditures are substantiated. Even if CMS used OSCAR to monitor state survey agency compliance with statutory, regulatory, and other requirements, our analysis identified current OSCAR data shortcomings that need to be addressed. For example, it is difficult to use OSCAR to determine whether HHAs are being surveyed at least once every 36 months because the database includes HHAs no longer participating in Medicare, and states do not always enter survey results into OSCAR. We found that such problems produced incorrect information for about one-fourth of California’s HHAs. For example, OSCAR indicated that 129 California HHAs had not been surveyed, when in fact the HHAs had ceased participation or had been surveyed. Similarly, improper state entry of unduplicated admissions of patients receiving skilled services—numbers used by surveyors to determine correct HHA survey sample sizes—means that OSCAR cannot be used to monitor the medical record and patient visit sample sizes in certain states. Furthermore, because an HHA branch office does not have a provider number different from its parent’s, it is impossible to use OSCAR to identify branch locations surveyed in lieu of their parent office. CMS also lacks data to routinely monitor the home health survey training and experience of the personnel states assign to survey HHAs. CMS is not required to conduct federal monitoring surveys to assess how effectively states meet federal standards for surveying HHAs. Federal monitoring surveys are statutorily mandated for nursing homes. During a monitoring survey, federal surveyors either resurvey a nursing home soon after the state completes its survey (known as a comparative survey) or observe and coach state surveyors while the survey is being conducted (known as an observational survey). Federal monitoring surveys must be conducted annually in at least 5 percent of nursing homes in each state—a total of about 850 surveys. Although the majority of federal nursing home surveys are observational, regional offices conduct one to three comparative surveys in each state annually—depending on the number of nursing homes. CMS officials told us that they encourage the regional offices to conduct HHA monitoring surveys, but only 132 were actually undertaken from 1997 through 2000. Over this same 4-year period, states conducted over 18,000 HHA surveys. The bulk of federal monitoring surveys were completed in 1997 or 1998—only 10 were conducted during 2000. Furthermore, 91 percent of the federal HHA surveys were observational or training rather than comparative. In our nursing home work, we have recommended increased reliance on comparative surveys as a way to assess state performance, because such surveys are the only oversight tool that furnishes an independent measure whereby deficiency results can be compared with those of the states to determine the adequacy of state survey agency performance. When asked about the small proportion of comparative HHA surveys, 7 of the 10 regions said that they do not have adequate staff to conduct comparative HHA surveys, which are more time- consuming than observational surveys. For example, CMS’s Seattle office stated it has dedicated only 0.4 full-time-equivalent staff to oversee the region’s 190 HHAs, including conducting federal monitoring surveys and state agency training, OASIS support, certification, and state survey agency monitoring. Because few comparative surveys were conducted and the regional offices often lacked documentation of their findings, we did not attempt to analyze the results. CMS explained its lack of focus on HHA oversight by noting the emphasis since 1998 on monitoring nursing home surveys and its attempt to enhance HHA oversight through OASIS. Monitoring HHA quality through patient- focused OASIS data, however, is no substitute for CMS and regional office activities that would ensure state compliance with statutory and regulatory requirements for HHA surveys. For example, OASIS data do not indicate whether HHAs with COP-level deficiencies are being surveyed more frequently, as required. Regional offices said they lacked sufficient staff to increase oversight of HHA surveys, and CMS officials acknowledged that it is a challenge to meet all of the demands placed upon CMS staff. Although OBRA 1987 required the implementation of additional home health sanctions by April 1, 1989, termination from the Medicare program remains the only federal sanction that CMS uses. Termination is an all or nothing option reserved for HHAs that fail to return to compliance after a COP-level deficiency is cited. Officials in all but two CMS regional offices stated that termination is an effective option, not because HHAs are actually terminated but because most HHAs return to compliance before the termination process is effected. However, an HHA can avoid termination by taking short-term corrective action to show compliance at the surveyor’s revisit, thus stopping the termination process. The HHA may then revert to noncompliance until the next survey, take corrective action again, and so on, remaining certified almost indefinitely. Our analysis of OSCAR data identified 86 active HHAs nationwide with the same COP-level quality-of-care deficiency on consecutive surveys. While over half occurred on the two most recent surveys, 9 of the 86 had the same quality-of-care COP cited on three of four surveys. Nearly 84 percent of the recurring COP-level deficiencies involved the same two quality-of- care deficiencies: (1) lack of a physician-prescribed plan of care that was followed and periodically reviewed and (2) failure to provide skilled nursing services in accordance with the plan of care. Despite the recurrence of the same quality-of-care problems, these 86 HHAs still participate in the Medicare program. Our analysis also suggests that the actual termination of an HHA can be a time-consuming process reaching beyond the 23-calendar-day termination period that CMS sets for immediate and serious threat situations—even if a patient has been seriously harmed. According to CMS regions, seven HHAs were terminated from 1997 through 2000 when surveys or complaint investigations found immediate and serious threats to patients. Texas officials also brought to our attention an immediate and serious threat termination from 2001. Six of the eight terminations were not completed in the expedited time frame of 23 calendar days required by CMS. Although four of the six were terminated within 37 days, the other two terminations exceeded the 23-day period by over twice the allowed time—periods ranging from 52 days to about 9 months. The 52-day termination was initiated by a substantiated complaint investigation involving a patient who was hospitalized for 2 days for accelerated hypertension. The Texas HHA failed to monitor whether the patient took the prescribed hypertension medication, failed to inform the patient’s physician of elevated blood pressure readings, and failed to realize the patient had missed three cardiologist visits for lack of transportation. Appendix VIII describes the 9-month chronology of a Texas HHA placed on a 23-day termination track as a result of an immediate and serious threat involving a patient with pressure sores so serious that bone was visible through the open wound. Factors that contributed to the time required to terminate this HHA included (1) a court order postponing termination and (2) the delayed participation of a federal surveyor in a resurvey that validated the continued existence of an immediate and serious threat. The CMS regional office indicated that it had taken corrective action to prevent this type of delay from occurring in future serious and immediate threat terminations. For the few HHAs involuntarily terminated, 3 of the 10 CMS regions volunteered that they lacked the ability to cross-check earlier HHA information, such as owner names, against a new application, to determine if an HHA was later readmitted to Medicare or reapplied under a new name or location. CMS has set no specific time frame for establishing less severe intermediate sanctions as required by OBRA 1987, which include civil monetary penalties, suspension of all or part of an HHA’s Medicare payments, and appointment of temporary management to oversee an HHA during its efforts to return to compliance. HCFA stated in 1997 that it wanted to gain experience with intermediate sanctions for skilled nursing homes, which became effective in July 1995, before it implemented them for HHAs. In October 2001, CMS told us that it intended to coordinate the introduction of HHA intermediate sanctions with planned, but yet unscheduled, changes to the Medicare home health COPs. The difficulty of actually terminating an HHA underscores the value of other, less drastic sanctions. Intermediate sanctions, such as those implemented in 1995 for nursing homes, provide state survey agencies and regional offices with additional tools short of termination to help ensure compliance with Medicare COPs. For HHAs with standard-level deficiencies only, even if they are repeated and involve significant patient care issues, such as inadequate prescription drug monitoring, there is no federal sanction. Four CMS regional offices generally supported having intermediate sanctions implemented. With only the termination sanction available, seven states in our sample indicated difficulties in ensuring HHA compliance including (1) lack of assurance an HHA will follow its plan of correction after a resurvey, (2) the lengthy termination process that allows HHAs to correct their compliance problems, and (3) the fact that HHAs move in and out of compliance because they can fix problems regardless of how often they have occurred in the past. Although CMS contracts with states to enforce federal quality standards through surveys and complaint investigations, it does not adequately ensure that HHAs safeguard the well-being of patients by providing quality care. Thorough state surveys and investigations are critical, given the isolation and potential vulnerability of patients who receive care in their homes. The introduction of the home health prospective payment system makes state and federal oversight even more important because, in addition to encouraging efficiency, it also provides incentives for HHAs to decrease services in order to increase net revenues. As now performed, state survey activities are insufficient to adequately determine whether problems exist and how extensive they are—a situation that could be exacerbated by the reduced funding for HHA surveys. According to CMS officials, fiscal year 2002 funding is adequate for states to survey one-third of HHAs annually, but at least 11 states must survey more than one-third of their HHAs each year, raising a question about whether reduced funding may undermine the goal of inspecting all HHAs at least once every 3 years. Moreover, CMS oversight of state activities is too limited to identify the significant problems we have reported. Weaknesses in current state and federal HHA oversight that mask the status of the quality of care provided include: likely underreporting of serious care problems, as suggested by skewed findings of COP-level deficiencies in a small number of states, despite more consistent indications of potential care problems across all states based on adverse events reports; a survey process that gives surveyors vague criteria for surveying branches and identifying COP-level deficiencies; does not require HHAs to be surveyed periodically against all COPs, including compliance with the skilled nursing COP; and uses patient visit and medical record samples that are inadequate to detect the prevalence of quality-of-care problems; inconsistencies in the conduct of surveys nationwide that magnify shortcomings in the survey process, such as uneven adherence to the required minimum sample sizes across states, inadequate surveyor training or on-the-job experience, and failure to survey HHAs with COP-level deficiencies as frequently as required; a complaint process that does not compensate for survey weaknesses because it may discourage the submission of complaints in some states; does not ensure that serious complaints are promptly investigated; and often lacks tracking systems that would enable states to monitor complaints and enable the federal government to evaluate states’ responsiveness; limited use of federal oversight tools to monitor state performance, including measuring state survey activities against performance standards; routinely analyzing data on state survey results; and performing federal monitoring surveys, such as comparative surveys that allow federal surveyors to judge the adequacy of a recently completed state survey, as is required for nursing home surveys; and a single sanction that is too limited to prevent a cycle of recurring noncompliance for some HHAs. Given the significant delay in implementing intermediate sanctions for HHAs, the Congress should consider giving CMS a new deadline for issuing the necessary implementing regulations. To better ensure that state surveys comply with statutory, regulatory, and other CMS requirements, the Congress should consider requiring CMS to conduct federal monitoring surveys of HHAs, with priority given to comparative surveys. To strengthen the ability of the HHA survey process to identify and address problems that affect the quality of care, we recommend that the Administrator of CMS develop more specific branch oversight criteria and procedures for states and assign unique identification numbers for each HHA branch office to enable CMS to track survey results and facilitate its own branch oversight. develop more specific guidance and training for distinguishing between COP-level and lesser deficiencies and for improving the consistency across states in documenting deficiencies. improve the adequacy of the sampling process, such as increasing the size of the sample of medical records and patient visits, to better determine the prevalence of quality-of-care problems. ensure that resources are adequate for states to fully comply with the requirement to survey all HHAs at least once every 36 months and certain HHAs more frequently. To ensure that the complaint process adequately addresses quality-of-care problems, we recommend that the Administrator ensure that states eliminate barriers to filing complaints by improving the accessibility and effectiveness of hotlines and by not requiring complaints to be filed in writing. monitor states’ responsiveness to complaints, including developing assurances that serious allegations are promptly investigated and resolved. provide technical assistance to states as appropriate to develop consistently effective complaint tracking systems. To ensure that states comply with home health statutory, regulatory, and other CMS requirements designed to protect patient health and safety, we recommend that the Administrator adopt comprehensive state performance standards for HHAs, such as holding states accountable for (1) performing HHA surveys based on CMS’s variable 12- to 36-month survey schedule and (2) improving the timeliness and reliability of states’ OSCAR data entry. use OSCAR and other means to monitor and assess state survey performance on an ongoing basis. We provided a draft of this report to CMS and the 14 states included in the scope of our work for their review and comment. (See app. IX for CMS’s comments.) CMS concurred with all of our recommendations and indicated that it was already taking steps to implement them. CMS did not comment on our Matters for Congressional Consideration concerning the need for a new deadline to implement intermediate sanctions or the expansion of federal monitoring surveys to include state HHA surveys— with priority given to comparative surveys. In its comments, CMS elaborated on the initiatives already under way to address shortcomings in state HHA surveys and the survey process that would respond to our recommendations. However, CMS generally did not specify implementation time frames. We believe that timely implementation of these recommendation is integral to better ensuring the quality-of-care provided by HHAs. As our report points out, several key initiatives have encountered significant implementation delays, suggesting the importance of a clear sense of priorities and accountability for deadlines. For example, CMS still has not implemented intermediate HHA sanctions as directed by the Congress in 1987. In response to OBRA 1987, the agency proposed revised COPs in 1997 to achieve a more outcome- oriented survey process but currently projects that the final COPs will not be issued until mid-2003. As a result, the home health COPs still lack patient-specific outcomes to help measure the quality of care. In its comments, CMS cited a study initiated in 1999 to evaluate the nursing home complaint process, a study whose findings could be applied to complaint systems for other provider types, such as HHAs. After almost 3 years, however, the study is currently undergoing CMS review with no specific time frames to implement the report’s recommendations. The 33- month contract awarded in October 2001 to develop improved survey protocols to measure HHA quality of care and promote consistency in the survey process will not be implemented for several years. While we recognize that the implementation of some initiatives legitimately requires planning, research, and testing, we also believe that improving HHA surveys and oversight requires establishing clear priorities and concrete implementation timetables. CMS oversight of state survey activities is one area that need not wait for additional research or study. Yet, CMS commented that its development of a new HHA oversight program would hinge on a contract to be awarded by October 2002 to inventory and determine the utility of data in monitoring state survey activities. We believe that CMS could take immediate steps, using existing data, to hold states accountable for HHA survey requirements—such as those covering survey frequency, patient visit and record review samples, and extended surveys. CMS has already enhanced oversight of state compliance with nursing home survey requirements by periodically analyzing OSCAR data and undertaking both on- and off-site measurement of state performance against specific standards. Additional study is not needed to extend of this approach to HHA oversight, such as ensuring that HHAs with COP-level deficiencies are surveyed annually and that states do not assign an inappropriately low investigation category to HHA complaints, resulting in investigations that are not timely and that may reduce the likelihood of substantiating allegations. CMS commented that the national HHA survey budget—which is based on states’ historical costs of conducting surveys—adequately supported the current estimated workload. However, we found that states often were not conducting the number of required surveys, which would then understate actual funding requirements. In addition, CMS indicated the current funding levels are sufficient to allow surveys of one-third of HHAs annually, but we found that 11 states must survey a greater proportion each year. CMS acknowledged the need for additional resources to address other shortcomings in the survey process, such as (1) changing its policies to include a review of all COPs on certain surveys, (2) routinely requiring surveys of branch offices, and (3) developing policies and procedures for actively and regularly monitoring compliance with CMS survey requirements. California and Kansas officials also commented that additional CMS funding was needed to improve state oversight and compliance with CMS requirements, and California acknowledged that the priority assigned to nursing home surveys was a contributing factor to delays involving HHA surveys. CMS commented that it will be a challenge to ensure that adequate resources are available and proposed addressing some survey process shortcomings by using OASIS data to more efficiently focus resources on branch offices with poor outcomes or by increasing sample sizes at HHAs with poor outcomes. Kansas commented that we had overstated the need for on-site surveys of branch offices, concluding that it would be a waste of valuable survey time. In contrast, Indiana emphasized the importance of adequate branch oversight, commenting that it had developed a state database to monitor branch offices. Our point was that because states are not required to routinely survey branch offices, there is limited knowledge about the quality of care provided by branch offices. Moreover, states lack a way of separately recording the results of branch office surveys because branches operate under their parents’ provider numbers. CMS concurred and indicated it is taking steps to improve oversight of branch offices. CMS, in its technical comments, and Florida indicated that our comparison of COP-level deficiencies cited during surveys and adverse events reports was inappropriate, that is, not an “apples-to-apples” comparison. As our report stated, we recognized that adverse event reports were developed as a tool to help state survey agencies target specific cases for HHA review and that they do not necessarily result in COP-level deficiencies, which are documented through record reviews and patient visits during on-site surveys. The purpose of this comparative analysis was to illustrate the wide variability in state citations of COP-level deficiencies in contrast to the more consistent indications through OASIS adverse events reports of potential care problems across all states. The greater variability among states in documented COP-level deficiencies indicated to us a likely understatement of serious care problems. We also presented other evidence to support this conclusion, such as examples in several states where surveyors did not document deficiencies because they viewed themselves as advisors, and examples of quality-of-care deficiencies in two states that were cited at the standard level, while other states cited problems of similar severity as COP-level deficiencies. Massachusetts clarified its rationale for documenting certain deficiencies at the standard level rather than at the COP level as states with similar deficiencies had done, which we described in appendix VI. The state commented that standard-level deficiencies were cited because, in the professional judgment of the surveyors, the outcome was not severe enough to warrant a COP-level deficiency, the deficiencies were not widespread, the deficiencies had been corrected prior to a follow-up visit, or the HHA had implemented systemic changes to correct the problem prior to the surveyor’s arrival at the HHA. We continue to believe that the likely patient harm in the two Massachusetts surveys was at least as severe as deficiencies cited at the COP-level in other states. The first survey included deficiencies that resulted in the death of one patient, and, for another patient, a week’s delay in treating an infected wound. The second survey included deficiencies that resulted in a patient’s developing a new pressure sore and in not being assessed for physical therapy to achieve the maximum potential for walking. Furthermore, any judgment on how widespread a problem may or may not be is only one of several criteria for determining whether a COP-level deficiency is warranted. We believe that Massachusetts’ comments reinforce our finding that subjectivity in documenting similar problems can—and does—result in understatement of COP-level deficiencies. CMS and 10 states also provided technical comments, which we incorporated as appropriate. We are sending copies of this report to the Secretary of Health and Human Services and to the Administrator, Centers for Medicare and Medicaid Services. We also will make copies available to others upon request. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. Please contact me at (202) 512-7118 or Walter Ochinko at (202) 512-7157 if you have questions about this report. Staff acknowledgments are listed in appendix X. To assess the quality of care provided by HHAs, we analyzed survey results and compliance with federal requirements using CMS’s On-Line Survey, Certification, and Reporting (OSCAR) system. Although OSCAR data indicated that there were 6,905 active HHAs on August 17, 2001, we focused our review on the 6,318 most recent surveys conducted since March 31,1998, and entered into OSCAR as of August 17, 2001. We chose this approximately 40-month time frame because, according to federal requirements, all HHAs should have been surveyed at least once every 36 months, and the additional 4-1/2 months allowed time for states to enter the survey results in OSCAR. If an HHA was surveyed more than once since March 31, 1998, we only included the results of the most current survey in our analysis. Our analysis excluded the results of the most recent surveys for 587 HHAs conducted before April 1, 1998, because the majority of these surveys were conducted in 1996 or earlier and therefore may not accurately reflect the current quality of these HHAs. Our assessment nationwide of HHA compliance with the annual federal survey frequency requirements included surveys of active HHAs conducted on or after January 1, 1998, and entered into OSCAR as of August 17, 2001. This date was chosen to allow for implementation of the variable survey cycle, which requires certain categories of HHAs to be surveyed more frequently, such as agencies that have COP-level deficiencies within 24 months of their current survey. For those HHAs that had two surveys and a triggering event requiring an annual survey (such as a change in ownership since the previous standard survey), compliance with the annual survey requirement was determined by (1) calculating whether the elapsed time between the current survey and the previous survey or triggering event was greater than 13 months or (2) calculating whether the elapsed time since the current survey or triggering event was greater than 13 months (allowing an additional 2-1/2 months for states to enter the survey results into OSCAR). For those HHAs that had only one survey on or after January 1, 1998, and a triggering event requiring an annual survey, compliance was determined by calculating whether the elapsed time since the current survey or triggering event was greater than 13 months (again, allowing an additional 2-1/2 months for states to enter the survey results into OSCAR). To ensure the accuracy and completeness of the OSCAR data used in our analysis, we worked with CMS regional offices and states from April through September 2001 to determine why active HHAs had current surveys more than 3 years old—the 587 HHA surveys we excluded from our analysis of HHA quality. We learned that either the more recent survey results had not been entered into OSCAR, the HHA had been terminated, the HHA was deemed by other entities to meet Medicare COPs, or the HHA only served Medicaid recipients (66 of 6,905 HHAs in OSCAR as of August 17, 2001). No survey results would be expected or required in the last three instances. One state, California, accounted for the majority of HHAs with current surveys that were over 3 years old. The CMS regional office told us that during this time, the state had assigned a higher priority to conducting nursing home surveys than to conducting HHA surveys. To assess state survey activities, we reviewed operations in 14 states. We conducted fieldwork in California and Texas, states that have the largest number of HHAs. We met with state officials and surveyors to discuss survey activities at both parent and branch offices, the complaint intake and referral process, and enforcement activities. In Texas, we also observed an HHA survey and complaint investigation. We used a structured survey to collect information about HHA survey activities and processes in 12 other states from diverse geographic regions—Arkansas, Colorado, Connecticut, Florida, Georgia, Indiana, Kansas, Louisiana, Massachusetts, Ohio, Pennsylvania, and Utah. We selected these states because OSCAR data showed that they had consistently cited no, or very few, COP-level deficiencies since 1998. To analyze the nature and severity of COP-level quality-of-care deficiencies, we reviewed 132 COP deficiencies from 80 HHA surveys conducted by 32 states since December 31, 1999, and entered into OSCAR as of August 17, 2001. These surveys contained at least one of five quality- of-care-related COP deficiencies and cited deficiencies in at least 1 of 11 associated standards. The five COPs included acceptance of patients, plan of care, and medical supervision; skilled nursing services; home health aide services; clinical records; and comprehensive assessment of patients. According to officials from the states in our sample, these COPs were the most closely associated with quality of care. Overall, 32 states cited at least one of the five COPs, and 19 states cited none. We reviewed all applicable surveys from 30 states that cited at least one of the five COPs but randomly selected 25 surveys from California and Texas because of the large number of such COP-level deficiencies documented. To determine whether states were consistent in citing COP-level deficiencies, we also reviewed 16 surveys from Massachusetts and Georgia that cited deficiencies in 3 or more of the 11 associated standards—but not the COP—and abstracted those cases that seemed comparable in severity to cases other states cited at the COP level. We selected Massachusetts and Georgia from the 19 states that cited no deficiencies in any of the five quality-related COPs because they were included in our 14-state sample. A registered nurse on our staff with home health experience reviewed our assessment of surveys for clinical accuracy and significance. To test the adequacy of states’ complaint investigation procedures, we asked each of our 14 sample states to identify all complaints filed against each HHA in the state during 2000, including the investigation priority, when the investigation was started and completed, and whether the complaint was substantiated. We selected a sample of 93 complaint investigation files to review. In general, these complaints were filed against HHAs that had no deficiencies on their standard surveys in 2000. A registered nurse on our staff with home health experience reviewed our analysis of these 93 complaints for clinical accuracy and significance. We also assessed the operation of the complaint hotlines in all 14 states by contacting them both during and after business hours. To analyze the training and experience of state HHA surveyors, we extracted surveyor identification numbers from OSCAR for all HHA surveys conducted in 2000 by Florida, Kansas, and Louisiana. We selected these states because they were part of our 14-state sample and their surveyors are or can be used to inspect both nursing homes and HHAs. We limited our analysis to these three states because of its time-consuming nature—unlike survey results, it is not possible to produce OSCAR analytical reports on the assignment or training of surveyors. OSCAR data allowed us to determine how many individuals had participated in HHA surveys and the number of HHA surveys they had conducted. We then asked state officials to indicate whether these surveyors had attended CMS’s basic HHA training course. We also contacted Arkansas, California, and Texas—states with surveyors who focus on HHAs or on HHAs and related provider types and who do not conduct nursing home surveys—to determine whether the surveyors had generally attended CMS’s basic HHA training course. To determine the adequacy of federal oversight efforts, we interviewed officials at CMS headquarters and in selected regional offices. We reviewed statutory requirements, CMS regulations, and policy guidance regarding HHA survey activities. Using a structured survey, we collected more detailed data from CMS’s 10 regional offices on their states’ HHA inspection activities and their own oversight and enforcement efforts. We also interviewed CMS officials about the federal budgeting process for state HHA survey activities and reviewed budget trends since 1997. Table 8 lists the 15 Medicare COPs for HHAs. The first group of COPs contains COPs required to be reviewed on a standard survey, and the remaining COPs must be reviewed if any one of the initial COPs is cited as a deficiency. To contrast the COPs with the nursing home requirements, table 9 lists nine selected quality-of-care requirements reviewed during nursing home surveys. These tables illustrate the differences in orientation between the HHA and nursing home survey processes: the HHA COPs, while addressing broad process-related requirements, do not focus on outcomes as do some nursing home requirements. Table 10 shows branch offices in each state as a percentage of total HHA operating locations, that is, parent, subunit, and branch offices. Table 11 expands the comparison of current survey results and adverse events from our 14 sample states (see fig. 1) and shows the number of HHAs with COP-level deficiencies cited by each state for the approximately 40-month period we analyzed. We reviewed 80 surveys with a total of 132 quality-of-care related COP- level deficiencies to identify instances where it appeared likely that a patient was harmed as a result of poor quality care provided by the HHA. For the vast majority of COP-level deficiencies, the documentation in the survey reports supported the potential for harm to patients. However, in 16 of the 80 surveys that contained sufficient documentation for us to draw a conclusion about patient harm, we determined that 22 patients were likely to have been harmed. Although a COP-level deficiency can be cited for a situation that harms or has the potential to harm patients, the survey reports do not explicitly state the level of harm reflected in the patient examples. From the information in the survey reports, we were unable in other cases to determine if there was no harm or if it was simply not documented. Table 12 contains abstracts from those 16 surveys describing the patient’s condition, the plan of care ordered by the physician, deficiencies in the care provided by the HHA, and the likely patient harm. The information contained in the table is drawn from the surveyors’ descriptions of the deficiencies found. Table 13 describes standard-level deficiencies cited in Georgia and Massachusetts HHA surveys that resulted in likely harm to patients. We selected these 2 states for review because they were part of our 14-state sample and did not cite any of the 5 quality-of-care COPs that we examined but did cite 3 or more of the 11 standards associated with those COPs. These deficiencies appear at least as serious as deficiencies cited at the COP-level in other states (see app. V) and indicate that serious quality problems are likely understated. Because the state agency cited only standards but did not cite the COPs from which the standards were drawn, the only available sanction, that of termination, could not be used even if the HHA failed to correct the deficiencies. In commenting on a draft of this report, Massachusetts noted that in the professional judgment of its surveyors, the care deficiencies summarized in table 13 did not warrant COP-level deficiencies either because the outcome was not severe enough to warrant a COP-level deficiency, the deficiencies were not widespread, the deficiencies had been corrected prior to a follow-up visit, or the HHA had implemented systemic changes to correct the problem prior to the surveyor’s arrival at the HHA. We continue to believe that the likely patient harm in the two Massachusetts surveys was at least as severe as deficiencies cited at the COP-level in other states. The first survey included deficiencies that resulted in the death of one patient, and, for another patient, a week’s delay in treating an infected wound. The second survey included deficiencies that resulted in a patient’s developing a new pressure sore and in not being assessed for physical therapy to achieve the maximum potential for walking. Furthermore, any judgment on how widespread a problem may or may not be is only one of several criteria for determining whether a COP-level deficiency is warranted. We believe that Massachusetts’ comments reinforce our finding that subjectivity in documenting similar deficiencies can—and does—result in understatement of COP-level deficiencies. CMS has only one requirement for initiating complaint investigations against HHAs—complaints that represent a potential immediate and serious threat to a patient must be investigated within 2 workdays of receipt. Nine of the 14 states we contacted have established a state requirement that complaints alleging harm (but which do not rise to the level of immediate and serious threat) be investigated in 10 days or less. For less serious complaints—those not rising to the level of either immediate and serious threat or harm—states have established lower- priority investigation categories such as 30-day, 45-day, 60-day, and “next- on-site” (which generally means the complaint will be investigated during the HHA’s next standard survey, which could be imminent or in the distant future). The states placed 79 of the 93 complaints we reviewed in one of these lower-priority investigation categories—that is, beyond 10 days. In reviewing the 79 complaints, we determined that 21 appeared to present potential harm to the patient and required more immediate investigation. Our analysis showed that in some instances a complaint was investigated more quickly than the assigned category. However, we believe that the category assigned implied that the complaint was a low priority for investigation. Three of these examples were discussed earlier in this report. The remaining 18 examples are summarized in table 14. In commenting on a draft of this report, Pennsylvania indicated a willingness to establish a 10-day complaint investigation category if CMS increased funding. Currently, the state prioritizes HHA complaints for investigation in either 2 days or 56 days. Likewise, a Connecticut official indicated that CMS did not provide sufficient resources for the state to complete its complaint workload. This appendix describes the 9-month process—from September 28, 2000, through July 1, 2001—of terminating an HHA that was under an expedited 23-day termination process because of surveys finding immediate and serious threats to patients. We selected this case to illustrate the difficulty associated with expeditiously terminating an HHA from participating in Medicare. Factors that contributed to the time required to terminate this HHA included (1) a court order postponing termination and (2) the delayed participation of a federal surveyor in a resurvey that validated the continued presence of an immediate and serious threat. According to the CMS regional office, corrective action was subsequently taken to prevent this type of delay from occurring in any future serious and immediate threat terminations. On September 28, 2000, less than a year following an ownership change, three separate complaints against the HHA’s branch office were investigated. The investigation was expanded into a state standard survey of the HHA’s Medicare conditions of participation. During a home visit to a 99-year-old patient, who was the subject of one of the complaints, the state surveyor discovered an immediate and serious threat to the patient as well as potential harm to other patients. The patient was taken to the emergency room and subsequently admitted to the hospital, where she died 9 days later. At the completion of the survey, the state surveyor recommended (1) immediate termination from the Medicare certification program, with immediate suspension of the HHA’s state license and the imposition of state administrative penalties, and (2) initiation by the HCFA regional office of a 23-day termination process to expire on November 7, 2000. In November 2000, the federal district court granted the HHA a temporary restraining order to postpone termination from the Medicare program by HCFA. Before the order expired, the state survey agency conducted a resurvey and again found the HHA out of compliance with several conditions and standards and in an immediate and serious threat situation. The state survey agency and HCFA regional office disagreed about whether the November survey had identified an immediate and serious threat. The state asked the HCFA regional office to have a federal surveyor resurvey the HHA. The third resurvey—with a federal surveyor participating—was conducted 4 months later in April 2001. Again the HHA was out of compliance with several conditions and standards, and an immediate and serious threat to a patient was found. Following the April resurvey, the HHA agreed to withdraw from the Medicare program, on July 1, 2001, and its state license was revoked that day. Table 15 provides a detailed timeline of the patient’s treatment provided by the HHA, the state surveys conducted, and the actions taken by the state and CMS’s Dallas regional office. The following staff made important contributions to this work: Jack Brennan, Patricia A. Jones, Dean Mohs, Beth Morrison, Peter Schmidt, Paul M. Thomas, and Opal Winebrenner.

Summary: The 6,900 Home Health Agencies (HHAs) that serve Medicare beneficiaries must meet federal requirements, known as conditions of participation (COP), to ensure that they have the appropriate staff, are following the plan of care specified by a physician, maintain medical records to document the care provided, and periodically reassess each patient's condition. Although nationwide surveys done at HHAs since 1998 have identified a small proportion of agencies with serious deficiencies, the extent of the problem may be understated, and dangerous situations affecting home health patients may occur more often than documented. Shortcomings in the survey process and inconsistencies in state surveys make it difficult to assess the quality of care delivered and may mask potential problems. The ability to lodge complaints about an HHA and have them resolved promptly is important to protecting patient health and safety. HHA oversight by the Centers for Medicare and Medicaid Services (CMS) has been too limited to identify the problems GAO found in the survey process. CMS does not review state compliance with 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.