Medicare Home Health Agencies: Weaknesses in Federal and State Oversight Mask Potential Quality Issues
Published: 2002-07-19T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Home health agencies (HHA) play an important role in the U.S. health care  system—allowing individuals who are unable to leave home without great  difficulty to receive certain medical or therapeutic care in their own  homes. In 2000, Medicare, the federal health care program for elderly and  disabled Americans, covered home health services for 2.5 million  beneficiaries at a cost of $8.7 billion. The approximately 6,900 HHAs that  serve Medicare beneficiaries must meet federal requirements, known as  conditions of participation (COP), intended to ensure that, among other  things, HHAs 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. To verify  compliance with these and other requirements, the federal government  contracts with states to periodically conduct an inspection, known as a  standard survey, at each HHA. The survey includes a review of a sample of  medical records and interviews with patients in their homes. If an HHA  fails to meet a Medicare COP—a serious deficiency that adversely affects  (harms) or has the potential to adversely affect (potential to harm)  patients—it can be terminated from the program. Oversight of HHAs has  become even more important since the implementation of a new  prospective payment system in October 2000 that encourages HHAs to  provide care more efficiently but also provides an incentive to reduce  services in order to increase net revenues.
In 1997, we reported on serious shortcomings in both HHA surveys and the  survey process that resulted in the failure to detect and exclude HHAs  with quality problems. First, HHAs obtained approval to serve Medicare  beneficiaries too easily. The requirements to become a Medicare HHA  were minimal, and surveys done at an HHA’s start-up provided little  assurance that the HHA was capable of furnishing high-quality care.  Second, periodic state surveys failed to assess HHAs against all COPs and  did not cover care provided by branch offices—satellite locations that  operate under the supervision of a “parent” HHA approved to participate  in Medicare. Third, few HHAs were terminated from Medicare when  serious deficiencies were uncovered. Because the federal government had  not implemented additional, statutorily authorized sanctions, such as civil  monetary penalties, terminating an HHA from Medicare was the only  available sanction for HHAs with serious deficiencies. Termination,  however, rarely occurred because HHAs are given an opportunity to return  to compliance after a deficiency is identified. Several recommendations  we made have not been implemented, including ensuring that all HHAs are  periodically assessed against all COPs and implementing additional  sanction options.
In December 2000, the Congress directed that we assess quality-related  aspects of HHAs, including the operation of branch offices. To do so, we  addressed four questions: (1) what is known about the quality of care  provided by HHAs, (2) is the current survey process adequate to identify  quality-of-care problems at both parent and branch offices, (3) are state  investigations of complaints made against HHAs effective in protecting  patients, and (4) is federal oversight of state survey activities and  enforcement efforts adequate? To answer these questions, we analyzed  information from the On-Line Survey, Certification, and Reporting system  (OSCAR), a federal database that tracks the results of state HHA surveys;  visited survey agencies in California and Texas, states with the largest  numbers of HHAs; surveyed 12 additional states in order to evaluate their  survey and complaint processes; reviewed a sample of 96 survey reports  from the 34 states that cited deficiencies in certain quality-related COPs or  associated standards; and reviewed a sample of 93 complaints from our  14-state sample. We also interviewed officials at the Centers for Medicare  and Medicaid Services (CMS), an agency within the Department of Health  and Human Services, and surveyed CMS’s 10 regional offices about  inspection requirements and federal oversight activities. CMS administers  Medicare and oversees the contracts with state survey agencies. We  reviewed statutory requirements and CMS regulations regarding HHA  surveys. We performed our work from January 2001 through June 2002 in  accordance with generally accepted government auditing standards.   (App. I presents a detailed discussion of our scope and methodology.)
subsections: section_title: Background
paragraphs: 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.
section_title: Limited Number of Identified Deficiencies May Understate Prevalence of Serious Care Problems, Creating Uncertainty About Overall Quality
paragraphs: 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.
subsections: section_title: Wide Variability in Citing Deficiencies Questions Credibility of State Surveys
paragraphs: 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.
section_title: State Surveys Document Potentially Serious Quality-of-Care Problems
paragraphs: 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.
section_title: Weaknesses in Survey Process and Inconsistencies in How States Conduct Surveys Mask Potential Quality Problems
paragraphs: 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.
subsections: section_title: Recent Changes Have Not Fundamentally Altered the Process Focus of HHA Surveys, nor Have They Addressed Other Serious Weaknesses
paragraphs: 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.
section_title: Surveys Remain Essentially Process- Oriented despite Use of OASIS Data during Surveys
paragraphs: 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.
subsections: section_title: Weaknesses in Other Federal Survey Requirements Are Not Being Addressed
paragraphs: 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.
section_title: Inconsistencies in How States Conduct Surveys Help Explain Interstate Variability in Citing Deficiencies
paragraphs: 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.
subsections: section_title: Inconsistent Categorization of Quality-of-Care Deficiencies
paragraphs: 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.)
section_title: Inadequate Surveyor Training and Experience
paragraphs: 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.
section_title: Survey Requirements Not Consistently Followed
paragraphs: 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.
section_title: Cut in HHA Survey Funding Could Undermine States’ Ability to Conduct All Required Surveys
paragraphs: 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.
section_title: Some States’ HHA Complaint Investigation Practices May Not Ensure Protection of Patients
paragraphs: 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.
subsections: section_title: Some States’ Procedures and Practices Could Discourage the Filing of Complaints
paragraphs: 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.
section_title: Many Complaints Alleging Possible Harm to HHA Patients Are Not Categorized for Prompt Investigation
paragraphs: 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.
section_title: Adequacy of Management Information Systems for Monitoring Complaint Investigations Varies across States
paragraphs: 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.
section_title: Federal Oversight for HHA Surveys and Available Sanctions Are Too Limited
paragraphs: 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.
subsections: section_title: CMS Oversight of State HHA Surveys Is Too Limited to Address Inconsistencies
paragraphs: 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.
section_title: CMS Has Not Implemented the Full Array of Federal Sanction Options
paragraphs: 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.
section_title: Conclusions
paragraphs: 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.
section_title: Matters for Congressional Consideration
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
section_title: Appendix I: Scope and Methodology
paragraphs: 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.
section_title: Appendix II: Medicare COPs for HHAs and Selected Nursing Home Quality-of-Care Requirements
paragraphs: 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.
section_title: Appendix III: Branch Offices as a Percentage of Total HHA Operating Locations
paragraphs: Table 10 shows branch offices in each state as a percentage of total HHA  operating locations, that is, parent, subunit, and branch offices.
section_title: Appendix IV: HHAs Current Survey Results Compared with Adverse Events Episodes for All States
paragraphs: 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.
section_title: Appendix V: Documented Examples of Likely Harm from 80 HHA Surveys
paragraphs: 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.
section_title: Appendix VI: Inconsistencies between States in Deficiency Levels Cited in HHA Surveys
paragraphs: 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.
section_title: Appendix VII: Complaints to Which States Assigned Questionable Investigation Time Frames
paragraphs: 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.
section_title: Appendix VIII: Termination Chronology of an HHA Cited for Immediate and Serious Threat to Patients
paragraphs: 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.
section_title: Appendix IX: Comments from the Centers for Medicare and Medicaid Services
section_title: Appendix X: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.