Management Issue 5: Quality of CareTopics on this page:
Ensuring the quality of care provided to beneficiaries of Federal health care programs continues to be a high priority of OIG. OIG has produced a large body of work related to quality-of-care issues in a variety of settings, such as hospitals, nursing homes, and clinical trials. OIG has also examined a variety of factors that may affect the provision of care, including the impact of reimbursement systems on the provision of care, the effectiveness of oversight and enforcement systems, and the adequacy of mechanisms used to screen potential health care employees. Additionally, OIG partners with DOJ, Medicaid Fraud Control Units, and other State law enforcement offices to investigate and prosecute instances of substandard care that led to patient harm. Administrative Remedies To supplement or, when appropriate, substitute for CMS or State enforcement actions, OIG pursues administrative remedies, often in conjunction with civil actions brought by DOJ. The False Claims Act, the Federal Government’s primary civil enforcement tool for fraud, has been used successfully to address poor quality of care. These cases often involve allegations of widespread or systemic problems that result in harm to residents of nursing facilities, such as staffing shortages, failure to implement medical orders or services identified on the care plan, failure to ensure that residents are protected from harm, medication errors, and the unnecessary development of facility acquired medical complications such as infected pressure ulcers. OIG is also developing exclusion actions against individuals and entities whose conduct results in poor care, with particular emphasis on higher level officials of nursing facilities and chains. To illustrate, Federal prosecutors in Missouri charged American Healthcare Management (AHM), a long-term care facility management company, its Chief Executive Officer, and three nursing homes with criminal conspiracy and health care fraud based on their imposition of budgetary constraints that prevented the facilities from providing adequate care to residents. The investigation found that numerous residents suffered from dehydration and malnutrition, went for extended periods of time without cleaning or bathing, and contracted preventable pressure sores. The corporate defendants were convicted and fined, entered into a False Claims Act settlement requiring them to pay $1.25 million, and agreed to be excluded from participation in Federal health care programs. The primary owner was convicted of a false statement misdemeanor offense, was sentenced to 2 months’ incarceration, and agreed to be excluded for 20 years. Finally, in February 2007, AHM’s former CEO was sentenced to 18 months of incarceration and fined $29,000. OIG also negotiates quality-of-care CIAs as part of the settlement of such False Claims Act cases. In cases involving poor quality of care, the CIA requires an outside quality-of-care monitor selected by the OIG and includes effective enforcement remedies for breach of the CIA, such as specific performance requirements, stipulated penalties, and exclusion. Over the last 7 years, many major nursing home chains, mid-size corporations, and individual health care facilities have operated under CIAs with independent quality monitors. OIG currently has 10 CIAs with nursing homes and psychiatric facilities (or chains) with independent quality monitor requirements. These 10 active quality of- care CIAs cover operations in about 400 long-term care and psychiatric facilities across the country. In addition to conducting these ongoing monitoring efforts, OIG is examining the performance of nursing home chains operating under CIAs over the past several years to evaluate the effect of those CIAs on compliance and the quality of care provided by those chains. Shortcomings in Program Oversight and Enforcement Systems OIG continues to have concerns about shortcomings in program oversight and enforcement systems that may result in insufficient identification or prevention of the delivery of substandard care in a variety of health care settings. For example, a 2007 OIG study assessed services provided to beneficiaries with consecutive Medicare stays involving hospitals and skilled nursing facilities and found that 35 percent of consecutive stay sequences were associated with quality-of-care problems and/or fragmentation of services. For this study, OIG defined fragmentation as a pattern of unnecessary discharges or transfers across multiple stay sequences when the same levels and types of services could have been consolidated into fewer stays. Medicare paid an estimated $4.5 billion for these fragmented or poor quality services. Quality-of-care problems that reviewers found included medical errors, accidents, failure to treat patients in a timely manner, inadequate monitoring and treatment of patients, inadequate care planning, and inappropriate discharges. OIG recommended that CMS direct Quality Improvement Organizations (QIO) to monitor fragmentation and quality of care across consecutive stay sequences and the quality of care provided during the individual stays within those sequences, and encourage both QIOs and fiscal intermediaries to monitor the medical necessity and appropriateness of services provided within these consecutive stay sequences. In another 2007 report, OIG assessed CMS’s oversight of the Medicare hospice program. Currently, hospices are assigned a lower priority for survey and certification inspections than other health care organizations. The report found that, as of July 2005, 14 percent of hospices were past due for certification and, on average, had not been surveyed fo 9 years—3 years longer than the CMS standard at that time. OIG also found that health and safety deficiencies were cited for 46 percent of hospices surveyed, most frequently for patient care planning and quality deficiencies. OIG recommended that CMS provide guidance to State agencies and CMS regional offices regarding analysis of existing data to target “at-risk” hospices for certification surveys. OIG also recommended that hospices be included in Federal comparative surveys and annual State performance reviews and that CMS should seek legislation to establish additional enforcement remedies for poor hospice performance. At present, CMS’s only enforcement remedy is termination of a hospice provider from the Medicare program. In a 2006 report, OIG reviewed the requirements for, and State oversight of, Medicaid personal care service attendants. These attendants assist the elderly and persons with disabilities or temporary or chronic conditions with daily activities (e.g., bathing, dressing, meal preparation). This review found substantial variation, both across States and within States, in the requirements for these attendants and found that oversight and administration of personal care programs were fragmented among different State agencies. OIG concluded that more consistent attendant requirements, less fragmentation in program administration, or some level of standardization within States may make monitoring attendant requirements less cumbersome and enhance quality assurance. Systemic Issues OIG is continuing to evaluate systemic issues that directly affect patient care. For example, studies are currently under way to examine the cyclical noncompliance of home health agencies with conditions of participation, to determine the nature and extent of hospice services provided to beneficiaries residing in nursing homes, to review the oversight of quality of care in Federal health centers, and to assess the impact of Part D on dual-eligible nursing home residents’ receipt of prescription drugs. OIG is also undertaking a congressionally mandated review of serious medical errors, referred to as “never events,” such as a physician performing surgery on the wrong patient. Increased Monitoring In response to OIG’s recent report related to consecutive inpatient hospital and skilled nursing facility stays, CMS plans to increase monitoring of quality-of-care problems associated with consecutive stays. CMS is also working with the providers to improve care for Medicare beneficiaries regardless of where care is provided. Additionally, CMS is requiring the QIOs to categorize complaints to provide better data on lapses in care continuity with an emphasis on improved documentation. CMS also plans to include hospices in the annual State Performance Review and is exploring and implementing methods to become more efficient in targeting its resources toward providers most in need of closer oversight. Additionally, CMS plans to publish new Conditions of Participation (CoP) for hospices in 2008. The new CoPs will establish a framework for Quality Assessment and Performance Improvement and will amend the hospice section of the “State Operation Manual” to enable State surveyors to make more consistent decisions regarding compliance with Medicare regulations. CMS is also considering whether to pursue establishing new enforcement remedies for poor hospice performance. Finally, CMS indicated that greater inclusion of hospices in the validation surveys must await additional resources. Improved Enforcement CMS is also taking steps to improve its enforcement of nursing home quality requirements. Recognizing the need to focus more attention on homes that historically provided poor care to residents, in January 1999, CMS implemented a Special Focus Facility program that involved enhanced monitoring of two nursing homes in each State. In December 2004, CMS revised its Special Focus Facility program to expand the scope of the program from about 100 homes nationwide to about 135 homes. CMS also revised the method for selecting nursing homes by reviewing 3 years’ rather than 1 year’s worth of deficiency data to better target homes with a history of noncompliance. Additionally, CMS strengthened its enforcement for Special Focus Facilities by requiring immediate sanctions for homes that failed to significantly improve their performance from one survey to the next, and by requiring termination for homes with no significant improvement after three surveys over an 18-month period. In 2004, CMS also established a voluntary program to help nursing homes improve the quality of care provided to residents. QIOs worked for 12 months with one to five nursing homes with significant quality problems in 18 States to help them redesign their clinical practices.
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