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#7 Ensuring Quality of Care and Safety for Vulnerable Populations

Why This Is a Challenge

Programs operated and administered by HHS touch the lives of nearly all Americans. HHS faces special challenges in serving particularly vulnerable populations, including recipients of nursing home care, hospice care, and home- and community-based services (HCBS); Indian Health Service (IHS) beneficiaries; and children. People may also be especially vulnerable based on the type of conditions they have, such as mental health or substance abuse issues or multiple chronic conditions.

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Key Components of the Challenge

Nursing Home Care. Problems continue with the quality of care and safety of people in nursing facilities, as well as concerns related to preventing abuse of nursing facility residents. For example, in a review of a nursing home's residents who were hospitalized with urinary tract infections, we found that providers did not always render services to residents in accordance with their care plans before the residents were hospitalized with urinary tract infections. Other problems OIG has identified include substandard care causing preventable adverse events, limited compliance with Federal regulations for reporting abuse and neglect, lack of monitoring of hospitalization rates, failure to correct deficiencies identified during the survey process, and employment of caregivers who do not meet relevant licensure requirements.

Hospice Care. Hospice care provides comfort for terminally ill beneficiaries and supports family and other caregivers. Problems include inadequate oversight of certification surveys and staff licensure requirements, care planning failures, inadequate medical and nursing care, fraudulent enrollments undertaken without beneficiary consent, and enrollment of beneficiaries who are not terminally ill.

Home- and Community-Based Services (HCBS). HCBS, including personal care services (PCS), help beneficiaries continue to live in their homes and avoid costly and disruptive facility-based care. PCS, a critical component of HCBS, serve several targeted populations, including people with mental illness or physical, cognitive, or developmental disabilities. PCS help promote beneficiary choice and preferences, but payment, compliance, and quality vulnerabilities persist and may serve to undermine HCBS goals of offering beneficiaries safe and high quality care outside of an institutional setting. (For more information on vulnerabilities related to Medicaid PCS, see TMC #2.) OIG and State Medicaid Fraud Control Units cite high amounts of PCS fraud, some of which involve the abuse or neglect of beneficiaries by PCS attendants that have resulted in deaths, hospitalizations, and less severe degrees of patient harm. Vulnerable beneficiaries may be unable to report the abuse and neglect because of limited communications skills or may be reluctant to report on PCS attendants whom they feel dependent.

Indian Health Service. IHS is the principal Federal health care provider for American Indians and Alaska Natives. HHS must ensure adequate access to care and quality of care for IHS beneficiaries. Recruiting and retaining competent clinical staff, aging facilities, hospitals unable to render competent emergency or high-level care, and limited resources for referred care remain pressing challenges. (HHS's challenge in combating diversion of opioids and other controlled substances as well as abuse and misuse of prescription drugs is addressed in TMC #6. HHS's challenge in ensuring appropriate use of grant funds is addressed in TMC #5.)

Children. In partnership with the States, HHS operates Medicaid and the Children's Health Insurance Program to provide medical care for over 36 million children, including children from financially needy families, children in foster care, and children with disabilities. The Child Care and Development Fund (CCDF) supports childcare for about 1.4 million children from low-income families while their guardians work or attend school. Ensuring that these intended beneficiaries enjoy access to safely-delivered, high-quality services remains a longstanding challenge for HHS. OIG reviews revealed that many children covered by Medicaid do not receive required dental services, and many children in foster care do not receive required medical services. HHS also operates several programs that provide care for children arriving in the United States without legal status and who are unaccompanied by parents or guardians. (HHS's challenge in adequately overseeing these programs is addressed in TMC #5.)

Progress in Addressing the Challenge

Strengthening Processes to Promote Quality Improvement. HHS continues its efforts to improve the quality of nursing home, hospice, and HCBS programs; care for IHS beneficiaries; and services for especially vulnerable children. In July 2016, the Centers for Medicare & Medicaid Services (CMS) updated a booklet entitled "Preventing Medicaid Improper Payments for Personal Care Services." This guidance addresses problem areas identified by OIG and advises PCS agencies and attendants how to avoid improper payments in the following areas: (1) inadequate documentation for claims; (2) claims for ineligible services; (3) services without adequate supervision; (4) services rendered by unqualified providers or without adequate verification and documentation of qualifications; and (5) claims for home care services supposedly rendered to beneficiaries while the beneficiary was away from home and receiving institutional care.

In August 2016, CMS also issued an Informational Bulletin entitled "Suggested Approaches for Strengthening and Stabilizing the Medicaid Home Care Workforce" that discussed States' ability to implement basic training for home care workers in topics such as first aid and CPR certification.

HHS continues its efforts to incentivize improved quality of care by linking payment to value and promoting transparency. (For more information on delivery system reform, see TMC #9.) In September 2016, CMS published a final rule to improve the quality of nursing home care. The rule updates the requirements for long-term-care facilities that participate in Medicare and implements provisions of the Patient Protection and Affordable Care Act, including requirements for facilities to implement a quality assurance and performance improvement program to ensure that facilities continuously identify and correct quality deficiencies and promote and sustain performance improvement. CMS has also worked to improve the "Five Star Quality Rating System" to better inform beneficiaries and their families about nursing home options. In July 2016, CMS published a final rule on the Skilled Nursing Facility (SNF) Quality Reporting and Value Based Purchasing Programs. CMS continues to develop the SNF Quality Reporting Program (QRP) measures mandated by the Improving Medicare Post-Acute Care Transformation Act of 2014, including reviewing prescribed medication regimens and accounting for potentially preventable hospital readmissions. The rule also establishes penalties for SNFs that fail to submit required quality data to CMS.

HHS is also developing policies and procedures for public reporting of quality data. In July 2016, HHS updated the hospice Quality Reporting Program to include new quality measures and announced a plan to begin publicly reporting hospice quality measures via a Compare site in calendar year 2017. In August 2016, CMS directed State Survey Agency Directors to ensure that nursing homes do not misuse photography or recordings to compromise residents' right to privacy, confidentiality, and dignity. HHS continues to work closely with law enforcement partners at the Department of Justice and through the Federal Elder Justice Interagency Working Group to promote better care for elderly persons and to prosecute providers who subject them to abuse or neglect.

CMS has also been working to develop a new tool to improve person-centeredness of home- and community-based services. The Consumer Assessment of Healthcare Providers and Systems´┐Ż HCBS Survey helps HCBS programs assess the experiences of beneficiaries. The Survey facilitates comparisons across the hundreds of State Medicaid HCBS programs throughout the country that target different adults with disabilities; including frail elderly, individuals with physical disabilities, people with developmental or intellectual disabilities, those with acquired brain injury, and persons with severe mental illness. The new tool is available for voluntary use in HCBS programs, including both fee-for-service programs as well as managed long-term services and support (LTSS) programs, as part of quality assurance and improvement activities. Aspects of LTSS covered by the survey are staff reliability, communication with staff, getting help from case managers, choice of services, personal safety, adequacy of medical transportation, and community inclusion and empowerment.

HHS has expressed its commitment to improving quality of care in IHS, especially in the Great Plains where recent reports of quality failures have been most pronounced. Recently, HHS created the Executive Council on Quality Care to improve patient safety at IHS hospitals and clinics. IHS' own quality improvement plans include development of a new Quality Framework and establishment of an Office of Quality in IHS Headquarters. IHS has also undertaken a survey initiative to assess IHS hospitals' compliance with conditions of participation and will track resulting performance data. IHS is also undertaking training initiatives for Area Office staff, service unit leaders, and hospitals, the latter with assistance from the Joint Commission. Additionally, IHS and CMS have committed to continue supporting IHS hospital improvement through the Quality Improvement Network - Quality Improvement Organization and Hospital Engagement Network programs.

In 2014, Congress reauthorized the Child Care and Development Block Grant Act. The Act sets basic health and safety standards for CCDF-funded childcare, requires staff background checks, and requires States to monitor childcare programs serving CCDF-funded children annually. HHS continues efforts to ensure that children enrolled in Medicaid can access Medicaid-covered services, including dental care. These efforts include assistance for States and requirements for States to establish access monitoring review plans.

Protecting Beneficiaries from Dishonest and Potentially Dangerous Providers. Successful enforcement activities continue to identify providers and grantees who violate program rules and prevent them from misappropriating additional funds or harming program beneficiaries. In June 2016, a national health care fraud takedown resulted in civil and criminal charges against 301 individuals, including numerous Medicaid HCBS providers. In July 2016, a national operation to combat CCDF fraud generated 18 prosecutions.

Sometimes, OIG determines that providers have rendered such inferior care that protecting the programs and beneficiaries going forward necessitates excluding those providers from serving program beneficiaries. In other situations, OIG determines that the programs and beneficiaries are better served by allowing the offending provider to continue serving beneficiaries but under close supervision to ensure that future care meets safety and quality standards. To achieve this goal, OIG invests substantial efforts in helping providers improve. OIG has developed an innovative quality-oriented corporate integrity agreement (CIA) process to work with providers so they may better serve beneficiaries. OIG has placed nearly 40 nursing home companies (covering more than 900 facilities) under CIAs that include quality-monitoring provisions designed to ensure that beneficiaries receive the care they deserve. For example, one dental chain that targeted children enrolled in Medicaid was initially placed under a CIA to address substandard care. However, when the provider failed to meet the terms of the CIA and quality-of-care problems persisted, the CIA was terminated and the provider was excluded from further participation in the Federal health care programs.

What Needs To Be Done

HHS must strengthen procedures to ensure that providers and grant recipients comply with all relevant program rules and deliver safe and high-quality services to the programs' intended beneficiaries. Specifically, HHS should continue to prioritize quality of care in nursing homes and hospices as well as the care rendered as HCBS, with particular focus on PCS. HHS should monitor how often nursing home residents are hospitalized and develop additional resources to help providers avoid adverse events. In addition, HHS should improve internal controls and offer better guidance and training for surveyors to ensure that nursing homes with recorded quality and safety issues correct their deficiencies. CMS should improve coordination with State agencies to ensure that care providers meet relevant licensure requirements. HHS should also improve hospice oversight by (1) increasing physician involvement in decisions regarding general inpatient care, (2) establishing additional remedies for poor-performing hospices, (3) educating providers and beneficiaries about hospice enrollment requirements, and (4) developing and disseminating model text for hospice election statements. HHS should also continue developing policies that effectively link payment to quality.

Ensuring high-quality HCBS and enabling beneficiaries to avoid institutionalization relies heavily on appropriate PCS. CMS must do much more to address vulnerabilities in HCBS, such as PCS. As Medicaid expands, so too will beneficiaries' reliance on HCBS as they seek to avoid institutional care settings. As CMS continues its work to expand access to HCBS, it should also focus on strategies to prevent fraud, waste, and abuse and safeguard beneficiaries' safety. CMS should follow through on commitments to improve PCS program integrity by promulgating regulations and issuing clarifying guidance to States on the range of vulnerabilities that expose beneficiaries to risk of unsafe or suboptimal care.

HHS should ensure the integrity of Medicaid-funded PCS by establishing minimum Federal qualification standards for providers that are based on the needs of the individual being served; improving CMS's and States' ability to monitor billing and quality of care; and issuing operational guidance for claims documentation, beneficiary assessments, person-centered plans of care, and supervision of personal care attendants when hired by an agency. For self-directed programs in which a beneficiary directs his or her own PCS, CMS and the States should improve oversight of controls to ensure individual health and welfare and financial integrity. HHS should also issue guidance to States regarding adequate prepayment controls and help States access data necessary to identify overpayments.

HHS must better oversee IHS hospitals to identify and rectify quality issues and help hospitals implement data-driven quality improvement methods. Specifically, IHS should (1) implement a quality-focused compliance program, (2) establish standards for Area Office/Governing Board oversight activities, (3) set hospital performance metrics, and (4) better train hospital administrators and staff. In addition, CMS should conduct more frequent surveys of non-accredited hospitals.

The Administration for Children and Families must fully implement its new authorities to ensure safer CCDF-funded childcare. HHS should develop a comprehensive plan to ensure children's access to Medicaid-covered dental services, such as by working with States to (1) develop and achieve service benchmarks, (2) identify areas of provider shortages and address barriers to Medicaid participation, and (3) analyze payment policies.

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