August 31, 1999

Thompson letter on GPRA - HHS Attachment 2

OPEN GAO RECOMMENDATIONS ON HHS

MAJOR MANAGEMENT PROBLEMS

THE SCOPE AND COMPLEXITY OF HHS PROGRAMS CREATE CHALLENGES WITH COORDINATION, OVERSIGHT, AND PERFORMANCE MEASUREMENT

Problem description: Coordinating the efforts of the numerous administrators of the HHS programs, which include HHS’ 11 agencies and state and local governments, is critical to ensuring program efficiency and effectiveness. HHS must also coordinate with a number of other federal, state, and local agencies that have programs with similar goals. While HHS recognizes these needs, it has not delineated how it plans to ensure effective program coordination. Certain program characteristics, such as those that give the states the flexibility to design their own programs, make coordination and oversight a daunting task. Compounding this difficulty is the need for HHS to develop adequate performance measures to ensure accountability.

There are 49 open GAO recommendations related to this major management challenge. In addition to the 12 recommendations discussed in the following table, there are 37 recommendations involving the Health Care Financing Administration’s (HCFA) oversight of institutions for persons with mental retardation, HCFA’s release of data on health maintenance organization (HMO) performance, Head Start programs, the Food and Drug Administration’s (FDA) steps to improve the safety of human tissue banks, HCFA’s assessment of organ procurement organization performance, FDA’s oversight of medical device tracking and recall systems, federal lead poisoning screening programs, the Medicare managed care appeals process, HCFA’s monitoring of the use of home oxygen equipment, and the Substance Abuse and Mental Health Services Administration’s monitoring and assessment of methadone maintenance treatment programs.

Report No. and Date	Recommendation
HEHS-95-2 Oct. 20, 1994	The Secretary of Health and Human Services should systematically review imaging utilization information developed by HCFA and use the authority provided under the Omnibus Budget Reconciliation Act of 1993 (OBRA) to develop any additional regulations needed to reduce overutilization through abusive self-referral practices.
HEHS-97-23 Oct. 22, 1996	The Secretary of Health and Human Services should direct the Administrator of HCFA to require standard formats and terminology for important aspects of health maintenance organization (HMO) informational materials for beneficiaries, including benefits descriptions.

HEHS-98-25 Dec. 5, 1997	The Secretary of Health and Human Services should direct FDA to act in several areas to improve the safety and efficacy of donated human tissue and to increase FDA’s ability to regulate tissue facility activities. FDA should move ahead with its plan to require reproductive and stem cell facilities to adhere to all requirements of the current regulation.
HEHS-98-21 Mar. 17, 1998	To improve the effectiveness of FDA’s foreign inspection program to ensure that only safe, pure, and high quality drugs are imported into the United States, the Commissioner of FDA should reexamine and revise FDA’s foreign inspection strategy to provide adequate assurance that all foreign manufacturers exporting approved pharmaceutical products to the United States comply with U.S. standards. At a minimum, the strategy should include (1) timely follow-up inspections of all foreign manufacturers that have been identified as having serious manufacturing deficiencies and that promised to take corrective action and (2) periodic surveillance inspections of all foreign pharmaceutical manufacturers, not just those considered high-risk.
HEHS-98-186 June 30, 1998	To determine whether the Head Start program is making a difference in the lives of those it serves, HHS should assess the impact of regular Head Start programs by conducting a study or studies that will definitively compare the outcomes achieved by Head Start children and their families with those achieved by similar non-Head Start children and families.
HEHS-99-18 Jan. 15, 1999	To improve screening rates within federal health programs, HCFA and the Health Resources and Services Administration (HRSA) should improve the monitoring of compliance with federal lead screening policies within the Medicaid and health center programs. Specifically, HCFA should require state Medicaid agencies to report on the lead screening services that are provided to children within the Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program and to document progress in meeting lead screening performance goals. HCFA should require the states that do not meet expectations to develop plans for improving their performance. HRSA should use current monitoring mechanisms to better ensure that health centers follow all federal lead screening policies.
HEHS-99-36 Feb. 26, 1999	To improve management and oversight of the Medicare Incentive Payment program, the Secretary of Health and Human Services should integrate the program into the Department’s overall access-to-care strategic planning and performance measurement activities.
HEHS-99-46 Mar. 18, 1999	To strengthen its ability to ensure that nursing homes maintain compliance with Medicare and Medicaid quality-of-care standards, the Administrator of HCFA should improve the effectiveness of civil monetary penalties and continue to act to shorten the delay in adjudicating appeals, including monitoring progress made in reducing the backlog of appeals.
HEHS-99-46 Mar. 18, 1999	To strengthen its ability to ensure that nursing homes maintain compliance with Medicare and Medicaid quality-of-care standards, the Administrator of HCFA should strengthen the use and effect of termination. The Administrator should (1) continue Medicare and Medicaid payments beyond the termination date only if the home and state Medicaid agency are making reasonable efforts to transfer residents to other homes or alternate modes of care, (2) ensure that reasonable assurance periods associated with reinstating terminated homes are of sufficient duration to effectively demonstrate that the reason for termination has been resolved and will not recur, and (3) revise existing polices so that the pre-termination history of a home is taken into account in taking a subsequent enforcement action.
HEHS-99-80 Mar. 22, 1999	To make complaint investigations a more effective tool for protecting nursing home residents’ health and safety, the Administrator of HCFA should revise federal guidance and ensure state agency compliance by developing additional standards for the prompt investigation of serious complaints alleging situations that may harm residents but are categorized as less than immediate jeopardy. These standards should include maximum allowable time frames for investigating serious complaints and for complaints that may be deferred until the next scheduled annual survey. States may continue to set priority levels and time frames that are more stringent than these federal standards.
HEHS-99-80 Mar. 22, 1999	To make complaint investigations a more effective tool for protecting nursing home residents’ health and safety, the Administrator of HCFA should revise federal guidance and ensure state agency compliance by strengthening federal oversight of state complaint investigations, including monitoring states’ practices regarding priority-setting, on-site investigation, and timely reporting of serious health and safety complaints.
HEHS-99-68 Apr. 12, 1999	To help ensure that the Medicare managed care appeals process provides adequate protection to Medicare beneficiaries, the Administrator of HCFA should develop criteria for plans to use in determining when initial decisions and appeals should be expedited.

HHS NEEDS RELIABLE AND COMPREHENSIVE DATA AND DATA SYSTEMS TO MANAGE PROGRAMS AND ASSESS RESULTS

Problem description: HHS does not have access to the data needed to effectively manage its extensive health insurance programs, grant-making activities, and regulatory responsibilities. Developing and maintaining systems to ensure access to such data, however, are challenging, since many important HHS programs are administered by program partners, such as state and local governments. Yet without these systems, HHS cannot adequately oversee its programs. Technical concerns about computer capabilities posed by the year 2000 add further complexity. Of particular concern is the possible interruption of Medicare services and payments.

There are 26 open GAO recommendations related to this major management challenge. In addition to the 10 recommendations discussed below, there are 16 recommendations involving child support enforcement, Medicare billing, the FDA’s financial management of property, and FDA’s implementation of the Safe Medical Devices Act of 1990.

Report No. and Date	Recommendation
AIMD-97-78 May 16, 1997	To help HCFA improve its ability to use effective systems development practices and improve its software acquisition capability, the Secretary of Health and Human Services should direct the Administrator of HCFA to (1) obtain an independent assessment of its software acquisition capabilities using the Software Engineering Institute's software acquisition capability maturity model, and implement improvements to correct any identified weaknesses and (2) report its findings to both HHS and the Office of Management and Budget.
AIMD-97-72 June 30, 1997	To maximize the federal government’s return on costly technology investments, the Secretary of Health and Human Services should direct and ensure that the Assistant Secretary of the Administration for Children and Families develops and implements a structured approach to reviewing automation projects to ensure that significant systems development milestones are identified and that the costs of project decisions are justified during the entire effort. Each major systems phase should be reviewed and, at critical points--analysis, design, coding, testing, conversion, and acceptance—the Office of Child Support Enforcement should, according to preestablished criteria, formally report to the state whether it considers the state ready to proceed to the next milestone or phase.
AIMD-98-91 Apr. 15, 1998	To implement HCFA's current plans to expeditiously realize dollar savings in the Medicare program through the use of claims auditing edits, the Administrator of HCFA should require, in any competition, that vendors have comprehensive claims auditing edits, which at a minimum address the mutually exclusive, incidental procedure, and diagnosis-to-procedure categories of inappropriate billing codes.
AIMD-99-51 Feb. 22, 1999	To correct weaknesses identified in prior audit reports and strengthen controls over automated data processing (ADP) equipment, the Commissioner of the FDA should finalize and implement proposed procedures to conduct comprehensive property inventories and component-specific spot audits.
HEHS-97-21 Jan. 29, 1997	To improve FDA’s adverse event reporting system’s ability to serve as an early warning system about medical device problems as intended by the Safe Medical Devices Act of 1990 (SMDA 90), the Commissioner of FDA should document corrective actions or adverse event reports that result from analysis and investigations of device problems.
HEHS-97-21 Jan. 29, 1997	FDA’s study of an adverse event reporting system based on a representative sample of user facilities should focus on whether this approach can provide manufacturers and FDA with the quantity and quality of information needed to rapidly identify and correct problems with devices that have varying usage rates.
HEHS-98-229 Sept. 15, 1998	In keeping with its goal of improving state reporting, the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), should develop an action plan for how the agency will increase states’ reporting of accurate, complete, and consistent treatment need data in block grant applications and include a summary of these actions in the Department of Health and Human Services’ year 2000 performance plan.
HEHS-99-18 Jan. 15, 1999	To improve the awareness of providers and the public about the prevalence of elevated blood lead levels among young children in their communities and to enhance the effectiveness of targeted screening efforts, HCFA and CDC should work more closely with state Medicaid and CDC-supported programs to encourage information-sharing and the development of data needed to better identify at-risk children. Specifically, state Medicaid programs should be encouraged to work with state health departments to develop systems to identify the prevalence of elevated blood lead levels among children in Medicaid.
HEHS-99-18 Jan. 15, 1999	To improve the awareness of providers and the public about the prevalence of elevated blood lead levels among young children in their communities and to enhance the effectiveness of targeted screening efforts, HCFA and CDC should work more closely with state Medicaid and CDC-supported programs to encourage information-sharing and the development of data needed to better identify at-risk children. Specifically, CDC should require grant applicants to (1) demonstrate that they have, or have systems to obtain, representative, reliable data on the prevalence of elevated blood lead levels in their states or communities or to commit to conducting periodic surveys to obtain such data and (2) commit to developing mechanisms for distributing such information to the public and providers.

HEHS-99-46 Mar. 18, 1999

To strengthen its ability to ensure that nursing homes maintain compliance with Medicare and Medicaid quality-of-care standards, the Administrator of HCFA should develop better management information systems. The Administrator should enhance the Online Survey, Certification, and Reporting (OSCAR) system or develop some other information system that can be used both by the states and by HCFA to integrate the results of complaint investigations, track the status and history of deficiencies, and monitor enforcement actions.

PROGRAM INTEGRITY IS A CONTINUING CHALLENGE FOR HHS

Problem description: With HHS’ broad range of programs, large numbers of grantees and contractors, huge volume of vendor payments, and millions of beneficiaries, it must always be vigilant in protecting its programs from fraud, waste, abuse, and mismanagement. The sheer dollar size of HHS’ programs makes them attractive targets, and the consequences can be severe. HHS needs to improve its processes for identifying and preventing fraud, waste, abuse, and mismanagement and to maintain constant vigilance in the future. The $200 billion Medicare program exemplifies the importance of such efforts.

Report No. and Date	Recommendation
HEHS-99-92 Apr. 12, 1999	In order to help Medicare beneficiaries make informed health care decisions and reduce the administrative burden on agency staff and managed care organizations (MCO), the Administrator of HCFA should require MCOs to produce one standard, Federal Employees Health Benefits Program (FEHBP)-like document for each plan that completely describes plan benefit coverage and limitations, and require MCOs to distribute this document during sales presentations and upon request.
HEHS-99-92 Apr. 12, 1999	In order to help Medicare beneficiaries make informed health care decisions and reduce the administrative burden on agency staff and managed care organizations (MCO), the Administrator of HCFA should fully implement HCFA’s new contract form for describing plans’ benefit coverage, the Plan Benefit Package (PBP), for the 2001 contract submissions to facilitate the collection of comparable benefit information and help ensure full disclosure of plans’ benefits.
HEHS-99-92 Apr. 12, 1999	In order to help Medicare beneficiaries make informed health care decisions and reduce the administrative burden on agency staff and managed care organizations (MCO), the Administrator of HCFA should develop standard forms for appeals and enrollment.
HEHS-99-92 Apr. 12, 1999	In order to help Medicare beneficiaries make informed health care decisions and reduce the administrative burden on agency staff and MCOs, the Administrator of HCFA should take steps to ensure consistent application of the agency’s marketing material review policy.