oversight

Health Services Quality and Public Health Issue Area--Active Assignments

Published by the Government Accountability Office on 1997-01-02.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

               United States General Accounting Office

GAO            Health, Education and Human Services
               Division


January 1997   T                  c
               Health Services
               Quality and Public
               Health Issue Area
               Active Assignments




               06OA
                  A9 2\
                      1)
GA/A-9-1(1
Foreword


           This report was prepared primarily to inform Congressional members and
           key staff of ongoing assignments in the General Accounting Office's Health
           Services Quality and Public Health issue area. This report contains
           assignments that were ongoing as of January 2, 1997, and presents a brief
           background statement and a list of key questions to be answered on each
           assignment. The report will be issued quarterly.

           This report was compiled from information available in GAO'S internal
           management information systems. Because the information was
           downloadedfrom computerized data bases intended for internal use, some
           information may appear in abbreviated form.

           If you have questions or would like additional information about
           assignments listed, please contact Bernice Steinhardt, Director, on
           (202) 512-6543.




           Page 1                                                       GAO/AA-97-14(1)
Contents

                                                                                                   Page
PUBLIC HEALTH
   New *REVIEW OF STRUCTURE AND ACTIVITIES OF FOUNDATIONS RESULTING FROM NONPROFIT HOSPITALS'         1
           CONVERSION TO FOR-PROFIT STATUS.
   New     COMPLIANCE WITH REQUIREMENTS FOR RESEARCH ON TRANSPLANTATION OF HUMAN FETAL                1
           TISSUE.
   New . ASSESSMENT OF DRUG PREVENTION AND TREATMENT STRATEGIES.                                      1
   New *REVIEW OF FDA'S EFFORTS TO ENSURE THE SAFETY OF HUMAN TISSUE FOR        TRANSPLANTATION.      2
OTHER ISSUE AREA WORK - HSQP
         . QUALITY OF CARE FOR MEDICARE ESRD PATIENTS.                                                2
         .REVIEW OF THE IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990.                       2
         .MEDICARE: ACCESS TO DIABETES CARE IN HMOS AND FFS.                                          3
        .INTERNATIONAL MEDICAL GRADUATES PRACTICING UNDER VISA WAIVERS.                               3
        ,REVIEW OF FDA'S ANNUAL INSPECTION OF MAMMOGRAPHY FACILITIES.                                 3
        ,FDA REGULATION OF TOBACCO PRODUCTS.                                                          4
        .MEDICARE WMOS: ENROLLMENT PATTERNS OF THE CHRONICALLY ILL.                                   4
        . FDA INSPECTIONS OF FOREIGN DRUG MANUFACTURING FACILITIES.                                   4
   New .OUTCOMES OF PURCHASER USE OF PERFORMANCE MEASUREMENT INFORMATION.                             S
   New XSTATE AND LOCAL GOVERNMENT ACCESS TO FEDERAL SUPPLY SCHEDULE PRICES FOR                       5
          PHARMACEUTICALS.
   New . PHARMACY BENEFITS IN SELECTED FEHBP PLANS.                                                   5
   New . IMPACT OF PURCHASER REQUIREMENTS ON HMOS.                                                    6
    Health Services Qualith and Public Health




    PUBLIC HEALTH
         TITLE:   REVIEW OF STRUCTURE AND ACTIVITIES OF FOUNDATIONS RESULTING FROM NONPROFIT HOSPITALS'
                  CONVERSION TO FOR-PROFIT STATUS (108295)

                  BACKGROUND: Increasingly investor-owned corporations are buying/joint venturing with nonprofit hospitals.
                  Nonprofit hospitals converting to for-profit status must direct the net value of their assets to a charitable
                  purpose. Most hospitals endow these funds to a foundation. Congress is concerned about the trend in nonprofit
                  hospital conversions and the impact on charity care.
                  KEY QUESTIONS: (1) What is the status of nonprofit hospital conversions to for-profit status? (2) To what
                  extent are funds from conversions directed to foundations? and (3) How are foundations fulfilling their
                  charitable mission?




         TITLE:   COMPLIANCE WITH REQUIREMENTS FOR RESEARCH ON TRANSPLANTATION OF HUMAN                             FETAL
                  TISSUE (108299)

                  BACKGROUND: Transplantation of human fetal tissue has promise for patients with such conditions as
                  juvenile diabetes and Parkinson's disease. Yet NIH supported research has been controversial due to ethical
                  concerns. 1993 legislation stipulated certain donor protections.
                  KEY QUESTIONS: (I) To what extent has research on the transplantation of human fetal tissue adhered to
                  informed consent procedures, audit requirements, state and local laws, and reporting requirements? (2) To what
                  extent have there been reported violations in the acquisition of human fetal tissue for use in transplantation?




         TITLE: ASSESSMENT OF DRUG PREVENTION AND TREATMENT STRATEGIES (108300)




K~~~~~
Health Services Quality and Public Health




PUBLIC HEALTH
    TITLE: REVIEW OF FDA'S EFFORTS TO ENSURE THE SAFETY OF HUMAN TISSUE FOR                        TRANSPLANTATION
           (108306)

             BACKGROUND: The American Association of Tissue Banks (AATB) has accreditated about 60 tissue banks
             but an unknown number of banks are not accredited. In 1993, because of concerns about human tissue safety,
             FDA issued interim rules for tissue bank operations, including donor screening and disease testing, to guard
             against disease transmission from tissue transplantation.
             KEY QUESTIONS: Are tissue banks being adequately monitored to guard against the transmission of diseases?
             (1) To what extent has FDA identified the universe of tissue banks in the nation? (2) To what extent has FDA
             monitored the safety of human tissue? (3) What inspections has FDA conducted and what are their results?


OTHER ISSUE AREA WORK - HSQP
    TITLE: QUALITY OF CARE FOR MEDICARE ESRD PATIENTS (101497)

             BACKGROUND: Medicare pays about $7 billion per year for 250,000 victims of End Stage Renal Disease
             ESRD). HCFA has reported results from a study of the quality of care for ESRD beneficiaries showing room for
             improvement. However, the study does not differentiate among provider types. Some allege that ESRD patients
             enrolled in HMOs receive poorer quality care.
             KEY QUESTIONS: 1. What are the accepted performance indicators for measuring the quality of care provided
             to ESRD patients? 2. Compared with these standards, how does the quality of care for patients with ESRD
             differ across provider types?




    TITLE:   REVIEW OF THE IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990 (108236)

             BACKGROUND: To increase the amount and timeliness of data that FDA receives about medical devices,
             Congress passed the Safe Medical Devices Act of 1990 (SMDA). The Act requires device-user facilities to
             report medical device related deaths to FDA and injuries to manufacturers. Although the Act took effect in
             1991, FDA has not yet issued its final rule on user reporting.
             KEY QUESTIONS: (1) Are user facilities complying with the Act? (2) What action has FDA taken on medical
             device reports submitted by user facilities? (3) What actions are manufacturers taking in response to reports
             received? (4) What is the cost effectiveness of the Act's requirements and implementation? (5) What
             recommendations does GAO have for improvement?




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Health Services Quality and Public Health




OTHER ISSUE AREA WORK - HSQP
    TITLE:   MEDICARE: ACCESS TO DIABETES CARE IN HMOS AND FFS (108255)

             BACKGROUND: Experts agree that many diabetics are not receiving the services needed for adequate disease
             management, whether they are enrolled in fee-for-service (FFS) or managed care. Because uncontrolled
             diabetes can result in excess worsening health and high costs, both Medicare beneficiaries and health providers
             have incentive to manage the disease more effectively.
             KEY QUESTIONS: (1) What clinical practices are recommended for diabetes care? (2) To what extent are
             Medicare diabetics receiving recommended services? (3) How widespread are diabetes management programs
             among Medicare HMOs? What approaches are used by HMOs and FFS providers to manage diabetes care? (4)
             What data are available to show improvement in the utilization of services?




    TITLE:   INTERNATIONAL MEDICAL GRADUATES PRACTICING UNDER VISA WAIVERS (108258)

             BACKGROUND: Under an educational/cultural exchange program, foreign physicians must return home after
             U.S. residency training. The return req. can be waived at fed./state agencies' request if a doctor agrees to work
             in a needy area. In 1995, there were over 1,000 waivers for physicians; however, there are concerns that the 4
             agencies & states are not coordinating and monitoring placements.
             KEY QUESTIONS: (1) Are federal and state programs for requesting J-l visa waivers for physicians
             effectively coordinated to help meet the needs of medically underserved communities? (2) Do controls exist to
             assure that physicians are fulfilling commitments to practice in underserved communities?




    TITLE:   REVIEW OF FDA'S ANNUAL INSPECTION OF MAMMOGRAPHY FACILITIES (108261)

             BACKGROUND: In 1995, under the Mammography Quality Standards Act (MQSA), FDA began contracting
             with states to annually inspect mammog: facilities. States report compliance problems to FDA for enforcement.
             FDA recovers inspection costs by charging facilities inspection fees. There are concerns re. excessive
             requirements/costs. This will be our second report mandated by the Act.
             KEY QUESTIONS: Ql. To what extent does FDA's inspection criteria and procedures assure compliance with
             MQSA quality standards? Q2. Are there opportunities to improve efficiencies and reduce FDA inspection costs
             to facilities?




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Health Services Quality and Public Health




OTHER ISSUE AREA WORK - HSQP
    TITLE: FDA REGULATION OF TOBACCO PRODUCTS (108264)

             BACKGROUND: In 1995, FDA issued proposed regulations that would prohibit the sale of tobacco products to
             minors. The House Agriculture Subcommittee has been trying for almost 2 years to obtain information relative
             to the FDA personnel involved with tobacco issues and the documentation used to support the proposed
             regulation. GAO was asked in November 1995 to assist in this endeavor.
             KEY QUESTIONS: Determine (1) FDA resources used to develop the rule; (2) how FDA concluded it has
             jurisdiction over tobacco products; (3) actions taken by FDA to develop the rule, and how FDA evaluated other
             regulatory options; (4) how FDA assessed the impact of the rule on tobacco production and farmers; and (5) how
             FDA responded to congressional requests on the matter.




    TITLE:   MEDICARE HMOS: ENROLLMENT PATTERNS OF THE CHRONICALLY ILL (108269)

             BACKGROUND: Given their richer benefits, HMOs are expected to attract the chronically ill. Yet, there are
             indications that the chronically ill do not enroll in HMOs in proportion to their fee-for-service (FFS) numbers. If
             so, (a) the chronically ill may be dissatisfied with HMOs and (b) HCFA may be overpaying HMOs for serving a
             relatively healthy population.
             KEY QUESTIONS: (1) What proportion of FFS beneficiaries have chronic conditions? How much more did
             Medicare spend on the chronically ill than the nonchronic? (2) Do chronically-ill beneficiaries transfer from FFS
             to HMOs in proportion to their representation in FFS? (3) Do beneficiaries with chronic conditions stay or
             rapidly disenroll from HMOs?




    TITLE:   FDA INSPECTIONS OF FOREIGN DRUG MANUFACTURING FACILITIES (108279)

             BACKGROUND: FDA inspects foreign facilities to ensure that only safe, pure, and high quality drugs are sold
             in the U.S. But, FDA studies have identified serious problems with the foreign inspection program, and raised
             concerns about whether deficiencies identified during inspections of foreign drug facilities may be exposing
             American consumers to unsafe and adulterated drugs.
             KEY QUESTIONS: (1) How does FDA manage inspections of foreign drug manufacturing facilities? (2) How
             has FDA corrected management problems that were identified in two internal studies of the foreign inspection
             program? (3) What manufacturing problems have been found during inspections of facilities in China and India
             and how were these problems addressed?




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Health Services Quality and Public Health




OTHER ISSUE AREA WORK - HSQP
    TITLE: OUTCOMES OF PURCHASER USE OF PERFORMANCE MEASUREMENT INFORMATION (108291)

             BACKGROUND: Corporate purchasers now have available to them quality of health care information that was
             unavailable several years ago. Little is known, however, about how purchasers use this information to make
             health insurance purchasing decisions or its effect on the quality of care furnished. HCFA, in its new purchasing
             role, could learn from these experiences.
             KEY QUESTIONS: (1) What performance criteria are set by purchasers for health plans and what process is
             used by purchasers to influence the achievement of these criteria? (2) What process is used by health plans in
             reacting to such criteria? (3) What are the results of the interaction between purchaser and health plans? (4)
             What can HCFA learn from purchasers?




    TITLE: STATE AND LOCAL GOVERNMENT ACCESS TO FEDERAL SUPPLY SCHEDULE PRICES FOR
           PHARMACEUTICALS (108294)

             BACKGROUND: In proposed regulations for opening federal supply schedules (FSS) to state, local, and Indian
             tribal governments, GSA excluded the FSS for pharmaceuticals because of concerns that it could result in higher
             drug prices for government purchasers. The Congress required that GAO assess the economic implications of
             extending FSS drug prices to other government entities.
             KEY QUESTIONS: (1) What is the potential effect of opening the pharmaceutical FSS to state and local
             governments on drug prices paid by federal, state, and local government entities? (2) What is the potential
             economic effect of opening the pharmaceutical FSS to state and local governments on businesses that sell
             pharmaceuticals?




    TITLE:   PHARMACY BENEFITS IN SELECTED FEHBP PLANS (108298)

             BACKGROUND: In 1995, Federal Employee Health Benefits Program (FEHBP) plans spent $2.4 billion on
             prescription drugs for about 4.1 million enrollees. Moreover, prescription drug payments have grown from 14%
             in 1990 to 21% in 1995 of total FEHBP health care costs. FEHBP plans are using pharmacy benefit managers
             (PBMs) to manage their prescription drug benefits and control rising costs.
             KEY QUESTIONS: (I) Why have these FEHBP plans contracted with PBMs to provide pharmacy benefits?
             (2) What types of services do the PBMs provide these FEHBP plans? (3) How do these FEHBP plans evaluate
             PBM performance in terms of savings and quality of care?     (4) Why are some still concerned about the
             quality of pharmacy services provided by PBMs and their effect on retail pharmacies?




                                                                 5
Health Services Quality and Public Health




OTHER ISSUE AREA WORK - HSQP
    TITLE: IMPACT OF PURCHASER REQUIREMENTS ON I4MOS (108302)

           BACKGROUND: Health care purchasers, including HCFA, are increasingly asking for information from
           HMOs about HMO performance, especially clinical performance. However, little objective information is
           available about how HMOs generate and validate the information they disseminate, or how they use the
           information to improve health care.
          KEY QUESTIONS: (1) What types of information are purchasers requesting? (2) How are HMOs generating
          and validating the information they provide? (3) What HMO resources are devoted to collecting and analyzing
          this data? (4) How do HMOs use the information and what effect does it have on their quality improvement
          efforts? (5) Is there a need for greater standardization of measures?




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