1. Technology and Health Care HCA 701 November 10, 2005

2. Technology Assessment The process that examines the available evidence to form a conclusion as to the merits or role of a particular technology in relation to its possible use, purchase or reimbursement in current medical practice.  Examines the safety, effectiveness, efficiency and appropriateness  Includes medical devices, procedures and standards, and pharmaceuticals To maximize quality: the most effective health care service that science can provide Can we afford it?

3. Categories of Technology Devices - "the quiet heroes of health-care innovation"  Diagnostic devices (MRI, CAT, SPECT, etc.)  Treatment devices Medical and surgical procedures (examples):  Radial keratotomy used to improve vision.  Genetic testing  Treatment head injuries, cancers, joint replacements, etc. Pharmaceuticals  Efficient and appropriate uses for FDA approved drugs  Labeling – language used to delineate the clinical use of a drug (indications, dosage, adverse effects, etc.).  Understanding the long-term affects of uses of some drugs,  Understanding alternative uses for drugs (e.g., manoxodil)

4. Technology Life Cycle Investigation – laboratory and clinical studies to discover or create, refine and package a new diagnostic or treatment modality. Promotion – introducing the technology into the buying community. Acceptance and utilization – incorporating the technology into practice. Decline – as technology is supplanted by superior new technology. Obsolesce – when the new technology is obsolete and no longer appropriate.

5. Targeting Technologies for Assessment Improve individual patient outcome Positively affect a large population Reduce treatment costs Reduce unexplained treatment variation.

6. Three Components of Technology Assessment High Utilization  Rapidly increase uses of a technology may signal inappropriate or excessive utilization. (e.g., Cesarean births rates)  Uses of high technology for common conditions may be inappropriate  E.g., use of mammography for women under the age of 50 has sparked controversy on the practice of high technology. Potential for Harm  Requires different standards and assessment priorities for different risk factors in patients. High Cost – willingness of payers to pay form some technological procedures or diagnoses.

7. Performing Technology Assessment Scientific assessment: does it work? Clinical assessment: does it work better than something that already exists? Economic assessment: Cost (use of Cost benefit analysis). Social or societal issues:  will providers use it?  Will patients use it?  Are secondary benefits more detrimental than primary benefits?

8. Problems in Performing Technology Assessment Lack of Evidence (not enough literature or patients to study, or poorly conducted research) Lack of Agreement on How to Perform the Assessment (may lead to different results using different techniques) Inconsistent Evidence (may result from different or inconsistent research methods) Legal Interference (can be influenced from biased resources) Breadth of Topics (difficult to successfully study or assess all technologies) New Information (assessment process must be ongoing to adequately compare new uses)

9. The Impact of Pharmaceuticals on Health Care Prescription drugs account for more than 15% of health care spending ($162 billion) Faster growth than all other segments of health care Prescription drug coverage over the last 10 years has been a catalyst for growth Primarily a large multinational corporate enterprise  10 largest pharmaceutical companies accounted for 60% of all Rx sales in U.S. in 2004

10. Components of Pharmaceutical Development Manufacturing and Production Research and Development Selling and Promotion

11. Top 10 Pharmaceutical Companies, U.S. Sales 2004 Corp.U.S. Sales in (Billions) % Growth over previous year % Market Share Pfizer$30.7513.1 Glaxo Smith Kline18.818.0 J & J16.276.9 Merck & Co.15.086.4 Astra Zenneca11.3134.8 Novartis10.274.3 Sanofi-Aventis10.0134.3 Amgen9.5234.1 Bristol-Myers Squibb 9.2-43.9 Wyeth8.2113.5 Total Top 10139.159.3

12. Top 10 Products 2004 ProductManufacturerRx in MillionsMarket Share LipitorPfizer74.82.1 HYCD/APAPMallinckrodt49.51.4 SynthroidAbbot47.41.3 NorvascPfizer38.31.1 ToprolAstraZeneca35.01.0 ZoloftPfizer33.10.9 ZocorMerck29.60.8 HYCD/APAPWatson29.00.8 AlbuterolWarrick26.80.8 AmoxicillinTeva26.20.7

13. Where the promotional money goes (In Billions of Dollars)

14. Major Issues for Prescription Drug Policy Consumerism and the results of direct to consumer marketing Brand drugs vs. generic drugs  Benefits  Controlling patents Drug importation Government’s role in controlling prices  Can the market place take care of this?

15. Using Outcomes and other Assessment Tools to Improve Quality Quality Improvement

16. Consider quality as a major priority over cost, choice or doctor, or range of service Sources for information comes from family and friends Concerned about the physician’s skills, but place increasing emphasis on communication skills, care attitude and certification How Individuals Determine Quality

17. The degree to which health services for individuals increases the likelihood of desired outcomes and are consistent with professional practices (IOM, 1990) Quality Defined

18. The Debate on Variation of Care Influenced the quality pursuit Variations to care can be found between regions, between hospitals, and between physicians within hospitals Typically a result of clinical decisions made based on individual physician’s experience and training If you cannot measure quality, you cannot improve it

19. True definition of Quality The perception of quality varies  Technical quality  Service quality  Art of science of care  Economy of care Overall standard: examine the efficiency, effectiveness and the appropriateness of care

20. Technical Performance (Quality of Care or clinical quality) Interpersonal Care (Quality of Life or Service Quality) Elements of Performance

21. Applying the best in current knowledge and technology to a personal health problem Outcomes compared for effectiveness Based on future expectations Technical Performance

22. Care that meets individual and social expectations and standards Patients communication of symptoms to the clinician Clinician communication of options to the patient Interpersonal Performance

23. Organizations that measure performance Joint Commission on Accreditation of Healthcare Organizations (JCAHO)  Non-profit organization that surveys and rates health care organizations and sets standards for care  Voluntary organization for hospitals but usually essential in qualifying for reimbursement National Committee for Quality Assurance (NCQA)  Uses HEDIS - standardized performance measures designed provide purchasers and consumers with information compare the performance of managed health care plans and their providers (Physician “report cards”) Institute of Medicine  Provides scientifically informed analysis outside government realm to improve health Agency for Healthcare Research and Quality (AHRQ) (HHS)  Examines Evidence Based Medicine

24. (Donebedian, 1980) ProcessOutcomes Model of Health Care Quality Structure

25. Creating the capacity for quality Staff qualifications Safety and Sanitation Care documentation Adequacy of care resources Organizational Structure measures Structure Measures

26. Activities between the provider and patients or between provider and provider Initial care assessment and comprehensiveness Care plan based on assessment Compliance with treatment protocols/guidelines/standards of care Process Measures

27. Change in health status to due to antecedent (structure/process) activities Short-term measures Long-term measures Outcome Measures

28. Intervening Factors  Severity of Illness Non-Health Factors  Patient Compliance  Social Support  Patient Motivation Outcome Standards

29. Must consider the appropriateness of outcome standards Assume that the are representative of the condition (do they reflect treatment goals) Validity of Outcomes – the outcomes are attributable to prior success Outcome Standards cont.

30. Mortality Rates Co-morbidity Health Status Patient Satisfaction Access to care Measures of Quality Outcomes

31. Disease management targets disorders that require a comprehensive care system Focus is on chronic illness Emphasis is on preventive care that delays of prevents complications caused by acute care illness Uses practice guidelines and clinical support tools Uses a clinical team approach Improving Outcomes through Disease Management

32. Structure Staff Qualifications Care Resources Safety Standards Documentation Process Needs Assess Care Planning Protocol Adherence Outcomes Short-term Long-term Intervening Factors Severity of Illness Patient Compliance Social Support Revised Model of Healthcare Quality

33. Practice Guidelines Once referred to as “Cookbook Medicine” Intended to influence the direction of patient care Systematically developed statements to assist practitioner decisions about the appropriateness of care Intended to decrease variations of care Criticized that de-emphasizes the “art” of care Prefers the use of “evidence based care”