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Twenty Priority Assessment Areas The twenty national priorities identified In this pilot study include fourteen coccal conditions and six medical technology assessment areas. The cI~n~cal conditions include one cardiovascular, one infectious, Pro gastrointestinal, Free musculoskele~, one neoplastic, one respiratory, one ophthahnolog~c, and two psychiatric conditions. Most of He phony clinical conditions are prevalent in me adult and elderly patient popula- tion. In addition, two priority clinical conditions (breast cancer and pregnancy) affect women; one clinical condition (prostatism) occurs only in men; and five clinical conditions Human ~mmunodeficiency virus infection, joint disease and injury, pregnancy, psychiatric disorders, and substance abuse) can commonly affect He pediatric as wed as adult patient populations. Of the six priority technologies, five are major groups unto multiple clinical indications: two groups of diagnostic procedures, one group of therapeutic procedures for organ failure, one group of ~erapeubc devices to restore or support physiologic function, and one system of support technologies for acutely id patients. The sixth technology (e~poi- etin) is an emerging Snag. AD identified technologies may be used to manage multiple clinical conditions in venous patient populations. Each of the following entries defines the priority assessment area and descnbes why it satisfies the primary and secondary pnonty-setting cnte- na presented in Chapter 2. For each clinical condition He related altema- tive medical technologies are indicated' and for each technology He possible clinical indications are considered. The clinical condidon and 27

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28 NATIONAL A5SE5SME1VTPR10RmES medical technology areas, listed in alphabetical order, represent a prelimi- nary set of national priorities for the evaluation of medical practice. The supporting documentation presented under each pr~or~ty-setting criterion is not of whom type or quality. It is illustrative, however, of Me types of information needed to substantiate national priorities and can serve to guide further data collection efforts. CLINICAL CONDITIONS Breast Cancer Breast cancer, a malignant tumor of the breast, is We second most common cause of death from cancer in women Dung cancer having recently passed breast cancer) and the most common cause of death from cancer in women 40 ~ 50 years of age (American Cancer Society, 1989; Eddy, 1989~. Several technologies are used in association win this clinical condition: mammography and breast examination for screening; breast biopsy for diagnosis; and surged, radiotherapy, chemotherapy, and hormonal therapy for treatment. Each of these altemative technologies may have seven van ants and may be used individually or in combina- tion. As clinical studies continue to address unanswered questions about screening and treaunent of breast cancer, standards for medical practice are in a state of flux (Eddy, 1989; ReDnan, 1989~. Assessments concem- ing breast cancer would have the potential to do the following. Improve Individual Patient Outcome The 5-year survival rate for women with breast cancer is 60 percent (American Cancer Society, 1989~. Unproved clinical interventions for this condition may help decrease morality rates, physical symptoms, side effects of treatment (e.g., disfigurement, pain, nausea, and hair loss), and the mental anguish caused by breast cancer and fear of breast cancer. Affect a Large Patient Population Breast cancer occurs in approximately ~ in 10 women in the United States. In 1989, an estimated 142,000 new cases of breast cancer occurred and an estimated 43,000 women died of the disease (Amencan Cancer Society, 1989~. Reduce Unit or Aggregate Cast Many of the alternative technologies have high aggregate costs. For example, screening 25 percent of American women between the ages of

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7WEN7YPRIORI.IY ASSESSME~AREA5 29 40 and 75 years by breast examination and mammography would cost $1.3 bilDion fly, 1989~. The National Cancer Institute estimates the cost of breast cancer diagnostic workup and subsequent treannent to be about $16,000 per case (Eddy, 1989~. Reduce Unexplained Variations in Medical Practice Practice styles vary widely among physicians who treat and try to prevent breast cancer (Rebrnan, 1989~. For instance, variations have been reported in the use of procedures such as breast biopsy (Wennberg, 1984; Roos et al., 1988; McMahon et al., 1989), local excision of benign breast lesions (Wennberg, 1984; Chassin et al., 1986; Roos et al., 1988; McMahon et al., 1989), and mastectomy (Chassin et al., 1986~. Advance Medical Knowledge Screening mammography has been shown to improve survival in women ages 50 to 60, but there is controversy about its role in women in other age groups (Andersson et al., 198g). Although chemotherapy and radiother- apy following surgery have been shown to improve survival in some patient subgroups, their effectiveness in other groups remains to be cIari- fied (Fisher et al., 1989; Mansour et al., 1989~. Affect Policy Decisions Population-based studies may lead to a broader consensus on national guidelines for the prevention, diagnosis, and treatment of breast cancer that could influence coverage and reimbursement policies. For example, coverage of screening mammography by the Heath Care Financing Ad- m~rustration (HCFA) is expected to be the first major preventive proce- dure to be reimbursed by Medicare (Federal Register, January 23, 1989~. Cataracts Cataracts, which are opacifications of the lens of the eye, can cause progressive loss of vision in older persons. Some patients attempt to cope with decreasing vision through changes in eyeglass prescnptions. Treat- ment of this clinical condition in most patients, however, involves surg~- cal removal of the affected lens followed by implantation of an intraocular artificial lens. Lasers can be used to remove opacifications of He lens capsule that can develop after previous cataract surgery. A recent in- crease in the number of cataract operations has raised concerns about He appropriateness and effectiveness of surgery in venous clinical situations.

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30 NATIONAL ASSESSMENT PRIORITIES Assessments concerning cataracts would have the potential to do Me following. Improve Individual Patient Outcome Because they impair vision, cataracts affect a patient's functioning and ability to carTy out activities of daily living. Cataracts represent one of the major causes of treatable blindness and disability in the United States (Stark et al., 1983~. Affect a Large Patient Population An estimated 5.2 minion Americans have cataracts that interfere wad visual function (National Center for Health Statistics, I.G. CoUins, 1988~. These numbers are likely to increase over the next 30 years as the proportion of elderly persons increases (Manano, 1989~. In addidon, cataract extraction is He most common of aU major and minor surgical procedures among Medicare beneficianes, with between I.2 mildion and I.6 million performed annually (Helloing and Keene, 1989a; Stark et al., 1989~. Reduce Unit or Aggregate Cost The annual cost of cataract surgery and the associated visual rehabilita- tion has been estimated to be over $2.5 billion (National Advisory Eye Council, 1987~. In 1987, cataract surgery accounted for 6.5 percent of the entire Medicare Part B budget (Health Care Financing A~nin~s~abon, 1989b). Reduce Unexplained Variations in Medical Practice Chassin et al. (1986) documented variations in the rate of use of the procedure of lens extraction. High variations in the incidence of hospi- ~ization for lens operations have also been noted (Wennberg, 1984; Roos et al., 19g8; McMahon et al., 1989~. Affect Policy Decisions Given He apparent Refold or greater increase in the annual number of cataract operations in the past decade, Congress, HCFA, and others are increasingly interested in alternate reimbursement and cost-containment strategies (Stark et al., 1989~.

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OWENS PRlORl7Y ASSESSMENT A REAS 31 Enhance the national capacity for technology assessment Because cataracts are a reversible cause of functional disability, this clinical condition may be used as a mode} for He development of func- tional status and quality of life measures applicable to over clinical conditions. Chronic Obstructive Pulmonary Disease Chronic obstructive pulmonary disease (COPD) encompasses the cat cal states of chronic bronchitis, persistent asthma, and emphysema. The patients, who are usually smokers' may have frequent respiratory infec- tions, be short of bream, and develop heart failure and respiratory failure. Diagnosis and assessment of the progression of the disease is often made by clinical history and physical examination, chest x rays, and blood and pulmonary function tests. Outpatient treannent involves support systems such as smoking cessation programs and drugs such as airway-dilating medications, antibiotics, and oxygen. Inpatient management may also include aggressive respiratory therapy, including placement of the patient on a ventilator in an intensive care unit. Assessments concem~ng COPD would have the potential to do the following. Improve Individual Patient Outcome Despite the poor prognosis of this disease, more elective management of COPD may improve the quality of life of patients whose severe shortness of breath often Innits their daily activities. Affect a Large Patient Population COPD is Be fifth leading cause of death In Be United States, claiming more man 70,000 lives each year (Amencan Cancer Society, 1989~. Dunng 1985 the diagnosis-related group (DRG) of"COPD" was He thirteenth most frequently paid DRG under the Medicate Prospective Payment System (Hughes and Bans, 1987~. Reduce Unit or Aggregate Cost The annual cost of care for a Medicare patient hospitalized for COPD is more than $24,000 per patient (Health Care Financing Administration, 1989a). Hughes and Bans (1987) estimate that Medicam paid $435 million during 198S for expenditures associated with the DRG of COPD.

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32 NATIONAL AS~SMEN6TPRIORmES Reduce Unexplained Variations in Medical Practice Very high variations in the hospitalization rate for patients win CORD and "adult bronchitis and asthma" have been found ~ multiple studies (Wenoberg, 1984; Roos et al., 1988; McMahon et al., 1989~. Phelps and Parente (1989) estimate mat an annual national welfare loss of $550 minion and SI90 million respectively are associated with variations In medico practice for COPD and adult bronchitis and asthma. Address Social and Ethical Implications The prospect of permanent respirator dependence in the late stages of COPD raises serious ethical issues for padents, Weir families, and Weir clinicians. Enhance the National Capacity for Technology Assessment COPD may serve as a prototype for studying the relative effectiveness of technologies, such as oxygen therapy, Cat are provided in various heals care delivery sites (e.g., the home, hospital ward, or intensive care units. Coronary Artery Disease This is a broad cI=cal condition Cat includes patients at risk for coronary altered disease, asymptomatic pad ents with coronary artery dis- ease, padents with stable and unstable angina pectons, patients win myocardial infarction, and patients with complications resulting from coronary artery disease such as congestive heart failure and sudden dean. Screening and diagnosis of this condition relies on a variety of modalities such as cholesterol testing, electrocardiography, stress testing, catheten- zation, and several imaging technologies. There are many strategies for torment, including modification of risk factors, drug therapy, angioplasty, and coronary meIy bypass surgery. New and emerging technologies such as ~romboly~c agents and laser a~erectomy have furler broadened Me range of management options but have also increased me uncertainty as to which strategies are He most effective. Better understanding of the clinical condition of comnaIy meld disease and its clinical management would have He potential to do He following. Improve Individual Patient Outcome Tltis clinical condition results in a high degree of modality, morbidity, and disability; it can severely limit a pa~dent's activity, independence, and quality of life (Amencan Heart Association, 1989~.

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TWENTY PRIORITY ASSESSMENT AREAS 33 Affect a Large Patient Population Coronary artery disease is He leading cause of dead in He United States, accounting each year for 520,000 deaths and I.5 million myocardial infarctions (Amencan Heart Association, 1989; National Center for Heath Statistics, 1989a). hn 1987, cardiac ca~etenzation was the fourth most frequent surgical procedure performed nationwide, at 866,000 per year (ECR1, 19894~. Reduce Unit or Aggregate Cost Interventions associated with the diagnosis and treatment of coronary array disease and lost productivity as a result of this clinical condition cost the United States almost $80 billion in 19g6 (Amencan Heart Asso- ciation, 19X9~. Reduce Unexplained Variations in Medical Practice Geographic variations in the incidence of hospitalization have been docu- mented for chest pain, angina pectons, acute myocardial infarction, and major cardiovascular operations (Wennberg, 1984; Roos et al., 19X8; McMahon et al. 1989~. Phelps and Parente (1989) estimate that an annual welfare loss of $950 minion is associated with variations in the use of coronary bypass procedures, a loss of $620 million is associated with variations in He use of cardiac catheterization for circulatory disorders, and a loss of $460 million and $220 minion are associated with variations in medical practice related to angina pectons and myocardial infarction, respectively. Advance Medical Knowledge There is a great need to define He optimal strategies for screening, prevention, diagnosis, and therapy. This will require defining testable hypotheses regarding altemative technologies for each of He clinical states within this broad clinical problem. GalIbladder Disease Patients win galIbladder disease may experience pain and other SyITlp- toms associated win gallstones and Heir complications. This clinical condition is diagnosed by clinical history, physical exa~minabon, labora- tor', testing, and imaging technologies (e.g., ultrasound and nuclear medi- cine). For many years, the standard intervention for symptomatic gall- stones has been cholecystectomy, i.e., surgical removal of the gallbladder.

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34 NYLONS ~sF-C9M~PHo~= Over me past several years alternative therapies have become available, including gallstone~issolv~ng drugs that can be taken orally, gallstone- dissolving agents Hat can be insdIled directly into Be gallbladder, endo- scopic removal of gallstones, arid extracoIpoleal shock wave li~otnpsy. Assessments concerning gallbladder disease would have the potential to do the following. Improve Individual Patient Outcome Gallbladder disease can cause food intolerance, gastrointestinal dysfi~nc- tion, severe pain, infection, and even death. An individual with gallstones has a 10 percent chance of developing these symptoms or other complica- tions requiring surgery within 5 years (McPhee and Greenberger, 1987~. Affect a [large Patient Population Among people over 40 years of age, 20 percent of women and 8 percent of men have gallstones (McSherTy, 1981~. The 536,000 gallbladder operations performed in 1987 make cholecystectomy Me tenth most fre- quent surgical procedure performed in the United States (ECRI, 1989d). Reduce Unit or Aggregate Cost The annual cost of gallbladder surgery alone is Bought ~ be $3 billion (McSherry, 1981~. In addidon, many of the newer, less invasive therapies require numerous expensive diagnostic imaging studies. Reduce Unexplained Variations in Medical Practice McMahon et al. (1989), Roos et al. (1988), and Wennberg (1984) have identified variations in hospitalization rates for gallbladder disease and disorders of the biliary tract. Chassin et al. (1986) identified geographic vanadons in the use of cholecystectomy. Advance Medical Knowledge As new technologies for gallbladder disease emerge, new enters to guide the selection of the best therapy for individual patients need to be devel- oped. Gastrointestinal Bleeding This clinical condition refers to bleeding from the upper or lower gastrointestinal (Gb tract from causes such as peptic ulcer disease or malignancy (especially colorectal and stomach cancer). Associated tech-

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7WEWIY PRIORITY ASSESSMENT A tE IS 35 nologies for screening and diagnosis include fecal occult blood testing, endoscopic procedures, and imaging modalities. Some behaviors and dietary measures, such as cessation of alcohol use and He use of antacids and dietary fiber, help to prevent the diseases that can cause GI bleeding. Treatment strategies erdist the use of Snags, medical devices, and proce- dures such as endoscopic sclerotherapy, laser phomcoagulation, and emer- gency surgery. Assessments concerning G! bleeding have the potential to do the following. Improve Individual Patient Outcome Gastrointestinal bleeding can cause weakness, exacerbations of cardio- vascular disease, and death Mortality in hospitalized patients with upper gastrointestinal bleeding is approximately 10 percent (Peterson, 1988~. Some of the underlying causes of G! bleeding, e.g., cancer, can be life- th~eatening by themselves. Affect a Large Patient Population Several causes of G! bleeding are very common For example, the prevalence of symptomatic peptic ulcer disease is between 6 and 15 percent (McGuigan, 1987), and colorectal cancer is Me second most common cancer overall, accounting for 150,000 new cases and 61,000 deans each year (Amencan Cancer Society, 1989~. The importance of this problem is also reflected by the rapidly increasing frequency of endoscopic procedures. In the interval from 1983 to 1986, We volume of upper GI endoscopy, sigmoidoscopy, and colonoscopy billed to Medicare increased by 43, 216, and 121 percent, respectively (Mitchell et al., 1989~. Reduce Unit or Aggregate Cost All endoscopic procedures, including upper endoscopy, colonoscopy, and sigrnoidoscopy, were among Me most expensive surgical produces for the Blue Cross and Blue Shield Fede~ Employee P=grmn (Blue Cross and Blue Shield Association, 1989b). In addition, Me cost of screening colonoscopy for a I-year cohort of new Medicare benefic~anes over their lifetime is estimated at $2 billion (Office of Technology Assessment, 19~. Reduce Unexplained Variations in Medical Practice Vanations exist in the practice styles and clinical management strategies for gastrointestinal bleeding (Office of Technology Assessment, 1990~. For instance, Chassin et al. (1986) documented geographic variations in

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36 NATIONAL AS5E5SMENTPRIORmES me use of the procedure of upper G! endoscopy. There is also evidence of vanations In He incidence of hospitalization for G} hemorrhage (Wennberg, 1984; Roos et al.' 1988; McMahon et al., 1989~. Affect Policy Decisions Colorectal cancer screening by fecal occult blood testing and sigrnoido- scopy has been recommended by several groups, yet it remains of un- proven cost-effectiveness (Office of Technology Assessment, 1990~. Assessment of this topic could have a direct impact on coverage decisions made by payers about screening for colorectal cancer. Human Immunodef~ciency Virus Infection The population affected by human immunodeficiency virus (HIV) infection includes individuals with acquired immune deficiency syndrome (AIDS, the end stage of infection), patients with a spectrum of mild to severe symptoms, and persons who are HIV-posi~ve in blood tests but are asymptomatic. Infected persons range in age from newborns to adults. Stemming the HIV epidemic primarily depends on prevention educat- ing against sexual and Unug abuse practices that constitute high-r~sk behavior. Treatment efforts entail He use of approved and experimental drugs such as zidovudine LAZE and dideoxyinosine (ddI) to combat the Unman infection, and oral and inhaled andbiodcs to fight and prevent opportunistic infections. Recently, the National Institute of Allergy and Infectious Diseases announced the results of two clinical teals Hat showed He benefits of AZr therapy for patients win early symptoms of HIV infection and for some persons with HIV infection who are asymptomatic (National Institute of Allergy and Infectious Diseases, 1989~. Assess- ments concerning HIV infection wood have the potential to do the fol- lowing. Improve Individual Patient Outcome AIDS is an incurable fated disease whose man~festabons range from weight loss and fatigue to AIDS dementia, life-threatening secondary infections, and malignancies. The psychologic, emotional, and physical effects of AIDS am devastating. Affect a Large Patient Population The total number of reported AIDS cases in the United States now exceeds Il5~000 and is projected by the Centers for Disease Control to

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TWENTY PRIORITY ASSESSMEIVT AREAS 37 reach 285,000 by the end of 1991 (Public Health Service, 1988; Centers for Disease Control, 19893. Those who might benefit from early Aver treatment represent another 100,000 to 600,000 HIV-infected persons who are either asymptomatic or have early signs of HIV infection (Marx, 19893. The total number of Amencans infected with HIV is estimated to be I.0 minion to 1.5 minion (Public Health Service, 1988~. Reduce Unit or Aggregate Cost Direct medical care costs of persons with AIDS have been estimated at $6 billion by 1991 fin 1988 doDars3 (Scitovsky and Rice, 1987; Hanger, 1988; Scitovsky, 1989~. Because AIDS in the United States afflicts pnmanly young adults (ages 20 to 49 ~ who are in the productive periods of their lives, the indirect costs of the epidemic have been estimated at $55.6 billion in 1991 (Scitovsky and Rice, 1987~. The medical costs of treating persons infected with HIV, but who do not yet have AIDS, have been estimated to be $5 billion per year (Amo et al., 1989~. Reduce Unexplained Variations in Medical Practice Treatment of AIDS varies widely, especially across geographic areas, with regard to the use of Inpatient hospital services and self-help activities of affected groups (Sisk, 197. Advance Medical Knowledge Many aspects of the pa~ogenesis and clinical manifestations of this disease are not wed understood. Future research promises to improve knowledge about viruses, immune function, and their relationship to opportunistic infection and cancer. Address Social and Ethical Implications Many social and ethical issues surround this coccal condition because of its association with homosexual behavior and Intravenous drug abuse. HIV testing raises concerns about confidentiality, loss of insurance, and discr~minabon. Fur~ennore, cans for refonn of AIDS drug clinical trials suggest a perceived need for greater access to new and expenmental drugs. Affect Policy Decisions Attempts to expedite the development and approval process for technolo- gies for managing HIV infection could help direct limited resources to He most promising and cost-effective methods of prevention, care, and cure.

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44 NATIONAL ASS=SMENTPRIORmES Reduce Unit or Aggregate Cost Payments for Medicare beneficiaries receiving inpatient services for TURF accounted for $750 minion In 1986 expenditures, at $3,396 per discharge (Helloing and Keene, 1989b). Reduce Unexplained Variations in Medical Practice The variations in hospi~zation rate and choice of procedure are high (Wennberg et al., 1988~. In addidon, unexplained variations In moronity and cooperation rates after TURP, compared with rates after open prostat- ectomy, have raised much concern (Roos et al., 1989~. Advance medical knowledge The biologic cause of BPH and its possible relation to prostatic cancer are examples of areas for further study. New and emerging drug and hormonal therapies may increase the range of effective treatment options. Enhance the National Capacity for Technology Assessment Studies of BPH based on patient evaluations of post-treatment functional status may aid in developing and refining ways to assess differences in patient satisfaction with different treatment outcomes (Fowler et al., 1988~. Psychiatric Disorders This assessment area includes clinical conditions such as anxiety states, depression, mania, schizophrenia, organic mental syndromes, and person- ality disorders. Addictive disorders, such as alcohol and drug abuse, are considered under the separate topic of substance abuse. Modalities for the treatment of psychiatric disorders include psychotherapy, psychosocial interventions, pharmacotherapy, and electroconvulsive therapy. Many of these treatment approaches can be used in either inpatient or outpatient settings. Assessments concerning psychiatric disorders would have the potential to do He following. Improve Individual Patient Outcome A patient with a psychiatric disorder can experience psychologic suffer- ing, social maladjustment, physical debilitation, and family disruption. For instance, major depression is associated with 30 to 70 percent of aU suicides (National Institute of Mend Health, 1985~. The morbidity and mortality of a psychiatric disorder could be alleviated win more effective treannent.

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TWENTY PRIORITY ASSESSMENT AREAS 45 Affect a Large Patient Population Psychiatric problems are among the most common afflictions of children and adults Onstitute of Medicine, 1984~. The lifetime prevalence of psychiatric disorders in the United States is about 20 percent (Regier et al., 1988). Reduce Unit or Aggregate Cost The total cost to society for psychiatric disorders is estimated to be $72 billion (in 1983 dollars) annually in the United States. This figure in- cludes We direct costs of treatment and support ($33 billion) and the indirect costs of moronity, reduced productivity, and lost employment ($37 billion)' as wed as the costs of social welfare programs, crimes and incarceration ($2 billion) (Harwood et al., 1984~. Reduce Unexplained Variations in Medical Practice Phelps and Parente (1989) estimate that the national annual welfare loss (in dollars) associated with variations in the treatment of psychosis is $740 minion, and that the loss associated with variations in Me treatment of depressive neurosis is $190 million. Very high variations in hospitali- zation rates for acute adjustment reactions, depressive neurosis, psycho- sis, and organic mental syndromes have also been reported (Wennberg, 19g4; Roos et al., 1988; McMahon et al., 1989~. Advance Medical Knowledge There are significant unresolved questions about the effectiveness and appropriateness of many psychotherapeutic and pharmacologic treatment approaches for psychiatric disorders. Affect Policy Decisions The unmet mental health needs of the U.S. population are substantial, especially among Me homeless and the uninsured Constitute of Medicine, 1988; Hilfiker, 1989~. Assessment of this major public health and social problem could assist policymakers in meeting Mat need more effectively. Substance Abuse This condition includes dependence on and nondependent abuse of alcohol, prescription drugs (such as tranquilizers), and illicit Snugs (such as cocaine, heroin, and marijuana). Strategies for addressing substance abuse draw on a wide variety of technologies. They include social and

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46 NATIONAL ASSE5SMENTPRlORmES educational programs for prevention; drug testing for screening; psycho- therapy, pharmacotherapy, and hospitalization for detoxification and treat- ment; and support systems such as social, psychologic, and residential support for rehabilitation. Substance abuse has been consistently identi- fied by the government, information media, and public as one of the nation's most ~mpormnt problems. Assessments concerning substance abuse would have the potential to do the following. Improve Individual Patient Outcome The morbidity and moronity impact of substance abuse is indicated by the fact that more than half of all homicides, suicides, assaults, motor vehicle accidents, drownings, and fires are alcohol- or dn~g-related (West al., 1984). Affect a Large Patient Population The lifetime prevalence of substance abuse and dependence has been estimated to be about 16 percent nationwide (Regier et al., 1988~. Reduce Unit or Aggregate Cost The total cost to society of substance abuse in 1983 doBars was estimated at $176 billion. This figure includes $16 billion for direct costs of treannent and rehabilitation; $125 billion in indirect costs because of modality, reduced productivity, and lost employment; and $34 billion in other related costs attributable to motor vehicle accidents, crime, incar- ceration, and social welfare programs (Harwood et al., 1984~. Redluce Unexplained Variations in Medical Practice Phelps and Parente (1989) estimate that the national annual welfare loss (in dollars) associated with vacations in medical practice related to alco- ho} and Snug abuse use is $210 milBion. Address Social and Ethical Implications Practices such as drug testing have raised a number of ethical questions regarding the proper balance between an individual's right to privacy and due process of law and the state's obligation to protect the health, safety, and welfare of the community.

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D~N7YPRlORm ASSES~ENTARE4S 47 Advance Medical Knowledge The incomplete understanding of the biologic and environmental detenni- nants of substance abuse is a significant impediment to He unprovement of care and a compelling reason to increase efforts for me cnbcal evalu- ation of prevention and treatment strategies. Affect Policy Decisions The enormous financial costs of these problems and their adverse impact on society, particularly youth, make this a major domestic policy issue. TECHNOLOGIES Diagnostic Imaging Technologies Diagnostic imaging is Be practice of detecting and characterizing potentially diseased organs by viewing human anatomy non~nvasively. The most familar fume of diagnostic imaging employs conventional x rays; but the technologies include far more intricate and costly means such as ultrasound, radioisotope scans, computed tomography (CD, mag- netic resonance imaging (MRI), positron-emission tomography SPED, single photon emission computerized tomography (SPECT), and others. New contrast agents and radiopharmaceubcals form another set of emerg- ing imaging technologies. Conducting assessments within the family of diagnostic imaging technologies would have the potential to do the fol- low~ng. Improve Individual Patient Outcome In many cases, new imaging modalities have replaced He need for more invasive and risky diagnostic procedures. Better info~madon may detect disease in an earlier stage and subsequently decrease morbidity and mor- ~ity. Reliable information about the absence of disease can decrease patient anxiety associated with uncertainty. Affect a Large Patient Population In 1986, the total number of diagnostic imaging procures was 172 million nationally (Amencan Healthcare Radiology Adm~n~suaton, 1987~. Medicare beneficiaries received 64 million of Hose imaging examina- tions (Helloing and Keene, 1989a).

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48 N A T I O H A L 3 4 5 5 E S S M & V T. P. R l O. R. m E S Reduce Unit or Aggregate Cost Hospices devoted $2.2 billion of their total S8.3 billion for equipment spending to diagnostic imaging equipment (ECRI, 1989a). In 1986, 8.5 percent of charges for Medicare Part B were for diagnostic radiology physician services, accounting for $2.2 billion (Helloing and Keene' 1989a). Address Social and Ethical Implications The ownership of outpatient imaging facilities by clinicians who may also refer patients to the same facility raises conflict-of-interest concerns. The need for professional guidelines or other policies regulating clinician self- referral may merit further examination (ReLnan, 198S; Hyman and Wil- liamson, 1989~. Advance Medical Knowledge The relative advantages and disadvantages of imaging modalities are often described in relatively crude qualitative terms. The sensitivity and specificity of many of these technologies are not well characterized. The relative clinical usefulness of images produced by different generations of the same class of devices has not been evaluated systematically. Further- more, well-infoImed guidance for appropriate sequencing of multiple testing with different diagnostic imaging modalities and the extent to which new modalities can replace older ones is often inadequate. Affect Policy Decisions Because of He high capital and maintenance costs of technologies like MRI and PEN, planning and funding agencies may use certif~cate-of-need (CON) policies to control the number and distnbution of imaging facili- ties. Currently, very few CON programs cover the growing sector of outpatient imaging facilities (Baum, 1989~. Hence, payment and pur- chasing policies for imaging equipment are areas for fueler development. Diagnostic Laboratory Testing Diagnostic laboratory testing is a family of diverse technologies used for betel ng He presence of a clinical condition or identifying its cause. In He context of a heady care facility, diagnostic laboratory testing usually refem to any or all of He ente~pnses of the chemistry, hematology, microbiology, immunology, and pathology laboratories. Diagnostic test- ~ng involves medical devices, interpretation protocols, and professional laboratory staff. It might refer to a single test such as a home pregnancy

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TWENTY PRJOR17Y ASSESSMENT AREAS 49 test or to a battery of tests such as antibody testing. Taken individually, tests have relatively small effects on costs; however, the lack of controls on test ordenng and Heir easy availability provided by sophisticated automation has magnified their unpact on health care. Assessments in me area of diagnostic laboratory testing would have the potential to do the following. Improve Individual Patient Outcome Many diagnostic laboratory tests have an invasive component that can cause discomfort and pose health nsks. An addition, high test volumes increase the number of false-positive results that may lead to more inva- sive, yet unnecessary, tests. Affect a Large Patient Population Over 173 minion diagnostic laboratory procedures were reimbursed un- der Medicare Part B in 1986 (Helloing and Keene, 1989a). Reduce Unit or Aggregate Cost Diagnostic laboratory tests cost more than $100 billion in 1987 (Grady, 1988~. The costs of laboratory testing account for more than 14 percent of the average inpatient hospital bill and a higher percentage of the outpa- tient bin (Grady, 1988; Hardey et al., 1989; Women, 1989; Travers, 1989~. Advance Medical Knowledge Many commonly used laboratory tests have never been evaluated system- aticaBy. Some studies estimate Hat over 60 percent of preoperative laboratory tests may be performed without documented and appropriate clinical indications (Kaplan et al., 1985~. Affect Policy Decisions Simple, specific changes in hospital laboratory policy may directly affect clinician test-ordenng behavior. For example, one medical center de- creased by 50 percent the number of manual leukocyte differential counts (a labor-~ntensive white blood cell count) by requiring that the test request be written out rather than merely checked off In a box on He standard test order form (Eisenberg and Williams, ~ 98 ~ ).

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so Erythropoietin N A T I O N A L A S S E S S M E ; N T. P. R l O. R. m E S E~h~poietin (EPO) is a genetically engineered version of a natural hormone that stimulates red blood cell production. This drug may be used in patients with chronic red blood cell deficiencies (anemias) associated with clinical conditions such as chronic kidney disease, cancer, and AIDS. The Food and Drug Administration recently approved the use of EPO for the treatment of severe anemia in patients with end-stage renal disease (ESRD) (Young, l989~. For these patients, EPO is a new altemative to traditional blood transfusion. Assessing the emerging technology of EPO would have the potential to do the following. Improve Individual Patient Outcome EPO is reported to be efficacious in treating the anemia of ESRD and its related symptoms: weakness, fatigue, and activity limitation (Eschbach et al., 1987~. Moreover, the use of EPO should provide clinical benefits similar to those of blood transfusion with fewer of the risks, e.g., the risk of blood-bome viral infections such as hepatitis and HIV infection. Affect a Large Patient Population This technology may be used for the estimated 100,000 Americans who suffer from the anemia of chronic kidney disease (Young, 19891. The population of patients with anemias caused by other condition~such as predialysis kidney disease, cancer chemotherapy, AIDS, rheumatoid ar- ~ritis, and autologous blood transfusion candidatesfor which EPO therapy may be applicable is even larger (ECRI, 1989b; Eschbach et al., 1989~. Reduce Unit or Aggregate Cost Me use of EPO could lead to direct savings associated with lower use of transfusions and tissue-type screening and fewer days of hospitalization. However, the annual cost per patient for EPO therapy is expected to range from $4,000 to $8,000 (ECRI, 1989b). Affect Policy Decisions The potential use of EPO for several classes of patients win kidney disease, and other clinical conditions, would require HERA and private third-party payers to develop reimbursement policies.

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7WEMY PRIORITY ASSESSMENT AREAS 51 Implantable Devices This high-pnor~ty topic represents a family of new and emerging devices that are implanted in He body to perfonn a physiologic function' but do not directly replace an organ or body part Included in this group are unplantable devices such as pacemakers, automatic cardiac defibriBa- tors, infusion pumps, cochiear implants, nettle stimulators, vascular ac- cess ports, and intrauterine contraceptive devices. Assessments concem- ing implantable devices would have the potential to do Be following. Improve Individual Patient Outcome These devices can provide a wide range of patient benefits. They can help avert fatal cardiac evens; restore lost or absent heanng; improve touch, sensation, and muscle function; and prevent unwanted pregnancies. Affect a Large Patient Population Many patients could be aided by these devices. Implanted defibnDators might be applicable in aU high-nsk survivors of acute myocardial infarc- tion. Over 105,000 pacemakers are implanted annually, and eventually a projected 30,000 implantable cardiac defibriBators might be used per year (Project HOPE, 1988~. Infusion pumps might be used for patients ~quir- ing hormonal replacement therapy (e.g., all insulin-requinng diabetics), administration of anti-antythmic agents, and administration of drugs for chronic pain relief. Reduce Unit or Aggregate Cost The cost per case is estimated to be $7,500 to S9,500 for pacemakers, $7,000 lo $12,000 for ~mplantable infusion pumps, $8,500 to SI4,250 for cochIear implants, and $28,000 for unplantable defibnUators Object HOPE, 1988~. The aggregate economic impact in fiscal year 1989 on Medicare expenditures was estimated to be $15.7 minion for pacemakers, $12.5 minion for implantable defibnDators, $4.0 minion for ~mplantable infusion pumps, and $2.8 million for cochIear implants Project HOPE, 1988). Reduce Unexplained Variations in Medical Practice Phelps and Parente (1989) estimate an annual welfare loss of SIS0mil1ion associated win variations in the use of pacemaker procedures.

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52 Intensive Care Units NATIONAL ASSESSME=PRIORITIES Intensive care units (ICUs) are systems of technologies for treating a vanes of life-th~eaten~ng cI~rucal conditions. They include medical and surgical ICUs as wed as specialized neonatal, pediatric, coronary, bum, trauma, and neurolog~c ICUs. ICUs include technologies for diagnosis such as continual cardiopulmonary monitoring and rapidly accessible laboratory and imaging services; technologies for life-sustain~ng inter- ventions, including cardiopulmonary resuscitation, mechanical ventila- lion, emergency cardiac pacing, and titrated infusion pump drug thera- pies; and health care professionals specially trained in critical care. As- sessments related to ICUs would have the potential to do the following. Improve Individual Patient Outcome ICUs save lives that would otherwise be lost. For instance, the modem coronary care unit has halved the risk of sudden death after myocardia] infarction. Dramatic changes in survival rates have also been shown for patients with acute complications of cI~rucal conditions such as major bums, trauma, and drug overdose (Office of Technology Assessment, 19~. Affect a Large Patient Population Four minion adult padents are admitted to medical and surgical ICUs every year, and 65,000 adult patients occupy medical and surgical ICU beds In the United States every day. Intensive care now accounts for about 7 percent of all hospital beds. An estimated 275,000 deaths per year occur in patients who have been in special care, accounting for about half of the annual Medicare hospital deaths (Knaus et al., 1989~. Reduce Unit or Aggregate Cost Intensive care is thought to be responsible for approximately 15 to 20 percent of hospital expenses. In 1982, it accounted for between $13 billion and S15 billion of costs associated with patients in adult ICUs and coronary care units (Office of Technology Assessment, 1984). In 19889 intensive care costs were approximately equivalent to 1 percent of the U.S. gross national product (Knaus et al., 1989~. Reduce Unexplained Variations in Medical Practice Reported mortals rates in ICUs range from less than 10 to greater than 40 percent. This may be due to variability in criteria for admission, length of stay, efficacy of intervention, and other factors (Office of Technology Assessment, 1984; Knaus et al.' 1989~.

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7WEN7Y PRIORITY ASSESSMENT AREAS 53 Address Social and Ethical Implications Decisions to forego or discontinue life-susta~n~ng procedures arise fre- quently in the ICU sewing. Policies to help patients, their families, and clinicians deal with these difficult choices become more impomnt as new technologies that allow medical support to extend life furler at both extremes of age become available. or Advance Medical Knowledge Even though intensive care has been accepted as a standard of care, there is a lack of sufficient data that substantiate the long-te~ medical benefits of ICUs for many clinical conditions. Better studies are needed of the individual technologies comprising the ICU and of the ways to stratify the ICU population to predict patients who will have good outcomes (some of whom may not need intensive care or may need less of it) as weld as patients who win have bad outcomes (some of whom may not benefit from intensive care). Affect Policy Decisions Because ICU patients often have multiple diseases of great seventy, the DRG classification and payment system may not adequately capture the costs of treating them (Office of Technology Assessment, 1984~. hn- provement of payment coding systems for care in an ICU may serge as a prototype for modifying existing disease and procedure classification schemes. Organ Transplantation and Replacement This is a set of technologies that includes all therapeutic implantations of a human or artificial organ to treat organ failure. Organ transplantation and replacement involves technologies Hat have been recognized as established (e.g., heart, kidney, and cornea transplantation), new Diver and bone marrow transplantation), and emerging (pancreas ~nsplanta- tion and certain artificial organs). Assessments of organ transplantation and replacement technologies would have the potential to do the follow- ~ng. Improve Individual Patient Outcome Successful organ transplantation can reverse a patient's previous chronic disease and significantly reduce Be associated mortality, morbidity, d~is- ability, and diminished quality of life.

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- ~ NYLONS ~~M~PHO~= Affect a Large Patient Population Abe number of organ transplants has increased every year. In 1988, nearly 14,000 major organ transplants Dcidney, hean, liver, and bone marrows and 37,000 comeal transplants were performed (United Network for Organ Shanng, 1989~. The curmnt number of eligible candidates for major organ transplants is estimated to be between 40,000 and 66,000 (American Council on Transplantation, 19893. Reduce Unit or Aggregate Cost Transplantation p~ures have high unit costs. Average unit costs range *om: $3,000 to S7,000 for a cornea, S30,000 to $40,000 for a kidney, S130.000 to $200,000 for a heap and S135,000 200.000 for a liver (Amencan Council on T=nsplar~ation, 1989~. Auroras Social and Ethical Implications Because Mere are many more potential recipients than donor organs, ethical issues arise about how these limited resources can be allocated fairly. Advance Medical Knowledge Furler developments in t~plan~ion should continue to uncover infor- mation about nomad and abnormal immune function (e.g., rejection of Dansplanted organs), as well as elucidate We clinical manifestations of rapidly reversing organ failure. Affect Pokey Decisions Recent attempts have been made, with varying success, to increase the number of donor organs by passing legislation Squiring hospitals in the Medicare system to routinely inquire about organ donation (Project HOPE, 1988~. Assessments may also provide Me basis for more informed cover- age and reimbursement policies by Bird party-payers.