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The changing environment for technological innovation in health care.

A distinguishing feature of American health care is its emphasis on advanced technology. Yet today's changing health care environment is overhauling the engine of technological innovation. The rate and direction of technological innovation are affected by a complex of supply- and demandside factors, including biomedical research, education, patent law, regulation, health care payment, tort law, and more. Some distinguishing features of technological innovation in health care are now at increased risk. Regulatory requirements and rising payment hurdles are especially challenging to small technology companies. Closer management of health care delivery and payment, particularly the standardization that may derive from practice guidelines and clamping down on payment for investigational technologies, curtails opportunities for innovation. Levels and distribution of biomedical research funding in government and industry are changing. Financial constraints are limiting the traditional roles of academic health centers in fostering innovation. Despite notable steps in recent years to lower regulatory barriers and speed approvals, especially for products for life-threatening conditions, the Food and Drug Administration is under great pressure from Congress, industry, and patients to do more. Technology gatekeeping is shifting from hundreds of thousands of physicians acting on behalf of their patients to fewer, yet more powerful, managed care organizations and health care networks. Beyond its direct effects on adoption, payment, and use of technologies, the extraordinary buying leverage of these large providers is cutting technology profit margins and heightening competition among technology companies. It is contributing to unprecedented restructuring of the pharmaceutical and medical device industries, leading to unprecedented alliances with generic product companies, health care providers, utilization review companies, and other agents. These industry changes are already having considerable effects on investment patterns and the development, adoption, and use of new technologies. Until recently, new technologies that offered the prospect for health benefit, however, marginal or unproven, were paid for with little or no regard to cost. Technical wizardry alone no longer carries the day in health care. Today's health care market increasingly demands what other markets do--measurable improvements in benefits at acceptable costs--and innovators have begun to respond accordingly. Even so, certain key venues for health care innovation are at risk.

Biomedical Technology↗

Clinical benchmarking for the office practitioner enabled by the online health record

Payer organizations, regulatory entities, and delivery networks are placing increasing pressure on physicians to report aggregate information about their patients and practice of medicine. Historically, clinicians have been ill-equipped to respond to these pressures when their practices have relied upon payer records for clinical information management. Key Industry Drivers: Physicians need specific information from their practices for the purposes of contract management, preventive care, office productivity, and utilization reviews. Value Statement: Clinical data captured at the point of care can support reporting requirements, and supplement or replace laboriously-collected data derived from billing and other administrative systems. Information from the Online Health Record can empower the individual physician to assess what is going on in their practice of medicine, as opposed to being "profiled" by an external entity. We created a secure web-based system that provides access to a clinical data mart, to allow online benchmarking for the individual or office practitioner. Providers used a web-enabled documentation system to document the clinical facts of the encounter. A nightly set of routines extracts data from the online chart into the clinical data mart built in a relational database. The system uses a clinical vocabulary server to map provider-entered strings to normalized clinical concepts. The system loads chart data into a dimensional data model, to simplify data representation and ensure fast query performance. Providers can access their own profiles from a secure web browser.

Journal Article↗

Pharmacokinetics/pharmacodynamics in drug development: an industrial perspective.

In a health care environment dominated by the growth of managed care organizations, generic competition, therapeutic substitution and drug utilization review, drug development is an extremely risky proposition. Consequently, it is imperative to incorporate a mechanistic approach to drug development that combines a thorough understanding of a drug at the molecular/cellular level with a rigorous preclinical, and clinical pharmacology program. This should enable the sponsor to evaluate multiple hypotheses during the early "learning" phases of clinical development (Phases I and IIA) and to eliminate nonpromising candidates early on while drug development costs are low. Clinical research done properly in the early stages of drug development will also set the stage for designing and conducting optimal "confirming" registrational Phase IIB/III studies for promising drug candidates. Pharmacokinetics (PK) and pharmacodynamics (PD) modeling and simulation are crucial components of a mechanistic approach to optimal drug development and their application has significant impact in both early and late development efforts. This communication describes several applications of pharmacokinetics and pharmacodynamics modeling and simulation that were important in guiding, optimizing and ensuring the success of development efforts for drug candidates in the therapeutic areas of cardiology and oncology. These examples are used to illustrate and discuss the use of the current state-of-the-art in pharmacokinetics and pharmacodynamics modeling and simulation at numerous stages in the development cycle and to postulate on future directions in this area.

Clinical Trials as Topic↗

The hospitalist.

Efforts to improve the efficiency and quality of hospital inpatient care have led to the movement to replace the primary care physician with the hospitalist as the inpatient physician of record. A hospitalist serves as the physician of record after accepting referrals of hospitalized patients from primary care physicians. The hospitalist then keeps the primary care physician informed of major healthcare decisions during the patient's entire hospital stay. One of the forces promoting the hospitalist movement is the assumption that inpatient care provided by a small number of physicians is less costly, of higher quality, and less variable than the care provided by primary care physicians who see patients only briefly once a day. Hospitalists are accessible throughout their shifts and can better respond to changing patient needs. With this model of care, hospitalists have taken a more proactive role in redesigning support-care systems based on the needs of the patient. Many perform quality improvement and utilization review, and engage in the development of clinical practice guidelines. Concern over the hospitalist model has focused on the break in continuity of care. Patients and their families may feel that they are losing a physician whom they know and for whom they have some level of comfort and confidence. As the hospitalist movement picks up momentum, so too does its expectation to improve and provide for quality end of life care.

Case Management↗

Electronic prescribing in ambulatory practice: promises, pitfalls, and potential solutions.

OBJECTIVE: To examine advantages of and obstacles to electronic prescribing in the ambulatory care environment. DATA SOURCES: MEDLINE and International Pharmaceutical Abstract searches were conducted for the period from January 1980 to September 2000. Key words were electronic prescribing, computerized physician order entry, prior authorization, drug utilization review, and consumer satisfaction. In September 2000, a public search engine (www.google.com) was used to find additional technical information. In addition, pertinent articles were cross-referenced to identify other resources. DATA EXTRACTION: Articles, symposia proceedings, and organizational position statements published in the United States on electronic prescribing and automation in healthcare are cited. DATA SYNTHESIS: Electronic prescribing can eliminate the time gap between point of care and point of service, reduce medication errors, improve quality of care, and increase patient satisfaction. Considerable funding requirements, segmentation of healthcare markets, lack of technology standardization, providers' resistance to change, and regulatory indecisiveness create boundaries to the widespread use of automated prescribing. The potential solutions include establishing a standardizing warehouse or a router and gaining stakeholder support in implementation of the technology. CONCLUSIONS: Electronic prescribing can provide immense benefits to healthcare providers, patients, and managed care. Resolution of several obstacles that limit feasibility of this technology will determine its future.

Ambulatory Care Information Systems↗

HMO behavior and stock market valuation: what does Wall Street reward and punish?

This article analyzes the variation in returns to owning stock in investor-owned health maintenance organizations (IOHMOs) for the period 1994-1997. The average return (measured by the change in the market value of the stock plus dividends) was close to zero, but returns were positive and high for firms operating in local markets that were and remained less competitive, with large nationwide scope, and with less rapidly growing panels of contracted physicians. Indicators of a firm's strategic direction were abstracted from their annual reports; firms pursuing a merger or acquisition strategy, and those emphasizing a utilization review strategy, showed lower returns than those that did not. Other strategy and market variables were not related to stock market returns over this period, and were also generally not related to price-earnings ratios. This analysis supports the view that competitive HMO markets best constrain profits to investor-owned firms.

Annual Reports as Topic↗

ERISA preemption and Oklahoma laws on managed care.

The Employee Retirement Income and Security Act of 1974 ("ERISA") affects Oklahoma managed care laws and thus the practice of medicine in complex and important ways. Because ERISA was enacted before managed care became an industry, ERISA's provisions have had unanticipated effects and become controversial. Insurers and managed care organizations have been quite successful in taking advantage of ERISA's preemption provisions to avoid being controlled by state laws, including those that regulate insurance. Congress is presently seeking to change this to varying degrees in the different versions of the "Patient Protection" bills. ERISA preempts state laws that "relate to" the administration of an ERISA covered plan. Numerous courts and legal scholars have sought to define what this language means with respect to state managed care laws. ERISA preemption affects patients' rights to sue utilization reviewers and insurers (as opposed to healthcare providers) for negligent determinations of "medical necessity" that interfere with treatment. Moreover, it interferes with Oklahoma's laws governing the quality of benefits, including those concerning external review of insurance benefit determinations. This article provides practitioners with a roadmap to one of the most important debates in healthcare today to facilitate informed participation in the political process on these issues.

Employee Retirement Income Security Act↗

Denials of reimbursement for hospital care.

Much of the negative perception of managed care focuses on fear of denials of certification for reimbursement. This study examined more than 50,000 concurrent utilization reviews completed over a four-year period (1998-2001) at a large teaching hospital. The results showed a denial rate of less than 1.5% of all patients reviewed, higher denial rates among certain clinical services, higher rates of reviews among certain services only partially explained by volume of admissions, and a lack of patient criteria to receive care in the inpatient setting as the most frequent reason given for denial.

Concurrent Review↗

[Computerized physician order entry, a tool for added safety in the hospital].

DRUG-RELATED IATROGENIC NOSOCOMIAL ILLNESS: Remains a matter of concern in the public health area. Responsibility of hospitals is challenged by the ever increasing number of patients' claims. Dysfunction in the drug-prescribing and delivery system account, to a large extent, for medication errors, some of them resulting in adverse drug events. Most generally, medication ordering by the physician is handwritten, without nominative recapitulating prescriptions, and followed by nurse transcriptions and a global medication order is transmitted to the pharmacy. This system does not integrate the pharmaceutical analysis of the prescription, before distribution of the drugs. THE COMPUTERIZED DRUG ORDER ENTRY PROCESS: The prescription is entered directly and is displayed on the computer screen, together with the previous prescriptions for the same patient. Transcription is hence eliminated. Depending on the sophistication of the software, the prescription undergoes a series of tests; warnings and reminders can be displayed online before the physician validates the prescription. Moreover, various guidelines in some aspects of drug therapy may be presented online before the prescription is completed. POSSIBILITIES: The pharmacist's access to the complete prescriptions permits analysis of the quality and safety of the prescriptions and the adequation with eventual current applicable recommendations. Prospective drug utilization review, with immediate feedback to the prescribing physician in case of concern, may be undertaken, further improving the quality of drug therapy. Moreover, a work sheet is printed out for the nurses, further enhancing the safety of drug administration and validation. The computerized drug network also permits the development of other functions. A TOOL FOR SAFETY: Currently available reports in the literature suggest that computerized drug prescription reduces the incidence of prescribing errors, improves the appropriateness of drug choices, optimises therapeutic follow-up, and reduces the incidence adverse drug events and leads to substantial reduction in drug expenditures.

Computers↗

Case management: key to access, quality, and financial success.

Several strategic, organizational, and operational variables drive successful case management programs. Organizational goals and accountability for support by administrative and medical staff leaders set the stage for a comprehensive program. The integration of utilization review, discharge planning, and other functions into the role of the case manager improves productivity and continuity. Choosing a model for assigning patients, a variable unique to the institution, should be carefully considered. Regardless of the power of strategic goals or the creative selection of a model, daily practices that promote daily review and communication will reveal all of the opportunities for improved performance. Complications are avoided one patient at a time and patients deserve vigilance. Length of stay is shortened 1 day at a time and we can no longer afford to miss these opportunities. In the period of high census, an unnecessary day for one patient at the end of his/her stay may mean another patient being diverted to another hospital away from his/her physician and past medical records. Creating constructive physician partnerships and cooperative relationships with postacute care providers can bring a case management program to higher level of performance. While many organizations have employees called "case managers," fewer have a comprehensive approach that has the potential to drive so many important indicators of performance.

Case Management↗

A curriculum in systems-based care: experiential learning changes in student knowledge and attitudes.

BACKGROUND: To provide efficient, quality patient care, physicians must have a fundamental understanding of how the health care delivery system functions and how to appropriately use the various components of this system. As part of the Undergraduate Medical Education for the 21st Century (UME-21) initiative, the University of Miami in partnership with AvMed Health Plans, a nonprofit managed care organization (MCO) developed a longitudinal educational program that prepares all students for medical practice in emerging systems of care. METHODS: The program, which spans the 4-year undergraduate curriculum, incorporates didactic sessions and practical experiences to teach about the clinical, managerial, financial, and ethical aspects of systems-based care. During the third year of medical school, students visit the administrative offices of AvMed Health Plans for a day-long series of presentation-discussions and experiential tours through the various administrative departments. There, they experience first-hand all facets of a systems-based approach to care using evidence-based practice guidelines, utilization review, quality measurement and improvement, and chronic disease management. RESULTS: An attitudinal survey, constructed to evaluate general attitudes toward managing care and MCOs, was administered to students at the beginning of their first, second, and third year and immediately before and after their visit to AvMed during their third year. Using factor analysis, there were no significant differences in students' attitudes at the beginning of the first, second, or third year nor immediately before the seminar day at the MCO. However, the day-long seminar at AvMed did have a favorable effect on attitudes toward systems of care and MCOs in general. In addition, students performed well on post-evaluation knowledge assessments addressing fundamental concepts of systems of care and the function of an MCO in managing the care of its members. The visit to the MCOs (AvMed) offices and the day-long curriculum was replicated at another medical school, with similar effects on students' attitudes. CONCLUSIONS: Medical students have neutral-to-negative opinions of systems of care and MCOs. Early educational experiences such as classroom lectures and panels that address managing care issues have minimal effect on these opinions. However, bringing medical students to an MCO's administrative offices, seeing first-hand how systems of care operate, and having an open dialogue with physician administrators does effect a positive change in medical student opinions of a system in which care is managed. In addition, medical students can gain new knowledge about effective systems-based practice.

Clinical Clerkship↗

Relation of insulin receptors to insulin resistance.

The status of insulin-receptor interactions in a variety of insulin-resistant states is reviewed. Utilizing large adipocytes from adult rats and small fat cells from young rats, we have conducted a series of in vitro experiments in an attempt to determine the cellular alteration(s) responsible for the insulin resistance associated with obesity. Stimulation of glucose oxidation by insulin is reduced in large cells. Studies using a mimicker of insulin action, spermine, as well as measurements of 125I-insulin binding to large and small cells indicate that receptor number and affinity are not responsible for hormone resistance. Furthermore, when rapid and direct measurements of sugar uptake were made, insulin stimulation was virtually identical in both cell types. These findings indicate that large adipocytes have an efficient insulin-responsive D-glucose transport system and suggest that the apparent hormone resistance may be due to alterations in intracellular glucose metabolism. It has been proposed that altered insulin-receptor interaction underlies the insulin resistance of human obesity. We have investigated this particular aspect of insulin action by 125I-insulin binding studies. Similar numbers of insulin receptors per cell and affinity for insulin were observed in adipocytes obtained from normal weight subjects and morbidly obese patients. Thus, the initial step in insulin action is unaltered in human obesity.

Adipose Tissue↗

Physicians perception of health insurance in Saudi Arabia.

OBJECTIVE: To assess physicians views on health insurance and its implication on the health care system. METHODS: We carried out a cross-sectional study in 2 major hospitals in Riyadh, Kingdom of Saudi Arabia. Data were collected from January to December 2002 through self-administered questionnaires that were distributed to a total sample of 400 physicians. The instrument consisted of 28 items that focused on assessing physicians' perception towards health insurance and its effect on health services. We performed a descriptive statistics and analysis of variance using the Statistical Package for Social Sciences. RESULTS: Overall, 151 physicians (38%) completed the survey. This study clearly shows that access to health care services is a major concern; more than 94% of the respondents agree that everyone in the Kingdom should have access to healthcare services. Respondents also agree that health insurance will improve access to healthcare services for all citizens. Physicians also believed that health insurance would lead to more regulations and utilization review of services, create more competition between healthcare providers, and create new jobs in the healthcare sector. Saudi physicians reported a higher mean score for 11 items with significant p-values as compared with non-Saudi physicians. CONCLUSION: Physicians in this survey believed that accessibility is a major policy concern, and that health insurance will have a positive effect on access to the health care system. Yet, accessibility is an illusive term with many aspects that go beyond the identification of need for health care to the actual delivery of health care services and the organizational structures to match the needs of society. Cooperation as a national health system should be built on collaborative efforts rather than market competition in itself. It has been suggested that markets are stronger in the role of delivery than in the financing of health care, that markets tend to promote more expenditure on technological innovation rather than producing the most desired set of social outcomes. Cooperative health insurance can be an answer to the current problems facing the health care system in the Kingdom of Saudi Arabia as long as it remains cooperative rather than competitive.

Attitude of Health Personnel↗

A survey of medical quality assurance programs in Ontario hospitals.

OBJECTIVE: To determine the prevalence and types of medical quality assurance practices in Ontario hospitals. DESIGN: Survey. SETTING: All teaching, community, chronic care, rehabilitation and psychiatric hospitals that were members of the Ontario Hospital Association as of May 1990. PARTICIPANTS: The person deemed by the chief executive officer of each hospital to be most responsible for medical administration. INTERVENTION: A questionnaire to obtain information on each hospital's use of criteria audit, indicators inventory, occurrence screening and reporting, and utilization review and management (URM) activities. OUTCOME MEASURES: Prevalence of the use of the quality assurance activities, the people responsible for the activities and the relative success of the URM program in modifying physicians' performance. RESULTS: Of the 245 member hospitals participants from 179 (73%) responded. Criteria audits were performed in 136 (76%), indicators inventory in 43 (24%), occurrence screening in 44 (25%), occurrence reporting in 61 (34%) and URM in 123 (69%). In-hospital deaths were reviewed in 157 (88%) of the hospitals. In all, 87 (55%) of the respondents from hospitals that had a URM program or were developing one indicated that their program was successful in modifying physicians' practices, and 29 (18%) reported that it was not successful; 26 (16%) stated that the effect was still unknown, and 16 (10%) did not respond. Seventy (40%) stated that results of tissue reviews were reported at least 10 times per year and 94 (83%) that medical record reviews were reported at least as often. The differences in the prevalence of the quality assurance activities between the hospitals were not found to be significant. CONCLUSIONS: Many Ontario hospitals are conducting a wide variety of quality assurance activities. Further study is required to determine whether the differences in prevalence of these activities between hospitals would be significant in a larger, perhaps national, sample. Strategies are needed to ensure universal involvement and participation in the improvement of the quality of care and the assessment of the cost-effectiveness of health care treatments. Recommendations to achieve these objectives are suggested.

Follow-Up Studies↗

Stemming the tide of health care costs.

The government and third party carriers have concentrated their cost containment efforts in the wrong areas: reducing physician payments and restricting patients' access to care, while increasing bureaucratic administrative costs at all levels. There has been no net benefit from this cost containment effort. Shifting income from one group to another is not the solution. For those economists who require proof of this assertion, a study for validation is recommended. For one year a single state could be chosen to implement these recommendations: rapid reimbursement to avoid costly appeals; no utilization review or second opinions; no precertification; notification of patients before a procedure of the reimbursement amount; providing a percentage share of any insurance company savings resulting from physician review of itemized hospital bills; enacting meaningful tort reform to affect that 17% of physicians' costs and countless "defensive" lab and hospital expense; publishing comparative costs of common procedures by hospitals; and publishing comparative prices for common drugs by pharmacies. My hypothesis is that the costs of health care will be reduced below other states, while saving enormous "managed care" administrative costs. Dramatically reducing the huge noncaregiving costs of medicine, which make up at least 30% to 40% of the health care dollar, would enable all the uninsured and uninsurables to have the excellent, readily accessible health care they need at no increase over current expenditures. "Cost shifting" in all its many forms could be eliminated. We simply must cause a proper allocation of funds through appropriate regulation of insurance companies and their excessive administrative charges, meaningful tort reform, and the education of our physicians and the public in cost efficient, high-quality medical care.(ABSTRACT TRUNCATED AT 250 WORDS)

Cost Control↗

Risk factors for early readmission among veterans.

This study was undertaken to identify demographic, clinical, and social risk factors for early readmission in the veteran population. Readmissions within 30 days of discharge were considered "early." A randomly selected 50 percent sample of 6,317 veterans discharged consecutively from one Department of Veterans Affairs medical center (VAMC) was used to build a logistic regression model for early readmission. Of these patients, 22 percent had early readmissions. The adjusted odds ratios (OR) of greater magnitude for early readmission (p less than .05) were associated with discharge from a geriatrics/intermediate care bed (OR = 2.75 relative to medical ward), discharge diagnosis of a chronic disease (OR = 2.03-2.67 relative to acute or self-limiting disorders), and two or more surgical procedures performed during the index admission (OR = 1.87 relative to no surgery). Increasing distance from the VA hospital and increasing age also added readmission risk (OR = 1.18 and 1.10, respectively). Length of stay and the social risk factors of marital status and place of disposition were not sufficiently predictive to enter the model. The model was validated successfully on the second 50 percent sample of patients. We conclude that clinical and demographic factors are more predictive of early readmission than are social factors. Early readmission models could be used to improve VA discharge planning and to focus quality assurance and utilization review efforts on providers whose early readmission rates exceed those predicted by the models.

Adult↗