Out with the Old, In with the Old?

   Laws and institutions must go hand in hand with the progress of the human mind. As that becomes more developed, more enlightened, as new discoveries are made, new truths discovered and manners and opinions change, with the change of circumstances, institutions must advance also to keep pace with the times. - Thomas Jefferson, 1816

   Hopeully, the January energy that seems to bring us a renewed resolve to get organized, to start over - to do things right - has not lost its momentum. This third year of this millennium we still face many of the same old problems that were present in healthcare last year, the year before that, and even 20 years ago.

   Despite enormous accomplishments in medicine and exponential advances in technology, the quality of the healthcare provided in our country remains a problem. Americans spend $4,270 a year per person on healthcare,¹ more than any other country in the world. Recent government reports² and other publications³ underscore the need to examine the quality of our healthcare and the structure of its delivery system. One researcher³ believes our system has two underlying problems: 1) professional uncertainty with regard to clinical decision making, as well as with the establishment of guidelines or other criteria used to determine the appropriateness of care; and 2) rising costs and efforts to contain costs. An enormous chasm exists between the health services that should be provided (based on current professional knowledge and technology) and those that many patients actually receive. This all boils down to understanding the reasons for today's overuse, misuse, and underuse of medical technology.

   Practice variances continue to be abundant. Great uncertainty exists among practitioners and among geographic locations and clinical settings ? particularly in the areas of wound, ostomy, and continence care. The lack of data persists despite the efforts and financial investments of professional organizations, manufacturers, the National Institutes of Health, and the Agency for Healthcare Research and Quality (AHCRQ, formerly the AHCPR). Each year, the AHCRQ spends more than $6 million to maintain a registry of clinical guidelines. The agency's National Guideline Clearinghouse (www.guideline.gov) has more than 1,000 guidelines currently on file.³

   Still, many crucial questions remain unanswered. What percentage of clinicians, for example, would you guess actually make decisions for wound, ostomy, and continence patient care that are grounded in science rather than personal opinion? Do physicians, who are responsible for writing orders and overseeing patient care, have ready access to outcomes-based data - evidence to guide their decision? How strong should evidence be before it is integrated into clinical practice? Should clinical decisions be based on oral presentations of research findings, or should they be delayed until the data are actually published? How concerned should clinicians be about the composition of expert panels that develop guidelines for care? Should clinicians follow guidelines if they feel their specialty was not properly represented on the panel? To what extent does a clinician's specialty or experience (eg, WOC nurse) influence the outcomes of care?

   In our country, clinical trials generate the evidence base used for decision making in all areas of medicine, including the establishment of health insurance payment and coverage policy. The quality of clinical trials (the backbone of medical research around which clinical practice is molded) has come under scrutiny by the government.⁴ Minorities, such as blacks and women, are often underrepresented in clinical trials. This limits informed decision-making by consumers as well as clinicians.

   The problem of quality research segues into healthcare reimbursement. The Centers of Medicare and Medicaid Services (CMS) evaluate clinical trial data and other published research in order to develop appropriate evidence-based coverage and payment policies for new technologies. Both private and public payers must discontinue providing coverage or payment for medical techniques for which data are lacking. One author³ suggests that payers might pool resources and standardize the process for evaluating data and establishing coverage policies for new technologies.

   Coverage and payment policies directly impact utilization by clinicians and consumer access to new technologies. Payment and coverage decisions are driven by efforts to contain and reduce healthcare costs. The cost of American healthcare is expected to increase by 9.9% this year, exceeding an astounding $1.5 trillion dollars⁵ by year's end. Drugs and medical devices account for the lion's share of these cost increases. Efforts over the last 20 years to contain and reduce healthcare costs by reducing overutilization has lead to underuse of all types of services. Both situations are detrimental to quality care and cost. When compared to fee-for-service plans, data from the 1980s to early 1990s show a reduction in use of costly techniques by managed care organizations (MCO). Until government regulations were changed, this trend continued for Medicare beneficiaries enrolled in Medicare MCOs compared to "traditional" Medicare. Interestingly, at the same time, the states having a high penetration of managed care were also leaders in adopting and using new technologies. By the 1990s, these states fell behind in their acquisition of new technology.

   Increased out-of-pocket expenses resulting from payor utilization restrictions can influence a clinician?s, as well as a patient's, decision about what constitutes necessary and unnecessary medical procedures and purchases. Medicare coverage and payment of ostomy supplies is a perfect example. Last year, a government report⁶ found that ostomy supplies have a higher rate of nonassignment than other covered medical supplies and a higher percentage of claims in excess of 115% of the Medicare allowable. This suggests that Medicare beneficiaries with ostomies may be experiencing more of a financial burden for the cost of their medical supplies than do other Medicare beneficiaries.⁷ Because most ostomy patients are over 65 years old, many are living on fixed incomes. Therefore, larger out-of-pocket expenses directly impact purchase decisions, personal preference, and could likely result in underuse of appropriate types and amounts of supplies, negatively impacting quality of life.

   Uncertainty continues to plague clinical decision making as healthcare costs keep rising. Current approaches to cost containment may have negative effects on tomorrow's healthcare. So many new technologies are emerging that even with rapid dissemination, new data are quickly made obsolete by the introduction of new techniques and products. More information is needed about the kinds of financial incentives and arrangements that influence clinical practice. Understanding true cost-effectiveness will help shape future policies for new technologies and their impact on the quality of life. Our problems are massive and complex but not insurmountable.

   A new year provides a perfect opportunity to truly "be out with the old and in with the new." We should resolve to begin looking at healthcare with a much more critical eye and advance, as Thomas Jefferson said, to keep pace with the times.

   It is not enough for a nation merely to have added years to life ? our objective must also be to add new life to those years. -John F. Kennedy

1. Anderson GF, Hurst J, Hussey PS, Jee-Hughes M. Health spending and outcomes: trends in OECD countries, 1960-1998. Health Affairs. 2000;29(3):150?157.

2. Institute of Medicine. Hurtado MP, Swift EK, Corrigon JM, eds. Envisioning the National Health Care Quality Report. Committee on the National Quality Report on Health Care Delivery. Washington, DC: National Academy Press, March 30, 2001.

3. McNeil BJ. Shattuck lecture: hidden barriers to improvement in the quality of care. N Engl J Med. 2001;345(22):1612?1620.

4. United States Government Accounting Office. NIH Clinical Trials: Various Factors Affect Patient Participation. October 30, 1999. HEHS-99-182.

5. Health Care Financing Administration. National health expenditures, 2000-2010. Washington DC, 2001;2001.

6. Department of Health and Human Services. Office of Inspector General. Balance Billing for Medical Equipment and Supplies. January 2001. OEI-07-99-00510.

7. Turnbull GB. Ostomy supplies out of balance. Ostomy/Wound Management. 2001;47(4):2?3.