Is That Test Necessary? The Key to Laboratory Utilization Management

We have a big problem with waste in this country. An estimated $750 billion—or 30 cents of every dollar spent on healthcare—is spent on unnecessary care, according to the National Academy of Medicine, formerly the Institute of Medicine.(1) Research indicates that almost every family in the United States has experienced over-testing and overtreatment, resulting in costs that hit the average American household hard. For some families, inappropriate care means less money to spend on food, clothing, and shelter.

In 2012, approximately one in six families (16.5%) had difficulty paying their medical bills within a 12-month period. Within that group, one in 11 families (8.9%) had outstanding medical bills they were unable to pay at all (Figure 1).(2) Unwarranted drug prescriptions, surgeries, imaging, and laboratory tests are strangling America’s healthcare system, one patient at a time.

Figure 1. Percentage of families with selected financial burdens of medical care.

The 300 million people in the United States undergo about 15 million nuclear medicine scans, 100 million CT and MRI scans, and 7 to 10 billion laboratory tests annually.(3) Excessive testing not only is costly, but also can be harmful. Take, for example, imaging studies. Exposing patients to the risk of radiation that is not clinically indicated may be linked to an increase in some types of cancer. Furthermore, the clinical value of any test or procedure depends on the likelihood that an individual has a significant medical problem in the first place. If, for instance, someone has deep central chest pain and shortness of breath, there is a high probability of a serious cardiac event, and an electrocardiogram (ECG) not only is appropriate, but provides significant value. Conversely, in people with no signs or symptoms of heart trouble, an ECG in all likelihood provides no useful information. There is no justification for performing these tests on healthy people, yet millions are done each year.

The clinical laboratory also plays an important role in utilization related to cardiac events. In 2010, more than 17 million patients with chest pain seen in emergency departments received cardiac biomarker testing. Researchers at Johns Hopkins Bayview Medical Center used a two-fold approach to significantly reduce unnecessary blood testing when evaluating symptoms of chest pain and heart attack.(4) The team started by educating physicians and provided information about proven testing guidelines. Interventions then were implemented in the computerized provider order entry (CPOE) system. The objective of the study was to reduce the rate at which clinicians order biomarker testing for the diagnosis of acute coronary syndrome, using scientific evidence as the baseline.

The study focused on levels of troponin, a protein that increases in the blood when heart muscle is damaged. Studies indicate that tests for troponin are performed up to four times within a 24-hour period—not only is this considered excessive, but they also are ordered in combination with other cardiac biomarkers, including creatine kinase (CK) and creatine kinase-MB (CKMB). At Johns Hopkins Bayview Medical Center, institutional guidelines were written to suggest ordering troponin alone, without CK or CKMB, for patients suspected of having acute coronary syndrome. Going one step further, the guidelines set restrictions on repeat orders, limiting those for troponin to no more than three within an 18- to 24-hour period. As a result of this study, overall cardiac biomarker test orders decreased by 66% over a 12-month period, with a corresponding reduction in patient charges of $1.25 million.(4)

Reducing unnecessary hospital admissions is not only cost effective, but can actually save lives.

Looking at test utilization more broadly, an annual visit to a primary care physician (PCP) for most adults usually includes blood tests, a urinalysis, and an ECG. Many individuals and providers believe that there is no such thing as a bad screening test. If something is wrong, it’s better to know in order to receive treatment to prevent morbidity and mortality, right? Wrong. In 2012, the American Board of Internal Medicine Foundation (ABIM) launched a campaign, Choosing Wisely, designed to initiate conversation between doctors and patients regarding the use of unnecessary tests and procedures. To date, 60 medical specialty societies have made more than 300 recommendations addressing overuse.(5) The Society of General Internal Medicine, in conjunction with Choosing Wisely, states that “regularly scheduled general health checks without a specific cause including the ‘health maintenance’ annual visit, have not shown to be effective in reducing morbidity, mortality or hospitalization, while creating a potential for harm from unnecessary testing.”(6) Spurious positive test results often lead to a cascade of more tests and procedures, increased downstream costs, and suboptimal outcomes for patients.

Under a grant from the ABIM, a group of internists, family practice physicians, and pediatricians, known as the Good Stewardship Working Group, identified a number of common primary care practices as overused(7) (see the sidebars Top Five List in Internal Medicine and Top Five List in Family Medicine).

The Top Five Lists in Primary Care: Meeting the Responsibility of Professionalism

Using data from federal medical surveys, physicians from Mount Sinai Medical Center and Weill Cornell Medical College in New York estimated that unnecessary testing and treatment within the 12 primary care practices accounted for a staggering $6.8 billion in 2009. The single test most commonly ordered without justification was a complete blood count (CBC). In 56% of routine physical examinations, physicians inappropriately ordered CBCs and similar tests, adding up to almost $33 million in unnecessary costs.(8) Field testing indicated support among physicians for evidence supporting the practices, the potential positive impact on quality of care and cost, and the ease of implementation.

Cost aside, care that is not needed can be harmful to patients. Reducing unnecessary hospital admissions is not only cost effective, but can actually save lives. About one in three inpatients experience an adverse event while in the hospital, the vast majority of which require some kind of medical intervention. Further, 7% are irreversibly harmed or die as a result.(9) Apply that same logic to laboratory testing, and it is clear that more harm than good can result from inappropriate testing. For example: in a routine urinalysis, clinicians look for protein or blood in the urine to check for chronic kidney disease. If the initial test is positive, an ultrasound of the kidney may be ordered, followed by a biopsy. Although the risk is relatively small, the biopsy can result in hemorrhage and, in worst case scenarios, kidney removal. Kidney biopsies are reasonable and appropriate in patients with symptoms of kidney disease. However, looking for disease in an otherwise healthy patient and performing interventional procedures is wrong and can be dangerous.

Unnecessary Tests and Procedures: The Problem, the Causes, and the Solutions

Why, then, do physicians continue to order tests, procedures, and other expensive treatment options without supporting evidence? This question is especially perplexing given that nearly three out of four physicians believe that doctors order unnecessary tests at least once per week.(10) Moreover, research from the 2014 study commissioned by ABIM reveals that physicians would order a laboratory test on an insistent patient even though they knew it was unwarranted as follows(10):

• 73% of physicians say the frequency of unnecessary tests and procedures is a very or somewhat serious problem.

• 66% of physicians feel they have a great deal of responsibility to make sure their patients avoid unnecessary tests and procedures.

• 53% of physicians say that even if they know a medical test is unnecessary, they order it if a patient insists.

• 70% of physicians say that after they speak with a patient about why a test or procedure is unnecessary, the patient often avoids it.

• 58% of physicians say they are in the best position to address the problem, with the government as a distant second (15%).

• 72% of physicians say the average medical doctor prescribes an unnecessary test or procedure at least once a week.

• 47% of physicians say their patients ask for an unnecessary test or procedure at least once a week.

The answer is multifaceted, ranging from lack of understanding of the diagnostic value of a test to general clinical uncertainty. At the national level, under fee-for-service reimbursement the healthcare sector rewarded volume and fueled the “more-is-better” mindset. As stated by Doug Campos-Outcalt, a family physician in Phoenix, “Nobody ever gets sued from ordering unnecessary tests.”(11) Patients also bear some responsibility when they pressure physicians to order tests that may not be clinically indicated. Physicians, in turn, put pressure on labs to run tests to keep their patients happy. It’s a vicious cycle that comes at great cost in both spending and outcomes.

Patients and physicians can overlook the fact that laboratory tests deliver value only if they provide meaningful information that leads to an accurate diagnosis and supports clinical decision making, drives patient-centered outcomes, and contributes to reduced healthcare costs. In short, laboratory tests provide value only if they are clinically valid, clinically efficacious, cost-effective, and properly interpreted.

Recent studies confirm what pathologists and medical laboratory professionals have long known: a substantial number of primary care physicians are uncertain about which test is the right test. Moreover, they are uncertain how to properly interpret the results of some tests. This uncertainty can lead to diagnostic errors, including delayed or inaccurate diagnoses, failure to use appropriate tests, use of obsolete tests or therapies, and failure to review and act on test results. A national study performed by Hickner et al.,(12) which included almost 1800 internal medicine and family practice providers, attempted to identify challenges primary care physicians face in ordering and interpreting clinical laboratory tests. Over the past two decades, the number of available laboratory tests has increased to more than 3500. On average, one PCP sees just over 80 patients per week, ordering lab tests on approximately one-third of them. Survey results indicate PCPs are uncertain about ordering tests 15% of the time and uncertain with interpreting the results 8% of the time.(12) Nationally, this translates to 500 million primary care patient visits annually, with degrees of uncertainty potentially impacting 23 million patients.

Laboratory tests provide value only if they are clinically valid, clinically efficacious, cost-effective, and properly interpreted.

What’s driving all this uncertainty? On the ordering side, the cost to patients and managed care restrictions are listed among the top challenges. In addition to the issue of deciphering large test menus with hundreds—sometimes thousands—of test options, clinicians are challenged with different names for the same test and ordering test panels when a single test is more appropriate. Test reporting poses challenges as well, with problems arising when physicians don’t receive the results or receive results in confusing report formats. Solutions to these complex problems are not simple. However, using information technology platforms, such as the CPOE system, to alert and inform physicians of an inappropriately ordered test at the point of order entry have proven successful. Use of algorithms and other decision support tools has been effective as well by creating pathways that intuitively lead to the most appropriate test option. Unfortunately, physicians tend not to seek out assistance or consultation from laboratory professionals, even though these individuals are experts regarding the tests their labs perform.

There is no panacea for improving care and reducing cost in a system riddled with inefficiency and waste. Doctors alone cannot solve the problem. It is up to every doctor, hospital, healthcare organization, medical educator, insurance company, and government agency to recognize the problem and explore ways to engage patients in decisions that affect their care, share useful information on treatment options, and ensure that services, when utilized, are necessary, appropriate, and beneficial for optimal care. Improving patient education and communication with physicians is central in changing practice patterns, but that is only the starting point. Goethe captures the path forward: “Knowing is not enough; we must apply. Willing is not enough; we must do.”(13)

References

1. The National Academies of Sciences, Engineering, Medicine. Transformation of health system needed to improve care and reduce costs. September 6, 2012. www.nationalacademies.org/hmd/Reports/2012/Best-Care-at-Lower-Cost-The-Path-to-Continuously-Learning-Health-Care-in-America/Press-Release-MR.aspx.

2. Cohen RA, Kirzinger WK. Financial burden of medical care: a family perspective. NCHS Data Brief. 2014 Jan;(142):1-8.

3. Gawande A. Annals of health care: overkill. The New Yorker; May 11, 2015.

4. Larochelle MR, Knight AM, Pantle H, Riedel S, Trost JC. Reducing excess cardiac biomarker testing at an academic medical center. J Gen Intern Med. 2014;29:1468-1474.

5. Kerr EA, Ayanian JZ. How to stop the overconsumption of health care. Harvard Business Review; December 11, 2014. https://hbr.org/2014/12/how-to-stop-the-overconsumption-of-health-care .

6. Sussman J, Beyth RJ. Choosing wisely: five things physicians and patients should question. Society of General Internal Medicine. https://www.sgim.org/File%20Library/JGIM/Web%20Only/Choosing%20Wisely/General-Health-Checks.pdf .

7. The Good Stewardship Working Group. The top 5 lists in primary care: meeting the responsibility of professionalism. Arch Intern Med. 2011;171:1385-1390.

8. Andrews M. $6.8 billion spent yearly on 12 unnecessary tests and treatments. Kaiser Health News; October 31, 2011. http://khn.org/news/michelle-andrews-on-unneccesary-tests-and-treatments/ .

9. Gamble M. Study: one-third of patients experience adverse events during hospital stay. Becker’s ASC Review; April 18, 2011. www.beckersasc.com/asc-accreditation-and-patient-safety/study-one-third-of-patients-experience-adverse-events-during-hospital-stay.html .

10. ABIM Foundation. Choosing Wisely. May 1, 2014. http://abimfoundation.org/what-we-do/choosing-wisely .

11. Andrews J. Doctors estimate $6.8 billion in unnecessary medical tests. Washington Post. October 11, 2011. https://www.washingtonpost.com/national/health-science/doctors-estimate-68-billion-in-unnecessary-medical-tests/2011/10/28/gIQANpEXZM_story.html?utm_term=.b7d9858ae297 .

12. Hickner J, Thompson PJ, Wilkinson T, et al. Primary care physicians’ challenges in ordering clinical laboratory tests and interpreting results. J Am Board Fam Med. 2014 Mar-Apr;27(2):268-74.

13. Horvath AR. From evidence to best practice in laboratory medicine. Clin Biochem Rev. 2013;34(2):47-60.

Top Five List in Internal Medicine

1. Don’t do imaging for low back pain in the first six weeks unless red flags are present. Red flags include, but are not limited to, severe or progressive neurological deficits or when serious underlying conditions such as osteomyelitis are suspected. Imaging of the lumbar spine before six weeks does not improve outcomes but does increase costs. Low back pain is the fifth most common reason for all physician visits.

2. Don’t obtain blood chemistry panels (e.g., basic metabolic panel) or urinalyses for screening in asymptomatic, healthy adults. Only lipid screening yields significant numbers of positive results among asymptomatic patients. Screen for type 2 diabetes mellitus in asymptomatic adults with hypertension.

3. Don’t order annual electrocardiograms or any other cardiac screening for asymptomatic, low-risk patients. There is little evidence that detection of coronary artery stenosis in asymptomatic patients at low risk for coronary heart disease improves health outcomes. The potential harm of this routine annual screening exceeds the potential benefit.

4. Use only generic statins when initiating lipid-lowering drug therapy. All statins are effective in decreasing mortality, heart attacks, and strokes when dosing is titrated to achieve appropriate low-density lipoprotein (LDL) cholesterol reduction. Switch to more expensive brand-name statins (atorvastatin [Lipitor] or rosuvastatin [Crestor] only if generic statins cause clinical reactions or do not achieve LDL cholesterol goals.

5. Don’t use DEXA screening for osteoporosis in women under age 65 or men under 70 years with no risk factors. Risk factors include, but are not limited to, fractures after age 50 years, prolonged exposure to corticosteroids, a diet deficient in calcium or vitamin D, cigarette smoking, alcoholism, and/or a thin and small build. Screening is not cost-effective in younger, low-risk patients, but is cost-effective in older patients.

Source: Reference 7.

Top Five List in Family Medicine

1. Don’t do imaging for low back pain in the first six weeks unless red flags are present. Red flags include, but are not limited to, severe or progressive neurological deficits or when serious underlying conditions such as osteomyelitis are suspected. Imaging of the lumbar spine before six weeks does not improve outcomes but does increase costs. Low back pain is the fifth most common reason for all physician visits. Red flags include, but are not limited to, severe or progressive neurological deficits or when serious underlying conditions such as osteomyelitis are suspected.

2. Don’t routinely prescribe antibiotics for acute mild to moderate sinusitis unless symptoms (which must include purulent nasal secretions AND maxillary pain or facial or dental tenderness to percussion) last for seven or more days OR symptoms worsen after initial clinical improvement. Most maxillary sinusitis in the ambulatory setting is due to a viral infection that will resolve itself on its own. Despite consistent recommendations to the contrary, antibiotics are prescribed in over 80% of outpatient visits for acute sinusitis. Sinusitis accounts for 16 million office visits and $5.8 billion in annual healthcare costs.

3. Don’t order annual electrocardiograms or any other cardiac screening for asymptomatic, low-risk patients. There is little evidence that detection of coronary artery stenosis in asymptomatic patients at low risk for coronary heart disease improves health outcomes. The potential harm of this routine annual screening exceeds the potential benefit.

4. Don’t perform Pap tests on patients younger than 21 years or women status post hysterectomy for benign disease. Most dysplasia in adolescence regresses spontaneously; therefore, screening Pap tests done in this age group lead to unnecessary anxiety, morbidity, and cost. Pap tests have low yield in women after hysterectomy (for benign disease), and there is poor evidence for improved outcomes.

5. Don’t use DEXA screening for osteoporosis in women under age 65 or men under 70 years with no risk factors. Risk factors include, but are not limited to, fractures after age 50 years, prolonged exposure to corticosteroids, diet deficient in calcium or vitamin D, cigarette smoking, alcoholism, and/or a thin and small build. Screening is note cost-effective in younger, low-risk patients, but is cost-effective in older patients.

Source: Reference 7.