by maureen young the current trends

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TAKE CONTROL OF YOUR HEALTH®



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BENEFITS OF TESTING, TRENDS AND FUTURE OF DIRECT ACCESS TESTING.

Laboratory testing has changed dramatically in the past 20 years. Not

only are there more testing options based on new technologies and

knowledge in the medical field, but many individuals are more aware

of the information that these tests can provide. Three large areas of

testing include clinical testing, drug testing and DNA paternity and

genetic testing. All of these tests have grown in both awareness and

usage by consumers and they have supplied people with critical

information that has improved lives by preventing and managing

disease, making our workplaces safer and identifying biological

relationships to provide for our children and give us information about

our genetic makeup.

The ability to research medical conditions on the internet prompts

people to search for diseases and syndromes that match their

symptoms and then to ask their health care provider to perform tests

or to seek them out independently. Once the test results return,

patients can ask pointed questions about what the results mean and

what the impact will be on their health.

Consumers are also asking for safety in the workplace and on our

highways creating the need for drug and alcohol testing, both pre-

employment and throughout the life of a job for some employees. A

drug-free workplace policy encourages employees to behave more

responsibly and deters them from drug use, especially if the policy is

enforced with drug testing. The American public can feel a little more

secure knowing that drivers, medical staff or co-workers have been

discouraged from drug use while on the job.

Paternity testing and other types of genetic testing are on the rise and

are more accurate than ever before. Welfare reform has prompted

changes in how parentage is identified when children are born and

encourages DNA paternity testing to ensure paternal support of the

children of unwed mothers. Because the tests are so accurate,

courts rely on them to determine child support, custody and even ANYLABTESTNOW.COM

THE CURRENT TRENDS IN LABORATORY TESTING

by mAureen young

JuNe 2014

[PArT ONe Of TWO]

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BENEFITS OF TESTING

immigration. In addition, more people have become interested in their own genetics, either to find out whether they are at risk

for certain cancers or diseases that are hereditary or to learn more about their ancestry. Advances in the technology for genetic

tests have provided a wider range of tests and more detailed information.

Current changes in our health care system caused by the Affordable Care Act (ACA) have prompted people to evaluate where

their health care dollars are being spent and then to make changes to the services they buy and to question health care

decisions more closely. A more informed public is more likely to ask their health care providers why certain tests are performed

and not others and to track their test results over time. The current focus on preventive care and testing allows for early

detection of disease as well as the ability to avoid certain diseases, such as type 2 diabetes.

While there are individuals who would prefer not to know that they have, or are at risk for, a specific disease, the trend is toward

greater awareness of our health. The public is bombarded with information and commercials that pit healthful living and

preventive medical and lifestyle care with bad habits and unhealthy options. The news and the marketing industry promote

health and wellness through healthier food, gym memberships and anti-aging or weight loss programs. This information is

interspersed with ads for fast food, which tries to position some of its meals as nutritious, and sedentary lifestyles centered

around an abundance of television shows that contribute to our national epidemic of obesity and poor health. With both of these

media influences battling for attention there is always a need for laboratory tests that can get people back on track by helping to

influence them to make healthier choices.

Benefits of TestingThere are many reasons that people are willing to seek out a specific test that their health care professional may not have

recommended. Organizations may also request or even require that employees obtain specific tests. The tests requested by a

company for its employee is usually based upon the concept that the test will save them money in insurance premiums either

by deterring employees from using drugs or alcohol or by encouraging them to take better care of themselves by using tests that

highlight health issues which are preventable with medication or lifestyle changes. Some of the reasons that people seek out

laboratory tests include:

1. The Quest Drug Testing Index (DTI) shows trends in drug abuse and misuse and has found high patterns of misuse

of drugs in women and men of all ages and health plan categories. This information often causes healthcare providers

and policy makers to take additional measures to educate patients about the dangers of prescription drug misuse and to

monitor them for medication compliance.

2. The early detection of disease and the prevention of further disease, side effects and even death, encourages many

people to seek out tests, both clinical and genetic.

3. Testing allows for the ongoing monitoring of chronic disease and helps patients and their healthcare providers to know if

treatments are effective in the management of disease.

4. Paternity testing is currently a key piece of managing child support and is sought out not only by men who are required

to support children they believe may not be theirs but by courts when there is doubt as to parentage with regards to

custody and child support decisions.







TRENDS IN DIRECT ACCESS TESTING

The internet has been a boon for individuals who want to learn more about

their own health and how to improve it or to prevent disease. Some claim that

it may be too much of a good thing. The American Association for Clinical

Chemistry (AACC) published an article titled “The Google factor: Are the

Worried Well Making Healthcare Sick?”1. The author states that “for the

worried well, the Internet can turn a bout of fatigue into an opportunity to think

about poisonings, malnutrition, and cancer.

Patients don’t bear all the blame, however. The u.S. healthcare industry

promotes overtesting in outpatients because it is primarily based on a fee-

for-service system. even labs play a role in overutilization because, to the

extent that they participate in fee-for-service medicine, overutilization can

provide significant financial benefits.” A Washington Post article in June of

2014 described a health research group’s opposition to hospitals’ offerings

of low-cost cardiovascular tests and screenings. The group, Public Citizen,

stated that for many people the tests are unnecessary and can cause undue

worry and medical procedures. However, an opposing opinion is that for those

people who are at a high risk, either due to lifestyle factors or heredity, these

tests can make them aware of their options for prevention and treatment of

heart attack or stroke.

The availability of tests and medical information to the general public has

contributed to our ability to make more informed health care decisions for

ourselves. removing health care providers from some of the decisions that we

make regarding health puts us in the driver’s seat and gives us more control.

While the large amount of information and testing that consumers now have

access to can be overwhelming and cause some people to jump on the testing

bandwagon, the benefits of increased knowledge can be used to improve

health care outcomes for many people.

“…Direct access testing (DAT), also known as direct-to-consumer (DTC)

testing or patient-authorized testing, has been growing in popularity over the

past several years…DAT is a reflection of Americans’ focus on health and

preventive medicine, offering the opportunity for patients to take a more active

role in their own health care.”2 DAT, which has been available for decades, is

permitted in most states, and includes over the counter home tests, such as

pregnancy tests. One of the major benefits of these tests is that a prescription

or doctor’s order is not required, saving consumers the time and expense of a

visit to the doctor. The home tests originally available in drugstores expanded

to include walk-in laboratory tests that offer a wide range of screenings.







Many of the tests available at retail or wellness centers are basic, simple tests

for general health such as complete blood counts (CBC), cholesterol or lipid

panels, throat and urine cultures, diabetes screenings (blood glucose tests),

chemistry panels, PSA tests for prostate cancer, thyroid tests, HIV antibody

tests, blood typing, pregnancy tests and urine drug screens. Some laboratories

have expanded their offerings to include genetic tests for paternity or broader

ancestry information.

Tests like these provide valuable information and the ease of access provides a

simple way for consumers to track and monitor their health and manage their

health conditions. Direct access testing also allows consumers to obtain tests

that are convenient and/or anonymous that they might otherwise avoid or not

consider. Some people are willing to pay higher rates for convenience and

anonymity to obtain the information they need to manage their health.

One drawback of obtaining a test independently is that a physician isn’t

there to interpret the results for the consumer. Labs are required to provide

reference ranges so that individuals are able to tell if the test results are

abnormal. This helps consumers but may also cause significant stress or

anxiety if the test provides new information about a health condition. results

that are out-of-range may need to be interpreted by a healthcare provider,

who can provide a bigger picture based on the patient’s individual clinical

signs, symptoms and medical history to guide patients in the management of

disease. Additionally, most insurance companies do not cover tests that are

not ordered by a physician so individuals will have to pay out-of-pocket for DAT

testing.

The diagnostic and medical laboratories industry has benefited directly from

the shift during the past 5 years from attempts to cure disease and treat it, to

the detection and prevention of disease and personalized care.3 This trend

toward preventive care stimulates the demand for industry services as more

physicians monitor patients’ blood and tissue and use MrI technology to test

for health issues. Testing supports physicians’ diagnostic abilities and is part of

the full range of medical services that includes prevention, diagnosis, treatment

and monitoring.

The recession created reduced industry revenue growth and fewer individuals

were willing to purchase the health insurance offered through their employers.

This is expected to reverse and the diagnostic and medical laboratories

industry will benefit from healthcare reform and the growing aging population,

boosting revenue. Older Americans tend to develop heart disease, liver

disease or cancer as they age, spurring the elderly to be tested more frequently

for these diseases.

TRENDS IN DIRECT ACCESS TESTING







CHANGES IN HEALTHCARE

Healthcare is in the midst of huge changes due to both the ACA and medical

advances. robert L. Michel, editor-in-Chief of the Dark report presented to

the National Lab Training Conference V describing changes in health care

and laboratory medicine that he expects to see by the year 2020.4 During

his presentation in 2009 he stated that “knowledge based” lab testing

providers is a wide open segment. In Mr. Michel’s view the utilization of lab

tests will skyrocket over the next decade for several reasons:

1. Currently those under the age of 65 get 2 lab tests per year, while

those over 65 obtain 9 or more lab tests per year on average. There

are 80 million baby boomers rapidly advancing the age of 65+.

2. Middle class patients want access to healthcare and the latest

technology.

3. People are willing to pay for lab tests just as they willingly pay their

dog and cat veterinary bills today.

4. The health of Americans is worsening.

5. We are seeing a shift from reactive to proactive medicine.

6. Personalized medicine is a paradigm shift in healthcare and

Americans want to be treated individually and not “just like everyone

else”. The move toward personalized care is based on each individual

patient’s specific health factors.

7. Testing has become easier with fast, point-of-care tests.

Interest in Direct Access Testing (DAT), in which consumers order tests

directly from the lab without a doctor visit or consultation, has been

fueled by greater consumer access to medical information, direct-to-

consumer advertising and an emphasis on consumer empowerment.

“Laboratory medicine will play an ever greater role in repairing the fractured

health care system as stakeholders increasingly demand scientific evidence

for clinical decision making and strategies to address care quality, outcomes

and cost.”5 While this raises concerns about misinterpretation of test results,

it also provides an opportunity for laboratories to provide interpretative

services to help consumers understand their results rather than relying on

a doctor to interpret results. Between 1998 and 2006 revenues from DAT

have grown 40% (not adjusted for inflation) and spending growth on lab

tests rose 7% annually from 2006-2008. The majority of tests (66%) are

clinical pathology tests. Pharmacogenomics, tests that look at a person’s

genetics to determine how they will respond to a particular drug, has seen

the largest growth, followed by oncology or cancer testing. from 2009 to

2014 laboratory testing has seen 3% growth annually with total revenues of

$53 billion.







DIRECT ACCESS TESTING IS ON THE RISE

The demand for direct access testing is expected to grow based on several factors:

1. efforts to improve the quality of health care are relying on the appropriate use of lab testing for early detection of

disease and patient management that is safer, more effective, more efficient and cost-effective.

2. An aging population and corresponding increase in the prevalence of chronic diseases are accelerating the use of lab

tests to screen, diagnose and manage patients. Medicare enrollees will reach 89 million by 2050. Population growth

contributes to this number.

3. The Human Genome Project has allowed for a larger number of genetic tests and provides better information for

targeted treatment to reduce adverse drug reactions.

4. Technological innovations and improved laboratory instrumentation make direct access testing more accurate and

easier to obtain.

5. There is a link between certain biomarkers and patient outcomes leading physicians to use this information to better

guide treatment decisions.

6. The increasing amount of health information, media attention to health care issues, and direct-to-consumer

advertising of new tests have all enhanced consumer awareness of and interest in lab testing.

To better manage and treat disease more providers and labs have taken steps to develop web based portals. Accessing

medical information online so that test results can be retrieved quickly is expected to make health care more effective and

proactive.

The health care industry is increasingly using lab data as an objective, scientific indicator of performance and outcomes.

One example of this is the helpfulness of lab test data in measuring outcomes for type 2 diabetes, which depends on the

association between test results (biomarkers) and patients’ long term health. Screening for type 2 diabetes with a fasting

plasma glucose test and/or oral glucose tolerance test can detect the disease in its preclinical phase. During the 10 to 15

years after clinical diagnosis, tight glycemic control can improve patient outcomes by reducing the risk of blindness and end

stage renal failure. In 2006, failure to test regularly accounted for 7,100 to 15,900 avoidable diabetes-related deaths and $1.3

to 1.7 billion in avoidable hospital costs.

There is little published research on the cost-effectiveness of lab testing, but as payers face increasing scrutiny of their

decisions about coverage of new testing technologies, the economic impact of lab testing on the health care system is

generating greater interest in cost-effectiveness analysis.

The convergence of multiple factors including the rising cost of health care, the growing number of uninsured and

underinsured people (which may change with the ACA), the aging population and the greater prevalence of chronic disease

is severely challenging the health care system. Laboratory medicine will play a more prominent role in repairing the health

care system as stakeholders increasingly demand scientific evidence for clinical decision making and strategies to address the

significant shortfalls in quality, outcomes and cost.

To learn more about the trends in laboratory testing, call 1-800-384-4567 or email us at [email protected] to schedule an appointment with one of our franchise sales professionals.







BIBLIOGRAPHY

1Astion, Mike. “The Google factor.” Clinical Laboratory News 40.1 (2014): n. pag. AACC. American Association for Clinical

Chemistry, Jan. 2014. Web. June 2014.

2“Where Lab Tests Are Performed”. American Association for Clinical Chemistry, 1 Oct. 2012. Web. 24 June 2014. http://

labtestsonline.org/lab/labtypes/start/6.

3“Diagnostic & Medical Laboratories in the uS: Market research report”. IBISWorld. April 2014. Web. http://www.ibisworld.

com/industry/default.aspx?indid=1575

4Michel, robert L. “Healthcare’s Transformational Journey: Laboratory Medicine in the Year 2020.” National Lab

Training Conference V. Orlando, fL. June 2009. Web. www.aphl.org/conferences/proceedings/documents/2009/2009_

NLTCV/020Michel.pdf.

5The Lewin Group. “under the Microscope: Trends in Laboratory Medicine.” California HealthCare foundation. Ihealthreports.

April 2009. Web. http://www.chcf.org/~/media/MeDIA%20LIBrArY%20files/PDf/L/PDf%20LabDataTrends.pdf

by maureen young the current trends

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