Precision medicine may transform patient treatment and disease prevention. But it won’t go too far without lab tests—the highest volume medical activity. More than seven billion clinical lab tests are annually performed in the U.S., the American Clinical Laboratory Association says.
Precision medicine takes into account individual variability in genes, environment and lifestyle, the National Institutes of Health explains. It’s an approach to medicine allowing doctors to predict more accurately disease treatment and prevention strategies likely to be successful.
But what does this mean to clinical diagnostic and genetic labs?
As doctors pinpoint care (instead of turning to a one-size-fits-all protocol), labs must optimize test utilization. Lab test costs and appropriateness grow in importance, making a strategic IT approach and tools necessary to keep pace with precision medicine.
“The future is great for labs that are starting now to leverage diagnostics. They don’t just manage tests. First-mover labs are optimizing utilization by influencing the ordering process, supporting connectivity environments and creating test ordering rules to deal with overutilization and underutilization,” says Rob Atlas, senior vice president of strategic solutions, Sunquest Information Systems, and founder, Atlas Medical.
Pharmacogenomics Drive Personal Medicine
Pharmacogenomics make precision medicine possible. That’s because pharmacogenomics study the effect of a person’s unique genetic makeup on their response to medications.
In fact, testing people for gene variation could eliminate 700,000 serious drug reactions in the U.S. each year, according to an article in the Wall Street Journal. The Food and Drug Administration (FDA) estimates $136 billion is spent annually on adverse drug reactions alone.
Also, about 95% of people have at least one genetic variation affecting a drug’s effectiveness, the Wall Street Journal story pointed out.
So, labs are in a powerful position as precision medicine unfolds. How can labs, in partnership with physicians, optimize tests post utilization to increasingly pinpoint the right drug for the patient now? And how can labs cost-effectively perform the tests?
For example, new lab tests are aimed at identifying drugs to best fight Hepatitis C, which affects about four million Americans.
Quest Diagnostics announced in April 2016 tests to predict whether two recently approved FDA medicines-Zepatier and Daklinza-will fight a patient’s specific type of hepatitis C. Or will the liver-destroying virus resist them?
The new Quest services underscore the value of diagnostics to advance precision medicine, Quest said in a statement.
Indeed, the right drug choice could put a patient on a path to a cure, saving tens of thousands of dollars for a course of treatment, noted a story in the Associated Press, which pointed out the Quest tests cost about $700 to $750 each, and insurers are covering them.
Quest also introduced, over the last few years, molecular testing to identify six Hepatitis C virus “genotypes.”
Still another test for gene variation has the propensity to explain why 25% of people can’t absorb Plavix, pointed out the Wall Street Journal.
Pharmacogenomic gene variation tests reportedly range in price from $500 to $2,000 and are covered by insurers in some cases. But sometimes they are not reimbursed.
Growing Tests Menu Could Add to Doctors’ Confusion
So many genes. So many exciting test capabilities.
And so many insurance networks in which to operate.
It’s no wonder doctors are uncertain about tests to order. Research by the University of Illinois Chicago (UIC) School of Medicine suggests internal medicine and family medicine doctors are uncertain about ordering tests 15% of the time, and they are unclear about interpreting results 8% of the time, a UIC statement pointed out. That may not sound like a lot until you add up the number of physicians and patients – equating 23 million times per year.
Top reasons they are uncertain are: lack of information about costs (53%) and insurance restrictions (40%). The increase in the number of tests available to physicians has doubled during the last two decades, increasing interpretation challenges. Missing results and unclear report formats add uncertainty about appropriate tests.
According to Genelnsight, “As the amount of genetic information assayed in each test continues to grow, it becomes more difficult for laboratories to track knowledge associated with identified variants. In addition to identifying variants, laboratories offering genetic sequencing-based tests must write reports that explain the clinical significance of the often unique set of variants found in a patient. The quality of those reports is critical to the effective integration of genetic information into clinical practice.” (GeneInsight was recently acquired by Sunquest Information Systems.)
Labs Adopt Coordinated Diagnostics
First-mover labs surmount today’s diagnostics challenges. They adopt Coordinated Diagnostics®, the model for the practice of diagnostics across the healthcare continuum. It is the delivery of knowledge and expertise in real-time to support collaboration and coordination among care providers, diagnostic testing facilities, patients, payers and other stakeholders.
Coordinated Diagnostics advances informed decision-making while improving outcomes, reducing costs, ensuring more efficient use of resources and enhancing the patient experience. The aims may sound familiar: precision medicine appears to have the same intentions.
Sophisticated technology, such as the Coordinated Diagnostics Platform from Atlas Medical is necessary to support patient centricity and precision medicine. The world’s only Coordinated Diagnostics Platform provides scalable, cost effective software solutions for hospital labs and independent labs.
Beyond Test Utilization, Labs Reach for Test Optimization
A variety of challenges must be recognized during the creation of a test utilization program. These include gender and age criteria for tests, catalog confusion due to custom panel names, frequency rules, pricing, and a lack of other objective criteria which can be supported by implementation of rules or algorithms. Rules and algorithms are indeed a key component in the transition to a test optimization program. Publically available algorithms from major medical organizations and specialty groups provide recommendations specific for lab tests and imaging studies; take a look at choosingwisely.org.
“Our strategic IT approach takes labs’ test utilization management to the next level—a utilization optimization level. ATLAS works with labs to build the right architecture, including algorithms and rules, create a patient centric repository and leverage diagnostics to ultimately impact outcomes and reduce costs,” says Rob Atlas.
Pathologists, laboratory leaders and IT professionals nationwide choose Atlas Medical to build the right architecture to support inpatient, outpatient, inreach and outreach lab services.
Here’s an overview of architecture for supporting precision medicine and Utilization Optimization:
Create a Patient Centric Repository, a patient matching and communications engine with patient identification and diagnostics data across multiple encounters, labs can coordinate diagnostics in challenging landscapes, such as those involving precision medicine and pharmacogenomics testing.
Adopt a clean orders strategy with the ATLAS’ Physician Portal, PSC (Patient Service Center) Portal and Advanced EMR Connectivity. These solutions enable diagnostic testing facilities to support electronic orders and results reporting with physician offices, patient service centers and other labs.
Deploy the Utilization Optimization solution to leverage the Patient Centric Repository, educate ordering providers about tests and intervene in real-time during the ordering process to share important test cost messages and content about best practice recommendations with ordering doctors.
An easy-to-use algorithm and rule–authoring environment allows messages to be developed such as: “You are ordering a genetic test that is more than $900. To proceed with this test, you will need pre-authorization.” Pre-authorization forms automatically print at ordering sites, too.
Notifications and interventions can happen at time of order placement, when a test is ordered by a particular doctor or particular site or when a tests involves a certain insurer—to name just a few options.
“We are renowned for our ability to customize solutions to labs. Labs can implement a technology platform now that works with their current assets and supports patient centricity and personalized medicine,” Rob Atlas says.
How is your lab preparing for and addressing precision medicine?
What are the lab’s most press challenges in moving toward test utilization optimization?