Healthcare providers order laboratory testing to assist in patient care. It is estimated laboratory testing has an impact on > 70% of medical management decisions. Prior to the COVID-19 pandemic, laboratory test volumes would double about every five to ten years in the United States, Canada, and the United Kingdom. Unfortunately, it is estimated that about 20% of all lab testing ordered in the United States is unnecessary. Furthermore, some testing is even underutilized. These ordering errors may cause patient harm. Furthermore, there are inherent issues in the Unites States’ healthcare system that perpetuate these ordering errors. The solution is multifaceted and may include clinical decision management tools through the electronic health record (EHR), pre-authorization, and laboratory utilization management.
Consider this fictional scenario to illustrate how easy it is for unnecessary testing to be ordered. A pregnant patient decides to have genetic carrier screening performed because it was offered by her OBGYN. Her health insurance provided by her employer was billed for the testing. She is a carrier of cystic fibrosis (CF). Her reproductive partner is also tested for CF and is negative. Six years later, the patient is pregnant again, but she is with a new partner, OBGYN, and has moved across the country. She works part time and has different health insurance through her new partner. She remembers she had genetic testing with her previous pregnancy but cannot recall what condition was positive. She requests records three times from her previous OBGYN, but they haven’t come yet. The current OBGYN decides to do a carrier screening panel instead of waiting for the records since the patient is in her second trimester. Once again, she is a carrier of CF and her current partner tests negative. The new insurance pays for her genetic testing. This second genetic panel for the patient was unnecessary. In an ideal world, the patient would have access to her records and send them to the second provider. Even better, there would be seamless portability of records among medical providers through a standardized EHR system.
Computerized Provider Order Entry (CPOE) systems in conjunction with clinical decision support tools (CDST) integrated in the EHR have shown a positive impact on redundant testing. CPOE is a system that uses computerized algorithm(s) which may prevent unnecessary testing. An example is a block or flag that appears in the EHR when the patient has a test repeated unnecessarily within a specific time frame. Hospital microbiology labs have used CDST to prevent the ordering of specific bacterial cultures when they are not needed. Electronic algorithms integrated into the EHR are cost-effective and efficient for medical staff. However, they may require considerable Information Technology (IT) infrastructure support when trying to integrate new systems into a provider’s EHR. Some medical facilities may not have the funding or IT support to implement CPOE and CDST.
Pre-authorization, also known as prior authorization (PA) is another tool to reduce healthcare costs and testing redundancy. PA involves getting approval from an insurance company for a lab test, medication, or procedure before the order is placed. The purpose of PA is to minimize healthcare costs without adversely affecting patient care. However, unlike CPOE and CDST, PA has many unintended consequences and may not always be efficient when performed by the medical staff. It is reported physicians may spend almost 15 hours a week in the PA process. Some may argue that PAs may impede a healthcare provider’s ability to care for their patients. Insurance companies, on the other hand, are also trying to minimize their costs to prevent unnecessary testing. Coverage for genetic testing by payors is extremely unpredictable. They also want to ensure the tests being performed will impact patient management. Ideally, PA should be automated, not impede patient care, and based on medical guidelines. Fortunately, Beacon LBS has a PA service which can ease the burden placed on medical practices.
Genetic testing has increased exponentially in the last 20 years. This is, in part, due to new gene discoveries, technological advances in testing, and its relative cost effectiveness. During this same time, clinical genetic counselors have been integrated into medical practice where genetic tests are ordered. Interestingly, patients expect genetic counselors to be knowledgeable about PA, testing costs, and health insurance coverage among other “genesurance” subjects; and these topics should be discussed during a session where genetic testing is offered. Additionally, one study reported 75% of patients expected insurance and financial cost to be discussed by the genetic counselor, but only 37% of patients had these same expectations of their primary care physician.
The PA process for genetic testing by genetic counselors is complex and time-consuming, similar to the experience of physicians. Healthcare professionals are already stretched to the limit with their time and clinics are sometimes understaffed. When a genetic counselor is employed in a medical practice, they quite often take on this additional responsibility. It is unknown if genetic counselors are the best medical professionals for this task based on their qualifications and further study is warranted for this topic.
Many labs have instituted utilization management processes in response to these challenges. Utilization management, in certain situations referred to as genetic testing stewardship, is selecting the right test for the right patient at the right time. Essentially, a genetic counselor evaluates a test order and may contact the ordering provider to review the most appropriate testing strategy based on clinical guidelines. One study reported a utilization management policy modified about 25% of genetic testing orders with projected cost savings of about $600,000 to $1,600,000 annually. Another lab reported modifying just 2% of 2367 genetic testing orders in a six-month period resulting in a cost savings of about $98,000. Other studies from large commercial genetic testing laboratories have demonstrated an average savings of $48,000 per month by instigating a laboratory utilization management program. Clearly, labs that have utilization management programs are saving money and increasing efficiencies. This also justifies the hiring of genetic counselors in the laboratory and broadens the role of the genetic counselor by translating their skillset into a utilization management system.
The healthcare system in the United States has many challenges to providers, clinical laboratories, and payors. The goal is optimal and efficient patient care while minimizing barriers and reducing costs. This balance is challenging and complicated by the COVID-19 pandemic, which has been described previously. CPOE and CDST may add to efficiencies when ordering test via the EHR system but can be challenging to integrate on an information technology level. Prior authorization is meant to control costs but can be time-consuming and may be restrictive to the clinician. Utilization management for the laboratory can result in significant cost savings to labs and payors, but some labs may not have these programs in place. The solutions to these and other barriers described is multifaceted and will not be solved in isolation. When clinicians, laboratories, and payors work collaboratively to solve such problems, patients will ultimately benefit.
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