June 17, 2019 | Jennifer Dien Bard understands the frustration of having a vast menu of available molecular diagnostic tests but being limited by reimbursement restrictions. "Restrictions of these molecular testing modalities due to reimbursement challenges can directly lead to delays in treatment or ineffective treatment for many patients," she says.
Dien Bard is the director of Microbiology and Virology Laboratory at Children's Hospital Los Angeles and an associate professor of pathology at Keck School of Medicine, University of Southern California. She argues that new, clinically useful tests must secure reimbursement coverage so that labs can make use of them.
On behalf of Diagnostics World News, Kaitlyn Barago asked Dien Bard about how her lab chooses diagnostics tests, diagnostic stewardship, and the biggest challenges ahead.
Editor's note: Kaitlyn Barago is a Conference Producer for the Next Generation Dx Summit held in Washington, D.C. August 20-22. Dien Bard will be speaking on the Molecular Diagnostics for Infectious Disease program. Their conversation has been edited for length and clarity.
Diagnostics World News: When it comes to choosing which diagnostic test to implement in your lab, what are some of the factors that you consider?
Jennifer Dien Bard: There are multiple factors that I would look at to determine what would fits the needs of the microbiology laboratory. Ultimately the goal is to implement new diagnostic tests that are "better, faster, and cheaper." However, one or two of these factors may be more important in certain situations. For example, if I was looking to change from a culture-based method to molecular method, clearly the new test must be faster and "better" in the sense that is more sensitive and specific, but cheaper would likely not be a requirement as it is expected that molecular diagnostic tests are more expensive than culture-based methods. On the other hand, if the laboratory is already using molecular approaches for a specific target or syndrome, meeting all three criteria may be more necessary to warrant switching to an alternate test. Other features that I would look for include the following: random access capability, hands on time, ability to test continuously throughout the day, targets included in the panel, and the potential clinical impact.
What do you think are some of the biggest challenges ahead for reimbursement of new diagnostic tests in the clinical lab?
I cannot stress enough the importance of the clinical laboratories in the diagnosis of infectious diseases. Furthermore, the continued emergence of innovative diagnostic tests can further advance clinical care. Unfortunately, a major challenge that clinical laboratories face is reimbursement woes for such tests as large multiplexed panel to diagnosis respiratory and gastrointestinal infections. It is unfortunate that laboratories may be forced to maintain insensitive tests that limit the detection of causative agent.
Restrictions of these molecular testing modalities due to reimbursement challenges can directly lead to delays in treatment or ineffective treatment for many patients. To help overcome these challenges, clinical rigorous evidence-based studies that demonstrate the clinical utility and health economic benefits of molecular diagnostic tests is crucial.
Is there a role for diagnostic stewardship? Can you define what diagnostic stewardship means to you?
To maximize the impact that laboratory medicine has on patient management and outcome, diagnostic stewardship is paramount. And the interesting thing is that diagnostic stewardship has always existed—there were always policies and procedures in place in the laboratory to prevent unnecessary testing. However, in the past few years diagnostic stewardship has become even more critical in the era of rapid molecular diagnostics. The ability for the microbiology laboratory to provide fast and on-demand molecular testing have in turn increased the risks of clinically inappropriate testing.
To simplify it, diagnostic stewardship refers to performing the right test on the right patient at the right time. For example, rejecting an order for C. difficile PCR on a patient that presents with one diarrheal episode while on laxative is practicing diagnostic stewardship. Drs. Kevin Messacar and Sam Dominguez and colleagues published an excellent mini-review in the Journal of Clinical Microbiology in 2017 (doi: 10.1128/JCM.02264-16) summarizing the role of diagnostic and antimicrobial stewardship. They emphasized the need for judicial testing for appropriate patients only to ensure that accurate and clinically relevant results are generated to positively influence clinical care while maximizing resources.
What are some technologies, ideas, or tests that you see coming down the pipeline that you are looking forward to and why?
It has been an exciting decade for infectious diseases diagnostics with the emergence of numerous innovative testing approaches including syndromic testing and next generation sequencing. I am looking forward to the future multiplexed assays that target additional syndromes such as bone and joint infections and expanded whole blood panels that can bypass the incubation requirements. Expanded panels coming to the market should improve existing syndromic panels. I am also looking forward to future panels that can integrate host response (biomarkers) with rapid molecular diagnostic tests to identify patients at high risk for infection. Pairing rapid phenotypic susceptibility with any future panels would be beneficial as it can directly prompt antimicrobial optimization.