PLUGS News

Medical Necessity Policies: Creating Opportunities for Better Test Utilization and Fair Payment

Date: Jul.1.2023
Authors: Mike Astion, MD, PhD

Mike Astion, MD, PhD, has been working in collaboration with insurers since he worked at the University of Washington in 2007. He brought that experience with him to Seattle Children’s Hospital, which launched PLUGS in 2013. The partnership includes analyzing laboratory insurance claims, performing evidence reviews, creating or reviewing medical necessity policies, advocating for specific CPT coding over nonspecific codes, improving preauthorization for genetic tests, and explaining successful lab-payer collaborations through webinars and publications (Table 1). Astion, who cofounded the PLUGS program, is medical director of laboratories at Seattle Children’s Hospital and professor of laboratory medicine and pathology at the University of Washington in Seattle.

Finding My Niche in Laboratory Stewardship as a Genetic Counselor 

Date: Apr.1.2023
Authors: Susan Schowalter, MS, CGC

Working in laboratory stewardship is not where I expected to find myself when I was in graduate school for genetic counseling. In my training program, I was introduced to a wide range of settings where genetic counselors can work. In clinical settings, I saw genetic counselors meeting with patients, coordinating and providing education about genetic testing. While I enjoyed rotating in these clinics, I struggled with the reality that wait times to be seen by the genetics clinic were far too long to accommodate all the patients that could benefit from genetic testing, and genetic teams were stretched thin to care for existing patients too.

Leveraging Reference Laboratories to improve laboratory Stewardship in Health Systems

Date: Apr.1.2023
Authors: Michael L. Astion and Donna D. Cooper, MS, MBA

Over the past 2 years, COVID-19 profoundly strained hospital labs. Volume increases for some tests related to COVID-19 diagnosis and management increased as much as 26,000%, despite overall testing volumes declining significantly (1). Throughout the pandemic, health systems struggled to monitor unpredictable patterns while juggling laboratory management, staffing issues, and supply gaps.

As they emerge from the worst of the COVID-19 pandemic, hospitals and health systems face significant financial challenges. The American Hospital Association estimates that the effects of COVID-19 hospitalizations, combined with cancelled and forgone services, may represent an average financial impact of $50.7 billion in monthly losses for American hospitals (2). These financial challenges put pressure on labs to lower costs and increase efficiency.

Three Perspectives on Optimizing the Use of Next Generation Sequencing for Infectious

Date: Jan.1.2023
Authors: Erin Chung, MD, Drew Bell, PhD, Caleb Stokes, MD, PhD,

One of the central archetypes of clinical practice is the mystery of a patient who is clearly sick yet lacks a definitive diagnosis. With infectious disease, the near-infinite diversity of pathogens makes this dilemma a unique challenge. The advent of tests that perform rapid genetic sequencing to identify nonhuman, microbial genomic information (also known as metagenomic next-generation sequencing, or mNGS) offers a singular appeal in this setting: The genetic identity of the pathogen could provide an immediate answer to the central mystery of the infected patient. Unfortunately, the cost of mNGS is typically 10–20 times that of most conventional laboratory tests for infectious disease.

How can clinicians and labs deploy mNGS to maximize diagnostic yield while minimizing cost? We offer three perspectives from key stakeholders, as well as a theoretical framework for optimizing clinical benefit and laboratory stewardship.

 Good Governance in Laboratory Stewardship: A Roadmap for Success

Date: Jan.1.2023
Authors: Tony Smith, BS(HCM), MLT(ASCP)

An effective laboratory stewardship roadmap includes a vision for a culture of laboratory stewardship in the organization. Stewardship initiatives often are driven from a system level, but most have their genesis within the laboratory and garner support in a bottom-up approach. Such strategies push laboratories to continually quantify the laboratory’s value within the health system.

How to Successfully Navigate the Insurance Denial Appeal Process for Genetic Tests

Date: Jul.1.2022
Authors: Sam Huang, MD, and Jessie Conta, MS, LGC

Seattle Children’s Hospital (SCH) implemented a laboratory test stewardship program with focus on genetic testing in 2012. Key to the program has been the hospital’s ability to standardize the prior authorization process and integrate it with the test stewardship review program. Given genetic testing’s relative cost and evolving coverage policies, aligning test requests with payer requirements has been critical to reducing financial liability for patients, families, and the institution (1).

Resolving the Ammonia Paradox

Date: Jul.1.2022
Authors: James Hellewell, MD, MS, and Richard Gilroy, MD

A paradox is a statement or proposition that, despite sound (or apparently sound) reasoning from acceptable premises, leads to a conclusion or action that is senseless. In the ammonia paradox, measuring ammonia levels in confused cirrhotic patients with hepatic encephalopathy (HE) is, to paraphrase Adrian Reuben, MD, an action that creates greater confusion in those ordering
the test than the confusion present in the patient (1).

Supply Chain Meltdown? Laboratory Stewardship to the Rescue

Date: Apr.1.2022
Authors: Elise Occhipinti, MD

Supply chain challenges have plagued the clinical laboratory throughout the COVID-19 pandemic. Increased, unpredictable demand for laboratory testing has coincided with global delays and raw material shortages. The pandemic exposed the weaknesses of “just in time” inventory management, leaving many laboratories without inventory. Laboratories worldwide have endured alternating shortages, from nasal swabs, viral transport media, and pipette tips, to molecular testing reagents.

Taking Data Visualization for Blood Management to the Next Level and Beyond

Date: Apr.1.2022
Authors: Ryan A. Metcalf, MD, CQA(ASQ) and Alexander Lex, PhD

Patient blood management (PBM) is a multimodality, multidisciplinary approach to stewardship in transfusion medicine. It involves optimization of anemia and hemostasis with a goal of avoiding unnecessary transfusions. Now considered standard of care, PBM is patient-centered and can improve quality while reducing costs. The recent intermittent national blood shortages make PBM more important than ever (1).

Simplifying the Test Menu to Beat Choice Overload

Date: Jan.1.2022
Authors: Charlene Bierl, MD

Ensuring patients receive the right test at the right time is a foundation of laboratory stewardship. Toward this goal, laboratories have tried many tactics to guide ordering practices and optimize the laboratory test menu. Laboratory directors can remove obsolete tests or introduce reflex algorithms that automatically trigger additional tests based upon initial laboratory findings.

Not Just Kitting Around: Optimizing Alternate Sample Coordination for Genetic Tests

Date: Jan.1.2022
Authors: Claire Wittowski

Alternate specimen collection kits for genetic testing aren’t new—so-called spit kits and cheek swabs have been around for more than a decade (1). Although blood is often the preferred sample type for genetic testing due to the large amount of high-quality DNA that can be extracted from white blood cells, alternate sample types such as saliva and buccal cells can provide enough DNA to perform most genetic testing. Based on the clinical scenario, these samples may be easier to collect or preferred for testing to provide the most accurate results.

Patient-Centered Laboratory Stewardship Can Reduce Financial Toxicity

Date: Oct.1.2021
Authors: Michael Astion, MD, PhD, and Brian R. Jackson, MD

In a previous article, we described lab stewardship as a set of activities, policies, and procedures that improve five elements of lab testing: access to testing, test ordering, result retrieval, result interpretation, and financial fairness for patients. We also explained why lab stewardship must be patient-centered. Here we describe how laboratories can help patients with financial decisions and avoid subjecting them to financial toxicity.

Is a Benefits Investigation Really Beneficial? An interview with Heather Agostinelli

Date: Oct.1.2021
Authors: Jane Dickerson, PhD, DABCC, and Jessie Conta, MS, LGC with Heather Agostinelli

As clinical laboratory professionals who prioritize patent care, we believe patients deserve to understand how much a service will cost, whether insurance will cover the cost, and whether they will be financially liable. Tools to support pricing transparency for lab testing align with these stewardship principles. So, how can we find out what a test will cost? We invited Heather Agostinelli, vice president of strategic revenue operations at XIFIN, to share her expertise.

Moving Toward Patient-centered Laboratory Stewardship

Date: JUL.1.2021
Authors: Michael Astion, MD, PhD, and Brian R. Jackson, MD

Patient-centered care has become a popular term within the medical establishment. In this article, we apply some of these patient-centered principles to laboratory stewardship, with a special focus on access to testing.

HbA1c Access and Opportunity During the COVID 19 Pandemic

Date: JUL.1.2021
Authors: Derick Lim, MS, SC(ASCP)CM, MLS(ASCP)CM, Khushbu Patel, PhD, DABCC, and Tracey G. Polsky, MD, PhD

Getting the right test to the right patient at the right time is a common goal for medical and laboratory professionals working on laboratory stewardship. This mantra translates into ensuring that laboratory resources are optimized for patient-centered care.

The Building Blocks of a Pharmacogenomic Program

Date: APR.1.2021
Authors: Jennifer Eichmeyer, MS, CGC, and Christine Munro, MS, MPH, CGC

In this era of personalized medicine, the field of pharmacogenomics is experiencing significant growth and growing interest. Pharmacogenomic (or pharmacogenetic) testing analyzes specific genetic variants to better understand how a person may respond to medications.

How Precision Medicine Combats Underused Genomic Testing

Date: APR.1.2021
Authors: Ryan S. Nelson, PharmaD, and Howard L. McLeod, FASCO, FCCP

Medical oncologists strive daily to provide the best cancer care for each of their patients. However, the rapid rate of practice-changing developments makes keeping up to date a significant challenge.

Aligning Genetic and Genomic Test Reimbursement With Value of Tests

Date: JAN.1.2021
Authors: Julie M. Eggington, PhD, and Megan E. Garlapow, PhD

Very small helms guide very large ships. Similarly, in vitro diagnostics account for only about 2.3% of healthcare expenditures in the U.S. but have an outsized influence on clinical decision-making. The enormous impact of diagnostics on patient health underscores the critical need to drive quality improvements with those who helm clinical genetic and genomic testing.

So Many Choices: Selecting Reference Labs Using a Standard Process

Date: JAN.1.2021
Authors: Elizabeth Weinzerl, MD

Genetic testing is increasingly coming into the mainstream, with genetic and genomic testing now available for thousands of genetic conditions. Many hospital laboratories send out genetic tests to reference laboratories, often at considerable cost.

Q&A: Help, COVID-19 Has Devoured My Lab Stewardship Program
Date: OCT.1.2020
Author: Michael Astion, MD, PHD

The COVID-19 pandemic overshadows every conversation at my hospital and laboratory so much that I can’t push any stewardship projects forward. People say they are overwhelmed by the pandemic even though not all my colleagues have work dominated by COVID-19. My own motivation to focus on stewardship—still a high priority for my institution—is waning. Please help me.

Can we talk? Addressing biases through thoughtful conversation
Date: OCT.1.2020
Author: Jessica Shank, MS, LCGC

Laboratory stewardship programs are poised to shape ordering practices and support providers throughout the healthcare system. Teams comprised of pathologists, genetic counselors, sendout staff, laboratory managers, and trainees seek to provide safe, high-value tests for patients. Lab stewardship team members, acting as consultants throughout healthcare organizations, rely not only on their expertise in laboratory medicine but also on their interpersonal skills in communicating their knowledge. A significant portion of a laboratory stewardship program’s work involves decision-making about test ordering and results interpreting. Facilitating decision-making is a psychosocial skill commonly referencing the patient-provider relationship.

When Lab Testing Offered for Free Is Not Really Free
Date: JUL.1.2020
Author: Darci Sternen, MS, LCGC, Jessie Conta, MS, LGC, and Jane Dickerson, PhD, DABCC

A free or reduced-rate test is a clinical test offered by a reference laboratory to some or all patients at no charge or at a reduced charge. A lab might have many reasons to not charge for a test, but the most common involves tests subsidized by a pharmaceutical company. In these cases, a pharmaceutical company pays a laboratory for the cost of performing a test, and the laboratory then passes on those savings to the collecting institution and to the patient. Other reasons include tests performed as research funded by other means (for example, grants) and new clinical tests for which the performing laboratory is trying to raise awareness and drive business.

Navigating the Wild, Wild West of Diagnostic and Serology Testing in the COVID-19 Pandemic
Date: JUL.1.2020
Author: Jennifer Kasten, MD, FASCP

As the SARS-CoV-2 virus hit U.S. shores, the nation suddenly needed widescale, reliable diagnostic testing infrastructure in place—and fast. It turned out to be harder than non-laboratorians might think to manufacture out of thin air 5 million validated, accurate polymerase chain reaction (PCR)-based tests for a novel virus. The early quality control plan, which involved central testing available only at the Centers for Disease Control and Prevention (CDC), with no scope for laboratory-developed tests, proved to be woefully inadequate to meet demand, and the CDC’s tests were plagued with technical concerns.

Benchmarking: A Promising Practice for Lab Stewardship Toolkits
Date: APR.1.2020
Author: Joseph Rudolf, MD

As clinical laboratories continue to experience pressures to lower costs and enhance performance in a resource-constrained environment, our need for data-driven tools to guide our operations is ever-increasing. In this setting, looking at solutions employed in other industries that face similar pressures to produce the highest-quality products at competitive price points can prove useful.

Lab Stewardship in the Era of Genomic Testing
Balancing Emerging Technologies With Clinical Practice
Date: APR.1.2020
Author: Tina Lockwood, PhD, DABCC, DABMGG

This is a very exciting era in laboratory medicine as virtually every day new genetic tests and emerging laboratory technologies enter the market. With these advancements also comes the (fun) challenge of distinguishing clinical testing from research testing. Making this distinction matters in two key ways. First, from a regulatory standpoint, it would be financially irresponsible to bill patients and insurers for research testing. Second, in terms of clinical implications, we have to demonstrate the value of classifying variants (clinical validity), then show that variant classification impacts patient clinical outcomes (clinical utility). Laboratory test stewardship programs provide an important foundation for striking an appropriate balance between implementing new genetic tests and meeting standards for clinical validity and utility, paying particular attention to the size of genetic panels.

Ethics of Al and Big Data in Laboratory Medicine
Date: JAN.1.2020
Author: Brian Jackson, MD, MS

Today a new technology is changing the world in even more dramatic and far-reaching ways: artificial intelligence (AI). It has revolutionized advertising, entertainment, and education, and is invading many other areas of our lives. Some of the most obvious examples include self-driving cars, phones that understand our speech, and online search engines that answer virtually any question. Less obvious examples operate behind the scenes in retailing and service industries. And the medical world has high expectations for AI to improve healthcare.

How to Say No to Sendouts
Strategies for coping with tests that aren’t ready for clinical use
Date: OCT.1.2019
Author: Michael Astion, MD, PhD

Bill Malone, managing editor of Clinical Laboratory News, interviewed Mike Astion, MD, PhD, medical director of the laboratories at Seattle Children’s Hospital, about how to approach these kinds of tests. Astion is a co-founder of the Patient Centered Laboratory Utilization Guidance Service (PLUGS), a member-based network of more than 100 hospitals and commercial labs whose mission is to improve test utilization.

The 3 C’s of Improving Lab Stewardship: Collaboration, Champions, CPOE
An illustrative story of improving testing for C3 glomerulonephropathy
Date: OCT.1.2019
Author: Jane Dickerson, PhD

Impact and ease of implementation are two general ways to categorize laboratory stewardship interventions (1). For example, sending an email about best practice guidelines is easy to do but most likely will have little impact on actual practice. Conversely, building rules in an electronic health record to alert when best practice guidelines are not being followed is more difficult to implement but has a higher impact on actual practice. A recent meta-analysis by Rubenstein and colleagues reviewed the effectiveness of various laboratory stewardship interventions, and found that those with the highest evidence ratings involved computerized-provider order entry (CPOE) systems and combined interventions (2). But, as discussed in a recent lighthearted editorial in Clinical Laboratory News, knowing what to do and actually doing it are different things that involve different skills (3). What follows is a practical story of both knowing and doing. While the story highlights a specific esoteric test, the approach this case describes would apply broadly to any stewardship challenge.

Blurred Lines
Comparing Direct-to-Consumer and Clinical Testing
Date: JUL.1.2019
Authors: Jacquelyn Riley, MS, LGC, and Katie Stoll, MS, CGC

As the direct-to-consumer (DTC) sector of the laboratory industry has exploded, advocates have asserted that these tests remove potential barriers in our traditional healthcare system and increase access to important health information while boosting both convenience and privacy.

Overdiagnosis: An Unintended Side Effect of Diagnostic Testing
An interview with: H. Gilbert Welch, MD, MPH
Date: JUL.1.2019
Author: Jane Dickerson, PhD, and Brian Jackson, MD

Jane Dickerson, PhD, and Brian Jackson, MD, of CLN Laboratory Stewardship Focus recently interviewed physician and author, H. Gilbert Welch, MD, MPH, about the problem of overdiagnosing patients. A general internist who for the past 2 decades has studied the problem of overdiagnosis, Welch is nationally recognized for his many journal articles and books on the topic, including Overdiagnosed: Making People Sick in the Pursuit of Health (1) and most recently, Less Medicine, More Health: 7 Assumptions that Drive Too Much Medical Care (2).

Perimortem Genetic Testing in a Children’s Hospital
A Team Approach to Policy Development
Date: APR.1.2019
Author: Darci L. Sternen, MS, LCGC, and Bonnie Cole, MD

Genetic testing in the perimortem period—immediately before or after a patient’s death—involves unique ethical and logistical issues in pediatric hospitals. Genetic testing may be necessary to confirm an underlying diagnosis, yet testing may not be medically necessary because the results will not change medical care for the child.