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Beyond Test Results: Defining the Role of Clinical Laboratories in Value-Based Population Health Equity

Laboratories are reinventing their place in healthcare delivery by investing in strategic restructuring to meet ever-changing needs in their communities

Monique Dodd, PharmD, PhC, MLS(ASCP)CM, Rick VanNess, MS, and David Grenache, PhD, DABCC, FADLM

Clinical laboratories figure prominently in the continuum of care by delivering timely and accurate results to clinicians. As the U.S. healthcare system evolves into a value-based care model, laboratories are moving from transactional interactions to approaches that support integrated services and proactive population health (1). This means they are actively evaluating the strength of their data and capitalizing on their domain knowledge to develop actionable insights from longitudinal trends within the data (2).

This domain knowledge is key. Clinical expertise and information technology advancements are just two essential ingredients for this innovative multidisciplinary approach (2). Together, a data infrastructure modeled to stratify risks and a strategy to close care gaps are the building blocks for delivering better healthcare information to providers, payors, and patients.

TriCore Reference Laboratories, an independent, not-for-profit clinical laboratory serving the state of New Mexico since 1998, has been collaborating with other stakeholders in the state to build a value-based care model. New Mexico is considered rural and has one of the most ethnically diverse populations of all U.S. states, with nearly 50% Hispanic residents, 11% American Indian and Alaska Native, 2% Black or African American, and 1% Asian (3). Nearly one-third of New Mexico’s 2.1 million inhabitants reside in rural communities (4). Even as access to healthcare generally keeps expanding in these areas, many residents still face barriers to care. These social determinants of health factor significantly in whether people seek access to healthcare services and are becoming a critical component of population health initiatives across the state.

Health insurance coverage is only one determinant of whether a person will pursue healthcare services. Uninsured individuals face unaffordable healthcare and pay more out-of-pocket expenses, and the elderly generally access healthcare services more than their younger counterparts and are at higher risk of complications from chronic diseases. This results in higher healthcare expenses for the elderly who also become vulnerable to insurance claim denials.

In New Mexico, 9% of the population lacks insurance; this burden falls disproportionately on American Indians and Alaskan Natives (16.2%) and Hispanics 11.9% (5). The state’s rural areas have the highest proportion of people age 65 or older, who compose about 18% of the state’s population, and have an uninsured rate of 6.5%  (3,5,6). At the end of 2019, approximately 10.5% of people younger than age 65 lacked health insurance (7). Of those who were eligible for Medicaid and market subsidies, 6.1% and 29% were uninsured, respectively (5).

By stratifying risk and identifying care gaps, clinical laboratories have leading roles in understanding these populations and supporting proactive approaches to health equity (1,2). Recognizing the strength of its data, a laboratory can help clinical partners achieve the highest standard of care for all individuals. This change occurs by reducing health disparities and modifying determinants of health to realize health equity across all communities (8,9).

Value of Laboratory Data in Health Equity

Across the continuum of care, laboratories serve as clinical informants for healthcare partners, highlighting risks and care gaps within a population. By evaluating trends and developing guideline-derived algorithms to identify and manage health conditions, laboratories create descriptive and proactive models to support clinical decisions.

Hepatitis C Virus

Hepatitis C virus (HCV) causes acute and chronic infection of the liver, which can progress to hepatocellular carcinoma if not diagnosed early and treated effectively (10). Most individuals go years without symptoms, and HCV infection remains grossly undiagnosed. Individuals at high risk for HCV infection include current or past injected-drug users, children born to HCV-infected women, and those infected with HIV (11). No vaccine prevents HCV, but newer direct-acting antiviral drugs show a cure rate of greater than 99% (12). Clinical guidelines on treating and managing HCV call for all diagnosed individuals to be treated—with few exceptions (11,12).

On December 15, 2017, the New Mexico Human Services Department (NMHSD) declared that denial of treatment for HCV infection should not be influenced by any degree of liver damage, and that access to treatment only requires a diagnosis of HCV (13). This declaration specifically imposed changes in contracts of the state’s Medicaid program with managed care organizations (MCO) to improve access to treatment for Medicaid members across the state (14). Under this order, health plans have absorbed more HCV treatment costs among their enrolled members, which was met with a per member per month subsidy from NMHSD (15). As more individuals seek treatment—with a 12-week course of first-line medications costing between $39,600 and $94,500—payors are designing strategies to help manage and effectively distribute costs associated with chronic HCV infection (16, 17). These strategies are noble and essential as NMHSD’s subsidy to payors was also met with a penalty of up to 0.3% of their entire capitated payment if the payor did not treat at least 90% of their members with an HCV claim. Laboratories are thus positioned uniquely to help their payor partners achieve these aims, both of which advance value-based care and improve equal access to healthcare throughout their shared communities.

Clinical laboratories can identify potential health inequities within the population of HCV infected individuals by using data such as age, insurance status, and address, and by developing clinical insights from these factors in combination with laboratory results indicative of chronic health conditions, such as a detectable HCV viral load. Laboratories can pinpoint populations that need screening based on clinical guideline recommendations and also individuals who potentially need treatment.

According to TriCore’s data repository, an estimated 1.1% of New Mexicans have a detectable HCV viral load, indicating a need for treatment. About 14% of these individuals are older than age 65, and 13.5% are insured through Medicaid. Losing both these populations to follow-up when individuals elect not to pursue additional medical treatment remains a concern of providers. Understanding social determinants of health that would influence an individual’s reasoning for not seeking care when diagnosed with HCV is valuable to improving health equity.

Laboratory data algorithms can be configured into clinical analytical tools to help care coordinators provide targeted patient outreach and close care gaps. Partnering with Blue Cross Blue Shield of New Mexico (BCBSNM) in this effort, TriCore found that 28% of BCBSNM members covered by Medicaid had a reactive HCV antibody screening test but no follow-up confirmatory viral load test. Additionally, of the 1.4% of BCBSNM Medicaid members with a detectable viral load within the past year, nearly 15% had their first detectable viral load. For care coordinators, this information conveys a new HCV diagnosis and prompts them to work with providers to evaluate a patient’s readiness for treatment. This supports the need for partnerships between laboratories, payors, and providers to break down barriers to healthcare and create an environment supportive of health equity opportunities.&

In 2016, New Mexico ranked 48th in the U.S. for live births to women who received prenatal care before the third trimester (18), with only 63.4% of women having a healthcare visit in their first trimester (national average, 77.2%) (19). That same year, the March of Dimes gave New Mexico a “C” rating owing to its 9.5% preterm delivery rate (national ranking, 30th overall) (20). Studies have tied coordinated care in pregnancy to a reduction in preterm deliveries among women enrolled in Medicaid (21, 22, 23). To improve New Mexico’s performance in prenatal care and birth outcomes, NMHSD required MCOs providing coverage to Medicaid recipients to track, report, and better their prenatal and postpartum care quality measures. Additionally, NMHSD financially incentivized continual progress with these measures, as a means of improving outcomes for Medicaid beneficiaries (21).

To meet NMHSD’s requirements, MCOs utilize medical claims data, communications from healthcare providers, prescription records, and member self-reporting to identify pregnancies, coordinate prenatal care needs, and detect births. However, most prenatal care claims are not filed until after infants are delivered, resulting in latent data (24, 25). Also, rural patients might lack awareness of or access to obstetric services, thereby potentially seeking routine care in emergency settings, not receiving ongoing prenatal care, and not accessing healthcare services until they go into labor.

In prenatal care, clinical laboratories provide more reliable and timely data than insurance claims (26, 27, 28). By combining patient results across providers and locations, laboratories create a longitudinal picture of prenatal care gaps to facilitate timely obstetric care. While not all prenatal visits include laboratory testing, the American College of Obstetricians and Gynecologists (ACOG) recommends laboratory testing milestones according to specific gestational age (29); this enables laboratories to verify the presence or absence of routine prenatal care. Additionally, a patient’s longitudinal history of laboratory testing indicative of high risk (e.g., diabetes, urinary tract infection, age, etc.) furthers a laboratory’s ability to innovatively enhance the value of a single prenatal test.

TriCore created a prenatal algorithm over an 11-month period, testing its ability to enhance care coordination provided by a New Mexico MCO, BCBSNM. Our study indicated that of the 1,355 BCBSNM Medicaid members identified as pregnant:

  • More than 65% identified for needing prenatal care were not reflected in BCBSNM claims data;
  • 77% were in their first trimester;
  • 64% received at least 80% of ACOG’s recommended medical laboratory testing; and
  • Women who received regular prenatal care:
  • l Used emergency care 25% less;
  • l Had fewer births requiring a NICU admission; and
  • l Had fewer preterm deliveries.

These results indicate that clinical laboratory data-driven algorithms provide real-time and longitudinal insights; using these laboratory generated insights, BCBSNM was able to identify more pregnant members, increase the number of women receiving early prenatal care, monitor ongoing prenatal care, and affect the likelihood of an uncomplicated gestation. The American Journal of Managed Care recently published this study (30).

Diabetes

Diabetes is a growing epidemic in the United States with an estimated annual cost in 2017 of $327 billion, including $237 billion in direct medical costs and $90 billion in reduced productivity (31). To help prevent or delay the progression of diabetes mellitus complications, the American Diabetes Association (ADA) sets forth annual care guidelines (32). One recommendation calls for patients with diabetes who are meeting treatment goals to receive a hemoglobin A1c (HbA1c) test twice annually, and those not meeting glycemic management targets to undergo quarterly testing. Additionally, ADA recommends a random urine albumin-to-creatinine ratio (uACR) at least annually to monitor microvascular kidney complications. Organizations that assess the quality of healthcare adopt these guidelines, and similar to prenatal care, NMHSD incentivizes the annual improvement of these measures among MCOs that provide health insurance to Medicaid recipients.

Health plans work to improve these annual measurements each year through a variety of mechanisms. A popular method involves contacting eligible members and assisting in their diabetes management by educating them, coordinating visits among their providers, and focusing on preventative services to reduce costly complications. This process, commonly referred to as care management (33), assesses the needs of each member by utilizing a variety of data elements such as medical claims data, communications from providers, prescription records, and member self-reporting. Some of these data sources (e.g., diagnosis data) might contain errors (34,35), which could limit the effectiveness of care management operations. By delivering accurate and timely clinical results laboratories have the potential to identify and track patients who need diabetes care management. To prove this concept, TriCore again collaborated with BCBSNM by providing patient-focused analytics. For nearly 4 months, both organizations aimed to determine if our laboratory could better identify BCBSNM Medicaid members with diabetes and whether BCBSNM care management could improve their diabetes quality measures.

The study, published in The Journal of Applied Laboratory Medicine, demonstrated that TriCore’s insights could accurately identify BCBSNM’s members with diabetes (36). Further, the report describes how this insight allowed BCBSNM’s diabetes care management team to achieve higher completion rates with recommended annual HbA1c and uACR testing in the study group. In 2017, BCBSNM’s HbA1c compliance rate within Medicaid was 82% (36), which led to development of an algebraic forecast for the study group’s year-end completion rate. With an estimated 89% annual completion rate, the study demonstrated that collaboration between BCBSNM and TriCore could achieve a 7% higher rate of compliance with HbA1c testing among eligible diabetic patients. This higher rate of compliance would assist BCBSNM in exceeding its contractual obligations with NMHSD and avoid the monetary penalty associated with HbA1c testing for members with diabetes.

After assessing the impact of this collaboration, TriCore then calculated the financial incentives NMHSD assigned to these diabetes quality measures. TriCore determined that NMHSD assigned $3,693,000 per measure, parsed among MCOs based on the number of Medicaid enrollees. Dividing the total NMHSD incentive by the total number of Medicaid members with diabetes indicated that each Medicaid recipient with diabetes is worth $55.10 for each quality measure (38). New Mexico’s reimbursement rate for an HbA1c test (based on the CMS Clinical Lab Fee Schedule) was $11.27 in 2018 and lowered to $9.13 in 2020 (39). When comparing the HbA1c reimbursable test rate against the NMHSD quality incentive rate, we found that an HbA1c test in New Mexico is worth less than one-fifth the value per patient. This indicates NMHSD’s strong desire to ensure all Medicaid recipients are integrated into care and creates an opportunity for laboratories to assist in this effort.

Discussion

As these examples demonstrate, clinical laboratories have access to valuable and actionable insights, derived from their data warehouses, that can be used to improve both individual and population health. This is particularly relevant for communities that experience barriers to care. Notably, a laboratory does not need to serve an entire state in order to make a difference. Strategies like those described here can be applied on a smaller scale.

Clinical laboratories leverage their value most effectively in partnership with others. Clinicians, educators, payors, care coordinators, and, of course, patients themselves are all necessary ingredients for success. Laboratory partners have so much to gain from positioning themselves as leaders in value-based healthcare among these diverse teams and from making their voices heard and contributions recognized. This makes sense, given the large amount of information and decision-making derived from laboratory data.

However, laboratory professionals also possess the domain knowledge required to effectively translate these data into actionable insights. Measuring the value of clinical laboratories beyond lab-focused metrics is no simple matter and will take time, energy, and resources to realize. Nonetheless this goal can be realized, and the process of doing so has already begun.

Monique Dodd, PharmD, PhC, MLS(ASCP)CM is the Manager of Enterprise Clinical Solutions at Rhodes Group in Albuquerque, New Mexico.+Email: [email protected]

Rick VanNess is the Director of Product Development at Rhodes Group in Albuquerque, New Mexico.+Email: [email protected]

David Grenache, PhD, DABCC, FADLM, is the Chief Scientific Officer at TriCore Reference Laboratories in Albuquerque, New Mexico.&+Email: [email protected]

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