Keywords aged - medication adherence - medication therapy management - clinical informatics
- chronic disease
Background and Significance
Background and Significance
The coronavirus disease 2019 pandemic exacerbated health and health care-related disparities
and inequities observed in multicultural populations.[1 ]
[2 ] Black and Hispanic communities, examples of historically medically marginalized
populations, utilize less preventive health services in the United States when compared
to White populations.[3 ]
[4 ] Across the gamut of preventive services, these racial and ethnic minority groups
are less likely than Whites to obtain primary (e.g., influenza vaccinations),[5 ] secondary (e.g., colorectal screenings),[6 ] tertiary (e.g., chronic condition monitoring),[7 ] and quaternary (e.g., overmedicalization review)[1 ] preventive care. In addition to experiencing barriers in access to care to prevent
disease and worsening of existing disease, multicultural groups have more disease
burden and inferior health outcomes when compared to Whites. For instance, prevalence
of chronic conditions such as type 2 diabetes mellitus (T2DM)[8 ]
[9 ] and hypertension is greater in Blacks and Hispanics than Whites[10 ]; moreover, Black and Hispanic populations with T2DM have poorer glycemic[11 ] and blood pressure control,[12 ] than non-Hispanic White populations.
While race and ethnicity are well-known risk factors, age is also associated with
disparity (i.e., differences in health closely linked with social, economic, and/or
environmental disadvantage) and inequity (i.e., a type of health disparity that stems
from unfair and unjust systems, policies, and practices and limits access to the opportunities
and resources needed to live the healthiest life possible) in preventive health care.[13 ] Older adults receiving Medicare, most of whom are aged 65 years or older, have complex
health needs involving several comorbidities, which require extensive preventive care.
Multicultural Medicare members have more morbidity,[14 ]
[15 ] mortality,[16 ] and health care costs[16 ] when compared to White Medicare members. These differences necessitate the development
of evidence-based interventions to decrease the disparities and inequities observed
in preventive health for multicultural Medicare beneficiaries by improving the delivery
of chronic disease care management (CM) for minority groups.
Pharmacotherapy is essential to chronic disease CM for Medicare members, as this population
consumes more than 30% of all prescriptions.[17 ] Within this group, approximately 50% take ≥5 medications, and 12% take at least
10 medications regularly.[18 ] To help address drug therapy management in this vulnerable population, the Medicare
Prescription Drug, Improvement, and Modernization Act of 2023 issued by Centers for
Medicare and Medicaid Services (CMS) required that Medicare Advantage plans offering
prescription drug coverage have a medication therapy management (MTM) program.[19 ] Plan-sponsored MTM programs are most often furnished by a pharmacist and designed
to administer the plan to optimize therapeutic outcomes through improved medication
use, and to reduce the risk of adverse events. The main goals of MTM programs are
to (1) provide education about medication use, (2) improve medication adherence, and
(3) prevent, identify, and resolve adverse drug events (ADEs). Other secondary goals
of MTM programs may include improving established quality performance metrics (i.e.,
CMS Star Rating and Healthcare Effectiveness Data and Information Set [HEDIS] scores)
and increasing member satisfaction. To achieve these goals, distinct clinical strategies
are required,[20 ] but all necessitate member engagement and data-informed insights to address their
medication use needs and to determine their eligibility for MTM; as such, a pharmacoinformatics
framework must be designed, implemented, and adopted to meet the requirements to administer
MTM, monitor pharmacovigilance, and improve the medication use processes for our members
overall.
There is an unmet need for programs that effectively support chronic disease management
in multicultural older adults. To address these needs, a payor-led Multicultural Clinical
Initiative (MCI) was designed to deliver a CM program that has multiple connected
goals to identify and deliver tailored preventive health interventions, including
the optimization of pharmacological control of T2DM and/or hypertension in multicultural
older adults and to improve medication use processes for this cohort.[21 ]
Objectives
This study aims to describe an informatics-based approach used to execute and evaluate
results of a member-centric, pharmacoinformatics-informed engagement program to deliver
culturally tailored microinterventions to close medication-related gaps in care utilizing
multidisciplinary care coordination. The operational framework will be described,
and the influence of the medication use processes will be reported in a multicultural
Medicare Advantage cohort.
Methods
High-level Overview of the Multicultural Clinical Initiative Framework
The MCI framework has been previously described.[21 ] Briefly, several competencies were obtained to design an intervention appropriate
for this population: (1) patient-centered (e.g., care focuses more on the patient's
problem than the diagnosis), (2) transdisciplinary (e.g., inclusive care team beyond
clinicians including social and societal services), (3) evidence-based (e.g., use
of best available evidence to support decision-making), (4) quality improvement-oriented
(e.g., the systematic improvement of care), and (5) informatics-enabled (i.e., the
integration of digital technology to transform data into insights that can be acted
upon).
Implementation of this culturally tailored engagement and its interventions were informed
by core competencies listed above. During intervention mapping, competencies obtained
were paired with evidence-based frameworks to support health equity advancement, particularly
in areas related to social determinants of health (SDoH) and health behavior. These
formative studies supported the phase-based clinical CM. Three separate prospective
qualitative interviews were conducted to better understand the health and health care
needs of a multicultural Medicare member population. The interviews were conducted
with follow-up quantitative surveys and content analysis in the following groups:
(1) Black and/or Hispanic Medicare consumers, (2) providers (i.e., the care team)
treating this population, and (3) health plan colleagues (i.e., case managers and
social workers employed by the large health plan).[21 ]
Overview of the Multicultural Clinical Initiative Pharmacoinformatics Framework
The MCI was operationalized across eight key components ([Fig. 1 ]): (1) a rich and diverse data foundation; (2) application of artificial intelligence
techniques; (3) interoperability processes between data warehouses containing medical
and pharmacy claims data, health care utilization, member data summaries, and electronic
health records; (4) multiple data platforms curating member-specific HEDIS and CMS
Star Ratings measures to inform gaps in care; (5) CM engagement dashboard for the
MCI population featuring logic-queried Star- and HEDIS-driven clinical intervention
factors specific to pharmacy measures; (6) evidence-based nursing- and pharmacy-related
standardized workflows; (7) utilization of clinical decision support (CDS) tools;
(8) a designated platform for nurse care managers and pharmacists with cultural competency
training to deliver information and knowledge using multichannel for member and provider
engagement. The expanded scope of pharmacists' practice in this program enables clinical
preventive services, chronic disease management, and transitions of care to address
unmet clinical and social needs of this population including health inequities and
health disparities.
Fig. 1 Multicultural Clinical Initiative pharmacoinformatics framework. Key foundational
competencies directly enable the identification and delivery of culturally tailored
microinterventions to close medication-related gaps (e.g., medication adherence, statin
use in persons with T2DM) in care utilizing multidisciplinary care coordination. CM,
care management; Rx, prescription; T2DM, type 2 diabetes mellitus.
Risk-stratified Member Identification
The MCI program leverages interoperability between data warehouses for risk stratification
of member eligibility. Rule-based logic and predictive modeling identify Medicare
Advantage members that self-identify as Black and/or Hispanic with diagnoses of T2DM
and/or hypertension, residing in Texas (TX), Florida (FL), or Pennsylvania (PA), and
an a priori population health risk stratification score threshold of > 78%. These
states (i.e., TX, FL, and PA) were selected based on member need (i.e., high prevalence
of Black and Hispanic members and/or disparities in gaps in care). The risk stratification
algorithm (U.S. patent pending) is an evidence-based, proprietary scoring tool that
leverages seven different predictive models to estimate clinical and economic burden
and actionable metrics (i.e., fall risk, drug safety indications, and avoidable emergency
department visits). Predictive models are based on a plurality of data sources such
as demographics, medical and pharmacy claims, diagnosis codes, biomarkers, laboratory
results, health care utilization, gaps in care, and SDoH. The inclusion threshold
(i.e., greatest risk for inferior medical outcomes > 78%) is based on member risk,
potential benefit, and care manager capacity.
All eligible members are routed to a nurse-led CM program following standardized workflows
supporting CMS-required MTM including pharmacist-led consultation, if eligible. Event-driven
alerts, such as an inpatient stay, escalate intensity of CM activities such as decreased
time to CM outreach and provision of synchronous medication review and consultation.
Dashboard for Care Management Engagement
Warehouse data are operationalized on a dashboard for nurse-led CM and quality measures
specific to HEDIS and CMS Star Ratings are leveraged. These quality metrics are well-established
and widely used evidence-based tools to evaluate health care quality and performance.
As such, a majority of health plans and health care organizations are required to
report these data on an annual basis. Their widespread adoption in the health care
industry renders them ideal for comparative analysis and program benchmarking. Specific
to this study, these data inform if medication-related gaps in care (e.g., received
statin therapy, poor glycemic control [hemoglobin A1c > 9%]) are met. Additionally,
those measures (e.g., related to Rx nonadherence) are utilized to derive clinical
intervention factors indicating members are at-risk of suboptimal medication-related
outcomes along with other proprietary algorithms to monitor for drug safety (e.g.,
interactions, contraindications) and polypharmacy (e.g., number of drugs prescribed
per member).
Nurse-led Care Pathway
Upon eligibility, CM is notified of engagement prioritization and members are outreached
telephonically by a dedicated nurse CM by order of priority. Prior to CM delivery,
the CM (1) conducts a medical chart review via an internal CM platform with data warehouse
interoperability; (2) consults quality dashboards to review medication-related gaps
in care and risks; (3) performs standardized workflows to complete a thorough medication
review including medication reconciliation; (4) escalates and/or facilitates communication
with the provider(s) and dispensing pharmacy of record. The care manager utilizes
documentation templates for case management and care planning including SDoH care
considerations. All MCI care managers hold an active, unrestricted registered nurse
license and receive specialized competency training following a structured, evidence-based
curriculum. The expanded skill set enables care managers to develop trusting, meaningful,
and mutually beneficial relationships with the member and their care team. After foundational
trust is established, care managers provide ongoing, support, education, and assistance
to members through various channels (i.e., telephonic, email, and mail). CM activities
vary depending on gaps in care; however, general goals of CM engagement are to (1)
provide support and education for members; (2) deploy strategies to improve medication
adherence; (3) reinforce behavioral strategies for chronic condition management; (4)
complete and document standardized assessments; (5) facilitate communication and/or
referrals with other members of the care team, if necessary. All members are then
referred to a dedicated pharmacist for additional care coordination.
Pharmacist-led Care Pathway
A dedicated pharmacist (1) conducts a comprehensive medication review or MTM, if eligible,
utilizing the claims data warehouse; (2) outreaches members' providers to remedy medication-related
concerns (e.g., duplicative treatments, dose optimization, gaps in care, and high-risk
medications); (3) uses CDS tools to review potential medication interactions, contraindications,
and legacy medications; (4) provides medication adherence counseling to explore barriers
(i.e., accessibility and/or resources) and map members to resources available within
their benefit plan and geography (e.g., autorefills, 100-day maximum supply, lowest
cost pharmacy). Members with a recent hospital discharge to home are escalated using
event-driven alerts, prioritized for urgent case review (i.e., postdischarge medication
reconciliation), and are provided with transitions of care from a dedicated team.
At the close of the consultation, the pharmacist will provide the member and provider
with documentation including the MTM review, if applicable.
Study Design Overview
The pharmacoinformatics framework was leveraged to conduct a retrospective, observational
cohort analysis of the MCI program. Administrative claims data were de-identified,
aggregated, and analyzed to evaluate the influence of the medication use processes
microinterventions conducted January 1, 2022, through September 30, 2023. Inclusion
criteria for the study were Medicare Advantage members with intervention eligibility
who identify as Black and/or Hispanic with diagnoses of hypertension and/or T2DM;
residing in FL, TX, or PA; meeting a risk stratification score threshold (> 78th percentile);
and received a pharmacy referral. Exclusion criteria consisted of members with recent
CM activity in the last 60 days and/or engaged in or enrolled in CM in the last 90
days; specific plans (dual eligible special needs or value-based plans); members with
diagnoses of rare diseases, chronic kidney disease, and/or heart failure, and members
enrolled in specialty clinical CM including cancer programs or value-based design
programs; and receipt of hospice care or recent stay at a long-term care facility.
Primary outcomes were pharmacy engagement metrics, such as total referrals, and pharmacovigilance
to identify acute events to escalate CM and other safety-related measures including
drug duplication, drug interactions, drug–disease interactions, noncompliance, and
dosing issues. Secondary outcomes were member and provider outreach as a proxy for
informatics-identified quality-related gaps in medication adherence.
Results
A total of 3,721 Medicare Advantage members (78.3% Black and 21.7% Hispanic) were
engaged in MCI CM and received pharmacy referral from January 1, 2022, through September
30, 2023. Of these engaged members, 95% had a physician relationship and 54% had four
or more chronic diseases. During this timeframe, pharmacist referral and consultation
identified 258 acute events that escalated their CM. Additionally, pharmacy reviews
with provider outreach (n = 185) informed polypharmacy-related safety issues including drug duplication (n = 48), drug interactions (n = 21), drug–disease interaction (n = 5), and noncompliance and/or dosing issues (n = 27). Outreach (n = 160) was provided to inform members of gaps in care for specific Stars and HEDIS
measures related to medication adherence. Provider outreach was delivered to address
Stars-informed care gaps related to statin use in persons with diabetes (n = 80) and management of chronic obstructive pulmonary disease (n = 6) as a comorbidity.
Discussion
Medication dispensing is the best-known role of the pharmacist, but pharmacists are
a key member of the health care team and scope of practice extends beyond that responsibility.
Health care reform law, such as the Patient Protection and Affordable Care Act,[22 ] supports the expanded scope of work for pharmacists to provide counseling, MTM,
and disease state management, for example, which reimburses these activities.[23 ] In this study, the expanded role of the pharmacists' patient care process[24 ] enables care coordination with CM nurses and other providers (e.g., member's primary
clinician) to optimize and personalize member health and medication-related outcomes
in a multicultural senior population to alleviate health disparities and advance health
equity. The patient-centeredness approach, whereby engagement between the pharmacist
and the Medicare members, has demonstrated improved medication adherence.[25 ]
The employment of informatics-based operational tools to provide actionable insights
was leveraged to identify needs and improve medication use-related workflows in Medicare
members led by a multidisciplinary team. To identify Black and or/Hispanic members
most at-risk for poor clinical outcomes, a proprietary population-based health risk
score that incorporated various predicted risks and effect on care outcomes was calculated
for each member. Operational key performance indicators (e.g., number of enrollees
and engagement rate) and clinical outcomes (e.g., monthly performance rates for quality
measures) were monitored monthly using a dashboard. Real-time analytical and artificial
intelligence-based tools were leveraged to provide timely information to prepare tailored
pharmacy-related microinterventions led by the pharmacist, including pharmacovigilance
monitoring.
Pharmacists play a pivotal role whereby they maintain the rational and safe use of
medicines; they are engaged in pharmacovigilance activities including identification
of acute events and management of episodic ADEs to support medication and patient
safety. ADEs are responsible for 15% of hospital admissions in patients 65 years or
older and 20% of patients admitted to intensive care.[26 ]
[27 ] Addressing risk factors (e.g., polypharmacy, comorbidities, length of hospital stay,
cardiovascular agents, anti-infection treatments)[28 ]
[29 ] for ADEs in an outpatient setting is challenging, but optimizing informatics-driven
workflows provides population-level insights at scale, but drill down to identify
and mitigate individual acute (e.g., severe ADEs) and chronic (e.g., medication compliance)
risks. This study identified 258 acute events that triggered escalated CM. These findings
have significant real-world implications as they highlight the critical role of actionable , informatics-enabled interventions that successfully prevent avoidable disease exacerbation,
complications, and downstream sequalae.
This payor-led pharmacoinformatics framework supports the timely resolution of pharmacy-related
risks for Medicare members by enhanced communication. Unlike traditional communications
between the pharmacists and prescriber that are transaction-based and single-drug-focused
at the point of dispensing, the pharmacist-led surveillance system coordinates communication
with the member, and their nurse care manager and provider/prescriber into a process
of care that is ongoing and person-centered.[30 ] Further, contrary to most pharmacist–prescriber interactions, the MCI program pharmacist
has access to relevant health care data with expanded interoperability into warehouses
(e.g., electronic health records (EHR), medical and pharmacy claims) to derive a complete
picture of the member's health (e.g., medical history, all medications being taken,
diagnostic findings to target correct therapies, etc.) at the point of care and can
surmount Health Insurance Portability and Accountability Act (HIPAA)-related barriers,
as the member's health care benefits are covered by the payor.[30 ] Management of chronic conditions in these high-risk Medicare members requires coordination
of information to bring resolution. In addition to clinical data, pharmacists collect
information from the member to identify and deliver education needs, and assess barriers
and behaviors, while acting as a trust broker of their care. To foster that trust
and build the relationship, the multidisciplinary team has received cultural competency
training and employed motivational interviewing techniques to better understand members'
health status and foster deeper relationships with their clinicians by their ongoing
and person-centered communications.
This study has a few limitations. Currently, the program is only offered to eligible
members who self-report as Black and/or Hispanic and reside in FL, TX, or PA, as such
the sociodemographic scope and geography of the study are limited. Additional members
may be eligible for the program, as race and ethnicity reporting are often incomplete
demographic fields in structured health care data. Efforts to improve race and ethnicity
data collection will enhance the ability to provide more services; moreover, in an
increasingly diverse multiracial and multiethnic world, representation is critical
and there is a moral imperative to ensure datasets are accurate and inclusive. However,
socioracial asymmetries persist, such that individuals of historically marginalized
races/ethnicities, and mixed races and/or ethnicities do not self-report due to experienced
social justice issues including racism. At the time of submission, data for the HEDIS
Measuring Year 2023 were not available. Therefore, the data presented only fully represent
2022 HEDIS-related member outcomes attributable to program microinterventions. Additionally,
future mixed-methods studies will include qualitative data to evaluate member, provider,
and care manager experiences to corroborate program outcomes and directly inform program
enhancement and expansion.
The MCI program will continue to invest in its organizational capacities to further
enable interoperability in the multicultural data ecosystem (e.g., gaps in care, utilization,
patient safety) as additional member-level race, ethnicity, and language data and
cohort-level demographic and geographic data sets are acquired, assimilated, and aggregated.
Data processing and additional analytics-driven modeling will support knowledge sharing
between data assets to facilitate real-time notifications to improve decision support
and timely member outreach that influences member experience. Additionally, the expansion
of CDS tools for CM providers has the potential to increase efficiency and streamline
pharmacy-related workflows for member engagement.
In the future, the MCI program will expand to include all geographies and other populations
(e.g., Asian, Native American) of Medicare members and broaden community engagement.
Risk stratification thresholds and their corresponding quality measures will pinpoint
additional geographic hotspots of need, and the expansion of local and community partnerships
to provide education, resources, and support for custom events (e.g., heart and mental
health) will be provided to address the identified disparities. Organizations can
better support Medicare members by broadening engagement and connectivity, both operationally
with resources and needs assessment, beyond clinical settings; partnerships between
the providers and the communities where they serve will support community-based preventive
interventions to provide vaccinations, health screenings, and education.
Conclusion
The application of pharmacoinformatics by a payor-led MCI program demonstrated quality
improvements in Medicare Advantage member identification including risk stratification,
timely outreach for pharmacy-related safety issues, and improved efficiency of multidisciplinary
care coordination involving medication use process workflows.
Clinical Relevance Statement
Clinical Relevance Statement
Informatics-driven improvement of medication use processes led by payors can positively
augment health and health equity outcomes in older multicultural populations at scale
using a multidisciplinary CM program based on evidence-based practice and inclusion
of cultural competencies. As our health care system prepares for a rapidly aging population
that is becoming increasingly racially and ethnically diverse, it underscores the
importance of tailoring health care interventions to meet the specific needs of our
nation's population.
Multiple Choice Questions
Multiple Choice Questions
What are the goals of MTM?
Provide education about medication use
Improve medication adherence
Prevent, identify, and resolve ADEs
All of the above are goals of MTM.
Correct answer: d. MTM services are intended to address issues of polypharmacy, preventable
ADEs, medication adherence, and medication misuse.
Pharmacovigilance is the science and activities related to the detection, assessment,
understanding, and prevention of adverse effects or any other medicine-related problem.
What are examples of safety-related measures observed for pharmacovigilance?
Correct answer: e. Pharmacovigilance should improve patient care and safety related
to use of medicines, as such, data surveillance within pharmacy information systems
to identify safety-issues related within the medication use processes step of monitoring
and reporting is critical. Safety-related measures include identification of drug
duplication, drug interactions, drug–disease interactions, polypharmacy, and dosing
issues.
