## Abstract

Nonelderly disabled Medicare beneficiaries have a higher prevalence of chronic conditions, higher utilization of prescription medications, and increased demand for clinical services when compared to beneficiaries 65 years of age and older who are not disabled. Out-of-pocket costs and medication-related problems are major barriers to medication compliance and achievement of therapeutic goals. A school of pharmacy partnered with a nonprofit organization that provides care to individuals with developmental disabilities. The present study highlights outcomes resulting from (a) providing Medicare Part D plan optimization services to lower prescription drug costs and (b) Medication Therapy Management services to evaluate safe and effective medication use in this beneficiary population. Provided interventions were shown to reduce overall medication costs and identify significant medication-related problems.

Medicare is a health insurance program administered by the U.S. federal government. Medicare beneficiaries include individuals 65 years of age and older and those under 65 who meet certain eligibility criteria, such as being permanently disabled (Centers for Medicare and Medicaid Services [CMS], 2017a). A disability can be defined as a physical or mental limitation that interferes with a person's ability to perform activities or interact with their environment (Centers for Disease Control [CDC], 2017). More specifically, a developmental disability (DD) is classified as having a childhood onset (i.e., prior to the age of 18) and resulting in lifelong impairment (CDC, 2017; National Institutes of Health [NIH], 2017). Examples of DD include autism, Down syndrome, epilepsy, cerebral palsy, and other conditions that affect critical thinking or social functioning (Coyle, Putman, Kramer, & Mutchler, 2015; Valley Mountain Regional Center [VMRC], 2017). It is estimated that approximately 25% of the 7 million individuals with an intellectual and developmental disability (IDD) in the United States receive health insurance under Medicare and/or Medicaid whereas the other 75% are covered as a dependent or have private insurance. Due to increased longevity and the availability of noninstitutional care, these numbers are rapidly inverting (Engquist 2012).

To qualify for Medicare based on disability alone, an individual must collect Social Security Disability Insurance (SSDI) for at least 24 months (CMS, 2017b). Moreover, in order to collect SSDI, a person must have a disability that is expected to last for at least 1 year or result in death (Social Security Administration [SSA], 2017a). For the purpose of this study, Medicare beneficiaries under the age of 65 who are disabled are defined as nonelderly disabled beneficiaries (NEDBs), whereas beneficiaries 65 years of age and older are defined as traditional beneficiaries who may or may not be disabled.

After becoming eligible for Medicare, beneficiaries are entitled to a variety of health benefits. Medicare Part D is the outpatient prescription drug benefit (CMS, 2017a). Most beneficiaries can get prescription drug coverage through Part D in one of two ways: (a) a Medicare Advantage prescription drug plan (MA-PD), which provides medical, hospital, and prescription drug benefits from a single private insurance company; or (b) a stand-alone prescription drug plan (PDP) which offers only prescription drug benefits (CMS, 2017a).Some beneficiaries can also get or continue prescription coverage through their employer or union group. If such private coverage is at least as good as the Standard Part D benefit it is deemed to be creditable coverage. In 2012, approximately 75% of NEDBs, versus 63% of traditional beneficiaries, had a Part D plan (Cubanski et al., 2016). Part D plans typically require beneficiaries to pay a monthly premium, annual deductible, and co-payments/co-insurance for each medication. These parameters can vary significantly between plans (CMS, 2017a). Medicare Part D plans offer change on an annual basis and each plan varies in their drug formulary coverage and cost-sharing structure. Most Medicare beneficiaries are only allowed to switch their Part D plan once annually, during the open enrollment period (October 15th–December 7th). Many beneficiaries fail to take advantage of this and are likely to have higher than necessary out-of-pocket (OOP) prescription drug costs.

Beneficiaries with limited income and resources may be eligible for additional governmental assistance with their Part D costs. Those with incomes no higher than 150% of the federal poverty level (FPL) may qualify for a Low-Income Subsidy (LIS), also known as Extra Help. Those beneficiaries with an income between 100% and 135% of the FPL may qualify as full LIS recipients, whereas those between 135% and 150% of the FPL may qualify as partial LIS recipients (SSA, 2017b). Additionally, those with an income at or below 100% of the FPL may qualify for Medicaid, a joint state and federal program that provides additional cost-sharing assistance with Medicare premiums, deductibles, and co-payments/co-insurance (CMS, 2017a, 2017b). Medicare beneficiaries who qualify for Medicaid or LIS are defined as subsidy recipients and typically have a large proportion of their Part D costs covered.

Beneficiaries receiving both Medicare and Medicaid are referred to as dual eligible beneficiaries or Medi-Medi's (CMS, 2017a). In 2012, 35% of NEDBs received Medicaid assistance versus only 10% of traditional beneficiaries (Cubanski et al., 2016). Dual-eligible beneficiaries have higher rates of chronic illnesses, disabilities, and accrue health care costs more than 60% higher than their nondual eligible counterparts (Morgan, 2018). Dual-eligible beneficiaries account for approximately 21%, but account for 36% of the costs, of all Medicare beneficiaries (The Arc of the United States, n.d.). About 7% of all dual eligible beneficiaries are individuals with IDD who encounter numerous challenges with daily living and difficulties with navigating two different healthcare systems (State and Federal Government). For example, dual-eligible beneficiaries receiving prescription medications must have their medications billed to Part D first, and then Medicaid will be secondary and may cover medications not covered by the Part D plan. Despite these safety net programs, many disabled beneficiaries still encounter considerable economic, clinical, and humanistic challenges that require novel ways of addressing their needs.

In 2014, Part D drug expenditures were $2,658 higher per annum in NEDBs versus traditional beneficiaries (Cubanski et al., 2016). Although many disabled beneficiaries have prescription drug coverage, some still face high OOP drug costs that often contribute to cost-related medication nonadherence (CRN; Naci et al., 2014). One study found that the percentage of patients with CRN was over three times higher in NEDBs than traditional beneficiaries (Cubanski et al., 2016). When Part D was first introduced in 2006, CRN for NEDBs initially decreased (Naci et al., 2014). However, in subsequent years CRN has increased and this change has been attributed to decreased formulary coverage and higher drug costs (Naci et al., 2014; Piette, Rosland, Silveira, Hayward, & McHorney, 2011). Accordingly, a greater number of NEDBs with multiple chronic conditions face the dilemma of whether to purchase medications or spend on basic necessities (Naci et al., 2014). Nearly 50% of NEDBs have delayed or foregone healthcare due to cost considerations (Cubanski & Neuman, 2010). This creates a perpetual cycle for NEDBs where economic constraints may contribute to deterioration in their health and well-being, which begets increased healthcare expenditures (Cubanski & Neuman, 2010). Nonelderly disabled beneficiaries often have an increased demand for clinical services due to a high prevalence of chronic conditions, higher rates of multiple medication use, and a decreased utilization of preventative services (Chronic Conditions Data Warehouse [CCDW], 2016; Reichard, Stolzle, & Fox, 2011). Patients with IDD are also more likely to have a lower socioeconomic status that is inversely related to health outcomes. (Anderson et al., 2013). A retrospective study utilizing the 2006 Medical Expenditure Panel Survey found that patients with disability had higher incidences of seven common chronic disease states—including heart disease, hypertension, and hyperlipidemia—compared to all patients without disability (Reichard et al., 2011). These findings are especially true in patients with IDD who, when compared to nondisabled beneficiaries, suffer disproportionately. They are also more likely to have psychiatric disorders, epilepsy, and gastrointestinal disorders. Many of the pharmacological agents used to treat the conditions listed previously are known to have metabolic side effects that further increase their risk of heart disease and other endocrine disorders (Anderson et al., 2013). Patients with disabilities are also higher utilizers of medications. In 2014, NEDBs utilized an average of 4.2 medications/month, compared to an average of 2.9 medications/month for traditional beneficiaries (CCDW, 2016). NEDBs with IDD have an even higher level of polypharmacy with one study reporting an average of 6.5 medications per patient (Anderson et al., 2013). Quality-of-life outcomes may also differ significantly in those with disabilities. When compared to traditional beneficiaries, NEDBs are three times more likely to report being in “fair” or “poor” health (Cubanski et al., 2016). Moreover, 58% of NEDBs versus 34% of traditional beneficiaries report having at least one limitation in activities of daily living (ADL; Cubanski et al., 2016). A positive correlation has been found between the severity of the limitation in ADL for beneficiaries with disabilities and their dissatisfaction with received medical services (Jha, Patrick, Maclehose, Doctor, & Chan, 2002). A series of interviews with staff members from the Aging and Disability Resource Centers revealed that although the needs of aging patients with disabilities parallel those of the general aged population, services have not been adequately developed or tailored to target this patient population (Coyle et al., 2015). Valley Mountain Regional Center (VMRC) is a private nonprofit organization that provides a variety of services to those with developmental disabilities (DD) in several counties throughout California Services provided to beneficiaries by the VMRC include behavioral interventions, adult day programs, and diagnostic services (VMRC, 2017). The VMRC is a private nonprofit that contracts with the State of California (VMRC, 2017) and receives funding from the Centers for Medicare and Medicaid and the State of California Department of Developmental Services. For most beneficiaries, Medicare is the first payer of formulary-covered medications under their Part D benefit (CMS, 2017a). For dual eligible beneficiaries, Medicaid pays for much of the cost after Medicare has first paid its share (CMS, 2017a). The VMRC has various programs that help pay for the remaining prescription costs not covered by Medicare and Medicaid including nonformulary medications (VMRC, 2017). The present study was a pilot project between the VMRC and the University of the Pacific to improve the economic and clinical outcomes of Medicare beneficiaries with DD. Economic outcomes were assessed through Medicare Part D plan optimization, whereas clinical outcomes were evaluated through the provision of Medication Therapy Management (MTM) services. An MTM intervention typically includes a comprehensive evaluation of a patient's medication regimen to improve medication adherence, minimize the risk of adverse drug events, and identify any other medication-related problems (MRPs; Olivera, Brummel, & Miller, 2010). The goal of the study was two-fold: (a) to lower prescription drug costs through optimization of a beneficiary's Part D plan and (b) to ensure safe and effective medication use through the provision of MTM services. ## Method The University of the Pacific, Thomas J. Long School of Pharmacy partnered with the VMRC to provide Medicare Part D plan optimization and MTM services to the VMRC beneficiaries with DD during 2016 Medicare open enrollment period (October 15th–December 7th). The VMRC provided consent and access to beneficiary medical and prescription drug records that enabled provision of the interventional services. VMRC beneficiaries varied in age from 26 to 79 years old and all had Medicare Part D PDPs. Trained student pharmacists utilized the Medicare Plan Finder Tool (available at www.medicare.gov) to perform a personalized plan search and identify potential cost savings opportunities through Part D plan optimization. Medication lists were obtained from beneficiary records and, when necessary, medications were verified by contacting the beneficiary's pharmacy. Beneficiary-specific data including demographics, medication profile, and potential cost savings by switching to a different PDP were recorded using a standardized survey. Beneficiaries were enrolled into a lower cost PDP if one existed and cost savings were recorded. Future Part D coverage, including whether a change in enrollment was completed or continuation of previous coverage was maintained, was communicated to the VMRC. Medication Therapy Management services were performed and MRPs were identified, including the following: cheaper therapeutic alternatives, potentially inappropriate medications, therapeutic duplications, contraindicated medications, potentially severe drug-drug interactions, and potentially severe drug-disease interactions. Student pharmacists utilized multiple pharmacy information databases during the provision of MTM services including Lexicomp, Clinical Pharmacology, UpToDate, Facts and Comparisons, and Micromedex. The type and frequency of each MRP were recorded during each MTM intervention. Student pharmacists presented their MTM findings and recommendations to resolve MRPs to a supervising licensed pharmacist for verification and approval. Medication-related problems were then communicated to beneficiaries' VMRC providers via a standardized prescriber communication form that detailed the nature of the problem and provided recommendations for problem resolution. Each MTM intervention included the creation of a personalized medication record via the MeducationRS program. The MeducationRS program creates an effective medication regimen summary and pictograph based on health literacy research to improve medication adherence. Each beneficiary's medication summary was given to the VMRC to distribute to the beneficiary and/or their caregiver. Actual or potential cost savings data due to MTM interventions were not calculated. Descriptive statistics were used to describe beneficiary characteristics including sex, age, race/ethnicity and number of prescription medications (Table 1). Inferential statistics including Fisher's Exact Test and Mann-Whitney were performed to examine differences between the prevalence of MRPs (Table 2) or potential Part D cost savings as a function of subsidy status, respectively. Alpha was set a priori to 0.05. All statistics were conducted using IBM SPSS Statistics 25 (Armonk, New York). Table 1 Patient Demographics Table 2 Medication Therapy Management (MTM) Problems ## Results The VMRC beneficiary data was separated into two groups, subsidy and nonsubsidy recipients. In total, 76 beneficiaries received Medicare Part-D optimization and MTM services; 54 (71.1%) were subsidy-recipients (dual eligible, full LIS, or partial LIS) and 22 (28.9%) were nonsubsidy recipients. Potential cost savings data were collected for 75 of the 76 beneficiaries evaluated. We found that 61 (81.3%) of all beneficiaries had potential cost savings opportunities by switching PDPs (i.e., Part D plan optimization). The aggregate potential yearly cost savings for subsidy-recipients and nonsubsidy recipients were$97,625 and $27,904, respectively. The average potential cost savings/beneficiary, regardless of subsidy status, was$1,652. The average potential cost savings was $1,808 for subsidy recipients and$1,268 for nonsubsidy recipients (p = 0.51).

Study beneficiaries were prescribed, on average, about seven medications each. When broken down by subsidy status, the subsidy patients had on average one more prescription compared to nonsubsidy recipients (7.l vs. 6.6 prescriptions respectively). In total, 42 out of 74 (56.8%) beneficiaries had at least one MRP. Of the total MRPs that were identified, 11 were cheaper therapeutic alternative available, nine were therapeutic duplication, eight were contraindicated drug, 28 were drug-drug interactions, three were drug-condition interaction, and eight were considered potentially inappropriate medications for beneficiaries over 65 years old according to the 2015 Beers criteria. There were no significant differences in the number of MRPs between subsidy and non-subsidy patients (Table 2). Of these MRPs identified, 18 were deemed significant enough to complete a prescriber communication form to discuss the issues with the prescribing physician.

## Discussion

Each Medicare Part D plan may change its cost structure and formulary annually. Most states offer a large number of possible plans and selecting the most appropriate Part D plan can be a daunting challenge for most patients, especially those with IDD. We observed that over 80% of NEDBs, regardless of subsidy status had potential OOP savings opportunities by switching PDPs for the upcoming year. Therefore, it is critical that annual plan re-examination during the Medicare open enrollment period is completed. Subsidy recipients receive additional assistance with the cost of their formulary-covered Part D drugs and it was found that their average OOP savings was 2.4 times higher than that of nonsubsidy patients after optimization. This difference was originally attributed to a potentially higher incidence of nonformulary medications in the subsidy group before optimization but upon analysis, the reduction of nonformulary medications by plan optimization was comparable between the groups. The cause for this difference is not known at this time and warrants further investigation. It is important for dual-eligible beneficiaries and their advocates to understand that starting in 2019 they can switch Part D plans once per calendar quarter in the first 9 months of the year, during a limited time after a change in LIS or Medicaid status, or after CMS or state initiated enrollment (CMS.gov., 2018). Accordingly, subsidy-receiving beneficiaries should examine Part D plan offerings any time a new medication is added to their regimen and if it is not on their current Part D plan formulary, subsidy-receiving beneficiaries should consider switching plans. Nonsubsidy beneficiaries are also highly encouraged to re-evaluate their plan, but are typically only allowed to change plans annually during the open enrollment period. Without Part D plan optimization, unnecessary financial hardship may ensue and negatively affect the beneficiary, or agencies like the VMRC that helps subsidize drug costs.

The second intervention included evaluating medication regimens through MTM services. The need for MTM services in NEDBs is particularly important given that this population tends to have more chronic conditions and medication needs than traditional beneficiaries (CCDW, 2016; Reichard et al., 2011). In this study, the NEDBs had an average of seven prescription medications (range 0–19). This number is considerably higher than the average number of medications reported in disabled beneficiaries (4.2 medications) or traditional beneficiaries (2.9 medications) in 2014 (CCDW, 2016). The frequency and type of identified MRPs in our study population highlight the importance of MTM services in the population with DD covered by Medicare. Medication Therapy Management interventions can improve patient therapeutic outcomes by identifying and potentially preventing MRPs. Moreover, the identification and mitigation of MRPs have the potential to reduce utilization of future healthcare services and costs while also improving the quality-of-life of the beneficiary.

Organizations that serve individuals with DD with Medicare coverage can greatly benefit from partnering with a school of pharmacy, the State Health Insurance Program, or any other entity that assists beneficiaries with optimizing their Part D plan. By optimizing the Medicare Part D benefit for this population, limited local, state, and federal resources can be redirected towards other programs and services to further improve the care and well-being of this population instead of subsidizing OOP costs that could be covered under their Medicare Part D benefit.

## Limitations

Data collection and interventions for study beneficiaries were based solely off records provided by the VMRC. Incomplete records resulted in two study beneficiaries for whom cost savings data were irretrievable. Additionally, the medication list for each assisted beneficiary did not always distinguish between whether the beneficiary was taking the brand or generic medication, if available. Depending on drug entry on the Plan Finder Tool, a beneficiary's OOP cost and plan selection can vary greatly. As such, when possible, the beneficiary's pharmacy was contacted to verify all medication information.

Given the logistics of this intervention, direct patient interviews were not feasible. As such, when conducting the MTM intervention, the impact of identified MRPs or verification of certain information (e.g., how they were taking the drug versus how it was prescribed, adverse drug reactions) was not always directly corroborable. It is possible that the prevalence of MRPs reported in this study could underestimate the true frequency. Severe MRPs found during MTM services were communicated to the VMRC via a Prescriber Communication Form; however, the acceptance rate of these recommendations was unknown, as the VMRC did not record outcomes after they communicated these findings directly to the beneficiary's prescriber(s). Additionally, cost savings as a result of MTM interventions were unable to be tabulated and only Part D optimization was used to determine overall cost savings data. We would expect that our cost savings data actually underestimate the total savings because of this.

Last, this study was a pilot project and had a relatively small sample size of 76. As a result, the outcomes of this study may not be generalizable to the larger IDD VMRC population. Continuation and expansion of the present study could determine its replicability and increase the validity of our findings. Future efforts will address many of these limitations by providing a more streamlined approach to ascertaining patient information in order to limit both the time required for each intervention and uncertainties associated with the patient information.

## Conclusion

Individuals with DD and those who serve them face numerous potential barriers in healthcare utilization and costs. Pharmacists and other trained health care providers are ideally positioned to help this population lower their OOP prescription drug costs through Medicare Part D plan optimization while also improving their clinical and humanistic outcomes through the provision of MTM services. By providing these services, cost savings can be realized by beneficiaries and the local, state, and federal programs/agencies that serve this population.

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