Jean P. Hall, PhD

 To inform state Medicaid programs and managed care organizations, as well as to build their capacity to serve enrollees with complex needs related to serious mental illness (SMI).

 Quantitative and qualitative analyses of survey results from a sample of Medicaid enrollees with SMI in Kansas in 2016 and 2017 (N = 189).

 Surveys were conducted by telephone or in person at community mental health centers. Analyses of descriptive statistics from closed-item responses and coded transcripts were used to identify major themes in open-item responses.

 Respondents reported high rates of comorbid physical and mental health conditions and current or past tobacco use. Most were unemployed, and some were homeless or living in unstable conditions. Participants indicated a need for better information and communication; improved access to prescriptions, dental care, reliable transportation, medical supplies, and equipment; and a wider physician/provider network. They wanted care coordinators to provide more frequent and responsive contact, better information about benefits and resources, and help navigating the system.

 Individuals with chronic and complex conditions can be challenging for managed care organizations to support, especially Medicaid enrollees with SMI, who experience high rates of comorbid physical health conditions and complex healthcare needs. To the extent that managed care organizations can help this population navigate their coverage and use more of the available benefits, barriers to care and unmet needs can be reduced or eliminated and outcomes subsequently improved.

Managed care organizations can better serve Medicaid enrollees with serious mental illness by helping them use more of the available benefits and removing identified barriers to care. This study adds to the knowledge base about actions that managed care organizations can undertake to improve care for this population, including:

Frequent contact between care coordinators and enrollees with serious mental illness

Understandable explanation of benefits and help navigating services

Reliable and accessible nonemergency medical transportation

Access to medical supplies and equipment for comorbid conditions

Geographically expanded provider networks, including specialists

Affordable Care Act reforms and Medicaid expansion have increased insurance coverage and access to care for individuals with serious mental illness (SMI), but the most effective way to implement reforms to meet individual needs for this population is still unclear.

 Currently, 38 states and the District of Columbia contract with comprehensive managed care organizations (MCOs) to coordinate and integrate healthcare coverage for at least some of their Medicaid enrollees, and this number is likely to grow.

 The premise underlying this use of managed care is that coordination will improve enrollees’ care experiences and lower program costs by reducing rates of crisis and acute care, decreasing duplication of services, and improving medication management.

 Individuals with chronic and complex conditions can be the most challenging for MCOs to support, especially Medicaid enrollees with serious mental illness (SMI), who experience higher-than-average rates of chronic medical illnesses and disability and have complex healthcare needs.

 Given this population’s significant healthcare requirements, historically poorer outcomes, greater unmet needs, and potential for increased enrollment via Medicaid expansion, their experiences are of interest to MCOs.

Little information exists on the outcomes of individuals with SMI in Medicaid managed care. Although each state Medicaid program is unique, state-specific studies provide helpful insights into the managed care experiences of Medicaid enrollees with chronic and complex needs. For example, a 2013 survey of Medicaid enrollees with disabilities—administered within 8 months of the Kansas Medicaid transition to managed care&mdash;found that 46% of respondents experienced at least 1 problem accessing care or services after implementation.

 Problem areas included limitations in covered benefits, small provider networks, lack of effective communication with MCOs, difficulties with care coordination, and issues with nonemergency medical transportation. Similarly, a 2013-2014 study found that Illinois Medicaid enrollees with SMI fared worse than enrollees with other disabilities and had more unmet needs under both Medicaid fee-for-service and managed care models.

Since 2013, Kansas Medicaid (KanCare) has been administered by 3 for-profit MCOs, which are paid on a capitated basis. Prior to this time, behavioral health services were provided through a capitated managed care arrangement, whereas physical health services were covered on a fee-for-service basis. Approximately 26,600 adults with SMI were enrolled in KanCare as of 2012, the great majority of whom receive services through 1 of 26 community mental health centers (CMHCs) in the state.

 Kansas is among the states with the longest experience with integrated managed care for physical and mental health and thus is an important benchmark for other states moving to integrate mental health benefits through MCOs. As the healthcare and Medicaid landscapes continue to evolve, it is important that policies and practices incorporate beneficiaries’ perspectives in order to identify and address barriers to care.

 This study extends knowledge about integrated managed care experiences of enrollees with SMI and barriers to care.

This study used primary data collected via survey from KanCare enrollees with SMI and was approved by the University of Kansas Institutional Review Board.

The sample consisted of adult Medicaid enrollees who received services and support from 6 CMHCs in Kansas. These CMHCs serve urban, suburban, and rural parts of the state and recruited participants via flyers, newsletter articles, and mailings that included a toll-free number to take a phone survey and dates when they could complete the survey in person at their local CMHC. Survey administrators read a study information document to all participants and obtained verbal consent.

Survey respondents (N = 189) ranged in age from 18 to 83 years (with 36% in the largest age group, 50-59 years) and were primarily women (68%) and white (60%), with less than 10% identifying themselves as Hispanic. Stakeholder checks with CMHC staff confirmed that sample demographics were typical of the SMI Medicaid population that they serve.

The authors developed the survey in consultation with the Health Care Foundation of Greater Kansas City (now Health Forward Foundation) and the participating CMHC directors.

 The survey consisted of demographic items and closed- and open-ended questions about respondents’ satisfaction and experiences with KanCare, possible areas of unmet need, and suggestions for improvement.

 Questions from existing federal and state surveys were included to facilitate comparisons with the Kansas population. The authors administered surveys between October 2016 and February 2017.

Descriptive statistics were calculated using SPSS software (IBM Corp; Armonk, New York). Responses to open-ended questions were entered into NVivo software (QSR International; Melbourne, Australia) and analyzed through an iterative process. All authors independently read the open-ended responses and discussed them holistically before 1 author conducted initial inductive coding.

 All authors participated in refining codes and themes through reflection, repeatedly revisiting the data, and group discussion until achieving consensus.

 Quotes were then selected to represent themes and illustrate findings.

 summarizes respondents’ demographic, insurance, and health characteristics. The most common level of education was a high school diploma or General Educational Development certificate. Just 13.8% of respondents reported being employed for pay, and slightly more than half were dually eligible for Medicare and Medicaid. Just 11% owned a home; 63% rented a home, apartment, or room; and the remaining 27% lived with family members without paying rent, lived in a group home or shelter, or were homeless.

By design, all respondents had an SMI diagnosis. More than half (52%) reported having multiple mental health conditions. Approximately one-third (31%) indicated that their primary condition was schizophrenia; 23%, bipolar disorder; and 17%, depression. On average, respondents reported having 15 days of poor mental health during the last 30 days, compared with 3 days for Kansans in general.

 More than one-third reported having more than 15 days of poor mental health during the prior month.

Compared with 15% of the Kansas general population, 53% of respondents reported being in fair or poor health.

 In addition, 73% of respondents reported having at least 1 chronic physical health condition. Approximately 1 in 5 respondents reported not having a physical exam in the prior 12 months. Finally, 55% were current users of tobacco compared with 18% of the general population, and an additional 15% were former users.

 These findings underscore the significant needs and importance of access to care among Medicaid beneficiaries with SMI.

Kansas requires its Medicaid managed care contractors to provide enrollees with “a person or entity formally designated as primarily responsible for coordinating healthcare services” and “monitoring Members with ongoing medical or behavioral health conditions,” commonly referred to as a care coordinator.

 Despite this requirement, a majority of respondents (75%) reported that they did not have an assigned MCO staff person who coordinated their plan and services, and another 7% were unsure whether one was assigned to them. Many respondents expressed confusion regarding the role of a care coordinator. Those who recognized having a coordinator (19%) reported considerable variability in frequency of contact and perceived helpfulness. Although MCOs may intentionally vary intensity of contact, many respondents felt that the frequency was insufficient.

Open-ended responses to questions about what the care coordinator did and could have done better to help them get the services/supports they needed offer insight into the range of experiences. Many reported that the coordinator helped with appointments, medications, transportation, and equipment or provided encouragement to maintain healthy behaviors. At the same time, 29% of respondents who had experience with a coordinator reported problems, including staff turnover, lack of or discontinued contact, and unreturned calls. 

 contains quotes from respondents describing the value and challenges of these experiences. Respondents wanted a consistent care coordinator who was knowledgeable about their needs, could suggest beneficial services and supports, and would contact them consistently. When asked what the coordinator could do better, respondents suggested offering more frequent contact, providing more information on benefits/resources, and returning calls/being easier to contact.

Respondents identified various unmet needs and barriers to care that have implications for integrating care and meeting complex needs. Following are thematic findings related to information and communication, transportation, medical supplies/equipment, and physician visits/provider networks. Quotes that illustrate these themes are in 

. Respondents also cited limited access to prescription drugs and dental care as potentially disruptive to their health. These topics have been addressed in other publications.

 Many respondents indicated they were unable to fully understand their coverage and needed better help understanding it. For some, KanCare was their first experience with an insurance company. They reported extreme confusion about what services were covered and which providers were in network—along with frustration at not being able to obtain such information in a timely and accessible manner. Several pointed out that the information booklet was overwhelming or unreadable to them and was not updated often enough. Many respondents reported that when searching for accurate and up-to-date information, they had difficulty reaching someone by phone, received inconsistent or inaccurate information, or were directed to the website for answers. This last concern was especially problematic for those without internet access. Just 19% of respondents reported looking up information about their plan in written material or online, and of those who did, 50% had a problem finding or understanding the information. In contrast, nearly half (47%) had called their MCO customer service in the last 12 months, and a majority (55%) of them reported difficulty getting the help they needed.

Difficulty accessing coverage information created a significant barrier to navigating the healthcare system and accessing needed services. Respondents tended to be unaware of covered services, could not identify how to access needed services, or experienced large bills or denial of claims or recommended treatments without fully understanding why. These negative experiences often discouraged them from pursuing needed health services. Perhaps related to this area, respondents also frequently cited a need for improved customer service.

 Nonemergency medical transportation (NEMT) is a federally required benefit for Medicaid beneficiaries that is often essential to their ability to access needed services. In this sample, many individuals did not have a car, could not drive due to medication adverse effects, or could not use public transportation due to anxiety, memory loss, lack of availability, or costs. Although several (8%) identified NEMT as a KanCare service that they liked most or found most beneficial, many respondents were not aware that transportation was available to them and noted lack of transportation as a barrier to getting needed medical care. Thirty-nine percent of respondents used NEMT provided by one of the MCOs. Among these respondents, just 36% reported no problems, and many others indicated such problems as transportation that did not show up or was canceled, late rides, and long wait times before or after appointments related to transportation scheduling. In addition, MCOs required enrollees to book their transportation 3 days in advance, which was often impossible for those with an urgent need or an appointment rescheduled by the provider. This requirement was especially challenging for those who had unstable living arrangements who may not have known where they would be staying in 3 days in order to provide the pickup location. Policies that restrict how many individuals can accompany someone using NEMT were also problematic and posed a barrier, particularly for those with caregiving responsibilities for minors, who reported that they could not afford childcare and must take their children with them. Overall, respondents reported frequent missed appointments due to these problems.

 More than three-fourths (76%) of respondents reported needing some sort of medical equipment or supplies for conditions other than SMI. Of these, 27% were unable to access supplies or equipment. Common equipment needs were continuous positive airway pressure (CPAP) machines for sleep apnea, orthopedic devices (eg, crutches, walkers, canes, braces, scooters), diabetic supplies (eg, testing strips, glucose meters, shoes), and portable oxygen concentrators. Sleep apnea is a serious medical condition that can lead to other health complications if not properly treated. Difficulty monitoring glucose levels can result in serious complications for those with diabetes. Portable oxygen and mobility devices allow individuals to walk for exercise and potentially improve health.

 An encouraging 82% of respondents reported visiting a primary care physician for a preventive care checkup in the prior 12 months. Among those who had not, the most frequently cited reason was a limited provider network/difficulty finding a primary care physician who accepted KanCare. More broadly, 24% of respondents reported that they were unable to see specialty providers—again, mainly due to difficulty finding one who accepted KanCare, with the most frequently reported provider types being mental health providers, pain specialists, orthopedic surgeons, and podiatrists.

Study findings indicate that KanCare and its MCOs are critical to supporting the health and well-being of Kansas Medicaid enrollees with SMI. Respondents generally appreciated the coverage and security of knowing that they had financial protection against catastrophic medical costs. At the same time, they reported numerous ways that KanCare coverage could be improved to better meet their physical and mental health care needs. Interestingly, most problems identified in the current study are similar to those reported by KanCare enrollees with other disabilities early in the program implementation via the same MCOs.

 Because the MCOs are paid on a capitated basis, they may lack incentives to implement improvements that are likely to increase their current costs.

 However, in many instances, gaps in coverage seem to be shortsighted. For example, coverage for CPAP devices for sleep apnea could offset spending on obesity-related problems and heart disease over time. Similarly, alleviating transportation barriers may result in more continuity of care—or less disruption of care, which has been known to lead to longer-term health problems for enrollees. States should consider a variety of contract and rate-setting strategies to support and promote program improvements, especially for nonmedical services.

Care coordination has the potential to support better access to care and improved outcomes for enrollees with complex conditions. Indeed, many of the study respondents who worked with a care coordinator reported positive experiences. To the extent that care coordinators can assist enrollees in navigating their coverage, expanded use of services and supports could alleviate some barriers to care and unmet needs. Additional research into the cost-effectiveness of nonmedical interventions for at-risk populations is needed to promote expanded use of care coordinators and other forms of support.

 The particular challenges of this population, such as numerous comorbidities and difficulty processing and understanding information, make individualized support by a qualified professional especially important in accessing appropriate care and other necessary services. Because KanCare does not provide Medicare services for dually eligible enrollees, care coordinators may sometimes be limited in their ability to successfully coordinate services for this segment of the population.

Consistent with other research, our findings demonstrate the valued connections and significance of the relationships between enrollees and care coordinators.

 However, some respondents who encountered a change in care coordinators reported differences in their experiences with each. More research is needed to better understand the skills and interpersonal dynamics that influence these relationships and, consequently, health outcomes.

Respondents reported great difficulty in obtaining accurate and timely information about their coverage. They identified lack of internet access, difficulty with the printed materials, and inability to reach a person on the phone as some of the specific barriers to accessing coverage information. Respondents were more likely to call customer service for information than to look to written materials or the internet. Regardless of the source, a majority of those who sought information or assistance experienced problems getting what they were looking for. Future research should determine whether Medicaid enrollees and/or individuals with SMI have different information or customer service needs than other managed care populations.

Difficulties identifying in-network providers and inadequate provider networks were reported as barriers to care across all 3 MCOs. Addressing these problems will be essential to making coverage more responsive to the needs of not only Kansans with SMI but also all Kansans enrolled in Medicaid now and in the future. As noted by CMS, inaccuracies in provider network information “can create barriers for members to receive services critical for their health and well-being.”

To access healthcare services, reliable and efficient transportation is crucial for Medicaid enrollees with SMI. Missed appointments and delayed care are known consequences of transportation barriers.

 Although some respondents used NEMT, others were not aware that it was available. Those who did use NEMT often reported it to be unreliable and inefficient (eg, long wait times before or after appointments due to imposed transportation schedules, advance-scheduling requirements). These types of MCO-imposed restrictions cause unnecessary impediments to the practical use of NEMT. A number of existing alternative models for providing NEMT have the potential to address respondents’ concerns.

 MCOs should monitor the effectiveness of their services and routinely assess the unintended consequences of restrictive NEMT policies.

Two limitations to the generalizability of these findings are evident. First, the sample was drawn from 6 CMHCs in a single state. However, this state was an early adopter of integrated physical and mental healthcare through MCOs and thus provides important insights for other states as they begin to do so. Second, respondents self-selected into the study, and the sample size was relatively small. Nevertheless, the CMHCs indicated that the sample was generally representative of the study population, and saturation was achieved with open-ended responses. Use of a survey also introduces the possibility of recall bias. Participant responses in this study, however, were similar to those in an earlier study of KanCare,

 including reports of care coordination experiences. Future studies might compare administrative data with self-reports to assess the frequency and nature of care coordination contacts.

Consumer-provided insights gained from Kansas—an early adopter of integrated managed care for physical and behavioral health&mdash;can inform state Medicaid programs that are contemplating or in the early stages of Medicaid managed care implementation by highlighting key issues that may require monitoring and oversight. Further, these findings can benefit MCOs as they build their capacity to better serve enrollees with complex needs. Individuals with SMI can be one of the most challenging populations for MCOs to support.

 When the barriers to care and unmet needs identified by respondents in this study are reduced or eliminated, more Medicaid managed care enrollees with SMI may echo the study respondent who said, “Sometimes it all becomes too overwhelming for me with my PTSD and this guy [care coordinator] helped a lot.”

 University of Kansas (JPH, TAL, NKK), Lawrence, KS.

 This study was funded by Health Care Foundation of Greater Kansas City (now Health Forward Foundation) (contract #FY16-4766).

 The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

 Concept and design (JPH, TAL, NKK); acquisition of data (JPH, TAL, NKK); analysis and interpretation of data (JPH, TAL, NKK); drafting of the manuscript (JPH, NKK); critical revision of the manuscript for important intellectual content (JPH, TAL, NKK); statistical analysis (JPH, TAL, NKK); provision of patients or study materials (NKK); obtaining funding (JPH, TAL, NKK); and supervision (JPH).

Articles

The authors studied Kansas Medicaid enrollees with serious mental illness and their experiences with integrated managed care and unmet needs.

Medicaid Managed Care: Issues for Enrollees With Serious Mental Illness

To demonstrate a threat to validity in using claims-based risk tools with chronically ill, underinsured populations.

We tracked disease burden of highrisk pool beneficiaries with potentially disabling health conditions receiving enhanced health insurance benefits through a federally funded research demonstration. At baseline, beneficiaries paid high premiums and cost sharing for risk pool coverage, and most met common criteria for underinsurance. Study benefits provided intervention group members premium and cost-sharing subsidies and additional coverage; control group members paid usual premiums and coinsurance and received usual benefits. We hypothesized that enhanced benefits for the intervention group would increase or stabilize health status measures and decrease case-mix weights, reflecting stabilized or reduced disease burden.

The SF-12v2 health survey was used to measure health status and the Johns Hopkins Adjusted Clinical Groups (ACGs), Version 8.2 with DX-PM model and prior cost for a non-elderly population, was used to measure disease burden.

 Over a 3-year period, SF-12v2 scores showed stable health status for the intervention group and significant decline for the control group, while ACG case-mix weights, major illnesses, and chronic condition counts rose significantly for the intervention group but remained stable for the control group. Increased resource utilization for the intervention group appears to have driven increases in ACG measures.

 When high cost-sharing constrains access to care, risk tools that rely on medical claims may not provide an accurate measure of disease burden.

		 Risk tools based on International Classification of Diseases, Ninth Revision, Clinical Modification codes assume that access to care is sufficient to adequately represent health status.

		 Access barriers may mean that many conditions, even major comorbidities, are not coded.

		While the Affordable Care Act (ACA) may bring coverage to millions of previously uninsured individuals, many will still face high cost sharing. In addition, they may have higher than average comorbidity because of lower socioeconomic status.

		 Since the ACA proposes to use individual risk scores in adjusting risk across exchanges, and because claims-based risk tools are widely used for other purposes, the potential bias associated with underutilization should be recognized.

A number of administrative tools have been developed to measure comorbidity—or burden of illness&mdash;through claims data. Instruments such as the Diagnostic Cost Group/Hierarchical Condition Category (DCG/HCC),

 the Johns Hopkins Adjusted Clinical Groups (ACGs),

 and the Chronic Illness and Disability Payment System (CDPS),

 were created to measure actuarial risk but have been extended to numerous other purposes, such as targeting high-risk patients for case management, profiling physician performance, and conducting outcomes research.

 Most recently, the Affordable Care Act (ACA) proposes to use individual risk scores to determine or validate average plan risk within health insurance exchanges.

 Plan average risk scores, in turn, will be used to reallocate premiums within exchanges so that plans with a disproportionate share of sicker individuals will be compensated for losses. Thus, the issue of the validity of commonly used risk tools is assuming increased importance and examining potential vulnerabilities is an urgent issue.

In the absence of readily available standardized clinical information, administrative data are often the only practical source of information for estimating illness burden. Typically tools such as the ACG and CDPS calculate a case-mix score by combining diagnostic and/or prescription drug codes with demographic variables associated with variation in utilization, such as gender and age. Some tools use prescription drug codes instead of or in addition to diagnostic codes.

Various authors have noted the limitations of these tools.

 This article makes the case for another common, unrecognized vulnerability. Specifically, the validity of administrative data as a proxy for comorbidity requires that beneficiaries have adequate access to healthcare services in order to generate a reasonably complete diagnostic profile. As this paper will demonstrate, scant or missing diagnosis codes and cost data can severely bias case-mix scores, even for very sick populations. Arguably, tools that use pharmacy data may compensate somewhat, because many chronically ill individuals use prescriptions even when they do not regularly see a provider. However, these tools are limited by the lack of specificity in the uses of many drugs. In addition, because many individuals now obtain prescriptions from $4 generic drug retail programs, insurer prescription records can no longer be assumed to represent reliable records of utilization.

We illustrate these vulnerabilities with the ACG by showing how scores were influenced by a dramatic increase in utilization among a group of chronically ill adults participating in a research demonstration.

The Demonstration to Maintain Independence and Employment (DMIE) was a study of disability outcomes sponsored by the Centers for Medicare & Medicaid Services (CMS) under the Ticket to Work and Work Incentives Improvement Act (TW-WIIA) of 1999 and independently conducted by 4 states between 2006 and 2009.

 The demonstrations tested the hypothesis that improved access to healthcare and personal supports would prevent or delay transition to reliance on Social Security disability benefits among a population with potentially disabling conditions. The intervention was targeted to uninsured or underinsured populations whose high healthcare costs may have resulted in their delaying or forgoing needed health services. We hypothesized that the intervention would work over time by reducing barriers to care seeking, thus improving health status and reducing the burden of illness. This paper describes the experience of the Kansas DMIE, which recruited participants from the state high-risk insurance pool. The case-mix findings reported below pertain to the subset of the study population that was continuously enrolled for the first 2 years of the study. A more complete description of the full study population and outcomes is reported elsewhere.

As with most other state high-risk pools, the Kansas pool offers a benefit package modeled on nongroup coverage, which typically has less generous benefits and is more expensive than group coverage. At baseline, premiums were 125% of standard market rates. Deductibles ranged from $500 to $7500, with no benefits available prior to meeting the deductible, other than a $250 preventive benefit in some plans. Prescription coinsurance was 50%, and medical coinsurance was 30% in-network and 50% out-of-network, with out-ofnetwork charges not accruing toward the annual coinsurance maximum. Some plans had a $100,000 annual maximum, and all had a lifetime limit of $1 million. The coinsurance cap for in-network services was $5000 for single policies and $14,000 for family plans, with some plans having unlimited 10% coinsurance thereafter.

The study design was a clinical trial with applicants randomly assigned to equal-sized intervention and control groups. Control group members received high-risk pool benefits as usual, plus cash stipends for participation in surveys ($1200 paid in progressively increasing installments) and focus groups ($25 per session).

The intervention consisted of premiums subsidized to a flat $152 per month; elimination of all deductibles and coinsurance; cost-sharing limited to a $3 copay per service and charges in excess of reasonable and customary for out-of-network services; and a $1 million lifetime limit for DMIE-paid services. The intervention also provided nursing case management to coordinate care and pre-authorize benefits.

To be eligible, participants had to be enrolled in the state high-risk pool at least 6 months prior to recruitment and be aged 18 to 60 years, so that no one would turn 65 years during the study and attain Medicare coverage. They had to experience 1 or more health conditions that represented a potential for disability, as designated by CMS and the state program administrators. Data collected included claims files, surveys including standardized health status assessments and other questions, and focus group discussions. This research design and evaluation plan was approved by the institutional review board affiliated with the authors.

The program began recruiting participants in the fall of 2005 and offered intervention services from April 2006 through September 2009. Over this time a total of n = 508 subjects participated. The present analysis is limited to the subset of subjects who were continuously enrolled during the first 2 years of the study (n = 317, cohorts 1 and 2). The recruitment process is described in more detail elsewhere.

Although intervention and control groups were equal sized at baseline, large control group attrition resulting from dropping high-risk pool coverage created an imbalance in group size over time (n = 184 intervention, n = 133 control by the end of the second year). Comparison of demographic and health status data, including interviews that tracked reasons for disenrolling and types of replacement coverage, showed that those who disenrolled did not differ significantly from those who remained. Most disenrollees obtained group coverage through their own or a spouse’s employment, where there was no underwriting for pre-existing conditions. The reason cited for leaving high-risk pool coverage was almost exclusively the unaffordability of coverage.

Study participants were demographically similar to the overall high-risk pool population, except that they were on average slightly younger, reflecting the study’s eligibility cap. We found no statistically significant between-group differences in demographic variables or distribution of comorbidities (

). Most participants were aged 50 to 60 years, married, well-educated, and owned homes. Mean incomes were approximately $50,000 for individuals and $71,000 for families, with median individual incomes of $30,000 and family incomes of $50,000; 57% were below 400% of poverty when family size was included and 21% had incomes below 200% of federal poverty level. Occupations included homebased service or manufacturing enterprises, farming, professional services, and small business ownership. About 70% of participants earned at least some income from self-employment, explaining this population’s lack of access to group health insurance.

Baseline claims and self-reported diagnoses showed that participants experienced numerous comorbid conditions (Table 2). Musculoskeletal pain, cardiovascular conditions, and diabetes were among the most common; 19% had cancer, either active or by history. Forty-five percent reported at least 1 activity of daily living (ADL) limitation and 46% at least 1 instrumental activity of daily living (IADL) limitation, most commonly those requiring physical strength and mobility. Based on self-reported height and weight, 75% were overweight to obese (body mass index [BMI] >25), including 32% obese (BMI >30-40) and 11% morbidly obese (BMI >40).

Baseline claims showed high cost burden. Premiums averaged $460 per month, but ranged from $189 to $1011. Premiums for those aged 50 to 59 years (53% of the sample) ranged from $264 per month for a $7500 deductible plan to $878 per month for a $500 deductible plan. Only 3% of the sample enrolled in the $500 deductible plan, while almost one-half (46%) enrolled in $5000 or $7500 deductible plans. Median and mean out-of-pocket expenses were $1639 and $2472, respectively, compared with $960 and $575 nationally for nonelderly individuals covered by individual and group plans.14 Because of high deductibles and cost-sharing, participants, on average, paid 61% of allowed costs. Only 58% received reimbursement for more than one-half of allowed costs, and one-third received no reimbursement because they did not meet their deductible. Using a common definition of underinsurance— a deductible exceeding 5% or medical expenses exceeding 10% of family income; or if low-income, medical expenses exceeding 5% of family income&mdash;82% of the sample was underinsured.15 Because our data do not include expenses for other family members, the underinsurance rate is likely even higher.

In focus group discussions and during survey interviews, participants described how medical spending caused them considerable financial hardship and emotional stress. Twenty-two percent reported medical debt, with 25% owing $5000 or more and 6% $20,000 or more. They told of delaying or forgoing preventive services, diagnostic testing, elective surgeries, and medical equipment and employing strategies to stretch medication supplies, such as skipping pills, selectively not filling prescriptions, and continuing to use old medications after new ones had been prescribed.

They also reported enrolling in plans with high deductibles because these were the only ones for which they could afford the premiums.

The primary instrument for measuring health status was the SF-12v2, a scale derived from the SF-36.

We also administered the World Health Organization Quality of Life brief form (WHOQOL-BREF), the World Health Organization Health and Work Performance Questionnaires (HPQs), standardized ADL-IADL measures,

 and asked for self-reported diagnoses and health conditions. All instruments were administered by telephone at baseline and at 8-month intervals over the 41-month study period (5 rounds). SF-12v2 data are reported below for the first 4 rounds (baseline plus 3) corresponding with the first 2 years of the study. Claims data for case mix analysis are summarized for the corresponding 2-year period.

To measure comorbidity burden (case mix), we used the ACG, Version 8.2 with DX-PM model and prior cost for a non-elderly population.

We did not include prescription data because a preliminary analysis indicated it did not significantly affect outcomes for this study population. The ACG maps each beneficiary’s age, gender, and diagnostic codes to a single actuarial cell, or ACG, representing their estimated resource use. ACG reference unscaled concurrent weights, or case-mix weights, are ratios comparing estimated resource use for a given ACG with the average resource use of a nationally representative sample of insured individuals. The average case-mix weight for the national population is set at 1. Thus, someone with a case-mix weight of 2 has an estimated resource use twice the national average. Although ACG case-mix weights are measures of estimated resource use, they are also proxy measures of disease burden. Generally, weights greater than 1.0 indicate a population is sicker than the national average, and weights of less than 1.0 indicate it is healthier.

ACG software also produces other measures of disease burden, including Aggregated Diagnostic Groups (ADGs), Expanded Diagnostic Clusters (EDCs), counts

of major EDCs (chronic condition counts), and resource utilization bands (RUBs). Recent versions have also included a predictive model algorithm for forecasting cost.

This article demonstrates a threat to validity when using claims-based risk tools with chronically ill and/or underinsured populations whose underutilization masks actual risk or comorbidity.

The Validity of Claims-Based Risk Estimation in Underinsured Populations

This study assessed the impact of transition from Medicaid drug coverage to Medicare Part D on a sample of dually eligible adults younger than age 65 years with disabilities. 

Telephone survey of employed adults participating in the Kansas Medicaid Buy-In program, Working Healthy, about their experiences in accessing medications after their transition to Part D. 

A total of 328 (55%) individuals from a random sample of 600 agreed to participate in a survey administered by a university-based research unit during February and March 2006, which included 18 questions with yes/no, multiple choice, and open-ended responses. Participants resembled other Kansas dual eligibles demographically and medically, other than having slightly higher rates of mental illness and lower rates of mental retardation and some physical conditions. Participants' 2004 Medicare and Medicaid claims data were analyzed to obtain an overview of their comorbidities and previous prescription use. 

Twenty percent of participants reported difficulty obtaining medications, including drugs in Part D-protected classes; 13% were required to switch medications; and 8% stopped taking at least 1 medication. More than half did not know they could change plans monthly, potentially improving their access to medications. 

The high incidence of access problems despite Centers for Medicare & Medicaid Services (CMS) safeguards points to the need for ongoing monitoring of Part D. If the problems persist, CMS must be willing to modify the program and/or better enforce the rules already in place to avoid adverse outcomes for beneficiaries with disabilities. 

Problems experienced by dual eligibles with disabilities during transition to Part D are an early warning of possible trends for other Medicare recipients. 

Beneficiary access to medications was limited by plan availability, restrictive formularies, higher out-of-pocket costs, and documentation delays. 

One in 12 beneficiaries stopped taking at least 1 medication due to Part D transition barriers.

Transition to Medicare Part D affected not only 35.4 million elderly enrollees but also 6.4 million younger enrollees with disabilities, 2.5 million of whom have low incomes and previously obtained medications through Medicaid. Because Part D was conceived primarily as a benefit for elders, we sought to examine its effects on a dually eligible, younger group of beneficiaries who have significantly different, more expensive, and often unstable health conditions. 

The Centers for Medicare & Medicaid Services (CMS) instituted policies intended to "mitigate the risks and complications associated with an interruption of therapy" for dual eligibles taking certain categories of drugs.

To ensure continuous coverage, CMS required that dual eligibles be automatically assigned to a Part D plan but permitted them to change plans monthly. 

CMS required formularies to cover all or substantially all medications within 6 drug classes: antidepressants, antipsychotics, anticonvulsants, anticancer drugs, immunosuppressants, and antiretrovirals for treating HIV/AIDS.

CMS prohibited Part D plan sponsors from implementing prior authorization or step therapy requirements intended to "steer beneficiaries to preferred alternatives within these classes for enrollees who are currently taking a drug."

Regulations stipulate that patients stabilized on an antidepressant or antipsychotic drug before switching to Part D "should not be subject to utilization management strategies, such as prior authorization or requirements to first fail a preferred product (fail first), to continue therapy."

After evaluating Part D plans from a medical perspective, Elliott and colleagues anticipated that dual eligibles might discontinue essential medications because of increased cost sharing, or might have difficulty obtaining these medications because of formulary restrictions.

Hoadley and colleagues found that "some plans do not cover the drugs that would be expected if they were following these (CMS) guidelines without any exceptions."

In a 50-state survey of Medicaid officials, researchers found "failure of some plans to adhere to the CMS transition plan requirements or failing to cover all or substantially all of the drugs in the 6 protected categories."

The Department of Health and Human Services, Office of the Inspector General (OIG) investigated the extent to which Part D formularies include 200 drugs commonly used by dual eligibles under Medicaid.

The OIG found that some drugs in protected classes were not covered by as many as 41% of the formularies. Twenty-one drugs commonly used by dual eligibles were not covered by at least 25% of formularies and, in some cases, up to 57% of formularies. 

Survey participants consisted of 328 (55%) working adults from a random sample of 600 dually eligible enrollees in Kansas' s Medicaid Buy-In program, Working Healthy. Survey participants were more likely to live in an urban/semiurban area and had slightly higher rates of mental illness than the sample population, but were otherwise demographically comparable. 

Participants' demographic and comorbidity profiles were comparable with those of a random sample of 1375 other dually eligible Kansas Medicaid beneficiaries with disabilities. Participants had somewhat higher rates of serious mental illnesses (psychotic disorders and major depression) and lower rates of mental retardation and physical conditions such as cerebral palsy, respiratory disease, and heart disease, but were otherwise similar to other dually eligible Kansas Medicaid beneficiaries (

Participants were 57% female, with a mean age of 47.3 years. Race was reported as 89% white, 5% African American, 5% Native American, and less than 1% Asian and other races; 3% of participants reported Hispanic ethnicity. Demographically, this group closely resembled the general population of Kansas dual eligibles with disabilities, with slightly fewer African American and other races represented.

Participants lived in both urban and rural communities similar to the state's general population. 

Telephone interviews were conducted by a university-based research unit during February and March 2006. Participation in the survey was both voluntary and confidential. Each participant received a $10 stipend. An institutional review board approved the study. Administrative data on participants were obtained from calendar year 2004 Medicaid claims files, whereas data for other dual eligibles were from 2001-2002 Medicaid claims files. Comorbidity data were obtained by aggregating 

, codes of the primary diagnosis by 3-digit classes. 

The survey included 18 questions with yes/no, multiple choice, and open-ended responses. The full survey is available from the authors on request. 

Participants experienced 2 major types of issues in the months immediately after implementation of Part D: (1) limited access to medications and (2) limited knowledge of rules and regulations. 

Despite all the preemptive policies to ensure uninterrupted therapies, 20% (66/328) of participants had problems getting prescriptions filled. Moreover, 8% (26/328) reported they stopped taking at least 1 medication due to access issues. Of the 56 respondents who explained their difficulties, 46% (25/56) had to pay either the entire cost of the drug or more out-of-pocket costs than they did under Medicaid; 34% (19/56) needed drugs that were not in the formularies; and 11% (6/56) had difficulty with dosage or refill timing restrictions. 

More than one third (15/41) of respondents who identified the drug(s) they could not obtain experienced difficulty acquiring Part D protected class drugs; 4 respondents experienced difficulty getting more than 1 protected drug (

). Nine respondents reported problems obtaining antidepressants; 5 reported limited access to antipsychotics; 4 had difficulty getting anticonvulsants; and 1 reported trouble acquiring an immunosuppressant. Eleven (27%) respondents reported trouble getting benzodiazepines, a drug class not covered by Part D yet covered by Kansas Medicaid, indicating high need for these drugs and lack of information about navigating between Medicaid and Part D. Serious, even life-threatening withdrawal symptoms can result from abrupt cessation in a long-term user.

Fourteen percent (45/328) of survey participants indicated that they were required to get documentation to continue their prescriptions. More than half of these participants reported that documentation took more than 5 days, threatening or interrupting therapy. 

Many participants experienced limited access to drugs under the assigned plans. In fact, 23% (77/328) changed plans. Forty-four percent (34/77) of those who switched plans did so because their assigned plan did not meet their needs or cover needed medications, and 18% (14/77) switched because their local pharmacy did not accept the plan to which they had been assigned. 

Thirteen percent (43/328) of participants reported being required to change a medication. Sixty percent (26/43) of these respondents were required to switch to a generic form. Forty-four percent (19/43) were switched to a completely different drug or to a different formulation (eg, from an extended-release form to a regular form). Among the 35 respondents who could recall specific drugs from which they were required to switch, 37% (13/35) of the changes were in a protected drug class. 

More than half of the participants did not know that, as full-benefit dual eligibles, they could change plans monthly, if needed. Although some knew they could change plans, they did not know how to do so, nor whom to ask for help. 

Despite the small, geographically limited sample, this study is important to policy makers and plan sponsors as an early warning of possible trends. As high users of psychotropic medications, these participants serve as a barometer for the success of policies to protect continued access to certain classes of critical drugs. Although some of our findings appear to be transition related, they have the potential to seriously disrupt individuals' drug regimens and long-term well-being. For example, many individuals who were not required to make copayments under Medicaid were suddenly faced with multiple copayments and no protection if they were unable to meet them. Under Part D, the copayments are indexed and likely to rise each year, making the copayments a long-term issue of great importance. Other issues, such as lack of knowledge about the ability to change plans, can be addressed through additional outreach and educational efforts. However, the ability to better negotiate different plans is of little relevance if one's local pharmacy accepts only a single plan. As one participant noted, Part D is difficult when one lives in a small town, especially when one has a disability and, often, transportation difficulties. 

The fact that numerous people were unable to obtain medications included in protected drug classes is especially troubling and may have long-term implications. Further, drug substitutions that make economic sense may have therapeutic implications for people with disabilities (eg, those who need assistance taking medication may not have this assistance available multiple times throughout the day). Physical and cognitive limitations may make extended-release forms the only effective modality and may make the difference between the ability to live in the community and the necessity of being institutionalized. 

In combination, the barriers to access cited by survey participants may result in the inability to get needed medications. Indeed, 8% of our sample had completely stopped taking at least 1 medication since Part D implementation. 

Continued monitoring of Part D in the coming months and years is imperative. As state initiatives have emerged to fill the gaps in coverage left in the wake of Part D implementation, it is important not to lose sight of what can be done on a federal level to improve Part D. If the issues identified here persist, CMS must implement remedies. At the very least, Part D should maintain a level of coverage commensurate with that received by dual eligibles under Medicaid. 

From the Division of Adult Studies, Center for Research on Learning, University of Kansas, Lawrence, Kan. 

This research was funded through an evaluation contract with the Kansas Health Policy Authority (contract 0105-DHPF-1205-113). 

Jean P. Hall, PhD, Division of Adult Studies, Center for Research on Learning, University of Kansas, 1122 West Campus Rd, Rm 517, Lawrence, KS 66045. E-mail: jhall@ku.edu. 

Jean P. Hall, PhD

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