Call for Panels Call for Panels Understanding Beneficiaries to Inform Education to Improve Access to Medicare Programs Chair: Christopher Koepke, Centers for Medicare & Medicaid Services Sunday, June 25 • 8:30 am – 10:00 am Panel Overview: The Medicare Modernization Act represents the largest change in the Medicare program since its inception. It included the initiation of the discount drug card and the Medicare prescription drug coverage. It also expanded health care choices. Delivering these programs through a choice model allows beneficiaries to affect the delivery of their own health care. It is the Centers for Medicare & Medicaid Services responsibility to educate beneficiaries so they can access these programs. To improve CMS’ education efforts, it is important to understand how beneficiaries behave when making choices, what factors are important to them when exploring options, the level of beneficiary awareness, knowledge, and attitudes and how these factors affect behavior. This panel includes new research that provides insight into these issues. One study is a large survey that closely examines beneficiaries’ knowledge, awareness, and experience with Medicare prescription discount cards. Another provides in-depth analysis into behaviors beneficiaries undertake when making plan choices in the real world. A third uses conjoint analysis to examine factors that are important to beneficiaries when making a plan choice. A fourth examines the choice behaviors and motivations of those who have disenrolled from MA plans. Finally, results from tracking surveys during the Medicare prescription drug coverage initial enrollment period are used to assess the role of knowledge, attitudes, and other factors in enrollment decisions. These studies provide invaluable information to support CMS in its efforts to make programs more accessible to beneficiaries. ●Medicare Prescription Drug Coverage: Tracking Beneficiary Knowledge and Attitudes and their Relationship with Intention to Enroll and Actual Enrollment Throughout the Initial Enrollment Period. Christopher Koepke, Ph.D., Beth Simon, Ph.D. Presented By: Christopher Koepke, Ph.D., Deputy Division Director, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244; Tel: 410-786-5877; Email: christopher.koepke@cms.hhs.gov Research Objective: Track changes in beneficiary knowledge, attitudes, and enrollment throughout the Medicare prescription drug coverage initial enrollment period. Assess whether beneficiary knowledge or attitudes were related to enrollment? Assess other factors that affect the relationship between knowledge and attitudes and enrollment? Study Design: The study utilizes five survey waves from August 2005 to January 2006. Each survey was an independent national sample of 400 randomly chosen Medicare beneficiaries over 65 years of age. Knowledge was measured using nine different items including knowledge that you have to enroll to receive the benefit, it is available to everyone with Medicare, there is a deadline for enrolling, and there is a choice of plans. Attitudes measured included overall favorability, belief the program is confusing, and belief the program is a bad value. Prior to open enrollment, our dependent variable was intention to enroll which was measured as a four point scale of likelihood to enroll. After November 15, respondents were also asked whether they had enrolled. Control variables include type of insurance coverage, existence and type of previous drug coverage, exposure to Medicare prescription drug coverage information, and basic demographics. January wave results will be included in the final paper, but were not available for this abstract. The surveys were conducted by Voter Consumer Research. Population Studied: Medicare beneficiaries over 65. Principal Findings: All knowledge items increased at least 20 percentage points from August 2005 to December 2005. Knowledge that there was a deadline increased from 39% to 71%, knowledge that one had to sign up increased from 56% to 74%, knowledge that there was a choice of plans increased from 17% to 66%. Intention to enroll remained steady throughout the survey periods. But when combined with selfreported actual enrollment, there was a 10% jump in December. Attitudes remained fairly stable throughout the five month period. In December, the following knowledge items were related with the enrollment variables: missing the deadline meant higher costs, there was a monthly fee, there was a choice of plans, a low-income subsidy was available, and a person with current coverage needed to find out if it was as good as the Medicare coverage. Overall favorability towards the program was strongly related with enrollment as was belief in the value of the program. Belief the program was confusing was not strongly related with enrollment. Multivariate investigation to test whether any inferences from these relationships are spurious and to further investigate the conditions under which knowledge and attitudes are related to enrollment will be reported in June. Conclusions: As an agency that offers health care consumers choices in how they want their insurance delivered, CMS’ major communication goal is to make accurate information available to beneficiaries. One expected outcome from these activities would be an increase in knowledge. The results demonstrate that Medicare prescription drug coverage knowledge increased during the fall of 2005. There is also evidence that this knowledge and attitudes are related to intention to enroll. Implications for Policy, Delivery, or Practice: It is possible to educate aged beneficiaries on new programs. Knowledge and attitudes alone do not always drive behavior, which suggests the need for community based support systems to help beneficiaries understand the enrollment process and make decisions. Further investigation should be conducted into how support systems can help beneficiaries turn knowledge into behavior. Primary Funding Source: CMS ●Mapping Enrollment Behaviors in Medicare Prescription Drug Coverage Beth Simon, Ph.D., Christopher Koepke, Ph.D., Barbara Allen, MA, Donna Lloyd-Kolkin, Ph.D., David Newman, Ph.D. Presented By: Beth Simon, Ph.D., Social Science Research Analyst, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244; Tel: 410-786-6665; Email: beth.simon@cms.hhs.gov Research Objective: To develop an understanding of the actual behaviors of Medicare beneficiaries as they choose whether to enroll in the new Medicare prescription drug coverage. While accounting for socio-demographic and environmental factors, we map a range of behaviors that beneficiaries undertake (i.e., talking with family and friends; reviewing materials from drug plans; talking with health professionals, etc.) to create a series of typologies to investigate access to drug coverage. Research findings will inform how the Centers for Medicare & Medicaid Services (CMS) develops communication tools and strategies that educate Medicare beneficiaries about Medicare prescription drug coverage. Study Design: One hundred interviews (80 cross-sectional; 20 panel/prospective) are being conducted with Medicare beneficiaries in three rounds from January-April, 2005. Beneficiaries are segmented by current prescription drug coverage and no coverage; current enrollment status/intention to enroll in the Medicare prescription drug coverage; and basic demographics. Interviews explore beneficiaries’ behavioral processes as they navigate how and whether to enroll in drug coverage. Importantly, data are being gathered as beneficiaries are being influenced and making decisions so that reliance on retrospective recall of decision making is minimized. And, some respondents will be tracked prospectively before they’ve made a decision. Population Studied: Interview data are being gathered from Medicare beneficiaries aged 65 or older in seven geographically and demographically diverse markets. Respondents differ by current drug coverage status, intention to enroll and current enrollment status in the Medicare prescription drug coverage, along with basic demographic characteristics. Beneficiaries with employer coverage, in a Medicare Advantage plan, and those with Medicaid are excluded from this sample because they do not have to make the same decisions as the general Medicare population (i.e., due to existing coverage or facilitated enrollment). Principal Findings: Data are being gathered and analyzed from January-April, 2005. We anticipate this research will illuminate the behavioral processes that Medicare beneficiaries go through that, for some, culminates in enrollment in a Medicare prescription drug plan while, for others, the process ends in non-enrollment. Pre-testing suggests that, in different combinations, beneficiaries’ behavior includes and is shaped by conversations with friends and family, guidance from health professionals, marketing materials from drug plans, Medicare information channels, workshops, along with other influences and interactions. Beneficiaries’ behavior, along with their socio-demographic context, creates different pathways by which beneficiaries choose whether to enroll. CMS will use these data to create typologies of beneficiary behavior to better develop quantitative measures that evaluate influences on enrollment to, ultimately, improve beneficiaries’ access to prescription drug coverage in a competitive market. Conclusions: TBD when data are available Implications for Policy, Delivery, or Practice: Understanding influences on beneficiaries’ enrollment in Medicare prescription drug coverage will inform CMS’ development of communication tools and strategies. As CMS and others communicate with the Medicare population about the Medicare prescription drug coverage, it is imperative to understand—from the target audience’s perspective—what influences their enrollment decisions so that communication materials can best meet their needs. Primary Funding Source: CMS ●Medicare Beneficiary Knowledge of, Awareness of, and Experience with Prescription Drug Discount Cards Noemi Rudolph, M.P.H., Sunyna Williams, Ph.D. Presented By: Noemi Rudolph, M.P.H., Social Science Research Analyst, Office for Research, Demonstrations, and Information, Centers for Medicare & Medicaid Services, 7500 Secuity Boulevard, Baltimore, MD 21244; Tel: (410)786-6662; Email: noemi.rudolph@cms.hhs.gov Research Objective: To examine how knowledge and awareness of prescription drug discount cards vary between Medicare beneficiary cardholders and non-cardholders, and to assess cardholder experiences. Findings will be compared with those from a subsequent fielding focusing on Medicareapproved cards. Study Design: Questions were developed and cognitively tested, and then fielded as part of the 2003 Medicare Current Beneficiary Survey (MCBS). Questions focused on awareness of, knowledge of, and information-seeking behavior related to prescription drug discount cards. Cardholders (9%) were also asked about their experiences choosing a card and with enrollment, and perceived savings. Population Studied: The sample included 13,344 elderly and disabled community-dwelling Medicare beneficiaries. Principal Findings: Descriptive analyses showed that 60% perceived that they knew nothing or almost nothing about drug discount cards, over 70% found it somewhat difficult or very difficult to understand how much they can save using a card, and only 17% tried to find more information about cards. For cardholders, more than half expressed difficulty choosing a card and approximately 32% sought the help of others in choosing a card. However, almost 90% found signing up for a card to be very easy or somewhat easy. Two thirds of cardholders used their card all of the time to buy prescription drugs and approximately 75% were satisfied with their card(s). Inferential analyses showed that current cardholders (vs. noncard holders) were more likely to be older seniors, female, white, widowed, and lower income. There were no significant difference between card and non-card holders in education and perceived health status. A higher percentage of cardholders had no other drug coverage, suggesting that cardholders sought the cards because of lack of coverage. Those with Original (fee-for-service) Medicare, with or without a supplement, were more likely to be current cardholders. Those with Medicare managed care and Medicare-Medicaid dual eligibles were more likely to be non-card holders. Cardholders had greater perceived knowledge, greater perceived understandability of savings, were more likely to have sought information and have a greater desire for more information, and were more likely to have done something else to reduce the cost of prescription drugs than were noncard holders. Card holders answered a higher proportion of the drug card knowledge quiz item correctly than noncardholders (55% vs. 43%). Conclusions: Beneficiary perceived knowledge of prescription drug discount cards and perceptions regarding savings using cards were low, and few were interested in more information. Preliminary findings show differences between cardholders and non-cardholders in terms of other sources of drug coverage and knowledge about cards. Additional analyses underway examine predictors of drug card knowledge and comparisons with findings from the 2004 MCBS focusing on Medicare-approved cards. Implications for Policy, Delivery, or Practice: The choices for Medicare beneficiaries increased with passage of the Medicare Modernization Act that brought the Medicare Prescription Drug Discount Card Program, and now the Medicare Prescription Drug Coverage Program. Understanding factors associated with knowledge of, awareness of, and experiences with prescription drug discount cards can help the Centers for Medicare & Medicaid Services better target their educational efforts. Primary Funding Source: CMS ●What Can be Learned from Assessing Disenrollment Reasons from Medicare Advantage Health Plans: A Qualitative Analysis. Amy Heller, Ph.D., Lauren McCormack, Ph.D., M.S.P.H., Claudia Squire, MS, Jeremy Morton, MA, Lee Mobley, Ph.D., Philip Salib, BA, Amy Heller, Ph.D. Presented By: Amy Heller, Ph.D., Social Science Research Analyst, Center for Beneficiary Choices, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244; Tel: 410-786-9234; Email: amy.heller@cms.hhs.gov Research Objective: As part of the CAHPS Disenrollment Reasons Survey, Research Triangle Institute (RTI) with the Centers for Medicare & Medicaid Services, conducted research with a sample of beneficiaries to explore why certain subgroups are more likely than others to disenroll from their Medicare Advantage (MA) plans, to learn about their experiences during and after disenrollment and to gauge the importance of prescription drugs in their disenrollment choice. Study Design: In Spring 2005, RTI conducted this focus groups with Medicare beneficiaries who had responded to the 2004 Disenrollment Reasons Survey in three sites. In each site, RTI also conducted sessions with disabled beneficiaries under age 65. The result was 10 focus groups with 75 MA plan disenrollees. Population Studied: A sample of Medicare beneficiaries who disenrolled from MA plans with representation from the following groups: Disabled beneficiaries, beneficiaries who left their MA health plan and went to another MA plan, and those who returned to Original Medicare. Principal Findings: Many participants were either actively looking for a better plan or were open to the possibility of a new plan. Disabled beneficiaries indicated that drug coverage was an important factor for leaving their plan. Additionally, the disabled participants, for the most part cited similar reasons for disenrolling especially in regard to the drug coverage. However, their reasons for leaving appeared to be linked to their specific health care needs and a strong desire to stay with their current doctor and/or hospital. Across all three sites, a significant number of participants were enrolled in a MA HMO and were planning on returning to a MA plan. Being able to see the doctor they wanted or go to the hospital of their choice was more important than type of health plan. Participants’ experiences after disenrollment were mixed. Some participants reported being more satisfied with their new plan while others were either less satisfied or felt about the same. Some participants wanted more plan choice assuming that more plans would mean increased competition and lower prices, while others preferred fewer options. The role of prescription drug coverage in beneficiaries’ decision to disenroll from a health plan varied. Most participants across all sites had at least some drug coverage and those that had coverage under their old plan were likely to choose a new plan that also offered coverage. There was some confusion surrounding drug benefits such as drug tiers, use of a formulary and types of co-payments. Conclusions: Participants across all sites were able to articulate reasons for leaving their former health plan. Most participants across sites identified more than one reason for leaving their plan, but most were able to choose one most important reason for leaving. Most often cited reasons for disenrolling were the opportunity to save money or to follow a health provider. Implications for Policy, Delivery, or Practice: This research helps to explain how beneficiaries understand and choose among their health plan options, their enrollment behaviors and the importance of their prescription drug coverage. Primary Funding Source: CMS, ●Attributes Important to Medicare Beneficiaries Making Health Plan Choices and Prescription Drug Plan Choices: A Conjoint Analysis Decision-Making Experiment Sunyna Williams, Ph.D., Jack Fyock, Ph.D. Presented By: Sunyna Williams, Ph.D., Social Science Research Analyst, Office for Research, Demonstrations, and Information, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244; Tel: 410-786-2097; Email: sunyna.williams@cms.hhs.gov Research Objective: The research objectives were to examine (a) how Medicare beneficiaries trade-off various attributes when making health plan choices and prescription drug plan choices; (b) how attribute preferences and trade-offs vary across key beneficiary segments—FFS Medicare with Medigap vs. managed care, high vs. low drug spending, and lowincome vs. higher-income; and (c) how preferences may change with the introduction of the Medicare Modernization Act (MMA) provisions for preventive services coverage in 2005 and prescription drug coverage in 2006. Study Design: The study was conducted in July, August, and September 2003. The primary method was a conjoint analysis within-subjects decision-making experiment, for which each participant made a series of choices among hypothetical plans that varied in terms of several attributes. Each trial involved making a choice among three hypothetical plan options. There were 17 trials each for a health plan choice task and a prescription drug plan choice task. Health plan attributes included prescription drug coverage, as well as doctor choice, preventive services, plan premium, etc. Prescription drug plan attributes included coinsurance, deductible, maximum benefit, coverage of generic and brand drugs, plan premium, mail order and pharmacy access, , etc. Following the experiment, brief focus groups were conducted to further explore beneficiary perceptions of the health plan and drug plan attributes. Population Studied: Participants were nearly 300 Medicare beneficiaries recruited by professional research facilities in four cities across the U.S.—Philadelphia, Los Angeles, Atlanta, and Chicago. All were seniors, approximately 65% of whom were under 75 years of age, about 65% were female, and about 85% were white. Principal Findings: Overall, for the health plan choice task, after plan premium, drug coverage was the most important attribute, and preventive services was moderately important. Not surprisingly, therefore, with the incremental addition of the MMA provisions, the very strong preference for managed care-like plans decreases and then seems to disappear. Interestingly, although the strength of the preference decreases over time, those currently in managed care consistently prefer managed care-like plans. Overall, for the prescription drug plan choice task, deductible, maximum benefit, and plan premium were the most important attributes. Probably due to the cumulative changes in those three attributes, the strong preference for managed care-like plans, especially among those currently in managed care, increases over time. Conclusions: When making a health plan choice, the most important attributes for beneficiaries are plan premium, drug coverage, and preventive services, and when making a prescription drug plan choice, the most important attributes are annual deductible, maximum benefit, and plan premium. Interest in managed care appears to change over time, as Medicare adds preventive services coverage and then prescription drug coverage. Future research should use actual Part D plan attributes, and should examine other factors affecting choices, such as preference for one-stop shopping or motivation and skill to be an active consumer. Implications for Policy, Delivery, or Practice: These findings have implications for education and decision-support initiatives by Medicare and other stakeholders for beneficiaries making health plan and prescription drug plan choices. Primary Funding Source: CMS Call for Panels Opening up the Black Box of Quality Improvement Interventions: Lessons from a Formative Evaluation of Routine-Care Implementation of Depression Collaborative Care Chair: JoAnn Kirchner, Department of VA Sunday, June 25 • 8:30 am – 10:00 am Panel Overview: Spread of new technologies across healthcare organizations is a complex process whose determinants health service researchers are only recently beginning to study systematically. Successful routine-care implementation requires participation of stakeholders from a broad spectrum of professional backgrounds, skill sets, and organizational levels. Further, a variety of individual, organizational, and cultural characteristics may differentially affect stakeholder groups’ readiness and ability to embrace evidence-based implementation efforts. Capitalizing on its 25year investment in health services research, the Veterans Health Administration (VHA) has embarked on a series of research-clinical partnerships through the Quality Enhancement Research Initiative (QUERI). We conducted a formative evaluation of one of these partnerships, the TIDES program (Translating Initiatives for Depression Into Effective Solutions). This panel will be composed of 4 major sections. First, we will briefly describe the TIDES intervention and implementation methodology. Second, we will describe details of the multi-method formative evaluation conducted of this multi-site intervention. This evaluation included managers’ and providers’ views of the strengths and weaknesses of the implementation process, resulting in practical guidelines for working with busy frontline healthcare staff and critical methodological recommendations for improving the science underlying implementation research. Third, we will describe views of management and frontline staff on how best to establish a two-way dialogue between implementers and QI program participants, which is designed to facilitate program marketing and provide a mechanism for obtaining on-going feedback from local staff. Finally, we will discuss the effects of contextual and organizational characteristics on the extent of intervention penetration across practices. ●Improving Depression Treatment in Primary Care: Dissemination and Implementation Edmund Chaney, Ph.D., Lisa Rubenstein, M.D., M.S.P.H. Presented By: Edmund Chaney, Ph.D., Staff Psychologist, , Department of Veterans Affairs, Seattle VAMC, 1100 Olive Way, Suite 1400, Seattle, WA 98101; Tel: (206) 764-2815; Fax: (206) 764-2652; Email: edmund.chaney@med.va.gov Research Objective: Though effective and efficacious interventions have been documented, depression is frequently under-detected and under-treated in the primary care setting. To address this problem, the Veterans Health Administration of the U.S. Department of Veterans Affairs (VA) has funded Translating Initiatives for Depression into Effective Solutions (TIDES), an implementation process designed to introduce and support an evidence-based care model for treating depression in primary care. The goal of this implementation effort is to maximize the ease of spread of an evidence-based intervention through local, regional and national initiatives. Study Design: Using an Evidence-Based Quality Improvement (EBQI) protocol, TIDES establishes partnerships between VA regional network leadership and researchers who serve as implementation facilitators. Implementation of the treatment model includes 3 phases: primary implementation, regional dissemination and national dissemination. Implementation activities, as well as evaluation efforts, differ in each phase. Population Studied: The primary implementation occurred in 7 different primary care clinics located in 3 different regional networks. In addition, 3 sites (one in each regional network) served as a randomized control for evaluation of the implementation effort. Regional dissemination (currently under way) targets sustainability of the intervention at the primary implementation sites, as well as spread to additional sites within the original networks and to a fourth regional network. National dissemination efforts include linking existing organizations to support the development of a national organizational structure and capacity to support implementation, ensuring the fidelity of the treatment model in terms of existing treatment guidelines, linkage of the treatment model to national performance monitoring measures and the creation of stakeholder-specific marketing plans. Principal Findings: Findings from evaluation of the Primary Implementation Phase indicate that the intervention resulted in a stepped-care model of depression management consistent with models validated in efficacy and effectiveness trials. Findings also indicate patient adherence and satisfaction with care, as well as remittance of depression symptoms for 90% of patients followed in primary care and 50% of patients followed in mental health settings. Conclusions: Design and conduct of implementation efforts require a strong partnership between researchers and clinicians. In addition, there are substantial upfront investments required from both researchers and participating clinical networks and sites. This varies by clinic site and regional network. The average amount of time needed prior to model implementation was 27 months. Appropriate selection of a champion, tailored marketing, strong staff and management buy-in and leadership support are key components of the implementation process. Implications for Policy, Delivery, or Practice: The Veterans Health Administration is the largest publicly funded, integrated health care system in the United States. Findings with regard to the importance of using an EBQI process to gain leadership support and involvement and facilitate adaptation to local conditions may generalize to other managed-care settings. Primary Funding Source: VA ●The QI Implementation Process: Perspectives from Providers and Managers JoAnn Kirchner, M.D., Louise E. Parker, Ph.D., Laura Bonner, Ph.D., Elizabeth M. Yano, Ph.D., Mona J. Ritchie, Ph.D. Presented By: JoAnn Kirchner, M.D., Staff Physician, Health Services Research, HSR&D / CeMHOR, 2200 Fort Roots Drive, Building 58, (152/NLR), North Little Rock, AR 72114; Tel: (501) 257-1719; Fax: (501) 257-1718; Email: kirchnerjoanne@uams.edu Research Objective: Spread of new technologies across healthcare organizations is a complex process whose determinants health service researchers are only beginning to study. Successful implementation often requires participation of stakeholders from a broad spectrum of professional backgrounds, skill sets, and levels within the organization. Readiness to participate in implementation efforts may differ substantially among stakeholder groups. Further, a variety of individual, organizational, and cultural characteristics, structures, and processes may differentially affect stakeholder groups’ readiness and ability to embrace and participate in implementation efforts. The purpose of this presentation is two-fold. First, we describe methods we used in a formative evaluation of the TIDES program, a VA sponsored depression care quality improvement (QI) initiative. Second, we describe how we applied findings from this evaluation to identify implementation barriers and inform the TIDES QI effort in an ongoing process. We believe that our methods and findings are applicable to a broad range of QI improvement efforts within behavioral health as well as in other healthcare areas. As such we offer them as a blueprint for utilizing formative evaluation to guide quality improvement across the healthcare industry. Study Design: We conducted key informant interviews with TIDES participants concerning their experience with the implementation process as well as their perspectives concerning barriers to and facilitators of the quality improvement effort. We analyzed verbatim transcripts utilizing a grounded theory approach. To enhance coding consistency, a two-person team coded all the relevant text, refined their coding scheme and resolved coding differences. Population Studied: We interviewed a purposive sample of 72 stakeholders participating in the TIDES initiative. Informants included depression care managers involved in the QI effort and providers and managers from three VA service networks, five medical centers, and five intervention clinics. Principal Findings: Stakeholders provided cogent and practical recommendations regarding who to involve in implementation efforts, roles and characteristics of champions, roles for leadership and resources needed to support QI. They also offered general recommendations for conducting quality improvement initiatives so as to foster initial implementation, sustainability, and spread. Conclusions: Providers and managers can articulate specific activities to improve the implementation and spread of evidenced based practices though there was some variation across stakeholder groups. This type of information is useful on two levels. First, it can provide valuable feedback to the specific implementation effort studied. In fact, as the TIDES program is an on-going effort, we are able to utilize our findings to provide timely actionable feedback to the implementation team. Second, much of what our informants offered have broad implications for QI implementation and thus can inform the field in general. Implications for Policy, Delivery, or Practice: Quality improvement efforts within healthcare organizations are most likely to be effective when they are supported by the total system including all its many stakeholders. Therefore, successful implementation necessitates broad based inclusion of stakeholder input from diverse organizational levels. Such input can directly inform the implementation process and support the development of an equal partnership between managers and providers and those initiating the QI effort. Primary Funding Source: VA ●Creating a Two-Way Intervention Dialogue: Practical Suggestions for Facilitating Quality Improvement within Healthcare Organizations Louise Parker, Ph.D., JoAnn E. Kirchner, M.D., Laura Bonner, Ph.D., Jacqueline J. Fickel, Ph.D., Elizabeth M. Yano, Ph.D., Mona J. Ritchie, M.S.W. Presented By: Louise Parker, Ph.D., Consultant, 1 Warwick Park, Unit 1, Cambridge, MA 02140; Tel: (617) 497-4952; Email: parkerlouise@earthlink.net Research Objective: There are two primary competing healthcare quality improvement (QI) methods. Continuous Quality Improvement is a bottom-up, participatory approach. Evidence-Based Practice (EBP) is a top-down, expert-led approach. Participation promotes buy-in and takes local conditions and needs into account but can be burdensome. EBP advocates argue that by following expert developed guidelines, practitioners can provide quality care with minimal burden. We propose melding the two approaches by creating a two-way dialogue between implementers and healthcare facility staff. Providers can then avail themselves of the latest evidence while maintaining the ability to tailor interventions to fit local conditions. It is not exactly clear, however, how to conduct such a dialogue. We examined the ways in which managers and frontline providers prefer to communicate with QI implementers. We also examined the types of information that they reported would be most likely to convince them to adopt new ways of working. Our goal was to understand both how implementers can market quality improvement to staff and how staff, in turn, can convey information about local circumstances and implementation problems to implementers. Study Design: We conducted semi-structured interviews with frontline providers, frontline administrators, and middle and upper managers across five VA practices participating in a depression care QI initiative. Utilizing a grounded theory approach, we conducted a content analysis during iterative reviews of the verbatim interview transcripts. To enhance conceptual development and ensure coding consistency, two members of the research team coded all the relevant text and met regularly to resolve differences and refine their coding scheme and its underlying constructs. Population Studied: We interviewed 53 frontline providers and administrators and 19 middle and upper level managers. Principal Findings: Informants believed that stakeholders from all organizational levels should participate in QI implementation, although they expressed concerns about burden. Frontline staff offered practical suggestions for maximizing participation while minimizing its costs (e.g., utilizing existing meeting structures). Informants indicated that in-person communication is the most effective, although managers appeared to be more amenable to written communication (e.g., email) than were frontline providers. Neither group expressed a clear preference for either quantitative or qualitative information, although psychological research suggests that vivid qualitative information is the most persuasive. There were some differences between the types of argument content that managers and providers would find persuasive. For example, whereas both groups were interested in quality of care, only managers were interested in cost information. Both groups indicated that peers would be convincing information sources; managers indicated that they would also find experts convincing. Conclusions: Although concerned about the time that participation requires, informants believed that it was important for stakeholders from all organizational levels to be involved in QI efforts. They offered practical suggestions for facilitating participation and for transferring information between QI implementers and healthcare staff. Implications for Policy, Delivery, or Practice: We believe that successful QI requires two-way communication between QI implementers and managerial and frontline staff. We examined how best to communicate with and involve staff so as to increase the probability that they will remain engaged in QI efforts, thereby increasing the probability that those efforts will succeed. Primary Funding Source: VA ●Relationship between Organizational Context and Penetration of Quality Improvement Interventions: Case Studies from Implementing Depression Collaborative Care Elizabeth Yano, Ph.D., JoAnn E. Kirchner, M.D., Jacqueline J. Fickel, Ph.D., Louise E. Parker, Ph.D., Mona J. Ritchie, M.S.W., Chuan-Fen Liu, Ph.D. Presented By: Elizabeth Yano, Ph.D., Psychologist, VA GLA HSR&D, Center of Excellence, 16111 Plummer Street, Sepulveda, CA 91343; Tel: (818) 891-7711 x5483; Fax: (818) 8955838; Email: elizabeth.yano@med.va.gov Research Objective: Capitalizing on its 25-year investment in health services research, the Veterans Health Administration (VA) has embarked on a series of research-clinical partnerships through the Quality Enhancement Research Initiative (QUERI) to accelerate implementation of effective interventions into routine care. One of many national QUERI disease targets, depression is particularly common and disabling, with national implementation of collaborative care for depression being one of VA’s top primary care strategic priorities. Collaborative depression care forges shared care between primary care providers and mental health specialists through provider education, informatics-based decision support, leadership support, and a depression care manager, who provides telephone assessment of visit-based positive screens and telephone management and follow-up of depressed patients. Although substantial evidence demonstrates the effectiveness of collaborative care for improving depression management and patient outcomes, little is known about the factors underlying intervention penetration. We evaluated the influences of contextual and organizational characteristics on the degree of penetration during implementation of depression collaborative care in a sample of primary care practices. Study Design: We combined measures from administrative data from VA’s national standardized data repository (location, patient caseload, workload, staffing) with process evaluation results on penetration (proportion of providers referring patients to intervention; # consults made, # provider education sessions) and qualitative data from semi-structured interviews of VA managers, providers and patients to evaluate links between organizational context and effectiveness of implementation in VA primary care practices. Coder dyads analyzed interview data utilizing a grounded theory approach. We evaluated aggregated qualitative and quantitative data using cross-case analysis. Population Studied: Six first-generation primary care practices in three VA networks spanning five states participated in a depression QI initiative. We interviewed primary care and mental frontline providers, clinic administrators, senior and mid-level health care managers, depression care managers, a small sample of consumers enrolled in the intervention, and consumer representatives (n=106). Principal Findings: From 1-10% of primary care patients were diagnosed with depression across participating practices. The speed or extent of penetration was not influenced by primary care and mental health provider relationships, area characteristics, such as urban/rural location, or practice size with the exception of large practices (>13,000 patients), where penetration was poorest. Initiating an early collaborative care referral did not predict future referral behavior. Highest referral rates occurred among practices with the lowest levels of perceived mental health staffing. Conclusions: The extent of penetration of an otherwise effective depression QI intervention varied widely not by area or practice characteristics but by the extent to which clinics perceived that MH access was poor because of low perceived MH staffing levels. Implications for Policy, Delivery, or Practice: Although the VA represents an exceptional “laboratory” within which to translate research into practice given common electronic medical records, identifiable management structures, and common policies and procedures, effective penetration may have less to do with these enablers than local clinic characteristics and needs. Primary Funding Source: VA Call for Panels Early Results from the Cancer Care Outcomes and Research Consortium Chair: Nancy Keating, Harvard Medical School Sunday, June 25 • 8:30 am – 10:00 am Panel Overview: The Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium, funded by the National Cancer Institute and the Department of Veterans Affairs, is a national research study of the health care and outcomes of patients newly diagnosed with lung or colorectal cancer. The study examines care for a population-based cohort of more than 10,000 patients diagnosed with lung or colorectal cancer during 2003-2005 who were living in Northern California, Los Angeles County, North Carolina, Iowa, or Alabama, or who receive their care in one of 5 health maintenance organizations or in the Veterans Administration Health Care System. Data have been collected from multiple sources, including baseline patient surveys conducted approximately 4 months after diagnosis (or surveys of deceased patients’ surrogates), follow-up surveys conducted 12 months after diagnosis, medical record abstraction, surveys of physicians with key roles in the care of these patients, and surveys of caregivers of a sample of these cancer patients. The primary goals of CanCORS include determining how patient, provider and health system factors affect patterns of cancer care and how treatments received are associated with cancer outcomes in community populations. This panel will present results from 5 early analyses that address issues of patients’ preferences for treatment, patients’ use of alternative medications, providers seen by cancer patients, experiences of caregivers of cancer patients, and physicians’ reports of discussing end-of-life issues with terminally ill patients. ●Physician Factors Associated with Discussions about End-of-Life Care Nancy Keating, M.D., M.P.H., Mary Beth Landrum, Ph.D., Selwyn Rogers, M.D., Susan Baum, BS, Beth Virnig, Ph.D.; Haiden A Huskamp, Ph.D., Craig C Earle, M.D., Katherine L Kahn, M.D. Presented By: Nancy Keating, M.D., M.P.H., Assistant Professor of Medicine and Health Care Policy, Department of Health Care Policy, Brigham and Women's Hospital and Harvard Medical School, 180 Longwood Avenue, Boston, MA 02115; Tel: 617-432-3093; Fax: 617-432-0173; Email: keating@hcp.med.harvard.edu Research Objective: Guidelines recommend advanced care planning for patients with terminal illness and life expectancy of 1 year or less. We described physicians’ reports of when they discuss prognosis, do not resuscitate (DNR) status, hospice, and preferred site of death for terminally ill patients and identified factors associated with timing of these discussions. Study Design: Self-administered survey (57% response rate) where physicians were asked to assume they were caring for a patient newly diagnosed with metastatic cancer who is otherwise feeling well, with an estimated life expectancy of 4-6 months. Physicians were asked when they would discuss prognosis, DNR status, hospice, and preferred site of death. Response options were “now”, “when the patient first has symptoms”, “when there are no more non-palliative treatments”, “only if the patient is hospitalized”, and “only if the patient or family bring it up”. We used logistic regression models to identify physician factors independently associated with having discussions “now”. Population Studied: Physicians from 5 population-based sites, 5 integrated delivery systems, and 10 VA sites named by incident lung or colorectal cancer patients as providing key roles in their care. Principal Findings: The mean age of the 2,699 responding physicians was 50.2, 82% were male, 25% were surgeons, 16% medical oncologists, 7% radiation oncologists, and 52% noncancer specialists. Sixty-six percent of physicians would discuss prognosis “now”, while 18% would have this discussion only if the patient/family brings it up. Forty percent would discuss DNR status “now” with 20% waiting for the patient to have symptoms and another 25% waiting until there were no more nonpalliative treatments. Only 25% would discuss hospice “now” with 16% waiting for symptoms and 50% waiting until there are no more nonpalliative treatments. Finally, 20% would discuss preferred site of death now. In multivariable analyses, younger physicians were more likely to discuss prognosis, DNR status, hospice, and preferred site of death “now” (all P<0.001). Surgeons were more likely than noncancer specialists to discuss prognosis “now” (P=0.008), but noncancer specialists were more likely than cancer specialists to discuss DNR status, hospice, and preferred site of death “now” (all P<0.001). Physicians with more terminally ill patients were more likely than others to discuss prognosis “now” (P=0.04), and physicians in office (vs. hospital) practice were more likely to discuss hospice “now” (P=0.001). Conclusions: Many physicians do not discuss end-of-life options with terminally ill patients while they are still feeling well, instead waiting for onset of symptoms or until there are no more non-palliative treatments to offer. Younger physicians and noncancer specialists discuss end-of-life options sooner than older physicians and cancer specialists. Implications for Policy, Delivery, or Practice: Despite guidelines recommending discussion of prognosis, DNR status, hospice, and preferred site of death while patients are well, our findings suggest that different types of physicians have very different views regarding the appropriate timing of these discussions. More research is needed to understand physicians’ reasons for and patients’ preferences for timing, and the role of physicians’ propensity to treat metastatic cancer on the timing of discussions. Education and physician interventions may be necessary to increase advanced care planning for terminally-ill cancer patients. Primary Funding Source: NCI, Veterans Administration ●Complementary and Alternative Medicine Use and Correlates among Patients With Newly Diagnosed Colorectal and Lung Cancer Robert B. Wallace, M.D., MSc, Robert Fletcher, M.D., Jane Weeks, M.D., Angela Kuehl, D.Pharm., Jane Pendergast, Ph.D. Presented By: Robert B. Wallace, M.D., M.Sc., Professor of Epidemiology and Internal Medicine, Epidemiology, University of Iowa College of Public Health, 200 Hawkins Drive, Iowa City, IA 52242; Tel: 319-384-5005; Fax: 319-384-5004; Email: robert-wallace@uiowa.edu Research Objective: To determine the level and correlates of dietary supplement and alternative practitioner use among patients with newly diagnosed colorectal (CRC) or lung cancer. Study Design: Analysis of responses to a questionnaire that included items on complementary and alternative medicine practices and other factors potentially related to dietary supplement use, such as socio-demographic and clinical variables, satisfaction with care, and clinical trial participation. The survey was administered by telephone 4-6 months (mean 4 months) after diagnosis, and included patient but not proxy interviews. Population Studied: Seven geographically and institutionallydefined cohorts of newly diagnosed CRC and lung cancer patients throughout the United States (Total N = 4767). Principal Findings: Approximate 13% of CRC and lung cancer patients reported using alternative dietary supplements and about 6% had consulted an alternative practitioner at the time of the baseline survey, with little variation according to type of cancer. Of those seeking an alternative practitioner, about 10% reported traveling over 100 miles for this activity. Dietary supplement (DS) users were younger, more likely to be women, somewhat more highly educated and had higher reported family incomes. There was no significant difference between whites and non-whites in usage rates. DS use had increased substantially from the year before cancer diagnosis. Patients reported taking supplements for a variety of reasons, including for cancer treatment, lessening the side effects of cancer therapy, relieving cancer symptoms and for unrelated medical conditions. DS users were also more likely to use alternative practitioners than non-users. For both CRC and lung cancer patients, DS takers were less satisfied with the quality of their initial surgical and chemotherapy care, although this was statistically significant only for CRC patients. CRC, but not lung cancer patients were less likely to participate in any type of clinical trial during initial cancer management. Conclusions: The use of alternative dietary supplements and alternative practitioners is common among newly diagnosed CRC and lung cancer patients in this geographically dispersed cohort. DS use appears to be somewhat greater among those with higher education and income. DS use also appears to be a possible indicator of greater dissatisfaction with cancer care, and (at least among lung cancer patients) of lesser likelihood of clinical trial participation. Implications for Policy, Delivery, or Practice: Several patient characteristics and behaviors were associated with dietary supplement and alternative practitioner use is in patients with CRC and lung cancer. and these could have important implications for improving the therapeutic process. In followup analyses, we will explore the effects of these variables on clinical cancer outcomes. Primary Funding Source: NCI, Veterans Administration ●Physicians Involved in the Care of Patients with Recently Diagnosed Lung and Colorectal Cancer Katherine L Kahn, M.D., Nancy L Keating, M.D., M.P.H., Mary Beth Landrum, Ph.D., John Z Ayanian, M.D., M.P.P., Robert Boer, Ph.D., Carrie Klabunde, Ph.D.; Paul J Catalano, Ph.D., Presented By: Katherine L Kahn, M.D., Professor, Medicine, UCLA, RAND, 911 Broxton Avenue, Los Angeles, CA 90095; Tel: 310-794-2287; Fax: 310-794-0732; Email: kkahn@mednet.ucla.edu Research Objective: To understand the distribution of physicians and roles fulfilled for patients with incident lung and colorectal cancer. Study Design: Approximately four months after diagnosis, 1810 lung cancer (LC) and 2371 colorectal cancer (CRC) patients were surveyed by telephone to assess the types of physicians fulfilling key clinical roles. We examined the distribution of patients reporting a physician fulfilling 4 key roles and how often that role was fulfilled by a cancer (surgeon, medical or radiation oncologist) or non-cancer doctor. Population Studied: Incident LC and CRC patients diagnosed during 2003-2005 in five regions, five integrated health-care delivery systems, and 10 VA hospitals. Principal Findings: LC patients receiving surgery, chemotherapy, and radiation reported a mean of 3.6 (SD 1.3) unique physicians involved with their care vs. mean 3.0 (SD 1.2) for patients receiving none of these treatments. CRC patients receiving surgery, chemotherapy, and radiation reported a mean of 3.1 (SD 1.1) unique physicians involved with their care vs. mean 2.1 (SD 1.0) for patients receiving none of these treatments. Most patients reported having a primary-care physician (PCP) (80% for LC, 74% for CRC), a doctor most important in helping them decide whether or not to have tests or treatments (77%, 57%, respectively), a doctor in charge of treatment for the next six months (81%, 59%), and a doctor responsible for managing symptoms (79%, 56%). For more than 90% of patients reporting a PCP, that doctor was someone other than their surgeon, chemotherapy or radiation doctor. For 49% of LC and 31% of CRC patients, the PCP was also the physician patients reported as most important in at least one of three other key roles: helping them decide whether or not to have tests or treatments, the doctor in charge of treatments for the next six months, or the doctor most likely to know about their symptoms. Among patients reporting one doctor who was most important in helping them decide whether or not to have treatments, this physician was not a cancer specialist for 39% of patients with either LC or CRC. The doctor in charge of treatments for the next six months and the doctor responsible for managing symptoms was a cancer doctor for most patients (77% and 62%); for the remaining patients, a noncancer doctor fulfilled these roles. Conclusions: Early after a diagnosis of LC and CRC, most patients reported having several key providers of their care. Within the first 4 months, patients often received care from both primary care and cancer specialists. Across both cancers, 23% to 39% of patients reported a key management role fulfilled by a non-cancer doctor. For more than two-thirds of these patients, the non-cancer doctor fulfilled multiple roles. Implications for Policy, Delivery, or Practice: The management of patients with incident cancer typically includes several physicians fulfilling multiple key roles, including both primary-care and cancer physicians. These findings underscore the need to develop and maintain systems for coordinating care effectively among these multiple physicians for patients with newly diagnosed lung cancer or colorectal cancer. Primary Funding Source: NCI, Veterans Administration ●Fatalism and Treatment Preferences of Lung and Colorectal Cancer Patients: The Role of Demographic and Socio-Economic Variables Julie Ganther-Urmie, Ph.D., Elizabeth Chrischilles, Ph.D., Jane Weeks, M.D., John Brooks, Ph.D., Jane Prendergast Ph.D.; Dawn Provenzale, M.D., David Nerenz, Ph.D.; Dee West, Ph.D. Presented By: Julie Ganther-Urmie, Ph.D., Assistant Professor, Pharmacy, University of Iowa, S519 Pharmacy Building, Iowa City, IA 52242; Tel: 319-335-8616; Fax: 319-3535646; Email: julie-urmie@uiowa.edu Research Objective: To examine the relationship between fatalism/treatment preferences and socio-demographic factors in lung and colorectal cancer patients. Study Design: Data were from the Cancer Care Outcomes and Research Consortium (CanCORS) baseline patient survey. Preference measures included a summated four item fatalism measure, a single item measure of whether patients preferred treatment that extended life versus treatment that improved quality of life, and a single item measure of whether patients preferred treatment that extended life or treatment that conserved financial resources. Survey data were collected approximately 4 months after cancer diagnosis. Multivariate linear and logistic regression models were used to examine the relationship between socio-demographic variables and each of the preference measures. Independent variables for the model were: age, gender, marital status/living arrangement, race, income, education, health insurance status, and type of cancer. Population Studied: Population-based cohort of newly diagnosed lung and colorectal patients enrolled in the CanCORS study. Patients were from seven geographically diverse sites in the United States. Principal Findings: Levels of fatalism varied widely, with scores across the full scale range. Women, patients with lower education levels, patients with lower income levels, and patients who were married or living with a partner had significantly higher levels of fatalism. African-Americans and Asians had significantly higher levels of fatalism than white, non-Hispanics. The model explained a limited amount of variation in fatalism with an R squared of 12.6 percent (n = 4,129). About half of patients said they would prefer treatment that extended quantity of life, even if it meant more pain or discomfort, over treatment that focused on relieving pain and discomfort but would mean not living as long (n= 4,127). Younger patients, men, and patients who were married or living with a partner were significantly more likely to prefer quantity of life over quality of life. African-Americans were significantly more likely than white, non-Hispanics to prefer quantity of life over quality of life. Sixty-one percent of patients said they would prefer treatment that extended their life as much as possible, even if it meant using up all of their financial resources, over treatment that cost less but would mean not living as long (n = 3,948). Younger patients, men, and patients who were not married or living with a partner were significantly more likely to prefer quantity of life over conserving financial resources. African-Americans and Asians were significantly more likely than white, non-Hispanics to prefer quantity of life over conserving financial resources. Type of cancer was not significant for any of the models. Conclusions: There are some significant differences in preferences among different socio-demographic groups, but overall, socio-economic and demographic variables do a poor job of explaining variation in preferences. Implications for Policy, Delivery, or Practice: Some differences in treatment rates across different patient groups may be explained by patient preferences. However, socioeconomic and demographic variables explain only a small amount of the variation in preferences so it is important to explicitly assess patient preferences rather than make assumptions about preferences based on socio-demographic characteristics. Primary Funding Source: NCI, Veterans Administration ●Characteristics, Care Tasks, and Unmet Needs of Informal Caregivers of Cancer Patients Michelle van Ryn, Ph.D., M.P.H., Audie Atienza, Ph.D.; Mary Butler, M.B.A., Mark C Hornbrook, Ph.D.; Katherine L Kahn, M.D., Michelle Martin, Ph.D.; Sara Sanders, Ph.D., Michelle Sotak, BA; Julia Rowland, Ph.D., Courtney Van Houtven, Ph.D. Presented By: Michelle van Ryn, Ph.D., M.P.H., Associate Professor, Family Medicine & Community Health; Epidemiology, University of Minnesota, Room 225, 925 Delaware Street, S.E., Minneapolis, MN 55414; Tel: 612-6259105; Fax: 612-624-3037; Email: vanry001@umn.edu Research Objective: Changes in the health care system have shifted much of cancer care to the outpatient and home setting, resulting in increased family involvement in day-to-day care. Yet, limited information exists about informal cancer caregivers and the care they provide. We sought to identify the characteristics of informal caregivers of newly diagnosed lung and colorectal cancer patients, and assess the specific care they provide. Study Design: Caregivers of newly diagnosed CRC and lung cancer patients were mailed self-admininistered questionnaires soon after baseline interviews with the cancer patients were completed. We conducted analyses focusing on caregivers’ sociodemographic and health characteristics, type and amount of care provided, and training received for providing cancer care. Population Studied: Caregivers (N=642) of seven geographically and institutionally-defined cohorts of newly diagnosed CRC and lung cancer patients. Principal Findings: The majority (73%) of caregivers reported they alone did all or most of the home care. Most of the caregivers were spouses (60%) or other family members (35%). While the majority of caregivers (70%) live with the care recipient, 10% drove 30 minutes or more to provide care. Most provided care every day (65%), though a significant minority (20%) reported providing care one day a week or less. In addition to assisting with activities of daily living, many caregivers assisted with cancer specific care, including managing symptoms such as pain, nausea or fatigue (40%), making decisions about medications (30%) and monitoring the care recipient for treatment side effects (65%). Around 50% of caregivers who reported performing a cancer care task also reported not receiving any training to perform the task. Over half of caregivers reported that they did not have a choice in whether or not to provide care. Fifty percent reported currently working for pay, and of these, 70% reported having difficulty balancing work and care demands. Twenty percent reported that they also cared for children in their home. Only 42% of caregivers reported being in very good or excellent health. Caregivers reported various coping strategies with 10% reporting they use alcohol or other drugs to help them cope. On the positive side, around 80% reported feeling very close to their care recipient, and over 50% reported experiencing one or more positive aspects of providing care. Conclusions: A wide range of services for incident cancer patients are delivered in the home, by unpaid family caregivers, who are often untrained. A significant portion of cancer caregivers have difficulty managing their work and caregiving roles. Less than half of caregivers are in very good or excellent health themselves. Implications for Policy, Delivery, or Practice: Caregivers are an important resource for patients with incident cancer. For many, the challenges of caregiving, the lack of training, and the need to deliver care while also managing employment is problematic. A more systematic understanding of caregiver tasks and challenges will facilitate health systems and families to evaluate how to best provide caregiver services in a sustained, high quality manner. Primary Funding Source: NCI, Veterans Administration Call for Panels Impact of Medicare Critical Access Hospital Program on Rural Hospital Financial Viability and Access to Care in Rural Communities Chair: Boyd Gilman, RTI International Sunday, June 25 • 10:30 am – 12:00 pm Panel Overview: Today nearly one-quarter of all acute care hospitals in the United States receive cost-based reimbursement from Medicare under the Critical Access Hospital (CAH) program. The number of hospitals converting to CAH status has increased from less than 50 in 1998 to nearly 1,200 in 2005. As a result of the special financing program, in several Midwestern states over three-quarters of all acute care facilities now receive cost-based reimbursement. The CAH program was created by Congress in the 1997 Balanced Budget Act (BBA) to provide special financial dispensation to all limited-service hospitals located in isolated rural areas. The purpose of the CAH program was to ensure that Medicare beneficiaries in isolated rural communities had reliable access to emergency room and limited inpatient services, including the capacity to stabilize patients and arrange transport to an appropriate larger hospital for complex cases. The program was intended to provide more favorable financing to small facilities that, because of their lack of economies of scale, may have been financially disadvantaged by the implementation of Medicare’s inpatient and outpatient prospective payment system, The purpose of this panel is to describe the history and purpose of the CAH program; track the rapid and concentrated growth in the number of hospitals that have received CAH designation; and assess the impact of the CAH program on hospital financial performance, hospital closures, and access to acute and postacute care services in rural communities. ●Impact of Critical Access Hospital Status on Hospital Revenue, Profit Margins, and Hospital Closures Jeff Stensland, Ph.D. Presented By: Jeff Stensland, Ph.D, Senior Analyst, MedPAC, 601 New Jersey Avenue, N.W., Washington, DC 20001; Tel: 202-220-3700; Email: Jstensland@medpac.gov Research Objective: To quantify the impact of critical access hospital (CAH) status on Medicare payments, profit margins, and the closure of rural hospitals. Study Design: We compare cost-based Medicare payment rates per unit of inpatient, outpatient, and post acute care to the Medicare prospective payment systems’ rates. Costbased payments are taken from Medicare cost reports and prospective payment system rates are modeled using Medicare claims data. Hospital closure data was obtained from CMS. Population Studied: A sample of 498 of the approximately 1,200 critical access hospitals along with a comparison group of 551 small rural hospitals that had not converted to CAH status by 2003. Principal Findings: Critical access hospital revenues (and Medicare expenditures) increased at a 9.5% annualized rate of growth from 1998 to 2003. Comparison hospital revenues increased at a 3.3% annualized rate. The faster revenue growth at CAHs is almost all due to cost-based payment rates being significantly larger than Medicare’s prospective payment rates. Outpatient revenues and post-acute revenues per day increased rapidly after conversion to cost-based reimbursement. As Medicare revenues increased, profit margins improved significantly, and closures almost ceased. Conclusions: Much of the difference between payments received by CAHs and traditional hospitals reflects the benefit of cost-based outpatient payments and cost-based payments for post-acute patients in swing beds. Implications for Policy, Delivery, or Practice: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) essentially prevents new hospitals from entering the CAH program. Most of the existing 1,200 to 1,300 CAHs are expected to remain financially stable—many are even remodeling their facilities or building new facilities. Neighboring small rural hospitals that also lack economies of scale may have difficulty competing with CAHs if the CAHs receive significantly higher payment rates. Primary Funding Source: Other Government Funding ●Growth in the Number of Rural Hospitals under Medicare Cost-Based Reimbursement Boyd Gilman, Ph.D., Kathleen Dalton, Ph.D. Presented By: Boyd Gilman, Ph.D., Senior Economist, Division for Health Services and Social Policy Research, RTI International, 411 Waverley Oaks Road Suite 330, Waltham, MA 02452; Tel: (781) 434-1718; Fax: (781) 434-1700; Email: bgilman@rti.org Research Objective: The purpose of this paper is to describe the background and purpose of the Medicare Critical Access Hospital (CAH) program; discuss the eligibility requirements for conversion, with particular emphasis on state exemptions from the federal requirements; and track the growth in the number and the regional distribution of hospitals that have been awarded a CAH designation. Study Design: The presentation uses descriptive analyses of the number and location of hospitals converting to CAH status between 1998 and 2005 based on information from the March 2005 update of the CMS OSCAR files, supplemented by information through October 2005 from Flex Monitoring Project. Population Studied: Rural short-stay hospitals that converted to CAH status before October 2005. Principal Findings: The 41 facilities that were identified as CAHs prior to 1999 were already receiving cost-based reimbursement from Medicare under two existing rural demonstration programs. An additional 78 rural hospitals converted from PPS to cost-based reimbursement in 1999. By October 2005, 1,163 rural short-stay hospitals had been awarded a CAH designation, representing nearly one-quarter of all Medicare participating short-stay acute care facilities in the United States. However, given their small size, CAHs represent less than three percent of all certified acute care beds. Converting hospitals are geographically concentrated in the Midwest. Roughly three-quarters of all acute care hospitals in Montana, Nebraska and North Dakota, two-thirds of all hospitals in Iowa, Indiana and South Dakota, and onehalf of all hospitals in Kansas and Minnesota have converted to CAH status. One of the most important factors enabling the growth in converting hospitals has been the ‘necessary provider’ provision including in the enabling legislation. The provision allowed states to develop their own definitions of what constituted a necessary community service and these definitions were allowed to take precedence over the federal proximity criterion. More than 60% of the 959 hospitals that had converted by August 2004 were certified on the basis of their state designation as ‘necessary provider.’ Conclusions: There has been a rapid growth in the number of short-stay acute hospitals converting to cost-based reimbursement under the Medicare CAH program due in part to expansions in the eligibility requirements under subsequent legislation and in part to the authority of states to circumvent the proximity requirement by designating hospitals as ‘necessary providers.’ However, as a result of the recent elimination of the proximity waiver, there should be virtually no future growth in the CAH program as more than 90 percent of all non-metropolitan hospitals with 25 or fewer certified beds are already designated as CAH providers. Implications for Policy, Delivery, or Practice: The Medicare CAH program has been successful in getting rural hospitals to limit the scope of their services in exchange for more generous financing. By reimbursing hospitals on the basis of their costs rather than under the prospective payment systems, the CAH program has helped to ensure the availability of limited acute care services in rural communities. Primary Funding Source: CMS ●Impact of Critical Access Hospital Program on Financial Performance Mark Holmes, Ph.D., George Pink, Ph.D., Rebecca Slifkin, Ph.D., Presented By: Mark Holmes, Ph.D., Senior Research Fellow, Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, 725 Martin Luther King Boulevard, CB 7589, Chapel Hill, NC 27599-7590; Tel: (919_966-9694; Fax: (919)966-1634; Email: mark_holmes@unc.edu Research Objective: To determine whether and to what extent conversion to Critical Access Hospital (CAH) status affected hospital financial performance. Study Design: The Flex Monitoring Team has developed twenty financial performance indicators specifically for Critical Access Hospitals using Medicare Cost Report data. We compare these measures pre- and post- conversion to CAH status for approximately 700 hospitals, controlling for the timing of the conversion. Population Studied: Critical Access Hospitals for which a complete year of Medicare Cost Report data are available postconversion Principal Findings: Although some financial performance measures (such as profitability and liquidity) improved after conversion to CAH, other measures showed no correlation with conversion to CAH. Most measures exhibited a decline in the year immediately subsequent to conversion. Conclusions: Conversion to CAH status has generally increased financial performance of CAHs, thus improving the potential for their long term survivability. The pre-conversion dip underlines the importance of accounting for the decision to convert to CAH status in pre-post comparison studies. Implications for Policy, Delivery, or Practice: Rural residents depend on the survival of their community hospitals to have access to timely, quality healthcare. The CAH program was instituted to increase the survivability of small rural hospitals by alleviating financial pressures. Evidence that CAH conversion has improved the financial performance, and therefore the expected survivability of these hospitals, supports continuation of this program. Primary Funding Source: HRSA ●Participation in Skilled Nursing and Swing-bed Care in Rural Hospitals Following Conversion to Cost-Based Reimbursement Kathleen Dalton, Ph.D., Rebecca T Slifkin, Ph.D. Presented By: Kathleen Dalton, Ph.D., Senior Health Services Researcher, Health Care Finance & Payments, RTI International, 3040 Cornwallis Road, Research Triangle Park, NC 27709; Tel: (919) 451-5919 Research Objective: The supply and organization of postacute care is sensitive to changes in Medicare payment regulation. Between 1998 and 2003 Medicare transitioned from cost-based to prospective payments for all skilled nursing facilities (SNFs), and returned from prospective to cost-based payments for acute and swing-bed care in nearly half of rural hospitals as a result of the Critical Access Hospital (CAH) program. CAHs face new incentives to close SNF units and expand swing-bed care in order to maximize hospital cost-based payments. This study tracks changes in availability and use of inpatient skilled nursing services in rural areas during the period from 1996 to 2003, focusing on CAH participation in post-acute and long-term care before and after their conversion from PPS to CAH status. Study Design: Retrospective, observational study combining data from CMS certification files through September 2004 with hospital and nursing facility cost reports filed for periods ending through 2003. Descriptive analyses are provided by core-based statistical areas (CBSAs). These are supplemented by multivariate models of the probability of hospital-based SNF closure and of average swing-bed census, as functions of CAH status controlling for size, location, SNF case-mix or previous survey findings. Population Studied: Rural short-stay hospitals and Medicarecertified SNFs that were open between 1996 and 2003. Principal Findings: Contrary to expectation hospital-based SNFs have not closed more often in CAHs than in other rural hospitals, and swing bed use has grown only slightly faster in CAH settings than elsewhere. The proportion of Medicare SNF care delivered in swing-bed or hospital-based settings has declined steadily in both rural and urban counties, but the decline is less pronounced in the very rural counties where the majority of CAHs are located. In the six years following the 1998 implementation of SNF PPS, 15% of hospital-based facilities in very rural counties closed compared to 26% in micropolitan rural and 43% in metropolitan counties. Only 8% of CAH converters that operated SNFs in 2000 had closed their units by end of 2004, compared with 19% of other rural hospitals with SNFs. Multivariate models found hospitalbased unit closure was associated with for-profit ownership, higher Medicare utilization, higher wage-adjusted cost per day and lower average therapy case-mix. Closure was not significantly associated with CAH status, swing-bed participation or a history of survey deficiencies. Swing bed use increased substantially in a small group of CAHs but not overall; in regressions with multi-year data, increased swing census was not associated with CAH conversion. Conclusions: Although the reintroduction of cost reimbursement to rural hospitals creates strong reimbursement incentives to close non-cost-based units, there is no evidence yet that CAHs are more likely to close their PPS SNF units or substitute swing-bed for SNF unit care. Changes in swing-bed use following conversion vary strongly by region. Implications for Policy, Delivery, or Practice: Many CAHs have operated under cost reimbursement for only one or two years and these findings could change as managers grow more familiar with reimbursement maximization strategies. CAH participation in non-cost-based services should continue to be monitored. Primary Funding Source: HRSA Call for Panels Quality Improvement Programs to Improve Outcomes of Patients with Anxiety and Depression in Medical Settings Chair: Wayne Katon, University of Washington Sunday, June 25 • 10:30 am – 12:00 pm Panel Overview: Most people in the United States with depressive and anxiety disorders are treated in primary care and medical settings not by mental health professionals. However accurate diagnosis and treatment of depressive/anxiety disorders in these settings has been shown to be suboptimal. This symposium will describe four innovative programs tested in randomized trials that have been shown to markedly improve quality of mental health care and outcomes of patients with depression/anxiety disorders in medical settings. Dr. Katon will describe the Pathways study that tested a depression collaborative care intervention in patients with depression and diabetes compared to usual care which showed marked improvement in depression as well as a savings in medical costs over a two year period. Dr. Unützer will review results from the IMPACT trial which randomized 1801 elderly depressed patients in 8 health care settings to a nurse collaborative care program versus usual primary care. This study showed that the intervention was associated with improved depression, decreased functional impairment and decreased pain compared to usual care at a small increment in cost. Dr. Roy-Byrne will describe the results of a combined cognitive behavioral and medication intervention for primary care patients with panic disorder that was associated with improvement in anxiety and depressive symptoms and improved functioning compared to usual primary care. Dr. Zatzick will describe a randomized trial of a case management intervention for patients hospitalized for motor vehicle trauma who suffered from PSTD and/or substance abuse that was shown to be associated with a significant decrease in PTSD symptoms as well as use of alcohol over a 1-year period compared to usual care. ●Cost-Effectiveness and Probability of Cost-Offset of a Stepped Care Intervention in Patients with Diabetes and Depression Wayne Katon, M.D., Gregory Simon, M.D., M.P.H., Jurgen Unutzer, M.D., M.P.H., Ming-Yu Fan, Ph.D., Michael Schoenbaum, Ph.D., Michael Von Korff, Sc.D. Presented By: Wayne Katon, M.D., Professor and Vice-Chair, Psychiatry & Behavioral Sciences, University of Washington, 1959 NE Pacific St., Box 356560, Seattle, WA 98195-6560; Tel: (206) 543-7177; Fax: (206) 221-5414; Email: wkaton@u.washington.edu Research Objective: Patients with diabetes have a high prevalence of major depression, estimated at up to 15%. Patients with diabetes and comorbid depression compared to those with diabetes alone have increased symptom burden, functional impairment and medical costs as well as poorer self-care (adherence to diet, exercise and medication), higher HbA1c levels and higher mortality rates. These research projects tested the effect on depressive outcomes and costs of a quality improvement depression intervention for patients with diabetes and depression. Study Design: We will describe the 2-year incremental costeffectiveness of two trials that randomized 414 older adults with diabetes and depression (IMPACT) and 329 mixed-aged patients with diabetes and depression (Pathways Trial), respectively, to a collaborative stepped care intervention versus usual care. The stepped care intervention in each trial provided patients with a choice of problem-solving therapy, antidepressant medication and behavioral activation with potential augmentation of initial choice of treatment based on persistent depressive symptoms. Population Studied: In Pathways mixed age and in IMPACT, elderly (60 or older) patients with major depression and/or dysthymia and diabetes. Principal Findings: In the IMPACT trial, the two-year total ambulatory costs were $25 (95% CI -1638, 1689) higher in intervention versus usual care patients over a 2-year period and the incremental number of depression-free days associated with the intervention was 115 (95% CI 72, 159). The incremental cost per depression-free day was -$0.25 (95% CI 14, 15). A bootstrap analysis suggested a 50% chance of dominance of the intervention (the total ambulatory costs were less with greater clinical benefit). In the Pathways trial, the two-year total ambulatory costs were $605 (95% CI -1767, 556) less in intervention versus usual care patients and the incremental number of depression-free days associated with the intervention was 70 (95% CI 26, 114). The incremental cost per depression-free day in Pathways was -$9.7 (95% CI 31, 14). Conclusions: The results of the two trials suggests in patients with diabetes and depression that for no greater costs the depression stepped care intervention compared to usual primary care was associated with a marked increase in depression-free days and health care benefits in primary care patients with comorbid diabetes and depression. Implications for Policy, Delivery, or Practice: Improving recognition and treatment of depression in patients with diabetes is associated with decreased patient suffering and may save medical costs. Primary Funding Source: National Institute of Mental Health ●Project IMPACT: Improving Primary Care for Late-Life Depression Jurgen Unutzer, M.D., M.P.H. Presented By: Jurgen Unutzer, M.D., M.P.H., Professor and Vice-Chair, Psychiatry & Behavioral Sciences, University of Washington, 1959 NE Pacific Street, Box 356560, Seattle, WA 98195-6560; Tel: (206) 543-3128; Fax: (206) 221-5414; Email: unutzer@u.washington.edu Research Objective: Depressive disorders affect 5-10% of older adults seen in primary care. Late-life depression is associated with substantial suffering and impairment, high medical costs and poor adherence to medical treatment, and increased mortality. Although efficacious treatments exist, few depressed older adults receive adequate care. This study reports the cost-effectiveness of a collaborative care model to improve care for depressed older adults. Study Design: Adults aged 60+ with major depression or dysthymia were randomly assigned to usual care or to the IMPACT care model, which involved 12-month access to a depression care manager supported by a psychiatrist and a primary care expert. The study involved 1,801 depressed older adults from 18 primary care clinics in 8 organizations across the US. Independent surveys assessed clinical status, quality of life, functioning, and health care use at 3, 6, 12, 18 and 24 months; practices provided administrative data on health care costs and use over the study period. We assess intervention effects on depression, functional impairment, quality-adjusted life years (QALY), and costs per QALY, using intent-to-treat analyses. Population Studied: 1801 elderly patients (60 or older) with major depression and/or dysthymia enrolled in 8 health organization in 7 states. Principal Findings: Over two years, intervention patients had 107 more depression-free days (DFD) than those in usual care (P is less than 0.01), corresponding to a gain of 0.056-0.113 QALYs. Intervention participants also had less functional impairment and better physical functioning than usual care patients over a 2-year follow-up. There were no significant differences in total health care costs in intervention and control patients and the incremental outpatient cost / DFD was $2.76 (95 % CI -4.95, 10.47). Conclusions: The IMPACT intervention is highly effective for depressed older adults, relative to usual care and a high value investment when compared to other commonly provided medical treatments. Implications for Policy, Delivery, or Practice: The IMPACT model markedly improves depressive, functional and quality of life outcomes for depressed patients at a modest cost. Primary Funding Source: John A. Hartford Foundation ●Developing and Implementing Acute Care Collaborative Interventions Targeting PTSD & High-Risk Behaviors Douglas Zatzick, M.D., M.P.H., Peter Roy-Bryne, M.D., Joan Russo, Ph.D., Frederick Rivara, M.D., Gregory Jurkovich, M.D., Amy Wagner, Ph.D. Presented By: Douglas Zatzick, M.D., M.P.H., Associate Professor, Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Avenue, Box 359911, Seattle, WA 98104; Tel: (206) 731-4867; Fax: (206) 731-3236; Email: dzatzick@u.washington.edu Research Objective: Injured survivors of individual and mass trauma initially receive treatment in the acute care medical setting. Epidemiological investigations suggest that injured trauma survivors are at risk for the development of posttraumatic stress disorder (PTSD) and related comorbidities, yet few symptomatic patients attain high quality behavioral health services. The goal of this research is to develop a health services intervention to improve mental health outcomes of hospitalized trauma patients. Study Design: A team of clinician-investigators from mental health services, clinical psychology/efficacy, pediatric and, surgical backgrounds developed a collaborative care intervention that was delivered from a level I trauma center. The team combined injury care management, motivational interviewing targeting reductions in injury risk behaviors, and evidence-based cognitive behavioral psychotherapy and medications targeting PTSD, in a stepped care procedure. Clinical epidemiological methods were used to recruit a population-based sample of 120 acutely injured hospitalized patients. Inpatients were randomized to early collaborative care intervention or care as usual. Population Studied: 120 acutely injured patients hospitalized initially in a community care intervention versus usual care. Principal Findings: Over the 12-months after the injury patients receiving the combined intervention demonstrated significant reductions in PTSD symptoms (p less than .02) and high risk alcohol use (p less than .05). Intervention patients also demonstrated a non-significant reduction in recurrent traumatic injury as documented by automated trauma center health service utilization records (adjusted odds ratio = 0.43, 95% CI = 0.10, 1.96). Conclusions: A mental health services intervention aimed at trauma patients with PTSD and/or substance abuse markedly improved mental health and alcohol abuse outcomes over a 1year period compared to usual care. Implications for Policy, Delivery, or Practice: The discussion will highlight how the interdisciplinary team is using the results of effectiveness trials to impact American College of Surgeons’ acute care policy mandates for sustainable mental health services as a requisite for trauma center accreditation. Primary Funding Source: National Institute of Mental Health ●Collaborative Care for Primary Care Anxiety Disorders Peter Roy-Byrne, M.D., Michelle G. Craske, Ph.D., Murray B. Stein, M.D., Greer Sullivan, M.D., Alexander Bystrisky, M.D., Wayne J.Katon, M.D. Presented By: Peter Roy-Byrne, M.D., Professor and Vice Chair, Psychiatry & Behavioral Sciences, University of Washington, 325 Ninth Avenue, Box 359911, Seattle, WA 98104; Tel: (206) 341-4201; Fax: (206) 731-3236; Email: roybyrne@u.washington.edu Research Objective: Like depression, anxiety disorders in primary care are prevalent, disabling, and inadequately identified and treated. In addition, anxiety may be unique in being less well recognized, possibly because patients less often seek help or feel they have a treatable problem, and posing potentially greater problems with treatment engagement and adherence. This presentation will describe a series of studies designed to improve the delivery of evidence based treatment to primary care patients with anxiety. Study Design: Two randomized trials of mental health services interventions (psychiatrist collaborative care model, therapist cognitive behavioral and medication enhancement model) were compared to usual primary care for patients with panic disorder. Population Studied: The first study randomized 115 patients with panic disorder from 3 primary care clinics in the Seattle region. The second study randomized 232 patients with panic disorder from 3 geographic regions of the US (Seattle, San Diego, Los Angeles). Principal Findings: The first demonstrated the clinical and cost effectiveness of a psychiatrist-based intervention focusing on delivery of pharmacotherapy to primary care patients with panic disorder. The second demonstrated the clinical and cost effectiveness of a care manager-based intervention focusing on delivery of cognitive behavior therapy and primary care physician prescribed medication to primary care patients with panic disorder. The third study, currently underway, aims to test the clinical and cost effectiveness of an intervention program targeting the four most prevalent primary care anxiety disorders (panic, generalized anxiety, social anxiety and PTSD), accommodating patient preference for either medication or cognitive behavior therapy, employing motivational intervention strategies to maximize treatment engagement, utilizing a stepped-care paradigm to maximize treatment response over time, and employing personnel with no prior cognitive behavioral therapy experience who are systematically trained for the care manager role, to maximize generalizability and potential ease of dissemination. Conclusions: The quality of care and outcomes of patients with panic disorder can be markedly improved with collaborative care interventions with the potential of cost savings in overall medical costs. Implications for Policy, Delivery, or Practice: Improvements in outcomes of primary care patients with panic disorder can be accomplished with modest increments or no greater costs. Primary Funding Source: National Institute of Mental Health Call for Panels Hospice and the Challenge of Improving End-of-Life Care Chair: Melinda Beeuwkes Buntin, RAND Health Sunday, June 25 • 10:30 am- 12:00 pm Panel Overview: The Medicare Hospice benefit and payment system were implemented in 1983 and have changed very little since then. This panel will explore the current role of the hospice benefit in providing high-quality end-of-life care. One paper will examine how well the current hospice payment system reflects patient costs and how it might be improved. This is critical given that the types of patients seen by hospices, and the technology available to treat them, have changed dramatically since 1983. Two other papers explore the characterics of hospices. In particular, one looks at whether the incentives in the current payment system have led forprofit hospices to selectively enroll patients more likely to be profitable. The other examines cost reports and the financial perfomance of hospices directly to determine factors associated with hospice profitability. Finally, we conclude with a discussion of quality measurement in end of life care and the implications of the state of the science for our ability to monitor hospice performance. The panel will focus the insights these analyses provide on how some potential modifications of hospice financing and regulation might affect providers, Medicare, and patients and families. ●Hospice Ownership Status and the Delivery of Care Sabina Ohri, Ph.D. Candidate Presented By: Sabina Ohri, Ph.D. Candidate, Department of Economics, University of California, Irvine, 3151 Social Science Plaza, Irvine, CA 92697; Tel: (949) 824-7376; Email: sohri@uci.edu Research Objective: To study the effect of ownership status among hospices on a number of outcomes related to quality, referral sources and the type of care provided. Study Design: We estimate negative binomial regressions to estimate the effect of for-profit status on quality deficiencies. We also test for differences between for-profit and non-profit agencies in terms of overall staffing levels and the skill mix of the staff employed. Finally, we use ordinary least squares regressions to estimate the effect of for-profit status on referral sources. Population Studied: The analysis is based on a facility-level data set constructed by combining data from the California Office of Statewide Health Planning and Development, OSHPD, on all Medicare-certified hospices in California from 2002 through 2004 with data on hospice quality from the Automated Certification and Licensing Administrative Information and Management Systems, ACLAIMS, of the California Department of Health Services. The OSHPD data provides detailed measures on key facility characteristics, such as length of stay, staffing ratios, patient demographics, and other facility information. The ACLAIMS data provide annual counts of quality citations, based on audits by the California Department of Health Licensing and Certification Program. These direct quality measures pertain to several aspects of care. Principal Findings: The results suggest that there are significant differences across ownership types with respect to various outcomes. After controlling for facility and patient characteristics, for-profit agencies have more quality deficiencies. We find sizeable differences in the types of labor employed. While non-profit and for-profit hospices report similar numbers of visits per patient, for-profits make much less use of skilled providers, such as registered nurses. Forprofit and non-profit agencies also have very different referral networks, with for-profits receiving significantly more patients from long-term care facilities. Because of these different referral patterns, patients with dementia make up a larger share of the case-mix in for-profit hospices than in non-profit hospices. Conclusions: Medicare reimburses hospices on a fixed per diem basis, regardless of patient diagnosis. Because under this system patients with lower expected costs are more profitable, hospices have an incentive to selectively enroll low cost patients. While hospices cannot reject potential patients explicitly, we find evidence that is consistent with the fact that they influence their patient mix through their referral networks. We also find that the fixed per diem rate creates an incentive for for-profits to shirk on quality and to substitute lower skilled for higher skilled labor. Implications for Policy, Delivery, or Practice: These results suggest that the current Medicare reimbursement rate encourages for-profit hospices to enroll low cost patients from specific referral sources. The adoption of case-mix adjustments to the Medicare reimbursement rate could help eliminate these differences across ownership status. Primary Funding Source: No Funding ●Case Mix Adjustment and Hospice Costs Nancy Nicosia, Ph.D., Melinda Beeuwkes Buntin, Ph.D., Elaine Reardon, Ph.D., Karl Lorenz, M.D., Joanne Lynn, M.D. Presented By: Nancy Nicosia, Ph.D., Associate Economist, RAND, 1776 Main Street, Santa Monica, CA 90407; Tel: (310) 393-0411; Fax: (310) 393-4818; Email: nancy_nicosia@rand.org Research Objective: To examine potential refinements to the Medicare hospice payment system with an emphasis on understanding how patient characteristics impact service utilization. An important element of the analysis is our use of a proprietary dataset from a large hospice chain provider, which allows us to explore more detailed measures of service utilization. Study Design: The Medicare payment system for hospice care has remained largely unchanged since per diem rates were instituted in 1983. During the past two decades, payment levels have been updated for inflation based on a market basket, but otherwise the payment methodology has remained largely unchanged. Unlike other Medicare payment systems, hospice payments are not adjusted for case mix, urban/rural location (apart from the wage index), costly outliers or other potentially relevant factors. There is increasing concern that the payment methodology no longer accurately reflects costs because of changes in provider, patient, and service characteristics. This concern is compounded by the rapid expansion in the number of hospice providers, hospice use, and associated Medicare expenditures. These recent changes have raised interest in potential case mix adjustments to hospice payments. Given the current per diem payment structure and the change in the hospice population over time, we focus on three questions: How well does the current per diem system reflect hospice costs? Should case mix adjusters such as diagnoses be considered? Are the beginnings and ends of hospice stays more intensive? The proprietary dataset from a large chain provider comprises a rich set of variables that are useful in characterizing service utilization and examining the relationship between utilization and patient characteristics. The data allow us to examine the number of days of care, the number of visits, the timing of visits, and the labor costs associated with visits. Using multivariate regression analyses, we first examine how well the current per diem system explains service utilization. We then explore additional regressors available in the proprietary dataset to determine whether patient characteristics improve the predictive power of the model. Characteristics include diagnosis, nursing home residence, marital status, gender, race/ethnicity, and discharge status. Finally, we examine whether the intensity of care varies over a patient's stay. A critical issue is whether variation in the intensity of care (within a stay) creates incentives under the per diem system for providers to seek patients with longer lengths of stay. Population Studied: Analyses are conducted using a sample of Medicare beneficiaries admitted to the chain provider's facilities in 2002 and 2003. The sample is compared to the universe of Medicare hospice beneficiaries to examine generalizability Principal Findings: The findings are embargoed until the June MedPAC report is issued. Conclusions: The conclusions are embargoed until the June MedPAC report is issued. Implications for Policy, Delivery, or Practice: The findings will inform policymakers on potential adjustments to Medicare hospice payment policies. They will also speak to the benefits of increased hospice data collection. Primary Funding Source: The Medicare Payment Advisory Commission ●A Systematic Review to Identify Measures of the Quality of Symptom and End-of-Life Cancer Care Anne M Wilkinson, Ph.D., Karl Lorenz, M.D., M.S.H.S., Joanne Lynn, M.D., Sydney Dy, M.D., Richard A Mularski, M.D.; Lisa R. Shugarman, Ph.D., Ronda G. Hughes, Ph.D., Cony Rolon, Afshin Rastegar, M.D., Paul G. Shekelle, M.D., Ph.D. Presented By: Anne M Wilkinson, Ph.D., Behavioral/Social Scientist, RAND, 1200 South Hayes Street, Arlington, VA 22202; Tel: (703)413-1100; Fax: (703)413-8111; Email: Anne_Wilkinson@rand.org Research Objective: To systematically identify quality measures and the evidence for them to support quality assessment and improvement in the palliative care of patients with cancer in the areas of pain, dyspnea, depression, and advance care planning (ACP), and to identify important gaps in related research. Study Design: A systematic review of the literature (Medline, CINAHL, PsychInfo) in English 1995-2005 using terms for each domain for patients living with a cancer diagnosis throughout the continuum of care. (e.g., diagnosis to death) Pain and depression searches were limited to cancer, but we searched broadly for dyspnea and ACP - because the evidence base for dyspnea is more limited and experts advised that ACP measures would be generalizable to cancer. Population Studied: We undertook an extensive Internet and grey literature search and contacted authors. Measures were included if they expressed a normative relationship to quality and included a measurable numerator and denominator. Citations and articles were dual reviewed / abstracted by six palliative care researcher / clinicians who described populations, testing, and attributes for each measure. Principal Findings: The literature search identified 5,182 titles, and excluded 4,599 at abstract review. Of 532 articles, citations with measures included 19 for advance care planning, 6 on depression, 5 on dyspnea, and 20 on pain. We identeified 10 relevant measure sets (ACOVE, QA Tools, Cancer Care Ontario, Cancer Care Nova Scotia, Dana-Farber, Georgia Cancer Coalition, University Health Consortium, NHPCO, VHA, ASCO) We identified a total of 40 operationalized and 19 non-operationalized measures. The most measures were available for pain (15) and ACP (35), compared with only 5 available for dyspnea and 4 for depression. Few of the measures were published and few had been specifically tested in a cancer population. Conclusions: A large number of measures are available for addressing palliative cancer care, including many that are appropriate for hospice, but testing them in relevant populations is urgently needed. Basic research is urgently needed to address measurement in populations with impaired self-report. Implications for Policy, Delivery, or Practice: Hospices are not currently required to report quality measures. Few measures are suitable for accountability, but funding field testing of highest quality measures should be an urgent patient and family-centered priority to meet the needs of patients. Primary Funding Source: AHRQ ●A Systematic Review of Quality Measures for Evaluating Palliative Cancer Care Karl Lorenz, M.D. M.S.H.S., Sean O'Neill, BS, Susan Ettner, Ph.D. Presented By: Karl Lorenz, M.D. M.S.H.S., VA Greater Los Angeles Healthcare System; Email: Karl.Lorenz@va.gov Research Objective: To evaluate factors affecting the profitability of hospice in the context of a study of for-profit (FP) / not-for-profit (NFP) care. Study Design: We evaluated data from the California Office of Statewide Health Planning and Development 2003 Annual hospice survey, including cost reports. We evaluated as outcomes revenues, costs, and profits, as well as the intensity and skill mix of care, and the provision of charitable and special palliative services. To evaluate the influence of length of stay (LOS), we evaluated all outcomes on a per patient and per patient day basis. We estimated regression-adjusted differences in these outcomes by profit status, controlling for other organizational features and aggregate patient characteristics. Population Studied: 185 operational hospices Principal Findings: Hospices reported median revenue of $6865 / patient and $138 / patient-day (FP vs. NFP difference = -$20, p=0.045), median cost of $6737 / patient, and $135 / patient-day (difference = -$55, p=0.002), and median pre-tax profit of $334 / patient and $6 / patient-day (difference = $34 , p=0.026). Patients received a median of 29.9 visits / patient (difference = 8.8 visits, p=0.010), but there was no difference / patient-day. A median of 50.8% of all nursing visits were skilled (difference = -14.1%, p NFP (p=0.002). The proportion of non-cancer patients was associated with long term care referral, but in multivariate analysis, only the proportion of non-cancer diagnoses was independently associated with LOS (25th-75th percentile difference of 7.11 days, p=0.004). Few hospices provided charity care, and only 4% of hospices reported expenditures on chemotherapy and only 9% on radiation therapy. Conclusions: Overall hospice profitability is low, but FPs are more profitable than NFPs. Few hospices provide charitable care or special costly services. LOS is strongly associated with financial performance, and greater FP profitability is related to lower costs. FP hospices also provide less skilled care. Implications for Policy, Delivery, or Practice: Our findings raise the issue of how to improve access to hospice care for non-cancer patients while containing Medicare's hospice budget due to the longer LOS (and known higher overall costs to Medicare) of these patients. The impact of FP-NFP differences will require quality measures to understand the impact of these differences on patients, their caregivers, and the healthcare system. Primary Funding Source: No Funding Call for Panels Assessing the Value of Performance Measurement from Different Perspectives Chair: Irma Mebane-Sims, Joint Commission on Accreditation of Healthcare Organizations Sunday, June 25 • 3:45 pm – 5:15 pm Panel Overview: Nationally standardized performance measurement has become an integral component in the drive toward health care quality improvement. Hospital performance measures, developed by the Joint Commission on Accreditation for Healthcare Organizations and the Centers for Medicare and Medicaid Services, have been adopted by the Hospital Quality Alliance, become key components of the accreditation process and are now used in a wide variety of public and private programs that link financial incentives to the quality of patient care. It is important to evaluate both the utility and impact of these measures in a variety of contexts. Among the questions that should be addressed: How are these measures perceived by the hospitals that implement them? To what extent is the perception of the value of these measures linked to improvement actions undertaken? How do standardized performance measures compare with other indicators of hospital quality and patient mortality? And to what extent will quality incentive payments and public recognition relate to improvements in the quality of patient care? This panel will provide a variety of quantitative and qualitative perspectives to address these questions, as well as their implications for health care policy. ●Influence of Perceptions About Performance Measurement on Actions Taken to Improve the Quality of Patient Care Irma Mebane-Sims, Ph.D., Scott C Williams, PsyD, Stephen P Schmaltz, Ph.D., Richard G Koss, MA, Jerod M Loeb, Ph.D. Presented By: Irma Mebane-Sims, Ph.D., Associate Project Director, Division of Research, Joint Commission on Accreditation of Healthcare Organizations, 1 Renaissance Blvd, Oakbrook Terrace, IL 60181; Tel: 630.792.5981; Fax: 630.792.4981; Email: imebanesims@jcaho.org Research Objective: The Joint Commission requires accredited hospitals to collect core performance measurement data in any 3 of 5 areas: Acute myocardial infarction, AMI; heart failure; pneumonia; pregnancy and related conditions; and surgical infection prevention. A subset of these measures have been adopted by the Hospital Quality Alliance. The goal of this project was to assess how perceptions about the measures influence actions taken to improve quality. Study Design: Nearly 2000 hospitals accredited by Joint Commission were invited in 2005 to participate in a survey on the usefulness of performance measurement for quality improvement purposes. They were also asked about actions taken at their hospital in response to performance measurement data. In-person interviews were conducted with a subset of responders in 2006. Population Studied: Approximately 600 completed surveys were received. No significant differences were observed in survey responder/nonresponder hospitals in terms of urban/rural, bedsize and teaching/nonteaching. Not-forprofits were more likely to respond than for-profit and government-owned facilities. Some regional differences were seen -- a higher response rate in Mid-Atlantic states and a lower one in East-SouthCentral states. Quality Assurance Officers were interviewed in-depth at 40 hospitals. Principal Findings: Preliminary results indicate that the AMI, heart failure, pneumonia and surgical infection prevention measure sets were viewed as being useful for generating good questions about the quality of care--High/VeryHigh: 62.3%, 77.2%, 77.1%, and 75.1%, respectively; for identifying opportunities for improving hospital processes/outcomes-High/VeryHigh: 64.9%, 80.6%, 79.5%, 75.1%, respectively; and for identifying areas with the greatest potential for positive improvement--High/VeryHigh 59.5%, 73.3%, 73.4%, 71.1%, respectively. The pregnancy measures were perceived as being less useful for generating good questions about the quality of care, identifying opportunities for improvement, and identifying areas with the greatest potential for improvement-VeryLow/Low: 60.6%, 60.6%, 64.1%, respectivly. Correlations between how well hospitals performed on the measures and perceived value were not significant. The most common improvement actions taken by hospitals in response to AMI, heart failure and pneumonia measure data were: staff education--implemented by 88%-97% of responders; development/enforcement of clinical pathways/practice guidelines--75%-87%; development/modification of existing hospital processes--77%-91%; development/revision of documentation systems--73%-95%; development of preprinted order sets--75%-88%; and communication/dissemination of core performance measures results--94%-97%. Fewer of these improvement actions were undertaken in response to surgical infection prevention--44%, 24%, 40%, 32%, 23%, 44%, respectively, and pregnancy measures--13%, 5%, 6%, 5%, 4%, 22%, respectively. Conclusions: Preliminary analysis suggests a relationship between the perceived value of measure sets and the implementation of a variety of quality improvement actions. Further analysis of the impact of the improvement actions on measure rates is indicated. Implications for Policy, Delivery, or Practice: A better understanding of the impact of perception on behavior may lead to the development of ways to improve scores for performance measures and, ultimately, the quality of patient care. Primary Funding Source: AHRQ ●Choosing Low Mortality Hospitals: How Does the Hospital Quality Alliance Program Compare to Other Quality Metrics? Ashish Jha, M.D., M.P.H., E John Orav, Ph.D., Zhonghe Li, MA, Arnold Epstein, M.D., MA Presented By: Ashish Jha, M.D., M.P.H., Assistant Professor of Health Policy, Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115; Tel: 617.432.5551; Fax: 617.432.4494; Email: ajha@hsph.harvard.edu Research Objective: The Hospital Quality Alliance, HQA, program is the first national program to report publicly on the quality of hospital care. We sought to determine how the HQA program compares with other publicly available hospital rating programs and how effectively it identifies low mortality hospitals. Study Design: We calculated the HQA summary score for process-based quality indicators for acute myocardial infarction, AMI; congestive heart failure, CHF; and pneumonia for each hospital and examined its relationship with three other metrics of hospital quality: reporting to Leapfrog; being named a top hospital by the U.S. News and World Report ranking program; and being a teaching hospital. We also examined the relationship between performance and the four quality markers; HQA, Leapfrog reports, U.S. News and World Report rank, and hospital teaching status, and risk-adjusted mortality. Population Studied: Quality metrics were calculated for all acute-care hospitals for whom the data were available. Riskadjusted mortality rates were calculated among fee for service Medicare enrollees greater than or equal to 65 years. Mortality analyses were carried out for each clinical condition; AMI, CHF and pneumonia. Principal Findings: There were 3,720 hospitals that reported sufficient data to the HQA program to allow generation of at least one HQA summary score. Significantly higher HQAbased performance on AMI and CHF, but not pneumonia, was found among hospitals that reported data to the Leapfrog Group, hospitals that were highly ranked by U.S. News and World Report, and teaching hospitals. Patients treated at hospitals that were in the top quartile of performance on the HQA indicators had 11% lower odds of dying from AMI, 95% confidence interval, CI, 0.85 to 0.94, p<0.001; 7% lower odds of dying from CHF, 95% CI 0.88 to 0.98, p=0.006; and 15% lower odds of dying from pneumonia, 95% CI 0.81 to 0.89, p<0.001 than patients treated at hospitals in the bottom quartile of performance. Similarly, patients treated at hospitals that reported to Leapfrog had 5% to 12% lower odds of dying depending on the condition, p<0.05 for each, than those that did not, while patients in the U.S. News hospitals had 18% o 25% lower odds of dying, p<0.001 for each, than those in hospitals not ranked by U.S. News. Teaching hospital status was not associated with lower mortality rates for any of the three conditions. Conclusions: Patients choosing hospitals based on the ratings in the Leapfrog program, U.S. News rakings, or on teaching status will identify hospitals with better process quality. Patients that are treated at hospitals that perform well on the HQA program, U.S. News rankings or report data to the Leapfrog Group have lower odds of dying. Implications for Policy, Delivery, or Practice: Publicly available programs that rate hospital quality can aid patients, payers, and policymakers identify hospitals with better outcomes. Primary Funding Source: CWF ●Financial Incentives Work! Results from the CMS Hospital Quality Incentive Demonstration Project, Year 1 Denise Remus, Ph.D. Presented By: Denise Remus, Ph.D., Vice President, Clinical Informatics, Clinical Informatics, Premier, Inc, 404 West Greenbriar LA, Dallas, TX 75208; Tel: 214.212.7774; Fax: 704.733.5634; Email: Denise_Remus@Premierinc.com Research Objective: The CMS/Premier Hospital Quality Incentive Demonstration, HQID, project was set up to examine the following question: Can economic incentives effectively improve quality of care? Study Design: The study design is observational using both prospective and retrospective components; participants were self-selected and all had to be enrolled in the Premier PerspectiveTM database. Population Studied: All adult patient (age > 18) admissions to participating hospitals with any of four clinical conditions: acute myocardial infarction (AMI), heart failure, pneumonia and coronary artery bypass graft, CABG, procedures; and all Medicare patients, primary or secondary payer = Medicare, admitted for hip or knee replacement procedures. Principal Findings: The HQID uses data from individual quality measures, within each clinical area, to create an aggregate score or the Composite Quality Score, CQS, representing overall quality. The project incorporates both process; e.g., ASA on admission, oxygen assessment, and outcome measures; e.g., mortality, readmissions; 33 total for Year 1, across the five areas. Analyses of final validated data from Year 1 identified statistically significant improvements; all p < 0.001 from the first quarter of the project, Q4-03 to the fourth quarter of the project, Q3-04 in the CQS in all five clinical areas. Hospitals were placed in deciles based on CQS and the top 10% of hospitals, in each clinical area, received a 2% quality incentive payment from Medicare; the next 10% received a 1% bonus; $8.85 million was awarded to 123 top performers in year 1. The top 50% received public recognition. HQID participant data was compared to data of nonparticipating hospitals from Hospital Compare for the time period of Q2-04 to Q1-05 for the 17 process measures similar across the two projects. Preliminary analyses found that the average measure rate, percent of patients receiving intervention, was significantly higher, p < 0.001 for HQID participants compared to non-participants in 10 measures; significantly higher p < 0.05 in 2 measures; higher, but not significant, rates in 3 measures; lower, but not significant, rates in 2 measures; and significantly higher, p < 0.001 overall composite process score; 82.2% vs 73.2%. HQID n=259, Hospital Compare n=3303, limited to measure denominators > 24 cases. Preliminary data from Year 2 demonstrates continued improvement. Additional results will be presented including analysis of CQS by hospital characteristics and further evaluation of Year 2 data Conclusions: The HQID project, incorporating both quality incentive payments and public recognition, resulted in statistically significant improvements in the first year of the project and, for the majority of comparative measures, average rates significantly higher than a national sample of publicly reported data. Implications for Policy, Delivery, or Practice: The demonstration project has two more years of data to report, however initial findings based on performance in Year 1 indicate that financial incentives, along with public recognition, resulted in statistically significant improvement in quality as measured by CQS in five clinical areas. While additional research is necessary to examine other factors associated with the overall improvement, the preliminary data supports efforts to link financial payments to quality. Primary Funding Source: CMS, Premier, Inc Call for Panels How You Count is What You Get: Measuring Hospital Adverse Events Using Incident Reports, Patient Surveys, and Chart Reviews Chair: Joel Weissman, Institute for Health Policy, Massachusetts General Hospital Sunday, June 25 • 3:45 pm – 5:15 pm Panel Overview: This panel will include reports of research based on work from a collaborative federal grant to improve reporting and disclosing of medical errors in Massachusetts hospitals. Two papers will address the use of patient reports of adverse events. Based on a survey of about 2500 recently hospitalized patients from 16 hospitals, one paper will describe the frequency and type of adverse events as reported by discharged patients, and discuss the challenges in collecting medical data from patients. A second paper will compare the results from the survey with the results from a medical chart review. The chart review used methods similar to that of the original Harvard Practice Study on medical errors and malpractice. This is the first study to our knowledge to examine the concordance of patient-reported events with those found via traditional chart review. A third paper in the panel will examine data from the Massachusetts public reporting system, and assess its comparability with the reporting of “never-events” from the NQF. ●What do Patients Know that Hospitals Might Not? A Comparison of Adverse Events using Patient Reports and Chart Reviews Joel Weissman, Ph.D., Eric Schneider, M.D., MSc, Arnold Epstein, M.D., MA, Floyd Fowler, Ph.D., Catherine Annas, JD, Leslie Kirle, M.P.H. Presented By: Joel Weissman, Ph.D., Associate Professor, Institute for Health Policy, MGH/Harvard, 50 Staniford Street, 9th floor, Boston, MA 02114; Tel: (617)724-4731; Email: jweissman@partners.org Research Objective: To compare the frequency and concordance of patient reports of hospital adverse events (AEs) with adverse events discovered by medical record reviews. Study Design: A probability sample of recently hospitalized patients in 16 Massachusetts hospitals were interviewed by telephone to ask them to report on complications and “negative effects” from treatment that occurred during their hospital stay. A physician and nurse confirmed whether the events were injuries that could reasonably be attributed to medical care management, and then classified them into one of 19 categories of AEs. Trained nurses reviewed the same patients’ hospital medical records and likewise grouped AEs into the same 19 categories. Population Studied: We interviewed 2582 patients, 18 or older, hospitalized for medical/surgical care in Massachusetts between April 1, 2003 and October 1, 2003, who were discharged alive. Of these respondents, 998 verbally agreed to a review of their hospital medical records and mailed in a signed authorization, and hospital staff were able to locate the record. Principal Findings: Of the 998 study patients, 221 patients reported a total of 272 AEs, compared with 124 patients with 156 AEs found via chart review, resulting in 78% agreement. Although there is no single best source of medical error data, using hospital medical records as a “gold standard” yielded the following results for the use of patient report as a measure of the occurrence of an adverse event: Sensitivity = 61 / 124 = 49.2%; Specificity= 714 / 874 = 81.7%; Positive Predictive Value = 61 / 221 = 27.6%; ; Negative Predictive Value = 714 / 777 = 91.9%. The relative frequency of AE types was similar. Approximately 54% of patient-reported events were adverse drug events, compared with 50% from chart review. Likewise, 8% of patient-reported events were post-operative wound infections, compared with 11% from charts. After preliminary review, nurses searched the record for events reported by patients. Approximately 1/3 of all patient-reported events were identified post-hoc, but these events did not satisfy the clinical criteria established for nurses to record an event. No evidence was found in the chart for about ½ of patient-reported events. Conclusions: Agreement between patient reports and chartbased adverse events is moderate, although some of the disagreement is due to strict clinical criteria used in chart review. Patients identified many more events than were found by nurses conducting medical record review. If a patient reported no problems there was unlikely to be an injury documented in the charts. Implications for Policy, Delivery, or Practice: Until now, patients have been an under-utilized source of information on the occurrence of adverse events in hospitals. As with other survey tools that rely on patients to report on their medical experiences, in the future hospitals might consider postdischarge patient surveys as a tool for identifying adverse events that are not routinely available from medical records. Such an approach may prove to be a cost-effective method for screening cases for further investigation for quality problems. Primary Funding Source: AHRQ ●Patient Reports of Adverse Events While Hospitalized in Massachusetts Dragana Bolcic-Jankovic, MA, Floyd Fowler, Ph.D., Brian R. Clarridge, Ph.D., Eric C. Schneider, M.D., M.Sc., Catherine Annas, J.D., Joel S. Weissman, Ph.D. Presented By: Dragana Bolcic-Jankovic, MA, Assistant Study Director, Center for Survey Research, UMass-Boston, 100 Morrissey Boulevard, Boston, MA 02125; Tel: (617) 287-7200; Fax: (617) 287-7210; Email: dragana.bjankovic@umb.edu Research Objective: To describe the types of adverse events that patients report during recent hospitalizations and to examine the correlates of those events. Study Design: A probability sample of hospitalized patients in Massachusetts was interviewed by telephone. They were asked about adverse experiences that occurred during a recent hospital stay. Their reports were then reviewed by specially trained physicians to confirm that they were events that could reasonably be attributed to procedures, tests and care received in the hospital. Population Studied: 2582 adults, 18 or older, hospitalized for medical or surgical care (excluding maternity care) in a Massachusetts hospital between April 1, 2003 and October 1, 2003 who were discharged alive to a private residence in Massachusetts Principal Findings: Of the 2582 patients who were interviewed (~57% response rate), about 25 percent reported an adverse event that physician reviewers confirmed could reasonably be attributed to tests, treatments, procedures or hospital care. The most common type of report was an adverse reaction to drugs; injuries to nerves, blood vessels or organs were a distant second. Those who were given medications, had surgery, or spent time in ICUs were significantly more likely than average to report an adverse event. Gender and age were related to the likelihood of an adverse event (women and younger patients had more), but race and self-rated health status were not. About a third of the events reported were still said to be having an effect on patients’ lives at the time of the interview. Patients believed about half of the events were potentially preventable; the physician raters estimated more than a third were preventable. Conclusions: A significant number of patients say they experience adverse events as a result of the care they receive in hospitals, with reactions to new drugs being by far the most common. Many of these adverse events have long-lasting effects on patients. While the majority of these events, in the opinion of the patients, could not reasonably have been prevented, nearly as many think they could be prevented. In the majority of those instances, physician reviewers agree. Implications for Policy, Delivery, or Practice: Patients are rarely utilized as reporters of adverse events during hospital stays. Their voices should be heard in the effort to identify and reduce negative outcomes and medical errors. Primary Funding Source: AHRQ ●Public Reporting on Patient Safety by Acute Care Hospitals: Assessing the New National Quality Forum (NQF) ‘Never Event’ Standard Eric Schneider, M.D., MSc, Joel S. Weissman, Ph.D., Catherine Annas, J.D., Nancy Ridley, M.S., Arnold Epstein, M.D., M.A., , Presented By: Eric Schneider, M.D., MSc, Assistant Professor, Health Policy and Management, Harvard School of Public Health, 677 Huntington Avenue, #406, Boston, MA 02115; Tel: 617-432-3124; Fax: 617-432-4494; Email: eschneid@hsph.harvard.edu Research Objective: The Institute of Medicine has recommended that states establish reporting systems for serious incidents that occur in acute care hospitals, but states differ on the types of incidents considered reportable. To standardize reporting, the National Quality Forum (NQF) defined 27 never events: specific types of safety incidents that are preventable and serious enough that hospitals should report them to a state agency for disclosure to the public. Since 1986, the Massachusetts Department of Public Health DPH has required hospital reporting of serious incidents. Our objective was to evaluate the proportion of serious incidents reported by Massachusetts hospitals that fulfill the NQF never event criteria. Study Design: In this observational study, key data elements from the DPH database were abstracted from a sample of serious incident reports submitted by hospitals. Trained reviewers attempted to match each abstracted incident to an NQF-defined category. With these data, we assessed the prevalence of NQF never events among all serious incident reports and compared the characteristics of the NQF and nonNQF incidents, including the severity of injury, contributing factors, agency disposition, and corrective actions. Population Studied: A stratified, random sample of 762 serious incident reports submitted by 72 acute care hospitals in Massachusetts during 1999-2004. Principal Findings: Most of the serious incidents reported to the state involved serious injury with 20% judged fatal or life threatening, 58% judged serious, and 21% judged significant. The most common types of incidents were patient protection events (52%), surgical and procedure-related events (12%), care management events (7%), hospital environment events (4%), and product or device events (1%). Twenty-three percent of events were serious but did not fit one of these categories. Approximately one third of the incidents reported to DPH matched at least one NQF-defined never event. The matching within event categories was highly variable. The most common matches were for surgical and procedurerelated events, care management events, and product or device events. In contrast, patient protection events reported to DPH matched the NQF-defined never events much less frequently. Conclusions: The NQF “never events” define a relatively narrow set of patient safety incidents that occur in hospitals and have been reported in Massachusetts. Implications for Policy, Delivery, or Practice: Adopting the National Quality Forum standard for patient safety reporting might enhance comparability across state reporting systems, but would exclude serious incidents currently of interest to at least some states. Potentially, the NQF list could be expanded to include some of the types of serious incidents that have been reported in Massachusetts. Primary Funding Source: AHRQ, Call for Panels Prescription Benefits, Use, Spending, and Outcomes in the Elderly: Implications for Medicare Part D Chair: Jalpa Doshi, University of Pennsylvania Sunday, June 25 • 5:45 pm – 7:15 pm Panel Overview: With the implementation of Medicare Part D on January 1, 2006, researchers and policymakers are concerned about how the new program will affect different groups of Medicare beneficiaries. This panel presents a series of empirical papers which evaluate various aspects of the drug benefit and have direct implications for what may be observed under Part D. The first paper evaluates whether providing drug coverage itself will be sufficient to improve medication therapy patterns in Medicare beneficiaries with diabetes. The next paper evaluates price and substitution effects of multi-tiered copayment formularies, which have been widely used by Part D prescription drug plans. The third and fourth papers evaluate the impact of Part D and gaps in drug coverage, respectively, on prescription utilization and spending in Medicare beneficiaries with mental illness, a medically vulnerable group that most policy makers have been concerned about. The last paper complements the other panel papers on drug use and spending by evaluating how cost-sharing increases, which some beneficiaries will face under Part D, impact health outcomes using the example of blood pressure control in elderly veterans. ●Disease Burden and the Intensity of Medication Therapy for Medicare Beneficiaries with Diabetes: Will Part D Make a Difference? Bruce Stuart, Ph.D., Thomas Shaffer, MHS, Linda SimoniWastila, RPH, Ph.D., Ilene Zuckerman, PharmD, Ph.D. Presented By: Bruce Stuart, Ph.D., Professor, Peter Lamy Center, University of Maryland Baltimore, 515 West Lombard Street, Room 157, Baltimore, MD 21201; Tel: (410) 706-5389; Fax: (410) 706-1488; Email: bstuart@rx.umaryland.edu Research Objective: Guidelines for treating diabetes emphasize the need to maintain glycemic control and to take preventive measure to avoid hypertension, hyperlipidemia, and common infections like influenza and pneumonia. Medicare already covers flu shots and pneumonia vaccinations, but coverage for blood glucose regulators, antihypertensive agents, and lipid lowering agents has not been universally available until this year under the MMA. This paper is intended to assess the potential impact of Part D coverage on Medicare beneficiaries with diabetes taking into account the difficulties of managing diabetes for beneficiaries with significant disease burden. Study Design: This study categorized a national sample of Medicare beneficiaries with diabetes into 10 mutuallyexclusive, equal-sized groups based on their cumulative medical spending in 2001 (a proxy for disease burden). We then computed the prevalence and annual utilization rates within each group for 6 drug categories recommended for treatment of diabetes (blood glucose regulators, dyslipidemics, ACE-inhibitors, other antihypertensive agents, annual flu shot, and pneumonia vaccination in the past 5 years). Group-specific robust regression models were estimated for each drug class. Explanatory variables included domains for demographic characteristics, income, drug coverage, health status, and medical encounters. Chow tests for significant differences in coefficient values across the 10 groups were conducted to identify the differential impact of disease burden on factors predictive of the prevalence and intensity of drug use. Population Studied: 1,746 elderly and disabled Medicare beneficiaries with 2 or more paid claims indicating diabetes (ICD-9=250.xx, 357.2, 362.00-362.02, 366.41) in 2001 drawn from community-dwelling respondents in the 2001 Medicare Current Beneficiary Survey weighted to be nationally representative. Principal Findings: Annual population prevalence rates for the 6 drug categories ranged from a low of 42% for dyslipidemics to a high of 86% for antihypertensive agents. The lowest prevalence rates were found in the groups with the least disease burden. For 4 of the 6 drugs (blood glucose regulators, dyslipidemics, flu shots and pneumonia vaccinations) prevalence rates increased with disease burden but then sharply declined in the top two groups. A similar inverted “U” shape pattern was observed in the annual utilization rates for the 4 chronic care drug categories. Preliminary analysis indicates that these patterns are not significantly reduced by adjustments for demographics, income, drug coverage, and health status, but are highly sensitive to medical encounters, particularly the number of different physicians seen in the year. Conclusions: Medicare beneficiaries with diabetes receive suboptimal treatment for recommended drug therapies particularly among those with minimal or significant disease burdens (the highest prevalence rates and intensity of treatment were found in the middle of the range of disease burden). Implications for Policy, Delivery, or Practice: Our analysis indicates that expanded prescription coverage under the Medicare Part D drug benefit is unlikely to significantly improve medication therapy patterns for Medicare beneficiaries with diabetes. However, changes in disease management programs that may be associated with the new benefit may prove beneficial. Primary Funding Source: CWF ●Decomposing the Price and Substitution Effects Under Multi-Tiered Drug Copayment Programs Boyd Gilman, Ph.D., John Kautter, Ph.D. Presented By: Boyd Gilman, Ph.D., Senior Economist, Division for Health Services and Social Policy Research, RTI International, 411 Waverley Oaks Road Suite 330, Waltham, MA 02452; Tel: (781) 434-1718; Fax: (781) 434-1700; Email: bgilman@rti.org Research Objective: Tiered copayments are one of the most commonly used cost containment tools and are being widely used by private plans under the new Medicare Part D benefit. Copayments are designed to achieve two goals. First, by increasing the cost of all drugs paid by the enrollee, tiered copayments are design to promote a more efficient use of prescription medications and control plan spending. Second, by increasing the cost differential between brand named drugs and generics (or between preferred and non-preferred brand named drugs), tiered copayments are designed to encourage the substitution of cheaper drugs for more expensive equivalents. The purpose of this study is to decompose the overall impact of tiered copayments on drug utilization and spending into its price and substitution effects. Study Design: The study uses data from the 2002 MarketScan Medicare Supplemental and Benefit Plan Design Databases. Pharmacy claims for 400,000 retirees were merged with drug benefit design information for 24 employersponsored health plans. Plans were classified into 1-, 2- and 3tiered copayment groups. The price effect was estimated using the lowest plan copayment amount. The substitution effect was estimated using the mean copayment differential between tiers. Model covariates included demographic, health status, and medical plan characteristics. The models were estimated over all enrollees and enrollees with chronic conditions separately. Population Studied: Medicare beneficiaries with employersponsored drug coverage and their dependents. Principal Findings: A $5 increase in the lowest copayment amount resulted in an 8.8% decline in the number of prescriptions filled, a $1.2 decrease in total payments, a $154 increase in enrollee payments, and a 10.9% reduction in the number of prescriptions filled with generics. A $5 increase in the differential between the lowest and highest copayment amounts resulted in a 6.1% decline in the number of prescriptions filled, a $5.4 increase in total payments, an $18.5 increase in enrollee payments, and a 3.3% increase in the number of prescriptions filled with generics. All results were statistically significant at the 5% level or higher, except for the increase in total payment price effect. Conclusions: Both the price and substitution incentives under tiered copayments result in a lower number of prescriptions filled and higher out-of-pocket expenditures. However, by achieving these results through the substitution of cheaper generics or preferred brand named drugs for more expensive drug equivalents, the copayment differential incentive has a less deleterious effect on drug use than the copayment price incentive. Implications for Policy, Delivery, or Practice: Medicare retirees are sensitive to enrollee copayments in terms of both the quantity and type of medications used. By relying more on the cost differential between generic and brand named drug equivalents (rather than the price amount of all drug equivalents) to control risk, prescription drug plans can help reduce the potentially deleterious effect of cost containment on access to necessary medications. Primary Funding Source: No Funding ●Economic Implications of Medicare Part D for Persons with Mental Illness Dennis Shea, Ph.D., Linda Simoni-Wastila, Ph.D., Karen Volmar, M.P.H./J.D., Matthew Guldin, M.P.H. Presented By: Dennis Shea, Ph.D., Department Head and Professor, Health Policy and Administration, Penn State, 116 Henderson Building, University Park, PA 16802; Tel: 814-8632901; Fax: 814-863-2905; Email: dgshea@psu.edu Research Objective: This project examines the impact of Medicare Part D on drug coverage, utilization and spending among Medicare beneficiaries with mental illnesses. Study Design: The study includes a detailed literature review of the mental health economic issues in prescription drug coverage and use and an economic microsimulation of effects. Information from the literature review is applied to the microsimulation model to estimate the impact of subsidized drug coverage on enrollment by beneficiaries and the impact of coverage changes coverage on total spending and out-ofpocket costs in total and among important subgroups. Population Studied: The sample is drawn from individuals in the 2000 Medicare Current Beneficiary Survey who self-report or have a claim for a mental illness. Data for these individuals is projected to a 2006 baseline and the effects of Medicare Part D are simulated. Principal Findings: Medicare beneficiaries with mental illness, in some ways, had better drug coverage than the typical Medicare beneficiaries prior to Medicare Part D, due primarily to Medicaid. More than 60% had full-year coverage, and fewer than 1 in 5 had no drug coverage. Despite having higher total spending, they had lower out-of-pocket spending. Medicaid dual eligibles are generally protected from high costs through the low-income subsidies, although formularies may be a concern. Approximately one-fifth of Medicare beneficiaries with a mental illness face far larger challenges. These individuals are primarily work disabled with coverage through a family member or retired with employer coverage. Nearly half of this group has spending above the doughnut hole and could face increases in out-of-pocket costs of 10 to 20 percent if employers adopt standard plans. About 10 percent of Medicare beneficiaries with a mental illness had prior coverage with an HMO, Medigap plan, or state pharmaceutical assistance plan. The impact of Medicare Part D for this group, as well as for those without any prior coverage, hinges on their income. Those with modest incomes maintain or improve their current protection from high drug costs, but those with incomes above 150 percent of the poverty line will struggle with premium and cost-sharing. Conclusions: The impact of Medicare Part D on mentally ill Medicare beneficiaries depends primarily on prior coverage and income levels. The majority of such beneficiaries will find coverage maintained or improved; however, significant pockets among those with private sources of coverage or no prior coverage will not find their circumstances improved substantially. A minority, representing as much as 10 to 20 percent of Medicare beneficiaries with a mental illness, will find their coverage eroded. Implications for Policy, Delivery, or Practice: As policymakers and others implement Medicare Part D, careful attention should be paid to Medicare beneficiaries with a mental illness. In the initial phases, individuals with prior private coverage or no prior coverage may provide the greatest implementation challenges. In the longer term, the formulary and other care management issues will impact the large group of Medicaid dual eligible beneficiaries with a mental illness. Primary Funding Source: SAMHSA and Commonwealth Fund ●Drug Use in Severely Mentally Ill Medicare Beneficiaries: Impact of Discontinuities in Drug Coverage Ilene Zuckerman, PharmD, Ph.D., Linda Simoni-Wastila, BSPharm, Ph.D., Christopher Blanchette, MS, Bruce Stuart, Ph.D. Presented By: Ilene Zuckerman, PharmD, Ph.D., Associate Professor, Lamy Center on Drug Therapy and Aging, University of Maryland Baltimore, 515 West Lombard Street, 1st Floor, Baltimore, MD 21201; Tel: (410) 706-3266; Fax: (410) 706-1488; Email: izuckerm@rx.umaryland.edu Research Objective: The purpose of this study is twofold: To 1) describe the extent of drug benefits possessed by severely mentally ill Medicare beneficiaries and 2) determine how gaps in drug benefits influence use of prescription medications used to treat mental illness. Study Design: This study uses an observational cohort analysis using ordinary least squares regression, adjusting for sociodemographics, health status, comorbidities, and death. The primary outcome measures are total mental health drug, antidepressant and antipsychotic utilization, assessed as total counts of drugs used over 3 years. Gaps in drug benefits are measured as proportion of months not covered over three years, and reported categorically (0 gaps (full drug coverage), 1-24% gaps, 25-49% gaps, 50-74% gaps, 75-99% gaps, and 100% gaps (no coverage). Outcome and drug coverage gap measures are annualized, and account for time lost to death and loss-to-follow-up. Population Studied: The population studied is a pooled sample of three, 3-year cohorts of community-dwelling, severely mentally ill disabled and aged Medicare beneficiaries derived from the 1997 - 2001 Medicare Current Beneficiary Survey. Severe mental illness is assessed based on the existence of 2 or more relevant ICD-9 codes extracted from Part A and B claims. Principal Findings: Among our sample representing over 2.5 million SMI beneficiaries, over half (54.4%) had full drug coverage and 18.9% had no coverage. Controlling for sociodemographic and clinical confounders, beneficiaries with drug coverage gaps received 2.2 to 3.8 fewer mental health drugs annually than their fully covered peers, with those experiencing a 25-49%, 75-99% and 100% drug coverage gaps impacted the most severely (-3.7, -3.8, and -3.7 prescriptions, respectively). Drug coverage gaps involving the antipsychotics followed a similar pattern, while antidepressant use was not as dramatically impacted. Among antidepressant users, only those experiencing 50-74% and 100% coverage gaps receiving significantly fewer antidepressants annually (-1.3 and -1.7, respectively). Conclusions: This study is the first to demonstrate that any discontinuity in drug benefits can adversely impact use of mental health drugs in severely mentally ill Medicare beneficiaries. Because such coverage gaps in drug coverage are possible under the Medicare Modernization Act's "doughnut hole" design, this study provides an important first glimpse at what might happen to severely mentally ill individuals who enroll in the Part D plan. Such reductions in utilization of these important medications for this frail population may lead to adverse consequences, including symptom breakthrough, impaired cognitive function, and even mortality. Implications for Policy, Delivery, or Practice: As state and Federal policy-makers implement and evaluate the Part D component of the Medicare Modernization Act, further scrutiny of its impact on this medically vulnerable group is warranted. Further research is needed to examine outcomes associated with disruptions in pharmacologic treatment. Primary Funding Source: RWJF ●Impact of a Prescription Copayment Increase on Blood Pressure in Elderly Patients Jalpa Doshi, Ph.D., Bruce Y. Lee, M.D., MBA, Kevin G. Volpp, M.D., Ph.D. Presented By: Jalpa Doshi, Ph.D., Research Assistant Professor, Division of General Internal Medicine, University of Pennsylvania, 1222 Blockley Hall, Philadelphia, PA 19104; Tel: 215-898-7989; Fax: 215-898-0611; Email: jdoshi@mail.med.upenn.edu Research Objective: Medicaid dual eligibles in many states will pay higher prescription copayments under the new Medicare Part D than they paid under their state Medicaid programs. Near poor beneficiaries previously enrolled in state pharmacy assistance programs which have been abandoned in light of Part D may also face cost-sharing increases. Numerous studies suggest that small prescription copayment increases significantly reduce medication use, particularly within low income populations. However, little research has examined how copayment increases impact health outcomes. In February 2002, the Veterans Administration (VA) increased prescription co-payments from $2 to $7 for many veterans. This study takes advantage of this policy change and availability of electronic medical records in the VA system to examine how prescription copayment increases impact blood pressure (BP) among elderly patients of different income levels. Study Design: The study used VA medical records to examine antihypertensive medication use and BP during the 24-months pre- and post- copayment increase. Veterans with serviceconnected disabilities rated 50 percent or greater, and those with income below the VA pension level remained copay exempt and were a natural control group. However, given substantial differences in baseline characteristics and health trajectories of the two groups, we used a difference in difference (D-in-D) approach to compare changes in BP across patients of different income levels among elderly veterans who were subject to the copayment increase. Patient household income was derived from zip-code matched census data. D-in-D multivariate regressions examined changes in the days supply of antihypertensive prescriptions, mean systolic BP (SBP), and likelihood of SBP > 140 mm Hg following copayment increase across income quartiles (Q1: <=$37,959; Q2: $37,960 –$50,206; Q3: $50,207 – $60,000; Q4: >=$60,001). Patients in the highest income quartile were the reference group. Subgroup analyses were conducted among elderly patients with and without coronary artery disease(CAD) or diabetes. Population Studied: Veterans from the Philadelphia VA Medical Center who were aged >= 65 years and used antihypertensive medications in the pre-period and had BP readings in the pre- and post-periods(n=4,433). Principal Findings: Elderly patients in the lowest income quartile had, on average, a 1.9 mm Hg increase in mean SBP between the pre- and post-periods compared to decreases of 1.1 in the second quartile, 1.7 in the third quartile, and 1.7 in the highest income quartile. D-in-D multivariate regressions confirmed significant differences between the lowest and highest income quartile in terms of antihypertensive days supply [Q1*Post: - 31 days, p<0.001], mean SBP [Q1*Post: + 3.53 mm Hg, p<0.001], and odds of SBP>140 mm Hg [Q1*Post: OR 1.5; 95% CI (1.1 to 2.0)]. Similar results were observed in both higher-risk patients with and without a history of CAD or diabetes. Conclusions: Our results indicate that increases in medication co-payments may have negatively impacted BP control in lower income elderly veterans, including those at high cardiovascular risk. Implications for Policy, Delivery, or Practice: These findings suggest that the VA co-payment increase may have worsened disparities in cardiovascular outcomes between high and low income elderly veterans. Our findings also have important implications for poor and near poor Medicare beneficiaries who may face cost sharing increases under Part D. It will be critical for policymakers to monitor whether access to effective medications and the health of such seniors is adversely affected. Primary Funding Source: Pennsylvania Department of Health Call for Panels The Impact of Medicaid Program Changes on Low Income Adults: The Oregon Health Plan 18 Months Later Chair: Jeanene Smith, Office for Oregon Health Policy and Research Sunday, June 25 • 5:45 pm – 7:15 pm Panel Overview: This panel will discuss the most recent evidence of the effect of higher premiums and co-payments on a Medicaid population, using three distinct data sources to examine the effects of the 2003 introduction of higher premiums and co-payments on 100,000 members of the Oregon Health Plan (OHP), the Oregon Medicaid program. The three distinct studies are designed to capture perspectives of the OHP cutbacks at the individual level, program level, and system level. The first study, focusing on effects at the individual level, uses a longitudinal survey to collect selfreported data on utilization and health status on individuals who remained on the plan, as well as those who became uninsured when they could not afford the higher monthly premiums. The second study, focusing on the program effects, uses administrative claims data to assess the impact of higher co-payments on OHP enrollees’ cost and utilization. The third study, designed to capture the system-wide effects of the OHP cuts, uses administrative data from a statewide sample of emergency departments. These data provide an insight on the changes in emergency department utilization by payer-mix, allowing for an assessment of the effect of decreases in OHP enrollment on the use of the emergency department by the uninsured. Taken together, the three analyses provide a complete and robust assessment of the impacts of co-payments and premiums on a Medicaid population. ●The Impact Of Cost-Sharing and Benefit Changes On Adult Medicaid Beneficiaries: The Oregon Health Plan Matthew Carlson, Ph.D., Bill Wright, Ph.D., Tina Edlund, MS, Jeanene Smith, M.D., M.P.H. Presented By: Matthew Carlson, Ph.D., Assitant Professor, Department of Sociology, Portland State University, PO Box 751, Portland, OR 97207; Tel: 503-725-9554; Fax: 503-725-3957; Email: carlsonm@pdx.edu Research Objective: In March, 2003, changes were made to the Oregon Health Plan (OHP) including increased premiums and copays, benefit reductions, and a 6-month lockout for non-payment of premiums. In June, 2004 there were additional changes: copays were removed and some benefits reinstated. This prospective cohort study assesses the impact of OHP changes on enrollees’ insurance status, health care access and utilization, medical debt, and health status over the 18-month study period. Study Design: Data come from a prospective cohort study of a subset of OHP beneficiaries who were affected by OHP changes. A baseline, mail-return survey was conducted in October, 2003, 6 months after initial OHP changes were implemented (n=1378, 34% response rate). Twelve months later, a follow-up survey was conducted by mail and telephone (n=991, 72% response rate). Surveys were conducted in English and Spanish. Population Studied: Adults age 19 and older who were enrolled in the OHP for at least thirty days prior to February 15, 2003, just prior to the initial wave of program changes. Principal Findings: Eighteen months after OHP changes were implemented, 37% of the sample maintained continuous enrollment, 18% lost coverage for 1 to 6 months and 46% lost coverage for 6 months or longer. Most who lost coverage (53%) indicated program changes were the main reason. Length of time uninsured was strongly associated with unmet need, medical debt, and health status. For example, the rate of unmet need nearly doubled from 38% to 72% after 3 months without coverage. Rates of medical debt also doubled from 16% to 39% after 3 months without coverage. Selfreported health status significantly declined for those without insurance for more than six months. In this group, the percentage reporting “very good” or “excellent” health declined from 37% to 20% between the baseline and follow-up surveys. By contrast, individuals maintaining continuous coverage reported improved access to care, less financial impact, and stable health status over the 18-month study period. Conclusions: Increased costs and benefit reductions resulted in involuntary loss of coverage for thousands of low-income Oregonians. Most who lost coverage reported having no insurance for more than 6 months of the 18 month study period. Loss of coverage resulted in diminished access to care, increased medical debt, and for many, declining health status. By contrast, reducing cost-sharing and reinstating benefits may have had a positive impact on individuals who maintained coverage. This group reported improved access, reduced financial hardship, and stable health status over the 18-month study period. Implications for Policy, Delivery, or Practice: Even nominal cost sharing can impact Medicaid enrollees’ ability to maintain coverage. This is particularly true for those with very low incomes or the unemployed. Moreover, impacts of coverage loss including poor access, increased debt, and worsening health status dramatically increase after the first 3-6 months without coverage. Policies that promote continuous coverage are essential. In 2006, the OHP will no longer charge premiums for the lowest income beneficiaries (0-10% FPL) and will remove the lock-out period for non-payment of premiums. Primary Funding Source: CWF, Robert Wood Johnson Foundation ●Expenditure and treatment patterns after cost-sharing and benefit reduction in the Oregon Health Plan Neal Wallace, Ph.D., K. John McConnell, Ph.D., Charles A. Gallia, Ph.D. Presented By: Neal Wallace, Ph.D., Assistant Professor, Public Administration, Portland State University, PO Box 751, Portland, OR 97207; Tel: 503-725-8248; Fax: 503-725-8250; Email: nwallace@pdx.edu Research Objective: In response to state budget shortfalls in 2003, the Oregon Health Plan imposed cost-sharing and eliminated some benefits for adult beneficiaries who were not part of the categorically eligible Medicaid population. Copayments were imposed for inpatient care; emergency department use; hospital and individual practitioner ambulatory care; lab and radiology services; and, prescription drugs. Coverage of specialty outpatient treatment for mental health and substance abuse, durable medical equipment and some general medical supplies, eye care and dental services were eliminated. This study estimates the impact of costsharing and benefit reductions on average monthly expenditures, rates of utilization per beneficiary and average expenditures per service user, in total and by service type (inpatient, hospital outpatient, ambulatory professional, lab & radiology, emergency department and pharmaceuticals). Study Design: The study uses a quasi-experimental design with a non-equivalent comparison group. Policy effects are identified as the difference in difference between noncategorically eligible adults affected by the policy change (known as “Standard” beneficiaries) and TANF eligible adults before and after policy implementation. FFS claims, MCO encounter data and monthly enrollment data for Oregon Health Plan beneficiaries were the primary data sources. Only services covered pre- and post- policy were analyzed. Expenditures per claim/encounter were calculated at the average “full” FFS payment rate during the study period (i.e. without reductions for co-pays, third party reimbursement or other adjustments). Subjects were grouped into 61 service areas based on 130 designated primary care service areas in Oregon. Expenditure and utilization measures were calculated for the two eligibility groups, four 6-month study periods and 61 service regions yielding 488 aggregate observations. Fixed effects estimation is used to identify policy impacts. Population Studied: Individuals were included in the study sample if they were from 18-64 years old; had at least 6 months enrollment in each of two 12-month periods before and after the policy; and had at least 3 months enrollment in each of the two 6-month periods within the pre- and postpolicy study periods. This yielded a study sample of 15,200 Standard and 7,540 TANF eligible subjects. Within this sample, 9,999 Standard and 4,548 TANF eligible subjects had complete pharmacy data. Principal Findings: Average expenditures per beneficiary increased by 8% after cost-sharing and benefit reductions were imposed relative to the TANF control group. Hospital inpatient and outpatient expenditures increased and pharmacy expenditures decreased. The percentage of subjects using services in a month dropped overall, and for ambulatory professional services and pharmacy, while increasing for hospital inpatient and outpatient services and lab/radiology services. Expenditures per service user increased overall and for ED and ambulatory professional services, while decreasing for lab/radiology. Conclusions: The imposition of cost-sharing and benefit reductions for low-income adults in the Oregon Health Plan were found to raise expenditures per beneficiary within the remaining covered benefits and shift expenditures and treatment from ambulatory professional services and medications to inpatient and other hospital based services. Implications for Policy, Delivery, or Practice: Cost-sharing and benefit reductions may not provide expected cost-savings when applied to low-income individuals. Primary Funding Source: RWJF ●Changes in Emergency Department Use after Cutbacks in the Oregon Health Plan Robert A. Lowe, M.D., M.P.H., Molly E. Vogt, MA, K. John McConnell, Ph.D., Jeanene Smith, M.D., M.P.H. Presented By: Robert A. Lowe, M.D., M.P.H., Associate Professor, Center for Policy & Research in Emergency Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code CR-114, Portland, OR 97239; Tel: 503-494-7134; Fax: ; Email: lowero@ohsu.edu Research Objective: Although there has been widespread speculation that decreasing public insurance coverage will lead to higher rates of visits to the emergency department (ED) by the uninsured, there is a paucity of information to support this claim. We use a large scale disenrollment of 50,000 Oregon Health Plan (OHP, Oregon’s Medicaid expansion program) beneficiaries over a 3 month period (February 2003 through April 2003) to test this claim. The objective of this study was to measure the effect of the disenrollment on ED visits by uninsured, Medicaid, and privately insured patients. Study Design: Observational study using hospital administrative data. Population Studied: We obtained data from 15 of Oregon’s 59 EDs on all patient visits from 8/1/2001 to 2/28/2005. The 1,648,868 ED visits represent over 40% of all ED visits in the state. We used these datasets to ascertain date of visit, payer class, patient demographics, and clinical information. To avoid confounding by seasonal variation and to avoid data from a period of instability around the time of the cutbacks, we compared payer mix in 2002 versus 2004. We calculated relative risks (RRs) to compare the proportion of patients in a payer category in 2004 versus 2002 – supplementing this quantitative analysis with inspection of trends by month. Principal Findings: In 2002 ED visits by the uninsured averaged 4,704/month. Coinciding with the disenrollment of 50,000 OHP beneficiaries, ED visits by uninsured patients rose abruptly, from 4,637 visits in January 2003 to 6,424 in May 2003. The increase in uninsured visits was sustained, with ED visits by the uninsured averaging 6,819/month in 2004. As a percentage of all visits to the ED, visits by uninsured patients rose from 12.5% of visits in 2002 to 17.3% in 2004 (RR 1.39, 95% CI 1.38-1.40). ED visits by OHP enrollees fell from a mean of 9,440/month in 2002 to 8,942/month in 2004, and the proportion of visits by OHP enrollees fell from 25.0% to 22.7% (RR 0.91, 95% CI 0.900.91). ED visits by commercially insured patients showed a gradual decrease over the study period, falling from 13,027/month in 2002 to 12,183/month in 2004, and the proportion of commercially insured visits fell from 34.5% to 31.0% (RR 0.90, 95% CI 0.89-0.90). Although the admission rate for uninsured ED users was less than for any other payer category, there was a suggestion of increased illness severity among uninsured ED users after the cutbacks, as the admission rate increased from 4.4% to 6.2% (RR 1.41, 95% CI 1.35-1.48). Conclusions: Disenrollment of about 50,000 Oregon Medicaid beneficiaries in 2003 was followed by a 45% increase in uninsured ED visits, more than 25,000 uninsured visits/year, to our sample of 15 hospitals. Implications for Policy, Delivery, or Practice: With cuts in Medicaid programs pending around the nation, we should prepare for substantial increases in ED use by the uninsured. Primary Funding Source: RWJF Call for Panels Do Consumers Behave Differently in a CDHP? Chair: Judith Hibbard, University of Oregon Monday, June 26 • 8:30 am – 10:00 am Panel Overview: Consumer driven health plans are built on a number of assumptions about what will motivate consumers to change how they use care. It is assumed that financial incentives will increase information seeking, cost awareness, and stimulate more cost effective choices. In this panel four studies are presented that explore the validity of these assumptions. Three studies are based on longitudinal data that includes two years of claims data linked with two waves of survey data. Employees from a large manufacturing company who were newly enrolled in a CDHP, as well as employees who chose to stay in a traditional PPO plan are followed for a 2 year period. One study explores the degree to which CDHP enrollees are changing overtime in terms of their information seeking, engagement in health decisions, and if they are taking a more active role in managing their health, as compared to enrollees in a PPO. A second study examines whether these behaviors, (information seeking, decision engagement, and active management of health) are linked with lower utilization and costs. A third study examines the degree to which plan type affects patient consistency in taking prescribed medications for specific chronic illnesses. A fourth study is based on a controlled experiment, and examines how literacy affects consumer understanding of CDHPs and the choice of a CDHP. All four studies shed light on how consumers are likely to behave in this new environment and indicate what changes may be necessary for these plans to be successful. ●How well do Consumers Understand their Choice of a CDHP? An Experimental Study Ellen Peters, Ph.D., Judith Hibbard, DrPH, C.K. Mertz Presented By: Ellen Peters, Ph.D., Senior Research Scientist, Decision Research, 1201 Oak St, Eugene, OR 97401; Tel: 541485-2400; Email: empeters@uoregon.edu Research Objective: This study examines the relationship between numeracy skill, literacy level, and the comprehension of plan descriptions, including a CDHP and a PPO plan. We assessed how well those at different literacy and numeracy levels understood what a CDHP was, and whether comprehension affected choice. Study Design: A convenience sample (N=303) of employed age adults stratified by education chose between two health plans and completed six comprehension questions. The health plans were described as a new plan (a CDHP with an HSA account) and a more traditional plan similar to a PPO. Numeracy and reading literacy were assessed using standard approaches. Different approaches for presenting the information were tested using an experimental design. Principal Findings: Both literacy levels and numeracy skill provided significant independent prediction of comprehension of the two health plans with lower scores on both measures being associated with less comprehension. Despite understanding less about the health plans, the low numerate were more likely to choose the CDHP. Having the information side-by-side (instead of separating out the information that was common and unique to the plans) helped comprehension for those low and high in numeracy. Providing a framework for understanding the information helped comprehension only for those high in numeracy. Different ways of presenting the information did not influence choices. Conclusions: Understanding written materials which describe health plan design is difficult for consumers, particularly those who are low in literacy and numeric skills. Since a significant portion of the population is low in numeracy this is of concern. Choosing a CDHP with little understanding of what one is choosing would likely lead to dissatisfaction, inefficiencies and possibly serious health and financial consequences for the individual. Implications for Policy, Delivery, or Practice: The findings suggest that CDHP offerings made to a lower skilled population, should be done cautiously and with considerably more assistance than is typically provided to those making health plan choices. Primary Funding Source: Blue Cross Blue Shield Association ●The Influence of CDHPs on Enrollees’ Prescription Drug Utilization Jessica Greene, Ph.D., Judy Hibbard, DrPH, Martin Tusler, , Marc Berger, M.D., James Murray, Ph.D., Steven Teutsch, M.D., M.P.H. Presented By: Jessica Greene, Ph.D., Assistant Professor, Department of Planning, Public Policy and Management, University of Oregon, 1209 University of Oregon, Eugene, OR 97403; Tel: 541-346-0138; Fax: 541-346-2040; Email: jessicag@uoregon.edu Research Objective: In this study we examine the degree to which enrollment in consumer driven health plans influences prescription drug utilization. We examine cost effective changes, such as switching to generic and lower cost drugs, as well as reductions in utilization. CDHPs’ impact on prescription drug utilization is of particular importance given prescription drugs’ widespread use, essential role in controlling chronic illness, and rapidly increasing costs. Study Design: Using pharmaceutical claims data we examine whether the first year of enrollment in either a high deductible or lower deductible CDHP results in changes in prescription drug utilization patterns from the prior year, compared with those who were continuously enrolled in a three-tiered drug formulary plan. We assess whether there were changes in generic substitution, within class switches to lower priced drugs, the medication possession ratio, and discontinuation rates for eight classes of prescription drugs. Population Studied: We study the influence of health plan design based on the experience of one large employer in the manufacturing sector that first offered CDHP options in 2004. Our study sample includes company employees and their dependents, totaling 28,105 individuals. Principal Findings: Preliminary analysis suggests that enrollment in both high and lower deductible CDHPs leads to changes in prescription drug utilization that are cost effective. In some cases, enrollment in high deductible CDHPs, however, may also lead to reductions in use. We observe different patterns by drug class. Conclusions: We find that changes in pharmaceutical plan design influence enrollees' prescription drug utilization and that CDHP deductible levels matter. Enrollment in CDHPs is associated with cost effective prescription drug utilization, regardless of plan deductible level. Enrollment in high deductible CDHPs, in some cases, results in reductions in utilization. Implications for Policy, Delivery, or Practice: As enrollment in high deductible CDHPs increases, and plan designs change, it will continue to be important to monitor for reductions in prescription drug utilization and the impact that they may have on health outcomes. Primary Funding Source: RWJF, Merck ●How Does Enrolment in CDHPs Impact on Consumerist Behaviours? Anna Dixon, BA Cantab MSc (Econ), Judith Hibbard, DrPH, Jessica Greene, Ph.D. Presented By: Anna Dixon, BA Cantab MSc (Econ), Harkness Fellow in Health Policy, Planning, Public Policy, & Management, University of Oregon, 119 Hendricks Hall, Eugene, OR 97403-1209; Tel: 541 346-0874; Fax: 541 346-2040; Email: adixon@uoregon.edu Research Objective: To compare consumerist behaviours between enrolees in consumer directed health plans and a traditional PPO. Specifically to address the following research questions: How does use of health and cost information vary between enrolees of different plans? How do appropriate cost sensitive health care decisions and risky cost saving decisions vary between enrolees of different plans? Do self reported changes in awareness of costs and quality, and information use vary by plan type? How has use of health and cost information changed over one year among enrolees of different plans? How have cost sensitive health care decisions changed over one year among enrolees of different plans? Study Design: Employees completed either web-based or telephone surveys in summer 2004 and 2005. Included questions on health plan enrolment, employee health status, consumer characteristics, socio-demographics and selfreported behaviours. Population Studied: 2,104 employees of a large manufacturing company that offered employees choice of high or low deductible CDHPs in 2004, in addition to traditional coverage options including a PPO. Employees were eligible for the survey if they had worked for the company for at least a year, and were sixty years of age or younger. Principal Findings: Enrolees in the low deductible CDHP were more likely to have used health information and cost information in 2005 than either enrolees in the high deductible CDHP or PPO. There is weak evidence that enrolees in the CDHPs were more likely to make appropriate cost sensitive decisions. Enrolees in the CDHPs were significantly more likely to take risky cost-saving decisions. A smaller proportion of enrolees in CDHPs than in the PPO reported being more aware of quality than last year and a greater proportion reported being more aware of costs. A significantly greater proportion of enrolees in CDHPs than in the PPO reported feeling more in charge than last year. There were some significant differences in changes in use of health information and cost information over time between enrolees of different plans. Conclusions: The impact of CDHPs on information use differs between enrolees in high and low deductible plans. Enrolees in CDHPs appear more likely to forego, postpone or delay medical care than enrolees in PPOs. CDHPs have a small effect on changes in consumer behaviours over time. Implications for Policy, Delivery, or Practice: The expectation that exposure to cost sharing and increased availability of information resources under a CDHP would result in more active health care consumers appears not to be supported by data. The lack of positive expected benefits and evidence that health care consumers forego medical care in face of greater financial risk may prompt employers and other purchasers to re-evaluate the overall justification for introducing CDHPs. Primary Funding Source: CWF, Robert Wood Johnson Foundation Call for Panels Assessing Quality of Nursing Home Care Using the 2004 National Nursing Home Survey Chair: Judith Kasper, Johns Hopkins University Monday, June 26 • 8:30 am – 10:00 am Panel Overview: This panel’s objectives are to present the first analyses related to the quality of care based on the 2004 National Nursing Home Survey (NNHS) and to introduce the first National Nursing Assistant Survey. The moderator will relate the current state of knowledge regarding quality of care in nursing homes and give an overview of the surveys. Presentations will then focus on quality issues related to endof-life care, medication use, electronic information systems, and staffing. Discussants expert in the field from public policy and academia will relate the findings to current policy issues. The 2004 NNHS is one of a series of national probability sample surveys that collect data on nursing homes, their residents, and their staff. A major redesign in 2004 added survey items and a supplemental survey of nursing assistants. The data offer opportunities to evaluate residents’ quality of care in relation to facility organization and practices and staff training and certification. Data on residents include emergency department use and hospitalizations, medications, pain management, and end-of-life care. Data on nursing assistants address several relevant policy and practice issues: recruitment, health insurance access and coverage, use of public benefits, choice of profession, reasons for turnover, satisfaction and staying in the job, citizenship, education and training, and work-related injuries. The session will inform public and private policies on topics with important implications for quality of care received by a vulnerable segment of our population. ●The National Nursing Assistant Survey: A First-time Direct Care Worker Survey of Certified Nursing Assistants Employed in Nursing Homes Marie Squillace, Ph.D., R. Katz, R. Remsburg, E. Rosenoff Presented By: Marie Squillace, Ph.D., Senior Policy Analyst, DHHS/OS/ASPE, Hubert H. Humphrey Building, 200 Inependence Avenue, SW, Washington, DC 20201; Tel: 202690-6250; Email: marie.squillace@hhs.gov Research Objective: Collect a nationally representative sample of Certified Nursing Assistants (CNAs) working in nursing homes surveyed by the National Nursing Home Survey (NNHS) to provide an evidence base for understanding what draws individuals to careers as nursing assistants and to work in nursing homes, and what contributes to their satisfaction and likelihood of staying in their jobs. Study Design: Cross-sectional survey. CNAs were selected from a sub-sample of 790 nursing homes from the 1500 sampled in the 2004 NNHS. The National Nursing Assistant Survey (NNAS) was a telephone interview conducted separately from the NNHS. Population Studied: 3,014 CNAs responded out of 4,357 selected and eligible for the survey (69%). Principal Findings: Data on nursing assistants will address several issues that are important for policy and practice. These include questions related to how nursing assistants are recruited, health insurance access and coverage, use of public benefits, why nursing assistants choose their profession, reasons for turnover, what contributes to satisfaction and likelihood of staying in the job, citizenship status, role of education and training, and the extent and type of work-related injuries. Preliminary analyses will cover this spectrum and provide national statistics on these topics for the first time. Conclusions: The NNAS will provide current, in-depth information on several issues of importance for policy and practice that warrant special attention, including factors associated with job satisfaction and turnover. Although the major focus of the NNAS is to provide descriptive data, the survey also has exploratory, confirmatory, and developmental aspects. Information from this national sample survey will be linked to the NNHS data to examine associations between facility and resident characteristics and CNAs. Implications for Policy, Delivery, or Practice: Paraprofessional workers constitute the backbone of the formal long-term care industry providing assistance with activities of daily living to over 15 million Americans. Yet numerous studies point to a future labor force imbalance between the demand for long-term care supports and supply of the paraprofessional workforce. Reasons for this imbalance include the growing demand for long-term care from the aging baby boomer generation and recruitment and retention challenges faced by long-term care providers. While the U.S. Bureau of Labor provides employment estimates monitoring the labor force, no nationally descriptive information is collected directly from the paraprofessional workforce to describe what motivates individuals to choose careers as direct care workers in long-term care settings, and what contributes to the likelihood that they will continue in these positions based on their job satisfaction, environment, training, and advancement opportunities. The breadth and depth of information collected in the NNAS will inform federal, state and provider efforts aimed at recruiting a qualified and committed workforce. Primary Funding Source: DHHS/OS/ASPE ●End of Life Care in Nursing Homes: Skilled Nursing Homes with special programs and trained staff for hospice Robin Remsburg, Ph.D., R.N.Beth Han, Ph.D., M.D., M.P.H. Presented By: Robin Remsburg, Ph.D., R.N.., Deputy Director, Division of Health Care Statistics, Long-term Care Statistics Branch, CDC, National Center for Health Statistics, 3311 Toledo Road, Hyattsville, MD 20782; Tel: 301-458-4416; Fax: 301-458-4693; Email: rqr3@cdc.gov Research Objective: To estimate the prevalence of skilled nursing homes with special programs and trained staff for hospice in the U.S., and to examine factors associated with skilled nursing homes with special programs and trained staff for hospice. Study Design: This cross-sectional study, using the 2004 National Nursing Home Survey, provides the first nationally representative data on hospice, palliative, and end of life care among U.S. nursing homes. We examined ownership status; chain affiliation; the current number of nursing home beds; characteristics of facility administrator, director of nursing, and medical director; the percent of certified nursing assistants and registered nurses employed more than 1 year; the percent of beds certified by Medicaid only and by both Medicare and Medicaid; having special programs and trained staff for hospice; pain management; and formal contracts with outside hospice programs; staffing/patient ratios; region; and metropolitan/micropolitan area status. Chi-square tests at the bivariate level and multivariate logistic regression modeling were used. SUDAAN software was used to adjust for the complex sampling design and sampling weights. Population Studied: A total of 1167 skilled nursing homes. Principal Findings: In 2004, less than 19% of nursing homes had special programs and trained staff for hospice (SPTSH), compared to 26% of nursing homes had special programs and trained staff for pain management and 78% of nursing homes had formal contracts with outside hospice programs. Our multivariate results indicate that nursing homes with special program and trained staff for pain management compared to those without had more than fivefold (odds ratio (OR) = 5.67, 95% confidence interval (CI) = 3.48, 9.24) the odds of having SPTSH; the odds were more than 3 to 1 (OR=3.32, 95% CI=1.69, 6.51) that nursing homes with formal hospice contracts compared to those without would have SPTSH; private non-profit nursing homes had almost double the odds of having SPTSH (OR=1.99, 95% CI=1.22, 3.24) compared to their for-profit counterparts; nursing homes in the South had more than double the odds of (OR=2.48, 95% CI=1.45, 4.26) having SPTSH compared to those in the Midwest; and nursing homes with metropolitan or micropolitan status were associated with having fewer SPTSH than those without. Conclusions: Having a formal contract with outside hospice, having special programs and trained staff for pain management, South region, and nonmetropolitan/micropolitan status are associated with nursing homes’ having more special programs and trained staff on hospice. Implications for Policy, Delivery, or Practice: Hospice care in nursing homes offers a collaborative opportunity for nursing homes and hospices to provide end-of-life care to nursing home residents. To prepare special programs and trained staff for hospice, it is valuable for nursing homes to establish special programs and trained staff for pain management, a critical component of hospice care. Future studies are needed to examine why nursing homes in the South or in non-metropolitan/micropolitan areas are more likely to have special programs and trained staff for hospice. Primary Funding Source: CDC, NCHS ●Medication Practices for the Elderly in U.S. Nursing Homes Lisa Dwyer, M.P.H., Robin Remsburg, Ph.D., R.N. Presented By: Lisa Dwyer, M.P.H., Health Scientist, Longterm Care Statistics Branch, CDC, National Center for Health Statistics, 3311 Toledo Road, Hyattsville, MD 20782; Tel: 301458-4714; Fax: 301-458-4693; Email: ldwyer@cdc.gov Research Objective: (1) Present preliminary estimates of the use of medications by nursing home residents. (2) Determine the top ten therapeutic classes of medications taken by residents; and (3) Determine if nursing home residents are taking selected medications that are currently excluded from Medicare Part D Drug Benefit reimbursement. Study Design: Cross-sectional analysis of preliminary, unweighted data on medication usage by a sub-sample of nursing homes residents in the 2004 National Nursing Home Survey (NNHS). The specific survey questions were as follows: (1) what medications did the resident receive yesterday, including standing, routine, and as-needed medications; (2) what medications does the resident receive on a regularly scheduled basis but were not administered yesterday; (3) why were the medications prescribed; and (4) did the resident have any type of reaction to a drug or medication since admission or during the past 30 days. Population Studied: 11,885 nursing home residents, 65 or older, who were sampled in the 2004 National Nursing Home Survey (NNHS) and taking at least one medication. Principal Findings: Preliminary un-weighted data reveal the mean number of medications per resident was 9.0. Residents took prescription medications, over-the-counter medications, and vitamin/mineral and herbal supplements. The top ten therapeutic drug classes taken by these nursing home residents included vitamins/minerals, laxatives, analgesics, antidepressants, diuretics, and antipsychotics. Some medications considered potentially inappropriate for the elderly and other medications currently excluded from Medicare Part D Drug Benefit reimbursement, such as benzodiazepines and prescription vitamin and mineral products, were also administered to residents. Conclusions: Elderly nursing home residents take numerous medications for various medical conditions. The large number of medications taken per resident, many of whom are potentially very frail and sick, may raise patient safety concerns, such as drug interactions. The data also reveal that some residents took medications currently excluded from Medicare Part D reimbursement. Implications for Policy, Delivery, or Practice: Using the 2004 NNHS medication data, long-term care planners, researchers, and policy makers can gain a better understanding of the medications taken, therapeutic classes, the reasons they were prescribed, the prevalence of polypharmacy and potential interactions and thus implications for patient safety and quality of care. Current medication practices in U.S. nursing homes demonstrate that (1) patient safety initiatives are critical to monitoring the number and types of medications administered to residents and addressing their potential negative consequences and (2) the Medicare Part D Drug Benefit exclusions affect nursing home residents and the long-term care industry. Primary Funding Source: CDC ●Electronic Information Systems Use for Patient Care in US Nursing Homes: Data from the 2004 National Nursing Home Survey William S. Pearson, Ph.D., M.H.A. Presented By: William S. Pearson, Ph.D., M.H.A., Health Scientist, Long-term Care Statistics Branch, CDC, National Center for Health Statistics, 3311 Toledo Road, Hyattsville, MD 20782; Tel: 301-458-4699; Fax: 301-458-4693; Email: wpearson@cdc.gov Research Objective: To estimate the number of US nursing homes using electronic information systems and to examine how these systems were used. Study Design: Secondary analysis of the 2004 National Nursing Home Survey. National estimates were made for the numbers of homes using an electronic information system and the specific patient care activities they performed. These activities included management of patient records, management of medication orders and drug dispensing, physician order entry, laboratory orders and procedures, management of medication administration records, nursing assistant notes, and dietary notes. Population Studied: Nationally representative sample of 1,174 nursing homes from the 2004 National Nursing Home Survey, which represented 16,079 nursing homes nationally. Principal Findings: Almost one-half (47.2%) of the estimated 16,079 US nursing homes in 2004 were using an electronic information system for the management of patient records. 51.1% of all nursing homes were using an electronic system for medication orders and drug dispensing; 48.4% for physician order entry; 41.4% for laboratory orders and procedures, 38.1% for management of medication administration records, 17.5% for daily nursing assistant notes and 51.2% for dietary notes. Approximately 20% of all US nursing homes were not using an electronic information system for any of seven patient care activities. Seventeen percent were using their information system for at least one activity, and approximately 55% of nursing homes were using their information systems for 2 to 6 patient care activities. Just over seven percent of all homes were using their information system for all seven of the patient care activities. Conclusions: By 2004, many US nursing homes had adopted the use of an electronic information system for some type of patient care activity. However, the use of the information systems for patient care varied among the homes. Implications for Policy, Delivery, or Practice: This study presents data that allow researchers and policy makers to see where nursing homes stand at the beginning of our nation’s move toward a wired health information network. The use of information technology, primarily in the form of an electronic health record, has been proposed as a way to increase the efficiency of delivered services, raise the level of the quality care provided and decrease the number of medical errors. This study suggests that many nursing homes are using the technology for patient care services, although at varied levels. In 2004 Executive Order 1335 set forth a Federal Health IT initiative with the goal of having the majority of the US health care system wired and having most Americans covered by an interoperable health record within the next decade. Nursing homes are a large sector of the overall US healthcare system that provides care to an especially vulnerable population. Therefore, the use of electronic health records may help to ensure quality of care to this population. This survey will allow researchers to conduct studies on outcomes of patients that were treated in homes which utilized electronic information systems for patient care and will help to determine how the use of electronic information systems for patient care affect quality and outcomes. Primary Funding Source: No Funding Call for Panels Impact of Pay-for-Performance Programs on Quality and Costs of Health Care: Lessons from Massachusetts, New York, and California Chair: Eric Schneider, Harvard School of Public Health Monday, June 26 • 10:30 am – 12:00 pm Panel Overview: In health care, traditional forms of payment offer little incentive to physicians to assess or improve the quality of health care. Pay-for-performance (P4P) programs may remedy this by basing a portion of payment to physicians on the results achieved on measures of the quality of health care. While P4P programs have become increasingly popular and are under consideration as a new payment model for the Medicare program, little is known about their impact. Do they improve quality? Will they temper the rising costs of care? In this panel, 3 speakers will present the results of P4P evaluation projects in Massachusetts, New York, and California. The Massachusetts project is analyzing changes in physician group performance on standardized measures of the quality of primary care in response to P4P incentives initiated by competing health plans. The New York project is estimating both improvements in quality and the return on investment generated by a P4P program administered by a large health plan in partnership with a large physician organization. The California project is evaluating changes in performance of physician organizations on standardized quality measures in the wake of a statewide implementation of financial incentives and public reporting of performance scores. The panel presentations will offer valuable lessons about the optimal scope and structure of P4P programs. ●Rewarding Performance: Two-year Results from California’s Statewide Pay-for-Performance Experiment Cheryl Damberg, Ph.D., Kristiana Raube, Ph.D., Claude Messan Setodji, Ph.D. Presented By: Cheryl Damberg, Ph.D., RAND, 1776 Main Street, Santa Monica, CA 90407; Tel: 310-393-0411; Fax: 310260-8155; Email: damberg@rand.org Research Objective: 1) To examine changes in performance on a set of measures (clinical, patient experience, and Information Technology (IT)) between 2003 and 2005 among the universe of Physician Organizations (POs) exposed to a statewide pay-for-performance program in California. 2) To examine the distribution of payouts to POs by size, type of group, and region, and changes in winners and losers over the 3-year period. Study Design: 225 POs in California that contract with 7 largest health plans were exposed to financial and nonfinancial incentives (i.e., public reporting of performance scores). POs were scored on 6 clinical measures, 4 patient experience domains, and 2 IT domains (integrating clinical electronic data at group level for population management and supporting clinical decision-making at the point of care through electronic tools). The study uses clinical performance data (aggregated from 7 health plan administrative sources and self-reported, audited PO encounter data sources), patient survey data from an annual group-level CAHPS survey conducted in California, and PO self-reported information on IT capability. Data are reported for 2002, 2003, and 2004 (used to make payouts in 2004 and 2005; baseline is 2002). The unit of analysis is the PO (n=225, the universe of capitated POs contracting with the 7 health plans). Year-to-year changes in performance scores are computed; we examine relative improvements by rank position (e.g., quartiles of performance). Using a multivariate regression model, we also examine characteristics of the PO (e.g., size, region, IPA/medical group, # of physicians) that are associated with better performance. Lastly, we rank order POs by total payouts and assess year-to-year changes in the rank positions of POs based on bonus payments. Population Studied: 225 Physician organizations (medical groups and IPAs) in California; HMO and POS capitated enrollees of the 7 health plans (7 million enrollees). Principal Findings: Year-to-year improvements were observed in clinical measures (e.g., 56.3% of POs saw an average 1.1% point improvement in mammography screening rates; 77.4% saw an average 5.4% point improvement in cervical cancer screening, and 60.2% of groups saw an average 3.5% point improvement in HbA1c screening between 2003 and 2004), and patient experience improved on average between 1.1 and 8.8% points), and there was an increase from 34.4% of groups receiving bonus dollars for IT capability in 2004 to 52.9% in 2005. Performance scores and bonus dollars were higher on average among POs located in Northern CA and that were larger in size. Small, Independent Practice Association (IPA) groups tended to score lowest, in part because of difficulty obtaining complete encounter data from all of their practice sites to demonstrate performance on the indicators. Conclusions: Although performance improvement was observed between 2003 and 2005, the improvement was relatively modest. For some measures, the year-to-year change is likely due more to improvements in data capture rather than real performance improvement, as POs focused heavily in the initial years on ensuring data capture to demonstrate performance. The largest relative year-to-year changes in performance scores were observed among the lowest performers and these were the same POs that saw little or none of the bonus money. Incentive payments tended to reward those groups with historically high performance. Implications for Policy, Delivery, or Practice: Pay-forperformance programs are still in the early stages of development and implementation. At this stage, POs in California are focused heavily on modifying data systems to track performance and using enhanced IT capabilities to feed performance information back to individual physicians to drive behavior change and to create physician-level incentive structures. To gauge the ultimate impact of pay-for- performance on driving quality improvements will require sustained evaluation work. Primary Funding Source: California Healthcare Foundation ●Can Underuse Measures Reduce Cost? The ROI for Diabetes and Coronary Artery Disease Howard Beckman, M.D., Kathy Curtin, RN, MBA, Robert Greene, M.D. Presented By: Howard Beckman, M.D., Medical Director, , Rochester Individual Practice Association, 3540 Winton Place, Rochester, NY 14623; Tel: 585-242-9445; Fax: 585-242-0682; Email: hbeckman@ripa.org Research Objective: 1) To determine whether a P4P program involving a partnership between a large health plan and a large physician organization can generate a positive return on investment (ROI). 2) To describe a successful approach to engaging physicians in quality improvement and P4P. Study Design: P4P measures include patient satisfaction, quality and efficiency. Quality measures include acute diseases (sinusitis and Otitis media), chronic diseases (diabetes, CAD, asthma) and preventive services (mammography). Efficiency scoring was based on ETG comparisons within specialty groupings. Performance targets were set at the 90th national percentile if available. Year-end payments were based on a formula that encouraged both high levels of performance and interval improvement. Profiles were distributed three times a year and included updated lists of patients that had received services. ROI for the P4P program was estimated by calculating savings against trend. Total costs for patients with diabetes and coronary artery disease were compared to a rolling two year trend for the period 2000-2004. Costs included practitioner payments, inpatient and outpatient reimbursement, pharmaceutical costs, ancillary costs and other patient related plan payments such as durable medical equipment. Patients with total year costs greater than $100,000 or with other catastrophic illnesses from trauma or in addition to CAD and diabetes were excluded (liver transplantation from Hepatitis C, kidney transplantation from polycystic kidneys). Savings from other aspects of the P4P program are being analyzed. Population Studied: The RIPA/Excellus P4P partnership is based on services provided to 300,000 members of an HMO product serviced by 3500 practitioners. Principal Findings: The savings from diabetes and CAD in 2004 against the two year rolling trend amounted to $3,500,000 with a cost of the P4P program estimated at $1,150,000 yielding an ROI result of 3:1 for these two programs alone. In the chronic disease arena, reduction in costs was associated with increased use of pharmacologic agents and a resulting decline in hospitalizations. Increased use of pharmacologic agents led to lower LDL cholesterol and HbA1c. For example, the percentage of diabetic Excellus patients with an LDL<100 increased from 29% in 2003 to 39% in 2004 (based on HEDIS specifications). Over time, we observed that practitioners passed through Kubler-Ross’s stages of mourning. To physician’s anger, we responded with listening and non-judgmental understanding. In those seeds of anger were important concerns about how our program needed to be improved. Physicians asked us to be clearer about what we were incenting, and to explicitly define what they needed to change. Over the three years of the program, we have made more than 20 changes to our process. After we created increasingly actionable information, our reports became the template for change, not judgment. Now we receive many more requests for help with improvement than complaints about being evaluated. Conclusions: Promoting an evidence-based pathway for chronic disease and paying for improvement is both achievable and cost effective, generating, in this program, a minimum ROI of 3:1. Our results depended on integrating accurate, understandable, actionable reporting tools with a respectful, transparent process of interacting with the practitioner community. Implications for Policy, Delivery, or Practice: An optimal pay-for-performance program requires integrating evidencebased measures with dissemination of accurate, actionable data in a respectful, non-judgmental fashion. Attention to each of these components of the program is considered essential to success. Primary Funding Source: RWJF ●Performance of Physician Groups after Pay-forPerformance: Natural Experiments in Massachusetts Steve Pearson, M.D, M.Sc., Kathy Coltin, M.P.H., Ken Kleinman, Ph.D., Janice Singer, M.P.H., M.A., Barbra Rabson, M.P.H., Eric Schneider, M.D., M.Sc. Presented By: Steve Pearson, M.D, M.Sc., Special Advisor, Technology and Coverage Policy, Centers for Medicare and Medicaid Services and the NIH, Building 10, Room 1C118, Bethesda, MD 20892; Tel: 301-435-8717; Email: spearson99@yahoo.co Research Objective: There are now a wide variety of pay-forperformance contracts between health plans and physician groups, yet most evaluations of these initiatives have focused on a single intervention by a single health plan. As part of the Robert Wood Johnson Rewarding Results study, the Massachusetts Health Quality Partners (MHQP) project was designed to evaluate the impact on physician groups of the diverse set of pay-for-performance contracts initiated by all five major commercial health plans in the state between 2001 and 2003. Study Design: We created a Master Physician Database that aggregated Health Employment Data Information Set (HEDIS) performance across all health plans to provide a complete and annually updated profile of the quality performance of all individual physicians and physician groups in the state. In addition, a comprehensive survey of health plans’ pay-for-performance contracts was undertaken during the years 2001-2003, collecting information on the structure, scope, and magnitude of each contract containing a pay-forperformance element. The evaluation compares the change in quality performance between 2001 and 2003 of physician groups that have a pay-for-performance contract with the change in quality performance of matched comparison physician groups with comparable baseline quality performance in 2001. Population Studied: The 5 health plans participating in the MHQP collaborative contracting with over 90% of the state’s practicing primary care physicians and covering nearly 4 million enrollees (60% of the state’s population). Principal Findings: The Master Physician Database includes HEDIS performance data on 4,358 physicians practicing in 174 physician groups. In the baseline year of 2001, there were 4 contracts that included a financial incentive linked to quality performance, rising to 20 separate contracts by 2003. The HEDIS measures that were targets of financial incentives in 2001 included: diabetes management; mammography; cervical cancer screening; well-child visits; and pediatric and adult asthma management. By 2003, Chlamydia screening and antidepressant management had been added as quality targets. The incentive contracts were of different models: 1 was a withhold; 4 were grants to support quality improvement programs; and 15 were bonuses. The money tied to quality performance ranged from less than $5,000 for single physician groups to contracts with networks of physician groups that exceeded $2,000,000. At the time of abstract submission, the comparison of changes in quality performance between 2001 and 2003 in physician groups with pay-for-performance incentives (intervention) and concurrent comparison groups is ongoing. Results, including those from a multivariate model, will be available for presentation at the conference. Conclusions: A wide range of pay-for-performance contracts have been initiated in Massachusetts during the years 20012003. The variety of their structure, scope, and magnitude suggests that further analyses will be able to identify features of pay-for-performance contracts that are most closely correlated with significant improvements in quality performance (independent of secular performance trends). Implications for Policy, Delivery, or Practice: Distinguishing these critical features of pay-for-performance contracts will inform future efforts to reap the maximum gain from an incentive concept that has spread rapidly but is still quite early in its development. Primary Funding Source: RWJF Call for Panels Predicting Consumer Responses to New Types of Health Plans Chair: Sharon Arnold, AcademyHealth Discussant: Adam Atherly, Emory University Monday, June 26 • 2:00 pm – 3:30 pm Panel Overview: This panel will present and discuss recent research regarding potential consumer responses to new types of health insurance plans either created or encouraged by the Medicare Modernization Act (MMA). Most prominent among these are stand-alone prescription drug plans (PDPs). These plans are central to the goal of making affordable drug coverage available to all Medicare beneficiaries, but it is not known whether they will attract large and stable enrollments. For the working age population, MMA created tax advantages for health savings accounts, spurring substantial new interest in consumer-directed health plans (CDHPs). These plans feature combinations of deductible, co-insurance, donut hole, and catastrophic coverage, and consumer preferences with regard to these product features are not well understood. The session will start with a presentation by Austin Frakt, Ph.D., giving a descriptive overview of the Medicare PDPs that began enrolling beneficiaries in January. Costs to consumers and generosity of available coverage will be assessed. The second speaker, Steven Pizer, Ph.D., will present analysis of predicted market shares and adverse selection for PDPs, based on statistical modeling of beneficiary choices as reported on the Medicare Current Beneficiary Survey. Stephen T. Parente, Ph.D., will speak third, using data from four large employers to analyze consumer responses to a discrete set of product features of CDHPs. The panel will be chaired by Sharon Arnold, Ph.D., Senior Research Manager, AcademyHealth, and Adam Atherly, Ph.D., Associate Professor of Public Health, Emory University, will serve as discussant. ●Storm Clouds on the Horizon? Predicting Adverse Selection in Medicare Prescription Drug Plans Steven Pizer, Ph.D., Austin Frakt, Ph.D., Roger Feldman, Ph.D. Presented By: Steven Pizer, Ph.D., Health Economist, Health Care Financing & Economics, VA & Boston University, 150 South Huntington Ave. (152H), Boston, MA 02130; Tel: 857364-6061; Fax: 857-364-4511; Email: pizer@bu.edu Research Objective: To predict enrollment and selection into newly created Medicare prescription drug plans under a variety of competitive scenarios, and to assess the likely cost implications for different types of beneficiaries. Outpatient prescription drug coverage has not been available from Medicare except through HMOs. HMOs have limited appeal to beneficiaries because they restrict choice of provider and are not available in all areas. The Medicare Modernization Act of 2003 created new types of plans to expand access to drug benefits to beneficiaries who could not or would not join HMOs. The most important of these is the stand-alone prescription drug plan (PDP), which will provide coverage only for prescription drugs starting on January 1, 2006. As Congress considered creating these plans in 2003, some argued that prescription drug utilization is too persistent a phenomenon to be separately insurable, suggesting that PDPs would suffer from crippling adverse selection. Others argued that PDPs could thrive if subsidized deeply enough to attract broad enrollments. Study Design: We pool data from the Medicare Current Beneficiary Survey from 1999 through 2001 and merge with data on benefits and premiums from Medicare Personal Plan Finder and a major Medigap insurer. We estimate a nested logit model of insurance plan choice, separating HMOs, Medigap plans, and traditional fee-for-service (FFS) Medicare into three nests. Finally, we use the parameters of the model to simulate plan enrollments after the introduction of PDPs, with and without competition from HMOs. Population Studied: All non-institutionalized Medicare beneficiaries over the age of 65 and not enrolled in Medicaid or an employer-sponsored Medicare supplement. Principal Findings: In general, after excluding those enrolled in Medicaid and employer-sponsored plans, approximately 44% of the remaining beneficiaries will enroll in a PDP and drug expenditures for this group will be about 5% higher than the population average, indicating adverse selection. Most of this group (27%) is predicted to enroll in a non-drug Medigap plan as well as a PDP. These beneficiaries will have drug expenditures typically about 13% higher than the population average. A smaller number (17%) will enroll in a PDP without an additional supplement. Drug expenditures for this group will be about 7% lower than the population average. Beneficiaries enrolling in FFS and non-drug Medigap (10%) will have average drug expenditures about 30% higher than average. By contrast, HMO enrollees (30%) and enrollees in FFS only (17%) will have drug expenditures about 12% lower than the population average. Adverse selection into PDPs will be substantially worse in counties where HMOs are available. Conclusions: PDPs will acquire substantial market shares and experience mild and stable adverse selection. It will be ameliorated by risk-adjustment and risk-sharing arrangements, but the residual effects will cause premiums to escalate and benefits to be reduced relative to Medicare HMOs. Because PDPs will be offered on a regional basis, adverse selection caused by HMOs in urban areas will drive up premiums in rural areas where HMOs are not available. Implications for Policy, Delivery, or Practice: PDPs have the potential to provide stable prescription drug coverage to large numbers of Medicare beneficiaries. This study suggests that if Congress seeks to reduce future spending on Medicare, premium subsidies for PDP enrollees ought to be protected. In addition, permitting PDPs to further segment their service areas would improve equity between rural and urban areas. Primary Funding Source: RWJF ●The New Medicare Prescription Drug Plans: Availability, Costs, and Benefits Austin Frakt, Ph.D., Steven Pizer, Ph.D. Presented By: Austin Frakt, Ph.D., Health Systems Research Scientist, Health Care Financing & Economics, Department of Veterans Affairs, 150 South Huntington Ave. (152H), Boston, MA 02130; Tel: 857-364-6064; Fax: 857-364-4511; Email: frakt@bu.edu Research Objective: As of January 2006, for the first time all Medicare beneficiaries have the option to purchase subsidized coverage for outpatient prescription drugs through Medicare Part D. This new drug benefit is also significant in that it is the first universally available benefit financed by Medicare exclusively through private insurers. Three main types of private plans contract with Medicare to provide this coverage: local health maintenance organizations (HMOs), regional preferred provider organizations (PPOs), and regional prescription drug plans (PDPs). This paper examines the availability, costs, and benefits of the new drug plans. Study Design: Using data collected from the Centers for Medicare & Medicaid Services in late 2005, we built a dataset consisting of all Medicare PPOs, all PDPs and a sample of Medicare HMOs that were to be offered in 2006. The dataset includes information on plan name, premium, deductible, gap (a.k.a. donut hole) coverage, percent of top 200 drugs covered, and minimum and maximum co-payments. For a specific set of frequently prescribed brand-name drugs for a restricted set of nationally-available PDPs offered by large insurers we built a second dataset that included variables coding whether the drug was covered and, if so, its tier and co-payment/co-insurance. All analyses using these two datasets were descriptive. Population Studied: This is a study of private Medicare plans that offer outpatient prescription drug coverage in 2006. While it is relevant to the Medicare population, all analyses are at the plan level. Principal Findings: Where they exist, local HMOs tend to offer outpatient prescription drug coverage for premiums below those of PDPs or PPOs. Regional PPOs are not being offered in large numbers and are absent from some regions. PPOs are vastly outnumbered by regional PDPs. Even restricting attention to the small number of national PDPs, beneficiaries have meaningful choices, with substantial variation across plans in cost-sharing and formulary generosity as well as premium. Among PDPs, a small minority of plans offer coverage in the gap. Only one national plan offers gap coverage for brand-name drugs. Conclusions: The success of the new Medicare outpatient prescription drug benefit will hinge on the viability of regional PDPs. This study has shown that PPOs are not participating in large numbers and our other work suggests they face stiff competition from HMOs. Meanwhile, HMOs will continue but are unlikely to be offered in rural counties. Thus, for many beneficiaries, PDPs are the only option for drug coverage. The stability of the PDP sector is, therefore, central to the vitality of this new drug benefit. Implications for Policy, Delivery, or Practice: Variations in PDP benefit design expose plans to varying degrees of adverse selection. What design(s) will prove stable over time will become evident over the next several years. Another development to watch is how PDPs will react if Congress begins to reduce spending on subsidies, as recently proposed. Some plans could make up for a loss in government payments by increasing their deductibles or changing their formularies. Plans already offering the statutory minimum benefit and restrictive formularies would have to increase their premiums to make up the loss. If this happens, low-risk beneficiaries judging the increased premium not worth the benefit will decline coverage, potentially destabilizing these plans. Given the importance of PDPs to the vitality of Part D, it would be unwise for Congress to make swift or steep cuts to PDP subsidies. On the other hand, since PPOs are not a major component to Part D, targeting cuts to PPO subsidies is less likely to destabilize the program. Primary Funding Source: RWJF ●Health Insurance Demand Responses from New Price Structures Offered by Consumer Directed Health Plans Stephen Parente, Ph.D., Roger Feldman, Ph.D., Jean Abraham, Ph.D., Jon Christianson, Ph.D. Presented By: Stephen Parente, Ph.D., Assistant Professor, Carlson School of Management, University of Minnesota, 321 19th Avenue South, Rm 3-149, Minneapolis, MN 55455; Tel: 612-624-1391; Fax: 612-624-8804; Email: SParente@csom.umn.edu Research Objective: Consumer directed health plans (CDHPs) are attracting attention from consumers, employers, and policy-makers. CDHPs are high-deductible health insurance plans coupled with a tax-advantaged account that can be used to pay for eligible medical expenses. CDHP enrollment is currently estimated at approximately three to five million covered lives. The purpose of this paper is to examine the effect of ‘price’ on health plan choice. More specifically, we will determine whether the health care spending account in the new CDHP designs provides an incentive for consumers to choose these plans over conventional health insurance plans; and we will estimate the extent to which the ‘donut hole’ (i.e. the gap between the account and point where insurance coverage begins) is a disincentive for health plan choice. These two ‘prices’ are largely absent from the design of traditional health insurance plans, which feature relatively low deductibles and do not have health spending accounts. The research questions of this examination are: How does the introduction of Consumer Directed Health Plans (CDHPs) into mainstream health insurance affect plan choice? Specifically, what is the impact of the account, donut hole and deductible on the own-price elasticity of CDHPs? Study Design: This paper builds upon the plan choice estimation analysis from an earlier CDHP investigation. In that analysis, a logistic regression conditional upon the number of plan choices offered to a given employee was used. Our primary source of data for this analysis is the employee health plan choices from four large employers participating in a Robert Wood Johnson Foundation (RWJF) funded study. The data from employers represented approximately 250,000 covered lives. Each of these employers offers a CDHP along with traditional managed care plans. Population Studied: This is a study of employers that have offered CDHPs from 2003 to 2005. The analysis is relevant to the entire self-insured insurance market, as well as the individual market through simulation. Principal Findings: Early results show a positive impact of the health care spending account from which medical expenses are debited and negative responses to the new CDHP deductible developed as the difference between a traditional high deductible health plan and the consumer’s spending account. With respect to their respective elasticities, the CDHP deductible, known as the ‘donut hole,’ has a far more elastic price response than the health spending account. We examined the price elasticities in our health plan choice model, including employee premium, health account, donut hole and coinsurance. The largest of the elasticities is for the tax-adjusted employee premium. The least elastic response is for the employee health account. An interesting finding is the greater elasticity of coinsurance compared with the donut hole, or the difference between the deductible and the health account. Conclusions: Our results suggests that consumers have greater sensitivity to variations in coinsurance than to changes in the donut hole structure. These findings may challenge some detractors of CDHP plans who suggest consumers will not embrace a plan design with obvious increased cost sharing in the form of a large potential deductible, compared with coinsurance, a much more conventional method of costsharing. Implications for Policy, Delivery, or Practice: The evolution of CDHP benefit plan design has moved beyond early experiments. For these designs to be effective and attractive, the impact of their pricing structures must be understood. If CDHP designs are to be price to avoid the moral hazard potential suggest by our earlier work in Health Services Research (2004), attractive cost-sharing will have to be offered that encourages participation, while at the same, reduces the potential for higher than expected, risk-adjusted, medical expenditure. Primary Funding Source: RWJF, DHHS Call for Panels The Genomics Revolution: Challenges in Translating New Drugs and Diagnostics into Practice & Policy Chair: Kathryn Phillips, University of California, San Francisco Monday, June 26 • 2:00 pm – 3:30 pm Panel Overview: The genomics “revolution” is changing the inherent nature of the diagnostics, pharmaceutical, and biotech sectors and how medicine is practiced. The increasing ability to understand disease at the molecular level is a critical component of the larger trend towards “personalized medicine”. Personalized medicine is the targeting of interventions to individuals based on their specific characteristics, with the hope that such targeting will decrease costs and improve health outcomes. Our increased ability to target health care, however, raises many issues about translation from research into clinical practice and health policies. The genomics revolution has far-reaching implications across many sectors. Important questions include: What factors will determine the adoption of personalized medicine? How should new genetic tests be evaluated? Will health disparities increase if medicines are targeted only to specific populations? Can our system afford the high cost of many biological drugs? Who is in the driver’s seat in determining the value of new drugs and diagnostics and whether they should be reimbursed? This panel will address these challenging questions from several perspectives that will provide both an overview of key health services and policy issues as well as an update on what are currently the “hot” issues. Presentations will cover the economic and regulatory challenges to implementation of personalized medicine, the high cost of biological drugs in the US, recent changes in Medicare coverage and payment policies and the impact of the new Medicare prescription benefit, and evidence-based approaches to evaluating the use of genetic tests. We will draw from several sources and use multiple case studies to illustrate our points. ●The Paradigm Shift of Personalized Medicine: Economic & Policy Challenges Kathryn Phillips Presented By: Kathryn Phillips Research Objective: Quality of care, patient safety, and drug safety and effectiveness continue to be major issues. One proposed approach to addressing these concerns is personalized medicine, particularly the use of genetics to target medications (pharmacogenomics). The increased interest in personalized medicine, targeted therapies, and pharmacogenomics signals a paradigm shift from one-sizefits-all, “blockbuster” drugs toward niche markets. This paradigm shift has important implications across the board – for patients, providers, industry, insurers, and regulatory agencies. The objectives of this presentation are to: (1) Review the challenges in appropriately regulating the implementation of personalized medicine, focusing particularly on the role of the FDA, and (2) Review the challenges in implementing personalized medicine in clinical practice, using case studies to illustrate the larger issues. Study Design: We used case studies, literature review, and semi-structured interviews with key thought leaders from industry and government. Principal Findings: The advent of personalized medicine presents challenges to the FDA in pursuing its mandate of protecting the health and safety of the public. The FDA has responded by taking a proactive approach and has developed a variety of initiatives including development of advisory groups and inter-agency collaborative efforts, sponsorship of conferences, development of staff expertise, and development of guidance for genomic data submission, new testing approaches, and co-development of tests and drugs. Our case studies illustrate both currently successful uses of personalized medicine as well as future challenges. HER2/neu testing for Trastuzumab (Herceptin®, Genentech) therapy for breast cancer is one of the most familiar examples of biotechnology drugs used in clinical practice today and is considered a great success for the company that developed it and for the patients that have benefited. However, the story behind its development and approval illustrates many ongoing challenges that will increasingly be more widely relevant. For example, the lack of a clear gold standard test for HER2/neu was an obstacle to approval and continues to generate debate. In addition, Herceptin therapy is expensive and has not been shown to be cost-effective, and its approval was delayed in other countries because of the lack of evidence about costeffectiveness. Given the ongoing debate about the relevant diagnostic for identifying responders and uncertain costeffectiveness, Herceptin offers insights into the future of other biotech drugs with companion diagnostics. Another illustration is provided by microarray tests for mutations in CYP450 drug metabolizing enzymes, e.g., the AmpliChip CYP450® test (Roche Diagnostics), which was noted to be the “world’s first gene chip for broad diagnostic use”. These types of tests represent a significant increase in the potential application of pharmacogenomics because they are relevant to a wide range of individuals and drugs rather than only to a narrowly defined, high-risk population such as women with HER2/neu positive tumors. However, there are numerous challenges to their widespread application including regulatory ambiguities and the current lack of evidence about their clinical utility. Conclusions: Important economic and policy challenges include: Challenges in moving from the blockbuster model to personalized medicine; Challenges in the movement of biotech drugs and diagnostics through the pipeline from discovery to development to application; Challenges in regulating and evaluating drugs and diagnostics based on genetic information, including the role of the FDA, technology assessment, economic evaluation, and reimbursement policies. Implications for Policy, Delivery, or Practice: The experiences in implementing personalized medicine illustrate the complex issues involved in regulation of new technologies. This is particularly challenging when new technologies require integration of historically separate industries and regulations, as in the case of pharmacogenomics because it emerges from both the diagnostic and drug industries. The experiences also indicate the difficulties of health care assessment regulation in the U.S., which does not have a cohesive and comprehensive approach to technology assessment. Primary Funding Source: NCI, FDA ●High Cost, Low Coverage Drugs:Expenditures and Medicare Formulary Coverage For Biotechnology Drugs Jennifer Haas Presented By: Jennifer Haas Research Objective: The utilization of biotechnology drugs (“biologics”) has grown dramatically, yet little is known about expenditures and formulary coverage for these costly drugs. Objective is to examine: (1) recent trends in expenditures for the top 10 biotechnology drugs and (2) formulary coverage for these drugs under the Medicare Prescription Drug Plan. Study Design: Cross-sectional analysis of US sales of the top 10 biotechnology drugs from 2002 to 2004. Pharmaceutical sales data were extracted from the Knowledge Express Data Systems (UTEK Corporation). Formulary coverage was obtained from the Centers for Medicare and Medicaid Services. We calculate the percentages of prescription drug plans that include these biotechnology drugs in their formularies. We examine whether formulary coverage varies by drug, state (California vs Massachusetts), and plan type (stand-alone prescription drug plans vs Medicare Advantage drug plans). Population Studied: Medicare prescription drug plans in California (n=471) and Massachusetts (n=293). Principal Findings: Sales of the top 10 drugs have increased 47% from 2002 to 2004, with the biggest increase in sales of Aranesp (495%). A minority of these Medicare prescription drug plans included these drugs in their formularies, ranging from 12% for Rituxan to 35% for Remicade and Enbrel. Coverage for these drugs varies between California and Massachusetts. Stand-alone prescription drug plans are more likely to cover these biotechnology drugs than Medicare Advantage plans (77% vs 19%). Conclusions: Despite increasing sales of the top biotechnology drugs, a minority of Medicare plans in two states cover these products. Coverage varies by drug, state, and plan type. Stand-alone prescription drug plans may have better coverage for biotechnology drugs compared to Medicare Advantage drug plans. Implications for Policy, Delivery, or Practice: Careful evaluation of the value and formulary coverage of biotechnology drugs is needed. Primary Funding Source: NCI ●Medicare and New Technology Patricia Keenan Presented By: Patricia Keenan Research Objective: CMS national coverage decisions hold consequences for beneficiary health, Medicare costs, and availability of new treatments. Biotechnology in particular poses challenges for Medicare given its high cost, the potential for individualized treatments, and the lack of generics. Research Objectives: 1) Assess major changes in Medicare coverage and payment policy for new treatments, including biotech treatments. 2) Qualitatively examine the role of evidence quality, political attention, and costs in Medicare national coverage decisions. Study Design: Synthesis of regulatory changes in Medicare coverage and payment, and case studies and interviews of Medicare coverage decisions for 13 treatments. Principal Findings: Since 1999, the Medicare program has made substantial changes to incorporate a greater role of clinical evidence and expand opportunities for public input in coverage and payment decisions for new treatments. The case studies suggest that national coverage decisions show more variability in scope of coverage relative to the evidence for treatments with greater uncertainty in clinical evidence and policy goals. CMS creates tailored conditions of coverage to respond to uncertainty in clinical evidence and balance safety, access, and cost considerations. Some decisions interpret uncertain evidence more broadly, particularly for salient diseases with limited treatment alternatives. Other decisions interpret uncertain evidence more narrowly, particularly when treatment costs are potentially very high, and/or political input is mixed or limited. Conclusions: Medicare new technology policy poses substantial challenges for policymakers seeking to balance goals to promote access to beneficial treatments while minimizing the pressure of rising Medicare spending. Implications for Policy, Delivery, or Practice: Medicare policies for new medical treatments are likely to attract further attention as the Medicare prescription drug benefit expands the set of treatments that may be considered in the national coverage process. Challenges are also likely to become more pronounced as additional costly new technologies, such as specialized biotech treatments, become available to treat rare or life-threatening diseases with limited treatment alternatives. Primary Funding Source: RWJF, NIA ●Moving Forward on Evidence Based Assessment of Genomic Applications: The EGAPP Project Katrina Armstrong Presented By: Katrina Armstrong Research Objective: Background: The genomics revolution has created a pressing need for reliable and unbiased assessments of the utility of genetic tests and genomic technologies that can be used by a diverse set of stakeholders including providers, consumers, payers, public health officials and other policy makers. Objectives: The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Project is a three year model project funded by the CDC to develop a systematic, evidence-based process for evaluating genomic applications in transition from research to clinical and public health practice. The key characteristics of the EGAPP project are: (1) inclusion of a broad range of expertise; (2) independent, objective review linked to evidence; (3) focus on genomic technologies not addressed by other evidence based review processes; (4) engagement of a wide range of stakeholders; and (5) integration of experience from genetics advisory panels and existing U.S. and international processes for evidence based technology evaluation. Study Design: A 13 member Working Group was assembled representing a broad range of expertise (e.g. evidence based review, primary care, medical genetics, laboratory practice, epidemiology, health economics and bioethics). This independent Working Group meets quarterly and has formed subcommittees to accomplish concrete goals. Pilot studies and literature reviews have been used to answer preliminary questions related to the development and implementation of the EGAPP procedures. Principal Findings: The three initial subcommittees (Topics, Methods and Outcomes) have created novel approaches for prioritizing and selecting topics for review, developing analytic frameworks for the complex clinical and public health questions raised by genomic technology, and identifying the relevant outcomes across a broad set of domains including clinical, psychological, social and ethical consequences. Working titles for the first two topics selected for evidence review were “Screening for Hereditary Nonpolyposis Colorectal Cancer in Newly Diagnosed Colorectal Cancer Patients” and “Testing for Cytochrome P450 Polymorphisms in Adults with Non-Psychotic Depression Treated with Selective Serotonin Reuptake Inhibitors.” The evidence based reviews for these topics are underway through contracts with the Agency for Healthcare Research and Quality Evidence Based Practice Centers. The next steps are to identify and develop the products that will be disseminated to the target audiences once the reviews are completed, create sustainable processes for topic identification and selection, develop frameworks for incorporating the “gray” literature in the review process, and involve diverse stakeholders. Conclusions: Since its inception in 2005, the EGAPP Working Group has made substantial progress towards developing and implementing systematic processes for the evaluation of genomic technologies. This progress has built upon prior experiences with evidence based review, genetics advisory panels and public health policy. Implications for Policy, Delivery, or Practice: EGAPP has the potential to influence the translation of genomic technology into clinical and public health practice. The implications for the move to personalized medicine will be highlighted. Primary Funding Source: CDC Call for Panels Medical Surge Capacity Chair: Shayne Brannman, The CNA Corporation Monday, June 26 • 3:45 pm – 5:15 pm Panel Overview: Given the threat of terrorism and natural disasters, medical and public health systems face an increasing probability of a major public health emergency that will severely challenge their ability to adequately care for large numbers of patients. The response to a large-scale public health or medical emergency is generally a local responsibility. Initially, this response could involve multiple jurisdictions in a region, until sufficient external assistance arrives from neighboring states and/or the Federal government. Our panel explores how public health emergency preparedness research is currently being used in “real world” policy and operational settings to address surge capacity issues, and how the outcomes of this research are helping policy-makers shape future plans. We will discuss how research sponsored by the Agency for Healthcare Research and Quality (AHRQ) was used as the foundation for the development of the Federal Medical Station prototype, which was used during hurricanes Katrina and Rita to address bed capacity needs. Moreover, we will discuss gaps in preparedness legislation and policies. Management systems that need to be in place to better integrate medical resources during large-scale emergencies will be highlighted. An official with significant research and government health experience will moderate our panel. Panel membership includes an emergency medicine director from a large medical center; a senior policy manager within the Department of Health and Human Services; the project manager of the recently published Medical Surge Capacity and Capability Handbook; and a senior policy analyst with firsthand experience working on interagency medical issues. ●Rocky Mountain Regional Care Model Stephen Cantrill, M.D. Presented By: Stephen Cantrill, M.D., Associate Director of Emergency Medicine, Emergency Medicine, Denver Health Medical Center, 777 Bannock Street, Denver, CO 80204; Tel: (303) 436-7174; Fax: (303) 436-7541; Email: stephen.cantrill@dhha.org Research Objective: Rural areas face unique and demanding challenges when assessing the best potential solution to address hospital surge capacity needs, by either augmenting hospitals' capabilities or establishing alternative care sites. Federal Region VIII represents 3 percent of the country's population, but comprises about 16 percent of the land area. This region is the most rural region of the country with a significant portion classified as frontier. There are 28,100 community hospital beds in the region, but almost half of the beds are in Colorado and Utah, which comprise 70 percent of the region's population. Under an Agency for Health Research and Quality (AHRQ) grant, a Rocky Mountain Regional Care Model for Bioterrorist Events (RMBT) Working Group was established to address medical surge capacity issues/needs for Federal Region VIII (Colorado, Montana, North Dakota, South Dakota, Wyoming, and Utah). Study Design: The RMBT was an inter-agency and multidisciplinary working group that brought together key stakeholders in the region to identify surge capacity issues that were considered important and where solution development was necessary. Two well-known emergency medicine physicians, from a large academic medical center in Denver, led the RMBT Working Group. Through this collaboration and experience of the RMBT working group members, several products and tools were developed to address surge capacity issues for this region. Most notably, U.S. Northern Command identified a need to develop a tool to assist planners in selecting an alternative care site for providing medical care to victims of a bioterrorist incident. A tool was created through collaboration between the RMBT Working Group members and facility engineers that assists medical planners in ranking and scoring alternative care sites based on adequacy of facility characteristics such as ventilation, plumbing, and food supply and preparation areas. Potential alternative care sites could include schools, motels, recreation centers, churches, National Guard facilities, and stadiums. In order to address supplying and staffing these alternative care sites, the RMBT group discussed several alternatives. Population Studied: Federal Region VIII (Colorado, Montana, North Dakota, South Dakota, Wyoming, and Utah). Principal Findings: The group's solution to address bed, supply and equipment needs was the creation of medical caches that are stored for use in a fixed location or that can be transported to a remote site in a trailer. Three cache level lists were developed: -Level I, Hospital Augmentation Cache -Level II, Regional Alternative Care Site Cache -Level III, Comprehensive Alternative Care Site List Each of these lists includes cots and other supplies, but does not include a "facility." These caches are to be used in conjunction with an existing structure: either hospital or alternative care site. Pharmaceuticals are not included in the caches as the Strategic National Stockpile addresses this need. Conclusions: For mass casualty events, surge bed capacity can be created by pre-identifying alternative care sites and establishing caches of required materials and supplies. Implications for Policy, Delivery, or Practice: The findings from this research was used by the Office of Public Health Emergency Preparedness at HHS to help shape the national federal medical station prototype(deployable hospital program) used in hurricanes Katrina and Rita. Primary Funding Source: AHRQ ●Federal Medical Station Eric Trabert, M.P.H., Epidemiology, Monica Giovachino, M.S. Presented By: Eric Trabert, Masters Public Health, Epidemiology, Research Analyst, Healthcare Operations Team, The CNA Corporation, 4825 Mark Center Drive, Alexandria, VA 22311-1850; Tel: (703) 824-2260; Fax: (703) 824-2256; Email: trabere@cna.org Research Objective: The Office of Mass Casualty Planning within the Department of Health and Human Services (HHS) has developed a federal contingency care program to provide quarantine and bed surge capability during a catastrophic event in coordination with state and local health authorities. The prototype of this program is the Federal Medical Station (FMS), which was deployed after Hurricanes Katrina and Rita in response to the severe damage to the health infrastructure and expected demand for hospital beds. In a study sponsored by HHS, we performed an evaluation of FMS operations during Hurricanes Katrina and Rita. The study focuses on the integration of the FMS program into state and local emergency response operations. Since 9/11, Federal, state, and local authorities have been preparing for mass casualty events and developing plans to address shortfalls in surge bed capacity. Both HHS and the U.S. Department of Homeland Security are developing programs to provide extra capacity. Similar surge capacity initiatives are in place at state and local levels through HHS grant programs administered by the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and other agencies. Study Design: Our study used a three-step process of observation, reconstruction, and analysis. We deployed analysts to observe FMS operations during Hurricanes Katrina and Rita. These analysts kept detailed logs of their observations, conducted structured interviews with personnel involved in the response, and collected field data (e.g., operational logs, situation reports, and administrative records). We supplemented these data by conducting structured interviews with personnel located in other areas, such as Washington, DC and regional command centers, to gain additional information and insight on the response. We used the data that we collected to develop a timesynchronized database that included decisions, events, and actions related to FMS operations. We used the interviews to identify common themes and validate the reconstruction database. We also compiled data on personnel deployments and patient care where available. We analyzed key issues and identified lessons learned, performed a descriptive analysis of the types of medical and public health needs, and provided recommendations for improving FMS operations in the future. Population Studied: Site visits were conducted in Lousiana, Mississippi, Texas, and the Strategic National Stockpile. Principal Findings: Even as a prototype, the FMSs cared for a wide variety of patients in Louisiana, Mississippi, and Texas. As a result of this program status, many of the standard operating procedures for activating, deploying, setting up, and managing operations during an emergency were still in development. As one would expect, the training program associated with the FMS was also under development resulting in a very limited number of personnel trained to use, deploy, operate, and manage the asset. As a result, FMS assets were not always used effectively. One of our key findings is the need to institutionalize the FMS program at the regional level by engaging state and local public health authorities into a coordinated planning and training effort. Conclusions: The final report is still being prepared therefore final conclusions are still being developed as of this writing. Implications for Policy, Delivery, or Practice: Our analysis and recommendations can help guide public health authorities at all levels of government prepare for the next hurricane and other mass casualty events. Primary Funding Source: HHS ●Medical Surge Capacity and Capability Handbook CAPT Ann Knebel, Ph.D., Joe Barbera, M.D., Anthony Macintyre, M.D., Eric Trabert, M.S., Shayne Brannman, M.S. Presented By: CAPT Ann Knebel, Ph.D., Acting Deputy Director, Office of Mass Casualty, U.S. Department of Health and Human Services, Office of Public Health Emergency Preparedness, 200 Independence Avenue, SW, Washington, DC 20201; Tel: (202) 205-5129; Email: ann.knebel@hhs.gov Research Objective: Medical and health systems in the United States face the increasing probability of major emergencies or disasters involving large numbers of casualties and/or victims with highly specialized medical needs. An effective and coordinated response to such incidents requires the implementation of management systems that establish a methodology for managing medical and health response, as well as the development and maintenance of preparedness programs. Under sponsorship of the Department of Health and Human Services (HHS), the authors developed the Medical Surge Capacity and Capability (MSCC) Management System. The MSCC applies valid principles of emergency management and the Incident Management System (IMS) to describe how to manage, within a single system, the diverse health and medical entities involved in incident response. Study Design: The MSCC is based on the Medical and Health Incident Management (MaHIM) System, the first published U.S. effort to conceptually address the medical and health management issues that arise during major emergencies or disasters. We worked with the authors of MaHIM to translate their academic concepts into a practical, operationally oriented guidance for medical and health emergency planners. The study team also convened a panel of subject matter experts from across the country representing such diverse disciplines as public health, emergency medicine, emergency management, public safety, and the private sector to identify the most important themes to be presented in the handbook and to synthesize key and difficult concepts into an readily understandable format. Population Studied: Not Applicable Principal Findings: The MSCC Management System describes a framework of coordination and management integration across six tiers of response, ranging from the individual healthcare facility through jurisdictional, state, and federal government levels. It is designed to promote the integration of existing incident management programs used by hospitals, public health, and traditional response entities into an overarching management system for major medical response. Thus, health and medical disciplines can use the MSCC to coordinate effectively with each other, and to integrate with other response disciplines (e.g., public safety). Moreover, the MSCC guides the development of a health and medical response that is consistent with the National Incident Management System (NIMS). Conclusions: Examinations of major public health and medical emergencies reveal exceptionally complex management scenarios. The MSCC Handbook describes a management structure, based on valid emergency management and incident management principles, for the medical and health response to be orchestrated as a single system. Implications for Policy, Delivery, or Practice: The completed MSCC Handbook was distributed to HRSA and CDC regional and program coordinators, in additional to key health and medical response policy makers involved with coordinating emergency support function 8 of the National Response Plan. Primary Funding Source: HHS ●Integration of Federal, State, and Local Medical Resources in Catastrophic Events Matthew Payne, M.P.A. Presented By: Matthew Payne, M.P.A., Senior Advisor, Public Health, Healthcare Operations Team, The CNA Corporation, 4825 Mark Center Drive, Alexandria, VA 22311-1850; Tel: (703) 824-2043; Fax: (703) 824-2256; Email: paynem@cna.org Research Objective: The responses to Hurricanes Katrina, and Rita exposed the fragile relationship between communities, states and the Federal government as it relates to the provision of medical support to disasters. In the face of a catastrophic emergency, medical requirements can quickly overwhelm the capabilities of a community, state, region and the Federal government. Key to any successful response is the requirement of planners to understand the assets available in their inventory, the capabilities offered and the timeliness of their response. To better understand these relationships and provide recommendations for future system improvements, we are conducting an independent study that highlights the inherent roles and responsibilities of both governmental and non-governmental organizations. Additionally, the study identifies the challenges associated with providing a timely medical response to catastrophic disasters. All disasters are inherently local. Regardless of the eventual size, the first impacts of a disaster are felt locally. However, local resources are sometimes overwhelmed by the magnitude and resource requirements of the event. In these cases, assistance is required from community neighbors, the state, neighboring states and sometimes the Federal government. Using the experience and history of an actual response, this study examines the commonalities and constraints present in the authorities used by each organization to provide medical support. Study Design: Legislative and regulatory searches are being used to establish the inherent roles and responsibilities of the respective organizations. Internet searches and organizational interviews are being used to establish the types, capabilities and quantities of resources available and used to support the response. The combined products address: (1) the roles and responsibilities of individual facilities / organizations (e.g., hospitals and healthcare institutions) to care for their patients during catastrophic disasters; (2) the roles and responsibilities of the state to support these institutions, particularly private facilities; (3) non-Federal resources that can independently support an institution or state in the provision of care; and (4) the roles of the Federal government in supporting states and individual institutions. Population Studied: N/A Principal Findings: Study begun in December 2005 and will be completed in May 2006. Conclusions: Study begun in December 2005 and will be completed in May 2006. Implications for Policy, Delivery, or Practice: Throughout the study, we are comparing the relative costs and benefits of the different capabilities, assets and mechanisms. In assessing the relative benefits of particular approaches and assets, costs and benefits are weighed by timeliness of the asset, the capabilities provided and the cost burden to request its use. Based upon these results, we are drawing conclusions regarding the current systems to support the medical response to catastrophic disasters, making recommendations to improve the timeliness and efficiency of the overall response. Primary Funding Source: CNA Corporation (Self-Initiated) Call for Panels Implications of Public and Private Reporting of Performance Data: Mechanisms for Driving Quality Improvement Chair: Deirdre Mylod, Press Ganey Associates, Inc Tuesday, June 27 • 8:45 am – 10:15 am Panel Overview: Public vs. private reporting of quality information creates differential impact on hospitals’ response to feedback about their levels of performance. It is suggested that creating concern regarding public image and reputation and the provision of feedback itself may be the primary mechanisms by which organizations are prompted to engage in quality improvement activities following public reporting initiatives. These mechanisms may be strongest for organizations receiving public feedback that their performance is sub-par. This panel will begin with results and discussion of an experimental study comparing the effects of public, private and no reporting of data on hospitals and consumers. Information will then be provided regarding a statewide effort for cyclical public reporting in the state of Rhode Island interspersed with interim periods of private reports to hospitals. Rates of change will be compared between the public and private reporting cycle times with comparisons to national normative rates of change for hospitals receiving private reports. Finally data will be presented describing national trends in change based upon private reporting of patient perceptions of care. These trends will note facility characteristics that are associated with greater or lesser rates of change over time. Discussion throughout will focus on the mechanisms for change and the extent to which data from different research activities support these mechanisms. ●Impact of Public and Private Hospital Performance Reports on Quality, Market Share and Reputation Judith Hibbard, Dr. P.H. Presented By: Judith Hibbard, Dr. P.H., Professor, Department of Planning, Public Policy & Management, University of Oregon, 1209 University of Oregon, Eugene, OR 97403-1209; Tel: (541) 346-3364; Fax: (541) 346-2040; Email: jhibbard@uoregon.edu Research Objective: The purpose of these studies was to understand the effects of public vs. private reporting of clinical performance data on hospitals’ initiation and adoption of quality improvement activities and subsequent improvement in quality and on consumers’ knowledge about quality differences and choices regarding health care providers. Study Design: This study uses an experimental design in which hospitals received a public report of their clinical performance data, a private report of their data, or no report showing how their organization fared as compared to others. Hospitals were then surveyed regarding their beliefs about public reporting as well as their subsequent quality improvement activities. Patients were surveyed regarding their recall and use of the publicly reported information. Two- years later a follow up investigation showed actual hospital improvement and sustained changes in hospital reputation. Choice and market share were largely unaffected. Population Studied: The population studied included a set of hospitals included in a public report of clinical data. The other hospitals in the state were randomly assigned to receive either private confidential reports or no feedback on their performance. Principal Findings: The public reporting condition was associated with a higher mean number of quality improvement activities initiated related to the areas identified in the public report. In particular, hospitals with poor performance had significantly greater efforts for quality improvement if their data were made public. Hospitals in the public report condition were in general more likely to take some action toward quality improvement in the reported areas. Subsequent follow-up showed that public report hospitals made significantly more improvements in care especially for those with poor initial performance. Consumers who received evaluable information regarding hospital performance recalled the information and were able to more accurately identify high and low performers. Impact on hospital reputation was sustained over time. Market share did not change as a result of the public reporting. Conclusions: Public reporting of clinical quality information stimulated more quality improvement activities and more positive results over and above what was seen for hospitals receiving only private results. It is expected that in order for this effect to be noted, reports must be highly evaluable and widely disseminated and hospitals must anticipate that future public reports will occur. Implications for Policy, Delivery, or Practice: The data suggest that the use of evaluable public reporting may stimulate change in performance primarily through the mechanisms of concern regarding reputation as well as through the provision of feedback. These mechanisms may be particularly strong in situations where larger variations in care exist and may be felt most by hospitals with poorer initial performance. Primary Funding Source: RWJF change are compared to a national sample of hospitals receiving only private reports. Population Studied: Study population focuses on general acute care inpatient hospitals in the state of Rhode Island. The study uses continuous performance data as measured by patient surveys of care over the last 3 years. Principal Findings: Rates of improvement did not differ between public reporting periods and periods where only private reporting of data was available to hospitals. Rates of improvement were not greater for the Rhode Island sample than for a national sample of hospitals receiving public reports. Rhode Island hospitals used collaborative sessions immediately following public reporting cycles to share best practices and to focus collective efforts on areas where care could be improved. Conclusions: Findings suggest that in this particular climate where public reporting of data had become the norm, the differential impact of publicly reported data was not discernable. Instead, continuous rates of incremental change were noted regardless of the timing of public reporting. These findings may support the hypothesis that feedback itself promotes change. Alternatively, the relatively high performance of Rhode Island hospitals may preclude the public report from having the differential effect that has been noted elsewhere. Finally, the climate in Rhode Island which is accustomed to public reporting as an corollary of QI efforts rather than a feared impetus for QI may have effected the way hospitals responded to public and private reporting of data. Implications for Policy, Delivery, or Practice: Creating an environment where public reporting is both accepted and considered secondary to the purpose of quality improvement may reduce hospital concerns regarding initial reports and allow them to work together to learn effective means of improving care. Primary Funding Source: No Funding ●Rates of Change During Public and Private Reporting Cycles of Hospital Performance: Implications for Mechanisms Driving Quality Improvement Cathy Duquette, Ph.D., RN, CPHQ Presented By: Deirdre Mylod, Ph.D., Vice President, Research and Public Policy, Research & Development, Press Ganey Associates, Inc., 404 Columbia Place, South Bend, IN 46601; Tel: (574) 232-3387; Fax: (574) 232-3485; Email: dmylod@pressganey.com Research Objective: The objective of this research was to understand the normative amount of change in patient evaluations of quality over a 12 month time frame and to determine if hospitals’ success with making improvements in quality based upon private report of patient survey data varies by hospital characteristic, such as: size of hospital, religious affiliation, teaching status, region of the country, etc. Study Design: The study uses retrospective quantitative data gathered from patients in a continuous fashion over a 15 month time frame and compares hospital level performance from fourth quarter calendar year 2004 with fourth quarter calendar year 2005. Population Studied: The population studied included 815 general acute care hospitals that continuously survey their patients regarding the quality of care and service provided during an inpatient stay. Patient populations surveyed include Presented By: Cathy Duquette, Ph.D., RN, CPHQ, Vice President, Nursing and Patient Care Services, Nursing and Patient Care Services, Newport Hospital, 11 Friendship Street, Newport, VA 02840; Tel: 401.846.6400; Email: cduquette@lifespan.org Research Objective: The purpose of this study was to understand the effect of public vs. private reporting of patient survey information on rates of change in patient perception of hospital quality. Study Design: The paper describes the rates of improvement in scores from patient surveys following the legislation of regular cycles of public reporting of patient survey data in the state of Rhode Island. Comparisons are made between rates of change near, that is pre or post, public reporting time frames to rates of change when only private reporting with benchmarking is available to participating hospitals. Rates of ●Hospital Characteristics and Normative Rates of Improvement Using Private Feedback for Quality Improvement Deirdre Mylod, Ph.D., Jessica Langager, B.A. a random sample of all discharges of all insurance types, ages and medical service lines. Principal Findings: Hospitals vary in their ability to effect positive change based upon private reporting of patient evaluations. Some hospital characteristics are associated with an organization's ability to respond effectively with quality improvement efforts. Specifically, a Chi-square test indicated significant associations between region of the country, bed size and teaching status with the hospitals' demonstrated rate of change over a year cycle. Additionally, the hospitals' baseline performance was significantly and inversely associated with the amount of change seen over time indicating that lower performers had greater rates of positive change. Conclusions: From these data we can conclude that not all organizations are able to respond to private feedback in the same fashion. Some hospitals are able to respond positively and to use the data for quality improvement. Other types of organizations may face greater challenge in changing the quality of care for the better. Implications for Policy, Delivery, or Practice: From this study we learn about factors that may be important for managing change in the face of public reporting. Hospitals that respond well to private feedback may be best poised to show dramatic improvements when the stakes are raised and public reporting of patient views are available. However, other types of organizations may need significant support and direction to effect positive change. As in findings from public report studies, the effect of private reporting appears most positive for those organizations with lower baseline performance. Primary Funding Source: Press Ganey Associates Call for Panels Challenges in Developing a Quality Monitoring System for Cancer Care Chair: Melissa Hughes, Dana-Farber Cancer Institute Tuesday, June 27 • 10:30 am – 12:00 pm Panel Overview: In recent years, based on the evidence available, the quality of cancer care has been reported as uneven at best. In 1999, the Institute of Medicine released a report “Ensuring Quality Cancer Care”, concluding that there are no uniform standards to measure the quality of cancer care and therefore, tremendous gaps in our knowledge of the level of quality of care exist. The report recommended that “a cancer data system is needed to provide quality benchmarks for use by systems of cancer care.” Many efforts are now underway to create a routine quality-monitoring system for populations of patients with cancer. To this end, the National Comprehensive Cancer Network (NCCN) has developed a multi-institutional quality monitoring system to assess quality of breast cancer care for its participating cancer centers. The NCCN’s evidence-based guidelines and a uniform prospective data system provide a framework with which to measure quality of care. First, the panel will describe the components of the quality monitoring system, specifically the features of the outcomes database. We will then discuss institutional variation in quality indicators as defined by the NCCN guidelines; whether performance on selected quality indicators is associated with overall institutional performance; measures demonstrating underuse and overuse of post-mastectomy radiation; the impact of age on receipt of guidelinerecommended treatment; and a methodological approach to select priorities for quality improvement from this unique set of quality measures. Presentations will address the goals, implications and generalizability of NCCN’s quality monitoring system and highlight practical and methodological challenges to date. ●Development and Applications of Quality Measures: Studying Guideline-Concordant use of Radiation Therapy after Mastectomy in the National Comprehensive Cancer Network Rinaa S. Punglia, M.D., M.P.H., Melissa E. Hughes, MSc, Michael A. Bookman, M.D., Rebecca A. Ottesen, MS, Joyce C. Niland, Ph.D., Jane C. Weeks, M.D., MSc Presented By: Rinaa S. Punglia, M.D., M.P.H., , Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; Tel: 617-632-3972; Fax: 617632-2270; Email: rinaa_punglia@dfci.harvard.edu Research Objective: The National Comprehensive Cancer Network (NCCN) publishes comprehensive clinical practice guidelines and collects detailed clinical information about patients treated in its participating centers. Both of these functions are essential to the development of the NCCN’s quality monitoring system to assess the quality of cancer care delivered. We present an example of using quality measures to examine underuse and overuse of post-mastectomy radiation (PMRT), as defined by the NCCN practice guidelines, among women with Stage I-II breast cancer. Study Design: Current NCCN guidelines recommend PMRT for women at high risk of recurrence, as defined by tumor involvement in four or more axillary nodes, tumor size greater than 5 centimeters, and/or positive surgical margins. The guidelines also define patients at low risk of recurrence for whom PMRT is not recommended. Finally, the guidelines identify a cohort of women, those with one to three positive axillary nodes and/or close surgical margins, for whom the value of PMRT is uncertain. Using the framework created by the NCCN treatment guidelines, patients who received mastectomy were classified into three cohorts according to whether guidelines (1) recommended PMRT, (2) recommended against PMRT, or (3) made no definitive PMRT recommendation. We defined the absence of PMRT in the first cohort as underuse, and receipt of PMRT in the second cohort as overuse. Multivariable logistic regression was applied to each cohort to investigate the association of clinical and sociodemographic factors with receipt of PMRT. Population Studied: We analyzed consecutive patients at eight NCCN institutions with newly diagnosed unilateral Stage I or II breast cancer who received mastectomy as definitive surgery between 7/97-12/03 and continued to receive care at the institution for at least 365 days after presentation. Principal Findings: We identified 2,945 eligible women for our analysis who were then separated into treatment cohorts. We found that 87.0% (367/422) received PMRT in the “recommend PMRT” cohort, 4.6% (79/1710) in the “recommend against PMRT” cohort, and 33.2% (258/777) in the “consider PMRT” cohort. The only factor associated with underuse in the “recommend PMRT” cohort was not receiving chemotherapy (OR=0.07, p<0.0001). In addition to tumor characteristics, factors associated with overuse in the “recommend against PMRT” cohort included NCCN institution (OR=0.26-1.48, p=0.02) and receipt of chemotherapy (OR=2.31, p=0.02). Factors associated with PMRT in the “consider PMRT” cohort included NCCN institution (OR=2.0-13.8, p<0.0001), patient age (under 50 years: OR=3.24, 50-70 years: OR=1.92, relative to above 70 years; p=0.003), lack of early breast reconstructive surgery (OR=0.60, p=0.01 for those with reconstruction), and tumor characteristics. Conclusions: Concordance with definitive treatment recommendations was high in our centers. However, when current evidence does not support a definitive recommendation for PMRT, treatment decisions appear to be influenced not only by patient age and clinical characteristics, but especially by institution-specific patterns of care. Implications for Policy, Delivery, or Practice: NCCN’s evidence-based guidelines and a uniform data system provide an informative framework with which to measure and study quality of care received. Primary Funding Source: NCCN ●Institutional Variation in Concordance with Guidelines for Breast Cancer Care in the National Comprehensive Cancer Network: Implications for Choice of Quality Indicators Melissa E. Hughes, MSc, Jane C. Weeks, M.D., MSc, Melissa E. Hughes, MSc, Joyce C. Niland, Ph.D., Rebecca A. Ottesen, MS, Richard L. Theriault, DO, MBA, Stephen B. Edge, M.D. Presented By: Melissa E. Hughes, MSc, Project Manager of NCCN Breast Cancer Outcomes Database, Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; Tel: 617-632-2268; Fax: 617632-2270; Email: melissa_hughes@dfci.harvard.edu Research Objective: Concordance with the National Comprehensive Cancer Network (NCCN) breast cancer guidelines is examined annually across the NCCN institutions as part of an overall quality monitoring strategy. Using these concordance analyses, we tested the potential to differentiate performance at an institutional level. We also examined whether institutional performance on two widely accepted guidelines were valid indicators of overall performance across all guidelines. Study Design: To examine institutional performance on guideline concordance, we calculated and compared each institution’s standardized mean percent concordance for 19 guidelines spanning treatment recommendations for DCIS, Stage I, II and III breast cancer patients. Multivariable logistic regressions were used to determine whether inter-institutional differences in concordance for local and systemic therapy guidelines existed, after controlling for patient sociodemographic and clinical characteristics. We selected two candidate quality indicators of breast cancer care based on the strength of the evidence base: radiation therapy after breastconserving surgery in Stage I-II patients and adjuvant chemotherapy in Stage II, node positive, ER negative patients. We then used correlation analyses at the institution level to determine whether an institution’s performance on these two quality indicators was associated with its overall guideline concordance. Population Studied: From the NCCN outcomes database, we selected all women newly diagnosed with Stage 0, I, II, and III breast cancer who presented for care at eight participating NCCN institutions between July 1, 1997 and June 30, 2000. Patients were included in the analyses if they were followed at the NCCN institution for at least 365 days post presentation. The final sample was 4,315 women. Principal Findings: Mean concordance with NCCN breast cancer guidelines was generally high. However, guideline concordance varied across institutions, from a low of 74% (95% CI: 70-77) to a high of 84% (95% CI: 82-85). Interinstitutional differences in concordance with local (p<.0001) and systemic therapy (p=0.0006) guidelines persisted, even after controlling for patient socio-demographic and clinical characteristics. Concordance also varied by the level of evidence upon which the guidelines are based, with centers consistently demonstrating higher levels of concordance with guidelines based on higher-quality evidence. Mean percent concordance ranged from 81% to 91% for guidelines based on higher-level evidence, as compared to 59% to 73% for guidelines based on lower-level evidence. No significant correlations were found between an institution’s performance on the two candidate quality indicators and its performance on the other breast cancer treatment guidelines. Conclusions: Even among these NCI-designated comprehensive cancer centers, we found significant variation in concordance with guidelines across institutions. Since performance on two commonly recommended indicators did not predict an institution’s overall performance across all guidelines, we are exploring other strategies that might serve as efficient but robust alternatives to comprehensive concordance monitoring. Implications for Policy, Delivery, or Practice: Our experience suggests that comprehensive quality monitoring not only supports assessment of institutional performance, but also identifies opportunities for improvement and achievable quality benchmarks. Therefore, if a practical strategy for widespread dissemination of such monitoring can be identified, it could generate substantial improvements in the outcomes of women with breast cancer. Primary Funding Source: NCCN ●The National Comprehensive Cancer Network (NCCN) Internet-based Outcomes Database System Joyce C. Niland, Ph.D., Layla Rouse, MS, Monir Corona, Doug Stahl, Ph.D. Presented By: Joyce C. Niland, Ph.D., Director of Data Coordinating Center, Division of Information Sciences, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA 91010-3000; Tel: 626-359-8111; Fax: 626-301-8802; Email: jniland@coh.org Research Objective: While variations in care have been associated with both sub-optimal patient outcomes and increased treatment costs, it remains extremely difficult to measure and monitor quality of care routinely. An obstacle in quality measurement is inadequate information systems to support the effort. The NCCN Oncology Outcomes database was developed to support the creation of a multi-institutional quality monitoring system for the NCCN. Study Design: The NCCN Oncology Outcomes Database was designed for prospective data collection of detailed sociodemographic, clinical, treatment and outcomes data on eligible cancer patients across multiple sites into a single centralized data repository. Selection of clinical data to be collected included elements essential for measuring concordance with the NCCN oncology care guidelines. The database system accommodates two data input strategies: web-based forms to accommodate chart review and data entry based on inpatient and outpatient medical records by dedicated data managers, as well as downloads from existing institutional databases to achieve maximum efficiency. Population Studied: To date, the NCCN database collects data on patients with breast cancer, Non-Hodgkin Lymphoma (NHL), and colorectal cancer, with additional major cancer diagnoses planned for incorporation in the future. Principal Findings: As the NCCN Data Coordinating Center, the Division of Information Sciences at City of Hope National Medical Center is responsible for the development and deployment of this multi-institutional prospective database. In continual use since 1997, over 25,000 cancer patients have been enrolled in the database to date, including over 300 variables within data records collected longitudinally from different data sources. Not only does the system support the detailed data collection needed to measure quality, but it also provides the functionality to feedback performance on guideline concordance to NCCN providers via patient summary reports. Combining the familiarity of the Web environment with its cross-platform compatibility and secure real-time data access/submission capabilities, the NCCN database has been readily adopted by 15 participating centers to date. In user surveys, the majority rated the system as “good” to “excellent” with respect to layout and flow of the Web site, ease of downloading documents, ease of use as a database entry system, usefulness of on-line logic checks, and ease of use as a database reporting system. Requirements for a successful outcomes database will be described, and a demonstration of the NCCN system provided. Implications for Policy, Delivery, or Practice: Our experience with the NCCN system has shown that a robust health quality information system has the potential to support efforts to implement routine quality measurement and monitoring through the capture, codification, and analysis of information about patient treatments and related outcomes. The additional presentations within this panel will highlight some of these important healthcare quality findings and insights to date, made possible through the NCCN database. Primary Funding Source: NCCN ●The Impact of Age on the Receipt of GuidelineRecommended Systemic Therapy for Breast Cancer Eva M. Lepisto, MSc, Richard L. Theriault, DO, MBA, Joyce C. Niland, Ph.D., Eva M. Lepisto, MSc, Stephen B. Edge, M.D., Rebecca A. Ottesen, MSc, Jane C. Weeks, M.D., MSc Presented By: Eva M. Lepisto, MSc, Director of Outcomes Database Operations, , National Comprehensive Cancer Network, 500 Old York Road, Suite 250, Jenkintown, PA 19046; Tel: 908-918-1020; Fax: 908-918-1021; Email: lepisto@nccn.org Research Objective: Because older women are underrepresented in clinical trials, optimal care for many women with breast cancer has not been well-defined. Furthermore, comprehensive data on adjuvant treatment choice in non-Medicare enrollees, and on use of tamoxifen in all age groups, are limited. To inform the development of quality indicators for use in older women, we evaluated the impact of age on the receipt of guideline-recommended systemic therapy for breast cancer in the National Comprehensive Cancer Network (NCCN). Study Design: We developed adjuvant therapy quality measures from the NCCN breast cancer guidelines, and applied them to patients in the NCCN Breast Cancer Outcomes Database. Based on detailed clinical characteristics, each patient was assigned to a specific guideline node, according to the guideline version in place at the time of patient’s presentation. Univariate and multivariable analyses were conducted to evaluate predictors of treatment among women for whom guidelines recommended chemotherapy (with or without tamoxifen) and those for whom guidelines recommended tamoxifen alone. Multinomial logistic regression, controlling for patient, tumor, and clinical factors, was applied to assess whether age (in decades) was associated with 3 possible outcomes: receipt of recommended therapy, non-recommended therapy, or no therapy. Population Studied: An inception cohort of 3,405 women with Stage I-III breast cancer presenting for care to one of eight participating institutions between July 1, 1997 and June 30, 2000 was assembled. To be eligible for analyses, patients were required to be followed at the NCCN institution for a minimum of 365 days post-presentation. Principal Findings: Among patients for whom guidelines recommended chemotherapy +/- tamoxifen, age was strongly associated with treatment choice. Compared to age less than 50, each decade was associated with an increasing likelihood of treatment with tamoxifen alone (age 50-59: OR=3.2, 95%CI [1.2, 8.2]; 60-69: OR=14.9 [6.4, 34.5]; and 70+: OR=174.4, [75.6, 402.0]). Older women were also more likely to receive no treatment (age 60-69: OR=3.3 [1.5, 7.0]; 70+: OR=20.1 [9.7, 41.9]). Among women for whom the guidelines recommended tamoxifen alone, those over 70 were significantly more likely to receive no therapy (OR=3.81 [1.1, 12.9]). Treatment choice was influenced by NCCN institution in both models. For example, among women over 60 with node positive, ER positive cancers, the proportion treated with chemotherapy ranged from 41% to 91% across the centers. Conclusions: In these centers, systemic treatment choices, particularly, decisions about adjuvant chemotherapy are highly influenced by patient age. Implications for Policy, Delivery, or Practice: Clinical trials in older breast cancer patients are critical to determine whether the dramatic drop-off in chemotherapy use among women over 70 represents appropriate tailoring or poor quality care. Of greater concern, we found that the age gradient in chemotherapy use begins well before 70, despite evidence that chemotherapy in 50-69 year olds may decrease recurrence risk and/or mortality. The surprising variation in patterns of care across NCCN institutions suggests that physician biases and preferences play an important part in explaining this pattern. This highlights the potential value of linking comprehensive quality measurement programs to improvement efforts groups found to be at risk for suboptimal care. Primary Funding Source: NCCN ●Identifying Quality Targets for Breast Cancer Care Michael J. Hassett, M.D., M.P.H., Melissa E. Hughes, MSc, Rebecca A. Ottesen, MS, Stephen B. Edge, M.D., Richard L. Theriault, DO, MBA, Jane C. Weeks, M.D., MSc Presented By: Michael J. Hassett, M.D., M.P.H., , Center for Outcomes and Policy Research, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; Tel: 617-632-6631; Fax: 617632-2270; Email: michael_hassett@dfci.harvard.edu Research Objective: While high quality scientifically valid quality measures are in great demand, few exist. Those that do have not been tailored to the different applications for which they are used, such as grading providers, paying for performance or identifying priority areas for quality improvement. Our objective was to describe an explicit and systematic approach for selecting quality measures based upon their ability to improve outcomes for a population of women with breast cancer. Study Design: We developed a comprehensive set of 31 breast cancer quality indicators using the National Comprehensive Cancer Network’s (NCCN) clinical practice guidelines. To derive quality measures, we assessed practice performance relative to the standards outlined by the guidelines in 9,019 women less than 70 with newly diagnosed stage 0-III breast cancer treated at one of ten member institutions. We then ranked measures based on their ability to improve disease-free survival and quality of life for a population of women with breast cancer. Four attributes were used to rank the measures: 1) number of non-concordant patients, 2) mean concordance across all institutions, 3) highest concordance at any one institution, and 4) magnitude of benefit on disease free survival and quality of life experienced by patients who received the recommended rather than a non-concordant treatment. Values for the first three attributes were derived from the concordance analysis. Magnitude of benefit estimates were derived from a survey of the expert panel that developed the NCCN breast cancer guidelines. A simple algorithm was designed to incorporate all four attributes and create a numerical score for each quality measure. Scores were used to prioritize quality measures and identify those with the greatest potential to impact outcomes. Population Studied: Discussed within study design. Principal Findings: The top three quality measures were 1) whole breast radiation for stage I-II breast cancer treated with breast conserving surgery, 2) axillary lymph node surgery for stage I-II breast cancer treated with breast conserving surgery, and 3) adjuvant chemotherapy for stage II, node positive, hormone receptor positive breast cancer. Of the four attributes contributing to each quality measure’s score, the number of non-concordant patients correlated most highly with the final ranking. Quality measures based on lower quality evidence, containing few patients, or offering little room for improvement were less likely to rank highly. Magnitude of benefit values influenced the ranking where differences in the numbers of non-concordant patients were modest. Altering the relative weights of the attributes did not substantially affect the rankings. Conclusions: We describe an explicit and systematic method of identifying breast cancer quality measures that are unique because of their ability to impact patients’ outcomes. Our approach could also be used to rank quality measures across different disease or according to different outcomes. Implications for Policy, Delivery, or Practice: When developing quality measures it is essential to consider how they will be used; different quality measures may be required for different applications, goals, and populations. Identifying quality measures based on their potential to improve survival and quality of life may increase the efficiency and efficacy of quality improvement efforts and improve the outcomes of people who rely on our health care system. Primary Funding Source: NCCN