The Impact of the Medicare Modernization Act of 2003 on Cancer Care

Throughout my PhD training in health services research, policy and administration at the University of Minnesota, my research focused on patient and provider factors associated with cancer treatment outcomes and the influence that care guideline policies play in treatment. During my program, I worked as a research assistant in the Division of Health Policy and Management, and have successfully collaborated with an interdisciplinary team of healthcare professionals to produce more than 29-peer reviewed publications on cancer health services research. The logical next step in my research is to extend my evaluation to the role of other external factors, including policy changes and socio-demographic factors, associated with treatment patterns and outcomes for cancer care. The Department of Epidemiology and Biostatistics (DEB) at the University of Texas Health Science Center at San Antonio (UTHSCSA), where I am currently an Assistant Professor, provides an ideal research environment to address these issues as it provides access to a top-tier, multidisciplinary research institution and a National Cancer Institute (NCI)-designated cancer center with expertise and extramural funding related to evaluating health policy and outcomes for cancer care. The objectives of the proposed career development award are to build on the skills acquired during my doctoral program, creating a training program focused on elucidating the mechanisms associated with cancer treatment policy change and the resultant effect on cancer treatment patterns and outcomes on a population level. I will use the example of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003, which substantially reduced reimbursement for many mainstay generic cancer drugs, coupled with rising levels of generic drug shortages, to understand how policy influences treatment and outcomes for cancer in different geographic contexts. While initial studies suggest that the MMA may adversely affect the prescribing of generic treatment regimens for specific cancers, leaving high-cost brand name drugs as the primary treatment option, the broad impact of this policy on treatment patterns, drug shortages, and health outcomes in different geographic settings has not been assessed. The rationale for the award is to allow for the development of a long-term career in the evaluation of how health policy changes and quality guidelines affect the appropriate treatment and outcomes for cancer. Specifically, this career development award will provide the immediate benefit of a structured environment to: 1) enhance my statistical training in hierarchical and spatial statistical analysis of health data for evaluating policy changes; 2) improve my understanding of applied clinical cancer care and administration; and 3) develop competitive research grants as an independent investigator. The research design includes the novel application of hierarchical models and spatial analyses to evaluate the effect of the MMA on cancer treatment and outcomes among Medicare beneficiaries. Making primary use of the Surveillance Epidemiology and End Results (SEER) population-based cancer registry data linked to Medicare administrative claims, this research will: 1) describe drug treatment patterns for patented vs. generic drugs in Medicare-eligible breast, colon, and lung cancer patients before and after the implementation of the MMA across geographic areas and socio-demographic groups; 2) elucidate the relationship between drug reimbursement prices, documented drug shortages, and treatment before and after the implementation of the MMA; and 3) estimate changes in outcomes associated with variation in treatment practices after the introduction of the MMA including time to treatment initiation, total cost of cancer care and mortality. Combined, these analyses will provide the framework to identify how payment policies for chemotherapeutic drugs affect prescribing and treatment practices and health outcomes in the Medicare population. PUBLIC HEALTH RELEVANCE: Narrative The Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 aimed to address rising healthcare costs by reorganizing the payment structure for many therapeutic drugs, substantially reducing reimbursement rates for many generic chemotherapy drugs delivered in the outpatient setting. The aim of this proposed career development award is to evaluate how changes in cancer drug pricing as a result of the MMA have influenced patterns and types of cancer treatment in the US, receipt of recommended care and disparities in health outcomes across geographic areas and socioeconomic groups. Combined, these analyses will provide the framework to identify how payment policies for chemotherapeutic drugs affect prescribing and treatment practices in the Medicare population.