Can law improve the delivery of health care? The predominant view is that law serves as a barrier to reforming the health care delivery system. Health law scholars of all stripes blame regulations for impeding innovation, limiting competition, and exacerbating fragmentation in health care.

I argue that this view neglects an important—but overlooked—feature of health law: the dynamic relationship between laws that expand health insurance coverage and laws that regulate the delivery of health care. By expanding health insurance coverage and increasing the demand for health care, laws such as Medicare, Medicaid and the Affordable Care Act catalyze policymakers to experiment with reforms to delivery system regulations over time. I chart the evolution of three key areas of delivery system law, and find that insurance expansions have contributed to dramatic changes in each of these areas.

Recognizing health law’s “dynamism” sheds light on two debates that are central to health care reform. First, contrary to what some scholars have argued, it reveals that expanding health insurance coverage should be viewed as a catalyst for delivery system reform, rather than being in competition with it. Second, it strengthens the case for further expanding health insurance coverage. I argue that a dynamic regulatory system is better able to address problems of access, costs, and quality; to adapt to other changes in the underlying health care system; and to facilitate policy learning.

Background: Over the last twenty years, despite unprecedented new resources to global health, there has been insufficient progress to achieve the health-related 2015 Millennium Development Goals. Health systems have been perceived as the binding constraint. Major global health agencies have expanded their funding priorities from disease specific programs to include support for health systems strengthening. Strengthening health systems broadly is beyond the mandate of agencies such as the Global Fund. Nonetheless, since its inception, the Global Fund has supported health systems; however, it has had a long-running organizational struggle with how to do it. Mechanisms for health systems support have varied, and proposals for health systems support consistently have been of a lower quality than disease proposals. The Technical Review Panel of the Fund has criticized it for lack of clarity about what it means by health systems strengthening and called into question the Fund's ability to support effective responses to health systems constraints. Purpose: The purpose of this dissertation is to present a case study of the Global Fund's policies and strategy on health systems strengthening using the lens of neo-institutional theory. This dissertation explores the role legitimacy and the cognitive beliefs about health systems strengthening held by stakeholders in the Global Fund's environment have played in shaping the Fund's policies on health systems strengthening. Methods: Qualitative research methods are used to examine the beliefs about health systems strengthening held by members of Board delegations and the role these beliefs played in shaping the Global Fund's strategy on health systems strengthening. Official Global Fund documents were reviewed and primary data was gathered through 31 semi-structured in-depth interviews with members of the Board delegations, Secretariat, Technical Partner organizations and other relevant stakeholders in the Global Fund's environment to complement the document review. Findings: (1) Health system strengthening is a vague concept. (2) Depending on the context, there are two meanings - a technical one and a political one. (3) There is dispute over what constitutes acceptable health systems strengthening work. (4) Health system strengthening is essential for the success of the Global Fund, but there is disagreement over whether the Global Fund should engage in health system strengthening; if it does, how, and to what extent. (5) Linking funding to measurable health outcomes is essential for legitimacy. Health systems strengthening is beyond the scope of the Fund's mandate, current technical capacity and organizational design. The Fund ought to focus on what it does well, which is financing scale up of essential inputs. The Health Systems Funding Platform provides an opportunity for the Fund to support public health system strengthening in a way that will appease key stakeholders but still allow it to stay within the bounds of its disease-specific mission.

Highly structured data collected in a variety of biomedical applications such as electroencephalography (EEG) are discrete samples of a smooth functional process observed across both temporal and spatial dimensions. EEG data is conceptualized as region-referenced longitudinal functional data in which the functional dimension captures local signal dynamics, the longitudinal dimension tracks changes over the course of an experiment, and the regional dimension indexes spatial information across electrodes on the scalp. This complex data structure exhibits intricate dependencies with rich information but its dimensionality and size produce significant obstacles for interpretation, estimation, and inference. Motivated by a series of EEG studies in children with autism spectrum disorder (ASD), a set of computationally efficient methods for these high-dimensional data structures are proposed that both maintain information along each dimension and yield interpretable components and inferences.

The first half of the work considers decompositions of the total variation. To begin, a multi-dimensional functional principal components analysis (MD-FPCA) is introduced which decomposes the total variation into subject- and electrode-level components and for each level employs a two-stage functional principal components decomposition sequentially across functional and longitudinal time. Next, a hybrid principal components analysis (HPCA) for region-referenced longitudinal functional EEG data is proposed which utilizes both vector and functional principal components analyses and does not collapse information along any of the three dimensions of the data. The second half of the work shifts to modeling associations and introduces a covariate-adjusted region-referenced generalized functional linear model (CARR-GFLM) for modeling scalar outcomes from region-referenced functional predictors. CARR-GFLM utilizes a tensor basis formed from one-dimensional discrete and continuous bases to estimate functional effects across a discrete regional domain while simultaneously adjusting for additional non-functional covariates, such as age. Proposed methods not only help identify neurodevelopmental differences between typically developing and ASD children but can also be used to study the heterogeneity within children with ASD. The performance of all proposed methods is studied via extensive simulations.

Price variation is acceptable in most markets because: 1) higher prices reflect better quality or convenience; 2) the price, and usually the quality, of those goods is generally known to the consumer before that good is purchased, and at the very least after it is purchased; and 3) the "search costs" of discovering the price or quality is reflected in the final price. But these attributes are generally inapplicable to health care, where prices, though widely variable, are non-transparent and do not reflect the quality of medical services. This study investigates the determinants of price and drivers of price variation using adjudicated fee-for-service claims from a large commercial insurer with nearly three quarters market share. The scope of the study was narrowed to diagnostic and therapeutic colonoscopy, a well-defined procedure with substantial price variation. Consistent with both the empirical and theoretical work in the bargaining and price concentration literature, I found a substantial positive relationship between market share and a facility's colonoscopy price relative to the price in the market. I estimated that for every percentage point increase in a system or individual facility's bed share, relative price increases by three to four percentage points; this result was stable across a number of specifications and included controls for facility, system, and county characteristics. Further, I found that an increase in the Hirschman-Herfindahl Index (HHI) by 1,000 points was associated with a decrease in the coefficient of variation, a measure of spread, by only 1.6 percentage points. While this effect size was quite small in magnitude, (for comparison, the standard deviation of the coefficient of variation was 0.14), it was robust to the addition of several county-level controls. Colonoscopy is a well-defined procedure whose negotiated price within a given CPT code is highly variable and strongly dependent upon market share. Knowing which "policy lever" to pull to address price variation in the commercial market will require data on more markets and procedures to understand whether price variation is justified; if market share is associated with better quality, then price variation is warranted, but if market share represents only bargaining power, then variation may be unwarranted. The positive relationship between market share and price is of particular policy significance in the current political climate with merger incentives created by the 2010 Patient Protection and Affordable Care Act.