Use of Real-World Evidence for Regulatory Approval and Coverage of Medical Devices: A Landscape Assessment.

OBJECTIVES: To enhance the generalizability of the evidence it reviews, the US Food and Drug Administration (FDA) has encouraged manufacturers to expand the submission of real-world evidence (RWE). The extent to which this evidence, which is generated outside of research settings, can support decision making remains unclear. We described the current use of RWE for medical devices, assessed manufacturers' challenges in generating and using it for regulatory and coverage decisions, and identified opportunities to expand its use. METHODS: We conducted 27 solo and group interviews with FDA officials and representatives of device manufacturers, payers, and health technology assessment organizations. All interviews used a semistructured protocol and were transcribed to allow thematic analysis. RESULTS: Accessing and linking real-world data sources, identifying unique devices, capturing longitudinal data, limited staff expertise, and uncertain return on investment have hampered efforts to use real-world data. Many companies in our sample were conducting research using real-world data, but none had submitted RWE as the primary evidence supporting a premarket approval. FDA guidance was helpful, but regulatory requirements remained ambiguous and examples of successful regulatory decisions based on RWE were limited. Payers mainly used RWE to supplement experimental evidence in coverage decisions, evaluated both types of evidence in similar ways, and had concerns about the rigor of RWE. CONCLUSIONS: Technical challenges may slow efforts to generate and use RWE in the near term. Additional regulatory guidance and examples, greater use of rigorous study designs and analytic methods, and continued stakeholder engagement could accelerate the use of RWE.

Health system affiliation of physician organizations and quality of care for Medicare beneficiaries who have high needs.

OBJECTIVE: To test the hypothesis that health systems provide better care to patients with high needs by comparing differences in quality between system-affiliated and nonaffiliated physician organizations (POs) and to examine variability in quality across health systems. DATA SOURCES: 2015 Medicare Data on Provider Practice and Specialty linked physicians to POs. Medicare Provider Enrollment, Chain, and Ownership System (PECOS) and IRS Form 990 data identified health system affiliations. Fee-for-service Medicare enrollment and claims data were used to examine quality. STUDY DESIGN: This cross-sectional analysis of beneficiaries with high needs, defined as having more than twice the expected spending of an average beneficiary, examined six quality measures: continuity of care, follow-up visits after hospitalizations and emergency department (ED) visits, ED visits, all-cause readmissions, and ambulatory care-sensitive hospitalizations. Using a matched-pair design, we estimated beneficiary-level regression models with PO random effects to compare quality of care in system-affiliated and nonaffiliated POs. We then limited the sample to system-affiliated POs and estimated models with system random effects to examine variability in quality across systems. PRINCIPAL FINDINGS: Among 2 323 301 beneficiaries with high needs, 52.3% received care from system-affiliated POs. Rates of ED visits were statistically significantly different in system-affiliated POs (117.5 per 100) and nonaffiliated POs (106.8 per 100, P < .0001). Small differences in the other five quality measures were observed across a range of sensitivity analyses. Among systems, substantial variation was observed for rates of continuity of care (90% of systems had rates between 70.8% and 89.4%) and follow-up after ED visits (90% of systems had rates between 56.9% and 73.5%). CONCLUSIONS: Small differences in quality of care were observed among beneficiaries with high needs receiving care from system POs and nonsystem POs. Health systems may not confer hypothesized quality advantages to patients with high needs.

Racial and ethnic disparities in care for health system-affiliated physician organizations and non-affiliated physician organizations.

OBJECTIVE: To assess racial and ethnic disparities in care for Medicare fee-for-service (FFS) beneficiaries and whether disparities differ between health system-affiliated physician organizations (POs) and nonaffiliated POs. DATA SOURCES: We used Medicare Data on Provider Practice and Specialty (MD-PPAS), Medicare Provider Enrollment, Chain, and Ownership System (PECOS), IRS Form 990, 100% Medicare FFS claims, and race/ethnicity estimated using the Medicare Bayesian Improved Surname Geocoding 2.0 algorithm. STUDY DESIGN: Using a sample of 16 007 POs providing primary care in 2015, we assessed racial/ethnic disparities on 12 measures derived from claims (2 cancer screenings; diabetic eye examinations; continuity of care; two medication adherence measures; three measures of follow-up visits after acute care; all-cause emergency department (ED) visits, all-cause readmissions, and ambulatory care-sensitive admissions). We decomposed these "total" disparities into within-PO and between-PO components using models with PO random effects. We then pair-matched 1853 of these POs that were affiliated with health systems to similar nonaffiliated POs. We examined differences in within-PO disparities by affiliation status by interacting each nonwhite race/ethnicity with an affiliation indicator. DATA COLLECTION/EXTRACTION METHODS: Medicare Data on Provider Practice and Specialty identified POs billing Medicare; PECOS and IRS Form 990 identified health system affiliations. Beneficiaries age 18 and older were attributed to POs using a plurality visit rule. PRINCIPAL FINDINGS: We observed total disparities in 12 of 36 comparisons between white and nonwhite beneficiaries; nonwhites received worse care in 10. Within-PO disparities exceeded between-PO disparities and were substantively important (>=5 percentage points or>=0.2 standardized differences) in nine of the 12 comparisons. Among these 12, nonaffiliated POs had smaller disparities than affiliated POs in two comparisons (P < .05): 1.6 percentage points smaller black-white disparities in follow-up after ED visits and 0.6 percentage points smaller Hispanic-white disparities in breast cancer screening. CONCLUSIONS: We find no evidence that system-affiliated POs have smaller racial and ethnic disparities than nonaffiliated POs. Where differences existed, disparities were slightly larger in affiliated POs.

Association of Primary and Specialty Care Integration on Physician Communication and Cancer Screening in Safety-Net Clinics.

INTRODUCTION: Primary care providers who lack reliable referral relationships with specialists may be less likely than those who do have such relationships to conduct cancer screenings. Community health centers (CHCs), which provide primary care to disadvantaged populations, have historically reported difficulty accessing specialty care for their patients. This study aimed to describe strategies CHCs use to integrate care with specialists and examine whether more strongly integrated CHCs have higher rates of screening for colorectal and cervical cancers and report better communication with specialists. METHODS: Using a 2017 survey of CHCs in 12 states and the District of Columbia and administrative data, we estimated the association between a composite measure of CHC/specialist integration and 1) colorectal and cervical cancer screening rates, and 2) 4 measures of CHC/specialist communication using multivariate regression models. RESULTS: Integration strategies commonly reported by CHCs included having specialists deliver care on-site (80%) and establishing referral agreements with specialists (70%). CHCs that were most integrated with specialists had 5.6 and 6.8 percentage-point higher colorectal and cervical cancer screening rates, respectively, than the least integrated CHCs (P < .05). They also had significantly higher rates of knowing that specialist visits happened (67% vs 42%), knowing visit outcomes (65% vs 42%), receiving information after visits (47% vs 21%), and timely receipt of information (44% vs 27%). CONCLUSION: CHCs use various strategies to integrate primary and specialty care. Efforts to promote CHC/specialist integration may help increase rates of cancer screening.

Provision of Social Services and Health Care Quality in US Community Health Centers, 2017.

Objectives. To describe the types of social services provided at community health centers (CHCs), characteristics of CHCs providing these services, and the association between on-site provision and health care quality.Methods. We surveyed CHCs in 12 US states and the District of Columbia during summer 2017 (n = 208) to identify referral to and provision of services to address 8 social needs. Regression models estimated factors associated with the provision of social services by CHCs and the association between providing services and health care quality (an 8-item composite).Results. CHCs most often offered on-site assistance for needs related to food or nutrition (43%), interpersonal violence (32%), and housing (30%). Participation in projects with community-based organizations was associated with providing services on-site (odds ratio = 2.48; P = .018). On-site provision was associated with better performance on measures of health care quality (e.g., each additional social service was associated with a 4.3 percentage point increase in colorectal cancer screenings).Conclusions. Some CHCs provide social services on-site, and this was associated with better performance on measures of health care quality.Public Health Implications. Health care providers are increasingly seeking to identify and address patients' unmet social needs, and on-site provision of services is 1 strategy to consider.

Access, Quality, And Financial Performance Of Rural Hospitals Following Health System Affiliation.

More than 100 rural hospitals have closed since 2010. Some rural hospitals have affiliated with health systems to improve their financial performance and potentially avoid closure, but the effects of affiliation on rural hospitals and their patients are unclear. To examine the relationship between affiliation and performance, we compared rural hospitals that affiliated with a health system in the period 2008-17 and a propensity score-weighted set of nonaffiliating rural hospitals on twelve measures of structure, utilization, financial performance, and quality. Following health system affiliation, rural hospitals experienced a significant reduction in on-site diagnostic imaging technologies, the availability of obstetric and primary care services, and outpatient nonemergency visits, as well as a significant increase in operating margins (by 1.6-3.6 percentage points from a baseline of -1.6 percent). Changes in patient experience scores, readmissions, and emergency department visits were similar for affiliating and nonaffiliating hospitals. While joining health systems may improve rural hospitals' financial performance, affiliation may reduce access to services for patients in rural areas.

Federally Qualified Health Center Strategies for Integrating Care with Hospitals and Their Association with Measures of Communication.

BACKGROUND: Federally qualified health centers have aligned clinical services and systems with local hospitals, but little is known about the specific care integration strategies health centers use or their impact on care. A research team examined the use of strategies by health centers to integrate care with hospitals and emergency departments (EDs) and their association with performance on measures of health center-hospital communication. METHODS: A Web-based survey was administered to health center medical directors in 12 states and Washington, DC, in 2017. The survey collected 10 self-reported measures of communication between health centers and hospitals/EDs and the extent to which health centers used different strategies to improve care integration. Health center and market characteristics that predict higher vs. lower integration activity were examined, and logistic regression was used to assess the relationship between integration activity and communication. RESULTS: Between 56% and 81% of health centers participated in quality improvement projects, health promotion initiatives, guideline alignment, or executive meetings with hospitals; far fewer established notification agreements regarding hospital/ED utilization. Health centers that were larger, were located in rural areas or states with Accountable Care Organization programs, reported fewer staff shortages, and had fewer minority patients were associated with greater integration activity. Higher levels of integration activity were associated with better performance on most communication measures in both inpatient and ED settings (p < 0.05). Integration activity was not associated with health centers' receipt of notifications after patients' ED visits. CONCLUSION: Health centers differ in the use of strategies to integrate care with hospitals. Overall, integration activity is associated with better communication.

Specialty care access for Medicaid enrollees in expansion states.

OBJECTIVES: Community health centers (CHCs) historically have reported challenges obtaining specialty care for their patients, but recent policy changes, including Medicaid eligibility expansions under the Affordable Care Act, may have improved access to specialty care. The objective of this study was to assess current levels of difficulty accessing specialty care for CHC patients, by insurance type, and to identify specific barriers and strategies that CHCs are using to overcome these barriers. STUDY DESIGN: Cross-sectional survey, administered during summer 2017, of medical directors at CHCs in 9 states and the District of Columbia, all of which expanded Medicaid. METHODS: Surveys were administered to medical directors at 361 CHCs (response rate, 55%) to assess the difficulty of accessing specialty care by insurance type and to identify the specialties for which it was most difficult to obtain new patient visits. The survey also elicited ratings of commonly reported barriers to obtaining specialty care and identified strategies used by CHCs to access specialty care for patients. Descriptive results are presented. RESULTS: Nearly 60% of CHCs reported difficulty obtaining new patient specialty visits for their Medicaid patients, most often for orthopedists. Barriers to specialty care reported by CHCs included that few specialists in Medicaid managed care organization (MCO) networks were accepting new patients (69.4%) and MCO administrative requirements for obtaining specialist consults (49.0%). To enhance access to specialists, CHCs reported that they entered into referral agreements, developed appointment reminder systems, and participated in data exchange and other community-based initiatives. CONCLUSIONS: Medicaid patients at CHCs face many barriers to accessing specialty care. Payment policies and network adequacy rules may need to be reexamined to address these challenges.

Primary Care Visit Regularity and Patient Outcomes: an Observational Study.

BACKGROUND: Regular primary care visits may allow an opportunity to deliver high-value, proactive care. However, no previous study has examined whether more temporally regular primary care visits predict better outcomes. OBJECTIVE: To examine the relationship between the temporal regularity of primary care (PC) visits and outcomes. DESIGN: Retrospective cohort study. PARTICIPANTS: We used Medicare claims for 378,862 fee-for-service Medicare beneficiaries, who received PC at 1328 federally qualified health centers from 2010 to 2014. MAIN MEASURES: We created five beneficiary groups based upon their annual number of PC visits. We further subdivided those groups according to whether PC visits occurred with more or less regularity than the median value. We compared these 10 subgroups on three outcomes, adjusting for beneficiary characteristics: emergency department (ED) visits, hospitalizations, and total Medicare expenditures. We also aggregated to the clinic level and divided clinics into tertiles of more, less, and similarly regular to predicted. We compared these three groups of clinics on the same three outcomes of care. KEY RESULTS: Within each visit frequency group, beneficiaries in the subgroup with fewer regular visits had more ED visits, more hospitalizations, and higher costs. Among beneficiaries with the most frequent PC visits, the less regular subgroup had more ED visits (1.70 vs. 1.31 per person-year), more hospitalizations (0.69 vs. 0.57), and greater Medicare expenditures ($20,731 vs. $17,430, p < 0.001 for all comparisons). Clinics whose PC visits were more regular than predicted also had better outcomes than other clinics, although the effect sizes were smaller. CONCLUSIONS: Temporal patterns of PC visits are correlated with outcomes, even among beneficiaries who appear otherwise similar. Measuring the temporal regularity of PC visits may be useful for identifying beneficiaries at risk for adverse events, and as a barometer for and an impetus to clinic-level quality improvement.

Patient-Centered Medical Home Implementation in Indian Health Service Direct Service Facilities.

In an effort to provide care that is more accessible, team-based, coordinated, and patient-focused, primary care practices are increasingly adopting patient-centered medical home (PCMH) models of care. In 2008, the Indian Health Service (IHS) launched its own PCMH initiative, Improving Patient Care (IPC), to improve the quality of care for American Indians and Alaska Natives (AI/ANs) who seek care in its clinics. The IHS provides comprehensive health care services to roughly 2.2 million AI/ANs from more than 567 federally recognized tribes across the United States. RAND researchers examine the peer-reviewed and grey literature and identify common PCMH implementation strategies and challenges to better understand the kinds of methods used by clinics across the United States-particularly small clinics and those located in rural or remote locations. The research team then held telephone discussions with representatives from seven IHS clinics that had received PCMH recognition as of July 2017. The discussions with clinic leaders sought to identify how components of the PCMH model had been implemented at their clinics; challenges associated with PCMH implementation; and key lessons and recommendations that could benefit clinics that have not yet received PCMH recognition.

Using Health IT to Coordinate Care and Improve Quality in Safety-Net Clinics.

BACKGROUND: Health centers provide care to vulnerable and high-need populations. Recent investments have promoted use of health information technology (HIT) capabilities for improving care coordination and quality of care in health centers. This study examined factors associated with use of these HIT capabilities and the association between these capabilities and quality of care in a census of health centers in the United States. METHODS: Cross-sectional secondary data from the 2015 Health Resources and Services Administration's Uniform Data System was used to examine 6 measures of HIT capability related to care coordination and clinical decision support and 16 measures of quality (12 process measures, 3 outcome measures, 1 composite measure) for health centers in the United States. Adjusted logistic regressions were used to examine health center characteristics associated with use of HIT capabilities, and adjusted linear regressions were used to examine associations between HIT capabilities and quality of care. RESULTS: Many health centers reported using HIT for care coordination activities, including coordinating enabling services (67.3%) or engaging patients (81.0%). Health center size and medical home recognition were associated with significantly greater odds of using HIT for enabling services and engaging patients. These HIT capabilities were associated with higher overall quality and higher rates of six process measures (adult screening and maternal and child health) and hemoglobin A1c control. CONCLUSION: Use of HIT for such activities as arranging enabling services and engaging patients are underleveraged tools for care coordination. There may be opportunities to further improve quality of care for vulnerable patients by promoting health centers' use of these HIT capabilities.

Examining differential performance of 3 medical home recognition programs.

OBJECTIVES: We examined differences in patient outcomes associated with 3 patient-centered medical home (PCMH) recognition programs-National Committee for Quality Assurance (NCQA) Level 3, The Joint Commission (TJC), and Accreditation Association for Ambulatory Health Care (AAAHC)-among Medicare beneficiaries receiving care at federally qualified health centers (FQHCs). STUDY DESIGN: We used data from CMS' FQHC Advanced Primary Care Practice Demonstration, in which participating FQHCs received assistance to achieve NCQA Level 3 PCMH recognition. We assessed the impact of the 3 recognition programs on utilization, quality, and Medicare expenditures using a sample of 1108 demonstration and comparison FQHCs. METHODS: Using propensity-weighted difference-in-differences analyses, we compared changes in outcomes over 3 years for beneficiaries attributed to FQHCs that achieved each type of recognition relative to beneficiaries attributed to FQHCs that did not achieve recognition. RESULTS: Recognized FQHCs, compared with nonrecognized FQHCs, were associated with significant 3-year changes in FQHC visits, non-FQHC primary care visits, specialty visits, emergency department (ED) visits, hospitalizations, a composite diabetes process measure, and Medicare expenditures. Changes varied in direction and strength by recognition type. In year 3, compared with nonrecognized sites, NCQA Level 3 sites were associated with greater increases in ambulatory visits and quality and greater reductions in hospitalizations and expenditures (P <.01), TJC sites were associated with significant reductions in ED visits and hospitalizations (P <.01), and AAAHC sites had changes in the opposite direction of what we anticipated. CONCLUSIONS: Heterogeneous changes in beneficiary utilization, quality, and expenditures by recognition type may be explained by differences in recognition criteria, evaluation processes, and documentation requirements.

Utilization of health care services among Medicare beneficiaries who visit federally qualified health centers.

BACKGROUND: Previous studies have disagreed on whether patients who receive primary care from federally qualified health centers (FQHCs) have different utilization patterns than patients who receive care elsewhere. Our objective was to compare patterns of healthcare utilization between Medicare beneficiaries who received primary care from FQHCs and Medicare beneficiaries who received primary care from another source. METHODS: We compared characteristics and ambulatory, emergency department (ED), and inpatient utilization during 2013 between 130,637 Medicare beneficiaries who visited an FQHC for the majority of their primary care in 2013 (FQHC users) and a random sample of 1,000,000 Medicare fee-for-service (FFS) beneficiaries who did not visit an FQHC (FQHC non-users). We then created a propensity-matched sample of 130,569 FQHC users and 130,569 FQHC non-users to account for differences in observable patient characteristics between the two groups and repeated all comparisons. RESULTS: Before matching, the two samples differed in terms of age (42% below age 65 for FQHC users vs. 16% among FQHC non-users, p < 0.001 for all comparisons), disability (52% vs. 24%), eligibility for Medicaid (56% vs. 21%), severe mental health disorders (17% vs. 10%), and substance abuse disorders (6% vs. 3%). FQHC users had fewer ambulatory visits to primary care or specialist providers (10.0 vs. 12.0 per year), more ED visits (1.2 vs. 0.8), and fewer hospitalizations (0.3 vs. 0.4). In the matched sample, FQHC users still had slightly lower utilization of ambulatory visits to primary care or specialist providers (10.0 vs. 11.2) and slightly higher utilization of ED visits (1.2 vs. 1.0), compared to FQHC users. Hospitalization rates between the two groups were similar (0.3 vs. 0.3). CONCLUSIONS: In this population of Medicare FFS beneficiaries, FQHC users had slightly lower utilization of ambulatory visits and slightly higher utilization of ED visits, compared to FQHC non-users, after accounting for differences in case mix. This study suggests that FQHC care and non-FQHC care are associated with broadly similar levels of healthcare utilization among Medicare FFS beneficiaries.

Pathways to Medical Home Recognition: A Qualitative Comparative Analysis of the PCMH Transformation Process.

OBJECTIVE: To understand the process of practice transformation by identifying pathways for attaining patient-centered medical home (PCMH) recognition. DATA SOURCES/STUDY SETTING: The CMS Federally Qualified Health Center (FQHC) Advanced Primary Care Practice Demonstration was designed to help FQHCs achieve NCQA Level 3 PCMH recognition and improve patient outcomes. We used a stratified random sample of 20 (out of 503) participating sites for this analysis. STUDY DESIGN: We developed a conceptual model of structural, cultural, and implementation factors affecting PCMH transformation based on literature and initial qualitative interview themes. We then used conventional cross-case analysis, followed by qualitative comparative analysis (QCA), a cross-case method based on Boolean logic algorithms, to systematically identify pathways (i.e., combinations of factors) associated with attaining-or not attaining-Level 3 recognition. DATA COLLECTION METHODS: Site-level indicators were derived from semistructured interviews with site leaders at two points in time (mid- and late-implementation) and administrative data collected prior to and during the demonstration period. PRINCIPAL FINDINGS: The QCA results identified five distinct pathways to attaining PCMH recognition and four distinct pathways to not attaining recognition by the end of the demonstration. Across these pathways, one condition (change leader capacity) was common to all pathways for attaining recognition, and another (previous improvement or recognition experience) was absent in all pathways for not attaining recognition. In general, sites could compensate for deficiencies in one factor with capacity in others, but they needed a threshold of strengths in cultural and implementation factors to attain PCMH recognition. CONCLUSIONS: Future efforts at primary care transformation should take into account multiple pathways sites may pursue. Sites should be assessed on key cultural and implementation factors, in addition to structural components, in order to differentiate interventions and technical assistance.

Medicare Advantage and Fee-for-Service Performance on Clinical Quality and Patient Experience Measures: Comparisons from Three Large States.

OBJECTIVE: To compare performance between Medicare Advantage (MA) and Fee-for-Service (FFS) Medicare during a time of policy changes affecting both programs. DATA SOURCES/STUDY SETTING: Performance data for 16 clinical quality measures and 6 patient experience measures for 9.9 million beneficiaries living in California, New York, and Florida. STUDY DESIGN: We compared MA and FFS performance overall, by plan type, and within service areas associated with contracts between CMS and MA organizations. Case mix-adjusted analyses (for measures not typically adjusted) were used to explore the effect of case mix on MA/FFS differences. DATA COLLECTION/EXTRACTION METHODS: Performance measures were submitted by MA organizations, obtained from the nationwide fielding of the Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) Survey, or derived from claims. PRINCIPAL FINDINGS: Overall, MA outperformed FFS on all 16 clinical quality measures. Differences were large for HEDIS measures and small for Part D measures and remained after case mix adjustment. MA enrollees reported better experiences overall, but FFS beneficiaries reported better access to care. Relative to FFS, performance gaps were much wider for HMOs than PPOs. Excluding HEDIS measures, MA/FFS differences were much smaller in contract-level comparisons. CONCLUSIONS: Medicare Advantage/Fee-for-Service differences are often large but vary in important ways across types of measures and contracts.

Federally Qualified Health Center Clinicians And Staff Increasingly Dissatisfied With Workplace Conditions.

Better working conditions for clinicians and staff could help primary care practices implement delivery system innovations and help sustain the US primary care workforce. Using longitudinal surveys, we assessed the experience of clinicians and staff in 296 clinical sites that participated in the Centers for Medicare and Medicaid Services (CMS) Federally Qualified Health Center (FQHC) Advanced Primary Care Practice Demonstration. Participating FQHCs were expected to achieve, within three years, patient-centered medical home recognition at level 3-the highest level possible. During 2013-14, clinicians and staff in these FQHCs reported statistically significant declines in multiple measures of professional satisfaction, work environment, and practice culture. There were no significant improvements on any surveyed measure. These findings suggest that working conditions in FQHCs have deteriorated recently. Whether findings would be similar in other primary care practices is unknown. Although we did not identify the causes of these declines, possible stressors include the adoption of health information technology, practice transformation, and increased demand for services.

Implementation of Medical Homes in Federally Qualified Health Centers.

BACKGROUND: From 2011 through 2014, the Federally Qualified Health Center Advanced Primary Care Practice Demonstration provided care management fees and technical assistance to a nationwide sample of 503 federally qualified health centers to help them achieve the highest (level 3) medical-home recognition by the National Committee for Quality Assurance, a designation that requires the implementation of processes to improve access, continuity, and coordination. METHODS: We examined the achievement of medical-home recognition and used Medicare claims and beneficiary surveys to measure utilization of services, quality of care, patients' experiences, and Medicare expenditures in demonstration sites versus comparison sites. Using difference-in-differences analyses, we compared changes in outcomes in the two groups of sites during a 3-year period. RESULTS: Level 3 medical-home recognition was awarded to 70% of demonstration sites and to 11% of comparison sites. Although the number of visits to federally qualified health centers decreased in the two groups, smaller reductions among demonstration sites than among comparison sites led to a relative increase of 83 visits per 1000 beneficiaries per year at demonstration sites (P<0.001). Similar trends explained the higher performance of demonstration sites with respect to annual eye examinations and nephropathy tests (P<0.001 for both comparisons); there were no significant differences with respect to three other process measures. Demonstration sites had larger increases than comparison sites in emergency department visits (30.3 more per 1000 beneficiaries per year, P<0.001), inpatient admissions (5.7 more per 1000 beneficiaries per year, P=0.02), and Medicare Part B expenditures ($37 more per beneficiary per year, P=0.02). Demonstration-site participation was not associated with relative improvements in most measures of patients' experiences. CONCLUSIONS: Demonstration sites had higher rates of medical-home recognition and smaller decreases in the number of patients' visits to federally qualified health centers than did comparison sites, findings that may reflect better access to primary care relative to comparison sites. Demonstration sites had larger increases in emergency department visits, inpatient admissions, and Medicare Part B expenditures. (Funded by the Centers for Medicare and Medicaid Services.).