Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.

Changing home care aides: Differences between family and non-family care in California Medicaid home and community-based services.

In California Medicaid home-and-community-based services (HCBS), recipients' family members receive payment as home care aides (HCAs). We analyzed data on first-time HCBS recipients to examine factors associated with the likelihood of switching HCAs within the first year of services. Those with family HCAs were less than half as likely to change than those with non-family HCAs and racial/ethnic minorities with non-family HCAs had the highest switching rates. Lower wages and local unemployment were associated with switching of non-family HCAs but not family HCAs. Policymakers can foster continuity of home care by paying family members for home care and raising worker wages.

Concentration of Physician Services Across Insurers and Effects on Quality: Early Evidence From Medicare Advantage.

BACKGROUND: A growing proportion of Medicare beneficiaries is covered by private insurers through Medicare Advantage, yet little is known about how these plans are structured in terms of relationships with physicians and implications for quality of care. OBJECTIVE: The objective of this study was to assess whether greater physician concentration of services across insurers was associated with higher quality in Medicare Advantage (MA), overall and particularly among MA insurers serving a high proportion of vulnerable enrollees. RESEARCH DESIGN: A retrospective cohort design with regression analysis. DATA SOURCES: The primary dataset was 2014 MA encounter records submitted by insurers to the Centers for Medicare and Medicaid Services, covering 600,329 physicians across 119 insurers. These data were merged with Centers for Medicare and Medicaid Services data on MA contract quality rating as well as physician characteristics in the Medicare Data on Provider Practice and Specialty file. MEASURES: Two measures were generated to capture the concentration of physician services across insurers: the percentage of a physician's Medicare services which was through MA (MA penetration); and the percentage of a physician's MA services with a specific insurer (insurer share of MA services). RESULTS: Greater MA penetration and insurer share of MA services were each associated with higher MA plan quality. The relationship between insurer share and quality was stronger in contracts with a relatively high percentage of disabled enrollees. CONCLUSION: Greater physician concentration of services across MA insurers was associated with a higher quality of care overall and especially among vulnerable enrollees.

Predictors of Nursing Facility Entry by Medicaid-Only Older Adults and Persons With Disabilities in California.

Nearly one-third of adult Medicaid beneficiaries who receive long-term services and supports (LTSS) consist of older adults and persons with disabilities who are not eligible for Medicare. Beneficiaries, advocates, and policymakers have all sought to shift LTSS to home and community settings as an alternative to institutional care. We conducted a retrospective cohort study of Medicaid-only adults in California with new use of LTSS in 2006-2007 (N = 31 849) to identify unique predictors of entering nursing facilities versus receiving Medicaid home and community-based services (HCBS). Among new users, 18.3% entered into nursing facilities, whereas 81.7% initiated HCBS. In addition to chronic conditions, functional and cognitive limitations, substance abuse disorders (odds ratio [OR] 1.35; 95% confidence interval [CI]: 1.23, 1.48), and homelessness (OR: 4.35, 9% CI: 3.72, 5.08) were associated with higher odds of nursing facility entry. For older adults and persons with disabilities covered by Medicaid only, integration with housing and behavioral health services may be key to enabling beneficiaries to receive LTSS in noninstitutional settings.

Development of an adaptive, personalized, and scalable dementia care program: Early findings from the Care Ecosystem.

Katherine Possin and colleagues report on the implementation, development, and early findings of the Care Ecosystem, an adaptive, personalized, and scalable dementia care program.

Health Care Expenditures After Initiating Long-term Services and Supports in the Community Versus in a Nursing Facility.

BACKGROUND: Individuals who receive long-term services and supports (LTSS) are among the most costly participants in the Medicare and Medicaid programs. OBJECTIVES: To compare health care expenditures among users of Medicaid home and community-based services (HCBS) versus those using extended nursing facility care. RESEARCH DESIGN: Retrospective cohort analysis of California dually eligible adult Medicaid and Medicare beneficiaries who initiated Medicaid LTSS, identified as HCBS or extended nursing facility care, in 2006 or 2007. SUBJECTS: Propensity score matching for demographic, health, and functional characteristics resulted in a subsample of 34,660 users who initiated Medicaid HCBS versus extended nursing facility use. Those with developmental disabilities or in managed care plans were excluded. MEASURES: Average monthly adjusted acute, postacute, long-term, and total Medicare and Medicaid expenditures for the 12 months following initiation of either HCBS or extended nursing facility care. RESULTS: Those initiating extended nursing facility care had, on average, $2919 higher adjusted total health care expenditures per month compared with those who initiated HCBS. The difference was primarily attributable to spending on LTSS $2855. On average, the monthly LTSS expenditures were higher for Medicare $1501 and for Medicaid $1344 when LTSS was provided in a nursing facility rather than in the community. CONCLUSIONS: The higher cost of delivering LTSS in a nursing facility rather than in the community was not offset by lower acute and postacute spending. Medicare and Medicaid contribute similar amounts to the LTSS cost difference and both could benefit financially by redirecting care from institutions to the community.

The Effectiveness of Emergency Department Visit Reduction Programs: A Systematic Review.

STUDY OBJECTIVE: Previous reviews of emergency department (ED) visit reduction programs have not required that studies meet a minimum quality level and have therefore included low-quality studies in forming conclusions about the benefits of these programs. We conduct a systematic review of ED visit reduction programs after judging the quality of the research. We aim to determine whether these programs are effective in reducing ED visits and whether they result in adverse events. METHODS: We identified studies of ED visit reduction programs conducted in the United States and targeted toward adult patients from January 1, 2003, to December 31, 2014. We evaluated study quality according to the Grading of Recommendations Assessment, Development, and Evaluation criteria and included moderate- to high-quality studies in our review. We categorized interventions according to whether they targeted high-risk or low-acuity populations. RESULTS: We evaluated the quality of 38 studies and found 13 to be of moderate or high quality. Within these 13 studies, only case management consistently reduced ED use. Studies of ED copayments had mixed results. We did not find evidence for any increase in adverse events (hospitalization rates or mortality) from the interventions in either high-risk or low-acuity populations. CONCLUSION: High-quality, peer-reviewed evidence about ED visit reduction programs is limited. For most program types, we were unable to draw definitive conclusions about effectiveness. Future ED visit reduction programs should be regarded as demonstrations in need of rigorous evaluation.

Integrating Health Care for the Most Vulnerable: Bridging the Differences in Organizational Cultures Between US Hospitals and Community Health Centers.

Policymakers have increasingly promoted health services integration to improve quality and efficiency. The US health care safety net, which comprises providers of health care to uninsured, Medicaid, and other vulnerable patients, remains a largely fragmented collection of providers. We interviewed leadership from safety net hospitals and community health centers in 5 US cities (Boston, MA; Denver, CO; Los Angeles, CA; Minneapolis, MN; and San Francisco, CA) throughout 2013 on their experiences with service integration. We identify conflicts in organizational mission, identity, and consumer orientation that have fostered reluctance to enter into collaborative arrangements. We describe how smaller scale initiatives, such as capitated model for targeted populations, health information exchange, and quality improvements led by health plans, can help bridge cultural differences to lay the groundwork for developing integrated care programs.

Safety net integration: a shared strategy for becoming providers of choice.

With the expansion of coverage as a result of federal health care reform, safety net providers are confronting a challenge to care for the underserved while also competing as a provider of choice for the newly insured. Safety net institutions may be able to achieve these goals by pursuing greater delivery system integration. We interviewed safety net hospital and community health center (CHCs) leaders in five US cities to determine what strategies these organizations are employing to promote care integration in the safety net. Although there is some experimentation with payment reform and health information exchange, safety net providers identify significant policy and structural barriers to integrating service delivery. The enhanced Medicaid payments for CHCs and the federal requirement that CHCs retain independent boards discourage these organizations from integrating with other safety net providers. Current policies are not mobilizing safety net providers to pursue integration as a way to deliver more efficient and effective care. Medicaid and other policies at the federal and state level could be revised to overcome known fragmentation in the health care safety net. This includes addressing the conflicts in financing and governance arrangements that are encouraging providers to resist integration to preserve their independence.

Supporting the needs of state health policy makers through university partnerships.

State Medicaid programs and other state health agencies need to monitor and evaluate changes in health insurance coverage, access to care, financing, and the quality of health care delivery. The availability of new financial resources through the Patient Protection and Affordable Care Act is accompanied by raised expectations for such accountability. While state agencies often contract with universities on an ad hoc basis for specific policy projects, fourteen states have established formal state-university partnerships so that their analytic and technical needs can be addressed more readily. After a brief overview of these partnerships, this article provides examples of their projects, which most often affect Medicaid policy, including work on program eligibility, provider payments, and optional benefits. State-university partnerships are working on policy-relevant projects that influence decision making. Like the variation in Medicaid programs across the country, no two partnerships are alike. They thrive in a mix of structures, using different means of contracting, and with varied degrees of data access. All partnerships are interested in building a national network to share innovative practices and projects, spawn comparative policy studies across states, and support the development of new state-university partnerships.

Improving the Safety of Computed Tomography Through Automated Quality Measurement: A Radiologist Reader Study of Radiation Dose, Image Noise, and Image Quality.

OBJECTIVES: The Centers for Medicare and Medicaid Services funded the development of a computed tomography (CT) quality measure for use in pay-for-performance programs, which balances automated assessments of radiation dose with image quality to incentivize dose reduction without compromising the diagnostic utility of the tests. However, no existing quantitative method for assessing CT image quality has been validated against radiologists' image quality assessments on a large number of CT examinations. Thus to develop an automated measure of image quality, we tested the relationship between radiologists' subjective ratings of image quality with measurements of radiation dose and image noise. MATERIALS AND METHODS: Board-certified, posttraining, clinically active radiologists rated the image quality of 200 diagnostic CT examinations from a set of 734, representing 14 CT categories. Examinations with significant distractions, motion, or artifact were excluded. Radiologists rated diagnostic image quality as excellent, adequate, marginally acceptable, or poor; the latter 2 were considered unacceptable for rendering diagnoses. We quantified the relationship between ratings and image noise and radiation dose, by category, by analyzing the odds of an acceptable rating per standard deviation (SD) increase in noise or geometric SD (gSD) in dose. RESULTS: One hundred twenty-five radiologists contributed 24,800 ratings. Most (89%) were acceptable. The odds of an examination being rated acceptable statistically significantly increased per gSD increase in dose and decreased per SD increase in noise for most categories, including routine dose head, chest, and abdomen-pelvis, which together comprise 60% of examinations performed in routine practice. For routine dose abdomen-pelvis, the most common category, each gSD increase in dose raised the odds of an acceptable rating (2.33; 95% confidence interval, 1.98-3.24), whereas each SD increase in noise decreased the odds (0.90; 0.79-0.99). For only 2 CT categories, high-dose head and neck/cervical spine, neither dose nor noise was associated with ratings. CONCLUSIONS: Radiation dose and image noise correlate with radiologists' image quality assessments for most CT categories, making them suitable as automated metrics in quality programs incentivizing reduction of excessive radiation doses.

When Can We Rely on Real-World Evidence to Evaluate New Medical Treatments?

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. The RWE label has been used to refer to a variety of departures from the methods of traditional randomized controlled trials. Recognizing this complexity and potential confusion, the National Academies of Science, Engineering, and Medicine convened a series of workshops to clarify and address questions regarding the use of RWE to evaluate new medical treatments. Those workshops identified three specific dimensions in which RWE studies might differ from traditional clinical trials: use of real-world data (data extracted from health system records or data captured by mobile devices), delivery of real-world treatment (open-label treatments delivered in community settings by community practitioners), and real-world treatment assignment (including nonrandomized comparisons and variations on random assignment such as before-after or stepped-wedge designs). For any RWE study, decisions regarding each of these dimensions depends on the specific research question, characteristics of the potential study settings, and characteristics of the settings where study results would be applied.