Adoption of Digital Health Technologies in the Practice of Behavioral Health: Qualitative Case Study of Glucose Monitoring Technology.

BACKGROUND: Evaluation of patients with serious mental illness (SMI) relies largely on patient or caregiver self-reported symptoms. New digital technologies are being developed to better quantify the longitudinal symptomology of patients with SMI and facilitate disease management. However, as these new technologies become more widely available, psychiatrists may be uncertain about how to integrate them into daily practice. To better understand how digital tools might be integrated into the treatment of patients with SMI, this study examines a case study of a successful technology adoption by physicians: endocrinologists' adoption of digital glucometers. OBJECTIVE: This study aims to understand the key facilitators of and barriers to clinician and patient adoption of digital glucose monitoring technologies to identify lessons that may be applicable across other chronic diseases, including SMIs. METHODS: We conducted focus groups with practicing endocrinologists from 2 large metropolitan areas using a semistructured discussion guide designed to elicit perspectives of and experiences with technology adoption. The thematic analysis identified barriers to and facilitators of integrating digital glucometers into clinical practice. Participants also provided recommendations for integrating digital health technologies into clinical practice more broadly. RESULTS: A total of 10 endocrinologists were enrolled: 60% (6/10) male; a mean of 18.4 years in practice (SD 5.6); and 80% (8/10) working in a group practice setting. Participants stated that digital glucometers represented a significant change in the treatment paradigm for diabetes care and facilitated more effective care delivery and patient engagement. Barriers to the adoption of digital glucometers included lack of coverage, provider reimbursement, and data management support, as well as patient heterogeneity. Participant recommendations to increase the use of digital health technologies included expanding reimbursement for clinician time, streamlining data management processes, and customizing the technologies to patient needs. CONCLUSIONS: Digital glucose monitoring technologies have facilitated more effective, individualized care delivery and have improved patient engagement and health outcomes. However, key challenges faced by the endocrinologists included lack of reimbursement for clinician time and nonstandardized data management across devices. Key recommendations that may be relevant for other diseases include improved data analytics to quickly and accurately synthesize data for patient care management, streamlined software, and standardized metrics.

Understanding and improving value frameworks with real-world patient outcomes.

OBJECTIVES: To provide recommendations that will improve approaches to measuring the value of new medical technologies to patients. STUDY DESIGN: Informed discussion by experts after literature review. METHODS: A working group was formed, and participants discussed how value frameworks should incorporate key features important to patients in evaluating new medical technologies, particularly for chronic diseases. RESULTS: The working group suggests that new value frameworks should integrate real-world evidence to complement randomized controlled trials, incorporate the ways in which real-world behavior mediates outcomes, and explicitly discuss how therapies affect real-world equity and disparities in care. CONCLUSIONS: Collective stakeholders that include key decision makers within our healthcare system need to recognize the importance of implementing real-world evidence and devote resources to further research into the chronic disease areas in which the impact of human behavior is amplified by the duration of disease and treatment.

Value-Based Payments and Incentives to Improve Care: A Case Study of Patients with Type 2 Diabetes in Medicare Advantage.

OBJECTIVES: To estimate the impact of increased glycated hemoglobin (A1C) monitoring and treatment intensification for patients with type 2 diabetes (T2D) on quality measures and reimbursement within the Medicare Advantage Star (MA Star) program. METHODS: The primary endpoint was the share of patients with T2D with adequate A1C control (A1C ≤ 9%). We conducted a simulation of how increased A1C monitoring and treatment intensification affected this end point using data from the National Health and Nutrition Examination Survey and clinical trials. Using the estimated changes in measured A1C levels, we calculated corresponding changes in the plan-level A1C quality measure, overall star rating, and reimbursement. RESULTS: At baseline, 24.4% of patients with T2D in the average plan had poor A1C control. The share of plans receiving the highest A1C rating increased from 27% at baseline to 49.5% (increased monitoring), 36.2% (intensification), and 57.1% (joint implementation of both interventions). However, overall star ratings increased for only 3.6%, 1.3%, and 4.8% of plans, respectively, by intervention. Projected per-member per-year rebate increases under the MA Star program were $7.71 (monitoring), $2.66 (intensification), and $10.55 (joint implementation). CONCLUSIONS: The simulation showed that increased monitoring and treatment intensification would improve A1C levels; however, the resulting average increases in reimbursement would be small.

Geographic Variation in Diagnostic Ability and Quality of Care Metrics: A Case Study of Ankylosing Spondylitis and Low Back Pain.

Studies examining geographic variation in care for low back pain often focus on process and outcome measures conditional on patient diagnosis but generally do not take into account a physician's ability to diagnose the root cause of low back pain. In our case study, we used increased detection of ankylosing spondylitis-a relatively rare inflammatory back disease-as a proxy for diagnostic ability and measured the relationship between ankylosing spondylitis detection, potentially inappropriate low back pain care, and cost. Using 5 years of health insurance claims data, we found significant variation in ankylosing spondylitis detection across metropolitan statistical areas (MSAs), with 8.1% of the variation in detection explained by a region's racial composition. Furthermore, low back pain patients in MSAs with higher ankylosing spondylitis detection had 7.9% lower use of corticosteroids, 9.0% lower use of opioids, and 8.2% lower pharmacy cost, compared with patients living in low-detection MSAs.

The social value of childhood vaccination in the United States.

OBJECTIVES: To determine the lifetime social value of using the guideline-recommended vaccines for children born in the United States in 2009. STUDY DESIGN: This study utilized an economic model with parameter values sourced from clinical and observational data, as well as the literature. METHODS: The model quantified the health effects of routine vaccination for 14 diseases in terms of quality-adjusted life-years (QALYs) saved. The health effects were then valued by applying an economic value of a QALY. Producers' profits were estimated using data on vaccine prices, profit margins, and the number of vaccines administrated in the 2009 US birth cohort. The costs of producing the vaccines were subtracted from the value of the health effects to yield the total social value of vaccination. The producers' and consumers' shares of this social value were calculated. Sensitivity analyses were conducted to determine how results depend on underlying parameter assumptions. RESULTS: Estimates indicated that vaccination of this cohort will save 1.2 million QALYs, relative to no vaccination. Of those health gains, 88% stemmed from reduced mortality and 12% from reduced morbidity. We estimated a social value of $184.1 billion from these gains, of which $3.4 billion accrues to manufacturers as profits, while $180.7 billion accrues to the rest of society. In sensitivity analysis, the total social value ranged from $40 billion to $675 billion, and the manufacturers' share ranged from 0.3% to 11.5%. CONCLUSIONS: Policy makers should account for this social value when considering policies affecting incentives to vaccinate and develop new vaccines.

Budget impact model: epigenetic assay can help avoid unnecessary repeated prostate biopsies and reduce healthcare spending.

BACKGROUND: The diagnosis of prostate cancer involves invasive, sometimes harmful, procedures that can entail negative quality-of-life implications to individuals and high additional costs to the US healthcare system when these procedures result in retesting and iatrogenic harms. It is estimated that $1.86 billion is spent annually on prostate-specific antigen (PSA) testing alone. An advanced epigenetic molecular diagnostic test that uses methylation-specific polymerase chain reaction to assess the DNA methylation status of GSTP1, APC, and RASSF1 genes associated with oncogenesis enables a higher degree of accuracy (previously unattainable through prostate biopsy procedures alone) and produces clinical, financial, and health benefits by reducing the number of medically unnecessary and costly repeated biopsies that are part of today's standard of care. OBJECTIVES: The purpose of this study is to quantify, using a budget impact model, the effect of a relatively new epigenetic assay on healthcare costs for commercial health plans that reimburse for the assay, by avoiding unnecessary repeated prostate biopsy procedures. METHODS: A budget impact model was developed to test the hypothesis that the epigenetic assay can produce cost-saving benefits to health plans, as well as clinical benefits to urologists and patients with prostate cancer, by providing guidance on how to offer patients more appropriate, and less costly, care. The budget impact model is presented from the perspective of a hypothetical commercial health plan, and direct costs are calculated over a 1-year time horizon, using 2013 Medicare fee-for-service rates. Using a plan of 1 million members, the model compares 1-year costs in a "reference scenario," in which the epigenetic assay is not used for the screening and diagnosis of prostate cancer, to costs in a "new scenario," in which the epigenetic assay is used to distinguish true-negative prostate biopsy results from false-negative biopsy results. RESULTS: Based on this analysis, administering the epigenetic assay to patients with histopathologically negative biopsies would result in a reduction of 1106 unnecessary biopsies for a health plan with 1 million members. The total 1-year cost of repeated prostate cancer biopsies to the health plan was found to be $2,864,142 in the reference scenario and $2,333,341 in the new scenario. This translates to a total budget impact, or an annual savings, of $530,801 to the plan. The total diagnostic cost was calculated to be $2584 per patient in the new scenario (using the genetic assay) compared with $3172 per patient in the reference scenario (that did not use the assay), resulting in a savings of $588 per patient management. CONCLUSION: This analysis shows that the net cost to a commercial health plan with 1 million members would be reduced by approximately $500,000 if patients with histopathologically negative biopsies were managed with the use of the epigenetic assay to differentiate patients who should undergo repeated biopsy and those who should not. Using this genetic-based assay can save costs to health plans and to the US healthcare and improve the clinical management of patients with elevated PSA levels.

How best to engage patients, doctors, and other stakeholders in designing comparative effectiveness studies.

Having patients, doctors, health plan managers, hospital executives, and other stakeholders participate in the design of comparative effectiveness studies can ensure that this vital research focuses on the evidence gaps most relevant to health care decision makers. Through a qualitative assessment of case studies, we identify five key principles for the effective engagement of a broad coalition of participants in research intended to improve health care and control costs. Those principles are to ensure balance among the participating stakeholders; get participants to "buy in" to the process and understand their roles; provide neutral and expert facilitators for research discussions; establish connections among the participants; and keep the participants engaged throughout the research process.

Translating medical effectiveness research into policy: lessons from the California Health Benefits Review Program.

CONTEXT: Legislatures and executive branch agencies in the United States and other nations are increasingly using reviews of the medical literature to inform health policy decisions. To clarify these efforts to give policymakers evidence of medical effectiveness, this article discusses the California Health Benefits Review Program (CHBRP). This program, based at the University of California, analyzes the medical effectiveness of health insurance benefit mandate bills for the California legislature, as well as their impact on cost and public health. METHODS: This article is based on the authors' experience reviewing benefit mandate bills for CHBRP and findings from evaluations of the program. General observations are illustrated with examples from CHBRP's reports. Information about efforts to incorporate evidence into health policymaking in other states and nations was obtained through a review of published literature. FINDINGS: CHBRP produces reports that California legislators, legislative staff, and other major stakeholders value and use routinely in deliberations about benefit mandate bills. Where available, the program relies on previously published meta-analyses and systematic reviews to streamline the review of the medical literature. Faculty and staff responsible for the medical effectiveness sections of CHBRP's reports have learned four major lessons over the course of the program's six-year history: the need to (1) recognize the limitations of the medical literature, (2) anticipate the need to inform legislators about the complexity of evidence, (3) have realistic expectations regarding the impact of medical effectiveness reviews, and (4) understand the consequences of the reactive nature of mandated benefit reviews. CONCLUSIONS: CHBRP has demonstrated that it is possible to produce useful reviews of the medical literature within the tight time constraints of the legislative process. The program's reports have provided state legislators with independent analyses that allow them to move beyond sifting through conflicting information from proponents and opponents to consider difficult policy choices and their implications.

Litigating the science of breast cancer treatment.

Beginning in the late 1980s, many health insurers refused to cover high-dose chemotherapy with autologous bone marrow transplant (HDC/ABMT) for high-risk and metastatic breast cancer patients. Insurers denied coverage because there was no persuasive evidence of clinical effectiveness. In response, many women sued to compel coverage. After years of litigation and the expenditure of approximately $3 billion, randomized clinical trials (RCTs) showed that the procedure was no more effective and possibly more harmful than conventional therapy. To understand whether and how litigation contributed to the diffusion of the procedure, we conducted a series of case studies that examine the litigation tactics and strategies used by defense and plaintiffs' counsel. Despite the fact that HDC/ABMT lacked proven scientific effectiveness, insurance defense attorneys were unable to stop the procedure's diffusion. Plaintiffs' attorneys had a much easier and more sympathetic story to tell and were able to exploit vulnerabilities facing the defense.

Evaluating medical effectiveness for the california health benefits review program.

An important aspect of the mandate assessments requested by the California legislature is a review of the scientific and medical literature on the medical effectiveness of the proposed health insurance benefit mandate. Although such a review bears many similarities to effectiveness reviews that might be undertaken for publication as research studies, several important differences arise from the requirements of the California legislation. Our reviews are intended to assist the legislators in deciding whether to support a specific mandate to modify health insurance benefits in a particular way. Thus, our assessments focus on how the scientific literature bears on the proposed mandate, which may involve a complicated chain of potential effects leading from altered coverage to ultimate impact on health. Evidence may be available for only some of the links in the chain. Furthermore, not all the evidence may be directly applicable to the diverse population of California or the subpopulation affected by the mandate. The mandate reviews, including the medical effectiveness analyses, may be used in a potentially contentious decision making setting. The legislative calendar requires that they need to be timely, yet they must be as valid, credible, and based on the best information available as possible. The focus on applicability also implies the need for informed, technical decisions concerning the relevance of the articles for the report, and these decisions need to be made as transparent as possible. These goals and constraints yield an approach that differs somewhat from an investigator-initiated review of the literature.

A comparative analysis of mandated benefit laws, 1949-2002.

OBJECTIVE: To understand and compare the trends in mandated benefits laws in the United States. DATA SOURCES/STUDY SETTING: Mandated benefit laws enacted in 50 states and the District of Columbia for the period 1949-2002 were compiled from multiple published compendia. STUDY DESIGN: Laws that require private insurers and health plans to cover particular services, types of diseases, or care by specific providers in 50 states and the District of Columbia are compared for the period 1949-2002. Legislation is compared by year, by average and total frequency, by state, by type (provider, health care service, or preventive), and according to whether it requires coverage or an offer of coverage. DATA COLLECTION/EXTRACTION METHOD: Data from published tables were entered into a spreadsheet and analyzed using statistical software. PRINCIPAL FINDINGS: A total of 1,471 laws mandated coverage for 76 types of providers and services. The most common type of mandated coverage is for specific health care services (670 laws for 34 different services), followed by laws for services offered by specific professionals and other providers (507 mandated benefits laws for 25 types of providers), and coverage for specific preventive services (295 laws for 17 benefits). On average, a mandated benefit law has been adopted or significantly revised by 19 states, and each state has approximately 29 mandates. Only two benefits (minimum maternity stay and breast reconstruction) are mandated in all 51 jurisdictions and these were also federally mandated benefits. The mean number of total mandated benefit laws adopted or significantly revised per year was 17 per year in the 1970s, 36 per year in the 1980s, 59 per year in the 1990s, and 76 per year between 2000 and 2002. Since 1990, mandate adoption increased substantially, with around 55 percent of all mandated benefit laws enacted between 1990 and 2002. CONCLUSIONS: There was a large increase in the number of mandated benefits laws during the managed care "backlash" of the 1990s. Many states now use mandated benefits to prescribe not only what services and benefits would be provided but how, where, and when services will be provided.

Independent medical review of health plan coverage denials: early trends.

Concerns among patients and physicians that health plans would deny coverage for medically necessary services has brought about legislation mandating independent medical review (IMR) of denied services. Among 1,400 cases submitted in California, the most common areas for dispute were cancer care, endocrine/metabolic care (especially for obesity), orthopedic care, and neurological disorders. Surgery and pharmacy services constituted 52 percent of cases. In 58 percent of cases, IMR upheld the health plan's decision, while in 33 percent of cases the health plan's decision was overturned, which suggests that external IMR provides additional patient protection in California's health care system.