Comparative effectiveness research, now that it has significant funding, can make a real difference to health insurers. But is the money going for truly useful projects?
Let’s recall that the American Recovery and Reinvestment Act (ARRA) of 2009 allocated $1.1 billion to comparative effectiveness research (CER), and that, by early August 2010, about half that amount had been awarded in grants. Specific grant opportunities had been announced for the remainder, but had not yet been awarded.
The Brookings Institution, in a Health Affairs article last fall, listed four common themes that are priorities for managed care:
Managed care and governmental payers clearly struggle with these important health care issues, which frequently involve patient motivation and behavior. Notably, payers are very interested in strategies to improve outcomes, as well as in identifying evidence-based medical treatment strategies for providers. Accordingly, an effective CER program that gives providers, patients, and payers strategies to reduce these problems would go far in reducing costs in the health care system as a whole.
The Brookings Institution, in that October 2010 Health Affairs article, collected and analyzed data related to how the $1.1 billion was being spent. Brookings also categorized how ARRA CER funding has been spent, including type of activity (e.g., evidence development and synthesis, infrastructure and methods development, CER translation and dissemination, clinical focus area, and several other factors).
Let us look at some CER programs already supported by ARRA.
Evidence development is important to managed care, and ARRA is supporting continued funding of the Look AHEAD (Action for Health in Diabetes) trial. Look AHEAD is a randomized clinical trial conducted at 16 centers that includes 5,145 overweight or obese patients (average body mass index of 36) who have type 2 diabetes. The trial compares the effects of an intensive lifestyle intervention (ILI) to less intensive, conventional methods of diabetes support and education (DSE). Four-year results have recently been published in the Archives of Internal Medicine. Compared to trial participants receiving the DSE intervention, ILI participants had greater weight loss, much greater improvements in treadmill fitness, improvements in systolic and diastolic blood pressure, and in levels of high-density lipoprotein cholesterol, triglycerides, and hemoglobin A1c. Trial participants will continue to receive the ILI and DSE interventions for up to 13.5 years. The primary long-term outcome of the trial is whether reductions in risk factors lead to a lower rate of major cardiovascular events, including acute myocardial infarction, stroke, and cardiovascular-related death. The trial will also assess the effect of weight loss and improved fitness on diabetes complications, general and mental health, and quality of life.
Rena Wing, PhD, the Look AHEAD steering committee’s chairwoman, noted that Look AHEAD trial results were consistent across different subgroups and study centers. Wing says that whereas drugs typically treat one or two risk factors, the ILI treats numerous factors. The Look AHEAD trial is also funded by the National Institute of Diabetes and Digestive and Kidney Diseases, other components of the National Institutes of Health, and the Centers for Disease Control and Prevention.
ARRA CER funds support multiple projects that both develop evidence and build managed care research infrastructure. An important example is the development of the Cardiovascular Surveillance System in the Cardiovascular Research Network (CVRN) of the HMO Research Network (HMORN).
HMORN is a group of 15 health plans around the country, including six Kaiser Permanente sites, which provide health care to a diverse population of 10.9 million beneficiaries. As of April 2010, 14 of the sites had implemented electronic medical records. The HMORN/CVRN has a uniformly structured database that includes payer type, patient demographics, pharmacy data, diagnostic data, and utilization (visits and stays) data. A two-year study develops the CVD Surveillance System for coronary heart disease, stroke, and heart failure in the CVRN, including therapeutic interventions, post-event outcomes, and important risk factors and confounders. The aggregate database from all 15 CVRN sites will incorporate stroke and heart failure data so that CVRN investigators and others can conduct CER and health disparity studies.
Another study employing the HMORN CVRN evaluates treatment and outcomes for atrial fibrillation (AF) in clinical practice. This study creates a cohort of 40,000 adults with AF. Two of the goals are to develop and test risk stratification methods for ischemic stroke and systemic thromboembolism in a large-scale community-based cohort of AF patients and to establish and characterize a contemporary registry of incident (new-onset) AF to provide critical insights into outcome event rates and subpopulation differences and to improve AF risk stratification models.
The Agency for Healthcare Research and Quality has used ARRA funds for several other studies that relate directly to managed care’s priorities. Three additional studies that each develop evidence and support managed care research infrastructure to facilitate further CER research, are shown in the table, “Three Federally Funded CER Studies,” below.
|Three federally funded CER studies of special interest to managed care|
|These projects prime examples of CER studies intended to develop evidence and/or to develop managed care infrastructure.|
|Disease||Description of project||Organization|
|Cardiovascular disease/diabetes||Promoting Adherence to Improve the Effectiveness of CVD Therapies (PATIENT) is a pragmatic random controlled trial comparing the effectiveness of two low-cost health information technology interventions utilizing interactive voice recognition messages and patient mailings to increase both initial use and ongoing adherence to three classes of medications used to treat CVD or diabetes.||Kaiser Foundation Research Institute|
|Diabetes||The HMO Research Network’s Diabetes Multi-Center Research Consortium Coordinating Center will build a national research network and a multisystem distributed database for conducting CER in the prevention and treatment of diabetes mellitus. The database will capture clinical data from electronic health records for 750,000 people with diabetes, and will be used to evaluate an intervention for early nonadherent patients compared to a control group and for observational evaluation of several different strategies provided to women who had gestational diabetes and are at very high risk for type 2 diabetes.||Kaiser Foundation Research Institute|
|Asthma/lung disease||Population-Based Effectiveness in Asthma and Lung Disease (PEAL) Network is intended to build an innovative infrastructure for research on asthma and lung disease by creating and linking standardized data sets from a state Medicaid population (TennCare) and four health plan populations. This project will also compare real-world adherence to, and effectiveness of, the major asthma controller regimens in diverse populations.||Harvard Pilgrim Health Care|
Since these CER studies are being conducted in managed care settings, the results may well be valuable to health plan clinical executives and administrators.
As for managed care’s keen interest in the value of biologics, the University of Pittsburgh Medical Center is developing the rheumatoid arthritis (RA) Comparative Effectiveness Research system to perform randomized observational studies comparing the effectiveness of different RA treatment strategies in clinical practice. A large network of rheumatologists is already connected via an electronic medical records system that will collect data on RA patients’ treatments, medical costs, and laboratory results. The study objective is to perform an analysis of biologic therapies for treating RA.
Joshua S. Benner, PharmD, ScD, of the Brookings Institution, describes the importance of comparing different care delivery systems, such as medical homes, traditional fee-for-service networks, and accountable care organizations in improving care and outcomes. Managed care’s interest in developing delivery systems that lead to improved outcomes is highlighted by the fact that of the top CER managed care priorities identified in the table below, three relate to delivery systems. In its assessment, Brookings estimated that 60.5 percent of the ARRA spending ($255.2 million) would be used to evaluate issues related to the delivery, organization, or financing of care, frequently for a specific condition or population.
|CER areas of greatest interest to health plans|
|We talked with three senior managed care executives who together have current or past responsibility for management of about 10 million beneficiaries and identified 10 top managed care priorities for CER, ranking them as extremely or very important. These were culled from the 100 CER priorities the Institute of Medicine (IOM) announced over a year ago as those that will most enable health plans to improve care for populations.|
|Compare effectiveness of…||Managed care selection rationale||IOM quartile|
|Strategies for enhancing patients’ adherence to medication regimens||We need patients more actively involved in managing their own conditions. For many chronic conditions, including cardiac disease, diabetes, asthma, osteoporosis, multiple sclerosis, and hepatitis C, discontinuation is a huge problem.||2|
|Comprehensive care coordination programs, such as the patient-centered medical home and usual care in managing children and adults with severe chronic disease, especially in populations with known health disparities||Care is about patients and physicians. Eighty percent of costs are associated with 20 percent of patients, and the issue of health disparities, such as later diagnosis of breast cancer in black and Hispanic women than in white women, is critical.||1|
|Different disease management strategies in improving the adherence to and value of pharmacologic treatments for the elderly||The elderly are a broad population with many chronic conditions. Effective disease management strategies and messages are key.||2|
|Genetic and biomarker testing and usual care in preventing and treating breast, colorectal, prostate, lung, and ovarian cancer, and possibly other clinical conditions for which promising biomarkers exist||In cancer, genetic biomarkers will help identify responders and nonresponders, creating a huge opportunity for cost savings. Genetic biomarkers may improve cancer treatment efficacy and safety and may reduce time lost to ineffective treatments.||1|
|Treatment strategies for atrial fibrillation, including surgery, catheter ablation, and pharmaceuticals||Atrial fibrillation is very significant in the elderly population. It is important to identify which treatment options are better for which patients.||1|
|Dissemination and translation techniques to facilitate the use of CER by patients, clinicians, payers, and others||Translating and applying CER findings to real-world day-to-day physician practice and patient interactions is key. It relates to patient-centered care, medical homes, EMRs, safety alerts, and payers’ utilization management policies.||1|
|Different strategies of introducing biologics into the treatment algorithm for inflammatory diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis||Price, cost, and value are issues. Where should biologics be in treatment algorithms? Are there lower cost alternatives? Are there biomarkers to identify patients who should be treated aggressively?||1|
|Accountable care systems and usual care on costs, processes of care, and outcomes for geographically defined populations of patients with one or more chronic diseases||With accountable care and shared risk between payers, physicians, hospitals, and other providers, and pay for performance, incentives should be aligned.||1|
|Different benefit design, utilization management, and cost-sharing strategies in improving health care access and quality in patients with chronic diseases (e.g., cancer, diabetes, heart disease)||There are probably 100 different benefit designs. Which are best in terms of overall outcomes and cost savings?||3|
|Treatment strategies for obesity (e.g., bariatric surgery, behavioral interventions, pharmacologic treatment) on the resolution of obesity-related outcomes such as diabetes, hypertension, and musculoskeletal disorders||Obesity is a huge issue and is frequently linked with significant chronic conditions that are costly, such as diabetes and cardiovascular disease.||3|
|The managed care experts who participated in this summary and evaluation are: Maria Lopes, MD., MS, chief medical officer of AMC Health (Geisinger), and former senior vice president and chief medical officer of Group Health Inc. (2.8 million beneficiaries), Ross M. Miller, MD, MPH, former vice president and senior medical director of Cigna (1.5 million beneficiaries), and current member of the Medi-Cal Drug Advisory Committee (6 million beneficiaries), and Renee Rizzo Fleming, RPh, MBA, former vice president for corporate pharmacy devices at HealthNow New York (800,000 beneficiaries). All are now independent consultants. They and other managed care experts and executives established the list from the much larger priority list published by the Institute of Medicine, and it is these three whose comments appear in the “selection rationale” column. — Sarah Collins
For the full list of IOM’s 100 CER priorities: www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx or http://bit.ly/hg8FtJ
In our very dynamic health care environment with its increasing pressures to improve outcomes and control costs, the planned expansion in health insurance coverage, and changes in health care payers and benefit design, successful CER and its rapid dissemination and adoption would be highly valuable to managed care.
There is substantial language in the Patient Protection and Affordable Care Act that significantly limits how Medicare can use CER results. The law states that Medicare may not use CER to develop cost-effectiveness measures to be used to determine coverage, payment, or incentive programs.
Private companies are not bound by that restriction, and can be expected to use the knowledge gained from even the federally funded research as they see fit. Moreover, major budget pressures on the federal government and on Medicare might lead Congress to loosen these restrictions.
Nonetheless, Medicare may find ways to use CER to make its coverage policies more evidence-based and ultimately increase the cost-effectiveness of its spending.
Private companies… can be expected to use the knowledge gained from the federally funded research as they see fit.