Quantitative imaging workshop XIX: Utilizing quantitative thoracic imaging to optimize population health final summary.

Lung cancer screening involves the use of thoracic CT for both detection and measurements of suspicious lung nodules to guide the screening management. Since lung cancer screening eligibility typically requires age over 50 years along with >20 pack-year tobacco exposure, thoracic CT scans also frequently reveal evidence for pulmonary emphysema as well as coronary artery calcification. These three thoracic diseases are collectively three of the leading causes of premature death across the world. Screening for the major thoracic diseases in this heavily tobacco-exposed cohort is broadening the focus of lung cancer screening to a more comprehensive health evaluation including discussing the relevance of screen-detected findings of the heart and lung parenchyma. The status and implications of these emerging issues were reviewed in a multidisciplinary workshop focused on the process of quantitative imaging in the lung cancer screening setting to guide the evolution of this important new area of public health.

Pharma APMs: Can the Industry Learn To Play Well With Others?

The alternative payment model (APM) is a nontraditional financial arrangement that rewards health care providers who deliver cost-effective, high-quality care. Now we are facing the possibility that pharmaceutical manufacturers and insurers will embrace APMs as a payment mechanism in some situations.

Pharma APMs: A Learning Curve Awaits You, Pharma.

There are some valuable lessons for pharmaceutical manufacturers in provider alternative payment models (APMs), but whether pharmaceutical APMs succeed or fail will depend on finding solutions to operational and logistical challenges-some of which are unique to the pharmaceutical industry. Pharmaceutical APMs may require the collection of information beyond the claims data that many provider APMs depend on.

Small Changes or Big Ones? The Case of Limits on Prescription Drug Copayments in California.

Despite standardization, advocates for various industries and certain patient needs continue to propose changes in coverage rules. Much of the advocacy is occurring at the state level with a focus on pharmaceutical coverage, such as equalizing cost sharing between oral and infused oncology drugs or setting limits on cost sharing for prescriptions.

The Self-driving Patient: How Health Care Will Catch Up.

Some providers will resent less obedient patients, but others will enthusiastically support more individually appropriate solutions and take risks with their patients. It's likely that the early adopters (most likely the more affluent and educated) will soon become a noticeable minority in some physicians' offices.

Medicare cost of colorectal cancer screening: CT colonography vs. optical colonoscopy.

PURPOSE: To compare the Medicare population cost of colorectal cancer (CRC) screening of average risk individuals by CT colonography (CTC) vs. optical colonoscopy (OC). METHODS: The authors used Medicare claims data, fee schedules, established protocols, and other sources to estimate CTC and OC per-screen costs, including the costs of OC referrals for a subset of CTC patients. They then modeled and compared the Medicare costs of patients who complied with CTC and OC screening recommendations and tested alternative scenarios. RESULTS: CTC is 29% less expensive than OC for the Medicare population in the base scenario. Although the CTC cost advantage is increased or reduced under alternative scenarios, it is always positive. CONCLUSION: CTC is a cost-effective CRC screening option for the Medicare population and will likely reduce Medicare expenditures for CRC screening.

Costs and repeat rates associated with colonoscopy observed in medical claims for commercial and Medicare populations.

BACKGROUND: Colorectal cancer is among the leading causes of cancer and cancer-related mortality in the United States. The incidence and mortality associated with CRC can be reduced with preventive screening. Inadequate bowel preparation has been associated with missed adenomas and the need for repeat colonoscopies. METHODS: Separate claims source databases were analyzed to determine the costs associated with colonoscopy in the commercial and Medicare populations. Observed repeat rates for colonoscopy within 4 years of initial screening were also examined. RESULTS: Among the 6 most commonly used billing codes, the average allowed cost for an episode of colonoscopy in 2010 was $2,146 in the commercial population and $1,071 in the Medicare population, with average cost sharing of $334 and $275, respectively. The portion of colonoscopies associated with a biopsy or polyp removal exceeded 50% in the commercial and Medicare populations. Approximately 57% of colonoscopies in the commercial population were associated with claims for a prescription bowel preparation product within 30 days prior to the procedure. Three branded and three generic bowel cleansing products accounted for approximately 75% of the total number of prescription claims for colonoscopy. Given literature reports that up to 25% of patients receive inadequate bowel preparation, the rate of repeat colonoscopy within 4 years of initial screening was lower than expected among patients who were not coded with common clinical reasons for early repeat: benign neoplasm, lesion, or polyp removed at initial screening colonoscopy. CONCLUSIONS: The reported rates of inadequate bowel preparation are 15% to 25%, but the rates of repeat colonoscopy found in our analysis are much lower; this is a risk concern considering the reported, significant miss rate of adenomas secondary to inadequate bowel preparation.

Treatment patterns and clinical outcomes among Medicare beneficiaries using antipsychotic medications for FDA-approved indications before and after transitioning from the community to a nursing home.

OBJECTIVES: This study examines the relationships between changes in antipsychotic medication (AP) use and acute clinical events (identified with administrative claims data) for patients with FDA-approved indications for APs following transition from the community (e.g. home) to a nursing home (NH) in a Medicare population. METHODS: A retrospective analysis was conducted using 100% Medicare fee-for-service (FFS) research identifiable files (RIF) claims data (2016-2018). Medicare beneficiaries with a condition for which APs are approved by the FDA were examined using logistic regression models to determine whether changes in AP use following transition from community to NHs were correlated with the likelihood of experiencing acute clinical events. RESULTS: We identified 38,448 Medicare FFS beneficiaries meeting our study criteria. A change in AP use after transition to a NH did not have a statistically significant association with acute skeletal events, coronary artery events, or cerebrovascular events (p = .55, p = .69, and p = .59, respectively). CONCLUSIONS: Between 2016 and 2018, Medicare FFS patients with approved-use indications for APs had lower average AP use following transition to a NH. Changes in the use of other medications of interest largely followed a similar pattern, indicating that these medications did not tend to be used as substitutions for APs. No clear relationship exists between increases or decreases in AP use and adverse events among NH residents who used APs and had FDA-approved conditions in the community setting.

Effect of stage shift and immunotherapy treatment on lung cancer survival outcomes.

OBJECTIVES: Non-small-cell lung cancer mortality has declined at a faster rate than incidence due to multiple factors, including changes in smoking behaviour, early detection which shifts diagnosis, and novel therapies. Limited resources require that we quantify the contribution of early detection versus novel therapies in improving lung cancer survival outcomes. METHODS: Non-small-cell lung cancer patients from the Surveillance, Epidemiology, and End Results-Medicare data were queried and divided into: (i) stage IV diagnosed in 2015 (n = 3774) and (ii) stage I-III diagnosed in 2010-2012 (n = 15 817). Multivariable Cox-proportional hazards models were performed to assess the independent association of immunotherapy or diagnosis at stage I/II versus III with survival. RESULTS: Patients treated with immunotherapy had significantly better survival than those who did not (HRadj: 0.49, 95% confidence interval: 0.43-0.56), as did those diagnosed at stage I/II versus stage III (HRadj: 0.36, 95% confidence interval: 0.35-0.37). Patients on immunotherapy had a 10.7-month longer survival than those who were not. Stage I/II patients had an average survival benefit of 34 months, compared to stage III. If 25%% of stage IV patients not on immunotherapy received it, there would be a gain of 22 292 person-years survival per 100 000 diagnoses. A switch of only 25% from stage III to stage I/II would correspond to 70 833 person-years survival per 100 000 diagnoses. CONCLUSIONS: In this cohort study, earlier stage at diagnosis contributed to life expectancy by almost 3 years, while gains from immunotherapy would contribute ½ year of survival. Given the relative affordability of early detection, risk reduction through increased screening should be optimized.

PROMETHEUS: Long-Term Exacerbation and Mortality Benefits of Implementing Single-Inhaler Triple Therapy in the US COPD Population.

Background: The US population includes 24 million to 29 million people with diagnosed and undiagnosed chronic obstructive pulmonary disease (COPD). Studies have demonstrated the safety and efficacy of single-inhaler triple therapy (SITT) in reducing COPD exacerbations. Long-term population implications of SITT use have not been quantified. Objectives: This simulation-based projection aimed to estimate the potential impact of widespread SITT use on the US COPD population. Methods: Exacerbation and all-cause mortality reductions reported in the Efficacy and Safety of Triple Therapy in Obstructive Lung Disease trial (ETHOS; NCT02465567) were used to project clinical outcomes in US patients meeting ETHOS trial eligibility criteria (ETHOS-Eligible) and patients meeting a practical definition of SITT eligibility (Expanded ETHOS-Eligible). The US COPD population was modeled with 1000 simulations of patient progression over 10 years. Agent characteristics were based on literature and claims analysis of the 2016-2018 Medicare 100% fee-for-service and IBM MarketScan® databases. Agent annual characteristics reflected incident cases, changes in COPD severity, treatment, mortality, and exacerbations under status quo treatment patterns and scenarios for the adoption of SITT. The scenarios assumed the reduced exacerbation and mortality rates associated with SITT according to ETHOS trial outcomes mean values. Results: Higher than current SITT adoption over 10 years would be expected to substantially reduce COPD exacerbation-associated hospitalizations by 2 million. Applying mean improvements reported in ETHOS for SITT would extend average patient life expectancy 2.2 years for ETHOS-Eligible patients and 1.7 years for Expanded ETHOS-Eligible patients. The number needed to treat to extend the average patient life by 1 year was 8 for the ETHOS-Eligible population and 10 for the Expanded ETHOS-Eligible population. Discussion: Widespread SITT adoption may be impeded by competitive pressures from generic treatments and nonadherence, and efficacy observed in clinical trials may not occur in real-world populations. Conclusions: Assuming ETHOS treatment effects and adherence translate to clinical practice, higher than current use of SITT can substantially reduce COPD exacerbations and hospitalizations and extend survival. These results should be viewed cautiously, because the improved outcomes for SITT in the ETHOS final retrieved vital statistics data were not statistically significant for all comparator therapy groups.

A 4-Year Retrospective Claims Analysis of Oral Corticosteroid Use and Health Conditions in Newly Diagnosed Medicare FFS Patients with COPD.

Purpose: We analyzed population-level administrative claims data for Medicare fee-for-service (FFS) beneficiaries to provide insights on systemic oral corticosteroid (OCS) use patterns and associated health conditions and acute events among patients newly diagnosed with chronic obstructive pulmonary disease (COPD). Background: COPD is a progressive inflammatory disease of the lungs, characterized by acute exacerbations that may lead to increased mortality. Short courses of systemic corticosteroids (SCS) are recommended to reduce recovery time from exacerbations, although SCS use has been associated with increased risk of adverse events. Methods: This study used 2013-2019 Medicare 100% FFS research identifiable files, which contain all Medicare Parts A, B, and D paid claims incurred by 100% of Medicare FFS beneficiaries. Descriptive statistics for patients newly diagnosed with COPD were analyzed, including OCS use, select health conditions and acute events, and COPD exacerbations. Statistical models were used to analyze the relationship between the incidence of select health conditions and events and cumulative OCS dosage. Results: Of Medicare FFS patients newly diagnosed with COPD, 36% received OCS in the 48 months following diagnosis, and 38% of OCS episodes lasted longer than the recommended 5-7 days. Patients had a variety of health conditions or acute events in the 24-month period prior to new COPD diagnosis, such as hypertension, depression/anxiety, type 2 diabetes, or osteoporosis, that could heighten the risks of OCS use. Patients treated with >1000 mg of prednisolone equivalent OCS in the 48 months following COPD diagnosis had a higher incidence of new conditions or events, including cardiovascular disease, heart failure, hypertension, obesity, dyspepsia, infections, and depression/anxiety, than patients with no OCS use. Conclusion: These results highlight the potential risks of OCS in COPD treatment, including prolonged use among complex Medicare patients, and reinforce the importance of preventive treatment strategies and therapy optimization early in the disease course.

Association of Stage Shift and Population Mortality Among Patients With Non-Small Cell Lung Cancer.

Importance: Early detection by computed tomography and a more attention-oriented approach to incidentally identified pulmonary nodules in the last decade has led to population stage shift for non-small cell lung cancer (NSCLC). This stage shift could substantially confound the evaluation of newer therapeutics and mortality outcomes. Objective: To investigate the association of stage shift with population mortality among patients with NSCLC. Design, Setting, and Participants: This retrospective cohort study was performed from October 2020 to June 2021 and used data from the Surveillance, Epidemiology, and End Results (SEER) registries to assess all patients from 2006 to 2016 with NSCLC. Main Outcomes and Measures: Incidence-based mortality was evaluated by year-of-death. To assess shifts in diagnostic characteristics, clinical stage and histology distributions were examined by year using χ2 tests. Trends were assessed using the average annual percentage change (AAPC), calculated with JoinPoint software. Kaplan-Meier survival analysis assessed overall survival according to stage and compared those missing any stage with those with a reported stage. Results: The final sample contained 312 382 patients; 166 657 (53.4%) were male, 38 201 (12.2%) were Black, and 249 062 (79.7%) were White; the median (IQR) age was 68 (60-76) years; 163 086 (52.2%) had adenocarcinoma histology. Incidence-based mortality within 5 years of diagnosis decreased from 2006 to 2016 (AAPC, -3.7; 95% CI, -4.1 to -3.4). When assessing stage shift, there was significant association between year-of-diagnosis and clinical stage, with stage I/II diagnosis increasing from 26.5% to 31.2% (AAPC, 1.5; 95% CI, 0.5 to 2.5); and stage III/IV diagnosis decreasing significantly from 70.8% to 66.1% (AAPC, -0.6; 95% CI, -1.0 to -0.2). Missing staging information was not associated with year-of-diagnosis (AAPC, -1.6; 95% CI, -7.4 to 4.5). Year-of-diagnosis was significantly associated with tumor histology (χ2 = 8990.0; P < .001). There was a significant increase in adenocarcinomas: 42.9% in 2006 to 59.0% in 2016 (AAPC, 3.4; 95% CI, 2.9 to 3.9). Median (IQR) survival for stage I/II was 57 months (18 months to not reached); stage III/IV was 7 (2-19) months; and missing stage was 10 (2-28) months. When compared with those with known stage, those without stage information had significantly worse survival than those with stage I/II, with survival between those with stage III and stage IV (log-rank χ2 = 87 125.0; P < .001). Conclusions and Relevance: This cohort study found an association between decreased mortality and a corresponding diagnostic shift from later to earlier stage. These findings suggest that studies investigating the effect of treatment on lung cancer must take into account stage shift and the confounding association with survival and mortality outcome.

Greater uptake, an alternative reimbursement methodology needed to realize cost-saving potential of oncology biosimilars in the United States.

BACKGROUND: Biologics are an important treatment option for solid tumors and hematological malignancies but are a primary driver of health care spending growth. The United States has yet to realize the promise of reduced costs via biosimilars because of slow uptake, partially resulting from commercial payer reimbursement models that create economic incentives favoring the prescribing of reference biologics. OBJECTIVE: To examine the economic feasibility of an alternative reimbursement methodology that prospectively shares savings across commercial payers and providers to shift economic incentives in favor of lower-cost oncology biosimilars. METHODS: Using 3 oncology monoclonal antibody drugs (trastuzumab, bevacizumab, and rituximab) as examples, we developed an alternative reimbursement model that would offer an additional per unit payment (or "extra consideration") such that providers' net income per unit for biosimilars and reference biologics become equal. Provider-negotiated rates (or payer-allowable amounts) and average sales prices were obtained from claims data and projected to develop prices/costs from 2021 through 2025. Scenario analyses by varying key model assumptions were performed. RESULTS: The alternative reimbursement model achieved 1-year and 5-year payer savings in the commercial market for all 3 drugs in the sites of service analyzed. The base analysis showed first-year cost savings to payers, net of cost sharing, of up to 9% in physician offices (POs) and up to 1% in non-340B hospital outpatient departments (HOPDs) for patients using the drugs analyzed. Five-year cumulative savings per patient ranged from about $12,600-$16,100 in PO and $2,200-$4,100 in HOPD. Payer savings varied depending on the characteristics of the provider with which the payer was negotiating (eg, lower- vs highermarkup providers, POs vs HOPDs). CONCLUSIONS: Positive payer savings shown in our modeling suggest that an alternative reimbursement arrangement could facilitate an economic compromise wherein commercial payers can save on biosimilars while providers' incomes are preserved. DISCLOSURES: Research funding was provided by Pfizer Inc. Yang and Shelbaya are employees of Pfizer Inc. and own Pfizer stock. Carioto, Pyenson, Smith, Jacobson, and Pittinger are employees of Milliman Inc., which received research funding from Pfizer Inc., for work on this study. Milliman, Inc., provides actuarial and other professional services to organizations throughout the healthcare industry. None of these are contingent, equity or investment relationships.

Applying Machine Learning Techniques to Identify Undiagnosed Patients with Exocrine Pancreatic Insufficiency.

BACKGROUND: Exocrine pancreatic insufficiency (EPI) is a serious condition characterized by a lack of functional exocrine pancreatic enzymes and the resultant inability to properly digest nutrients. EPI can be caused by a variety of disorders, including chronic pancreatitis, pancreatic cancer, and celiac disease. EPI remains underdiagnosed because of the nonspecific nature of clinical symptoms, lack of an ideal diagnostic test, and the inability to easily identify affected patients using administrative claims data. OBJECTIVES: To develop a machine learning model that identifies patients in a commercial medical claims database who likely have EPI but are undiagnosed. METHODS: A machine learning algorithm was developed in Scikit-learn, a Python module. The study population, selected from the 2014 Truven MarketScan® Commercial Claims Database, consisted of patients with EPI-prone conditions. Patients were labeled with 290 condition category flags and split into actual positive EPI cases, actual negative EPI cases, and unlabeled cases. The study population was then randomly divided into a training subset and a testing subset. The training subset was used to determine the performance metrics of 27 models and to select the highest performing model, and the testing subset was used to evaluate performance of the best machine learning model. RESULTS: The study population consisted of 2088 actual positive EPI cases, 1077 actual negative EPI cases, and 437 530 unlabeled cases. In the best performing model, the precision, recall, and accuracy were 0.91, 0.80, and 0.86, respectively. The best-performing model estimated that the number of patients likely to have EPI was about 12 times the number of patients directly identified as EPI-positive through a claims analysis in the study population. The most important features in assigning EPI probability were the presence or absence of diagnosis codes related to pancreatic and digestive conditions. CONCLUSIONS: Machine learning techniques demonstrated high predictive power in identifying patients with EPI and could facilitate an enhanced understanding of its etiology and help to identify patients for possible diagnosis and treatment.

No Apparent Workup for most new Indeterminate Pulmonary Nodules in US Commercially-Insured Patients.

BACKGROUND: A recent study estimated that more than 1.5 million Americans have an indeterminate pulmonary nodule (IPN) identified on a chest computed tomography (CT) scan each year outside of lung cancer screening programs. However, the cost and pattern of subsequent IPN workup have not been described for real-world settings. OBJECTIVES: To examine the pattern and cost of IPN workup in real-world practice using insurer administrative claims data for commercially-insured individuals. METHODS: The primary source for this retrospective observational study was the MarketScan® 2013-2016 databases, which include information on 28 to 47 million insured lives. The newly diagnosed IPN study population consisted of members with an IPN diagnosis code on a claim in 2014 who did not have prior diagnosis of an IPN or lung cancer in 2013 and who had coverage from 2014 to 2016. Subsequent claims were examined for workups included in the American College of Chest Physicians (ACCP) guideline recommendations and the costs of workup were tabulated. RESULTS: Of the 15 064 patients in the study population, only 5471 (36%) received any subsequent workup. The average and median costs of workup for these patients were $3270 and $2068, respectively. Spread across the commercially-insured population, the workup is estimated to cost between $1 and $2 per member per year. CONCLUSIONS: The majority of commercially-insured members with newly identified IPNs do not appear to have any guideline-recommended workup, despite a low incremental cost of such workup services on a population basis.

The Real-World Medicare Costs of Alzheimer Disease: Considerations for Policy and Care.

BACKGROUND: Headlines in popular media suggest that Alzheimer disease will bankrupt the Medicare program. Indeed, Alzheimer disease affects more than 5 million older Medicare beneficiaries. OBJECTIVE: To compare total Medicare-covered (allowed) costs of patients with Alzheimer disease with the risk adjusted costs of beneficiaries without dementia over their last years of life, using claims data. METHODS: Using the Medicare 5 Percent Limited Data Set claim files from 2006-2015, we conducted a cost impact analysis of costs for up to 8 years before the year of death. Risk adjustment was performed at a beneficiary level using Medicare's 2015 Hierarchical Condition Categories. Beneficiaries were classified into dementia categories based on their diagnoses during the last 3 years of life. Costs were trend adjusted to 2015. RESULTS: This study found that 40% of deceased beneficiaries have Alzheimer disease or unspecified dementia diagnoses in their claims history. In their last 9 years of life, Alzheimer disease added about 11% to the average $17,000 per year Medicare cost for same-risk beneficiaries without dementia. CONCLUSIONS: Like many diseases, Alzheimer disease and dementia are associated with aging, but unlike other diseases, families and Medicaid, rather than Medicare, bear most of the substantial cost burden. As research continues into Alzheimer treatments, it is not too early to consider how to better integrate Medicare and Medicaid to fund and improve patient outcomes, which will likely involve better diagnosis, treatment, and care coordination. DISCLOSURES: Funding for this project was provided by the Alliance for Aging Research, which received funding from Biogen, Eli Lilly, and Janssen Pharmaceuticals. Peschin and Jenkins are employed by the Alliance for Aging Research. Scott was employed by the Alliance for Aging Research at the time of this study and also reports consulting fees from Piramal Imaging, General Electric, and Allergan, outside of this study. Scott is chair of the Board of Directors for the Alliance for Aging Research, which is a volunteer position, and is also president of Applied Policy, a health policy and reimbursement consultancy. Pyenson and Steffens are employed by Milliman, which was contracted to work on this study. Goss Sawhney and Rotter were employed by Milliman at the time this work was performed. Milliman is a consultant to thousands of organizations in the health care industry.

Prevalence, Patterns, and Cost of Care for Children with Cerebral Palsy Enrolled in Medicaid Managed Care.

BACKGROUND: In the United States, many children with cerebral palsy (CP) obtain health care coverage through managed Medicaid, but little is known about the current demographics or management of this high-need, complex population. OBJECTIVE: To develop U.S. population-level information about the prevalence of CP, management patterns, and costs. METHODS: Data (2013-2015) were analyzed from a managed Medicaid database with coverage of children and adolescents in 15 states. Analyses included demographic information and use of 10 prespecified CP management options often used to manage spasticity. Code-based algorithms were applied to indicate presence of spasticity and determine the likely ambulatory status. RESULTS: In this claims analysis, the prevalence estimate of CP was 1.78 per 1,000 patients. Most (69.8%) children with CP had spasticity, of which 20.8% had hemiplegia, 15.6% diplegia, 32.9% quadriplegia, and 30.5% CP unspecified. Overall, 42.4% of children with CP were not treated with any of the 10 CP management options via Medicaid. Among treated children, the most common management options were physical therapy (37.1%), orthotics (29.9%), oral baclofen (13.5%) and botulinum toxins (9.4%). Overall annualized Medicaid costs were higher for children with CP versus children in the overall database population ($22,383 vs. $1,358). Within the CP population, costs were higher for those children who were likely nonambulatory than for those who were likely ambulatory ($43,687 vs. $10,368, respectively). CONCLUSIONS: Most children with CP have spasticity, and the costs of care are high. This study highlights wide variation in the way CP is managed, with many young patients not receiving CP management options via Medicaid. DISCLOSURES: This analysis was funded by Ipsen Biopharmaceuticals and conducted by Milliman. Pulgar and Bains were employees of Ipsen Biopharmaceuticals during the conduct of this study. Chambers is a consultant for OrthoPediatrics and an employee of the University of California. Pyenson and Ferro are employees of Milliman, as was Sawhney during the analysis. Gooch, Noritz, and Wright report no conflicts of interest. Part of this work was presented as a poster at TOXINS 2017: Basic Science and Clinical Aspects of Botulinum and Other Neurotoxins, held January 18-21, 2017, in Madrid, Spain.

Cancer chemoprevention and cancer preventive vaccines--a call to action: leaders of diverse stakeholder groups present strategies for overcoming multiple barriers to meet an urgent need.

The emerging field of cancer prevention through chemoprevention agents and cancer vaccines offers significant promise for reducing suffering and death from cancer. However, that promise may not be kept unless major barriers to progress are lowered or eliminated. Among the most significant barriers are the relatively small investment from government and industry in research and development of cancer preventive agents; a predominant emphasis of translational cancer research on therapeutic interventions for metastatic or advanced cancer; complexities of prevention trial design; a relatively uncharted Food and Drug Administration (FDA) approval process for preventive agents; insufficient public and patient understanding of the importance and potential for cancer preventive measures, with consequent unpredictable public and patient willingness to take preventive agents; an uncertain reimbursement from payors; and limitations in patent law, liability protection, and data package exclusivity that undermine the opportunity for recouping investment. Viewed individually or collectively, each of these barriers serves as a substantial deterrent to intellectual and financial investment by all sectors of the cancer community. In an effort to ultimately overcome these barriers, a Cancer Prevention Research Summit was assembled June 12-13, 2006 in Bethesda, Maryland, organized by C-Change with support from the AACR. The Summit brought together some 120 leaders from private, public, and not-for-profit entities, including cancer researchers and clinicians; federal health officials; regulatory agency representatives; pharmaceutical, biotech, and food industry leaders; patent attorneys; economists; public and private provider group executives; and advocates. Participants engaged in a detailed process to more carefully define the major barriers, identify potential solutions, and formulate initial priorities and recommendations for action. At the conclusion of this dialogue among experts, the following recommended actions were outlined: define policy solutions to patent, intellectual property, and liability law barriers; create an advisory document about the approval process for cancer chemopreventive agents and vaccines for the FDA; develop new design models for cancer chemopreventive clinical trials; outline the business case for chemopreventive agents and vaccines for federal research agencies, payors and investors; and implement a communications strategy to increase public awareness about the importance of chemoprevention and cancer preventive vaccines.

Taking stock of wellness.

The health cost crisis has spawned a thriving cost-control industry that offers an ever-growing number of "solutions." The authors of this article encourage employers to go back to the basics in evaluating these offerings, including their wellness policies and programs. This article describes the many ways different employers do wellness, the evidence base for wellness, how employers should target wellness candidates, and the elements of success and failure for wellness initiatives.