Randomized trial of four financial-incentive programs for smoking cessation.

BACKGROUND: Financial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain. METHODS: We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of $150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids. RESULTS: Overall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted the assignment, as compared with 13.7% of those assigned to deposit-based programs (P<0.001). In intention-to-treat analyses, rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs (range, 9.4 to 16.0%) than with usual care (6.0%) (P<0.05 for all comparisons); the superiority of reward-based programs was sustained through 12 months. Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates (13.7% and 12.1%, respectively; P=0.29). Reward-based programs were associated with higher abstinence rates than deposit-based programs (15.7% vs. 10.2%, P<0.001). However, in instrumental-variable analyses that accounted for differential acceptance, the rate of abstinence at 6 months was 13.2 percentage points (95% confidence interval, 3.1 to 22.8) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7% of the participants who would accept participation in either type of program. CONCLUSIONS: Reward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking. Group-oriented incentive programs were no more effective than individual-oriented programs. (Funded by the National Institutes of Health and CVS Caremark; ClinicalTrials.gov number, NCT01526265.).

Impact of CVS Pharmacy's Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014).

OBJECTIVES: To assess the impact of CVS Health's discontinuation of tobacco sales on cigarette purchasing. METHODS: We used households' purchasing data to assess rates at which households stopped cigarette purchasing for at least 6 months during September 2014 to August 2015 among 3 baseline groups: CVS-exclusive cigarette purchasers, CVS+ (CVS and other retailers), and other-exclusive (only non-CVS retailers). In state-level analyses using retailers' point-of-sale purchase data, an interrupted time series compared cigarette purchasing before (January 2012 to August 2014) and after (September 2014 to April 2015) tobacco removal in 13 intervention states with CVS market share of at least 15% versus 3 control states with no CVS stores. RESULTS: Compared with other-exclusive purchasers, CVS-exclusive purchasers were 38% likelier (95% confidence interval = 1.06, 1.81) to stop cigarette purchasing after tobacco removal. Compared with control states, intervention states had a significant mean decrease of 0.14 (95% confidence interval = 0.06, 0.22) in packs per smoker per month. CONCLUSIONS: After CVS's tobacco removal, household- and population-level cigarette purchasing declined significantly. Private retailers can play a meaningful role in restricting access to tobacco. This highlights one approach to reducing tobacco use and improving public health.

Untangling the relationship between medication adherence and post-myocardial infarction outcomes: medication adherence and clinical outcomes.

BACKGROUND: Patients who adhere to medications experience better outcomes than their nonadherent counterparts. However, these observations may be confounded by patient behaviors. The level of adherence necessary for patients to derive benefit and whether adherence to all agents is important for diseases that require multiple drugs remain unclear. This study quantifies the relationship between medication adherence and post-myocardial infarction (MI) adverse coronary events. METHODS: This is a secondary analysis of the randomized MI FREEE trial. Patients who received full prescription coverage were classified as adherent (proportion of days covered ≥80%) or not based upon achieved adherence in the 6 months after randomization. First major vascular event or revascularization rates were compared using multivariable Cox models adjusting for comorbidity and health-seeking behavior. RESULTS: Compared with patients randomized to usual care, full coverage patients adherent to statin, ß-blocker, or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker were significantly less likely to experience the study's primary outcome (hazard ratio [HR] range 0.64-0.81). In contrast, nonadherent patients derived no benefit (HR range 0.98-1.04, P ≤ .01 for the difference in HRs between adherent and nonadherent patients). Partially adherent patients had no reduction in clinical outcomes for any of the drugs evaluated, although their achieved adherence was higher than that among controls. CONCLUSION: Achieving high levels of adherence to each and all guideline-recommended post-MI secondary prevention medication is associated with improved event-free survival. Lower levels of adherence appear less protective.

Beyond negligence: avoidability and medical injury compensation.

Disenchantment with the tort system and negligence standard in the United States is fueling interest in alternate compensation systems for medical injury. One possibility is experimentation with administrative "health courts," through which specialized adjudicators would utilize neutral experts to render compensability determinations. Compensation would be based not on negligence, but rather on a broader avoidable medical injury (avoidability) standard. Although considerable interest in health courts exists, stakeholders frequently express uncertainty about the meaning and operation of an avoidability standard. Three nations-Sweden, Denmark, and New Zealand-have long operated administrative schemes. We conducted interviews with administrators and stakeholders in these systems. Our goal was to garner lessons on how to operate a health court, and specifically, how to develop and apply alternate compensation criteria such as avoidability. This article reports our findings on the origins and operations of the systems, the evolution of their compensation criteria, and how these criteria are actually applied. We found that all three systems had their primary genesis in ensuring compensation for the injured, as opposed to sanctioning providers. All have abandoned the negligence standard. The Nordic systems use an avoidability standard, principally defined as injury that would not occur in the hands of the best practitioner. Their experience demonstrates that this definition is feasible to apply. New Zealand's recent move to a no-fault system sheds light on the benefits and drawbacks of a variety of compensation standards. Key lessons for successfully applying an alternate standard, such as avoidability, include a strict adherence to national precedent, the use of neutral and experienced experts, and a block on routine transfer of information from compensation investigations to disciplinary authorities. Importantly, all three nations are harnessing their systems' power to improve patient safety, and the avoidability standard appears to be well suited for this task.

Physicians and drug representatives: exploring the dynamics of the relationship.

BACKGROUND: Interactions between physicians and drug representatives are common, even though research shows that physicians understand the conflict of interest between marketing and patient care. Little is known about how physicians resolve this contradiction. OBJECTIVE: To determine physicians' techniques for managing cognitive inconsistencies within their relationships with drug representatives. DESIGN, SETTING, AND PARTICIPANTS: Six focus groups were conducted with 32 academic and community physicians in San Diego, Atlanta, and Chicago. MEASUREMENTS: Qualitative analysis of focus group transcripts to determine physicians' attitudes towards conflict of interest and detailing, their beliefs about the quality of information conveyed and the impact on prescribing, and their resolution of the conflict between detailers' desire to sell product and patient care. RESULTS: Physicians understood the concept of conflict of interest and applied it to relationships with detailers. However, they maintained favorable views of physician-detailer exchanges. Holding these mutually contradictory attitudes, physicians were in a position of cognitive dissonance. To resolve the dissonance, they used a variety of denials and rationalizations: They avoided thinking about the conflict of interest, they disagreed that industry relationships affected physician behavior, they denied responsibility for the problem, they enumerated techniques for remaining impartial, and they reasoned that meetings with detailers were educational and benefited patients. CONCLUSIONS: Although physicians understood the concept of conflict of interest, relationships with detailers set up psychological dynamics that influenced their reasoning. Our findings suggest that voluntary guidelines, like those proposed by most major medical societies, are inadequate. It may be that only the prohibition of physician-detailer interactions will be effective.

Economic value of pharmacist-led medication reconciliation for reducing medication errors after hospital discharge.

OBJECTIVES: Medication discrepancies at the time of hospital discharge are common and can harm patients. Medication reconciliation by pharmacists has been shown to prevent such discrepancies and the adverse drug events (ADEs) that can result from them. Our objective was to estimate the economic value of nontargeted and targeted medication reconciliation conducted by pharmacists and pharmacy technicians at hospital discharge versus usual care. STUDY DESIGN: Discrete-event simulation model. METHODS: We developed a discrete-event simulation model to prospectively model the incidence of drug-related events from a hospital payer's perspective. The model assumptions were based on data published in the peer-reviewed literature. Incidences of medication discrepancies, preventable ADEs, emergency department visits, rehospitalizations, costs, and net benefit were estimated. RESULTS: The expected total cost of preventable ADEs was estimated to be $472 (95% credible interval [CI], $247-$778) per patient with usual care. Under the base-case assumption that medication reconciliation could reduce medication discrepancies by 52%, the cost of preventable ADEs could be reduced to $266 (95% CI, $150-$423), resulting in a net benefit of $206 (95% CI, $73-$373) per patient, after accounting for intervention costs. A medication reconciliation intervention that reduces medication discrepancies by at least 10% could cover the initial cost of intervention. Targeting medication reconciliation to high-risk individuals would achieve a higher net benefit than a nontargeted intervention only if the sensitivity and specificity of a screening tool were at least 90% and 70%, respectively. CONCLUSIONS: Our study suggests that implementing a pharmacist-led medication reconciliation intervention at hospital discharge could be cost saving compared with usual care.

Allergic to generics.

A 69-year-old woman with several medical problems believes that she is allergic to generic medications. She frequently conflicts with her long-time primary care physician, who, as required by the patient's insurance coverage, refuses to prescribe brand-name drugs when generic alternatives are available. This conflict intensifies to a crisis when the patient develops life-threatening problems and still will not take prescribed generic medications. The presentation of this real case is accompanied by a discussion of the ethical dilemmas of the patient's physician, who must weigh the interests of a patient who clings to beliefs that the physician thinks are unfounded against the interests of a just rationing program and the broader population it serves.

The Leapfrog standards: ready to jump from marketplace to courtroom?

The Leapfrog Group, a consortium of large employers, aims to use its collective purchasing power to motivate hospitals to implement particular measures designed to improve patient safety and the quality of care. While these criteria are meant to be purely aspirational, and while Leapfrog's effort is praiseworthy, we caution that the articulation of these standards of care may have unintended legal consequences. Efforts by aggressive medical malpractice attorneys could rapidly transform Leapfrog's standards from marketplace advantages for compliant hospitals to performance expectations required by law. This undesirable potential outcome compounds the importance of selecting these standards with the utmost care.

Physicians' professional responsibility to improve the quality of care.

Physicians have long recognized a professional responsibility to improve the quality of care. However, that responsibility should be evolving in light of developments in both the science of quality improvement and the ethical base of professionalism. Over the last 30 years, quality science has moved from static/structural measures to a much more sophisticated set of outcome and process issues. It has also self-consciously integrated notions of continuous improvement. The ethical base of professionalism is also more dynamic, today emphasizing the policy activist attributes of so-called civic professionalism. The combination of modern quality measurement/improvement and activist professionalism is a virtual call to arms for the profession to advocate care that is systematically better. Recent developments in the domain of quality dealing with medical errors can be used to illustrate this synergy, and provide a set of mandates for the new professional commitment to quality.

Physician-citizens--public roles and professional obligations.

Although leaders and other commentators have called for the medical profession's greater engagement in improving systems of care and population health, neither medical education nor the practice environment has fostered such engagement. Missing have been a clear definition of physicians' public roles, reasonable limits to what can be expected, and familiarity with tasks that are compatible with busy medical practices. We address these issues by proposing a definition and a conceptual model of public roles that require evidence of disease causation and are guided by the feasibility and efficacy of physician involvement. We then frame a public agenda for individual physicians and physician organizations that focuses on advocacy and community participation. By doing so, we aim to stimulate dialogue about the appropriateness of such roles and promote physician engagement with pressing health issues in the public arena.

Eliminating medication copayments reduces disparities in cardiovascular care.

Substantial racial and ethnic disparities in cardiovascular care persist in the United States. For example, African Americans and Hispanics with cardiovascular disease are 10-40 percent less likely than whites to receive secondary prevention therapies, such as aspirin and beta-blockers. Lowering copayments for these therapies improves outcomes among all patients who have had a myocardial infarction, but the impact of lower copayments on health disparities is unknown. Using self-reported race and ethnicity for participants in the Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MI FREEE) trial, we found that rates of medication adherence were significantly lower and rates of adverse clinical outcomes were significantly higher for nonwhite patients than for white patients. Providing full drug coverage increased medication adherence in both groups. Among nonwhite patients, it also reduced the rates of major vascular events or revascularization by 35 percent and reduced total health care spending by 70 percent. Providing full coverage had no effect on clinical outcomes and costs for white patients. We conclude that lowering copayments for medications after myocardial infarctions may reduce racial and ethnic disparities for cardiovascular disease.

Quality of care at retail clinics for 3 common conditions.

OBJECTIVES: Evaluation of quality of care across retail clinics in a geographically diverse population has not been undertaken to date. We sought to evaluate and compare the quality of care for otitis media, pharyngitis, and urinary tract infection received in retail medical clinics in CVS pharmacies ("MinuteClinics" [MCs]), ambulatory care facilities (ACFs), and emergency departments (EDs). METHODS: We used 14 measures constructed from RAND Corporation's Quality Assurance Tools and guidelines from the American Academy of Pediatrics, the American Academy of Family Physicians, and the Infectious Diseases Society of America. Our cohort was drawn from Aetna medical and prescription claims, 2009-2012. Members were matched on visit date, condition, and propensity score. Generalized estimating equations were used to compare quality across clinic type, overall, and by index condition. RESULTS: We matched 75,886 episodes of care, of which 20,153 were eligible for at least 1 quality measure. MCs performed better than EDs and ACFs in 7 measures. In a multivariable model, MCs performed better than ACFs and EDs across all quality measures ([OR 0.42; 95% CI, 0.40-0.45; P < .0001; ACF vs MC] [OR 0.29; 95% CI, 0.27-0.31; P < .0001; ED vs MC]). Results for each condition were significant at P < .0001. CONCLUSIONS: Quality of care for these conditions based on widely accepted objective measures was superior in MinuteClinics compared with ACFs and EDs.

An integrated pharmacy-based program improved medication prescription and adherence rates in diabetes patients.

A substantial threat to the overall health of the American public is nonadherence to medications used to treat diabetes, as well as physicians' failure to initiate patients' use of those medications. To address this problem, we evaluated an integrated, pharmacy-based program to improve patients' adherence and physicians' initiation rates. The study included 5,123 patients with diabetes in the intervention group and 24,124 matched patients with diabetes in the control group. The intervention consisted of outreach from both mail-order and retail pharmacists who had specific information from the pharmacy benefit management company on patients' adherence to medications and use of concomitant therapies. The interventions improved patients' medication adherence rates by 2.1 percent and increased physicians' initiation rates by 38 percent, compared to the control group. The benefits were greater in patients who received counseling in the retail setting than in those who received phone calls from pharmacists based in mail-order pharmacies. This suggests that the in-person interaction between the retail pharmacist and patient contributed to improved behavior. The interventions were cost-effective, with a return on investment of approximately $3 for every $1 spent. These findings highlight the central role that pharmacists can play in promoting the appropriate initiation of and adherence to therapy for chronic diseases.

The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money.

In this article we highlight the important role that medication therapy can play in preventing disease and controlling costs. Focusing on coronary artery disease, we demonstrate that prevention, with the appropriate use of generic medications, appears far more cost-effective than previously documented, and it may even save on costs. For example, an earlier study estimated that reducing blood pressure to widely established clinical guidelines in nondiabetic patients cost an estimated $52,983 per quality-adjusted life-year if a brand-name drug was used. However, we estimate that the cost is just $7,753 per quality-adjusted life-year at generic medication prices. As the nation attempts to find strategies to improve population health without adding to the unsustainably high cost of care, policy makers should focus on ensuring that patients have access to essential generic medications.