Written Comments on Incentives to Promote Health Information Technology

Joint Testimony to Senate HELP Committee on Stabilizing Individual Insurance Market

ACP Statement to the Senate Finance Committee on Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences

ACP Statement for the Record to the Senate HELP Committee for the hearing 'Examining Health Care Workforce Shortages: Where Do We Go From Here?'

ACP Statement for the Record to the Subcommittee on Primary Health and Retirement Security of the Senate Health, Education, Labor and Pensions (HELP) Committee for the hearing - A Dire Shortage and Getting Worse: Solving the Crisis in the Health Care Workforce

Universal Insurance for American Health Care: A Proposal of the American College of Physicians

U.S. Senate Ways and Means Committee.

The Role of the VA in an Evolving Health Care System

Redesigning Medicaid During a Time of Budget Deficits

Physician Workforce and Graduate Medical Education in the United States of America.

Raising the Bar for Procedural Competency Among Hospitalists

Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 170, No 6

Background: Although depression is common among patients receiving maintenance hemodialysis, data on their acceptance of treatment and on the comparative efficacy of various therapies are limited. Objective: To determine the effect of an engagement interview on treatment acceptance (phase 1) and to compare the efficacy of cognitive behavioral therapy (CBT) versus sertraline (phase 2) for treating depression in patients receiving hemodialysis. Design: Multicenter, parallel-group, open-label, randomized controlled trial. (ClinicalTrials.gov: NCT02358343) Setting: 41 dialysis facilities in 3 U.S. metropolitan areas. Participants: Patients who had been receiving hemodialysis for at least 3 months and had a Beck Depression Inventory-II score of 15 or greater; 184 patients participated in phase 1, and 120 subsequently participated in phase 2. Intervention: Engagement interview versus control visit (phase 1) and 12 weeks of CBT delivered in the dialysis facility versus sertraline treatment (phase 2). Measurements: The primary outcome for phase 1 was the proportion of participants who started depression treatment within 28 days. For phase 2, the primary outcome was depressive symptoms measured by the Quick Inventory of Depressive Symptoms–Clinician-Rated (QIDS-C) at 12 weeks. Results: The proportion of participants who initiated treatment after the engagement or control visit did not differ (66% vs. 64%, respectively; P = 0.77; estimated risk difference, 2.1 [95% CI, −12.1 to 16.4]). Compared with CBT, sertraline treatment resulted in lower QIDS-C depression scores at 12 weeks (effect estimate, −1.84 [CI, −3.54 to −0.13]; P = 0.035). Adverse events were more frequent in the sertraline than the CBT group. Limitation: No randomized comparison was made with no treatment, and persistence of treatment effect was not assessed. Conclusion: An engagement interview with patients receiving maintenance hemodialysis had no effect on their acceptance of treatment for depression. After 12 weeks of treatment, depression scores were modestly better with sertraline treatment than with CBT. Primary Funding Source: Patient-Centered Outcomes Research Institute, Dialysis Clinic, Kidney Research Institute, and National Institute of Diabetes and Digestive and Kidney Diseases.

Development of a Framework and Tool to Facilitate Cost-of-Care Conversations With Patients During Prenatal Care

Background: Studies show that patients want to engage in cost-of-care conversations and factor costs into the formulation of care plans. Low-income patients are particularly likely to defer care because of costs, suggesting that cost-of-care conversations may be an important factor in health equity. Little guidance is available to clinicians and health systems for how to integrate effective cost-of-care conversations into clinical practice or to address specific cost needs of low-income patients. Objective: To develop a framework and tool to assist cost-of-care conversations with low-income patients during prenatal care. Design: A qualitative study using human-centered design methods. Setting: University medical center–based obstetrics-gynecology (ob-gyn) practice. Participants: 20 pregnant or recently postpartum women, 16 clinicians, and 8 support and executive staff. Results: Pregnant women accumulate substantial indirect costs that interfere with treatment adherence and stress patients and their relationships. Frequency and duration of appointments are primary drivers of indirect costs; the burden is exacerbated by not knowing these costs in advance and disproportionately affects low-income patients. Working with ob-gyn clinicians, staff, and patients, a paper-based tool was developed to help patients forecast treatment demands and indirect costs, and to help clinicians introduce and standardize cost conversations. Limitations: Data were collected from a small number of stakeholders in a single clinical setting that may not be generalizable to other settings. The tool has not been tested for effects on adherence or clinical outcomes. Conclusion: A communication tool that helps pregnant patients understand their care plan and anticipate indirect costs can promote cost-of-care conversations between clinicians and low-income patients. Primary Funding Source: Robert Wood Johnson Foundation.

Characteristics of High Cardiovascular Risk in 1.7 Million Chinese Adults

Background: As cardiovascular risk increases in China, interest in strategies to mitigate it is growing. However, national information about the prevalence and treatment of high cardiovascular disease (CVD) risk is limited. Objective: To assess the prevalence and treatment of high CVD risk as well as variations in risk across population subgroups. Design: National project of CVD screening and management. Setting: 141 county-level regions in all 31 provinces of China. Participants: Local residents aged 35 to 75 years. Measurements: Rates of high CVD risk were assessed both in the overall study population and by age, sex, body mass index, geographic region, and socioeconomic status. Multivariable mixed models were fitted to assess the associations between individual characteristics and high CVD risk. Statin and aspirin use was evaluated among persons at high risk for CVD. Results: Among 1 680 126 participants, 9.5% (95% CI, 9.5% to 9.6%) had high risk for CVD. Mixed models identified persons who were of Han ethnicity, had medical insurance, were currently using alcohol, or were obese as more likely to be at high risk for CVD. Of those with high CVD risk, only 0.6% (CI, 0.5% to 0.6%) and 2.4% (CI, 2.3% to 2.5%) reported using statins and aspirin, respectively. Among persons with high CVD risk and hypertension, 31.8% were receiving antihypertensive medications. Limitation: Samples were not nationally representative. Conclusion: Of the 1.7 million participants, 1 in 10 had a high risk for CVD; among those at high risk, fewer than 3% were receiving statins or aspirin. An immense opportunity exists for risk mitigation in this substantial population. Primary Funding Source: Ministry of Finance and National Health Commission, China.

Should This Woman With Dense Breasts Receive Supplemental Breast Cancer Screening?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center: Annals of Internal Medicine: Vol 169, No 7

Breast cancer will develop in 12% of women during their lifetime and is the second leading cause of cancer death among U.S. women. Mammography is the most commonly used tool to screen for breast cancer. Considerable uncertainty exists regarding the age at which to begin screening and the optimal screening interval. Breast density is a risk factor for breast cancer. In addition, for women with dense breasts, small tumors may be missed on mammography and the sensitivity of screening is diminished. At the time of publication, 35 states had passed laws mandating that breast density be reported in the letters that radiologists send to women with their mammogram results. The mandated language may be challenging for patients to understand, and such reporting may increase worry for women who are told that their risk for breast cancer is higher than average on the basis of breast density alone. The U.S. Preventive Services Task Force and the American College of Radiology (ACR) have each issued guidelines that address breast cancer screening for women with dense breasts. Both organizations found insufficient evidence to recommend for or against magnetic resonance screening, whereas the ACR advises consideration of ultrasonography for supplemental screening. In this Beyond the Guidelines, 2 experts—a radiologist and a general internist—discuss these controversies. In particular, the discussants review the role of supplemental breast cancer screening, including breast ultrasonography or magnetic resonance imaging for women with dense breasts. Finally, the experts offer specific advice for a patient who finds her mammography reports confusing.

Cost-Effectiveness of Alirocumab: A Just-in-Time Analysis Based on the ODYSSEY Outcomes Trial: Annals of Internal Medicine: Vol 170, No 4

Background: The ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial included participants with a recent acute coronary syndrome. Compared with participants receiving statins alone, those receiving a statin plus alirocumab had lower rates of a composite outcome including myocardial infarction (MI), stroke, and death. Objective: To determine the cost-effectiveness of alirocumab in these circumstances. Design: Decision analysis using the Cardiovascular Disease Policy Model. Data Sources: Data sources representative of the United States combined with data from the ODYSSEY Outcomes trial. Target Population: U.S. adults with a recent first MI and a baseline low-density lipoprotein cholesterol level of 1.81 mmol/L (70 mg/dL) or greater. Time Horizon: Lifetime. Perspective: U.S. health system. Intervention: Alirocumab or ezetimibe added to statin therapy. Outcome Measures: Incremental cost-effectiveness ratio in 2018 U.S. dollars per quality-adjusted life-year (QALY) gained. Results of Base-Case Analysis: Compared with a statin alone, the addition of ezetimibe cost $81 000 (95% uncertainty interval [UI], $51 000 to $215 000) per QALY. Compared with a statin alone, the addition of alirocumab cost $308 000 (UI, $197 000 to $678 000) per QALY. Compared with the combination of statin and ezetimibe, replacing ezetimibe with alirocumab cost $997 000 (UI, $254 000 to dominated) per QALY. Results of Sensitivity Analysis: The price of alirocumab would have to decrease from its original cost of $14 560 to $1974 annually to be cost-effective relative to ezetimibe. Limitation: Effectiveness estimates were based on a single randomized trial with a median follow-up of 2.8 years and should not be extrapolated to patients with stable coronary heart disease. Conclusion: The price of alirocumab would have to be reduced considerably to be cost-effective. Because substantial reductions already have occurred, we believe that timely, independent cost-effectiveness analyses can inform clinical and policy discussions of new drugs as they enter the market. Primary Funding Source: University of California, San Francisco, and Institute for Clinical and Economic Review.

The Path to Routine Genomic Screening in Health Care

Intensive Models of Hepatitis C Care for People Who Inject Drugs Receiving Opioid Agonist Therapy: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 170, No 9

Background: Many people who inject drugs (PWID) are denied treatment for hepatitis C virus (HCV) infection, even if they are receiving opioid agonist therapy (OAT). Research suggests that HCV in PWID may be treated effectively, but optimal models of care for promoting adherence and sustained virologic response (SVR) have not been evaluated in the direct-acting antiviral (DAA) era. Objective: To determine whether directly observed therapy (DOT) and group treatment (GT) are more effective than self-administered individual treatment (SIT) in promoting adherence and achieving SVR among PWID receiving OAT. Design: Three-group, randomized controlled trial conducted from October 2013 to April 2017. (ClinicalTrials.gov: NCT01857245) Setting: Three OAT programs in Bronx, New York. Participants: Persons aged 18 years and older with genotype 1 HCV infection who were willing to receive HCV therapy on site in the OAT program. Of 190 persons screened, 158 were randomly assigned to a study group and 150 initiated treatment: DOT (n = 51), GT (n = 48), and SIT (n = 51). Intervention: 2 intensive interventions (DOT and GT) and 1 control condition (SIT). Measurements: Primary: adherence, measured by using electronic blister packs. Secondary: HCV treatment completion and SVR 12 weeks after treatment completion. Results: Mean age was 51 years; 65% of participants had positive results on urine drug testing during the 6 months before treatment, and 75% reported ever injecting drugs. Overall adherence, estimated from mixed-effects models using the daily timeframe, was 78% (95% CI, 75% to 81%) and was greater among participants randomly assigned to DOT (86% [CI, 80% to 92%]) than those assigned to SIT (75% [CI, 70% to 81%]; difference, 11% [CI, 5% to 18%]; Bonferroni-corrected P = 0.001). No significant difference in adherence was observed between participants randomly assigned to GT (80% [CI, 74% to 86%]) and those assigned to SIT (difference, 4.7% [CI, −2% to 11%]; Bonferroni-corrected P = 0.29). The HCV treatment completion rate was 97%, with no differences among groups (P = 0.53). Overall SVR was 94% (CI, 89% to 97%); the SVR rate was 98% in the DOT group, 94% in the GT group, and 90% in the SIT group (P = 0.152). Limitation: These findings may not be generalizable to PWID not enrolled in OAT programs. Conclusion: All models of onsite HCV care delivered to PWID in OAT programs resulted in high SVR, despite ongoing drug use. Directly observed therapy was associated with greater adherence than SIT. Primary Funding Source: National Institute on Drug Abuse and Gilead Sciences.

The Next Stage of Buprenorphine Care for Opioid Use Disorder

Buprenorphine has been used internationally for the treatment of opioid use disorder (OUD) since the 1990s and has been available in the United States for more than a decade. Initial practice recommendations were intentionally conservative, were based on expert opinion, and were influenced by methadone regulations. Since 2003, the American crisis of OUD has dramatically worsened, and much related empirical research has been undertaken. The findings in several important areas conflict with initial clinical practice that is still prevalent. This article reviews research findings in the following 7 areas: location of buprenorphine induction, combining buprenorphine with a benzodiazepine, relapse during buprenorphine treatment, requirements for counseling, uses of drug testing, use of other substances during buprenorphine treatment, and duration of buprenorphine treatment. For each area, evidence for needed updates and modifications in practice is provided. These modifications will facilitate more successful, evidence-based treatment and care for patients with OUD.

Cost-of-Care Conversations During Clinical Visits in Federally Qualified Health Centers: An Observational Study: Annals of Internal Medicine: Vol 170, No 9_Supplement

Background: The Centers for Disease Control and Prevention estimates that 10% of the U.S. population delays or avoids health care because of cost concerns. It is unknown whether and how cost-of-care conversations occur in primary encounters, especially settings that provide care to vulnerable patients. Objective: To describe cost-of-care conversations with financially vulnerable (<400% federal poverty level) adult patients during clinical encounters. Design: Five observers shadowed a convenience sample of patients during encounters and then interviewed patients and clinicians after the encounter. Setting: Federally Qualified Health Centers in Texas (n = 2) and Pennsylvania (n = 2). Participants: A convenience sample of 67 adult patients seeking chronic disease management or prenatal care from 9 clinicians (5 medical doctors, 2 physician assistants, and 2 nurse practitioners). Measurements: Self-reported characteristics of patients, and frequency and characteristics of interviewer-observed cost-of-care conversations. Results: Because of missing responses from patient and clinician interviews, data are reported for 67 consenting patients. During 46.3% of encounters, some discussion of costs of care was observed. Discussion of indirect costs (lost work time or transportation) was observed in only 2.9% of encounters. In only 11.9% of encounters did the physician discuss costs of care. When costs were discussed, the conversation was not organized and did not take place in conjunction with the discussion of the treatment plan. Limitations: This exploratory work involved a small convenience sample, and generalizability to other settings is uncertain. Missing data prohibited meaningful analysis of patient and clinician interview data. Conclusion: In the 4 federally funded health centers studied, cost-of-care conversations occurred in a minority of clinical visits, discussions were unorganized, and indirect costs of care were rarely addressed. Whether more frequent discussion of the costs of care improves patient adherence and outcomes requires further study. Primary Funding Source: Robert Wood Johnson Foundation.