Advancing Access to Cell and Gene Therapies in Medicaid.

This Viewpoint presents the components of the payment model and the implementation challenges among the Center for Medicare and Medicaid Innovation, state Medicaid agencies, patients, and manufacturers.

Strengthening the Center for Medicare and Medicaid Innovation's Approach to Constructing Alternative Payment Models.

The Center for Medicare and Medicaid Innovation (CMMI) seeks to develop evidence-based alternative payment models (APM) to improve health care quality and reduce costs, but its performance in achieving these goals has been mixed. In October 2021, CMMI released its Innovation Strategy Refresh to highlight challenges faced by payment models and suggest new strategic approaches for the upcoming decade. While a welcome recast of organizational goals, the Refresh leaves space for how CMMI will address persistent issues. These include how CMMI can best engage physicians and patients in APMs, minimize conflicting incentives among APMs, reduce selection bias in model participation, and, ultimately, transition away from the fee-for-service framework that underlies much of Medicare reimbursement. This article provides guidance to CMMI's vision by examining challenges within CMMI's strategy for model building and offering solutions to mitigate these issues. These strategies include engaging beneficiaries in APM incentives, expanding operational flexibility to improve clinical behaviors (e.g., waivers), rectifying issues with conflicting model incentives, building voluntary short-term and mandatory long-term incentives to mitigate selection bias, and transitioning to an overriding population-based model to constrain net costs. Policy Points The Center for Medicare and Medicaid Innovation (CMMI) seeks to develop evidence-based alternative payment models (APM) to improve care quality and reduce health care cost, but its performance in achieving these goals has been mixed. In October 2021, CMMI released a "strategic refresh" of its goals but left space for how persistent issues to model development would be addressed. We propose strategies to engage physicians and patients in APMs, minimize conflicting incentives among APMs, reduce selection bias in model participation, and, ultimately, transition away from the fee-for-service framework that underlies much of Medicare reimbursement.

Patient and medication-related factors associated with opioid use disorder after inpatient opioid administration.

BACKGROUND: Examine baseline factors associated with a new diagnosis of opioid use disorder (OUD) within 12 months postdischarge among opioid-naïve patients who received an opioid prescription in the inpatient setting. DESIGN/SETTING: Retrospective cohort (surgery and nonsurgery) study of opioid-naive patients who had at least one prescription for an opioid during an inpatient hospitalist between 2014 and 2017. PARTICIPANTS: Twenty-three thousand and thirty-three patients were included. OBJECTIVE: The primary objective was to determine baseline factors associated with a new OUD diagnosis within 12 months of discharge. Baseline covariates included demographic information, clinical characteristics, medication use, characteristics related to index hospital encounter, and discharge location. FINDINGS: 2.1% of the sample had a new diagnosis of OUD within a year after receiving an opioid during hospital admission. Patients between ages 25 and 34 had higher odds of a new OUD diagnosis compared to those 65 years of age and older (odds ratio [OR]: 6.98, 95% confidence interval [CI]: 4.02-12.1 [nonsurgery] and 4.69, 95% CI: 2.63-8.37 [surgery]). Patients from a high opioid geo-rank region had higher odds of OUD diagnosis (OR: 2.08, 95% CI: 1.31-3.31 [nonsurgery] and 1.80, 95% CI: 1.03-3.15 [surgery]). History of nonopioid-related drug disorder, tobacco use disorder, mental health conditions, and gabapentin use 12 months prior to index date and white race were associated with higher odds of new OUD diagnosis. CONCLUSIONS: It is important to identify and evaluate factors associated with developing a new diagnosis of OUD following hospitalization. This can inform pain management strategies within the hospital and at discharge, and prompt clinicians to screen for risk of OUD.

Imaging versus Intervention in Managing Small Unruptured Intracranial Aneurysms: A Cost-Effectiveness Analysis.

OBJECTIVE: Current guidelines recommend active surveillance with serial magnetic resonance angiography (MRA) for management of small, asymptomatic unruptured anterior circulation aneurysms (UIAs). We sought to determine the cost-effectiveness of active surveillance compared to immediate surgery. METHODS: We developed a Markov cost-effectiveness model simulating patients with small (<7 mm) UIAs managed by active surveillance via MRA, immediate surgery, or watchful waiting. Inputs for the model were abstracted from the literature and used to construct a comprehensive model following persons from diagnosis to death. Outcomes were quality-adjusted life-years (QALYs), lifetime medical costs (2015 USD), and incremental cost-effectiveness ratios (ICERs). Cost-effectiveness, deterministic, and probabilistic sensitivity analyses were performed. RESULTS: Immediate surgical treatment was the most cost-effective management strategy for small UIAs with ICER of USD 45,772 relative to active surveillance. Sensitivity analysis demonstrated immediate surgery was the preferred strategy, if rupture rate was >0.1%/year and if the diagnosis age was <70 years, while active surveillance was preferred if surgical complication risk was >11%. Probabilistic sensitivity analysis demonstrated that at a willingness-to-pay of USD 100,000/QALY, immediate surgical treatment was the most cost-effective strategy in 64% of iterations. CONCLUSION: Immediate surgical treatment is a cost-effective strategy for initial management of small UIAs in patients <70 years of age. While more costly than MRA, surgical treatment increased QALY. The cost-effectiveness of immediate surgery is highly sensitive to diagnosis age, rupture rate, and surgical complication risk. Though there are a wide range of rupture rates and complications associated with treatment, this analysis supports the treatment of small, unruptured anterior circulation intracranial aneurysms in patients <70 years of age.

Infection incidence and management in multiple sclerosis patients after initiating disease-modifying therapy.

Disease-modifying therapies for multiple sclerosis (MS) are effective, but frequently cost $70,000+/year and can predispose patients to serious infections. This retrospective cohort analysis (N = 3,204) compared rates of infections over a 24-month period by MS medication route of administration and antimicrobial use. Infection rates were: 38.7% (oral), 37.3% (infused), and 36.8% (injectable). Of those infections, antimicrobials were prescribed in 86.5% (oral), 84.3% (infused), and 85.5% (injectable) cases. We found differences within bacterial and herpes zoster infection rates (and antimicrobial use) among new users by medication route of administration. Our findings suggest that pharmacovigilance may inform the shared-decision processes when choosing MS medications.

Need for payer-provider partnerships in addressing social determinants of health.

This article examines payer-provider partnerships in social determinants of health (SDoH) interventions, identifies important factors for an approach centered around return on investment (ROI) using integrated delivery and finance systems as case studies, and advocates for increased collaboration between payers and providers when addressing SDoH. Despite the numerous examples where payers and providers have attempted to independently address SDoH, there is limited evidence for the success of these interventions. Since most stakeholders individually do not have access to financial and clinical data, identifying an ROI for SDoH interventions is logistically challenging, but even when these data are available, stakeholders may not want to share their learnings due to negative findings and/or unwillingness to share proprietary information. These issues are further amplified by the effects of COVID-19 and its worsening effect on widening health disparities, but many payers and providers have risen to the challenge together. This article advocates for the importance of payer-provider partnerships to address SDoH and uses examples of integrated delivery and finance systems as case studies of how these partnerships could function. DISCLOSURES: No outside funding supported the writing of this article. Hartle is employed by Geisinger Health System. The other authors have nothing to disclose.

Health care utilization and costs associated with switching from DPP-4i to GLP-1RA or SGLT2i: an observational cohort study.

BACKGROUND: Because of improved clinical outcomes, recent American Diabetes Association guidelines recommend the use of newer antidiabetic agents-glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i)-by those with cardiovascular disease. It is unclear, however, how switching to these newer agents affects health care utilization and costs. OBJECTIVE: To compare health care utilization and costs between users of dipeptidyl peptidase-4 inhibitors (DPP-4i) who switch to GLP-1RA or SGLT2i and nonswitchers. METHODS: We used claims data from a large pharmacy benefit manager. Patients included were commercially insured adults with type 2 diabetes and a prescription claim for DPP-4i in 2016 or 2017. Using propensity score methods, we matched patients who switched to SGLT2i or GLP-1RA with those who remained on DPP-4i. Among matched samples, we conducted multivariable negative binomial regression to examine differences in the incidence of inpatient and emergency room (ER) visits and generalized linear regression to examine differences in health care costs. RESULTS: Among 47,953 patients who used DPP-4i in 2016 and 2017, 507 switched to SGLT2i and 808 switched to GLP-1RA. Propensity score matching of 1:6 resulted in 3,042 nonswitchers/507 switchers for the SGLT2i cohort and 4,848 nonswitchers/808 switchers for the GLP-1RA cohort. Switchers to SGLT2i experienced a 39% reduction (incidence rate ratio [IRR] = 0.61, 95% CI = 0.38-0.96), and GLP-1RA switchers experienced a 29% reduction (IRR = 0.71, 95% CI = 0.52-0.97) in inpatient hospitalizations. ER visit rates did not differ significantly between switchers and nonswitchers. Switchers to SGLT2i did not have statistically significant differences in medical or pharmacy costs compared with DPP-4i users, while switchers to GLP-1RA had significantly higher total pharmacy costs (adjusted difference of $2,453.10, 95% CI = $1,837.20-$3,069.00). CONCLUSIONS: Switching from DPP-4i to GLP-1RA or SGLT2i was associated with fewer hospitalizations; however, higher pharmacy costs may outweigh savings from reduced hospitalizations, especially for GLP-1RAs. As newer diabetes guidelines steer specific populations to these drug classes, it is important to optimize drug pricing to realize their true value. DISCLOSURES: No outside funding supported this study. Neilson, Good, Swart, and Huang are employees of UPMC Center for Value-Based Pharmacy Initiatives and High-Value Care. Parekh reports employment at UPMC until July 2019. Munshi and Henderson are employed by Express Scripts. Newman has no disclosures to report.

Impact of Marijuana Legalization on Opioid Utilization in Patients Diagnosed with Pain.

BACKGROUND: Given efforts to reduce opioid use, and because marijuana potentially offers a lower-risk alternative for treating chronic pain, there is interest in understanding the public health impact of marijuana legalization on opioid-related outcomes. OBJECTIVE: Assess the impact of recreational and medical marijuana legalization on opioid utilization among patients receiving pharmacotherapy for pain. DESIGN: Retrospective claims-based study of commercially insured patients continuously eligible for pharmacy and medical benefits from July 8, 2014 to June 30, 2017. Index pain prescription period was defined between January 8, 2015 and June 30, 2015, and longer-term opioid use examined during 2-year follow-up. Marijuana state policy on July 1, 2015, was assigned: none; medical only; or medical and recreational. PARTICIPANTS: Patients aged 18-62 without cancer diagnosis. MAIN MEASURES: Patient receiving (1) opioid at index; (2) > 7 days' supply of index opioid; (3) opioid during follow-up; and (4) ≥ 90 days' opioid supply during follow-up. Multivariable regression assessed associations between opioid utilization and state marijuana policy, adjusting for age, gender, overall disease burden, mental health treatment, concomitant use of benzodiazepine or muscle relaxant, and previous pain prescription. KEY RESULTS: Of 141,711 patients, 80,955 (57.1%) resided in states with no policy; 56,494 (39.9%) with medical-only; and 4262 (3.0%) with medical and recreational. Patients in states with both policies were more likely to receive an index opioid (aOR = 1.72, 95% CI = 1.61-1.85; aOR = 1.90, 95% CI = 1.77-2.03; P < 0.001) but less likely to receive > 7 days' index supply (aOR = 0.84, 95% CI = 0.77-0.91; aOR = 0.76, 95% CI = 0.70-0.83; P < 0.001) than patients in states with no policy or medical-only, respectively. Those in states with both policies were more likely to receive a follow-up opioid (aOR = 1.87, 95% CI = 1.71-2.05; aOR = 2.20, 95% CI = 2.01-2.42; P < 0.001) than those in states with no policy or medical-only, respectively, and more likely to receive ≥ 90 cumulative follow-up opioid days' supply (aOR = 1.18, 95% CI = 1.07-1.29; P < 0.001) than those in states with no policy. CONCLUSIONS: Our analysis does not support the supposition that access to marijuana lowers use of chronic opioids for pain.

Using the Delphi method to identify meaningful and feasible outcomes for pharmaceutical value-based contracting.

In an effort to demonstrate measurable value of pharmaceuticals in the United States, many payers and drug manufacturers have entered into value-based purchasing contracts that link payment for prescription medications to patient outcomes, creating shared risk between the 2 entities. These agreements have emerged as part of a larger movement within the health care landscape to transition away from volume-based payment models and towards value-based designs that promote high-quality and affordable care. Key to the success of pharmaceutical value-based contracting is agreement on meaningful and measurable outcomes that reflect drug performance. Traditional value-based contracts are developed by pharmaceutical companies and payers and may not reflect values of other important stakeholders, such as patients, providers, and employers (when applicable). One approach to more effectively align the interests of all key stakeholders and to maximize the effect and transparency of value-based pharmaceutical contracts is to use the validated Delphi surveying technique, which can gather information and build stakeholder consensus on key elements before contract development. In this Viewpoints article, we describe our experience conducting Delphi studies in 5 disease contexts to inform pharmaceutical value-based contract development, including insights learned and practical considerations for real-world application. In addition, we outline advantages to using this validated consensus-building tool to solicit vital and underrepresented stakeholder input, foster transparency in the contract development process, and promote shared learning for future value-based initiatives. DISCLOSURES: No outside funding supported this project. All authors are or were employed by UPMC Health Plan at the time of this study and have no other disclosures to declare.

Effect of Carving in Pharmacy Benefits on Utilization and Costs.

BACKGROUND: Rising medical costs are a significant concern for employers offering health benefits to employees, and there is interest in identifying insurance plan designs that optimize the effect of pharmacy benefits on overall costs. For instance, employers must decide between plans that carve in pharmacy benefits (where medical and pharmacy benefits are integrated into 1 package through an insurer) versus plans that carve out pharmacy benefits (where pharmacy benefits are separately administered through a pharmacy benefit manager). Little is known about the effect of carving in pharmacy benefits on medical utilization and costs. OBJECTIVE: To compare the effect of carving in versus carving out pharmacy benefits on medical utilization, medical costs, and health management program participation in commercial health plans. METHODS: We performed a propensity score-matched analysis comparing carve-in and carve-out members of a regional health plan in 2018. Our primary outcomes were medical utilization (annual medical claims/1,000 members) and costs (medical costs per member per month [PMPM]). We categorized these into the following domains: inpatient, emergency department, outpatient/ambulatory surgery, urgent care, primary care, specialist services, and diagnostics (laboratory testing/imaging). We additionally assessed participation in health plan-based health management programs. RESULTS: We analyzed 9,633 carve-in members matched with 9,633 carve-out members. Compared with carving out pharmacy benefits, carving in was associated with 3.7% lower medical costs, with an $8.73 reduction in PMPM ($225.87 vs. $234.60), and no significant difference in medical utilization; significantly lower inpatient and urgent care claims (reduction of 9.29 claims/1,000 and 51.3 claims/1,000, respectively) and costs ($10.08 and $0.12 PMPM reduction, respectively); lower injectable medical therapy costs ($4.32 PMPM reduction); and higher durable medical equipment costs ($2.14 PMPM increase). Carve-in members also experienced 4.9% higher health management program participation. CONCLUSIONS: As employers attempt to understand the value of carving in versus carving out pharmacy benefits to health plans, our findings suggest that carving in pharmacy benefits is associated with reduced medical costs and hospitalizations. Our findings can assist in informing employer decision-making processes and, as a result, reducing costs of care. DISCLOSURES: No outside funding supported this study. Parekh was and Huang and Good are employed by the UPMC Centers for High-Value Health Care and Value-Based Pharmacy Initiatives. Manolis is employed by the UPMC Health Plan within the UPMC Insurance Services Division. Papa, Drnach, and Spiegel are employed by WorkPartners within the UPMC Insurance Services Division.

Identifying Outcome Measures for Migraine Value-Based Contracting Using the Delphi Method.

OBJECTIVE: To identify meaningful migraine outcome measures among key stakeholders to inform value-based contracts for migraine medications. BACKGROUND: Value-based contracts linking medication payments to predefined performance metrics aim to promote value through aligned incentives and shared risk between manufacturers and payers. The emergence of new and expensive pharmaceuticals for migraine presents an opportunity for value-based contract development. However, uncertainty remains around which outcomes are most meaningful to all migraine stakeholders. METHODS: This study utilized a Delphi survey to incorporate views from 82 stakeholders, including patients (n = 21), providers (n = 23), payers (n = 10), employers (n = 18), and pharmaceutical company representatives (n = 10). A list of 15 migraine-related outcomes was created from a literature review and subject matter expert consultation. Stakeholders reported on the value of these outcomes through a 5-point Likert scale and selection of their top 3 most meaningful outcomes. All participants except patients and employers also used a 5-point Likert scale to rate the feasibility of collecting each outcome measure. Consensus was defined as ≥75% agreement on the importance and feasibility of an outcome (Likert scores ≥4/5 or selection of an outcome as most meaningful). RESULTS: After 2 rounds, consensus was achieved for importance of 9 outcomes on the Likert scale. "Decrease in migraine frequency" reached 100% agreement (82/82), followed by "increased ability to resume normal activities" (96%, 79/82). When asked to choose the 3 most meaningful outcomes, stakeholders selected "decrease in migraine frequency" (88%, 72/82) followed by "decrease in migraine severity" (80%, 66/82). The 2 measures rated as most feasibly collected were "decrease in emergency department/urgent care visits" (95%, 40/42) and "decrease in migraine frequency" (90%, 38/42). There were statistically significant differences between non-patient and patient stakeholders in selection of "decrease in emergency department/urgent care visits" [20% (12/61) vs 0% (0/21), P = .031]; and employer and patient stakeholders in selection of "decrease in work days missed" [44% (8/18) vs 5% (1/21), P = .006] and "decrease in emergency department/urgent care visits" [22% (4/18) vs 0% (0/21), P = .037] as most meaningful outcomes. CONCLUSIONS: The measures "decrease in migraine frequency" followed by "decrease in migraine severity" were identified as top priority migraine outcome measures.

Value-Based Pharmaceutical Contracts: Value for Whom?

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between healthcare payers and pharmaceutical manufacturers in which the price, amount, or nature of reimbursement is tied to value-based outcomes. VBPCs are often complex, and the nature of who benefits and in what ways can be unclear. We discuss how VBPCs compare with value-based payer-provider arrangements in terms of performance-based reimbursements and alignment of incentives. In addition, we examine how VBPCs can affect costs, clinical outcomes, and access to medications. Because these contracts are unlikely to reduce costs in isolation, we recommend taking a patient-centered approach when developing VBPCs and tying VBPCs to more overarching payer drug cost reduction strategies.

Impact of Healthcare Delivery System Type on Clinical, Utilization, and Cost Outcomes of Patient-Centered Medical Homes: a Systematic Review.

BACKGROUND: As healthcare reimbursement shifts from being volume to value-focused, new delivery models aim to coordinate care and improve quality. The patient-centered medical home (PCMH) model is one such model that aims to deliver coordinated, accessible healthcare to improve outcomes and decrease costs. It is unclear how the types of delivery systems in which PCMHs operate differentially impact outcomes. We aim to describe economic, utilization, quality, clinical, and patient satisfaction outcomes resulting from PCMH interventions operating within integrated delivery and finance systems (IDFS), government systems including Veterans Administration, and non-integrated delivery systems. METHODS: We searched PubMed, the Cochrane Library, and Embase from 2004 to 2017. Observational studies and clinical trials occurring within the USA that met PCMH criteria (as defined by the Agency for Healthcare Research and Quality), addressed ambulatory adults, and reported utilization, economic, clinical, processes and quality of care, or patient satisfaction outcomes. RESULTS: Sixty-four studies were included. Twenty-four percent were within IDFS, 29% were within government systems, and 47% were within non-IDFS. IDFS studies reported decreased emergency department use, primary care use, and cost relative to other systems after PCMH implementation. Government systems reported increased primary care use relative to other systems after PCMH implementation. Clinical outcomes, processes and quality of care, and patient satisfaction were assessed heterogeneously or infrequently. DISCUSSION: Published articles assessing PCMH interventions generally report improved outcomes related to utilization and cost. IDFS and government systems exhibit different outcomes relative to non-integrated systems, demonstrating that different health systems and populations may be particularly sensitive to PCMH interventions. Both the definition of PCMH interventions and outcomes measured are heterogeneous, limiting the ability to perform direct comparisons or meta-analysis.

Impact of community pharmacist-led interventions in chronic disease management on clinical, utilization, and economic outcomes: An umbrella review.

BACKGROUND: Chronic disease represents a significant burden to the United States (US) health care system, with approximately 50% of all adults in the US having one or more chronic disease conditions. Pharmacist-led chronic disease management interventions are of special interest since 80% of medical treatments involve the use of prescription drugs. Moreover, community pharmacists are among the most accessible health care professionals to provide care for populations with chronic diseases. The impact of care provided by community pharmacists isn't well defined, with interventions taking on diverse forms with varied effects on outcomes. OBJECTIVE: The purpose of this review is to summarize evidence from secondary literature on community pharmacist-led chronic disease management interventions and the impact on clinical, utilization, and economic outcomes. METHODS: We conducted a systematic search of systematic reviews, meta-analyses, and narrative reviews using MEDLINE via PubMed, EMBASE.com and Cochrane Library databases published between January 1, 2007 and October 17, 2017. The following data were extracted: citation details, review type, number of primary studies included, disease state, description of the intervention, outcomes assessed, and results. RESULTS: Our search strategy retrieved 2296 titles and abstracts of which 15 references met our inclusion criteria. Selected articles covered 7 main diseases -diabetes, asthma, chronic obstructive pulmonary disease (COPD), hypertension, heart failure, hyperlipidemia, and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Community pharmacist-led interventions mostly consisted of patient consultations and education. In diabetes, interventions achieved significant reductions in hemoglobin A1c, total cholesterol, and low-density lipoprotein (LDL). Reviews also reported favorable reductions in blood pressure, improved medication adherence and reduced readmission rates in patients with heart failure, improved lung function in patients with respiratory conditions, and increased medication adherence in those with HIV/AIDs. Literature reporting economic and utilization outcomes were limited and mostly focused on pharmacy interventions in diabetes. In some cases, community pharmacy services demonstrated a decrease in medical and health care costs in patients with diabetes. CONCLUSION: We found that community pharmacists can improve clinical outcomes in a wide array of chronic diseases, including diabetes, hyperlipidemia, HIV/AIDS, cardiovascular and respiratory diseases. More robust studies are needed to further assess the impact of specific interventions on economic and utilization outcomes.

Examining Misaligned Incentives for Payers and Manufacturers in Value-Based Pharmaceutical Contracts.

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between health care payers and pharmaceutical manufacturers in which the price, quantity, or nature of reimbursement is tied to value-based outcomes. As value-based payment models have permeated through much of the health care payment landscape via reimbursement to payers and providers, VBPCs offer opportunities for manufacturers to similarly engage in performance-based models. This article compares 2 VBPC schemes: "pay-for-failure" schemes, in which manufacturers offer rebates or discounts to payers for treatment failure, and "pay-for-success" schemes, in which manufacturers offer rebates or discounts to payers for treatment success. Each method has its own short-term and long-term trade-offs, and both lead to some degree of misaligned incentives between payers and manufacturers. These incentive differences have important downstream effects, influencing patient selection, provision of wraparound services, and nature of reimbursements. This analysis contrasts potential benefits and disadvantages for each of these approaches and offers potential solutions to address misalignment. For example, although pay-for-success models may be more aligned between payers and manufacturers, pay-for-failure contracts can be innovative and effective in controlling costs and/or improving outcomes. To illustrate, VBPCs aimed to reduce costs could incorporate total cost of care reduction as a value-based outcome. The authors encourage payers and manufacturers to consider a blended alternative where pay-for-failure and pay-for-success outcomes could be incorporated as VBPC outcomes. Since little is known about the effect of each scheme on outcomes, further research on VBPCs is necessary to fully understand how differing incentives ultimately affect clinical outcomes and costs. DISCLOSURES: No outside funding supported the writing of this article. Good and Kelly are employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care, and Parekh was employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care at the time of this study. The authors have no other disclosures to report.

A Longitudinal Ambulatory Quality Improvement Curriculum That Aligns Resident Education With Patient Outcomes: A 3-Year Experience.

Quality improvement (QI) plays a vital role in practice management, patient care, and reimbursement. The authors implemented a 3-year longitudinal curriculum that combined QI didactics, intervention development, and implementation at university-based, community-based, and Veterans Administration-based practices. Highlights included Plan-Do-Study-Act cycle format, team-based collaboration to brainstorm interventions, interdisciplinary QI council to select and plan interventions, system-wide intervention implementation across entire clinic populations with outcome monitoring, and intervention modifications based on challenges. A pre-post survey assessed residents' confidence in QI skills and interdisciplinary team participation, while quarterly quality data assessed patient outcomes. All 150 internal medicine residents participated. Confidence in QI and interdisciplinary team participation improved significantly (P < .001). Patient outcomes improved for 6 of 9 targeted projects and were sustained at 1 year. This curriculum is a systems-based innovation designed to improve patient care and encourage interdisciplinary teamwork and can be adopted by residencies seeking to improve engagement in QI.

Impact of Star Rating Medication Adherence Measures on Adherence for Targeted and Nontargeted Medications.

BACKGROUND: In 2012, Medicare incorporated medication adherence targeting oral antidiabetic medications, renin-angiotensin system (RAS) antagonists, and statins as highly weighted components in its Star Ratings Program. In the same year, health plans began receiving quality bonus payments for higher star ratings. OBJECTIVE: We aimed to assess how these policy changes affected adherence to targeted and other chronic disease medications in the United States. METHODS: We performed interrupted time series analyses to assess monthly changes in medication adherence from 2010 to 2016 using health plans' Medicare claims submitted to a large pharmacy benefits manager. We conducted 2 sets of analyses. The first examined whether policy changes affected adherence to the 3 targeted therapy classes, and the second assessed the association between policy changes and adherence to 5 chronic disease classes not targeted by star ratings. For the second analysis, we further compared adherence between members who concomitantly used and did not use targeted medications. RESULTS: For star-ratings analyses, we studied 240 811 members on oral antidiabetic medications, 500 958 on RAS antagonists, and 471 135 on statins. Adherence for all star rating-targeted and nontargeted medications increased after 2012 (P < .001). Oral antidiabetic, statin, and RAS antagonist adherence was, respectively, 11.2%, 3.7%, and 8.1% higher than adherence without policy changes (P < .001). Nontargeted antihypertensive and antihyperlipidemic adherence trends were higher among those concomitantly on star rating-targeted medications compared with those who were not (P < .001). CONCLUSIONS: As policy makers strive to identify optimal quality measures for improving healthcare delivery, it is important to consider that incentives can promote improved performance in both targeted measures and related outcomes.

Waste in the US Health Care System: Estimated Costs and Potential for Savings.

Importance: The United States spends more on health care than any other country, with costs approaching 18% of the gross domestic product (GDP). Prior studies estimated that approximately 30% of health care spending may be considered waste. Despite efforts to reduce overtreatment, improve care, and address overpayment, it is likely that substantial waste in US health care spending remains. Objectives: To estimate current levels of waste in the US health care system in 6 previously developed domains and to report estimates of potential savings for each domain. Evidence: A search of peer-reviewed and "gray" literature from January 2012 to May 2019 focused on the 6 waste domains previously identified by the Institute of Medicine and Berwick and Hackbarth: failure of care delivery, failure of care coordination, overtreatment or low-value care, pricing failure, fraud and abuse, and administrative complexity. For each domain, available estimates of waste-related costs and data from interventions shown to reduce waste-related costs were recorded, converted to annual estimates in 2019 dollars for national populations when necessary, and combined into ranges or summed as appropriate. Findings: The review yielded 71 estimates from 54 unique peer-reviewed publications, government-based reports, and reports from the gray literature. Computations yielded the following estimated ranges of total annual cost of waste: failure of care delivery, $102.4 billion to $165.7 billion; failure of care coordination, $27.2 billion to $78.2 billion; overtreatment or low-value care, $75.7 billion to $101.2 billion; pricing failure, $230.7 billion to $240.5 billion; fraud and abuse, $58.5 billion to $83.9 billion; and administrative complexity, $265.6 billion. The estimated annual savings from measures to eliminate waste were as follows: failure of care delivery, $44.4 billion to $97.3 billion; failure of care coordination, $29.6 billion to $38.2 billion; overtreatment or low-value care, $12.8 billion to $28.6 billion; pricing failure, $81.4 billion to $91.2 billion; and fraud and abuse, $22.8 billion to $30.8 billion. No studies were identified that focused on interventions targeting administrative complexity. The estimated total annual costs of waste were $760 billion to $935 billion and savings from interventions that address waste were $191 billion to $286 billion. Conclusions and Relevance: In this review based on 6 previously identified domains of health care waste, the estimated cost of waste in the US health care system ranged from $760 billion to $935 billion, accounting for approximately 25% of total health care spending, and the projected potential savings from interventions that reduce waste, excluding savings from administrative complexity, ranged from $191 billion to $286 billion, representing a potential 25% reduction in the total cost of waste. Implementation of effective measures to eliminate waste represents an opportunity reduce the continued increases in US health care expenditures.

Trends in Prices, Market Share, and Spending on Self-administered Disease-Modifying Therapies for Multiple Sclerosis in Medicare Part D.

IMPORTANCE: Before 2009, only 4 self-administered disease-modifying therapies (DMTs) were approved for the treatment of multiple sclerosis (MS). Since then, 7 new agents have entered the market. OBJECTIVE: To assess trends in prices, market share, and spending on self-administered DMTs for MS in Medicare Part D from 2006 through 2016. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used claims data from 2006 through 2016 from a 5% random sample of Medicare beneficiaries (a mean of 2.8 million Medicare beneficiaries per year). All prescription claims for self-administered DMTs for MS (glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod hydrochloride, teriflunomide, dimethyl fumarate, and peginterferon beta-1a) were extracted throughout the study period. MAIN OUTCOMES AND MEASURES: The main outcomes were the annual cost of treatment with each medication, based on Medicare Part D prescription claims gross costs and US Food and Drug Administration-approved recommended dosing; market share of each medication, defined as the proportion of pharmaceutical spending accounted by every drug; and pharmaceutical spending per 1000 Medicare beneficiaries for all drugs. The relative contributions of Medicare Part D Plans' payments, Medicare catastrophic coverage payments, low-income cost-sharing subsidies, patients' out-of-pocket costs, manufacturers' coverage gap discounts, and other payments toward pharmaceutical spending were further quantified. RESULTS: Annual costs of treatment with self-administered DMTs for MS more than quadrupled from 2006 to 2016, from a mean (SD) of $18 660 ($1177) to $75 847 ($16 956) and at a mean rate of 12.8% every year. Brand-name glatiramers accounted for the largest market share across the study period, ranging between $25 552 of $79 411 per 1000 Medicare beneficiaries (32.2%) and $10 342 of $21 365 per 1000 Medicare beneficiaries (48.4%). Platform therapies experienced a substantial drop from 2006 to 2016 in favor of newer therapies, with decreases in the market shares of brand-name glatiramers (per 1000 Medicare beneficiaries: $2861 of $7794 [36.7%] to $25 552 of $79 411 [32.2%]), interferon beta-1a (30 µg; per 1000 Medicare beneficiaries: $2521 of $7794 [32.3%] to $11 298 of $79 411 [14.2%]), interferon beta-1b (Betaseron; per 1000 Medicare beneficiaries: $1460 of $7794 [18.7%] to $3588 of $79 411 [4.5%]), and interferon beta-1a (8.8/22/44 µg; per 1000 Medicare beneficiaries: $951 of $7794 [12.2%] to $6588 of $79 411 [8.3%]) and increases in fingolimod (to $6311 of $79 411 per 1000 Medicare beneficiaries [7.9%]), teriflunomide (to $7177 of $79 411 per 1000 Medicare beneficiaries [9.0%]), and dimethyl fumarate (to $15 262 of $79 411 per 1000 Medicare beneficiaries [19.2%]). Throughout the study period, pharmaceutical spending per 1000 beneficiaries increased 10.2-fold (from $7794 to $79 411), and out-of-pocket patient spending per 1000 beneficiaries increased 7.2-fold (from $372 to $2673). The relative contribution of federal payments toward pharmaceutical spending increased from $5335 of $7794 (68.5%) to $58 620 to $79 411 (73.8%). CONCLUSIONS AND RELEVANCE: Per this analysis, prices of self-administered DMTs for MS increased dramatically between 2006 and 2016. This resulted in a 7.2-fold increase in patient out-of-pocket costs.