The American Journal of Accountable Care. 2018;6(4):28-31

Two data points have preoccupied the national discussion on healthcare spending over the past several years: (1) that a small percentage of the US population drives a disproportionate amount of healthcare spending

 and (2) that the United States has the highest per capita healthcare spending among “high-income” countries.

 So far, results of efforts to bend the cost curve are mixed, at best. A third data point, which shows that spending on social services in the United States is lowest among industrialized nations compared with healthcare spending,

 is driving new thinking in the emerging field of complex care.

In recent years, we have seen increasing numbers of programs that radically redesign the delivery of healthcare and social services around the needs of individuals with complex health and social needs.

 Many share a commitment to person-centered, equitable care that bridges sectors, is delivered by interprofessional teams, and is driven by cross-sector data. Some health systems are already implementing large-scale screening and referral programs to address social drivers of health, but more targeted interventions are needed.

The vibrant innovation and variation among complex care models have drawn growing interest from large health systems, payers, and government agencies. In order for these successful models to spread and scale up, the field needs to move toward the development of clear standards of practice, shared research agendas, and clearer policy and payment solutions that create durable funding streams. To lead this effort, 3 organizations—the Camden Coalition of Healthcare Providers’ National Center for Complex Health and Social Needs, the Center for Health Care Strategies, and the Institute for Healthcare Improvement&mdash;joined together to create a framework to advance the field of complex care, namely, the Blueprint for Complex Care.

The effort was supported by The Commonwealth Fund, the Robert Wood Johnson Foundation, and The SCAN Foundation.

The Blueprint is organized along the Strong Field Framework,

 a methodology developed by the Bridgespan Group for assessing any given field of activity using 5 specific components. Emerging fields such as complex care must (1) unite around a shared identity, (2) advance standards of practice, (3) build a collective knowledge base, (4) bolster leadership and grassroots support, and (5) solidify funding and supporting policy. The framework recognizes that a key strategy for realizing social change is developing a field and its workforce. The Strong Field Framework was designed to illuminate complex care’s strengths and weaknesses and help structure the development of the Blueprint’s recommendations for the field.

In addition to the Blueprint’s cross-organizational leadership, the development process was designed to be as inclusive as possible. The analysis of the current state of the field and the recommendations for its advancement were informed by interviewing complex care innovators, convening complex care model builders, and surveying nearly 400 individuals with an interest in complex care. The Blueprint’s authors also sought to learn from other recently developed fields, such as palliative care, hospital medicine, and tobacco cessation.

Complex care is a person-centered approach to address the needs of people who experience a combination of medical, behavioral health, and social challenges that result in extreme patterns of healthcare utilization and cost. Complex care coordinates individuals’ care while reshaping ecosystems of care to deliver integrated services for those whose root causes of poor health defy existing boundaries among sectors, fields, and professions. These programs seek to be person-centered, equitable, cross-sector, team-based, and data-driven.

One of the major gaps identified by stakeholders was the lack of a shared definition and common language to describe complex care. Many definitions of complex care rely solely on high cost and high utilization patterns as the 2 main gauges of complexity,

 but there is increasing interest in more comprehensive descriptions that include behavioral health and social needs as additional key indicators of complexity. Stakeholder input was invaluable in leading the Blueprint authors to propose a definition that will bring much-needed clarity to the field. The Blueprint defines complex care as follows:

Complex care seeks to improve the health and well-being of a relatively small, heterogenous group of individuals who are repeatedly cycling through multiple healthcare, social service, and other systems but who do not derive lasting benefit from those interactions.

Although the intended population of complex care programs can vary significantly from program to program, the Blueprint proposes that complex care shares these common traits:

Successful complex care programs create coordinated, community-based ecosystems around the individuals they serve. These complex care ecosystems include traditional healthcare institutions, such as hospitals, primary care, and outpatient services, and more specialized services, including home healthcare and behavioral health services. Notably, they also integrate social services sectors, such as housing, transportation, criminal justice, and legal services.

Creating well-integrated complex care ecosystems requires overcoming deeply entrenched silos between organizations and sectors. Major challenges include data sharing, workforce development, and integrated funding and payment. Below are some recommendations for the field that are outlined in the Blueprint for Complex Care, along with examples of organizations that are addressing each of these challenges well.

Complex care programs need cross-sector data

 to identify individuals with complex health and social needs, meet those needs, and evaluate and improve service delivery. The Blueprint outlines strategies to address data-sharing barriers, including technical assistance and low-cost information technology overlays for complex care programs that include social services data and also communicate with larger electronic health record and health information exchange systems. AllianceChicago, a health data organization in Chicago, Illinois, recently partnered with Chicago community health centers to pilot HealthyRx, a program in which providers used an integrated data system to “prescribe” nonmedical community services.

Complex care providers encompass a spectrum of licensed and unlicensed healthcare and social service providers, including social workers, lawyers, community health workers, physicians, and nurses. To advance a cohesive field, core competencies must be codified for both patient-facing staff and organizational leaders. This will allow for the establishment of standard educational programs and materials and potentially include formal certification standards for complex care providers. This means that despite their different roles, all complex care providers should be proficient in a number of core areas, including trauma-informed care, team-based practice, and care planning. In advancing its field, the Center to Advance Palliative Care has developed a robust repository of educational materials and courses designed to codify and standardize best practices across providers. Such standardization ensures that providers and systems have the right tools and knowledge to deliver the best care in their own communities. The National Center for Complex Health and Social Needs, along with 4 regional academic hubs, operates a national interprofessional education program known as Student Hotspotting.

 The curriculum exposes students of allied health professions to the theories, skills, and practices of other health professionals working with individuals who have complex health and social needs in their own communities.

The current shift from fee-for-service to value-based payment provides incentives for health systems and others to focus on those with complex needs.

 However, sustainable, fully integrated payment models needed to support complex care are still rare. The Blueprint recommends continued experimentation, research, and technical assistance to develop and test alternative payment models that sustain complex care models and ecosystems. For example, accountable care organizations (ACOs) are among the entities most interested in and incentivized to invest in complex care.

 The National Association of Accountable Care Organizations has been working with leading ACOs to develop tailored payment models and interventions for patients with complex health and social needs.

In implementing these and other recommendations, the emerging field of complex care will have to balance the need for cohesion and leadership with the desire for inclusivity and shared ownership. To do that, the Blueprint proposes a coordinating structure for the field, to be convened by the National Center for Complex Health and Social Needs, that includes working committees of experts from across organizations. This structure will help orchestrate major field-building activities, develop resources, and serve as an entry point for individuals and organizations who want to contribute to the field.

Clearly, the current healthcare and social service systems are not working for those with complex needs, and this population would be better served by a cross-sector field tailored to their needs. The Blueprint is an important step toward advancing this field of complex care. It is the hope of the Blueprint authors and proponents that it helps clarify the shared values, principles, goals, and current state of the growing, dynamic complex care community. Others are invited to join experts to discuss, align, and lend expertise to further the common goal of improving the lives of people with complex health and social needs.

The Blueprint for Complex Care was released at the annual Putting Care at the Center Conference in Chicago on December 6, 2018.

The Blueprint for Complex Care was authored by Mark Humowiecki, JD; Teagan Kuruna, MPH; Rebecca Sax, MPH; and Margaret Hawthorne, MPH, of the National Center for Complex Health and Social Needs; Allison Hamblin, MSPH, and Stefanie Turner, MHI, of the Center for Health Care Strategies; and Kedar Mate, MD; Cory Sevin, MSN; and Kerri Cullen, MS, of the Institute for Healthcare Improvement. This article was drafted by Hannah Mogul-Adlin, MPH, of the National Center for Complex Health and Social Needs.

National Center for Complex Health and Social Needs, Camden, NJ; Center for Health Care Strategies, Hamilton, NJ; Institute for Healthcare Improvement, Boston, MA.

The Commonwealth Fund, the Robert Wood Johnson Foundation, and The SCAN Foundation.

 The authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

The 3 authoring organizations contributed equally to the article.

Rebecca Sax, MPH, Camden Coalition of Healthcare Providers, 800 Cooper St, Ste 700, Camden, NJ 08102. Email: rsax@camdenhealth.org.

1. Cohen SB. The concentration and persistence in the level of health expenditures over time: estimates for the U.S. population, 2011-2012 [AHRQ statistical brief no. 449]. Agency for Healthcare Research and Quality website. meps.ahrq.gov/data_files/publications/st449/stat449.shtml. Published September 2014. Accessed August 28, 2018.

2. Papanicolas I, Woskie LR, Jha AK. Health care spending in the United States and other high-income countries [erratum in 

. 2018;319(17):1824. doi: 10.1001/jama.2018.4940]. 

. 2018;319(10):1024-1039. doi: 10.1001/jama.2018.1150.

The American Health Care Paradox: Why Spending More Is Getting Us Less

4. Bradley EH, Elkins BR, Herrin J, Elbel B. Health and social services expenditures: associations with health outcomes. 

. 2011;20(10):826-831. doi: 10.1136/bmjqs.2010.048363.

5. McCarthy D, Ryan J, Klein S. Models of care for high-need, high-cost patients: an evidence synthesis. The Commonwealth Fund website. commonwealthfund.org/publications/issue-briefs/2015/oct/models-care-high-need-high-cost-patients-evidence-synthesis. Published October 29, 2015. Accessed August 28, 2018.

6. Long PV, Abrams M, Milstein A, et al, eds. 

Effective Care for High-Need Patients: Opportunities for Improving Outcomes, Value, and Health

. Washington, DC: National Academy of Medicine; 2017. nam.edu/wp-content/uploads/2017/06/Effective-Care-for-High-Need-Patients.pdf. Accessed October 18, 2018.

7. Six foundations combine forces to transform care delivery for high-need patients. Peterson Center on Healthcare website. petersonhealthcare.org/six-foundations-combine-forces-transform-care-delivery-high-need-patients. Accessed October 10, 2018.

8. Humowiecki M, Kuruna T, Sax R, et al. Blueprint for complex care: advancing the field of care for individuals with complex health and social needs. National Center for Complex Health and Social Needs website. nationalcomplex.care/blueprint. Published December 5, 2018. Accessed December 5, 2018.

9. The Bridgespan Group. The strong field framework: a guide and toolkit for funders and nonprofits committed to large-scale impact. The James Irvine Foundation website. irvine-dot-org.s3.amazonaws.com/documents/64/attachments/strongfieldframework.pdf?1412656138. Published June 2009. Accessed September 25, 2018.

10. Hayes SL, Salzberg CA, McCarthy D, et al. High-need, high-cost patients: who are they and how do they use health care? a population-based comparison of demographics, health care use, and expenditures. 

11. Hamilton A, Mohanty N, Bruno C, et al. Building trust for cross-sector data collaboration. National Center for Complex Health and Social Needs website. nationalcomplex.care/wp-content/uploads/2018/08/Building-Trust-and-Collaborating_.pdf. Published May 2018. Accessed July 24, 2018.

12. Bruno C, Fallen A, Kuruna T, Rodriguez J, Jensen AM. Navigating legal parameters for cross-sector data collaboration. National Center for Complex Health and Social Needs website. nationalcomplex.care/wp-content/uploads/2018/08/Navigating-Legal-Parameters_.pdf. Published June 2018. Accessed July 24, 2018.

13. National Center for Complex Health and Social Needs. The Interprofessional Student Hotspotting Learning Collaborative: spring 2018 overview. National Center for Complex Health and Social Needs website. nationalcomplex.care/wp-content/uploads/2018/05/student-hotspotting-overview.pdf. Published May 2018. Accessed November 1, 2018.

14. McClellan MB, Feinberg DT, Bach PB, et al. Payment reform for better value and medical innovation: a vital direction for health and health care. National Academy of Medicine website. nam.edu/wp-content/uploads/2017/03/Payment-Reform-for-Better-Value-and-Medical-Innovation.pdf. Published March 17, 2017. Accessed September 26, 2018.

15. Medicare Shared Savings Program accountable care organizations have shown potential for reducing spending and improving quality. HHS Office of Inspector General website. oig.hhs.gov/oei/reports/oei-02-15-00450.asp. Published August 28, 2017. Accessed October 18, 2018.

16. Dangi-Garimella S. Tying social determinants of ACO patients with high-need, high-cost care. 

 website. ajmc.com/conferences/naacos-fall2018/tying-social-determinants-of-aco-patients-with-highneed-highcost-care. Published October 5, 2018. Accessed October 18, 2018.

Articles

Complex care is cross-sector and person-centered, and it could bend America’s healthcare cost curve. The Blueprint for Complex Care gives this new field a national framework.

The Blueprint for Complex Care: Laying the Groundwork to Build a Field Across Sectors

The American Journal of Accountable Care. 2018;6(4):26-27

Three key movements—consumerism, big data, and technology&mdash;are transforming the landscape of value-based care. Nowhere is this transformation more evident, or more needed, than in the delivery of high-value clinical preventive services, which often go undelivered in today’s health system, resulting in gaps in care.

Preventive service delivery is ripe for disruption. To date, the healthcare industry has focused almost exclusively on the treatment of illness, often to the neglect of prevention. Meanwhile, the number of quality measures and clinical guidelines related to prevention has continued to grow. Clinical preventive services are generally low-risk, are appropriate for large numbers of people (ie, high volume), are guideline-driven, and support fundamental value-based care objectives. Despite this, preventive services are underutilized at alarming rates, contributing substantially to the overall number of care gaps and preventable deaths in any given population.

 Increase the use of evidence-based services.

 Provide services outside of the clinical setting.

Total Population or Community-Wide Prevention.

 Implement interventions that reach whole populations.

The CDC’s John Auerbach called attention to the need for innovative delivery of preventive services in his seminal 2016 article, “The 3 Buckets of Prevention.”

 Auerbach offers 3 areas of preventive care as fundamental to improving population health:

Auerbach’s second bucket of prevention, in which high-value services are liberated from traditional clinical settings in order to increase desirable utilization, is particularly relevant to health plans pursuing value-based care objectives. Historically, healthcare providers have lacked the tools to expand delivery of preventive services beyond the walls of their own clinic on a meaningful scale. Modest reimbursements, among other factors, have limited investment in potential solutions. As pressure mounts to meet quality measures and improve outcomes, health plans are bridging the gap between the doctor’s office and the places where health is actually generated: at home and in the community. Here are some of the ways leading health plans are embracing consumerism, big data, and emerging technologies to transform utilization of high-value preventive services.

Convenience is key to driving utilization of preventive services. Expanding care delivery to include nontraditional settings, thereby increasing convenience, is central to Auerbach’s second bucket of prevention. To meet this end, many health plans are turning to cost-effective delivery options in members’ homes. These offerings include low-cost testing, health needs assessments, and care delivery, depending on the acuity of health needs in the population. Convenient retail outlets have long partnered with health plans to deliver pharmacy services, but today’s retail pharmacies are investing in the ability to provide a litany of additional services, expanding the experience of care in a setting that members already frequent. Even the workplace, long treated as the domain of the worksite wellness industry, can be a valuable care setting to reach members where they already are. Health plans are increasingly working with partners to affect care across a variety of nontraditional settings.

Most health plans use large data sets to determine the members of a population who are eligible for a given service. Some plans are beginning to use big data to evaluate who will participate in a service, how to maximize the likelihood of participation, who will benefit most from that service, and what the ultimate clinical and financial impact of that utilization will be. Data on consumer behavior and social determinants of health are an important addition to the traditional melding of prescription, laboratory, and other clinical data points with claims. As the number of ways to deliver high-value service increases, more and more emphasis will be placed on evaluating the success of novel interventions so that plans can invest in what is working and abandon what is not.

Activating Members via Simple, Scalable Technology Solutions

To date, gap closure programs have focused on member engagement efforts predicated on personalized marketing and communication to appeal to healthcare consumers. In the 

 article “Know Your Customers’ ‘Jobs to Be Done,’&thinsp;”

 Christianson et al encourage organizations to view these personalized efforts through a new lens that emphasizes knowledge of a member’s challenges over knowledge of the member’s characteristics. The authors suggest that whenever a consumer purchases a product or service, they are essentially “hiring it to get a job done.” This approach favors solutions that focus on 

 a member consume preventive care—completing a job they need to do&mdash;rather than 

them to do so. It requires health plans to understand their members as people and consumers and to create a member experience that marries engagement tools with novel delivery solutions that can help members get those jobs done.

Health plans should also consider the jobs that providers need to get done and how technology can help. Providers are not opposed to the delivery of clinical preventive services; they view these services as an important part of their job. Gaps in delivery occur because providers are inundated with competing priorities and have few technologies available that are purpose-built for getting the jobs of prevention done. Investment is needed in integrations that allow providers to access alternative settings of care and novel delivery solutions, and, in turn, connect back to their usual workflow. Payers are increasingly part of the solution for getting these jobs done.

Preventive service strategies that encompass convenient, data-driven engagement beyond traditional care settings can have a profound effect on population health. By embracing consumerism, big data, and task-oriented technology platforms, health plans can drive care gap closure and achieve Quadruple Aim goals to positively impact health, decrease the cost of achieving that impact, and improve the experience of both members and clinicians along the way.

 Dr Sclar is employed by BioIQ, which provides healthcare services in home and retail settings.

Concept and design, drafting of the manuscript, critical revision of the manuscript for important intellectual content, and supervision.

Joshua Sclar, MD, MPH, BioIQ, 2300 Windy Ridge Parkway, Suite 850 South, Atlanta, GA 30339. Email:

1. Auerbach J. The 3 buckets of prevention. 

. 2016;22(3):215-218. doi: 10.1097/PHH.0000000000000381.

2. Christensen CM, Hall T, Dillon K, Duncan DS. Know your customers’ “jobs to be done.” 

. September 2016. hbr.org/2016/09/know-your-customers-jobs-to-be-done. Accessed July 10, 2018.

Preventive services are severely underutilized and contribute substantially to care gaps and preventable deaths. Three key trends promise improvement: consumerism, big data, and technology.

Health Plan Strategies for Value-Based Care: Closing Gaps in Care Means Getting Serious About Prevention

The American Journal of Accountable Care. 2018;6(4):32-33

Liver impairment resulting in cirrhosis is associated with a host of serious complications, ranging from swelling and infections to liver cancer and liver failure.

 Risk factors for cirrhosis, a chronic liver disease (CLD), include long-term alcohol abuse, type 2 diabetes, hepatitis, age older than 50 years, male gender, and nonalcoholic fatty liver disease (NAFLD), which is a metabolic syndrome caused by obesity, high cholesterol, and high blood pressure.

 About 1 in 400 US adults has cirrhosis, and it is most common in those aged between 45 and 54 years, but these figures are likely underestimates due to undiagnosed cases.

 Cirrhosis is diagnosed by blood tests for liver enzyme levels, in conjunction with blood count tests and tests for viral infections like hepatitis; these tests can help physicians not only make a diagnosis of cirrhosis but also assess the severity and potentially pinpoint the cause.

 Additionally, imaging tests and biopsies can reveal liver scarring.

Although no specific cure exists for cirrhosis, it is most often treated by addressing its underlying causes. For example, patients with alcoholic liver disease will be advised to completely abstain from alcohol, whereas those with NAFLD may benefit from losing weight.

 Hepatitis C can now be cured with medication, and the effects of hepatitis B can be slowed by the use of antiviral medicines.

 Clinicians managing CLD and cirrhosis must also be vigilant in identifying and treating the numerous complications of the disease.

Among the most dangerous complications of CLD is hepatic encephalopathy (HE), a neurologic condition that impairs cognition, alters behavior, and can cause hepatic coma in the most severe cases.

 Between 20% and 80% of patients with cirrhosis experience minimal or covert HE, in which they lack obvious clinical signs of the disorder, but 30% to 40% of those with cirrhosis will experience fully symptomatic overt HE at some point.

 Patients with HE accounted for more than 110,000 hospitalizations per year between 2005 and 2009, making up about 0.33% of hospitalizations in the United States.

 Their in-hospital mortality decreased from 15.6% to 14.4% during this time, but the apparent severity of illness worsened over time, as both length of stay and inpatient charges increased.

HE is associated with a range of neurological and psychiatric manifestations. In its least severe form, symptoms like fatigue and mild impairments in attention, memory, and visuospatial acuity can go unnoticed, but as it worsens and becomes overt, family members may report personality changes, such as irritability or inappropriate behavior, and the patient experiences disorientation to time and space.

 Motor symptom abnormalities are common, including asterixis or “flapping tremor,” which precedes the stupor and coma that occur in the later stages.

 Clinicians use the West Haven grading criteria to assess the severity of HE and separate covert from overt HE.

HE can be classified according to severity, as with the West Haven criteria, but also according to underlying disease, time course, and presence of precipitating factors.

 Type A HE results from acute liver failure, type B results mainly from portosystemic bypass or shunting, and type C results from cirrhosis. Patients are categorized by time course as having episodic HE, recurrent HE (having intervals between bouts of less than 6 months), or persistent HE (constant behavioral alterations interspersed with overt HE relapses).

Although the exact mechanisms of the pathogenesis of HE are not completely known, there is some consensus among researchers that a synergistic effect of factors is to blame. Among these factors are ammonia levels, inflammation, bile acids, oxidative stress, and lactate.

 Specifically, hyperammonemia results in decreased excitatory neurotransmission, potentially related to γ-aminobutyric acid—benzodiazepine receptors, which can cause the neuronal dysfunction that leads to HE symptoms.

 Research has also pointed to the importance of neuroinflammatory responses in some patients and the potential role of gut microbiota.

A 4-pronged approach is most commonly recommended for managing overt HE and consists of (1) initiating care for patients with altered consciousness, (2) seeking and treating alternative causes of altered mental status, (3) identifying and correcting precipitating factors, and (4) commencing empirical HE treatment.

 With regard to the last step, the use of nonabsorbable disaccharides such as lactulose is recommended as an initial treatment to reduce ammonia absorption and encourage the growth of beneficial intestinal microorganisms, but poor adherence is common because patients are asked to titrate their doses based on their bowel movements, which can be challenging for those experiencing cognitive impairment.

 The antibiotic rifaximin has also been shown effective in improving symptoms and prolonging remission.

 Evidence for the use of probiotics (eg, yogurts with 

) in managing HE is unclear, but some studies suggest that they can reduce the risk of overt HE episodes compared with placebo.

Guidelines suggest delivering lactulose with or without rifaximin as prophylaxis to patients whose HE is in remission; this may help prevent recurrence, avoid hospitalizations, and improve quality of life.

 After patients achieve remission, it is generally suggested that they continue prophylactic therapy indefinitely, unless there is a specific precipitating factor for the patient’s HE that can be managed (eg, recurrent infection, variceal hemorrhage).

When HE persists and severely worsens a patient’s quality of life despite following therapeutic guidelines, physicians may consider liver transplantation, but the literature emphasizes the importance of identifying and embolizing portosystemic shunts before or during transplantation, as these can cause persistent HE even after a transplant.

 Patients and family members should be aware that other causes of mental impairment, such as Alzheimer disease, will not be reversed by the transplantation.

Given the recurrent nature and unclear mechanisms of HE, as well as the rising number of cases in the United States, there is a significant cost burden resulting from the condition. The total national costs were estimated at $724.5 million in 2009, up from $467.7 million in 2005.

 However, these estimates do not include outpatient care, nor do they account for indirect costs like lost wages, impaired quality of life, and shorter life expectancy.

Most direct costs are accrued by the federal government, as about two-thirds of patients with HE are covered by Medicare and Medicaid; the proportion of Medicare beneficiaries is expected to increase as the population ages.

Beyond these easily measurable costs to payers, HE has insidious economic and personal effects on patients and their families. Compared with patients with only cirrhosis, those with cirrhosis and HE were far less likely to be employed (19% with HE vs 87.5% with cirrhosis) and were associated with a higher level of burden on their informal caregivers, which was reported to be due to financial, scheduling, and emotional factors, including feelings of being trapped.

 Those caregivers also reported higher rates of depression and anxiety than those caring for patients with cirrhosis but not HE.

In light of these high costs to payers, health systems, patients, and families, many of the attempts to reduce the cost burdens of HE have focused on preventing hospital readmissions, mainly through prophylactic treatment with rifaximin.

 One quality improvement program produced encouraging effects on readmission rates by prompting goal-directed lactulose and rifaximin therapy within providers’ electronic order entry system.

HE represents a costly and damaging source of morbidity and mortality in the United States, and its detrimental effects are only expected to rise as the susceptible population ages and rates of precipitating factors for CLD, like diabetes, continue to increase. Keeping ahead of its burden will require a multipronged approach that ties together evidence-based treatments, clinical decision support tools, and readmission prevention strategies to result in the most cost-effective care possible for patients with HE.

1. Definition & facts for cirrhosis. National Institute of Diabetes and Digestive and Kidney Diseases website. niddk.nih.gov/health-information/liver-disease/cirrhosis/definition-facts. Published March 2018. Accessed November 9, 2018.

2. Chronic liver disease/cirrhosis. Johns Hopkins Medicine website. hopkinsmedicine.org/healthlibrary/conditions/liver_biliary_and_pancreatic_disorders/chronic_liver_diseasecirrhosis_85,P00662. Accessed November 9, 2018.

3. Diagnosis of cirrhosis. National Institute of Diabetes and Digestive and Kidney Diseases website. niddk.nih.gov/health-information/liver-disease/cirrhosis/diagnosis. Published March 2018. Accessed November 9, 2018.

4. Treatment for cirrhosis. National Institute of Diabetes and Digestive and Kidney Diseases website. niddk.nih.gov/health-information/liver-disease/cirrhosis/treatment. Published March 2018. Accessed November 9, 2018.

. 2016;375(17):1660-1670. doi: 10.1056/NEJMra1600561.

6. Flamm SL. Complications of cirrhosis in primary care: recognition and management of hepatic encephalopathy. 

. 2018;356(3):296-303. doi: 10.1016/j.amjms.2018.06.008.

7. Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by AASLD and EASL. American Association for the Study of Liver Diseases website. aasld.org/sites/default/files/guideline_documents/141022_AASLD_Guideline_Encephalopathy_4UFd_2015.pdf. Published 2014. Accessed November 9, 2018.

8. Stepanova M, Mishra A, Venkatesan C, Younossi ZM. In-hospital mortality and economic burden associated with hepatic encephalopathy in the United States from 2005 to 2009. 

. 2012;10(9):1034-1041.e1. doi: 10.1016/j.cgh.2012.05.016.

9. Ochoa-Sanchez R, Rose CF. Pathogenesis of hepatic encephalo&shy;pathy in chronic liver disease. 

. 2018;8(3):262-271. doi: 10.1016/j.jceh.2018.08.001.

10. Elwir S, Rahimi RS. Hepatic encephalopathy: an update on the pathophysiology and therapeutic options. 

. 2017;5(2):142-151. doi: 10.14218/JCTH.2016.00069.

11. Bajaj JS, Wade JB, Gibson DP, et al. The multi-dimensional burden of cirrhosis and hepatic encephalopathy on patients and caregivers. 

. 2011;106(9):1646-1653. doi: 10.1038/ajg.2011.157.

12. Flamm SL. Considerations for the cost-effective management of hepatic encephalopathy. 

13. Tapper EB, Finkelstein D, Mittleman MA, Piatkowski G, Chang M, Lai M. A quality improvement initiative reduces 30-day rate of readmission for patients with cirrhosis. 

. 2016;14(5):753-759. doi: 10.1016/j.cgh. 2015.08.041.

Hepatic encephalopathy, a complication of liver disease, is a serious neuropsychiatric condition that causes severe burden among patients and the healthcare system.

Care Management and Cost Burden in Hepatic Encephalopathy

To assess the association of the transition from incident opioid use to incident chronic opioid therapy (COT) with the trajectories of healthcare utilization and expenditures.

We used a longitudinal, retrospective cohort design, including seven 120-day time periods covering preindex (t

) periods with data from adults aged 28 to 63 years at the index date, without cancer, and continuously enrolled in a primary commercial insurance plan (N = 20,201).

 Multivariable analyses were performed on utilization (population-averaged [PA] logistic regression), expenditures (PA generalized estimating equations), and expenditure estimates (counterfactual prediction). The data used were from a commercial claims database (10% random sample from the IQVIA Real-World Data Adjudicated Claims - US database) from 2006-2015.

Patients on COT were more likely to use inpatient services (adjusted odds ratio, 1.11; 95% CI, 1.01-1.21) compared with those who did not. Although expenditures peaked during the index period (t

) for all users, differences in unadjusted average 120-day expenditures between COT and non-COT users were highest in t

 for total ($4607) and inpatient ($2453) expenditures. COT users had significantly higher total (β = 0.183; 

The period after incident opioid prescription but before transition to COT is an important time for payers to intervene.

The American Journal of Accountable Care. 2018;6(4):11-18

Half of Americans have experienced pain in the past year

and approximately 100 million experienced chronic pain.

 The majority of these patients have chronic noncancer pain (CNCP) and are of working age.

 CNCP can be managed using therapy regimens that include pharmacologic options and nonpharmacologic options (eg, electrical stimulation, physical therapy, psychological interventions, exercise), which have been shown effective.

 Opioids have been recommended by the CDC to be used only after considering a nonopioid regimen. Nearly 1 in 5 patients who presented to their healthcare provider with a painful condition in 2010 were prescribed an opioid, although the effectiveness of opioids in relieving CNCP has not been proven.

In addition to the lack of evidence that opioids effectively treat CNCP, opioid use leads to adverse health consequences.

 Study results have documented increased healthcare utilization and expenditures to patients and payers due to adverse effects of opioids.

 Patients prescribed opioids had higher emergency department (ED), inpatient, and outpatient visits, as well as increased analgesic use, out-of-pocket spending, and third-party spending, compared with patients not prescribed opioid medications.

 For example, in 2017, approximately 16 of every 10,000 ED visits in the United States were for suspected opioid overdose.

 The number of annual ED visits due to suspected opioid overdose increased by 27.7% from 2015 to 2016.

 From 1993 to 2012, the rate of hospital inpatient stays related to opioid overuse increased by 153%.

Patients who receive initial opioid therapy, even for only a few days, are at risk of transitioning to chronic opioid therapy (COT), defined as 90 days of use.

 Our preliminary analysis has shown that initial opioid prescription characteristics (parent opioid [eg, hydrocodone, oxycodone, tramadol], duration of action, and standardized dose) are the leading predictors of transitioning to COT.

 Both patients and payers can bear the economic consequences of COT, which result from exacerbation of current medical conditions, development of new physical and mental health conditions, and opioid-related adverse effects, including drug use disorder and opioid overdose.

is spent annually on these adverse consequences of opioids.

Researchers have estimated the economic burden of patients on opioid therapy

; studies that systematically examine the effect of the transition to COT on healthcare utilization and expenditures are sparse.

 Such studies are important because they assess a transition state earlier in the patient’s continuum of care,

 and this earlier period has been identified by the CDC as a time to take action to prevent the adverse consequences of opioid use.

 To date, only 1 study has analyzed the association of long-term opioid therapy and other opioid therapy with

 Using data from commercial health plans, the study reported that healthcare expenditures were higher among long-term opioid users compared with other opioid users.

 This study had some limitations, such as use of a nonstandard definition of long-term opioid therapy and unequal follow-up time periods between short- and long-term opioid users. The definition for chronic opioid use (>182 days) was different from the commonly used Agency for Healthcare Research and Quality (AHRQ) and CDC definition of at least 90 days.

 Furthermore, the study was not restricted to working-aged adults, who may have different transition rates and factors affecting those rates. Our study addresses the limitations of the prior literature and analyzes the impact of transitions from initiation of opioids to COT on economic outcomes in a nationally representative sample of working-aged adults using definitions concordant with definitions used by the CDC, AHRQ, and current literature.

Focusing on working-aged adults between 28 and 63 years is important because this group may have higher risk of transition to COT

 and their healthcare utilization patterns may be unique compared with those of elderly patients.

 Therefore, the objective of our study was to assess the association of transitioning from incident opioid use to incident COT with trajectories of healthcare utilization and expenditures using a nationally representative sample of commercially insured working-aged adults in the United States.

The data were derived from a 10% random sample of commercial enrollees released under licensing from the IQVIA Real-World Data Adjudicated Claims - US database.

A retrospective cohort design, with longitudinal data for seven 120-day time periods covering preindex (t

) periods, was used. The patient cohort consisted of working-aged adults who did not have cancer and who were initiated on opioids between January 2007 and May 2014. The first observed prescription for an opioid represented the index date. The preindex periods were identified before the index date, the index period was identified as the 120 days after the index date, and the postindex periods were identified after the end of the index period.

The sample was restricted to adults who were continuously enrolled in a primary commercial insurance plan (with pharmacy and medical benefits) during their entire observation period. Cancer was identified using 

International Classification of Diseases, Ninth Revision, Clinical Modification

) codes. Patients with at least 1 claim with any cancer code, except for nonmelanoma skin cancer, in any of the 12 diagnosis code fields available in the claims data were considered to have cancer.

 We excluded individuals who had more than 1 opioid prescription on the index date because we were unable to evaluate initial opioid regimen characteristics for these individuals. After applying the exclusion criteria, we observed 3776 adults in the COT group. A 5% random sample, approximately 5 controls per case, of patients without COT was selected to represent the non-COT group (n = 16,425) (

Dependent variables: healthcare utilization and expenditures. 

All healthcare utilization and expenditures were repeatedly measured for each time period. Utilization consisted of ED and inpatient services. ED use was identified using an algorithm based on place of service, procedure codes, and revenue center codes.

 Inpatient use was identified based on the claim having a not-null value for confinement number (a unique number of room and board records within a series containing the same facility provider ID on overlapping or contiguous dates, indicating hospitalization). Inpatient claims with the same confinement number were aggregated to get the admission and discharge dates. We measured utilization by any use of ED or inpatient services, defined as having at least 1 claim for these services during the 120-day time period.

Expenditures were distinguished by type of service (ED, inpatient, physician, and other [eg, surgical services, diagnostics, and laboratory tests]). Total expenditures (without prescription drugs) were the sum of ED, inpatient, physician, and other. Expenditures were calculated using the actual amount paid by the insurance plan and were converted to 2015 US dollars using the US Bureau of Labor Statistics Consumer Price Index for Medical Care Services.

 Opioids were identified using National Drug Codes (NDCs). NDCs for opioids were extracted from the National Library of Medicine’s RxNav and RxMix.

 A patient was classified as having incident COT if they had at least a 90-day supply of opioids during the 120-day index period.

 Time-invariant characteristics (patient’s sex, region of residence, and clinical factors) were measured during the 12 months before the index date. Age was calculated as of the index date for initial opioid prescription. Clinical factors were presence or absence of diagnoses for painful conditions,

 drug use disorders, and number of other chronic conditions adapted from HHS priority conditions for research, program, and policy.

 Painful conditions were categorized as conditions likely or highly likely to be associated with chronic pain.

 codes for drug dependence (304), drug abuse (305.2-305.9), and drug-induced mental disorders (292). The 

The clinical complexity of a patient was also measured during each time period by the number of unique medication classes. We also assessed concomitant medication use, benzodiazepines, and prescription nonopioid analgesics (NOAs) at each time period. Generic Product Identifier (GPI) codes were used to identify number of unique medication classes, as well as benzodiazepines (GPI-4, 57.10) and NOAs (GPI-2, 66 or 64). Additional independent variables included continuous time (range of 0-6 corresponding to t

The increase in healthcare utilization and expenditures associated with the transition to chronic opioid therapy places increased burden on payers and patients.

December 2018

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