Achieving the Quadruple Aim to deliver value-based allergy care in an ever-evolving health care system

Abstract

Objective:

To define the concept of value-based care in allergy, and to review challenges and opportunities in value-based health care delivery for allergists and immunologists.

Data Sources:

Articles describing practice variation, health care financing and reimbursement, shared decision-making, cost-effective health care delivery, patient-reported outcome measures, social determinants of health, and screening.

Study Selections:

A narrative review detailing concepts and approaches to improve value-based health care in the context of the Quadruple Aim to address the patient and physician experience, cost, and population health.

Results:

Efforts to improve cost-effective care can be informed by understanding unwarranted geographic practice variation and benchmarking best practices. Although evidence suggests that shared decision-making and addressing social determinants of health have critical roles in high-quality care, some practices such as routine laboratory screening for urticaria, premedication to prevent recurrent low- or iso-osmolar contrast reactions, extended observation of resolved anaphylaxis, food allergy screening, and penicillin allergy overdiagnosis have high costs in relation to overall societal benefit. Food allergy prevention, newborn screening for severe combined immune deficiency, and penicillin delabeling are examples of population-based opportunities in which allergists and immunologists can assist in creating health care value. Although efforts to incentivize value-based care have emerged in recent years, the degree to which process measures improve patient-important outcomes remain uncertain. Clinician wellness must be made a priority for continued effective practice.

Conclusion:

As health care systems continue to evolve, allergists and immunologists will play a key role in optimizing value by translating emerging evidence into practice and communicating novel approaches to prevent and treat allergic diseases.

Introduction

The practice of medicine is evolving at a rapid pace. Substantial breakthroughs have expanded the clinician’s ability to offer the latest diagnostic and therapeutic treatments to patients to reduce morbidity and mortality. But despite rapidly advancing medical knowledge, there is variation in global health care delivery even with the consensus that any clinical strategy offered should be safe, effective, patient-centered, timely, efficient, and equitable.¹ Toward a shared end, the Quadruple Aim to achieve value-based care has emerged as a guiding principle for health care systems to accomplish high-quality care.¹ Goals include (1) improving the patient experience, (2) improving the health of populations, (3) reducing the cost of care, and (4) improving the provider experience to prevent physician burnout. These tenets have encouraged innovation, such as understanding practice variation and benchmarking best practices, critically appraising evidence and clearly translating recommendations, rethinking health care delivery models and financing, and increasing focus on social and behavioral determinants of health (Table 1). The specialty of allergy and clinical immunology touches every aspect of medicine; as such, the practicing allergist/immunologist plays an integral role in an ever-evolving health care system to deliver high quality, value-based care.

Table 1.

Glossary of Terms Commonly Used in Value-Based Care

Value-based care: In contrast to volume-based care, value-based care is a complex synthesis of health care delivery that incorporates outcome (and process) measures in physician reimbursement. More broadly, value-based care encompasses the concepts described in the Quadruple Aim of health care.

Value-based pricing: A pricing model for therapy in which the reimbursement price of therapy depends on the outcomes that the therapy produces, and in which better outcomes can justify a higher value-based price.

Quadruple Aim: A value-based health care strategy that seeks the following: (1) improve the patient experience; (2) improve the health of populations; (3) reduce the cost of care; and (4) improve the provider experience.

Practice variation: The degree to which health care delivery differentially affects value. Practice variation may be warranted in settings of patient preference type of care, when medical knowledge does not adequately inform practice, and when disease incidence demonstrates geographical divergence. Conversely, differences in health care delivery by local physician supply, individual physician practice styles, and geographic differences in evidence-based care indicate opportunities for practice improvement.

Cost-effectiveness analysis: A complex valuation that grades both health outcomes and economic benefits of a particular aspect of clinical care using inputs that integrate the broad medical evidence surrounding a concept, the effect on a patient with the disease, and the costs (which can be explored at a patient, payer, or society level), which is explored over a particular time horizon of the condition.

GRADE: An approach, which can effectively identify critical evidence gaps and clearly translate evidence-based recommendations using the navigational signal of strong or weak (ie, conditional) terminology.

Burnout: A condition characterized by exhaustion, depersonalization, lack of efficacy, or personal accomplishment often associated with workplace stress.

Patient Protection and Affordable Care Act of 2010: A comprehensive health care reform law designed to expand insurance coverage, expand Medicaid, and support value-based care delivery methods.

Medicare Access and CHIP Reauthorization Act of 2015 (MACRA): A federal law that repealed Medicare’s Sustainable Growth formula and transitioned Medicare reimbursement models from rewarding health services volume to value-based care delivery.

Quality payment program (QPP): The overarching Medicare payment incentive program, as mandated by MACRA, to deliver high-quality, high-value care rather than high-volume care.

Merit-based incentive payment system: A track of the QPP that consolidates former quality reporting programs (Physician quality reporting system. Value-based payment modifier, and Meaningful use) and adds an Improvement activities category. Medicare reimbursement may be positively- or negatively-adjusted based on performance.

Alternative payment model: A incentive payment approach and track of the QPP that allows for providers to participate in qualified care pathways prioritizing quality and value. APMs can revolve around specific clinical conditions, care episodes, or defined populations.

Accountable care organization: A group of health care providers (clinicians, hospitals, and health systems) that voluntarily enter into a payment arrangement with Medicare to provide coordinated, high-value care for a defined population of patients. Similar arrangements with other payers (Medicaid, private insurers) are known as clinically integrated networks.

Physician-focused payment model technical advisory committee: Mandated by MACRA, it is the regulatory body that reviews stakeholder proposals for physician-focused payment models, a specific form of APMs.

Patient-centered asthma care payment: American College of Allergy, Asthma, and Immunology-proposed alternative payment model to deliver high-quality, high-value care for populations of asthma patients.

Qualified Clinical Data Registry: An entity that develops measures for CMS that are specific to a specialty, region, or health system.

National Quality Forum: Nonprofit organization that aims to stimulate health care improvements through the development of quality measures and standards.

Patient-Reported Outcome Measure: Standardized, validated questionnaires intended to systematically capture the status of a patient’s health condition from the patient’s perspective, free of clinician’s interpretation. Patient-reported outcome measure ideally focus on experiences that matter most to patients.

Abbreviations: APM, alternative payment model; CHIP, Children’s Health Insurance Program; CMS, Centers for Medicaid and Medicare Services; GRADE, grading of recommendations assessment, development, and evaluation; MACRA, Medicare Access and CHIP Reauthorization Act; MIPS, merit-based incentive payment system; QPP, quality payment program.

Creating Value in Health Care and Learning From Practice Variation

The value equation in health care is defined as the health outcomes achieved divided by the total cost of care, which can be evaluated for a patient’s specific medical condition or across a continuum of healthcare delivery. Health outcomes are a myriad and must be defined contextually—examples include quality-adjusted life years (QALY) (eg, the value of a perfect year of health relative to a condition), episodes of anaphylaxis averted, fatalities prevented, and hospitalizations. Moreover, the patient and provider experience are also important outcomes of health care delivery, although the provider experience is a metric that often receives less attention. However, as recognized by certain health care systems and defined in the Quadruple Aim, shared experiences by both patient and provider should not be underappreciated. The importance of physician wellness is emerging and burnout is associated with significant downstream effects resulting from emotional exhaustion and depersonalization.^2–4 Evaluating health care outcomes from both patient and provider perspective is important to optimize the understanding of value-based care.¹

Health care delivery can also be improved by understanding patterns of practice variation and benchmarking the best outcomes.⁵ Practice variation may be warranted in settings of patient-preference care (ie, when patients value influence in their choices), when medical knowledge does not adequately inform practice, or when disease incidence demonstrates geographical divergence.⁵ Conversely, differences in health care delivery because of access to care, individual physician practice styles, and geographic differences in evidence-based care indicate opportunities for practice improvement.⁵

The challenges in evaluating unwarranted practice variation are to realize the degree to which it exists, and to benchmark best practices. A few examples of unwarranted practice variation include global variation in food allergy screening,⁶ discretionary epinephrine autoinjector prescription in patients receiving allergen immunotherapy,⁷ routine laboratory screening in patients with chronic spontaneous urticaria,⁸ observation time for resolved anaphylaxis,⁹ and routine premedication to prevent recurrent radiocontrast media-immediate hypersensitivity reactions.¹⁰ Recent evidence suggests many so-called “routine” practice styles are not actually cost-effective practices.^6–12 For example, routine premedication to prevent recurrent hypersensitivity reactions to a low- or iso-osmolar non-ionic radiocontrast media costs well above the $10 million benchmark of cost-effective care to prevent 1 fatality and has been estimated to reach $131,211,400 to prevent 1 death.¹⁰ Similarly, extended emergency department observation of resolved anaphylaxis is not cost-effective unless it is associated with a 76% fatality risk-reduction.⁹

Providing value-based care necessitates understanding practice variation and the ability to translate evidence into practice. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach can effectively identify critical evidence gaps and translate evidence-based recommendations using strong or weak (ie, conditional) terminology (Table 2).¹³ The GRADE approach has become standard among guideline working groups and has been adopted by the Joint Task Force for Practice Parameters. Optimizing evidence translation, appreciating practice variation, and benchmarking are powerful tools to create value in health care.

Table 2.

The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Approach¹²

Strength of recommendation
	For the patient	For the clinician
Strong	Most individuals in this situation would prefer the recommended course of action and only a small proportion would not.	The attending provider should strongly consider the recommended course of action as a first-line management. Formal decision aids may have less of a role to help individuals make decisions consistent with their values and preferences.
Weak (Conditional)	Most individuals in this situation would prefer the suggested course of action, but many would not.	Different choices may be appropriate for different patients. Decision aids may be useful in helping individuals in making decisions consistent with their values and preferences. Clinicians should expect to spend more time with patients when working toward a decision.
Quality of evidence
High	There is high confidence that the true effect lies close to that of the estimate of the effect.
Moderate	There is moderate confidence in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low	There is limited confidence in the effect estimate. The true effect may be substantially different from the estimate of the effect.
Very Low	There is very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect

Although health outcomes are a clear area of focus, international variation in health care costs cannot be ignored. A specific example of enigmatic geographic cost variation is the pricing of epinephrine autoinjectors, although appropriate value-based pricing for devices has been suggested.^14,15

Financing Value-Based Care

The United States continues to dominate in health care expenditures as a percentage of GDP, and be dominated in overall health care system performance and value.¹⁶ This stark reality in the setting of finite resources has highlighted the critical need to achieve better value in health care delivery.¹⁷ In the United States, the shift toward value-based health care was mandated by the Patient Protection and Affordable Care Act in 2011, and this was hastened by the passage of Medicare Access and CHIP Reauthorization Act (MACRA) in 2015.¹⁸ Medicare Access and CHIP Reauthorization Act ended the Medicare Sustainable Growth Rate, and in its stead required the Centers for Medicaid and Medicare Services (CMS) to launch the Quality Payment Program (QPP) in 2017.¹⁸ Under the QPP, providers who care for a minimum number of Medicare beneficiaries must participate in 1 of 2 value-based care programs or be subjected to reimbursement reductions.¹⁸ Participants may earn positive payment adjustments or incentive bonuses for achieving a defined level of quality.

The first program, which should be familiar to allergists caring for adult patients, is known as the merit-based incentive payment system (MIPS).¹⁸ Under MIPS, a provider must do the following: (1) report up to 6 quality measures, including at least 1 outcome measure; (2) promote interoperability (ie, “meaningful use”); (3) demonstrate clinical practice improvement activities; and (4) report on resource use based on claims data.¹⁸ The MIPS 2017 data (performance year 1) show that 2969 allergy/immunology specialists were required to participate, with 89% fully participating at that time. Although allergy/immunology-specific payment performance data are not available, 93% of all clinicians eligible for MIPS earned a positive payment adjustment in 2017 (range < 0.01%−1.9%) and 5% of clinicians were penalized a negative payment adjustment (range −4.0 to −2.1%).¹⁹

The second option of the QPP is an alternative payment model (APM).¹⁸ Organized around a specific clinical condition, episode of care, or defined populations, APMs incentivize payments to reward high-quality and cost-efficient care.¹⁸ Although several types of APMs are currently ongoing (with several different models of innovation emerging), perhaps the most commonly known APM is the accountable care organization (ACO).¹⁸ The ACOs are groups of providers who agree to share risk and responsibility for the delivery, coordination, and cost of care to their population. This creates an incentive to achieve a defined set of process and outcome measures. Given that the ACO-covered population is generally regional, it is typically defined by the participating primary care providers, and thus, requires robust and high-functioning primary care practices and services.¹⁸

Specific to allergy/immunology and particular long-term conditions, a recent submission of the American College of Allergy, Asthma, and Immunology to the Physician-Focused Payment Model Technical Advisory Committee has proposed an APM for Patient-Centered Asthma Care Payment.²⁰ The Patient-Centered Asthma Care Payment is a bundled payment model with the goal of providing resources and flexibility to providers—primary care providers and asthma specialists alike working together as part of a so-called “asthma care team”—for value-based diagnostic and therapeutic management practices for patients with difficult to control asthma.²⁰ In addition to billing traditional evaluation and management codes, the asthma care team would use a new series of service codes tied to a specifically determined reimbursement.²⁰ With new streams of revenue through these new and supplemental payments, the asthma care team would assume accountability for managing the cost and quality of asthma care to their patient population.²⁰ Models are needed for other shared diagnoses with primary care beyond asthma, such as food allergy, allergic rhinitis, and eczema.

Challenges in Achieving Quality in a System

Appropriate outcome measurement is essential to evaluating the value of health care delivery. In this way, value-based health care programs drive outcome improvement by mandating the reporting of quality measures (outcome, process, or efficiency). For example, allergists enrolled in MIPS are required to report up to 6 separate quality measures (including an outcome measure) or report on a set of specialty-specific measures as stipulated by the QPP.¹⁸ In 2020, the allergy/immunology MIPS specialty measure set includes 10 measures (Table 3).¹⁸ Alternatively, or in addition to MIPS measures, an allergist can also report on non-MIPS measures through Qualified Clinical Data Registry (QCDR) of the American Academy of Allergy, Asthma and Immunology (AAAAI). In the 2020 AAAAI QCDR, 7 non-MIPS measures specific to asthma, allergen immunotherapy, and drug allergy (Table 4) have been included.²¹

Table 3.

2020 Allergy-Immunology Merit-Based Incentive Payment System Specialty Measure Set¹⁷

MIPS ID	Measure name	High priority	Measure type	Measure description
110	Preventive care and screening: influenza immunization	No	Process	Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization, or who reported previous receipt of an influenza immunization.
111	Pneumococcal vaccination status for older adults	No	Process	Percentage of patients aged 65 years and older who have ever received a pneumococcal vaccine.
130	Documentation of existing medications in the medical record	Yes	Process	Percentage of visits for patients aged 18 years and older for which the eligible professional or eligible clinician attested to documenting a list of existing medications using all immediate resources available on the date of the encounter. This list must include all known prescriptions, over the counter, herbals, and vitamin/mineral/dietary (nutritional) supplements and must contain the medications’ name, dosage, frequency and route of administration.
226	Preventive care and screening: Tobacco use: screening and cessation intervention	No	Process	Percentage of patients aged 18 years and older who were screened for tobacco use 1 or more times within 24 months and who received tobacco cessation intervention if identified as a tobacco user.
238	Use of high-risk medications in the elderly	Yes	Process	Percentage of patients aged 65 years and older who were ordered high-risk medications. Two rates are submitted: 1) Percentage of patients who were ordered minimum 1 high-risk medication. 2) Percentage of patients who were ordered minimum 2 of the same high-risk medication.
317	Preventive care and screening: Screening for high blood pressure and follow-up documented	No	Process	Percentage of patients aged 18 years and older seen during the reporting period who were screened for high blood pressure and a recommended follow-up plan is documented based on the current BP reading, as indicated.
338	HIV viral load suppression	Yes	Outcome	The percentage of patients, regardless of age, with a diagnosis of HIV with an HIV viral load less than 200 copies/mL at last HIV viral load test during the measurement year.
340	HIV medical visit frequency	Yes	Process	Percentage of patients, regardless of age, with a diagnosis of HIV who had at least 1 medical visit in 6 months of the 24-month measurement period, with a minimum of 60 days between medical visits.
374	Closing the referral loop: Receipt of specialist report	Yes	Process	Percentage of patients with referrals, regardless of age, for which the referring provider receives a report from the provider to whom the patient was referred to.
402	Tobacco use and help with quitting among adolescents	No	Process	The percentage of adolescents aged 12 to 20 years with a primary care visit during the measurement year for whom tobacco use status was documented and received help with quitting if identified as a tobacco user.

Abbreviations: BP, blood pressure; HIV, human immunodeficiency virus; MIPS, merit-based incentive payment system.

Table 4.

Non–Merit-Based Incentive Payment System, Allergy-Immunology–specific Performance Measures Included in American College of Allergy, Asthma, and Immunology Quality Clinical Data Registry^18,a

AAAAI ID	Measure name	Measure type
Asthma Measures
2	Assessment of asthma control: Ambulatory care setting	Outcome
17	Asthma control: Minimal important difference improvement	Outcome
11	Asthma assessment and classification	Process
12	Lung function/Spirometry evaluation	Process
Allergen Immunotherapy Measures
6	Documentation of clinical response to allergen immunotherapy within one year	Process
8	Achievement of the projected effective dose of standardized allergens for patients treated with allergen immunotherapy for minimum 1 year	Outcome
Drug Allergy Measure
18	Penicillin allergy: Appropriate removal or confirmation	Outcome

Abbreviations: AAAAI, American Academy of Allergy, Asthma and Immunology; ACAAI, American College of Allergy, Asthma, and Immunology; MIPS, merit-based incentive payment system.

^aMeasures developed by the Joint Task Force on Quality and Performance Measurement (a joint task force of the AAAAI and ACAAI)

Although incorporating these measurements is an important milestone toward delivering value, numerous challenges remain in truly achieving it. Between the MIPS allergy/immunology specialty set and AAAAI’s QCDR, only 5 measures evaluate health outcomes, whereas the majority pertain to process or efficiency measures.^18,21 This reflects a wider reality of quality measurement; but despite many measures, very few capture actual health outcomes, and even fewer are patient-reported outcomes.^18,21 Thus, we may be constructing a definition of value that allergists can presumably meet without much difficulty, yet not truly providing value-based care to our patients.

Process measurements can promote quality improvement if there is sufficient evidence that a care process both directly improves health outcomes and can be accurately captured.²² However, by definition, process measurement is not part of the value equation and it is uncertain if process measurement alone can improve health outcomes.²² It would be fair to ask why these are so heavily tied to reimbursement. In addition, a strong evidence base should support the clinical outcome/strategy being measured, and the measure requires condition-specific reliability and validity in the target population.²² Although not specific to allergy/immunology, measuring the outcomes of certain long-term conditions can be elusive given that the most relevant outcomes (eg, death, severe anaphylaxis) may be exceedingly rare or incorrectly captured by administrative claims data (or both).²² Clinically meaningful outcomes (eg, in food allergy, quality of life, fear, anxiety, impairment) may not be measured. In addition, given the necessity of specific patient behaviors in the management of allergic diseases (eg, allergen avoidance, adherence to daily or monthly medications), existing value-based health care models may unilaterally distribute accountability to providers and health care organizations without considering the patient’s role or circumstances beyond the patient or provider’s control.^{11,12,18–22} Finally, because quality measurement demands significant time and resources, care must be taken to select the most relevant and useful quality measures.^18–21

Practicing Value-Based Care

Despite challenges in aligning financial incentives among providers, payers, and suppliers relative to quality measurement reporting, there are other opportunities to bring value to patients with allergy.²³ In addition to adopting well-accepted National Quality Forum process measures (eg, influenza vaccination, closed-loop referral communication, and accurate medication documentation), strategies may include the following: (1) implementing standardized patient-reported outcome measurement (PROM)^23–26; (2) decreasing unwarranted practice variation through improved clinical guideline adherence⁵; (3) practicing shared decision-making^27,28; (4) developing innovative models of care delivery²⁹; and (5) addressing social determinants of health to improve patient outcomes.³⁰

Patient-Reported Outcome Measures

Patient-reported outcome measures can aid providers in clinical decision-making and population health management, especially in achieving the health outcome experiences that matter most to patients.²³ Patient-reported outcome measures can be especially effective for allergic conditions in which patient reported-symptoms may be the only identifiable health outcome (eg, chronic urticaria, rhinitis, and persistent asthma without exacerbations).²³ Patient-reported outcome measures used systematically and purposively can help elucidate true symptom burden and guide management, guarding against the overestimation of symptom control.³¹ A variety of measures for asthma are well known and commonly used in practice, such as the Asthma Control Test and Asthma Control Questionnaire, among others, and the use of PROMs is encouraged by clinical guidelines.³¹ Examples of measures that may be useful in assessing symptom burden and therapeutic response include the Urticaria Activity Score over 7 days for chronic urticaria and the Sino-Nasal Outcome Test-22 for sinusitis.^32,33 Similar measures for food allergy are of pressing need.

Shared Decision-Making

In clinical situations where there is equipoise among strategies for a given outcome or management step, and/or there is disutility associated with clinical strategies (eg, undue medication burden), it is imperative to understand patient values and preferences pertaining to diagnosis and treatment to best assist patients in selecting care pathways and avoid clinicians instilling their own values into patient choices.^27,28 Such a strategy is known as shared decision-making (SDM) and has been promoted as a strategy to achieve high-quality care. Because treatment options in chronic allergic diseases widely vary (with each approach generally having its own unique benefits, risks, and tradeoffs), SDM is vital during the clinical encounter.²⁷ Shared decision-making in asthma care leads to improved patient adherence, outcomes, and patient satisfaction.²⁷ Decision aids are tools to facilitate the process of SDM that has been promoted by statute in several states.²⁷

Identifying Unnecessary Testing and Procedures

The Choosing Wisely campaign is a prime example of efforts to decrease low-value health care services (ie, services that provide little or no benefit to patient-important outcomes).³⁴ Although Choosing Wisely recommendations start with the imperative “don’t…”, the campaign’s motto of “10 things physicians and patients should question” imply that clinical decisions to limit over-testing involve SDM.³⁴ Ideally, in SDM, the physician-patient partnership leads to an understanding of the risks, benefits, and alternative options to any given management strategy.²⁷ Specialty society partners have the latitude to specify which commonly ordered tests and procedures are prioritized and provide the supporting evidence for each recommendation.³⁴ An AAAAI task force group produced specialty specific Choosing Wisely recommendations (Table 5).³⁴ Real-life practices are commonly discordant with guideline recommendations that urge judicious testing and highlight the need to realize the low-value nature of some commonly ordered tests and procedures.⁸

Table 5.

American Academy of Allergy, Asthma and Immunology Choosing Wisely Recommendations: 10 Things Physicians and Patients Should Question³⁴

1. Don’t perform unproven diagnostic tests, such as IgG testing or an indiscriminate battery of IgE tests, in the evaluation of allergy.

2. Don’t order sinus CT or indiscriminately prescribe antibiotics for uncomplicated acute rhinosinusitis.

3. Don’t routinely perform diagnostic testing in patients with chronic urticaria.

4. Don’t recommend replacement immunoglobulin therapy for recurrent infections unless impaired antibody responses to vaccines are demonstrated.

5. Don’t diagnose or manage asthma without spirometry.

6. Don’t rely on antihistamines as first-line treatment in severe allergic reactions.

7. Don’t perform food IgE testing without a history consistent with potential IgE-mediated food allergy.

8. Don’t routinely order low- or iso-osmolar radiocontrast media or pretreat with corticosteroids and antihistamines for patients with a history of seafood allergy who require radiocontrast media.

9. Don’t routinely avoid influenza vaccination in egg-allergic patients.

10. Don’t overuse non-beta lactam antibiotics in patients with a history of penicillin allergy without an appropriate evaluation.

Abbreviations: CT, computed tomography; IgE, immunoglobulin E; IgG, immunoglobulin G.

Cost-Effectiveness

Cost-effective care defines a care pathway option that, relative to other choices and strategies for management, provides superior health outcomes at the lowest cost, thus providing an objective measure of the value of a health care dollar being spent.^35,36 Cost-effectiveness is a predominant feature of socialized/rationed healthcare systems like the United Kingdom National Health Service or single-payer systems that exist in most other countries but has only recently become a concern in the United States given that the health care system has seen a transformation in the payment reimbursement system in the past 40 years. Cost-effectiveness analyses use inputs that integrate medical evidence, management efficacy for the patient, and the cost impact (explored at a patient, payer, or societal level) over a specific time-horizon. The overall purpose is to maximize the value of services covered with the limited resources available. Cost-effectiveness outcomes are ordinarily focused on the QALY, which represents a year of perfect health relative to the condition of interest, and revolve around a spending threshold to gain a single QALY.³⁵ The quality-adjusted life year is important because it provides context to the quality of the time spent, and time without disease is worth more than time with the disease.³⁵ The threshold is often debated and somewhat controversial, but in the United States is typically $100,000/QALY (or $10 million per death prevented), derived in the 1970s from Medicare coverage of end-stage renal disease, and a societal standard for willingness to pay for a particular medical treatment (Figure 1).³⁵ Interventions that fall under this threshold are considered cost-effective.³⁵

Figure 1.

Cost vs effectiveness. The ICER can be used to determine the cost-effectiveness of strategies when neither strategy is dominated by the other in terms of superior outcomes with lower costs. The figure depicts the cost on the y-axis and effectiveness on the x-axis. When comparing 2 strategies, an incremental cost and incremental effectiveness can be calculated. Dividing the incremental cost of 2 therapies by their incremental effectiveness generates an ICER for comparison. If the incremental cost per quality of life-year exceeds $100,000, the therapy is not cost-effective. Alternatively, therapy is not cost-effective if the cost exceeds $10 million per death prevented. ICER, incremental cost-effectiveness ratio. (Adapted from Shaker M, Greenhawt M. Ann Allergy Asthma Immunol. 2019; 123:240–248 e241.)

Cost-effectiveness analysis is a lens to compare thresholds for value-based care. For example, a recent evaluation of the Choosing Wisely recommendation against routine diagnostic testing for urticaria confirmed this approach is not cost-effective and that from a US population perspective, screening costs could reach $1,833,501,483.⁸ Although in some circumstances strong patient preferences may effect results of cost-effectiveness analyses, in many cases, the degree of patient-preference sensitive care is unlikely to eclipse what would otherwise be low-value care. For example, for infant peanut allergy screening to be a cost-effective policy, the preference-sensitive trade-off would need to be implausibly high, equivalent to 20%−40% of a year of life to experience an index peanut anaphylaxis case under the supervision of an allergist vs at home (Figure 2).³⁷

Figure 2.

Cost-effectiveness of peanut allergy screening in the context of health state utility preference for in-clinic index reaction to peanut. The cost-effectiveness of competing strategies is indicated for the interaction between differential disutility of an in-clinic or at-home index anaphylactic reaction and peanut allergy prevalence in high-risk infants. Disutility is a term to quantitatively define the quality of life in relation to a year of perfect health, and differential anaphylaxis disutility indicates the negative effect of anaphylaxis at home vs in-clinic. Colors shown indicate the preferred strategy at a willingness to pay threshold of $100,000 per quality-adjusted life-year. Health disutility is a negative detriment of an allergic reaction (every −0.1 = 35.6 days of life in a year traded to avoid a reaction). Screening is not cost-effective unless a family is willing to trade the equivalent of more than 2 months of health to prevent anaphylaxis at home vs in clinic in an infant with a 40% risk of peanut allergy. (Reproduced from Greenhawt M, Shaker M. JAMA Netw Open. 2019; 2:e1918041.)

Social Determinants of Health

There has been an increasing public health focus to address the conditions in which individuals and communities are born, grow, live, learn, work, and play.³⁰ Broadly defined, key social determinants of health include economic stability, education, social and community context, health and health care, and neighborhood and the built environment.³⁰ In the context of health disparities, focusing on factors based in social conditions is appropriately diverting emphasis away from genetics and ancestry as the driver for poor health for many medical conditions.³⁰

Community and family socioeconomic factors and environmental exposures account for asthma outcome disparities along racial categories,³⁸ prompting calls to reorient policy, research, and clinical practice around a biopsychosocial framework.^30,39 Racial disparities may exist in food allergy outcomes, with higher rates of food allergy-related anaphylaxis and emergency department visits noted among minority populations.⁴⁰ Despite challenges in addressing social factors in individual patient encounters, the health system’s evolution in attending to often-overlooked social determinants of health is a vital component to quality health care delivery.

Extending Value Beyond the Allergy Clinic Through Prevention

Recent developments in allergic and immunologic diseases, particularly in prevention, have opened avenues to provide value at a population level, which are only evident through evidence translation, appreciation of practice variation, and benchmarking. Examples of such opportunities include peanut allergy prevention, newborn screening for severe combined immunodeficiency (SCID), and penicillin allergy delabeling.

Peanut Allergy Prevention

The Learning Early about Peanut and Enquiring about Tolerance studies reported the efficacy of infant peanut consumption for peanut allergy prevention.^41,42 Given the potential of wide-scale prevention of peanut allergy, national guidelines in 5 countries are now recommending infant allergenic food consumption (Figure 3),^43–47 with variation in recommendations for preemptive peanut sensitization screening. Regardless of screening practices, the consistent and unified message across all recommendations is that proactive infant peanut consumption, rather than avoidance or delay, may result in effective prevention of peanut allergy, including in groups thought to be low-risk.^48–50

Figure 3.

International variation in food allergy screening recommendations. Comparison of food introduction and screening recommendations in 5 countries. NIAID, The National Institute of Allergy and Infectious Diseases; SPT, skin prick testing.

Barriers to realizing the promise of infant allergenic food consumption for prevention are well-documented. Particularly salient to allergenic food introduction, medical reversal (ie, a change in policy recommendation as evidence evolves) delays the adoption of best practices if public health messaging is unclear.⁵¹ In light of this practical impediment, clear and consistent communication to pediatricians, family physicians, and dermatologists is required to facilitate appropriate recommendations to infants who will benefit from peanut consumption. Engaging multiple potential stakeholders to encourage discussions around peanut allergy prevention will be needed to have a population-level impact. In fact, in Australia, most parents reported learning about allergenic food introduction through a public health maternal and child health nurse and not through their pediatrician.⁵²

Screening before early introduction has many practical challenges and is another potential barrier. Although screening is intended to avoid unsupervised, severe index allergic reactions, its effectiveness in population-level peanut allergy prevention has not been rigorously evaluated. Experience from Australia suggests that a no-screening approach is safe.⁵² Data from the EarlyNuts study found similarly low adverse reaction rates to allergenic food in the general population before and after a change in national guidelines in 2016 for infant allergenic food consumption without preemptive screening; however, a low rate of anaphylaxis was reported (0.6% of infants with early peanut introduction).⁵² Robust modeling also indicates that screening for egg or peanut sensitization before introduction may result in more cases of food allergy prevented and is not cost-effective.^6,37,53 Other challenges to screening include clinician supply and access to care issues, clinician desire to perform oral food challenges to validate the screening results, and overdiagnosis because of imperfect diagnostic tests. In addition, screening creep to those deemed not to be high-risk or to other foods may also potentially lead to overdiagnosis. Injudicious screening practices or undeveloped referral pathways have the potential to lower the value proposition of food allergy prevention. Still, as evidenced by EarlyNuts, anaphylaxis can occur with early peanut introduction.⁵² Regardless of whether or not screening should be performed, early peanut introduction should proceed with small amounts gradually, with families advised to seek care if symptoms occur.

Newborn Screening for Primary Immunodeficiency

The use of T cell receptor excision circles (TREC) to screen for SCID is a public health success story.⁵⁴ An effective screening test should accurately detect a disease with serious consequences early enough for effective treatment to be implemented. The test itself should be affordable, accessible, and associated with minimal morbidity. Incorporating TREC into newborn screening meets each of these criteria, particularly because early detection of SCID facilitates early bone marrow transplant, which is associated with greater long-term survival (94% vs 69% survival for those transplanted before vs after 3.5 months of age).⁵⁵ Over the past decade, all 50 states have added universal SCID newborn screening to their panel, making the United States a global leader in this area. T cell receptor excision circles screening has shown that the incidence of SCID is higher than previous estimates, occurring in 1 in 58,000 births.⁵⁶ Incorporating universal newborn screening has increased survival of SCID-affected infants to 87% after immune reconstitution.⁵⁶ Value-based care is evident with TREC newborn screening, with cost-effectiveness recently estimated at 33,400 euros per QALY.⁵⁷

Penicillin Allergy Delabeling

Because penicillin allergy is commonly overdiagnosed and not assertively delabeled, assessing patients diagnosed as having penicillin allergy represents an opportunity for the allergist to lead value-based care.⁵⁸ Although 10% of the population may believe themselves to be allergic to penicillin, the incidence of penicillin anaphylaxis is less than 1%.⁵⁹ Penicillin allergy delabeling cost savings could reach $68-$143 million.⁵⁹ Recently the value of routine penicillin skin testing in patients with low-risk histories has been questioned, and a strategy of direct oral challenge without skin testing may be appropriate for many patients, particularly those with isolated, nonimmediate, benign rashes.⁶⁰

Fostering a Culture of Wellness

The consequences of ignoring wellness include physician burnout which affects an estimated 46% of the US physician workforce^2,4 Allergy and immunology physicians are not immune to burnout. A recent survey reported a burnout rate of 35% in the US allergy and immunology workforce.³ This is significant because symptoms of burnout (including exhaustion, depersonalization, and lack of efficacy or personal accomplishment) increase risk for depression, strained relationships, divorce, substance abuse, and suicide.^2,4 Rates of physician depression are estimated at 15% to 18% with attempted suicide rates of 1% to 2%.⁴ Burnout is associated with increased clinical and administrative workloads in addition to character attributes associated with physician attributes such as belief in service, sense of duty, perfectionism, and personal internalization of patient outcomes.^2,4 Fortunately, wellness resources are available⁴; and for clinicians struggling with depression or substance abuse, many states offer confidential physician health programs that do not interfere with licensure or medical practice (http://www.fsphp.org/state-programs).

Conclusion

Across the spectrum of medicine and health, the allergist has a pivotal role to play in leading value-based care. Evidence continues to evolve as we identify and fill knowledge gaps within medicine and translate evidence to practice. With clear-eyed evaluation of the risks, benefits, and costs of strategies and treatments, the care we provide can change and improve. Although management must be contextually tailored to each individual, we must also appreciate instances where our practice variation is unwarranted. Geographic differences and disparities in care present not only challenges, but more importantly opportunities to learn, understand, and benchmark best practices. Whether unwarranted variation results from true knowledge gaps or poor evidence translation to clinical practice, health care systems can evolve to promote value. With equal parts humility and advocacy, the role of the allergist will be to engage partners and lead system improvement on a global scale.

In the healthcare lexicon, the Quadruple Aim is a useful guide to consider and meet the health needs of patients, providers, and the larger society. Although reimbursement models will continue to change, challenge, and, at times, can become frustrating, the ever-present goal of system redesign must remain in focus because every system is designed to get the results that it gets. Through collaborative networks, collegial encouragement, and patient connection and engagement, allergists will continue to lead improvement as health care delivery enters this next decade.

Key Messages.

• The Quadruple Aim of value-based care is to: (1) improve patient experience, 2) improve the health of populations, (3) reduce the cost of care, and (4) improve provider experience.

• Health care delivery can be improved by understanding patterns of practice variation and benchmarking the best outcomes.

• Providing value-based care is critically dependent on the ability to translate evidence into practice.

• Financial incentives to promote health care value continue to evolve but identifying the most appropriate measures remains a challenge.

• Optimizing value-based care requires an understanding of social determinants of health while leveraging tools such as patient-reported outcome measures, shared decision-making, and cost-effectiveness to minimize unwarranted practice variation and benchmark best practice strategies.