HMPI

Expanding the Evidence Base for Precision Healthcare

Joseph B. Franklin, Amy P. Abernethy, Jason Arora, Brad Hirsch, Verily

Contact: joebfranklin@verily.com 

Abstract

What is the message? Our ability to achieve precision healthcare — care that is personalized, patient-centered, and accessible — will depend on new ways of generating the evidence necessary to inform decisions across the research and care ecosystem, including treatment decisions in the clinic, regulatory decisions by the Food and Drug Administration (FDA) and its international counterparts, and decisions related to coverage and payment by Medicare and other payers. This evidence must reflect the diversity of patients, provide longitudinal information on care, outcomes, and prevention and, above all, needs to be based on robust, reliable data from both traditional clinical trials and from “real-world” sources outside of clinical trials, such as electronic health records (EHRs).

What is the evidence? We share collective observations and learnings from our time in clinical practice, serving in roles at the FDA, and providing health technology and data solutions to hospital systems, patient advocate groups, and life science companies.

Timeline: Submitted: March 31, 2022; accepted after review: April 7, 2022.

Cite as: Joseph Franklin, Amy Abernethy, Jason Arora, Brad Hirsch. 2022. Expanding the Evidence Base for Precision Healthcare? Health Management, Policy and Innovation (www.HMPI.org), Volume 7, Issue 2.

Diverse and longitudinal: Precision care will require new ways of generating evidence

New and emerging technological capabilities for diagnosing, treating, and preventing disease promise significant advances in patient care. However, realizing the benefits of these achievements will require new methods for generating evidence that can inform more personalized care decisions.

While traditional clinical trials are a powerful tool, they tend to have significant limitations.[1] [2]  For example, it can be difficult for traditional clinical trials to recruit patients that are representative of the diversity in the population; many patients are systematically left out of clinical trials due to comorbidities, the practical challenges of participating in complex studies far from home, and other hurdles. Traditional trials collect only certain information during a short time window in a patient’s care, missing much of the data that may be relevant to understanding both the patient’s health background and long-term measures of safety and effectiveness for novel interventions. These limitations – stemming from a ‘closed system’ approach to clinical studies – impact the utility and generalizability of clinical trial findings in the real-world setting, resulting in outcome variation and the inability to consistently and accurately predict individual patient outcomes prior to therapeutic intervention.

Further, to inform personalized care decisions, the evidence base needs to reflect the values of patients. This means that we need rigorous methods for integrating patient-centered outcomes with more traditional clinical outcome measures.  For example, in nephrology, an important healthcare context which is explored in more depth below, mobility and other outcomes including wellbeing, quality of life, and treatment burden can provide critical insights into meaningful lifestyle improvements for dialysis patients.[3] [4]

From these gaps in the existing paradigm for evidence generation, we can identify discrete challenges to address: (1) increasing the depth of the evidence both by enhancing the diversity of the patients studied and by enhancing the richness of the study data to include sources like relevant biological (e.g., genomic) information, environmental factors, and improved patient-centered measures; (2) increasing the generalizability of the evidence by including people traditionally excluded from traditional clinical trials such as those with comorbidities; and (3) increasing the longitudinality of the evidence by supplementing traditional clinical trial data with datasets that provide information from timepoints both before and after the data collection period for a clinical trial.

High-quality RWD, novel clinical trial designs, and an integrated approach to evidence is critical for filling the gaps in the current clinical evidence paradigm

Extending our evidence generation in each of these dimensions – depth, generalizability, and longitudinality – cannot be achieved unless we develop new ways to collect and integrate data from both traditional clinical trials and non-traditional sources like real-word data (RWD). Practically speaking, we need tools to assemble high-quality datasets and use these datasets as a component of more modern clinical studies. We must also develop a more integrated, “totality of the evidence” approach to informing healthcare decisions, broadly, by including clinicians, regulators, and payers.

RWD is data collected from a variety of sources about a patient’s health status or about the care the patient has received. RWD is often regarded as “clinical data collected outside of the confines of a traditional formal clinical trial.” RWD can include electronic health records (EHRs), insurance claims, and data available outside the health system, such as sensor information from a watch, environmental exposure data, or genomic information from a tumor sample. RWD can be prospective (e.g., intentionally collected in a pragmatic clinical trial) or retrospective (e.g., passively collected in the EHR). The quality, reliability, and validation of RWD has, appropriately, generated significant attention, since RWD often is not collected with evidence generation in mind.

There is broad consensus, however, that the unrealized informational value of RWD justifies the development of a scientific framework and technical tools for collecting, assembling, and analyzing high-quality RWD in support of clinical evidence generation. FDA is a central driver of this consensus. In the closing months of 2021, FDA issued draft recommendations for collecting and validating RWD, including from EHRs and medical claims.[5]  FDA’s recommendations address issues that are critical for assembling longitudinal datasets, including linking data from different sources and avoiding potential issues associated with data linkage like data redundancy, inconsistency, and the reliability of matching data from the same patient from different datasets.[6] FDA’s current push to develop RWD guidance reflects the importance of these technical details and highlights the need for data scientists and software engineers to develop tools that can achieve the level of data quality and reliability that clinical evidence generation demands.

Broader use of high-quality, passively collected RWD is not a replacement for prospectively designed, randomized clinical trials (RCTs). And observational studies are only one use case for RWD. So, it is not surprising that some of the most valuable uses for RWD are in the context of prospectively designed studies: to supplement data gaps in RCTs, to improve study efficiency by filling in certain variables in the clinical trial dataset, and to allow data collection for RCTs to be more closely integrated into regular clinical care and the daily lives of patients.[7]

The development of these methods has been accelerated by the COVID-19 pandemic, which has revealed the value of pragmatic clinical studies (i.e., studies conducted in a real-world clinical setting) and decentralized or virtual clinical trial technologies. These modern approaches will make clinical studies more efficient and allow them to reach a more diverse set of patients in a wider variety of settings–key to increasing the representation and ability of clinical studies to inform personalized care. COVID-19 has also spotlighted the complexity of assembling health data from different sources. This is especially true in the UnitedStates, where paper vaccination cards became emblematic of the barriers to digitally monitoring vaccine performance on a large scale. More optimistically, COVID-19 revealed specific technology and business solutions that, if harnessed, will help us develop a data infrastructure that is more coherent, comprehensive, and accessible, more amenable to the generation of actionable evidence.[8]

In addition to enhancements in clinical trials, the increasing use of longitudinal RWD will enable a paradigm shift in the evaluation cycle for medical products. Under the current paradigm, after FDA approval, we can expect only marginal improvements in the evidence available to inform the use of a drug or device. The transition to modern evidence generation techniques, including longitudinal RWD datasets, will enable a continuous accumulation of post-market evidence for medical products, giving us better, more generalizable information about how to optimize the use of an intervention or diagnostic in individual  .

Although FDA’s work over the past several years has reinforced the importance of longitudinal, RWD-based evidence for regulatory decisions, there is a growing realization that this evidence will also be critical for supporting certain types of coverage and payment decisions.  In the context of Medicare, post-market data could be used to confirm that the evidence supporting approval of a treatment or diagnostic is generalizable to Medicare-age patients, for example, or to otherwise establish that the product meets the threshold of reasonable and necessary in the Medicare population. As the Centers for Medicare and Medicaid Services (CMS) has noted recently in the rulemaking context, FDA’s premarket review “relies on scientific and medical evidence that does not necessarily include patients from the Medicare population” due to a variety of factors, including the exclusion of certain participants from pre-market clinical studies due to comorbidities or concomitant treatments.[9] An active debate about how to fill these evidence gaps should be a central component of Medicare’s “objective of improving health outcomes while delivering greater value.”[10]

While much of the focus of RWD has been on the generation of high-quality evidence, we also need to develop the infrastructure for using evidence generated with novel methods.  Even the highest quality clinical evidence is only valuable if it is used to inform decisions—clinical decisions, regulatory decisions, or decisions involving healthcare delivery and payment. Each of these areas have strong, pre-existing decision-making frameworks that have evolved for decades around large, traditional RCTs. To put RWD and other sources of evidence to work, we must adapt to a “totality of the evidence” approach, in which the weight of each piece of available evidence is determined based on a variety of different factors like the fitness of the data for a particular analytical purpose.

FDA has made substantial progress towards applying a totality of the evidence approach by considering a variety of evidence types to inform regulatory decisions.[11] However, there is still significant work to do to ensure that healthcare stakeholders, including clinicians, regulators, and payers, have the information tools they need to make decisions when the available evidence is both increasingly complex and continuously accumulating. Only by tuning our healthcare decision-making to maximize the use of available evidence sources will we be able to put this evidence to work in the service of personalized care.

Kidney care as one example of a therapeutic area positioned to generate and use evidence to inform improved, precision

Historically, real-world data and evidence have been regarded as the purview of oncology and rare diseases. Advances in the science of RWD/RWE, accelerated by the COVID-19 experience, highlight the important opportunity of leveraging RWD/RWE broadly to achieve a “totality of the evidence” approach across more domains of healthcare. As this approach to evidence generation and use expands, nephrology is an exemplary therapeutic area demonstrating the evolving opportunity to generate and use evidence in new ways to personalize care for patients.

First, kidney care is an important clinical context for applying new evidence generation approaches. Given the racial and ethnic diversity of kidney disease populations, kidney care can be a role model for the development of practical solutions to involve diverse communities in research and develop generalizable datasets that are more reflective of all people. Engagement with kidney patient communities will be a crucial step for designing and evolving patient-centered outcomes, recruiting patients to participate in new registries, and incorporating patient input into broader areas like privacy controls.

Second, the structure and availability of kidney care data provide advantages for modern evidence generation. Many of the critical variables (e.g., creatinine) are already available as structured, reliable data elements in the EHR and other real-world datasets, and the outcomes meaningful to kidney care (e.g., time to need for dialysis) are easily tracked. Dialysis is uniquely suited to clinical studies that are integrated into regular care, including the routine collection of highly structured data, such as lab values.[12] [13] [14]  Dialysis sessions provide opportunities to engage with patients and evaluate patient-centered outcomes with higher resolution. We should build on these features by testing new methods for collecting and linking to RWD. As treatment and prevention reduce the need for dialysis–and as more kidney care moves upstream from the dialysis clinic–RWD and decentralized interaction with patients will be critical for providing longitudinality, generalizability, and depth to clinical studies.

Third, the imperative to monitor and evaluate medical product performance across time is harmonized with the goals of kidney patient care. New evidence generation approaches will focus on how medical products and specific interventions perform longitudinally–across time and the life-cycle of the medical product. Similarly, the management of kidney disease, like other chronic health conditions, is inherently longitudinal, tracking kidney function across time (e.g., change in glomerular filtration rate) and seeking approaches to modify the impact of disease.

It is fortunate that there are many approaches to generate longitudinal evidence in kidney care, because achieving the goal of truly transformative renal replacement therapies will necessitate a nuanced and data-driven approach to longitudinal safety and effectiveness monitoring. Take, for example, replacement kidney technologies that incorporate the complex software components–potentially including artificial intelligence and machine learning (AI/ML) needed to autonomously respond to a patient’s changing chemical and physical conditions in real time. The ability of AI/ML-based kidney replacement therapies to learn and change to the needs of the individual patient is what makes this approach so promising, but also why we need to ensure that we have a solution for continuous performance monitoring, a point that FDA has emphasized generally for AI-ML-based devices.[15] The need for RWD-based performance monitoring has been recognized in the renal replacement field, including in the  Kidney Health Initiative’s Technology Roadmap[16], but accomplishing this goal will require longitudinal data from a representative set of patients – a task that will not be practical or feasible without more streamlined methods for collecting and linking data from different sources.

Finally, kidney care provides an opportunity for using richer datasets to evaluate healthcare delivery and personalize care for all patients. This is especially true in the dialysis context where, to cite just one example, CMS manages performance-based financial incentives for dialysis centers, and commentators have raised concerns whether this program is effectively reducing inequities in kidney care.[17]  We have an obligation to consider how we can calibrate treatment guidelines and healthcare delivery using evidence that represents the real-world diversity of kidney disease patients.

A better understanding of biology is preparing the way for a new era of precision kidney care, which will require the matching of general clinical evidence with a detailed understanding of the specific biologic basis for disease in a particular patient. Echoing the evolution in cancer care over the last 20 years, precision kidney care is going to require the matching of the best available clinical evidence with the details of a person’s biology and clinical situation. Transformation in kidney care will require new evidence generation because legacy clinical trial infrastructure cannot support responsible evidence generation for every permutation of clinical biology and the personal needs of a particular patient. New solutions will be needed to combine traditional clinical trial data with real-world information that reflects the many scenarios of care and outcomes for each individual person. The goal posts for this work are clear: longitudinal, high- quality data that can support efficient clinical trials and continuous monitoring of medical products, and that can ensure that the needs of all people from all backgrounds are represented.

Looking forward: Continuous learning to improve care

Not only is an expanded approach to evidence generation essential for achieving a better understanding of medical product performance, it is also necessary for providing the generalizable evidence needed to achieve personalized care for all people. And by developing a system of continuously aggregating longitudinal data and evidence, we can close the loop between research and the clinic and ensure that care continuously improves over time.

Notes:

Amy P. Abernethy and Joseph B. Franklin formerly held roles in the US Food and Drug Administration (FDA).

 

References

[1] Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev Sci. 2015;16(3):475-485. doi:10.1007/s11121-014-0513-z

[2] O’Hare AM, Rodriguez RA, Bowling CB. Caring for patients with kidney disease: shifting the paradigm from evidence-based medicine to patient-centered care. Nephrol Dial Transplant. 2016;31(3):368-375. doi:10.1093/ndt/gfv003

[3]  Tong A, Winkelmayer WC, Wheeler DC, et al. Nephrologists’ Perspectives on Defining and Applying Patient-Centered Outcomes in Hemodialysis. Clin J Am Soc Nephrol. 2017;12(3):454-466. doi:10.2215/CJN.08370816

[4] Bowling CB, Plantinga LC. When All You Have Is a Hammer: The Need for Tools to Define and Apply Patient-Centered Outcomes in Hemodialysis. Clin J Am Soc Nephrol. 2017;12(3):382-384. doi:10.2215/CJN.00550117

[5] https://www.fda.gov/media/152503/download

[6] https://www.fda.gov/media/154449/download

[7] Real World Data and Evidence: Support for Drug Approval

Aliza M. Thompson, Mary Ross Southworth

CJASN Oct 2019, 14 (10) 1531-1532; DOI: 10.2215/CJN.02790319

[8] Lee, P., A. Abernethy, D. Shaywitz, A. V. Gundlapalli, J. Weinstein, P. M. Doraiswamy, K. Schulman, and S. Madhavan. 2022. Digital Health COVID-19 Impact Assessment: Lessons Learned and Compelling Needs. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/202201c.

[9] Final Rule, “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’”86 Fed. Reg. 62946-62947 (Nov. 15, 2021) (repealing the MCIT final rule of January 14, 2021).

[10] See 86 Fed. Reg. 62947 (Nov. 15, 2021)

[11] https://healthpolicy.duke.edu/sites/default/files/2020-08/Totality%20of%20Evidence%20Approach.pdf

[12] Real World Data and Evidence: Support for Drug Approval, Aliza M. Thompson, Mary Ross Southworth, CJASN Oct 2019, 14 (10) 1531-1532; DOI: 10.2215/CJN.02790319

[13] Cultivating a Research-Ready Dialysis Community

Jennifer E. Flythe, Julia H. Narendra, Tandrea Hilliard, Karen Frazier, Kourtney Ikeler, Andrew Amolegbe, Denise Mitchell, Adeline Dorough, Shoou-Yih Daniel Lee, Antoinette Ordish, Caroline Wilkie, Laura M. Dember, for the Building Research Capacity in the Dialysis Community at the Local Level Stakeholder Workshop Participants JASN Mar 2019, 30 (3) 375-380; DOI: 10.1681/ASN.2018101059

[14] Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative. Laura M. Dember, Patrick Archdeacon, Mahesh Krishnan, Eduardo Lacson, Shari M. Ling, Prabir Roy-Chaudhury, Kimberly A. Smith, Michael F. Flessner. JASN Oct 2016, 27 (10) 2955-2963; DOI: 10.1681/ASN.2016030340

[15] FDA, Artificial Intelligence/Machine LEarning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (January 2021), available online at https://www.fda.gov/media/145022/download.

[16] Kidney Health Initiative, “Technology Roadmap for Innovative Approaches to Renal Replacement Therapy,” (October 2018), available online at https://www.asn-online.org/g/blast/files/KHI_RRT_Roadmap1.0_FINAL_102318_web.pdf

[17] Toward Antiracist Reimbursement Policy in End-Stage Kidney Disease: From Equality to Equity. Kathryn Taylor, Deidra C. Crews. JASN Oct 2021, 32 (10) 2422-2424; DOI: 10.1681/ASN.2021020189

Regi’s “Innovating in Health Care” Case Corner

Case: The Himalayan Cataract Project (Stanford GSB Case A-237. Date: 07/12/21. 15 pages)

Authors: Summer Hu, Jiayin Xue, Susan Qi and Professor Kevin Schulman, Stanford University

Background: The Himalayan Cataract Project (HCP) began with a mission of curing cataract blindness in Nepal. Cataracts occur more frequently due to high UV light exposure of the population, especially for substance farmers in rural regions. However, the traditional surgery was lengthy, and the country lacked the time and resources to address the population in need. The HCP was developed to address this challenge – could they reduce the cost and increase capacity to meet the unmet needs. In this case study, we illustrate a time-driven activity-based cost (TDABC) study of the cataract surgery program that was developed to solve this problem. The case illustrates a strategic challenge of health care service delivery constrained by resources, and uses the TDABC approach to better understand the solution.

The case focused on five questions:

  1. The literature describes “Focused Factories” in health care as an opportunity to improve clinical outcomes and reduce costs of care for patients. How does the HCP story support this concept?
  2. Imagine that TIO has a goal of a 5 percent improvement in efficiency over the next 12 months. How could you use this TDABC study to measure performance improvement at TIO?
  3. You are a hospital CEO and read about this TDABC study at TIO. You were very excited by the approach and the findings. You would like to compare the results at TIO with the results at your hospital. Of course, you’d like to compare both the estimates of direct and indirect costs. What would be the response of the Chief Financial Officer to this suggestion? How robust would the estimates be for direct and indirect costs of the procedure?
  4. You have a meeting with your leadership team—what would you consider key takeaways from this TDABC study of TIO for your team?
  5. How does lower cost care translate into lower price care for patients under a fee-for-service payment model? Under a case-rate payment model? Under a capitated payment model?

Download the case here: The Himalayan Cataract Project

Auction Pricing for Medicare Services: Could It Be Applied to Cataract Surgery?

Laszlo Bollyky, Harker School, San Jose, California, and Kevin Schulman, Clinical Excellence Research Center, School of Medicine, Graduate School of Business, Stanford University

Contact: kevin.schulman@stanford.edu

Abstract

What is the message? Many government goods and contracts are priced competitively through auctions. However, one U.S. industry sector that hasn’t implemented this competitive pricing effort at scale is the healthcare sector. In this paper, we explore potential ways of allocating cataract surgery contracts through auction models. Using auction theory, we suggest it is possible to decrease prices compared to the current administered pricing scheme, while maintaining the quality of cataract surgery. 

What is the evidence? A review of game theory literature and a literature review of auction model applications. 

Timeline: Submitted: March 7, 2022; accepted after review: March 31, 2022.

Cite as: Laszlo Bollyky, Kevin Schulman. 2022. Auction Pricing for Medicare Services: Could It Be Applied to Cataract Surgery? Health Management, Policy and Innovation (www.HMPI.org), Volume 7, Issue 2.

Introduction

Cataract surgery is the most frequent surgical procedure in the United States. Because most recipients of cataract surgery are over the age of 65, Medicare is the predominant payor for this service. Currently, cataract surgery reimbursement is based on CMS’ administered pricing model. The resulting rules are clear and payments are predictable. Cataract surgery is a dynamic procedure, with ongoing advances in surgical technique and resources required to perform the service. Thus, the administered pricing model may lag improvements in clinical efficiency, leading to overpayment by Medicare. Competitive pricing models for other CMS benefits such as durable medical equipment have shown promise as a means to reduce costs. In this paper, we examine whether pricing cataract surgery through a competitive auction would lead to a more appropriate pricing model for Medicare. We suggest that implementation of an auction pricing model may be a more efficient method for determining reimbursement levels for cataract care, assuming quality of care and access to services would remain at current standards.

Overview of Cataract Surgery

A cataract is an opacity of the lens of the eye that may cause blurred vision, or, in very advanced cases, blindness. Cataracts occur frequently in older individuals. Poor nutrition, certain diseases, and medications such as corticosteroids can speed up cataract development. (1) Cataracts continue to be an important cause of blindness, accounting for 12.7% of blindness cases in North America. (2) There are no medical therapies for cataracts, making surgery the primary intervention for patients with this condition.

Cataract microsurgery combined with intraocular lens implantation can restore normal vision for most patients. (1) Cataract surgery is typically performed on an outpatient basis under local anesthesia. Monitored intravenous sedation is also commonly used; general anesthesia is only rarely necessary. Cataract surgery can be performed in 10 to 20 minutes by experienced doctors but typically patients spend 30 to 60 minutes in the operating room. (3) Patients often undergo cataract surgery in both eyes, but typically the surgery is sequenced to treat one eye at a time.

The most commonly used technique in the United States for cataract extraction is phacoemulsification. In this procedure, a small incision is made through which a vibrating probe is inserted to break up the existing aged lens. The fragments are removed, and a new, clear lens is inserted through the same incision. Most patients will have synthetic intraocular lenses (IOLs) implanted during this procedure. (4)

Patients are typically seen one week after surgery and then again one month after surgery to monitor for complications and to ensure wound healing. Corticosteroid or nonsteroidal anti-inflammatory drug drops are often prescribed postoperatively to reduce pain and inflammation. Modern cataract surgery is extremely safe, with very few major complications (5). Post-surgery, over 60% of patients reported 20/20 vision and 94.3% of patients reported 20/40 or better. (6)

Economics of Cataract Surgery

As of 2019, roughly 24.4 million people were affected by cataracts in the United States; more than 2 million cataract surgeries are performed in the United States each year and nearly 24,000 surgeons are qualified to administer the procedure. (7) Approximately 80% of these surgeries were covered by Medicare (8). Average cash prices for cataract surgery on a single eye are advertised as $3,500 per eye (9). The 2021 Medicare fee schedule provided a total facility payment amount of $2,079.16 for cataract surgery in the hospital outpatient department, and $1,039.30 in an ambulatory surgery center (10), with physician fees of $544.70 (CPT code 66984). (11)  Medicare pays for 80% of this amount, and patients pay the remaining 20%.

Even with the high price of cataract surgery in the United States, studies suggest that it is still economically attractive. One analysis suggested that cataract surgery provides 1.6212 QALYs over a 13-year timeframe, while bilateral cataract surgery provides 2.8152 QALYs. (12) At current Medicare payments, this suggests a cost per QALY of $1,618 for the first surgery.

Most Medicare fee schedules are determined through cost-based or administrative pricing of goods and services and are broken down into technical and professional components. The technical component pays for space, equipment, and other resources used for the service. The professional component pays for the services of the physician (or advanced practice provider). Each component of the payment can be paid separately (e.g., to an ambulatory care center and a physician), or combined into a global payment to one entity. For cataract surgery, technical fees can be set under Medicare’s Outpatient Prospective Payment System (OPPS) or Ambulatory Surgery Center (ASC) payment system (13). Prices for physician services are based on the Resource-Based Relative Value Scale model (RBRVS), assigning relative value units to each medical and surgical visit or procedure.

By definition, CMS uses an administered pricing payment model. In other words, CMS works to estimate the resources involved in the procedure and set a fair price for the service (rather than a cost-plus system, CMS attempts to provide payment based on the practice of an “efficient” provider. (14). These payment models often have complex features that adjust the payment rates to clinical severity, but these documentation requirements increase the burden on providers to ensure that they receive a fair payment for their service. Finally, these models are adjusted on an annual basis.

Advances in technology have dramatically changed cataract surgery as a procedure over time. This raises a question of how Medicare can set an appropriate price for a procedure in a dynamic and evolving clinical environment. Further, how does Medicare set a payment rate to provide incentives for further clinical and process improvements related to this surgical procedure. (15)

Auction Models

One conceptual model to consider in setting payment rates is an auction model. Auction models are useful ways to price transactions amid uncertainty over the true value of a good or service. Auctions are generally used by sellers when they lack a good estimate of the buyers’ underlying values for an item, such as when pricing fine art or when the government prices the sale of assets such as licenses for cellular spectrum or land-leases for oil or gas production. Reverse auctions can be useful when a buyer wants to purchase similar goods or services from multiple sellers. For example, federal agencies such as the Departments of Homeland Security and Veterans Affairs use these reverse auctions to obtain commercial items and services, mainly information technology equipment. (16) Reverse auctions have the power to drastically increase consumer surplus as competition among the suppliers drives down costs for the buyers.

Auction models are considered part of Game Theory. William Vickrey won the Nobel Prize in economics for his early work in describing auction models (17) while Robert Wilson and Paul Milgrom won the 2020 Nobel for their work advancing auction theory. (18)

The five main types of auction models are described in Table 1.

Table 1. Auction Models

Auction Model

(Ref)

Description Example Compared to Admin Pricing for Medicare Services?
English auction

(11)

Bidders openly bid against one another, with each subsequent bid required to be higher than the previous bid; multiple bids can be submitted per buyer. Bids are commonly called by an auctioneer or submitted electronically and displayed. Commonly used for selling goods such as antiques, artwork, other secondhand goods and real estate. The simultaneous ascending auction model created by Wilson and Milgrom for FCC auction of electromagnetic spectrum auction is a complex variation of this model allowing for simultaneous bidding. This model would not be practical for Medicare’s procurement of services from multiple providers
Blind Auction

(12)

Known as a “Sealed bid, first-price auction”, all bidders in this type of auction submit sealed bids. The highest bidder wins and pays the price they bid for the item. Auctions for mining leases are often blind auctions (with the potential for the “winner’s curse.”). Procurement auctions are often reverse blind auctions frequently run by governments to purchase goods or secure services from the lowest qualified bidder. A “reverse” blind auction would consider different provider offers to perform cataract surgery. Would need a mechanism to ensure that bidding was competitive (in other words, that the lowest bids would gain market share).
Vickrey auction

(13)

Also called “Sealed bid, second-price auction,” bidders in a Vickrey auction submit sealed bids just as in a Blind Auction. The highest bidder wins but pays the price of the second highest bidder. Vickrey auctions are commonly used in automated contexts such as real-time bidding for online advertising. Similar to blind auction but “winner’s curse” would be decreased.
Dutch auction

(14)

Also known as a “open descending price auction”, the price in a Dutch auction begins at a high value and lowers incrementally until it hits a predetermined price floor or all items are bid. This auction type is used to sell some quantity of like items. The Dutch auction model serves to achieve the highest possible price for sellers within the shortest possible time, ideal when dealing with a perishable product such as cut flowers. Each sale at the Aalsmeer tulip auction in the Netherlands starts with a predetermined highest asking price, lowering it until a bid is made or a reserve price is reached. Prices are shown on a clock and buyers typically have mere seconds to make a decision. A Dutch auction could optimize reimbursement for providers because bidding information is shared, providers place bids at differing rates based on individual valuation thereby decreasing consumer surplus and moving average reimbursement closer to market equilibrium
Walrasian auction

(15)

A type of “double auction”, in a Walrasian auction the auctioneer takes bids from both buyers and sellers in a market of multiple goods. The auctioneer progressively either raises or drops the current proposed price depending on the bids of both buyers and sellers, The price is ultimately set so that the total demand across all agents equals the total amount of the good. The Walrasian market model is used regularly in the financial markets. The NYSE looks at all the collected orders for a particular stock and selects the price that will clear the greatest number of trades before the opening bell to determine opening prices. This model is not applicable with a single buyer (CMS) and multiple sellers (providers) but if market was opened up to other healthcare payers/insurers then this model with a clearinghouse is potentially very efficient

 

 

Auction models vary according to the number of bidders (potential buyers) and sellers, the number of bids each bidder can place, the amount of information known by bidders prior to placing the bid, and the direction of the bidding from the opening bid (higher or lower). Auctions also vary based on the obligations of the bidders to purchase the items at the auction price. In other words, different auction models are designed to optimize the exchange between buyers and sellers under various market conditions. (19)

The English auction model is commonly used for selling goods such as antiques, artwork, and real estate. An auctioneer guides bidders who openly bid against one another, with each subsequent bid required to be higher than the previous bid. All bids are commitments to pay the price for the item, and an essential feature of the model is that the bidder must be aware of the current price of the item. The highest bid when the bidding stops, “wins” the auction and the final bid price is the transaction price. (20)

A Blind auction, also known as a “sealed-bid, first-price auction,” is commonly used for auctions of mining leases (20). It requires bidders to submit sealed bids that are commitments to purchase the item. The bidder offering the highest price wins and pays the price bid for the item; usually only one bid is placed per buyer. The bidder’s valuation of the good is considered heavily in this model.  However, the lack of transparency regarding other bids results in the high likelihood of “winner’s curse” where bidders pay more than necessary to obtain the item. (21) For example, two gold mining companies are inspecting a mining tract for lease. Company A estimates the land to contain gold valued at $750,000 whereas Company B estimates the same land contains gold valued at $675,000. Both have the same strategy in bidding to make a $25,000 profit. In this case, Company A would bid $725,000 whereas company B would bid $650,000. Company A won the bid, but after excavation, the plot contained only $700,000 in gold. Company A suffered the “winner’s curse” by overbidding, ultimately suffering $25,000 in losses.

Vickrey auctions have been thoroughly explored in literature. This model is similar to a Blind auction, but the winner pays the price of the second highest bidder rather than their own bid price. With this formulation, bidders are incentivized to bid their true value as they are guaranteed a return if they bid their true value. If they win the auction, they will pay less than the value they perceive (their bid price) since they pay the second highest bid price through this model.(17) While there are psychological effects that may result in irrational bids from individual buyers, the concept of “strategy-proof” uses game theory insights to understand how to create incentives for accurate bidding by the participants. This incentive to bid the true value has been dubbed “Vickrey’s Truth Serum.”

However, the strategy-proof feature of the Vickery model may not be readily apparent to bidders. One interesting experiment found that with proper dissemination of information about the model, i.e., providing a detailed outline to buyers within the market, bids were optimized (the net advice effect), and sincere bidding increased from 20.6% to 46.9%. When applied to large scale markets (such as government contracts and healthcare), such an approach could improve the efficiency of the auction model in establishing prices for a market. (22)

A Dutch auction, also known as an “open descending price auction”, is a model used to see large quantities of products such as bulbs at the Aalsmeer tulip auction in the Netherlands. Here, the first lot is offered a high price, and the price is lowered incrementally until it hits a predetermined price floor or all items are purchased. (23)

A Walrasian auction is a type of “double auction” used in setting opening prices for newly listed shares for the New York Stock Exchange. In this model, the auctioneer takes bids from both buyers and sellers in a market of multiple goods (in the sock example, shares). The auctioneer sets a price so that the total demand across all agents equals the total amount of the good. (24)

Auction Models Used in Healthcare

The use of competitive bidding in healthcare started in 2006 when Medicare set plan payments for its privately administered plans (“Medicare Advantage”) based on insurer bids. (25)  Medicaid programs also use competitive bidding to determine payments for their managed care plans (26). In 2011, Medicare introduced competitive bidding among suppliers for durable medical equipment. There have also been proposals to introduce competitive bidding programs for clinical lab tests and for physician-administered drugs. (27, 28)

The competitive auction bidding process is used for the procurement of DMEPOS items (defined as durable medical equipment, prosthetics, orthotics, and supplies such as oxygen tanks, walkers, and other smaller items). The bidding process works as follows: DMEPOS suppliers submit bids to the Centers for Medicare & Medicaid Services (CMS). Suppliers must bid separately for each product (including the price and quantity being offered) in each Medicare Service Area (MSA) they intend to service. Importantly, there is a ceiling price, the administrative price that would have been paid absent competitive bidding. CMS then choses suppliers based on an assessment of the bids across all of the categories and then builds the required level of supply at an MSA by offering contracts starting at the low bid and working up until the expected quantity of goods or services are procured. To maintain competition, each supplier is capped at 20% of the market,  with a small business set-aside in the contracting process. Contract prices are set based on the median price offered by the winning bids for a three-year contract period. (29)

This auction framework used for DMEPOS combines features of a Vickrey auction, where contracts are offered to the lowest bidder but at the median price of all of the winning bids, and a Walrasian auction, in which the auctioneer or, in this case, the federal government, sets a price that meets the market demand.

Competitive pricing for healthcare services has the potential to drastically decrease the out-of-pocket cost to patients, as well as the cost to Medicare. Yunan Ji, a Ph.D. Candidate in Health Policy and Economics at Harvard University, estimates that competitive pricing reduced the price of DMEPOS by as much as 46% for Medicare. (26)

Auction Pricing for Cataract Surgery Reimbursement

Medicare could use an auction model to set the price for cataract surgery services to address potential overpayments in the administered pricing model.

The first step in the process would be to carefully define the service on offer: technical and professional fees, included services such as anesthesia, and the type of lens to be used in the procedure. Included pre-operative and post-operative services would also have to be described (for example, the professional services would include pre-operative, operative, and post-operative services for a 90-day period).

At the end of the day, paying a lower price for a lower quality service is not a savings (Mark Pauly has called this concern a “quantity illusion”, paying less and getting less does not represent an increase in value). CMS could require bidders to submit quality data for entry into the program (pre-qualified bidders), or could condition payment on quality metrics. Of note, CMS does not have a quality threshold for payments in the fee-for-service market. When analyzing the efficacy of health insurance auctions, researchers from the University of Minnesota and George Mason University suggested that insurers should submit quality assurances prior to auctions. (30) A combination of pre-auction quality assurances and post-auction quality reports would allow buyers, in this case CMS, to maintain the quality of the service. Information feedback plays a crucial role in establishing long-term relationships between buyers/sellers and in forming successful markets. (30) The auctions would then be run from a combination of historical reports and projected reports, with additional credibility given to previously successful service providers.

In this auction, there would be many sellers but only one buyer, CMS. CMS could use bids to establish a national price under an Walrasian model (for example, CMS would use the bids to set a benchmark price but then offer that price to all providers), or CMS could use sealed bids with a quality projection to allocate services. In both scenarios, the quality assurance plan is a necessity. For example, in the Walrasian model, bidders would be required to fulfil and maintain a quality benchmark for inclusion in the market. In the latter option, CMS would assess each bid individually and, based on a bidder’s historical consistency, proposed success, and projected volume/price, could then accept or reject the bid. The use of the blind auction approach would restrict providers to only those with successful bids to encourage more aggressive bidding by providers. CMS could also use the current price as a ceiling to ensure that the program would reduce costs for Medicare.

In a market characterized by continuous improvement in technology and efficiency, auction models could provide a novel approach to pricing of cataract surgery for CMS. If successful, such an approach could transform the pricing of healthcare services for public payers in the United States.

References

  1. Asbell PA, Dualan I, Mindel J, Brocks D, Ahmad M, Epstein S. Age-related cataract. The Lancet. 2005 Feb 12;365(9459):599–609.
  2. Lee CM, Afshari NA. The global state of cataract blindness. Curr Opin Ophthalmol. 2017; 28: 98–103.
  3. Behrens, A. Cataract Surgery. Johns Hopkins Medicine. http://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/cataract-surgery. Accessed 15 Mar. 2022
  4. de Silva SR, Riaz Y, Evans JR. Phacoemulsification with posterior chamber intraocular lens versus extracapsular cataract extraction (ECCE) with posterior chamber intraocular lens for age-related cataract. Cochrane Database Syst Rev. 2014 Jan 29;(1):CD008812.
  5. Powe NR, Schein OD, Gieser SC, Tielsch JM, Luthra R, Javitt J, et al. Synthesis of the literature on visual acuity and complications following cataract extraction with intraocular lens implantation. Cataract Patient Outcome Research Team. Arch Ophthalmol. 1994;112(2):239-252.
  6. Lundström M, Barry P, Henry Y, Rosen P, Stenevi U. Visual outcome of cataract surgery; study from the European Registry of Quality Outcomes for Cataract and Refractive Surgery. J Cataract Refract Surg. 2013;39(5):673–679.
  7. Cataract Data and Statistics. National Eye Institute. https://www.nei.nih.gov/learn-about-eye-health/outreach-campaigns-and-resources/eye-health-data-and-statistics/cataract-data-and-statistics.
  8. French DD, Margo CE, Behrens JJ, Greenberg PB. Rates of Routine Cataract Surgery Among Medicare Beneficiaries. JAMA Ophthalmol.2017;135(2):163–165.
  9. Cost of Cataract Surgery. Better Vision Guide, Updated 2021. https://www.bettervisionguide.com/cataract-surgery-cost/. Accessed 21 Apr. 2021.
  10. Medicare Fee Policy Files”. Centers for Medicare & Medicaid Services. https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppsannual-policy-files/2021.
  11. “License for Use of Current Procedural Terminology, Fourth Edition (‘CPT Code 66984’).” Centers for Medicare & Medicaid Services. https://www.cms.gov/medicare/physician-fee-schedule/search?Y=0&T=4&HT=0&CT=0&H1=66984&M=5.
  12. Brown GC, Brown MM, Menezes A, Busbee BG, Lieske HB, Lieske PA. Cataract surgery cost utility revisited in 2012: a new economic paradigm. Ophthalmology. 2013; 120:2367–2376.
  13. “AMBULATORY SURGICAL CENTER SERVICES PAYMENT SYSTEM”. MedPac, 15 Oct. 2021.
  14. Scheinker D, Milstein A, Schulman K. The Dysfunctional Health Benefits Market and Implications for US Employers and Employees. JAMA. 2022;327(4):323-324.
  15. Owens B. Are fees for cataract surgery still too high? 2019;191(43):E1202-E1203.
  16. Buckley R. Reverse Auctions and Federal Agency Use. Nova Science Publishers, Inc; 2014.
  17. Vickrey W. Counterspeculation, auctions, and competitive sealed tenders. The Journal of Finance. 1961;16(1):8–37.
  18. De Witte M. 2020. The bid picture: Nobel prize winners explain the ideas behind their 2020 Nobel Memorial Prize in Economic Sciences. Stanford News. https://news.stanford.edu/2020/11/19/bid-picture-nobel-prize-winners-explain-auction-theory-collaboration/.

The Business of Health Care: Technology and Access

Karoline Mortensen, Steven G. Ullmann and Richard Westlund, University of Miami Herbert Business School

Contact: sullmann@bus.miami.edu

Abstract

What is the message? The annual conference of the University of Miami Center for Health Management and Policy addressed the impact of technology and access on patients and providers, workforce shortages, value-based care, and the substance abuse epidemic.

What is the evidence? The insights draw on the knowledge of executives, policy makers, and scholars with a deep base of experience in U.S. healthcare.

Timeline: Submitted: May 3, 2022; accepted after revision: May 3, 2022.

Cite as: Steven G. Ullmann and Richard Westlund. 2022. The Business of Health Care: Technology and Access. Health Management, Policy and Innovation (HMPI.org), Volume 7, Issue 2.

A condensed version of this paper was adapted for the May 2022 issue of South Florida Hospital News.

The University of Miami Center for Health Management and Policy at the Miami Herbert Business School held its 11th annual Business of Health Care Conference on April 1, 2022 with the theme, “Technology, Access, and The New Normal.” The audience, with more than 1,000 registrants from the region, the nation, and around the globe, reflected a wide geographic and sector diversity.

A key, unique feature that distinguishes this conference is a panel discussion among leaders of the major professional healthcare organizations who represent a broad spectrum of the sector. This year’s panel participants included Joseph Fifer, president, and CEO of the Healthcare Financial Management Association (HFMA); Matthew D. Eyles, president and CEO, America’s Health Insurance Plans (AHIP); M. Michelle Hood, executive vice president and COO of the American Hospital Association (AHA); Rachel Villanueva, MD, president of the National Medical Association (NMA); and Ernest Grant, PhD, president of the American Nurses Association (ANA). Patrick J. Geraghty, president and CEO of Guidewell – Florida Blue, moderated the discussion, and answered pressing questions as well.

There were four areas of discourse and insights within the conference theme of technology and access: the impact of technology and access on patients and providers, workforce shortages, value-based care, and the substance abuse epidemic.

Technology and Access: Impact on Patient and Provider

Telehealth was the initial point of discussion, with a focus on the positives and negatives regarding access to care. The greatest benefits seen by the panelists were the beneficial impacts on primary care and behavioral health, and access to those services. It was mentioned that this was particularly important for the purposes of increasing access to care in rural areas.

Ernest Grant (ANA) indicated that nurses have been using telehealth very effectively to help monitor patients. Further, telehealth can be used as a vehicle to bring together the entire care team. Joseph Fifer (HFMA) indicated, it was an “amazing step” to see the sudden growth of telehealth in an industry not known for making quick changes. But with all the positive aspects of telehealth as discussed by the panelists, there were also several caveats indicated, and even warnings. Fifer indicated that his organization’s members are evaluating processes and workflows to focus on best practices, adding, “we need to be sure that our processes center on the consumer rather than organizing around ourselves.” Matthew Eyles (AHIP) indicated that his member insurance providers want reimbursement allowances for different structures under telehealth. He indicated that “mandates would be harmful to innovation in telehealth.” All of this discussion may be irrelevant if Congress does not extend federal reimbursement for telehealth, currently scheduled for expiration on December 31, 2022.

The panelists noted tensions between the benefits and drawbacks of telehealth as it relates to access. Dr. Villanueva (NMA), representing the professional association for Black physicians, noted there is the strong feeling of the benefits of telehealth from the provider community, but there are barriers to providing access to residents in underserved communities. She stressed that “patients in underserved communities may not have computers, smartphones, access to broadband or the digital literacy needed to access telehealth services.”  Rachel Villanueva added that physicians need to look at meeting healthcare needs from the patient’s perspective and in communities with limited access, this may mean audio rather than video telehealth services.

Workforce Shortages

Workforce shortages are impacting the ability of patients to access care, provider ability to maintain or improve the quality of care, as well as the costs and revenue streams associated with the provision of care. The issue of nursing shortages has existed for decades but has been exasperated by the COVID-19 pandemic, said Dr. Grant. He noted that the combination of nurses taking retirement – a reflection of the aging nursing workforce – at the same time that the Baby Boomer generation is also retiring, is putting stress on the healthcare system and causing a critical situation. Dr. Grant suggested that another contributing factor causing nurses to leave the profession is many do not feel safe in their working environment, nor do they feel valued for their contribution.

Looking ahead, one of the issues impacting the future of the nursing workforce is a shortage of clinical nursing faculty members, as well as clinical or educational space to train. As such, applicants to nursing schools who would meet admission criteria must be turned away. Michelle Hood (AHA) indicated that this is another area where technology could help by utilizing simulation in combination with clinical and didactic education at academic institutions. Hood mentioned cross-training of skills for current professionals, as well as utilizing artificial intelligence and other technologies, and adjusting and updating care models as possible interventions. Noting that collaborative teams are critical to appropriate provision of care, Dr. Villanueva indicated that workforce diversity is important as well. “Only 5 percent of physicians today are Black, and medical education and policy leaders need to address that disparity in order to improve health outcomes for all Americans.”

Value-Based Care

Opening the discussion on value-based care, Pat Geraghty (Florida Blue) noted the importance of an alignment of incentives on behalf of patients, providers, and health plans. For instance, keeping patients physically and mentally healthy can reduce the overall cost of care, while providing incentives for providers. This approach can support appropriate technological innovations as well as greater equity in delivery of health care services.

Despite all the potential benefits of value-based care, the panelists agreed that there has been a slow growth of adoption of value-based healthcare systems, especially compared with the pervasiveness of traditional fee-for-service models. Noting that fee-for-service models still make up 82 percent of all plan types, Eyles said that providers who relied on fee-for-service models during the pandemic generally had worse financial outcomes than those with value-based arrangements. He emphasized the importance of examining how a health plan model connects to the provider payment model and how it interrelates with workforce reimbursement issues.

The uncertainty of costs and reimbursement models in today’s healthcare environment is another issue impacting value-based arrangements, according to Fifer. He said, “there is fear of taking a financial risk. When an organization is losing money, careers are at risk.” As costs in healthcare increase, financial risks also increase. He said there has been a 30 percent increase in overall hospital expense per adjusted discharge since February 2020, mostly due to the increased cost of hospital staffing. It was noted that for a 500-bed hospital that would mean $17 million of additional labor expenses since the pandemic. Hood indicated that providers serving larger Medicare and Medicaid populations have different financial risk profiles compared to facilities whose patients typically have commercial insurance. Indeed, Dr. Villanueva noted that in underserved communities, where patients tend to have a greater incidence of chronic disease, doctors tend to be in solo or small group practices and find it very difficult to move to a shared risk value-based model.

The Substance Abuse Epidemic

Regarding the epidemic of substance abuse in this country, the panelists initially focused on the opioid epidemic, both prescription-related issues and the deadly synthetic drug fentanyl. Dr. Villanueva indicated that “opioid use is a pandemic that has gotten worse in our community,” referring to the underserved Black population. “We see this as a chronic condition as well as a matter of policy,” she added.

Eyles noted the importance of analyzing prescriptions within a health plan network. He indicated the power of providing data to a clinician who is overprescribing as well as delivering information to plan members. The panelists agreed that there is indeed a significant purpose for prescribing opioids for pain management. It is not that opioid usage should be halted, but rather prescribed and managed appropriately for each patient.

The substance abuse epidemic is broader than just prescribing patterns and patients. Hood indicated that the American Hospital Association has a behavioral council for the issue of opioids in the workforce, as well as substance abuse in general. In fact, several panelists noted that the healthcare workforce itself is at increased risk due to ongoing stresses that can lead to anxiety and depression. However, the panelists noted that there are other forms of substance abuse that should also be addressed, such as alcohol. As the panelists agreed, the stigma associated with addiction is a major issue with alcohol and other forms of substance abuse. Therefore, they said it is vital to destigmatize abuse and allow it to be seen for what it is – a medical and behavioral health issue.

As the University of Miami Center for Health Management and Policy begins to plan for the next Business of Health Care Conference in 2023, we anticipate continuing the discussion with valuable insights from the leaders of these professional associations as we have done for the past decade of this conference’s history.

Did the Trump Administration Hurt or Help the ACA? It Helped.

Joseph Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute

Contact: JAntos@AEI.org

Abstract

What is the message? The Trump Administration provided Republicans long-sought opportunities to repeal the ACA and revamp the U.S. health system. So did Trump era policy actions impact access to affordable health care? We posed that question to two leading policy analysts with contrasting perspectives (read the opposing view here). 

What is the evidence? Analysis and interpretation of publicly available data from multiple sources.

Timeline: Submitted: January 19, 2022; accepted after review: January 20, 2022.

Cite as: Joseph Antos. 2022. Did the Trump Administration Hurt or Help the ACA? Health Management, Policy and Innovation (www.HMPI.org), Volume 7, Issue 1.

Introduction

Critics of the Trump administration have focused on policy actions they believe constitute evidence of sabotage against the Affordable Care Act (ACA).[1] While it is true that the former administration and many Republicans in Congress considered the ACA to be an overreach of federal regulation into the private health insurance market, it is important to distinguish between the overblown rhetoric (from both sides of the political aisle) during the Trump era and the net effect of that administration’s policies on enrollment in private health plans.

The mantra “repeal and replace” was taken by some as a threat to reverse the ACA’s insurance reforms and coverage expansion, resulting in a loss of coverage for millions of Americans. Although it was unclear what the replacement policy would be, most Republicans recognized that simply repealing the ACA would be inhumane and politically disastrous. The argument was not about whether people should have access to affordable health care, but rather how that should be accomplished.

Key themes—greater consumer choice, incentives rather than mandates, lower costs, greater responsibility for the states—were broadly accepted by the Trump administration without much clarity initially on how those ideas would be implemented.[2] The U.S. House or Representatives narrowly approved the American Health Care Act in May 2017, following intense debate among Republicans over the scope of the bill.[3] The Senate considered several proposals to repeal and replace the ACA, all of which failed to pass.

Controversy over substantial cuts in Medicaid spending, lack of consensus over changes in the ACA, and a one-vote majority in the Senate contributed to this defeat. Meanwhile, the Trump administration took actions to modify the operation of the insurance exchanges and expand coverage options outside the ACA framework. Despite criticism from advocates, none of these actions undermined coverage offered on the exchanges. Whether intentional or not, one of those policies made exchange coverage more attractive to low-income families.

Failure of Repeal and Replace

The Republican victory in the 2016 election led to a concerted, but ultimately failed, effort to legislate a more market-oriented replacement for the ACA. Party leaders had argued for repealing the ACA since it was enacted in 2010, and now they had an opportunity to make major changes in the law. A narrow majority in the Senate meant that the proposal needed to go through the reconciliation process to avoid a filibuster.

President Trump’s first executive order, signed on inauguration day, indicated he would seek a prompt repeal of the ACA and directed federal agencies to scale back its provisions to the extent possible.[4] The order was primarily a messaging exercise as it included no specific policies, but it set the administration’s tone helped initiate a nearly year-long effort by congressional Republicans to develop a replacement plan.

The American Health Care Act (AHCA) was narrowly approved by the House on May 4, 2017. The bill was criticized by the conservative House Freedom Caucus for failing to repeal major sections of the ACA, including the essential health benefits requirement and other insurance rules.[5] However, reconciliation rules in the Senate preclude provisions that do not change the level of federal spending or revenue, or where any such change is incidental to the provision’s policy effects. Since changes to ACA insurance regulations were likely to be dropped in the Senate, they were not included by the House.

Despite that limitation, the American Health Care Act addressed many Republican policy concerns.[6] Mandate penalties were repealed. To reduce adverse selection, states could allow insurers to increase premiums for applicants following a lapse in coverage. The ACA’s advance premium tax credit (APTC) was converted to fixed amounts that increase with the enrollee’s age rather than being tied to the enrollee’s income and the cost of the benchmark health plan. States were allowed to modify ACA insurance rules, including raising the limit on age rating and instituting their own set of benefit requirements. Other changes included repealing ACA tax increases, reducing federal support for state Medicaid programs, and promoting high-risk pools.

The Senate considered several proposals to reform or replace the ACA, none of which was passed.[7] The Better Care Reconciliation Act retained many of the provisions of the AHCA, including a premium surcharge for applicants with a lapse in coverage. The Obamacare Repeal Reconciliation Act repealed the coverage mandate as well as the APTC and cost-sharing subsidies. The Health Care Freedom Act was a stripped-down version whose main provision was to repeal the coverage mandate. The last attempt at a compromise was the Graham-Cassidy amendment to the AHCA, announced on September 13. It retained most of the AHCA’s provisions but also repealed the APTC and cost-sharing subsidies. Graham-Cassidy was not voted on for lack of support.

Expanding Options Through Regulation

By the fall of 2017 it was clear that Congress would be unable to enact a repeal and replace bill. On October 12, President Trump signed executive order 13813 directing federal agencies to develop federal regulations that could allow less expensive health insurance alternatives to exchange plans.[8] Three changes were envisioned.

  • Short-term, limited duration plans (STLD). Short-term health insurance policies provide coverage over a limited time period. They do not have to cover the ACA’s essential health benefits, they do not cover pre-existing conditions, and they are not required to cover people in poor health. Short-term plans offer lower premiums for more limited coverage.[9] To forestall possible erosion of the exchange market, the Obama administration limited short-term plans to no more than 90 days duration (instead of the prior limit of a year) and prohibited renewals (not previously banned).[10] The Trump administration reversed those restrictions, allowing short-term plans up to 364 days and allowing plans to extend coverage up to three years, subject to the approval of state insurance regulators.[11]
  • Association health plans (AHPs). AHPs allow small firms to jointly purchase health insurance, in essence operating as one large employer plan. This could give those firms scale economies and greater market power than they have purchasing insurance as separate companies. The Trump administration relaxed the requirement limiting AHPs to firms with a “commonality of interests” beyond simply offering a health plan to employees and allowed sole proprietors to purchase coverage through an AHP.[12]
  • Health Reimbursement Arrangements (HRAs). HRAs allow employers to give tax-free funds to workers for their families’ medical expenses, including deductibles and other cost-sharing payments and health items not covered by insurance. The Trump administration expanded the use of HRAs to allow those funds to pay premiums for individual health insurance and gave employers flexibility to offer either the employer’s plan or an HRA to broad classes of workers (salaried versus hourly workers, full- or part-time status, or geographic location).[13]

These initiatives offered the possibility of lower-cost insurance compared with exchange plans, which could expand the number of people with coverage but could increase premiums in the exchange market. The ACA already had a problem with adverse selection. Providing new plan options that would attract younger, healthier people away from exchange plans would worsen that situation to some extent.

Not surprisingly, interest groups that could be affected by the new regulations had an opinion about their impact backed up by dozens of consultant reports designed to confirm the group’s financial and political position. Less biased analyses came from the Congressional Budget Office (CBO) and the Centers for Medicare & Medicaid Services (CMS) chief actuary, but all projections of the effect of new policies are subject to considerable error.

CBO, in conjunction with the Joint Committee on Taxation, estimated that premiums for STLD plans could be as much as 60 or 90 percent below the lowest cost bronze plan in the exchange market, depending on the type of insurance product offered.[14] Such plans do not have to cover all of the ACA’s essential health benefits, premiums would be based on the individual’s expected health spending rather than spending in the local market, and the plans would be able to exclude coverage of pre-existing conditions or refuse coverage for a person likely to have high health costs. Association health plans would be about 30 percent less expensive than in the exchange market, primarily because premiums would be set based on spending in the AHP rather than in the broader community.

Enrollment patterns would change modestly as a result. About 5 million more people would newly enroll in an AHP or a short-term plan.[15] Of that amount, about 3 million would otherwise have been covered in the small group market, 1 million would have been covered in the nongroup market, and 1 million would have been uninsured.

The CMS Chief Actuary estimated that STLD plan enrollment would increase by about 1.9 million people in 2022 because of the new regulations.[16] Enrollment in exchange plans would decline by about 800,000. Because STLD plans are expected to enroll healthier individuals, those remaining in the exchanges would be relatively less healthy, causing average exchange premiums to rise by about 6 percent. Overall, the number of people covered by a STLD plan or in the individual market is expected to increase by roughly 0.2 million in 2022.

Such estimates are highly uncertain and depend on how the federal government implements its rules as well as the responses by state regulators, employers, and consumers. People with low health costs are more likely to shift from exchange plans to AHPs or short-term plans, which would adversely affect the exchange market. The impact depends on how many people actually switch plans, not the number who could benefit.  As we have seen in other contexts, consumers often continue with their current health plan even when far superior options are available.[17]

Early on, some observers argued that the Trump administration’s executive order would trigger risk segmentation that would drive up premiums and could eventually lead to dismantling the ACA exchanges.[18] Plausible estimates suggest that the new regulations would have a small but noticeable impact on the exchange market—if those regulations had not been stopped by court decisions and the Biden administration.[19] [20] [21]

Stopping Payment on Cost-Sharing Subsidies

On October 12, 2017—the same day that he signed the executive order to expand low-cost insurance options—President Trump took the more consequential step of halting federal payments to insurers for ACA-required cost-sharing reduction subsidies (CSRs). That action did not change the requirement that insurers lower cost-sharing requirements to eligible families, but insurers were now faced with billions in uncompensated costs.

This was the result of a long-standing dispute over whether Congress had formally appropriated funds for CSR payments. House Republicans took the Obama administration to court in 2014 over this issue, and in 2016 the District Court for the District of Columbia ruled that the government did not have authority to make the payments.[22] Legal action was delayed to give the parties a chance to resolve the matter, but no action was forthcoming. President Trump acted to halt what he called “bailouts” for insurers, undoubtedly expecting that this would change the course of the ACA.[23]

Halting CSR payments did change the course of the ACA, but perhaps not the way that was intended. Although the President’s decision came less than a month before the start of the ACA annual open enrollment period, insurers and state regulators quickly re-evaluated their positions and devised a workaround.  To make up for lost CSR funds, insurers substantially increased premiums for their silver plans with lower increases for plans at other metal tiers.

This “silver loading” strategy took advantage of ACA premium subsidies tied to the second lowest-cost silver plan in each market. The APTC increases dollar-for-dollar with the premium of the benchmark plan in each market area. Enrollees who receive the APTC are guaranteed that their premiums will not increase if they select the benchmark plan. This ensures a stable enrollment base even when silver premiums are rising sharply. It also increases federal payments—those dreaded bailouts—to insurers.

In addition, premiums for other metal tiers did not increase as rapidly as they would otherwise. With dramatically higher premium subsidies, many families could enroll in a lower-level bronze plan without having to pay a premium.[24] They could also purchase more generous coverage in the gold tier at a lower net premium than if they selected a silver plan.

While that was good news for families eligible for a premium subsidy, silver loading substantially increased silver plan premiums that had been affordable to unsubsidized families before the policy change. The U.S. Government Accountability Office (GAO) documented the shift in premium costs from subsidized to unsubsidized families between 2017 and 2018 for the 39 states using Healthcare.gov.[25] Average silver premiums increased by 44 percent, but net of subsidies silver premiums declined by 13 percent. Unsubsidized gold plan premiums increased by 24 percent, but subsidized gold premiums declined by an average 39 percent.

Overall enrollment declined modestly, from 9.2 million to 8.7 million, most likely because of a loss of families not eligible for the APTC. Plan choices shifted away from silver plans. About 74 percent of enrollment in 2017 was in silver plans, compared with 65 percent in 2018. The share of enrollment in gold and bronze plans both increased as families sought either better benefits or zero premiums.

Other estimates using data from all 50 states plus the District of Columbia indicate that silver loading caused a one-time bump up in average exchange premiums rather than a series of annual increases. Premiums weighted by plan enrollment increased about 30 percent between 2017 and 2018, followed by a nearly 3 percent increase in 2019 and a 0.2 percent decline in 2020.[26]

Other policy changes—a reduced advertising budget, less funding for navigators (who help people with enrollment), and a shorter open enrollment period—also had an impact on enrollment, but these had minor effects. The ACA had been in full operation starting with the 2014 plan year, and plan participation and enrollment had largely stabilized by 2017. Costs and benefits of plan offerings, not promotional activities, had become the key factors in determining whether a family would choose to enroll.

The Trump Legacy

Arguably, Donald Trump came too late to the presidency to make much of an impact on the ACA. Exchange plans had been in operation for three years before he was inaugurated, plan offerings had been approved in the fall of 2016, and the open enrollment period for 2017 was nearly completed. Any policy change would not take effect until 2018 or later.

Congressional Republicans had campaigned since 2010 on repeal and replace, but even the most ambitious proposal would have left the core of the ACA intact. Although public opinion was split along partisan lines on the ACA, most people had employer coverage and felt that they would not be directly affected by the new law.[27] The Republican argument over how to expand health coverage had been eclipsed in the public’s mind by a sense that a social wrong was being righted and the rest was just details.

Moreover, the health sector had moved on. Insurers had invested a great deal of energy and money over the prior six years to meet the ACA’s requirements and take full advantage of the new entitlement program. Providers had anticipated an opportunity to provide better care for more people—and get paid for it. Now that the ACA was in operation, there was little desire to make changes.

Republicans were able to reduce the ACA’s mandate penalty to zero as part of the tax reform bill passed in December 2017. Given the modest amount of the penalty, lax enforcement, and ample opportunities to be exempted from paying the tax, zeroing out the penalty was a symbolic victory. Even advocates for the mandate recognize that it had little effect on people’s decisions to purchase insurance.[28]

The Trump administration’s most significant policy change—halting CSR payments—increased federal costs and made exchange coverage more attractive to people eligible for the ACA’s premium subsidy. It also increased premiums for unsubsidized lower-middle income families—families no longer able to buy coverage they had before the ACA and who can’t afford more expensive exchange plans. Initiatives to expand lower-cost alternatives to exchange plans could have provided a path to coverage for these people, but those efforts were slow to develop and have since been discarded with the change in administrations.

The American Rescue Plan Act, signed into law on March 11, 2021, increases premium tax credits and makes them available to all families who purchase exchange coverage, regardless of income.[29] That expansion is limited to 2021 and 2022, although it is widely expected that the provision will be made permanent. The Congressional Budget Office and Joint Committee on Taxation estimate that 1.7 million people would gain exchange coverage in 2022, 1.3 million of whom were previously uninsured.[30] New enrollees are projected to account for $13.0 billion in federal costs, with most of that spending occurring in 2021 and 2022.[31]

Although more generous subsidies resolve a major inequity of the ACA, more spending exacerbates the problem of rapidly rising health costs that makes all forms of health insurance increasingly unaffordable. Creating a more efficient and effective health system that promotes competition and rewards innovation is necessary to sustainably improve access to affordable private health coverage. That should be the challenge going forward.

 

References

[1] Center on Budget and Policy Priorities. Sabotage Watch: Tracking Efforts to Undermine the ACA. https://www.cbpp.org/sabotage-watch-tracking-efforts-to-undermine-the-aca.

[2] Sarlin B. What is ‘Repeal and Replace?’ A Guide to Trump’s Health Care Buzzwords. NBC News. January 28, 2017. https://www.nbcnews.com/news/us-news/what-repeal-replace-guide-trump-s-health-care-buzzwords-n713366.

[3] Antos, J, Capretta, J. The Road Not Taken. In:  Emanuel E, Gluck A, editors. The Trillion Dollar Revolution: How the Affordable Care Act Transformed Politics, Law, and Health Care in America. New York:  Public Affairs, March 2020. P. 66-80. https://www.aei.org/wp-content/uploads/2020/04/Chapter-3-Trillion-Dollar-Revolution.pdf?x91208.

[4] Executive Office of the President. Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal. Executive Order 13765. January 20, 2017. https://www.federalregister.gov/documents/2017/01/24/2017-01799/minimizing-the-economic-burden-of-the-patient-protection-and-affordable-care-act-pending-repeal.

[5] Bade R, Dawsey J, and Haberkorn J. How a secret Freedom Caucus pact brought down Obamacare repeal. Politico. March 26, 2017. https://www.politico.com/story/2017/03/trump-freedom-caucus-obamacare-repeal-replace-secret-pact-236507.

[6] Jost T. “House Passes AHCA: How It Happened, What It Would Do, And Its Uncertain Senate Future.” Health Affairs. May 4, 2017. https://www.healthaffairs.org/do/10.1377/forefront.20170504.059967. Kaiser Family Foundation, “Summary of the American Health Care Act.” May 2017. http://files.kff.org.attachment/Proposals-to-Replace-the-Affordable-Care-Act-Summary-of-the-American-Health-Care-Act.

[7] Kaiser Family Foundation. Compare Proposals to Replace the Affordable Care Act. September 8, 2017. https://www.kff.org/interactive/proposals-to-replace-the-affordable-care-act/.

[8] Executive Office of the President. Presidential Executive Order Promoting Healthcare Choice and Competition Across the United States. Executive Order 13813. October 12. 2017. https://trumpwhitehouse.archives.gov/presidential-actions/presidential-executive-order-promoting-healthcare-choice-competition-across-united-states/.

[9] AgileHealthInsurance. Study Shows Major Premium Savings for Short Term Health Insurance as Compared to Entry-Level Obamacare Plans. February 18, 2015. https://www.agilehealthinsurance.com/health-insurance-learning-center/obamacare-vs-term-health-insurance-premiums.

[10] Internal Revenue Service et al. Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance. Federal Register. October 31, 2016. https://www.federalregister.gov/documents/2016/10/31/2016-26162/excepted-benefits-lifetime-and-annual-limits-and-short-term-limited-duration-insurance.

[11] Internal Revenue Service et al. Short-Term, Limited-Duration Insurance. Federal Register. August 3, 2018. https://www.federalregister.gov/documents/2018/08/03/2018-16568/short-term-limited-duration-insurance.

[12] Employee Benefits Security Administration, Department of Labor. Definition of “Employer” Under Section 3(5) of ERISA-Association Health Plans. Federal Register. June 21, 2018. https://www.federalregister.gov/documents/2018/06/21/2018-12992/definition-of-employer-under-section-35-of-erisa-association-health-plans.

[13] Internal Revenue Service et al. Health Reimbursement Arrangements and Other Account-Based Group Health Plans. Federal Register. June 20, 2019. https://www.federalregister.gov/documents/2019/06/20/2019-12571/health-reimbursement-arrangements-and-other-account-based-group-health-plans.

[14] Congressional Budget Office. How CBO and JCT Analyzed Coverage Effects of New Rules for Association Health Plans and Short-Term Plans. January 2019. https://www.cbo.gov/system/files/2019-01/54915-New_Rules_for_AHPs_STPs.pdf.

[15] Congressional Budget Office. How CBO and JCT Analyzed Coverage Effects of New Rules for Association Health Plans and Short-Term Plans. January 2019. https://www.cbo.gov/system/files/2019-01/54915-New_Rules_for_AHPs_STPs.pdf.

[16] Spitalnic P. Estimated Financial Effects of the Short-Term, Limited-Duration Policy Proposed Rule. Centers for Medicare & Medicaid Services. April 6, 2018. https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/ActuarialStudies/Downloads/STLD20180406.pdf.

[17] Sanger-Katz M. Why Most People Won’t Shop Again for Health Insurance. New York Times. December 11, 2014. https://www.nytimes.com/2014/12/12/upshot/why-most-people-wont-shop-again-for-health-insurance.html.

[18] Diamond D. Trump’s order could unwind Obamacare market. Politico. October 12, 2017. https://www.politico.com/tipsheets/politico-pulse/2017/10/12/trumps-order-could-unwind-obamacare-market-222765.

[19] Keith K. ACA Litigation Round-Up: Part II. Health Affairs Forefront. July 21, 2020. https://www.healthaffairs.org/do/10.1377/forefront.20200721.330502/full/.

[20] Keith K. ACA Litigation Round-Up: A Status Check. Health Affairs Forefront. February 1, 2021. https://www.healthaffairs.org/do/10.1377/forefront.20210201.561637/full/.

[21] Executive Office of the President. Executive Order on Strengthening Medicaid and the Affordable Care Act. Executive Order 14009. January 28, 2021. https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/28/executive-order-on-strengthening-medicaid-and-the-affordable-care-act/.

[22] Small L. House, states, Trump administration reach settlement in ACA subsidies case. Fierce Healthcare. December 18, 2017. https://www.fiercehealthcare.com/aca/house-states-trump-administration-reach-settlement-aca-subsidies-case.

[23] Kodjak A. Trump Warns Against ‘Bailouts’ For Insurance Companies In Bipartisan Health Care Deal. NPR. October 17, 2017. https://www.npr.org/sections/health-shots/2017/10/17/558370338/senators-reach-deal-to-stabilize-aca-insurance-markets-for-two-years.

[24] Pearson C., Sloan C, Carpenter E. Most Counties Will Have Free 2018 Exchange Plans for Low-Income Enrollees. Avalere. November 2, 2017. https://avalere.com/press-releases/most-counties-will-have-free-2018-exchange-plans-for-low-income-enrollees.

[25] U.S. Government Accountability Office. Health Insurance Exchanges:  HHS Should Enhance Its Management of Open Enrollment Performance. GAO-18-565. July 24,2018. https://www.gao.gov/assets/gao-18-565.pdf.

[26] Author’s calculation based on Gaba C. 2018-20 Rate Hikes. ACASignups.net. https://acasignups.net/rate-hikes/2018 (Total Avg. Increase CSR “AND” MANDATE SABOTAGE); https://acasignups.net/rate-hikes/2019 (Requested Avg. % Rate Change WITH 2018 sabotage); https://acasignups.net/rate-changes/2020 (Avg. 2020 Final Rates).

[27] Hamel L., Kirzinger A. et al. 5 Charts About Public Opinion on the Affordable Care Act and the Supreme Court. Kaiser Family Foundation. December 18, 2020. https://www.kff.org/health-reform/poll-finding/5-charts-about-public-opinion-on-the-affordable-care-act-and-the-supreme-court/.

[28] Kliff S. Republicans Killed the Obamacare Mandate. New Data Shows It Didn’t Really Matter. New York Times. September 18, 2020. https://www.nytimes.com/2020/09/18/upshot/obamacare-mandate-republicans.html.

[29] Park E and Corlette S. American Rescue Plan Act:  Health Coverage Provisions Explained. Georgetown University Health Policy Institute. March 11, 2021. https://ccf.georgetown.edu/wp-content/uploads/2021/03/American-Rescue-Plan-signed-fix-2.pdf.

[30] Congressional Budget Office. Reconciliation Recommendations of the House Committee on

Ways and Means (As ordered reported on February 10 and 11, 2021). February 17, 2021. https://www.cbo.gov/system/files/2021-02/hwaysandmeansreconciliation.pdf.

[31] Rae M, Cox C, Claxton G, McDermott D, and Damico A. How the American Rescue Plan Act Affects Subsidies for Marketplace Shoppers and People Who Are Uninsured. Kaiser Family Foundation. March 25, 2021. https://www.kff.org/health-reform/issue-brief/how-the-american-rescue-plan-act-affects-subsidies-for-marketplace-shoppers-and-people-who-are-uninsured/.

The Trump Administration’s Relentless Attack on Insurance for the Poor

Sara Rosenbaum, Harold and Jane Hirsh Professor of Health Law and Policy and Founding Chair of the Department of Health Policy, George Washington University

Contact: sarar@email.gwu.edu

Abstract

What is the message? The Trump Administration provided Republicans long-sought opportunities to repeal the ACA and revamp the U.S. health system. So did Trump era policy actions impact access to affordable health care? We posed that question to two leading policy analysts with contrasting perspectives (read the opposing view here). 

What is the evidence? Analysis and interpretation of publicly available data from multiple sources.

Timeline: Submitted: January 17, 2022; accepted after review: January 20, 2022.

Cite as: Sara Rosenbaum. 2022. The Trump Administration’s Relentless Attack on Insurance for the Poor, Health Management, Policy and Innovation (www.HMPI.org), Volume 7, Issue 1.

Health insurance for poor Americans represents one of the most dramatic shifts in policy from the previous administration to the current one.  Within days of taking office, President Biden issued and Executive Order on Strengthening Medicaid and the Affordable Care Act[1]. This order set in motion a series of regulatory actions to reverse actions undertaken by the previous administration – at times accompanied by strident speeches about the value of erecting barriers to access to health care for the poor[2]

During the Trump presidency, senior officials engaged in a systematic effort to roll back access to health insurance among low- income Americans.  For those of us who work in health policy and lived through the Trump years, the effort was amazing, not only because of the factual distortions and oversights on which it rested but because it was accompanied by a strident tone and grandiose claims.

Far from saving the poor, the Trump administration relentlessly pursued a series of strategies – in Congress, the courts, and through administrative actions — to depress access to individual publicly-subsidized health insurance offered through the Marketplace and Medicaid.  The coup de gras may have been its decision – in the face of a pandemic whose impact on health and the economy exploded into view by mid-March 2020 —  not to establish a special enrollment period in the federal Marketplace, even as nearly all states operating their own Marketplaces did so.  When access to affordable, good quality individual coverage mattered most, in other words, Trump officials, who took immense pride in their insurance market prowess, were nowhere to be found.  We saw the magnitude of their refusal to take this simple step – one completely within their control — when, within weeks of the Biden administration’s January 28th decision to move forward with a special pandemic enrollment period,[3] over 206,000 people had signed up (a 76,000 increase over the previous time period in 2020), with 385,000 awaiting application processing.[4]

Even a brief review of the facts underscores the deliberate approach of the administration.

By 2016, three years into full implementation of the Affordable Care Act, the number of uninsured Americans had fallen by 20 million, a 40 percent decline since the law’s 2010 enactment.  Improvements were evident across all racial groups and for the poorest people. [5]  To be sure, as Corlette and colleagues describe in their comprehensive assessment of the ACA’s impact on the individual insurance market,[6] there were shortcomings. Chief among these were inadequate affordability subsidies, a decision by the Obama administration immediately ahead of full implementation to allow underwritten policies to continue as “grandmothered” health plans (which in turn depressed enrollment of healthy people into ACA-compliant plans), and the flawed launch of the federal Marketplace website. These shortcomings were hardly insurmountable; Marketplace glitches were corrected, a wind-down policy for grandmothered plans could have been devised, and as it ultimately did under the American Rescue Plan Act, Congress could have rectified the subsidy problem by increasing the generosity of both the subsidy income scale and the level of individual subsidies. Instead Republicans launched unending attacks aimed at ruining the individual market by blocking payment of cost sharing subsidies due insurers and attempting unlawfully to undo the ACA’s three-year risk-corridor program whose purpose was to limit insurer risk as the new market settled in.[7] In spite of these early stumbles and unending opposition, the 2016 data showed the ACA’s significant impact on population insurance rates.

Yet by the first half of 2020, the number of uninsured had risen by over 4 million. Although this reversal of fortune coincided with gravest public health crisis in a century, it was not directly precipitated by the pandemic.[8]  Indeed, the evidence shows, the problem of unraveling coverage was in full swing by the middle of 2019, in the midst of an economy of unprecedented strength and with historically low unemployment. Rather than collapsing as a result of sudden economic setback, coverage steadily eroded under the Trump administration. By the eve of the pandemic, the number of uninsured Americans had risen by 14 percent over 2016 levels, from 28.2 million to 32.8 million.[9]

Several key factors appear to have driven this result; all were part of an ongoing effort to undermine the ACA and end Medicaid as a public entitlement program.  Cumulatively, and over time, the administration’s multi-pronged strategy exacted a major toll on health insurance coverage. This strategy can be summarized as follows: First, the administration pursued Congressional efforts to end the ACA and replace the Medicaid entitlement with a capped funding pool.  Once the intense “repeal and replace effort” collapsed at the end of the summer of 2017, officials turned to other means. By that first summer, confident that the ACA would be gone, administration officials eliminated consumer outreach and enrollment support (why bother if the Marketplace as it then functioned was going to go away?).[10]  Officials dramatically shortened the enrollment period and further pursued collapse of the subsidizes for the insurance market by refusing to pay cost sharing subsidies owed insurers. This latter strategy failed when state insurance commissioners allowed issuers to raise the price of silver premiums (termed “silver loading”) in order to blunt the impact of lost cost sharing subsidies and preserve a viable market.[11]  By tying revenue replacement to silver plans, commissioners effectively succeeded in using the federal premium subsidy system to compensate for the loss of cost sharing subsidies and fashioned a successful remedy that likely cost taxpayers more than simply paying the cost sharing subsidies.[12]

On the Medicaid front, the administration launched an effort to make Medicaid enrollment and renewal more difficult[13] (as the biggest single beneficiary group, children also appear to have paid the largest price for this policy with enrollment dropping steeply and the number of uninsured children rising).[14] Pursuing what they euphemistically termed “immigration reform”, the administration built a legal wall between legal immigrants and public insurance programs for which they are eligible by classifying enrollment in subsidized insurance as evidence of public charge, a classification that in turn can trigger loss or denial of permanent legal residency.[15]  As one might expect, the policy exacted an enormous price on immigrant access to insurance.[16]

Also worth noting in the context of actions aimed at depriving individuals of access to publicly funded insurance were the compulsory work experiments launched by the administration and directly helmed by Seema Verma, an ardent believer tying Medicaid eligibility to the “dignity” of work.[17] By the end of the administration, these demonstrations – a grievous misuse of the special experimental powers granted the HHS Secretary under the Social Security Act — were either approved or pending in 19 states.  Indeed, CMS continued to champion and approve the experiments even after a federal appeals court had halted Arkansas’s first-in-the-nation demonstration,[18] and even after independent evaluation of the truncated program (CMS permitted Arkansas to proceed even though the state had put absolutely no evaluation in place) had documented mass confusion on the part of the poor and ultimately, the erroneous loss of coverage by over 18,000 eligible people.[19]

Just as officials ignored the steady attack on access to affordable publicly subsidized insurance, so, too, did they systematically mischaracterize their actions with respect to the scope and structure of insurance coverage itself. As individual insurance commissioners were struggling to hold onto the ACA-compliant plan market in the face of the enormous instability visited on insurers over the 2017 time period,[20] the administration focused on opening the door to widespread sale of short-term limited duration health plans – junk insurance that depends on medical underwriting, insurmountable cost sharing, and hollowed out benefits.[21] Also an area of focus for the administration was easing longstanding rules aimed at stopping fraud in the market for association health plans in order to promote a new generation of fly-by-night companies that set up associations whose sole purpose is the sale of coverage that skirts ACA rules.[22]

Both of these strategies harm the individual market in two ways – by skirting the ACA rules and thereby opening consumers to access and coverage problems that health reform was designed to redress; and by siphoning healthier people out of the ACA compliant market, thereby further complicating the challenge of building an individual health insurance market that truly can function as the means by which people can buy comprehensive, affordable coverage that offers true protection against the cost of a broad range of health care.

Trump officials rounded out their conduct by pointing to their support for state “flexibility to address market challenges.”  As it turns out, this support chiefly took the form of a blatant misuse of yet other federal demonstration authority – Section 1332 of the ACA — in ways directly barred by the law itself.  Chief among the ways in which the administration pursued 1332 to enable states to move the subsidized insurance market away from ACA has been its approval of a Georgia plan – now the subject of a court challenge – that would effectively eliminate the use of a Marketplace, allow federal subsidies to flow to states that fall below ACA coverage standards, and ultimately result in substantial enrollment losses. [23] The Biden administration ultimately withdrew the rules change that permitted such deviations from the letter and spirit of 1332.[24]

To borrow a phrase from the Chief Justice’s opinion in King v Burwell, the landmark 2015 Supreme Court decision that literally saved the ACA’s market reforms and premium subsidies, Congress designed the ACA to strengthen the insurance market, not destroy it. The Trump administration pursued policies aimed at bringing down the entire system of affordable individual coverage and that were instrumental in spurring an overall decline in coverage among the very people who most need government to make insurance coverage possible. Furthermore, the policies officials pointed to with pride are ones that, if permitted to continue, would have undermined the market for affordable health plans in both the near-term and long-term.

Overcoming the damage left behind has taken a concerted effort by the Biden administration to make matters right – by establishing a special enrollment period for low-wage pandemic victims who lost their jobs during the pandemic, by withdrawing approval for Medicaid work experiments, by shutting down unlawful 1332 waivers, and by championing a more generous subsidy system to expand access to marketplace coverage.  By the end of 2021, not only had Medicaid coverage as a national priority been restored, but the Biden White House was able to point to a 4.6 million-person gain in access to subsidized health plans.[25]

References

[1] The White House, available at https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/28/executive-order-on-strengthening-medicaid-and-the-affordable-care-act/

[2] See, Speech: Remarks by Administrator Seema Verma at the National Association of Medicaid Directors (NAMD) 2017 Fall Conference, https://www.cms.gov/newsroom/fact-sheets/speech-remarks-administrator-seema-verma-national-association-medicaid-directors-namd-2017-fall

[3] Katie Keith 2021. “Biden Executive Order To Reopen HealthCare.gov, Make Other Changes,” Health Affairs Blog, https://www.healthaffairs.org/do/10.1377/hblog20210129.998616/full/

[4] Sarah Hansard, “Obamacare Sees Surge of Signups as Biden Reopens Enrollment,” Bloomberg News (March 4, 2021)

[5] Finegold et al., 2021.  Trends in the U.S. Uninsured Population, 2010-2020 (HHS/ASPE Issue Brief) (Feb. 11, 2021).  https://aspe.hhs.gov/system/files/pdf/265041/trends-in-the-us-uninsured.pdf

[6] Sabrina Corlette, Linda Blumberg, and Kevin Lucia, the ACA’s Effect on the Individual Insurance Market,” Health Affairs  39:3 436-444 (2020)

[7] Maine Community Health Options v United States (Supreme Court, April 27, 2020),  https://www.supremecourt.gov/opinions/19pdf/18-1023_m64o.pdf

[8] Paul Fronstin and Stephen A. Woodbury. 2020. How Many Americans Have Lost Jobs with Employer Health Coverage During the Pandemic?  (Commonwealth Fund, October 2020) https://www.commonwealthfund.org/publications/issue-briefs/2020/oct/how-many-lost-jobs-employer-coverage-pandemic

[9] Id.

[10] Timothy S. Jost.  2018. The Affordable Care Act Under the Trump Administration  (Commonwealth Fund, August 2018). https://www.commonwealthfund.org/blog/2018/affordable-care-act-under-trump-administration

[11] Timothy Jost. 2017. “Administration’s Ending Of Cost-Sharing Reduction Payments Likely To Roil Individual Markets” Health Affairs Blog  (October 13, 2017) https://www.healthaffairs.org/do/10.1377/hblog20171022.459832/full/

[12] Aviva Aron-Dine, Christen Linke Young. 2020. “Silver-Loading Likely To Continue Following Federal Circuit Decision On CSRs” Health Affairs Blog  (October 13, 2020) https://www.healthaffairs.org/do/10.1377/hblog20201009.845192/full/

[13] Center on Budget and Policy Priorities. 2020. Trump Administration’s Harmful Changes to Medicaid.   https://www.cbpp.org/research/health/trump-administrations-harmful-changes-to-medicaid

[14] Tricia Brooks. 2020. Child Enrollment in Medicaid and CHIP Remains Down in 2019 (Georgetown University Health Policy Institute, February 18, 2020). https://ccf.georgetown.edu/2020/02/18/child-enrollment-in-medicaid-and-chip-remains-down-in-2019/#:~:text=As%20of%20October%202019%2C%20the,Medicaid%20and%20CHIP%20held%20at%20.&text=In%20the%20first%2010%20months,or%202.2%20percent%20in%202018.

[15]  Wendy Parmet, 2019.  The Trump Administration’s New Public Charge Rule: Implications for Health Care and Public Health.  Health Affairs Blog (August 13, 2019), https://www.healthaffairs.org/do/10.1377/hblog20190813.84831/full/

[16] State of New York et al. v United States Department of Homeland Security et al. (19 Civ. 7777, S.D.N.Y., July 29, 2020)

[17] Seema Verma, Making Medicaid a pathway out of poverty” Washington Post  (February 4, 2018), https://www.washingtonpost.com/opinions/making-medicaid-a-pathway-out-of-poverty/2018/02/04/4570736a-0857-11e8-94e8-e8b8600ade23_story.html

[18] Alexander Somodevilla and Sara Rosenbaum. 2020.  Inside the D.C. Circuit’s Opinion in Gresham v Azar Health Affairs Blog (February 20, 2020), https://www.healthaffairs.org/do/10.1377/hblog20200220.823038/full/

[19] Benjamin D. Sommers et al., 2019. “Medicaid Work Requirements – Results from the First Year in Arkansas” New Eng. Jour. Med. 381: 1073-1082 (2019)

[20] Corlette et al., supra

[21] Dania Palanker, JoAnn Volk, and Kevin Lucia.  2018. Short Term Health Plan Gaps and Limits Leave People At Risk (Commonwealth Fund. October 30, 2018).  https://www.commonwealthfund.org/blog/2018/short-term-health-plan-gaps-and-limits-leave-people-risk

[22] Kevin Lucia and Sabrina Corlette.  2017.
President Trump’s Executive Order: Can Association Health Plans Accomplish What Congress Could Not? (Commonwealth Fund, October 10, 2017). https://www.commonwealthfund.org/blog/2017/president-trumps-executive-order-can-association-health-plans-accomplish-what-congress

[23] Katie Keith. 2021.  Lawsuit Challenges GA’s 1332 Waiver, ACA in the Biden Pandemic Plan.  Health Affairs Blog, (January 21, 2021)  https://www.healthaffairs.org/do/10.1377/hblog20210121.230640/full/

[24] Katie, Keith. 2021. Biden Administration Finalizes First Marketplace Rule Including New Low-Income Special Enrollment Period, Health Affairs Blog.   https://www.healthaffairs.org/do/10.1377/forefront.20210919.154415

[25] White House, Statement by President Biden on 4.6 Million Americans Gaining Health Insurance This Year, https://www.whitehouse.gov/briefing-room/statements-releases/2021/12/22/statement-by-president-biden-on-4-6-million-americans-gaining-health-insurance-this-year/

 

Framing & Covid-19 Vaccine Hesitancy: Experimental Evidence from India

Arzi Adbi, Department of Strategy & Policy, National University of Singapore Business School; Chirantan Chatterjee, Science Policy Research Unit, University of Sussex Business School, Hoover Institution (Stanford University); Economics, IIM Ahmedabad; Indian Health Outcomes, Public Health and Economics Research Centre; Pranjali Sharma, IIM Ahmedabad

Contact: c.chatterjee@sussex.ac.uk

Abstract

What will you learn? How can framing impact the preferences for Covid-19 vaccines? We find a relative importance of individual-benefit framing. Participants under individual-benefit frame were 6.7% more likely to consume vaccine and expressed 6.8% greater willingness to consume relative to those under societal-benefit frame, with this effect being greater for those who had never consumed adult vaccine in the past. While we did not find a significant difference between the deep and moderate discount frame on average, the effect of deep discount was prominent on the strata of individuals that had never consumed any adult vaccine in the past. Herein, individuals who received the deep-discount framing were 10.0% more likely to state their preference to consume vaccine and expressed 10.8% greater willingness to consume vaccine relative to those under the moderate-discount framing. These findings have practical implications for policymakers engaged in designing strategies to reduce vaccine hesitancy and save lives as the world continues to struggle to recover from Covid-19 with increasing vaccine mandates around the world.

What is the evidence? We partnered with India’s leading healthcare platform (Tata 1mg) to conduct a preregistered experiment (in a pre-vaccine available world in December 2020) with 2,000 Indians to investigate this question. Specifically, we investigate the effect of randomly assigned gain-vs.-loss frame, individual-vs.-societal benefit frame, Indian-vs.-American vaccine manufacturing firm, and deep-vs.-moderate pricing discount frame and examine their impact on stated preferences for vaccine consumption.

Links: Supplementary Evidence

Timeline: Submitted: October 2, 2021; accepted after review: November 5, 2021,

Cite as: Arzi Adbi, Chirantan Chatterjee, Pranjali Sharma. 2022. Framing & Covid-19 Vaccine Hesitancy: Experimental Evidence from India, Health Management, Policy and Innovation (www.hmpi.org), Volume 7, Issue 1.

Acknowledgements:  We are grateful for financial support from ICICI Bank Chair in Strategic Management Grant (10000406) at IIM Ahmedabad, Visiting Fellowship at Hoover Institution, Stanford University Grant (226294), and National University of Singapore Start-Up Research Grant (R-313-000-143-133). We do not have any conflicts of interest. We acknowledge helpful comments from Robin Banerjee, Constantin Blome, Jeremy Hall, Mario Macis, Anup Malani, Don Metz, Aparna Mittal, Manoj Mohanan, Tarun Rambha, Malcolm Reed, Emilia Simeonova, Yogesh Simmhan, Abhay Singhal, Dinesh Thakur. Support from Dr. Anuj Saini, Dr. Varun Gupta and their team at Tata 1mg is gratefully acknowledged. This study was approved by Institutional Review Board at IIM Ahmedabad (approval number IIMA IRB 2020-40).

Introduction

As of October 1, 2021, more than 4.5 million people have died during the ongoing coronavirus pandemic (Worldometers 2021). Deaths continue, particularly in India (officially with 0.448 million deaths), a developing country with over 1.3 billion people. The pandemic particularly wreaked havoc in its second wave in April-May 2021, as the country battled a severe shortage of potential solutions (Bhuyan 2021, Cohen 2021, Vaidyanathan 2021). Although several factors, including both supply-side and demand-side constraints (Dupas 2011, Niewoehner and Staats 2021, Norton et al. 2021, Taylor and Xiao 2014), are at play, research suggests that a critical challenge in the area of public health stems from vaccine hesitancy among the population,  a complex problem to solve worldwide, but especially in developing countries, despite the deleterious consequences of not consuming the vaccine (Yamin and Gavious 2013, Bloom et al. 2014, Kobayashi et al. 2021, Aziz et al. 2021, Lazarus et al. 2021, Milkman et al. 2021). This is particularly so in the second half of 2021 as vaccine mandates spread worldwide.

Prior research has documented that improving the reliability of services on the supply side increases vaccination rates to some extent, but even small incentives on the demand side have been found to create a large positive impact on reducing vaccine hesitancy in resource-constrained areas (Banerjee et al. 2011). A related strand of growing research suggests the possibility for healthcare practitioners, public health professionals including managers and policymakers, to reduce vaccine hesitancy with simple yet scientifically informed framing nudges (e.g., see Benartzi et al. 2017 for a recent review). For instance, studies have found that simply reminding high-risk people to get vaccinated (Regan et al. 2017), getting them to form implementation intentions by committing to a specific time (Milkman et al. 2011), and framing messages designed to specifically leverage insights from behavioral sciences, can increase vaccination rates among the population (Yokum et al. 2018, Luyten et al. 2019, Ward et al. 2020, Hornsey et al. 2020, Đorđević et al. 2021).

Our goal in this study is to extend this growing body of research by examining whether certain frames with subtle yet important variation in information provision (Haaland et al. 2021, Nyhan et al. 2014, List et al. 2021) may lead to greater willingness to consume the COVID-19 vaccine. To do so, we partnered with a leading online pharmacy and healthcare platform in India (Tata 1mg.com). We conducted a large-sample, preregistered experiment designed to investigate how individuals under distinct frames may differ in their stated preference to consume the COVID-19 vaccine (Vasquez et al. 2021). In particular our experiment was conducted in December 2020 to make sure that we have an uncontaminated view on vaccines before they were actually available in any part of the world. A large body of work based on framing theory suggests that how information is framed may lead to a nontrivial impact on how people perceive and react to the information (Tversky and Kahneman 1981, 2000, Chong and Druckman 2007, Levin et al. 1998). Thus, framing can influence individual preferences. While it is known that messages with distinct frames may influence intentions, it remains unclear whether some frames may be more effective than others in the context of the individual decision-making process regarding vaccination. This is precisely the research question we undertake by conducting a preregistered experiment in India.

A core dilemma in individual decision-making to vaccinate or not emanates from the interplay between the potential risks of adverse side-effects (Diestre et al. 2020, Larson et al. 2014, Masic and Gerc 2020), the affordability and ease of accessibility of vaccines (Arifoglu et al. 2012, Dupas and Miguel 2011, Inamdar and Alluri 2021, Kremer and Glennerster 2011), and the perceived advantages from free-riding, a phenomenon where the choice to free ride and exploit the vaccination behavior of others may increase vaccine hesitancy of an individual (Yamin and Gavious 2013). Prospect theory (Kahneman and Tversky 1979) suggests that presenting the same information but with variation in gain versus loss framing of the message may alter people’s preferences (Tannenbaum et al. 2015). Therefore, we examine whether loss-framed messages may lead to greater willingness to consume vaccine than gain-framed messages. In theory, as Yamin and Gavious (2013) propose, two core motivations may underlie an individual’s decision-making process regarding vaccination: self-interest and the interest of society (Fine and Clarkson 1986). Therefore, we examine whether the individual-benefit and societal-benefit emphasis frames may lead to differential willingness to consume vaccine. To further examine the crucial role of self-interest and the contemporary challenge of vaccine affordability, we also investigate the extent to which a deep-discount pricing frame may lead to greater willingness to consume vaccine than a moderate-discount pricing frame.

In our preregistered experimental investigation, any individual who on December 6 and 7, 2020 visited the website of Tata 1mg.com, India’s largest online pharmacy and healthcare platform, was offered the opportunity to participate in a healthcare-related survey. After obtaining their consent to participate in the survey, the participants were randomly assigned to distinct framing conditions: gain versus loss frame, individual versus societal benefit frame, Indian versus American firm as the country of origin (of the vaccine manufacturing firm) frame, and deep versus moderate discount pricing frame. In our preregistered experiment, we included the Indian versus American firm frame to abductively explore the possibility of whether an individual’s decision-making regarding vaccination may be driven by certain aspects of the liabilities of foreignness faced by foreign firms—i.e., the social and cultural barriers that may limit the embeddedness of foreign firms in the local environment of the host country (Zaheer 1995).

The findings of our preregistered experimental investigation reveal that certain frames are much more effective than others in leading to a greater preference and willingness to consume the vaccine. The results imply that the individual-benefit frame may encourage vaccine adoption more than the societal-benefit frame, and this effect is especially prominent among the individuals that have never consumed any adult vaccine in the past. Within the strata of individuals who have never consumed any adult vaccine, deep discount pricing may encourage vaccine adoption much more than moderate discount pricing. Although several factors influence the adoption of vaccines, the evidence-based insights of this study may help healthcare policymakers and firms to design strategies to increase vaccine adoption in developing countries.

Acknowledging that these results may not fully generalize beyond India, the specific setting investigated in our experiment, the findings of this study offer important implications for public health professionals, managers and policymakers designing demand-side strategies and policies to reduce vaccine hesitancy in a country of over 1.3 billion people and make progress toward herd immunity (Fefferman and Naumova 2015), a goal that seems elusive in the currently grim scenario. These results may also have implications for other developing economies and their public health strategies as the world struggles with eradicating vaccine hesitancy to come out with the global Covid-19 pandemic.

Experiment Design and Implementation

The Institutional Review Board at one of the author’s institutions approved the study protocols. The participants in the experiment gave informed consent in accordance with the guidelines set forth by the Institutional Review Board.

Sample Construction and Random Assignment of Framing Conditions

We conducted statistical power calculation to detect a traditionally considered small-to-medium effect size of d=0.35 (e.g., Dietze and Craig 2021: p. 357). A priori power analysis revealed that a sample size with 130 participants per randomized condition was required to achieve 80% statistical power with α=0.05. Because we have eight randomized conditions across the four distinct frames (gain-vs.-loss frame, individual-vs.-societal benefit frame, Indian-vs.-American frame, deep-vs.-moderate pricing discount frame), the total sample size required was 1,040 participants. Anticipating potential exclusions due to the lack of informed consent from some participants and due to the failure of some participants to successfully pass the attention checks, we documented in our preregistered plan to stop our data collection at N=2,000. We preregistered (https://aspredicted.org/blind.php?x=VCJ_JKK) the study’s design and data analysis plan on October 20. 2020. The data were collected December 6 and 7, 2020. The participants in the experiment were visitors to the website of Tata, www.1mg.com, India’s leading online pharmacy and healthcare platform.

In line with the preregistration plan, we stopped data collection at N=2,000. The participants were first requested for their informed consent to participate in the survey. Out of 2,000 participants, 1,952 participants gave their consent to participate (see Table 1). To ensure high data quality, in line with the preregistered analysis plan, the sample for analysis included only those participants who passed both attention-check questions. Thus, the sample size for our analysis is N=1,365 as 70% of the consenting participants (N=1,952) passed both attention checks (see Table 1). The first attention check question instructed, “For this question, please select number two to demonstrate your attention.” The second attention check question instructed, “For this question, please select number six to demonstrate your attention.” In both questions, respondents were given seven numbers to choose from 1 to 7.

Table 1. Sample Size and Research Design

N
Number of participants 2,000
Gave consent to participate 1,952
Passed both attention check 1 and 2 1,365

Notes: Following the preregistered analysis plan, we stopped our data collection at raw N = 2,000 and have N = 1,365 responses for analysis.

The participants were randomly assigned to the framing conditions: (i) gain versus loss frame,  (ii) individual versus societal benefit frame, (iii) Indian versus American firm as the country of origin (of the vaccine manufacturing firm) frame, and (iv) deep versus moderate discount pricing frame (see Table 1). The message each participant saw was in line with our preregistered plan, which followed the technique of random assignment of distinct messages in information provision experiments (Haaland et al. 2021, Nyhan et al. 2014, List et al. 2021). For example, a randomly assigned participant under the gain framing condition received the following message: “Some public health experts suggest that not consuming a COVID-19 vaccine may decrease the chances of infection by 4X. As per scientific evidence, vaccine provides many benefits to the society leading to increased life expectancy. But, COVID-19 vaccine developed in such a short span may not have proven efficacy. Many firms believe a vaccine will be meaningless if the public cannot afford it. Therefore, an Indian firm has announced a discount of 80%.”

Participants randomly assigned to the loss framing condition saw “increase the chances of infection by 4X” instead of “decrease the chances of infection by 4X” seen by participants randomly assigned to the gain framing condition, while all else remained the same. Participants randomly assigned to individual benefit emphasis condition saw “vaccine provides many benefits to the individual” instead of “vaccine provides many benefits to the society” seen by participants randomly assigned to societal benefit emphasis condition. Participants randomly assigned to Indian firm as country of origin of vaccine manufacturing firm condition saw “an Indian firm has announced” instead of “an American firm has announced” seen by participants randomly assigned to American firm as country of origin of vaccine manufacturing firm condition. Participants randomly assigned to deep discount condition saw “a discount of 80%” instead of “a discount of 20%” seen by participants randomly assigned to moderate discount condition.

The key predictors in our analysis were four variables: Loss Framing, Individual Benefit, Indian Firm, and Deep Discount. Loss Framing is set to 1 if the participant received loss framing message, and 0 if the participant received gain framing message. Individual Benefit is set to 1 if the participant received individual benefit emphasis message, and 0 if the participant received societal benefit emphasis message. Indian Firm is set to 1 if the participant received a message stating an Indian firm, and 0 otherwise. Deep Discount is set to 1 if the participant received a message with 80% discount, and 0 if the participant received a message with 20% discount.

After randomly receiving the above messages with subtle variation in the framing of the information, the participants were asked if they would be willing to consume the COVID-19 vaccine. We constructed a binary variable Consume equal to 1 if the participant answered “Yes” and to 0 if the participant answered “No” to this question. To allay the concern of order bias, the order in which “Yes” and “No” appeared as two options for the participant was made random. The participants were also asked about their willingness to consume a COVID-19 vaccine on a continuous scale from 0 to100, where 100 referred to a hundred percent willingness to consume the vaccine. We constructed a continuous measure “Willingness to Consume” to measure this stated preference. Consume and Willingness to Consume thus serve as the two main outcome variables of interest in our analysis. The participants also answered questions about their demographic characteristics including age, gender, education, and also answered important context-specific questions about whether they had consumed any adult vaccine in the past, their current exposure to COVID-19, ability to work from home, etc. Participants also answered the ten-item personality inventory questions, which we use to measure the five-factor model of personality: extraversion, agreeableness, conscientiousness, emotional stability, and openness to experiences (Digman 1990, Espinoza et al. 2020, McCrae and Costa 1999). All variables are described in Table S1 (in the supplementary material).

Methodology & Econometric Model

To formally estimate the average treatment effects of the framing messages, we estimate the following ordinary least squares (OLS) regression:

Yi = α + βc Rci + εi                                                                                                           (1)

The outcome of interest Y in Equation (1) is the stated preference of participant i to consume COVID-19 vaccine. As explained above, we measured the outcome of interest in two distinct ways: Consume (a binary variable) and Willingness to Consume (a continuous measure). Rc is a vector of four key predictor variables representing loss framing condition (gain framing condition serves as the reference category), individual benefit condition (societal benefit condition serves as the reference category), Indian firm condition (American firm condition serves as the reference category), and deep discount condition (moderate discount condition serves as the reference category). We first report OLS estimates with heteroskedasticity-robust standard errors. Then, we also test the robustness of the results obtained from the OLS regression model by using logistic regression model for the binary dependent variable Consume and by using Tobit regression model for the limited dependent variable Willingness to Consume.

Building upon Equation (1), we also estimated the following regression equation to increase the efficiency of estimation and to explore the association of stated preference with other characteristics of the individuals (Vasquez et al. 2021, Athey and Imbens 2017, Glennerster and Takavarasha 2013):

Yi = α + βc Rci + γ Zi + εi                                                                                                  (2)

Equation (2) is similar to Equation (1) with the only difference being the addition of control variables represented by a vector Z (Table 2 shows the control variables). For ease of interpretation, we report and discuss OLS estimates as the main results. We also test the robustness of the results obtained from OLS regression model by using logistic (i.e., logit) regression model for the binary dependent variable Consume and by using Tobit regression model for the limited dependent variable Willingness to Consume.

Findings

The final sample of 1,365 participants had an average age of 40.3 years (SD = 15.2), 13.8% were female, and 51.3% had never consumed any adult vaccine in the past. As shown in Table 2, randomized treatment conditions were well balanced on age, gender, time duration (in minutes) spent on the survey, and several other dimensions including their current exposure to COVID-19 at the time of the experiment.

Table 2. Balance Checks

Notes: The table reports the means across randomized conditions and the P-value of the null hypothesis that the difference of means between the randomized conditions equals zero. The balance checks are based on t-test comparison of means.

Descriptive Analysis

Figure 1 shows the descriptive patterns by comparing the mean values of dependent variables by randomized conditions. Figure 1a shows that under the loss framing condition, 76.1% of individuals stated they were willing to consume the vaccine, which is directionally higher than but not statistically distinguishable from the 72.3% of individuals under the gain framing condition (B=0.038; t(1363)=1.593; P=0.111; 95% confidence interval (CI) [-0.008, 0.084]). Figure 1a also shows that under the loss framing condition, average willingness to consume the vaccine was 72.3%, which is again directionally higher than but not statistically distinguishable from the 70.1% of average willingness to consume the vaccine under the gain framing condition (B=2.192; t(1363)=1.250; P=0.211; 95% CI [-1.247, 5.632]).

Figure 1. Stated Preference for Consuming COVID-19 Vaccine

Figure 1a 

 

Figure 1b 

 

Figure 1c

 

Figure 1d 

Notes: “Consume” is measured as a binary variable set to one if yes, zero is no. “Willingness to Consume” is measured as a continuous variable from 0 to 100, where 100 denotes 100% willingness to consume the COVID-19 vaccine.

Figure 1b shows that under individual benefit emphasis frame, 76.6% of individuals stated they were willing to consume the vaccine, which is directionally higher and also statistically distinguishable from the 71.8% of individuals under societal benefit emphasis frame (B=0.047; t(1363)=1.997; P=0.046; 95% CI [0.001, 0.094]). Similarly, Figure 1b also shows that under individual benefit emphasis frame, average willingness to consume the vaccine was 73.5%, which is again directionally higher and statistically distinguishable from the 68.9% of average willingness to consume the vaccine under societal benefit emphasis frame (B=4.662; t(1363)=2.664; P=0.008; 95% CI [1.229, 8.094]).

Figure 1c shows that under Indian firm condition, 74.1% of individuals stated they are willing to consume the vaccine, which is neither directionally very different nor statistically distinguishable from the 74.2% of individuals under American firm condition (B=-0.001; t(1363)=-0.051; P=0.958; 95% CI [-0.047, 0.045]). Figure 1c also shows that under Indian firm condition, average willingness to consume the vaccine was 71.5%, which is again neither directionally very different nor statistically distinguishable from the 70.9% of average willingness to consume the vaccine under American firm condition (B=0.557; t(1363)=0.318; P=0.751; 95% CI [-2.884, 3.998]).

Finally, Figure 1d shows that under deep discount condition, 75.1% of individuals stated they were willing to consume the vaccine, which is directionally slightly higher but not statistically distinguishable from the 73.2% of individuals under moderate discount condition (B=0.019; t(1363)=0.825; P=0.409; 95% CI [-0.027, 0.066]). In contrast, however, average willingness to consume the vaccine was 72.7% under deep discount condition, which is directionally higher and moderately statistically distinguishable from the 69.7% under moderate discount condition (B=3.020; t(1363)=1.723; P=0.085; 95% CI [-0.417, 6.458]).

Figure 2 shows the full empirical distribution of the continuous variable Willingness to Consume. We conducted Kolmogorov-Smirnov (KS) tests for equality of distributions across the randomized conditions. The KS test suggests that the distributions of willingness to consume are different under the individual-benefit frame compared with that under the societal-benefit frame (D=0.0786, P=0.029). In contrast, the KS tests fail to reject the equality of distributions under gain frame compared with loss frame (D=0.0489, P=0.389), Indian firm compared American firm (D=0.0344, P=0.815), and deep discount compared to moderate discount (D=0.0562, P=0.232).

Figure 2. Full Empirical Distribution of Willingness to Consume COVID-19 Vaccine

Notes. “Willingness to Consume” is measured as a continuous variable from 0 to 100, where 100 denotes 100% willingness to consume the COVID-19 vaccine.

Average Treatment Effects

We estimated ordinary least squares (OLS) regression as per Equation (1) to formally estimate the average treatment effects of the framing messages. Table S2 (in the supplementary material) shows that the results of the OLS regression analyses remain qualitatively similar to the patterns observed in Figure 1. We discuss the results of the models (Model 5 and 10 of Table S2) that simultaneously included all four key predictor variables in the same regression equation. Model 5 shows that compared to societal benefit framing, individual benefit framing increased the fraction of individuals who stated their preference to consume the vaccine (B=0.048; P=0.043; 95% CI [0.001, 0.094]). Given that under societal benefit framing condition, 71.8% of individuals stated their preference to consume the vaccine, the coefficient of 0.048 implies an increase of 6.7% under the individual benefit framing condition relative to societal benefit framing condition. Similarly, Model 10 shows that compared to societal benefit framing, individual benefit framing increased the average willingness to consume the vaccine (B=4.676; P=0.008; 95% CI [1.245, 8.107]). Given that under societal benefit framing condition, the average willingness to consume was 68.9%, the coefficient of 4.676 implies an increase of 6.8% under the individual benefit framing condition relative to societal benefit framing condition.

In addition, Model 5 of Table S2 shows that compared to gain framing condition, loss framing condition increased the fraction of individuals who stated that they will be willing to consume the vaccine (B= 0.039, P=0.099; 95% CI [-0.007, 0.085]) and Model 10 shows that compared to moderate discount, deep discount framing increased the average willingness to consume the vaccine (B=3.07; P=0.080; 95% CI [-0.362, 6.501]). These results obtained from OLS regression models remain robust to using logit regression models for the binary dependent variable Consume and to using tobit regression models for the limited dependent variable Willingness to Consume (see Table S3 in the supplementary material).

Thus, the regression analysis results suggest that individual benefit emphasis framing increased the stated preference to consume the vaccine relative to societal benefit emphasis framing. In contrast, Indian versus American firm framing had no differential impact. Deep discount framing showed an increase in average willingness to consume relative to moderate discount framing, and loss framing increased the fraction of individuals who stated that they will be willing to consume the vaccine relative to gain framing.

In an additional analysis, we also estimated average treatment effects of framing conditions by excluding those participants that were outliers in terms of survey completion duration. Following the preregistered analysis plan, we excluded responses from the participants who took less time than 5th percentile or more time than 95th percentile. Table S4 shows the results of this additional analysis: We continue to find evidence suggesting that individual benefit emphasis framing increased the stated preference to consume the vaccine relative to societal benefit emphasis framing.

In line with the preregistered plan, we also conducted regression analyses including the control variables to increase the efficiency of estimation and to explore the association of stated preference with other characteristics of the individuals. For ease of interpretation, we discuss the inference obtained from OLS regression models as the main results (Table 3, Models 1 and 3; also see Figure 3). We also show the results obtained from logit regression model for the binary dependent variable Consume and from tobit regression model for the limited dependent variable Willingness to Consume (Table 3, Models 2 and 4).

Figure 3. Estimated Stated Preference for Consuming COVID-19 Vaccine

Notes: Predictive margins are based on OLS regression estimates shown in Model 1 and 3 of Table 3.

Table 3. Estimates of Treatment Effects while Controlling for Individual Characteristics

Notes: Heteroskedasticity-robust standard errors; exact p-values are reported in parentheses; two-tailed tests have been used.  *** p<0.01, ** p<0.05, * p<0.1.

The results of Table 3 provide a similar inference as Figure 1 and Table S2 about the treatment effects of respective framing messages. Figure 3 shows that we continue to find that individual benefit framing increased the stated preference to consume the vaccine relative to societal benefit framing. Indian versus American firm framing had no differential impact. Deep discount framing showed an increase in willingness to consume relative to moderate discount framing, and loss framing increased the fraction of individuals who stated their preference to consume the vaccine relative to gain framing.

In addition to examining the framing effects, Table 3 sheds light on associations between other characteristics and stated preference for consuming the vaccine. Model 1 of Table 3 shows that a lower fraction of individuals who had never consumed any adult vaccines (compared to those who had consumed any adult vaccine in the past) stated their preference to consume the vaccine (B=-0.072; P=0.002; 95% CI [-0.118, -0.026]). Given that 79.6% of individuals who have consumed any adult vaccine in the past stated their preference to consume the COVID-19 vaccine, the coefficient of -0.072 implies a relative decrease of 9.0% in the stated preference to consume the vaccine by those who had never consumed any adult vaccine. Similarly, Model 3 of Table 3 also shows that compared to individuals who had consumed any adult vaccine in the past, those who had never consumed any adult vaccine have lower average willingness to consume the vaccine (B=-5.631; P=0.001; 95% CI [-8.915, -2.348]). Given that individuals who had consumed any adult vaccine in the past showed an average willingness to consume of 75.8%, the coefficient of -5.631 implies a relative decrease of 7.7% in the average willingness to consume among those who had never consumed any adult vaccine. Furthermore, Model 1 of Table 3 also shows that a higher fraction of individuals who already trust vaccine (compared to individuals who do not already trust vaccine) stated their preference to consume the vaccine (B=0.209; P=0.000; 95 % CI [0.167, 0.251]). Similarly, Model 3 of Table 3 also shows that compared to individuals who do not already trust vaccine, those who already trust vaccine expressed much greater average willingness to consume the vaccine (B=22.452; P=0.000; 95% CI [19.406, 25.498]). We also observe a positive association between the current exposure to COVID-19 and the stated preference to consume the vaccine (B=0.002; P=0.000; 95 % CI [0.001, 0.003]).

Heterogeneous Treatment Effects

Is there an evidence of any heterogeneous treatment effects? In post-hoc analyses, we find that the positive effect of individual benefit framing (relative to societal benefit framing) on the stated preference to consume vaccine is especially prominent in the strata of individuals who have never consumed any adult vaccine in the past. This pattern is evident from Figure 4 and the coefficient of Individual Benefit in Model 1 of Table 4 (B=0.076; P=0.029; 95% CI [0.007, 0.144]) and Model 3 of Table 4 (B=0.372; P=0.032; 95% CI [0.032, 0.712) from the OLS and logit regression models respectively for the outcome variable Consume, and in Model 5 of Table 4 (B=5.612; P=0.024; 95% CI [0.754, 10.469]) and Model 7 of Table 4 (B=7.975; P=0.029; 95% CI [0.819, 15.131) from the OLS and tobit regression models respectively for the outcome variable Willingness to Consume. These results imply that within the strata of individuals who had never consumed any adult vaccine, given that under societal benefit framing condition, 64.9% of individuals stated their preference to consume the vaccine, the coefficient of 0.076 in Model 1 (interpreting OLS estimate) of Table 4 implies an increase of 11.2% under the individual benefit framing condition relative to societal benefit framing condition. Similarly, within the strata of individuals that had never consumed adult vaccine, given that under societal benefit framing condition, the average willingness to consume was 63.6%, the coefficient of 5.612 in Model 5 (again interpreting OLS estimate) of Table 4 implies an increase of 8.8% under the individual benefit framing condition relative to societal benefit framing condition.

Figure 4. Estimated Stated Preference by Adult Vaccine Consumption in the Past

Notes. Predictive margins in the figure are based on OLS regression estimates shown in Models 1-2 and 5-6 of Table 4.

 

Table 4. Estimates of Heterogeneous Treatment Effects

Notes: Heteroskedasticity-robust standard errors; exact p-values are reported in parentheses; two-tailed tests have been used.
*** p<0.01, ** p<0.05, * p<0.1.

 

In addition, Figure 4 and Table 4 also suggest a positive effect of deep discount pricing frame relative to moderate discount pricing frame on the strata of individuals who had never consumed adult vaccine.  This pattern is evident from Figure 4 and the coefficient of Deep Discount in Model 1 of Table 4 (B=0.065; P=0.058; 95% CI [-0.002, 0.132]) and Model 3 of Table 4 (B=0.328; P=0.055; 95% CI [-0.006, 0.662) from the OLS and logit regression models respectively for the outcome variable Consume, and in Model 5 of Table 4 (B=6.842; P=0.006; 95% CI [2.015, 11.669]) and Model 7 of Table 4 (B=10.279; P=0.005; 95% CI [3.067, 17.490) from OLS and tobit regression models respectively for the outcome variable Willingness to Consume. These results imply that within the strata of individuals that had never consumed any adult vaccine, given that under societal benefit framing condition, 64.9% of individuals stated their preference to consume the vaccine, the coefficient of 0.065 in Model 1 (interpreting OLS estimate) of Table 4 implies an increase of 10.0% under the deep discount condition relative to moderate discount condition. Similarly, within the strata of individuals that had never consumed adult vaccine, given that under societal benefit framing condition, the average willingness to consume was 63.6%, the coefficient of 6.842 in Model 5 (again interpreting OLS estimate) of Table 4 implies an increase of 10.8% under the deep discount condition relative to moderate discount condition. Figure S1 shows the estimates of additional analysis exploring the heterogeneity in treatment effects by all other individual characteristics.

Looking Forward

Given the catastrophic Covid-19 pandemic, reducing vaccine hesitancy among vast populations has never taken on greater import for healthcare practitioners, such as public health professionals, the senior managers at vaccine-manufacturing firms and policymakers, engaged in enhancing vaccine uptake. With a staggering number of deaths and a record-high number of cases in settings with weak health systems like India, the continuing pandemic has placed even greater demands on the crucial role of reducing vaccine hesitancy as vaccine mandates spread globally to recover from the pandemic while misinformation continues to be a problem (Carrieri et al. 2019). Reducing vaccine hesitancy is an especially critical challenge in developing countries given that a nontrivial proportion of their populations typically do not consume adult vaccines (Vasquez et al. 2021).

Prior research studying individual decision-making processes regarding vaccination distinguish between two core motivations for becoming vaccinated: self-interests and the interests of society (Yamin and Gavious 2013, Fine and Clarkson 1986, Velan et al. 2011). Incentives, such as placing vaccination centers in more accessible locations, providing financial and nonfinancial remuneration to an individual for getting vaccinated, and reimbursing vaccination costs have been documented as a few drivers to reduce vaccine hesitancy (Banerjee et al. 2010, Dupas 2011, Kremer and Glennerster 2011, Mamani et al. 2013).

A growing body of literature, mostly investigating the context of developed countries such as the U. S. and the U. K., has set forth to explore the role of nudges in individual decision-making by examining how distinct ways of information provision can reduce vaccine hesitancy (Benartzi et al. 2017, Frew et al. 2014, Milkman et al. 2011, 2021). Examining the context of the U. S., Milkman et al. (2011) found that a nudge prompting individuals to plan the date and time of vaccination, succeeded in increasing the vaccination outcomes by reducing forgetfulness among individuals. Again, examining the context of the U. S., a recent study by Hendrix et al. (2014) found an increase in parents’ measles-mumps-rubella (MMR) vaccination intentions for their infants when framing messages that emphasized direct benefits to the child rather than benefits to the society. As Benartzi et al. (2017: p. 1045) highlight in a recent review, several low-cost nudges, such as a time-commitment nudge (Milkman et al. 2011), default-appointment nudge (Chapman et al. 2010), and information-enhancing campaigns (Kimura et al. 2007), have proven effective in enhancing the vaccination rates in developed country settings. Globally, many developed countries such as the U. S. and the U. K. are making significant investments in setting up “nudge units” both inside and outside of governments to benefit from behavioral insights. The irony is that the developing countries—which may arguably benefit most from the effects of low-cost nudging interventions on a large scale given their huge populations—are lagging behind in supplementing traditional policies with behaviorally informed policies.

Our study extends the growing literature on nudging interventions by exploring how certain frames can be more effective than others in increasing the willingness to consume vaccines in a large developing country. Results from our experiment highlight the relative importance of benefits to self as an important driver of vaccine intake intention, which is consistent with the conceptual view that people make their vaccination decision based on their self-interests (Yamin and Gavious 2013). Individuals who received the individual-benefit framing were 6.7% more likely to state their preference to consume vaccine and expressed 6.8% greater willingness to consume relative to those under the societal-benefit framing. Interestingly, however, this effect was especially pronounced among those individuals who had never consumed any adult vaccine in the past: Within this strata of people, individuals who received the individual-benefit framing were 11.2% more likely to state their preference to consume vaccine and expressed 8.8% greater willingness to consume relative to those under the societal-benefit framing. While we did not find average treatment effects of deep relative to moderate discount frame, the relative importance of deep discount was prominent on the strata of individuals who had never consumed any adult vaccine in the past. Within this strata, individuals who received the deep-discount framing were 10.0% more likely to state their preference to consume vaccine and expressed 10.8% greater willingness to consume relative to those under the moderate-discount framing.

Some of the null results in our experiment are noteworthy. We did not find consistent evidence of the relative importance of loss frame or gain frame in their effect on the stated preference to consume vaccine. In doing so, our study joins the body of work that suggest that the relative importance of loss versus gain framing may not be unconditional (Bartels et al. 2010, Block and Keller 1995). In addition, we also did not find any distinguishable relative effect of Indian vs. American firm frame on the stated preference to consume vaccine. This null finding is important as it suggests that an individual’s decision-making process regarding vaccination may not be driven strongly by the liabilities of foreignness faced by foreign firms.

For academic research, our findings are noteworthy in that they advance the understanding of individual decision-making processes regarding vaccination. Some frames can be more effective than others in reducing vaccine hesitancy. Importantly, our findings suggest that the preference to consume vaccines can be stimulated more by appeals to self-interest rather than concerns for society per se (Yamin and Gavious 2013, Hendrix et al. 2014). This finding advances knowledge of how certain frames can be more successful in increasing the demand for preventive healthcare actions. For practitioners, our results are important in that they have a clear potential for practical impact. Our findings suggest that healthcare practitioners can reduce vaccine hesitancy by framing messages that appeal directly to consumer’s self-interest. Because many people in developing countries do not have a preference to consume adult vaccines (Dupas 2011, Kremer and Glennerster 2011), the findings of this study have relevant implications for managers of firms and transnational organizations and policymakers that are actively engaged in designing strategies and policies to reduce vaccine hesitancy among billions of people across developing countries (Dupas and Miguel 2017, Rezaie et al. 2012). This is specifically important given that public health experts suggest that herd immunity may require a substantial proportion of the population in a country to consume COVID-19 vaccine (Allen 2021, D’Souza and Dowdy 2021, Lazarus et al. 2021, Inamdar and Alluri 2021).

There are limitations to our study that serve as future research opportunities. While this study focused on the potential drivers of demand-side behavior, considering the supply-side behavior is also important. For example, a recent study by Niewoehner and Staats (2021) investigates the role of incentives and performance feedback in vaccine provider behavior in the context of flu vaccinations in the U. S., and finds that social comparisons such as performance feedback dominate over the effect of additional financial incentives. It would be a fruitful research endeavor to study the interactions between the supply-side and demand-side behavioral interventions leveraging both financial incentives and non-financial nudges.

In our study, we were able to measure an individual’s stated preference to consume vaccine. Although the theory of planned behavior suggests that intentions are likely to be significant predictors of behavior (Ajzen 1991, Zubair et al. 2020), we want to be clear that our study did not measure the revealed behavior, i.e., the actual intake of vaccine. Under some conditions, the intentions may not necessarily translate into actual behavior (Sheeran 2002). In the absence of the individual-level data on actual vaccine intake from India, however, we view that our findings investigating the relationship between distinct framing conditions and intentions to consume COVID-19 vaccine are nevertheless valuable to understand the potential drivers that may enhance vaccine uptake saving lives. Self-reported intention to consume vaccine offers useful insight in healthcare research (Daly et al. 2021). Future research ought to investigate this relationship using the actual vaccine intake data. One may also wonder about the external validity of our experimental findings that come specifically from India. We view our main contribution as investigating the underpinnings of how distinct frames may influence an individual’s intention to consume the COVID-19 vaccine, and India as a large developing country provided a relevant context to study this question. It will be fruitful for future research to focus on generalizability and extension replications of our findings across other settings and cultures more broadly and identify the boundary conditions across societies.

Although we have focused on individual preference for COVID-19 vaccination in this study, our results may broadly inform how individual decision-making processes could work for other prophylactic products (i.e., for which one pays now for uncertain benefits in future, e.g., insurance). As with the decisions for vaccinations, for other prophylactic products and preventive technologies more broadly, the consumer demand in most of the developing world is relatively muted because of present biased preferences of many individuals (Dupas 2011, Kremer and Glennerster 2011). The insights from our experiment conducted to study the individual decision-making process regarding vaccination in a developing country setting, juxtaposed with the findings from a growing set of influential experiments conducted across developed country settings (Milkman et al. 2011, 2021, see Dupas and Miguel 2017 for a review), may inform the design of nudges for improving the uptake of prophylactic products and preventive technologies more broadly (Argyris et al. 2021).

 

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Effective Patient-Centric Engagement in Population Health: Using Marketing Segmentation Methods to Address Patient Non-Adherence

Stacy Wood, North Carolina State University; Richard C. Mather, Carolyn Hutyra, Duke University School of Medicine; and Kevin A. Schulman, Stanford University 

Abstract

What is the message? As we move from clinical medicine to digital medicine, we are moving from a one to one provider-patient relationship to a one to many provider-patient relationship. The key communication skill set in the former approach is considered “bedside manner,” but such an approach will not carry over to the digital environment. We suggest that a one to many relationship is best understood through the perspective of the field of marketing. In this paper, we highlight the potential development and application of a marketing approach to patient segmentation in making patient recommendations for population health.

What is the evidence? Collection and analysis of novel patient survey data from an orthopedics clinic. Using marketing theory, we develop a new segmentation technique to construct phenotypes of patient non-adherence that can be used to promote effective adherence interventions.

Links: Appendix 1

Timeline: Submitted: January 19, 2022; accepted after review: January 20, 2022.

Cite as: Stacy Wood, Richard C. Mather, Carolyn Hutyra, Kevin A. Schulman. 2022. Effective Patient-Centric Engagement in Population Health: Using Marketing Segmentation Methods to Address Patient Non-Adherence, Health Management, Policy and Innovation (www.HMPI.org), Volume 7, Issue 1.

Introduction

Population health has emerged as a focus of modern health care delivery systems1; one critical aim of this framework is to identify and stratify patients in need of clinical intervention or supportive care. To date, improved patient engagement has become the means of increasing the effectiveness of this approach and most efforts focus on enhancing interaction with the clinical team.

An alternative—and potentially more successful—approach is to identify the bases of health behaviors of individual patients within the population, and to influence those behaviors with tailored messages or programs. Such an approach would require us to reconceptualize the health care of populations as a challenge requiring deeper insights into individual patient expectations, perceptions, and choices. Scaling individual insights to large-scale targeting of populations is foundational to many service industries, and builds from the field of consumer psychology in marketing.

While medical practitioners may balk at the term “marketing,” the contrast between a marketing approach and a health services research approach to population health care can be instructive. Extant research suggests that consumer psychology insights could improve both our prediction of population health patterns and success in crafting interventions to help patients achieve improved health. Recent calls for this kind of “psychology of choice” approach indicate a growing interest among practitioners and policy-makers2 and medical leaders already see promise for the use of behavioral phenotypes specifically in adherence interventions3—what would this approach look like in practice? Here, we offer a case study.

Marketing, as an academic field, is based on understanding populations through their behaviors and choices.  However, characterizing each individual in a population on these domains is a daunting task. Fortunately, one central insight of marketing is that it is possible to group populations, not by demographic variables alone, but based on similarities in terms of individuals’ behaviors, attitudes, and beliefs. This approach is called market segmentation: the identification of sub-groups of the population (or “segments”) that have similar behavioral personae4. It leads to the development of actionable insights and is a powerful tool in accomplishing three objectives: a) imputing the specific motivations of any given individual, b) predicting patterns of behavior, and c) developing the means to influence suboptimal behaviors with segment-specific strategies and persuasive messages. This process of segmentation has become more refined with the increasing availability of different types of consumer data (that go beyond simple demographic information) and powerful analytic models.

Segmentation focused on changing behavior requires an understanding of how to influence people to take an action—for example, to choose to exercise, eat differently, or purchase goods and services. To date, this type of approach has been largely absent from discussions of population health. We set out to understand if an approach to market segmentation could provide unique insights in an effort to encourage a common health behavior-exercise, among a group of patients with a diagnosis of arthritis.

Methods

The methods here follow standard practices in marketing for conducting a segmentation analysis as adapted to a medical population where adherence to a physician recommendation is the key behavior of interest.

The eight stages of this process are indicated in Figure 1.

Figure 1. Using Segmentation to Address Patient Non-adherence: Analytical Process

Target Patient Behavior

To understand phenotypes of behavior for osteoarthritis knee patients in adhering to a clinician’s recommendation to exercise, we sought to understand the relevant drivers of nonadherence and the potential interest in four different types of predetermined intervention (described below).  In determining the relevant attitudes impacting this behavior, we considered whether it is more helpful to investigate why people engage in this behavior (motivations) or why they don’t (barriers/hurdles).  Since consumers are loss averse, marketers often find an analysis of hurdles to be more actionable in designing interventions to encourage a behavior.

Item Development

Qualitative interviews were conducted among osteoarthritis physicians and advanced practice providers (APPs) that included orthopedic surgeons, sports medicine and primary care physicians, physician assistants, and a health center administrator.  These interviews helped generate an exhaustive list of salient pain points or barriers faced by patients with knee osteoarthritis, as well as explanations and beliefs espoused by patients. Interviews were conducted with both individuals and groups for an approximate duration of one hour. Further input was obtained from an extensive review of the literature, and a review of public patient forums, including online chat rooms and social media posts.

Survey Development

A survey was created in Qualtrics and emailed to patients with knee OA. Survey questions included 32 possible exercise hurdles as well as relevant attitudes, interests, and beliefs (AIB). Hurdles were measured using a five-point scale: where 1 =Does not describe my feelings”; 2 = “Slightly describes my feelings”; 3 = “Moderately describes my feelings”; 4 = “Mostly describes my feelings”; and 5 = “Clearly describes my feelings.” We also included limited demographic items.

Respondents were also asked to assess their personal evaluation of four potential interventions to improve exercise: an insurance rebate, a social support group, an educational app, and a “gamified” reward program, with responses collected on a three point scale (1 = “Honestly, this would not help me exercise more,” 2 = “This might help me a little to exercise more,” and 3 = “This would greatly help me to exercise more.”).  Here, we measured individuals’ evaluations of interventions within the same survey as hurdles.  This does not need to be the case if other evaluative data for individuals already exists.

The full survey is included as Appendix 1.

Study Population

Individuals (ages 18-80) who received care at a large academic medical center with a clinical diagnosis of knee osteoarthritis and an email address on file, and who received an exercise recommendation from their clinician, were eligible for participation.

Survey Release

Email addresses were collected through an internal osteoarthritis database at a large, academic medical center. Participants received a securely delivered email from their orthopedic provider. The email contained a link to the Qualtrics consent form and survey. Subjects did not receive compensation for participation. No Protected Health Information (PHI) was collected.

Statistical Analysis

SPSS version 24 was used to analyze the data, including behavioral, attitudinal, and demographic characteristics. Two-Step Cluster Analysis (TSCA) was used to identify segments by selected variables.  TCSA allows for analysis of a combination of categorical and continuous variables. Additionally, it can yield clusters of differing sizes which is valid here because it is probable that groups based on attitudes toward exercise adherence are not of uniform size. The Bayesian Information Criterion (BIC) was applied to determine the number of discrete clusters when the model was unconstrained.

Analysis-of-variance tests identified characteristics that differ significantly between groups to understand the behavioral phenotype or “personality” of the segment.  Finally, we assessed key demographics (e.g., age, gender) by segment membership.

This study underwent review and approval by the Duke Medicine Institutional Review Board for Clinical Investigations (Pro00082003).

Results

5,159 emails were released to the osteoarthritis knee cohort. Of the emails released, 4,887 were delivered successfully. Emails to 272 participants had permanent fatal errors and could not be delivered. 657 participants responded to the survey for a 13.4% response rate. Of the 657 responses, 431 individuals indicated they had received an exercise recommendation from their provider following a knee osteoarthritis diagnosis and the segmentation analysis was conducted on these individuals.

Descriptive analyses (Table 1) indicate that the research population is more female and more highly educated than the population at large.

Table 1. Survey Population Demographic Descriptions

  Overall Population* Segment 1 Segment 2 Segment 3 Segment 4
n 431 100 95 118 60
Gender (% Female) 67.8% 77.0% 63.1% 72.0% 54.2%
Mean age 65 58 70 62 65
Education (% Obtaining)
1.      High school degree 22.0% 23.0% 22.3% 19.4% 21.6%
2.      College, Undergraduate degree 38.7% 37.0% 41.4% 38.1% 38.3%
3.      College, Graduate degree 38.5% 39.0% 36.1% 40.6% 40.0%
Use social media (% Yes) 74.3% 82.0% 76.8% 74.5% 56.6%

*Total survey respondents = 657; segmentation conducted on those who specified that exercise had been prescribed to them, n = 431. Segment sizes can be based on fewer than n = 431 depending on patterns of nonresponse within the survey.

 

Age of this population ranged between 55 and 75, with a mean age of 64.8.  Roughly 75% use social media and 19% have had a knee replacement surgery.  Exercise was recommended by a doctor (personal physician or orthopedic surgeon) most of the time, however, patients report that five minutes or less was devoted to talking about this recommendation in a majority (62%) of cases.

Segmentation

Segmentation was conducted by analyzing respondents’ evaluations of interventions to increase exercise. Two-Step cluster analysis was used to determine if there are multiple significant segments based on evaluations of the four interventions.  When the model is unconstrained, four segments emerge. The cluster analysis demonstrates fair cohesion/separation (Silhouette measure =.4) and the ratio of sizes (1.97) is also good.

Segment 3 is the largest at 31.6% of the population and indicates a clear preference for the social support group.  Segment 1 is the next largest at 26.8% of the population; this segment indicates interest in any of the interventions. Segment 2 is similarly sized at 25.5% of the population and prefers the insurance rebate.  Segment 4 is the smallest at 16.1% of the population; this segment likes none of the interventions (see Figure 2).

Importantly, exercise hurdles differed across the population. Only six hurdles have a mean above 2 indicating “slightly describes my feelings.” However, in analyzing the data, attention to the overall mean is misleading if the distribution of responses varies across clusters.   For example, concern for hurting one’s joint has a relatively low mean (mean = 2.09), however, considering the distribution of responses, we can see this is a function of both the ~68% of respondents who report this hurdle does not keep them from exercising (responded 1 or 2) and the ~20% of respondents who report that it does (responded 4 or 5).  The insight of segmentation is to consider these two groups differently—being afraid of hurting one’s joint is not a problem for many but a sizeable problem for others.

TSCA analysis created a segment membership variable in the database for each individual respondent. ANOVA with Bonferroni correction then was used to determine if other variables differed by segment.  We found significant differences for four AIB measures and eight exercise hurdles (Table 2) which are used to develop the segment personality.

Table 2. Differences in survey response by segment type. AIB measures used a 7-point Likert scale. Perceived hurdle measures used a 5-point Likert scale.

  Segment 1 Segment 2 Segment 3 Segment 4  
Descriptor Amiable Inept Tire Tread Theorist Feeling Old Able Alone
Population % 26.8% 25.5% 31.6% 16.1%
Mean age 58 70 62 65
Differences in AIB measures Sig: F(p)
1.      I’ve had health problems my whole life 2.85 2.51 2.64 1.92 3.45 (.017)
2.      I’ve been an athletic person in my life 4.39 5.13 4.84 5.63 4.87 (.002)
3.      I’ve always been the kind of person who loves to exercise 3.84 4.36 4.06 4.90 3.84 (.010)
4.      Joints are like tire treads – they only have so much “life” in them. 4.22 4.45 3.86 4.03 2.03 (.108)
Differences in perceived hurdles (“One thing that really keeps me from doing the exercise is that…”)
1.      I don’t feel like I’m seeing the results as fast as I should. 2.18 1.93 2.19 1.71 2.79 (.040)
2.      I start strong but get discouraged. 2.26 2.00 2.24 1.51 6.32 (.000)
3.      I don’t enjoy the exercise. 2.10 1.73 2.21 1.69 4.02 (.008)
4.      It reminds me that my body has aged. 1.78 1.84 1.91 1.29 4.10 (.007)
5.      I don’t like exercising alone. 1.83 1.46 1.78 1.27 5.13 (.002)
6.      I don’t know if I’m doing it right. 1.82 1.46 1.60 1.28 5.05 (.002)
7.      I don’t have anybody to show me. 1.59 1.22 1.44 1.12 5.03 (.002)
8.      I’m not the athletic type. 1.66 1.38 1.70 1.37 2.53 (.056)

 

Segment “Personality” Development

Examining the four segments, we see that two segments (#1 and #3) do not perceive themselves as athletic, whereas the other segments (#2 and #4) do.  Thus, the first divide in this population appears to be an indentity-orientation attitude as either non-athlete or athlete.

Figure 2.  Interpretation of four segments with personae descriptors.  Note that, for each segment, the figure highlights the key hurdles to exercise adherence, ways the clinician can identify likely patient membership in a segment, and the persuasive levers for the most appealing intervention for each segment.

Of the non-athletes, segments #1 and #3 differ in their feeling toward exercise. Segment #1 is interested in exercise (reporting that they start strong), but often get discouraged because they aren’t seeing results fast enough and don’t know if they are doing the exercises right.  We term this segment, the “Amiable Inept.”  They are interested in all four interventions.

Segment #3 wants to avoid exercise, noting that they don’t enjoy exercise and it reminds them that their bodies have aged.  This segment we term, “Feeling Old.”  Here, comparing segments #1 and #3, we observe that neither group has a history of exercise, but the dominating feeling for one group is uncertainty/fickleness and the dominating feeling for the other is embarrassment/shame.

Of the athletes, we see divergent patterns that are focused on a key belief about how joints work.  Segment #2 reports enjoying exercise, but is worried by joint discomfort they feel and are anxious about further injuring their joint—this is predicated on their belief that joints are like tire treads and are a resource that is used up eventually.  Not surprisingly, then, they are interested in the insurance rebate. We term this segment, the “Tire Tread Theorists.”  On the other hand, segment #4 does not agree with a tire tread theory and reports no significant hurdles to exercising.  This group also reports no interest in any of the interventions and seems confident to manage on their own.  We term this segment, “Able Alone.”

Finally, we look at the descriptions of demographic variables by segment. These data did not improve our models—for example, the segment here that doesn’t exercise because of feeling old (Segment #3) is the second youngest of the population.

Discussion

Most approaches to population health focus on stratification of patients using clinical data. In this paper, we present an approach to understanding populations of patients using tools developed in consumer research. Using market segmentation, we were able to generate novel insights into barriers that impact patient adherence.

Overall, we found that adherence is influenced, not by demographic factors, but by different behavioral and attitudinal factors that subsequently predict the efficacy of different interventions. With knowledge of the different segments that exist, their relative size, and their unique barriers to engage in a behavior, we can better predict what interventions will be effective across the entire population and to design segment-specific interventions with a higher likelihood of success. This analysis illuminates key hurdles for each segment and, taken together, leads us to build a phenotype characterization (or “personality”) for each segment.  The phenotypes suggest how providers might identify any given patient’s likely segment membership through visual or conversational cues and better predict what intervention is most attractive to them. Importantly, it guides the precise persuasive content to include in an appeal to adopt the intervention.  In essence, this segmentation analysis allows us to understand why the individual is hindered and, therefore, why a particular solution will appeal to that patient.

This approach can offer patients the most appealing intervention approach and the tailored persuasive lever by segment.  For example, for segment #1, the persuasive message entails increasing patients’ ability to stick with it by increasing fun, confidence in skills, or an external monetary incentive when the going gets boring or results are slow.  The persuasive key for segment #2 is to increase assurance in exercising through educating them about the fallacy of the tire tread theory and using their lay theory that insurance companies wouldn’t incentivize a behavior that would cost more down the line.  For segment #3, the persuasive message is that a social support group will offer understanding from peers in the same situation. For Segment 4, persuasion to exercise is not needed and a clinician could instead share advanced fitness techniques, discuss specific implementation intentions, or suggest using personal technology (phones, FitBits, etc) to monitor adherence.

This segmentation approach is critical to our understanding of the effectiveness of population health interventions (Figure 3).

Figure 3.  Development of market size for each intervention.  This market size indicates the realistic cap on the number of likely adopters (“consumers”). We see that, because the social network intervention appeals to two of the larger segments, it is the intervention with the largest market size.

For example, the most popular intervention is the insurance rebate, but if launched, the best possible adoption rate would not be greater than 60% of the total patient population.  In other words, low adoption rates of interventions may not mean that they don’t work but that they work very well for a small segment of the population. Second, using tailored persuasive messages to encourage adoption of a relevant intervention is an important step toward target marketing, a practice that follows logically from segmentation insights.

Importantly, we examined patients at one academic medical center and with one medical condition, targeting one behavior. These findings do not generalize to other populations or target behaviors. However this should not be framed as a limitation of the analytic approach but rather as its point. The ease of running this sort of individualized analysis and its usefulness in increasing patient engagement suggest that such studies can and should be conducted to understand any number of desirable patient behaviors for specific populations.

Population health is an exciting and important challenge. Imagining effective population health will need to consider both clinical and behavioral dimensions of patient engagement. The data, the analyses, and the interventions required for effective population health need to extend far beyond current approaches. This paper provides insights into one interdisciplinary framework with the potential to dramatically increase the effectiveness of population health interventions and adherent patients.

Acknowledgements

We would like to thank the following individuals for their assistance in making this project a success: Rhett K. Hallows, MD, Ashley N. Grimsley, PA-C, Donald F. O’Malley, Jr., MD, Michael C. Comstock, MD, Samuel S. Wellman, MD, Andre C. Grant, MD, David E. Attarian, MD, Blake R. Boggess, DO, Scott L. Buckel, DO, Lee H. Diehl, MD, Christopher B. Cole, MMSc, PA-C, Joseph P. Shinnick, MHP, PA-C, Paul J.W. Tawney, MD, Thorsten M. Seyler, MD, Cody Malley III, ATC, LAT, PA-C, Alan Moses, PA-C, and Marianne Paul, PA-C.

 

References

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  2. Avorn J. The psychology of clinical decision making — Implications for medication use. N Engl J Med 2018; 378:689-691.
  3. Volpp KG, Krumholz HM, Asch DA. Mass customization for population health. JAMA Cardiol 2018; 3(5):363-364.
  4. Wind Y. Issues and advances in segmentation research. J Mktg Res 1978; 15(3): 317-337.

 

 

 

 

 

 

 

 

 

Word from the Editors

This issue begins our transition to a new editorial team. We are still in shock over the sudden loss of Will Mitchell, our Editor in Chief, in December. Will was a friend, colleague for over 20 years, and an energetic supporter of management education and tools in health care. We have complied comments from Will’s friends, colleagues, and students in this issue to help us all understand his broad impact on the field and his amazing attributes as a person. He will be sorely missed.

This is an exciting issue, one that combines health care business and policy in new ways. As the global COVID-19 pandemic marks a second year, we examine key issues around health insurance policy and how patient attitudes affect population health—as well as how technology can advance medical access, cost and innovation.

  • Sandra Waugh Ruggles, Juliana Perl, Zachary Sexton, Kevin Schulman and Josh Makower discuss the challenges of the current business model for breakthrough medical technologies. They present an analysis of how Medicare Coverage can be used to address the triple aim for Medicare beneficiaries – better care, better health, and lower cost.
  • Looking back at health policy during the Trump administration, Joseph Antos and Sara Rosenbaum offer contrasting perspectives on the impact of administration policies on access and coverage, and the impact of these actions on the most vulnerable.
  • Arzi Adbi, Chirantan Chatterjee and Pranjali Sharma examine the issue of information framing and the impact of differing frames on vaccine uptake in India.
  • Stacy Wood, Richard Mather, Carolyn Hutyra and Kevin Schulman continue the evaluation of marketing strategies on patient engagement with a study of segmentation strategies for patients with osteoarthritis.
  • Aazad Abbas, Jin Tong Du, Cari Whyne, Will Mitchell, and Jay Toor take us into supply chain management with a comparison of traditional procurement methodology to Total Cost of Ownership analysis in hospital procurement.
  • Danny Goel and Ryan Lohre discuss the potential of a novel technology, immersive virtual reality (IVR), in improving the efficiency and effectiveness of surgical training.
  • Rob Burns presents an overview of his new book examining the U.S. healthcare ecosystem, a very current overview of health care in the U.S.

Finally, Regi’s Case Corner features a new case examining Operation Warp Speed, the public-private partnership organized to accelerate the development of a COVID-19 vaccine in the US.

The COVID-19 pandemic stressed health care systems around the world. It exposed glaring gaps in equity within the health care delivery enterprise and across national borders, supply chain vulnerabilities across the system, and failures of data architectures in making information accessible to address the crisis. At the same time, the pandemic also offered hope in terms of the tremendous potential of biomedical innovation to bring vaccines based on novel science to the market with unprecedented speed and effectiveness.

It’s really important that we look back carefully to examine the pandemic and the response, to help highlight faults within the current system, and to help us innovate to a more effective and efficient system globally. This issue helps promote the dialogue around these opportunities.

Kevin Schulman, MD, MBA
Acting Editor in Chief, Health Management, Policy and Innovation (HMPI)
President, Business School Alliance for Health Management (BAHM)
Professor of Medicine, Stanford University

Regi’s “Innovating in Health Care” Case Corner

This issue of the Case Corner focuses on a case written by Kevin Schulman, Stanford University.

Case: Operation Warp Speed and the COVID-19 Vaccine (Stanford GSB Case SM-345. Date: 04/28/21. 23 pages)

Authors: Kevin Schulman and Abishek Thiagaraj, Stanford University

Background: In response to the emerging COVID-19 pandemic, the Federal Government launched Operation Warp Speed (OWS) to accelerate development of a vaccine directed to the SARS-CoV-2 virus. From the start, OWS was conceived of as a public-private partnership (PPP), bringing together the public and private sector into one collaborative effort. One of the major beneficiaries of OWS was the pharmaceutical firm Moderna, a company which had never produced an FDA approved product in its decade-long history. OWS was able to leverage research from the NIH to define the spike protein as a vaccine target. OWS was a tremendous success in that vaccines were developed and tested in record time. At the same time, there were questions of conflict of interest in selecting partners for the program, and failures of manufacturing and distribution that suggest the limit to accountability of OWS as a PPP mechanism. Finally, the focus of OWS on the US rather than the global market was a significant oversight was the pandemic has evolved.

The case focused on five questions:

  1. Did COVID-19 vaccine development require a PPP? What benefits did this structure provide? What risks did it entail?
  2. Transparency and a means to address conflicts of interests were major issues in the implementation of OWS. Are these elements required for a PPP? What are the risks of a PPP with and without these elements?
  3. OWS had a U.S. focus. What were the implications of this focus on the U.S., on the E.U., and on the developing world in terms of the global response to the pandemic? Did the U.S. population benefit from this approach?
  4. In considering a portfolio of vaccine technologies, did the PPP crowd in or crowd out other possible solutions for vaccine development?
  5. Should we measure success of this PPP by the time required for vaccine development, or the time required to achieve herd immunity through vaccine deployment? If the latter was the measure of success, was OWS successful? If we had the latter measure, would you have allocated more resources to building the U.S. public health infrastructure instead of OWS?

(Dr. John Muthee), COO (Dr. Justus Kilonzi) and Professor Medicine at Stanford (Dr. Kevin Schulman)

Download the case here: SM345 Operation Warp Speed