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Global Issues Driving US Healthcare Trends in 2021 and 2022

Web Exclusives - Industry Trends
F. Randy Vogenberg, PhD; John Santilli, MBA
Dr Vogenberg is Principal, Institute for Integrated Healthcare, and Board Chair, Employer-Provider Interface Council (EPIC), Greenville, SC; Mr Santilli is President, Access Market Intelligence, Trumbull, CT.
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This century has featured an increasingly interconnected marketplace in the United States and worldwide. Supply chains, research and development, and care-delivery knowledge, along with instant information sharing are now global. Access to the Internet, coupled with longstanding global travel for education or leisure, has inexorably altered the geographic limitations of healthcare and population health.

For the remainder of 2021 through the end of 2022, the key trends explored here will reflect the transition from pre– to post–COVID-19 healthcare environment and the related health reengineering by key stakeholders, global influences on domestic decision-making, as well as the effects of evolving federal or state government policies.

The post–COVID-19 healthcare environment will be much more complex than originally thought, continuing with the vaccines and COVID-19 testing, and as pressure on supply chains increases. As we move deeper into 2021, it will become increasingly clear that the country will be well into 2022 before we will return closer to normalcy.

Impact on Providers

The impact of COVID-19 on hospital-based care organizations has been traumatic. Relief would be most welcomed from staffing concerns, service shifts, a narrowed focus of care, the need for improved use of diagnostics, and unrelenting pandemic impacts. A key part of that relief would be herd immunity, which would allow for a more reasonably normal healthcare landscape. To that end, according to several industry trackers, the number of COVID-19 vaccines expected to be approved by mid- to late 2021 is 6.1 Getting those vaccinations into people has become the latest focus of institutional providers and other community and public health entities across the United States and the world.

Health systems rapidly built up home transitions and care services to support noninstitutional recoveries or rehabilitation that resulted from the pandemic. That trend will increasingly deliver patient care at home, and is driven by the Centers for Medicare & Medicaid Services (CMS)’s Acute Hospital Care at Home program announced in November 2020, with support from technologies such as clinical-grade wearables, remote patient monitoring, and artificial intelligence (AI)-based predictive analytics and machine learning.2

Healthcare consumerism was rising slowly before the pandemic, but the explosion of telehealth in 2020 quickly changed the lagging adoption of healthcare technologies.3 That shift in acceptance by healthcare consumers and providers has removed the geographic constraints that tied patients to their local hospitals and providers.3

As a result, interest in “smart” hospitals has never been more urgent. This shift in interest about the location of care coincides with the emergence of the Internet of Things. Akin to smart homes with speakers, lights, and cameras, automating and informing activities by healthcare professionals can be augmented when used appropriately in hospitals.4 Such application of the Internet of Things could help “scale the work of nurses on the frontlines, increase operational efficiency, and provide virtual patient monitoring to predict and prevent adverse patient events.”4,5

For the past decade we have been hearing about more health systems moving toward the goal of operating as one fully integrated care and information technology system. Patients who can no longer have in-person care visits or elective surgeries have become further disconnected from the care-delivery system. Easy access to electronic medical information proved cumbersome or difficult for patients or their families before and during the pandemic.

The pandemic has now also clearly illustrated how crucial it is for health systems to have real-time access to beds, providers, transport, and scarce resources such as protective equipment, ventilators, and drugs, so that patients could receive critical care without delay.4 Gone are predictable weekly, monthly, or annual hospital resources as the pandemic placed different demands on the care-­delivery system and its supply chain.

Telehealth applications will continue to be used for many routine care applications or appointments that do not require a hands-on approach. As some community-­based healthcare remains virtual, the industry must seek to refine interactions to establish a sustainable seamless patient (and doctor) experience. Pharmacies have been adapting technologies at a faster rate than most of healthcare, yet they have struggled with delivering optimal consumer experiences in a value-based clinical service.

Manufacturers—whether pharmaceutical, biotechnology, diagnostic, digital health, or device companies—will need to have at least a 2-fold approach to engage providers virtually and in person, based on the goal of the visit. Some observers suggest that manufacturers should invest “in technology and training to enable more robust remote engagement between sales reps and physicians.”6

Physicians in primary or specialty care settings alike are facing various reimbursement trends in 2021, ranging from how they code office visits to payers emphasizing more value-based care. Fiscal year 2020 was financially challenging for many healthcare practices, because clinicians were required to understand what was happening with revenue and expenses to help their sustainability during the pandemic and prepare their practices for the next few years.7

The continued trend of local hospitals merging into larger health systems had significantly affected local private practices.8 According to a report from Avalere Health and the Physicians Advisory Institute, between 2016 and 2018, hospitals had acquired 8000 medical practices and 14,000 physicians moved from private practices to the hospital setting.8 The impact of mergers on access to care is actively being reassessed, especially in rural or underserved areas, as a result of the COVID-19 pandemic.

Impact on Administrative Services

Healthcare providers of all types, especially those still reliant on fee-for-service reimbursement, who were forced to halt services to help stem the spread of the coronavirus suffered significant financial losses.9 The pandemic resulted in a rapid surge of telehealth appointments as providers and patients faced reduced in-person interactions or opted for online meetings.9

Payers and health benefit administrators finally began leveraging AI-based solutions to improve claims processing.10 The use of cognitive automation allows health insurers to engage with members in intelligent, personalized ways. As a result of the pandemic, general health and wellness with preventive care was in the spotlight. Short-term trends regarding routine primary care in the pandemic resulted in highlighting key gaps in healthcare management.10

Not to be left out, integrative medicine providers, following the lead of CVS Health, Cigna, and UnitedHealth Group, are purchasing existing primary care practices or establishing new ones that feature team-based clinicians beyond only medical. In addition to primary or urgent care, these new practices started in specialty areas, such as cardiology, oncology, or orthopedics, where lessons learned from aggressive rehabilitation medicine practices generated optimal outcomes, at a lower cost of care, mostly out of a hospital.

That trend coincides with the holistic cost-of-care trend that is now promoted by self-insured health plans and their administrative service organizations that focus reimbursement on total cost-of-care value propositions and collaborations across clinical stakeholders. This trend is bolstered by years of CMS moving from fee-for-service to outcomes-based reimbursement payment schemes. Of note, the Managing Director of Healthcare Intelligence at J.D. Power, James Beem, noted that “the major drug store chains are reaping the fruits of a strategy they’ve laid out…‘to become the center of gravity for consumer healthcare.’”11 Regardless of whether those economic fruits occur, the shift in care-delivery settings is undeniable.

As the site of care shifts, so does benefit plan coverage, albeit slowly. Related to the out-of-pocket costs of new and higher-priced drugs, 3 strategy examples that health plan sponsors have or should consider in their pharmacy benefit plan to address the rapidly rising costs of specialty drugs as a value-based strategy include12:

  1. A pass-through pharmacy benefit manager (PBM) contract that allows an employer to carve out any portion of the benefit if the PBM is not effectively managing the benefit
  2. An aligned benefit design in which “employers design their coverage options to control costs now and in the future for the types of specialty medications that they’re looking to cover”12
  3. Health plans that plan sponsors can design “in a way that works with their PBM to ensure copay assistance is not accumulated towards the member’s out-of-pocket” cost.12

Urgency About Affordability

As COVID-19 affected the economy, the already pressing issue of prescription drug affordability took on new urgency among the mix of financial strains. To assist newly unemployed or furloughed workers who lost vital health insurance, plans offered new solutions. One example was the Optum Perks Prescription Relief Program, which “integrates into an employer’s existing drug benefit plan to provide OptumRx members who are termed and have lapsed coverage with ongoing savings on prescriptions and continued access to mail order when their coverage ends.”13

Before the pandemic, tackling chronic diseases to lower the total cost of care for plan sponsors was already a political issue. As the pandemic progressed, evidence emerged that people with COVID-19 who also had chronic conditions, such as respiratory or metabolic disorders, suffered worse outcomes that included increased risks for intensive care unit admission and mortality. Those pandemic-related hospital data reinforced the value of early intervention and preventive and clinical support programs to lower the risk and costs of treating such higher-risk patients.

The transition to the 2021 Biden-Harris Administration came with an anticipated focus on health insurance and the coronavirus pandemic as early priorities.14 There would have been a focus on drug prices as well, but the consensus is now that we will not see major drug pricing initiative change until COVID-19 is behind us. The new administration further explored forming a panel to review independently drug benefits and determine fair prices, as well as capping drug price increases to the rate of inflation, but it remains to be seen what comes from Congress. Patients’ out-of-pocket costs, discouraging unreasonable drug price hikes, and negotiating prices could still happen.14

Wall Street expects declines in elective care to continue in the near-term as coronavirus cases keep fluctuating through 2021. Although the availability of multiple COVID-19 vaccines will likely help volumes, elective procedures are not expected to return to normal until the second half of 2021, according to J.P. Morgan analysts.15 There surely will be financial winners and losers in this scenario; to no surprise, those losers were related to elective procedures or procedures performed in hospital settings.

The key weaknesses were procedures that were not entirely critical and could be shifted to a setting outside the hospital, or those driven by higher income, such as high-risk brain or spine surgeries. Another analyst firm, Moody’s, “expects procedure volumes will continue to recover in 2021 as patients who deferred procedures to treat chronic illnesses return to their healthcare providers,” and it “predicts demand will be volatile based on the spread of COVID-19.”15

Technology-Driven Management

Beyond traditional hands-on care and therapeutic drugs to manage conditions, a rapid emergence of technology-driven care management and therapeutic solutions has arrived. As the new medical frontier, digital health is a fast-emerging continuum from data capture to therapeutics, providing cost-efficiency opportunities and ease of use for consumers. The issues created deal with the following breadth and depth of offerings that most people are not knowledgeable about.

Telehealth/telemedicine. From digital watches that can also monitor some basic body functions (eg, pulse, blood pressure, and temperature), there was a broader use of technology-enabled live virtual visits with clinicians during the pandemic that allowed continued care management, limited physical assessments, medication reviews, and screenings for triage.

Digital medicine/therapeutics. Digital medicine and therapeutics typically use cognitive behavioral therapy strategies that were the exclusive domain of psychiatrists and counselors, especially in addiction or mental health. Today, a broad array of digital therapeutics have been approved by the US Food and Drug Administration (FDA), but they require a better understanding of their supportive evidence and can be part of a combined care management strategy. These therapeutics offer a solution for access to care and affordability barriers that are facing the current marketplace.

Virtual care impact. Generational differences in the ability of patients to use digital or virtual care technologies proved to be a bigger issue than many thought at the start of the pandemic. How providers should address those utilization barriers is a common issue raised by health plan sponsors and consumer advocates to advance their ease of use at any age.

Cybersecurity is an issue that increased significantly during the pandemic in all aspects of daily life for patients as in-person transactions almost instantly moved to online primarily since 2019. Insurers, device manufacturers, care-delivery entities, schools, and banks have all felt the sting of being hacked from anywhere in the world through unique Internet access points.

AI and analytics. Understanding healthcare data has become even more important, as well as knowing what action(s) to take based on the data analyzed. Increasingly, real-time data assessments, projections, and models have been used to help manage the various health crises that emerged during the pandemic.

We have quickly seen the emergence of digital health (Figure 1) to the newer sector of out-of-hospital digital therapeutics. The pandemic has changed the acceptance of technology as part of healthcare, and digital therapeutics are poised to change how we access care. Digital therapeutics have become an exciting, incredibly competitive new frontier in healthcare, by delivering evidence-based therapeutic interventions to patients via software applications. At the higher end of treatment capability, digital therapeutics are meant to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions.

Figure 1

Although touted to be as clinically effective as pharmaceuticals in some conditions, the development time and/or treatment costs of digital therapeutics are significantly less than those of drugs, which usually take years and many more billions of dollars to bring to the US market. Coupled with clinician access issues and concerns regarding stigma in seeking care, the lower economic digital therapeutics cost is only one of a growing number of reasons that an increasing number of people are seeking digital therapeutics solutions.16

Impact on Drug Manufacturers

Having and successfully using multiple and/or duplicative supply chains for biologic, nonbiologic, diagnostics, devices, or vaccines is becoming a key differentiator among manufacturers of drugs as a result of the pandemic. International versus domestic supply chains are becoming more frequent. All these supply chain considerations are a vital part of the current care-delivery process in ways that we have never seen before in healthcare. Fundamentally, getting these supply chains and inventory levels correctly within the chain requires strategic systems thinking regarding all functions in the organization.

The topics for material suppliers, manufacturers, logistical providers, and end-user decision makers to consider more closely in healthcare delivery include17:

  1. Increasing storage and self-distribution
  2. Deeper relationships and backup suppliers versus sole source–focused efforts
  3. Novel supply chain models for new care settings in addition to efficiencies explored in existing settings
  4. Smarter, faster, and predictive information that is actionable to avoid drug shortages more quickly.

Although demand for COVID-19 testing will continue to accelerate over the next year, it benefits companies that develop and sell diagnostic tests, such as Abbott Laboratories. Other beneficiaries include life science companies that provide reagents used in these tests, such as Thermo Fisher Scientific, according to Moody’s analysts.15,18 With expected high demand and volume for COVID-19 tests through 2021, Abbott Chief Executive Officer Robert Ford reported its near completion of capacity expansion at US manufacturing sites, which “will enable production of tens of millions more of its BinaxNOW COVID-19 antigen tests per month for sale to schools, workplaces, and pharmacies.”15

Fewer drug prescriptions were dispensed in 2020 as a result of a decrease in physician visits, contributing to an overall slowdown in medication spending growth amid the pandemic.19 There was also an overall reduction in diagnostic visits, and thus a reduction in prescriptions in 2020 from doctor or telehealth visits. In general, such visits decreased by approximately 21% year over year, even as telehealth grew as a contributor to prescriptions being generated.19 Many healthcare observers identify this as a key trend that has become more prominent during the pandemic. Another trend is that telehealth visits are generating fewer prescriptions than face-to-face visits, particularly in specialties such as allergy, dermatology, psychiatry, endocrinology, and neurology.19

Looking at the overall pharmaceutical market slowing, Doug Long from IQVIA has said that “the total market on a dollar basis grew 5%, marking a slowdown over other recent years.”19 “Traditional [drugs] is growing 2%. Specialty [drugs] was over 10% in 20l8 and 20l9, and grew only 8.4% in 2020,” he noted.19

For pharmacy retailers and mail-order pharmacy, generic drugs represent the vast majority of prescriptions dispensed, and that has strengthened through medication compliance initiatives. In the total market, specialty drugs have a little more than a 49% share of the total market, which is expected to be 50% by 2021 or 2022.19 Mr Long predicts that more specialty biologics and biosimilars will come to market as the healthcare system contains the overall care costs.19

“Real world studies of COVID-19’s impact on health care utilization are arriving daily and their continued publication throughout the next year will be the defining characteristic of HEOR [health economics and outcomes research] in 2021.”1 One analysis of 81 international studies found a 37% median reduction in healthcare services.1

Gene-Based Therapies

Despite considerable progress, gene-based drugs are still mostly limited to the treatment of rare diseases. Drug developers are racing to broaden the reach of gene-based drugs using wide-ranging investment collaborations that can fund multiple research programs. Venture capital and private equity fundraising among investors remain ambitious during the pandemic. Some start-ups explore the use of unorthodox methods to turn gene-modifying medicines normally made through a complex, laborious process into off-the-shelf drugs. Such strategies could make treatments available beyond specialized centers.

Recently, “genetic medicines have shown great promise in treating a handful of rare diseases.”20

While the race to develop vaccines and treatments for COVID-19 dominated headlines in 2020, the pandemic also intersected with many existing trends in pharmacy and population health. The number of orphan drug sales has risen year over year as these drugs have been the focus of increased capital investment (Figure 2).

Figure 2

One reason for this is that gene editing enables researchers, and now drug manufacturers, to influence specific traits that can be inherited by new living cells, when new proteins are created by the division of existing cells. The same technology has also been used to create tests designed for fast detection of coronavirus infection.21 Collectively known as phenotypes, these traits of cells’ genes can “govern the cell’s longevity [and] its ability to survive against injury or illness,” which ultimately are related to curative health or the improved well-being of individuals.21

Newly approved biologic medicines, including gene therapies, cell therapies, and orphan drugs, now target rare diseases. At the same time, concern over how to pay for these expensive therapies also came to the forefront as COVID-19 affected the economy. Although new treatment options emerged for many conditions, oncology drugs are continuing the trend of expensive immunotherapies for cancer.13 In addition to cancer, the FDA approval pipeline also includes key potential treatments for chronic kidney disease and cardiovascular disease before the year’s end.13

Internet of Things and Healthcare

One key aspect exposed by COVID-19 is that our public health system relies on technology from the past century, including manual data entry and faxed forms, thereby ensuring that the data collected are flawed and delayed, and that we are unable to track accurately current and suspected cases of COVID-19 and other diseases, risk stratify patients, or monitor disease progression and predict future spread.22 Although this has been well-known, changing the antiquated and siloed nature of public health data systems and technologies has been targeted for improvement.

Although the pandemic has put a spotlight on drug development, developing a drug typically takes more than 10 years.22 However, in the wake of COVID-19, pharmaceutical manufacturers realize that the acceleration of traditional methods and collaboration is paramount. Newly created AI-powered discovery laboratories will expedite the time to insight.22

Virtual healthcare solutions will continue to develop, including telehealth visits, virtual hospital care, and home-based care.17 In February 2020, 0.1% of Medicare primary care visits were managed via telehealth; by April, that rose to 43.5% because of the pandemic.17 This growth is likely to continue as patients and providers adopt a new mindset about virtual healthcare. Therefore, these experts suggest, “It will be important for organizations to align their virtual strategy with the changing needs of their markets, growth strategy and evolving payment models.”17

The use of newer AI and automation is accelerating in healthcare as in other fields. A few metrics to watch for in care delivery are17:

  1. Quality and efficiency in diagnostic and therapeutic radiology
  2. Real-time analytics to expedite care, from in-home through institutional settings
  3. Productivity in nonclinical areas, such as the supply chain, revenue cycle, and customer service.

Tech-savvy entrepreneurs have rushed into healthcare as a result of the pandemic.23 Small, new biopharmaceutical companies are increasingly launching their own novel devices or drugs rather than having large pharmaceutical companies manage it for them. Those first-time drug launchers comprise >25% of all new drug applications submitted to the FDA since 2016.23

Self-Insured Plans

Through the Employee Retirement Income Security Act (ERISA) or the Taft-Hartley Act, self-insured plan sponsors work with administrative service organizations to execute their coverage strategy. Other employers may purchase insurance coverage through state-regulated insurance carriers.

Under fully insured plans, variations in claim costs, including a drop in elective health services delivered during the pandemic in 2020, raise unexpected questions for all stakeholders. The 3 key questions are: Will the reduction in elective services reverse course after the pandemic is over? What are the potential adverse consequences of patients missing visits to their physicians? And has the care-seeking behavior of patients been changed permanently because of the pandemic?24

The answers to these questions, according to a blog published by Health Affairs, are that “Although it is possible that all three scenarios might occur simultaneously, if the first two predominate, one would expect to see a post-pandemic bulge in demand for elective services well above baseline levels. If the third scenario prevails, the deficit in care giving during the crisis is unlikely to be reversed in the near term.”24

Care itself aside, the associated economic costs (Table) to sponsors of the health plan (ie, employers or insurers) can mean dramatic financial swings in a 2-year period. These fluctuations can result from deferred elective procedures, or from a worsening of a stable chronic condition that has gotten out of control.

Table

For clinicians, assuming that aggregate demand for elective services remains weak even after a vaccination is widespread, independent providers will have limited options to recoup lost revenue. “Small physician practices face particularly high financial risk, with 8 percent having closed by late July [2020] and additional closures forecast after the pandemic subsides. Small practices have little market power to set prices or generate new demand.”24 Although telehealth proved popular during the pandemic, its utilization has already decreased, along with expanded reimbursement for services.

The unknowns regarding returning to normalcy plague many aspects of how consumers spend their money. Even with pressure on some household incomes, consumers continue to spend while trying new brands and products. Perceptions regarding decisions as to the better value continue to be the primary drivers of the new spending behaviors of American consumers.

The goals of the Biden Administration of lowering premiums, enhancing the consumer experience, and reducing regulatory burden anticipate having CMS issuing further rule-making to address the Notice of Benefit and Payment Parameters for 2022 Final Rule proposals.25 Provider and user fee rate changes that the US Department of Health & Human Services (HHS) finalized for the 2021 benefit year represent consumer rate relief as cost-saving measures implemented over the past several years.25

During the 2021 presidential transition, HHS was working on a new regulation to facilitate enrollment into qualified health plans through approved private-sector, direct enrollment entities.25 Whether such new regulations stay or change again remains to be seen. One thing we know is that medical loss ratio–related refunds for underutilized medical benefit ratios have been happening in the fully funded and state exchange market more frequently than before the pandemic. It is anticipated by commercial plan sponsors that 2021-2022 will be “impact years” for such plans, resulting in patient subscribers or plan sponsors receiving refunded premium dollars.

The key emerging trends that will affect employees’ benefits throughout 2021 are listed in the Appendix. Other fast-trending areas include growing interest in the expanding digital health sector. The pandemic has accelerated the adoption of all aspects of consumer and professional digital health products, which is one of the few industries to have grown during the pandemic.

“One area of digital health, fueled by consumer demand that will be a top priority among plan sponsors in 2021, is the increased use of evidence-based digital therapeutics programs to treat chronic conditions,” along with mental health.26 Having coverage for digital software based on solid evidence-based clinical information helps to manage and treat a broad spectrum of conditions. As seen with smoking cessation, cancer, and diabetes, these digital solutions are becoming a fundamental tool in changing behavior to improve employee health outcomes. Alone or in combination with drugs and/or clinical support, promoting access to digital therapeutic programs, backed by rigorous clinical evidence and approved by the FDA, can lead to reduced direct healthcare and other indirect member costs for the employee and the plan sponsor.26

As is now seen with medication adherence services and support programs, plan sponsors are or will be seeking to promote the value of treatment adherence that improves their employees’ health and create total cost-savings.26 This trend is true with drugs and primary care but will now likely include digital therapeutics as well.

Because of the decrease in employer healthcare claims in the first half of 2020 since the pandemic, the Health Research Institute forecasted the 2021 medical cost trend compared with the 2020 estimated healthcare costs, and is normalizing for COVID-19 rather than using the actual 2020 costs.27 In typical fashion with an unknown, such plan advisory groups have developed 3 classic scenarios of medical spending trends for payers for 202127:

  1. “High-spending scenario: Spending grows significantly higher in 2021 after being down in 2020
  2. Medium-spending scenario: Spending grows at roughly the same rate in 2021 as it did from 2014 to 2019 and was expected to in 2020
  3. Low-spending scenario: Spending remains dampened in 2021.”

Conclusion

The key issues trending among US healthcare stakeholders apply to 2021 through 2022 at a minimum, and could extend to 2023 or later, depending on contract renewals or vendor changes.

The key trends focus on the peripandemic healthcare environment, which includes the reengineering of healthcare delivery via testing, treatment, and vaccination. Healthcare-related supply chain impacts during the pandemic illustrate the worldwide fragility and interdependence. Drug and supply shortages will continue to occur unless changes are made from manufacturers to the point of care. Accountability and stability are key areas to determine with trusted agencies, such as the FDA, regarding approved drug components and final packaging for sales.

Financial and peripandemic plan funding issues are putting pressure on all health plans for implementing risk mitigation—a primary purpose of health insurance. Such bottom-line financial impacts on plan sponsors have caused a reemergence of consumerism, transparency from insurer to broker to public disclosure in plan filings at state or federal agencies, and interest in plan sponsor execution of their fiduciary responsibility under ERISA or Taft-Hartley legislation.

Global influences on US domestic decision-making, the impact of evolving federal or state government policies, and access to affordable US healthcare continue with varying degrees of urgency, but are now actively debated in society. It remains uncertain how serious the societal interest is in how and when to make change happen collectively. With the linking of financial and business interests in settling healthcare uncertainties, the preponderance of publicly reported polls shows the direction of making change sooner than later.

Unsustainable trends of increased financial costs of care and lower access to standards of care—the 2 critical tenets of optimal healthcare—are driving outside innovation along with internal restructuring. What will be established in the next 6 to 30 months will last in the market for perhaps a generation as the appetite for focusing on healthcare change likely becomes a lower priority to other pressing national issues.

Author Disclosure Statement

Dr Vogenberg and Mr Santilli have no conflicts of interest to report.

References

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Last modified: September 22, 2021
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