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improving medical quality and the patient experience while reducing the cost of care.
−Removed: Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, playing a pivotal role to broaden access to laboratory insights to help people lead healthier and safer lives.
−Removed: We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and the detection of immune response to the virus, and have performed approximately 63 million of these tests.
−Removed: We have built up and maintain the testing capacity to handle surges in COVID-19 testing demands, including using our national courier, air fleet and logistics network to balance volume across approximately two dozen COVID-19 testing laboratories, and also through our laboratory referral partner program.
−Removed: We are working with federal, state and local governments, healthcare organizations, payers, suppliers, retailers, trade associations and other laboratories in the effort to bring as much COVID-19 testing as possible to the American people.
−Removed: We are also providing data on COVID-19 testing that we conduct to federal, state and local public health authorities, including the federal Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research.
−Removed: All of our employees, including our dedicated laboratory professionals, phlebotomists, air fleet team, and couriers take tremendous pride in the role we play and work tirelessly to help patients and communities access quality COVID-19 testing.
−Removed: We have seen how underserved communities are being disproportionately impacted by COVID-19 with tragic consequences.
−Removed: With the Quest Diagnostics Foundation, we launched Quest for Health Equity, an initiative to reduce health disparities in underserved communities in the U.S.
+Added: Quest Diagnostics was at the forefront of the response to the COVID-19 pandemic, playing a pivotal role to broaden access to laboratory insights to help people lead healthier and safer lives.
+Added: We provided both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and the detection of immune response to the virus, and have performed approximately 77 million of these tests.
+Added: We built up and maintained the testing capacity to handle surges in COVID-19 testing demands, including using our national courier, air fleet and logistics network to balance volume across approximately two dozen COVID-19 testing laboratories, and also through our laboratory referral partner program.
+Added: We worked with federal, state and local governments, healthcare organizations, payers, suppliers, retailers, trade associations and other laboratories in the effort to bring as much COVID-19 testing as possible to the American people.
+Added: We also provided data on COVID-19 testing that we conducted to federal, state and local public health authorities, including the CDC, and participated in studies with government and private institutions, aiding COVID-19 public health response and research.
+Added: All of our employees, including our dedicated laboratory professionals, phlebotomists, air fleet team, and couriers took tremendous pride in the role we played and worked tirelessly to help patients and communities access quality COVID-19 testing.
+Added: As the impact of COVID-19 moderates, we remain active in the continued response to COVID-19, including supporting ongoing testing needs and public health response.
+Added: We also saw how underserved communities were disproportionately impacted by COVID-19, and with the Quest Diagnostics Foundation, we launched Quest for Health Equity, an initiative to reduce health disparities in underserved communities in the U.S.
This initiative is providing a combination of testing services, education programs, alliances and financial support to efforts to address health disparities.
−Removed: Since its inception, we have launched over 25 programs across the U.S.
−Removed: and Puerto Rico, including supporting COVID-19 testing and vaccination events, educating young students on healthy nutrition choices and expanding research and mentorship opportunities for black and Hispanic scholars.
−Removed: Our approach to fighting the COVID-19 pandemic has been rooted in our vision of empowering better health through diagnostic insights.
−Removed: We believe that the challenges we are facing from the COVID-19 pandemic have brought us together, made us a stronger company and will help us capture the substantial opportunities in front of us.
+Added: Since its inception, we have committed approximately $30 million to approximately 65 programs launched across the U.S.
+Added: and Puerto Rico, including supporting COVID-19 testing and vaccination events, wellness events, educating young students on healthy nutrition choices and expanding research and mentorship opportunities for Black and Hispanic scholars.
+Added: Numerous Quest for Health Equity undertakings demonstrate our commitment to FQHCs and the people they serve, including by providing free lab testing services.
+Added: Our approach to fighting the COVID-19 pandemic was rooted in our vision of empowering better health through diagnostic insights.
+Added: We believe that the challenges we faced from the COVID-19 pandemic brought us together, made us a stronger company and will help us capture the substantial opportunities in front of us.
We have a two-point business strategy, reviewed by our Board of Directors, to achieve our vision and our goals.
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Growing through acquisitions.
−Removed: We endeavor to grow revenue each year by more than 2% through accretive, strategic acquisitions (our target is based on our revenues excluding the revenues from our COVID -19 testing).
+Added: We endeavor to grow revenue each year by more than 2% through accretive, strategic acquisitions (our target has been based on our revenues excluding the revenues from our COVID-19 testing).
Acquisition opportunities may include IDN outreach businesses, regional laboratory consolidation and businesses that will provide us with new capabilities.
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For example, we strive to build information platforms to help health plans manage utilization and population health, keep laboratory testing in network and provide an alternative to high-cost labs.
−Removed: We also offer extended care services to help close gaps in care designed to be attractive to payers, for example through our Quest HealthConnect offerings.
−Removed: In 2021, we made progress with value-based programs with UnitedHealthcare and broadened redirection and network leakage efforts with Anthem.
−Removed: We also renewed our longstanding
−Removed: relationships with Aetna (remaining a preferred laboratory provider and partner in Aetna's network) and EmblemHealth (one of the nation's largest non-profit health insurers).
−Removed: In addition, we expanded access, including with Highmark Delaware and other plans.
+Added: We also offer extended care services to help close gaps in care designed to be attractive to payers.
+Added: In 2022, we augmented our extended care offering by acquiring Pack Health, a patient engagement company that helps individuals adopt healthier behaviors to improve outcomes.
+Added: We expanded the plans with which we have a value-based
+Added: contracting relationship, fostering better alignment with the health plans.
+Added: We also renewed our longstanding strategic relationship with Blue Cross and Blue Shield of Florida, Inc.
Increasing share with IDNs.
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We have deployed a dedicated team to strengthen our relationships with IDNs, including with respect to their reference testing.
−Removed: We target three specific segments:
+Added: We target three specific opportunities:
reference testing, outreach testing and lab management.
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We purchase outreach testing businesses from IDNs that decide to exit that business.
−Removed: In 2021, we recorded our highest level of Professional Laboratory Services revenues to date and, as discussed below under the heading Deliver disciplined capital deployment, acquired the outreach testing business of Mercy.
+Added: In 2022, we continued to work with IDNs to help them execute their lab strategy, started providing laboratory management services to Lee Health, a community-owned health system in Southwest Florida, and entered an agreement to provide lab management services to Northern Light Health, a large integrated healthcare system in Maine.
+Added: In addition, as discussed below under the heading Deliver disciplined capital deployment, we acquired the outreach testing business of Summa Health, a large integrated healthcare system in Northeastern Ohio, and agreed to acquire select assets of Northern Light Health's outreach testing business.
+Added: We also were awarded a group purchasing agreement for our laboratory stewardship solution, including Quest Lab Stewardship TM Enterprise powered by hc1 ® , with Premier Inc., a leading healthcare improvement company uniting an alliance of hospitals, health systems and providers.
Key Professional Laboratory Services Offerings (Table 3)
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We are seeking to apply the capabilities gained by these efforts to other areas where we can make a meaningful difference in health care, including consumer genetics and offerings to pharmaceutical companies, IDNs and health plans.
−Removed: In 2021, we expanded our offerings with the addition of Biocept Inc.'s liquid biopsy test for non-small cell lung cancer.
−Removed: We also saw strong growth in non-invasive prenatal testing and a solid contribution in specialty genetics from Blueprint Genetics.
+Added: In 2022, we invested in our bioinformatics capabilities and our women's health sales force, and to accelerate growth in oncology, hematology, and pharma services.
+Added: We introduced the Solid Tumor Expanded Panel to help oncologists with therapy selection and Quest AD Detect, a blood test to aid in the early assessment of Alzheimer's disease.
+Added: During 2022, we saw strong growth in prenatal genetic testing and pharma services.
Building consumer-initiated testing.
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We will continue to focus on improving the consumer experience, including through improved digitization and other enhancements of our operations.
−Removed: For example, in 2021 we improved the functionality of our MyQuest ® app, taking into account consumer feedback.
+Added: For example, our "Schedule at Check In" capability, which encourages patients to make appointments, allowing us to better manage demand and phlebotomy productivity while enhancing the patient experience, is now deployed at approximately 85% of our patient service centers.
+Added: We have increased to approximately 80% the number of our patients coming to a patient service center who have appointments, and reduced average wait times in the centers.
+Added: We also are sending more messages to patients via SMS text, increasing the speed and utility of information flow to patients and patient satisfaction.
+Added: In addition, we are building the patient payment process into the digital customer experience, improving the patient experience, helping our patient concession rate, and reducing demands on phlebotomists.
Increasing consumer expectations inform our design for our consumer experience.
Consumer-Centric Initiatives (Table 4)
−Removed: Connectivity and access to information • >21.5 million registered users in our MyQuest ® health portal and mobile connectivity solution, up nearly 7 million from a year ago.
+Added: Connectivity and access to information • >27.5 million registered users in our MyQuest ® health portal and mobile connectivity solution, up over 6 million from a year ago.
• Quest lab results available for Android users through the CommonHealth app.
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• Improved on-line pre-registration and appointment scheduling.
−Removed: • Real-time payment determination for payers.
+Added: • Real-time payment determination.
Convenient access • Partnerships with Walmart and Safeway to expand convenient access to testing services at select Walmart and Safeway locations across the United States (approximately 200 locations at year end).
−Removed: Expanded access to basic healthcare services • Partnership with Walmart to expand access to basic healthcare services.
−Removed: Self-collection technology • Proprietary, consumer-friendly self-collection technology offered to consumers at home.
−Removed: Satisfaction • We are measuring consumer satisfaction, including Net Promoter Score.
−Removed: In 2018, we launched QuestDirect ® , our consumer-initiated testing offering that permits consumers to request their own lab tests, to allow consumers to take control of their health and to better understand their own health through access to personal diagnostic information.
+Added: Self-collection technology • Proprietary, consumer-friendly self-collection technology offered
+Added: Satisfaction • We are measuring consumer satisfaction.
+Added: In 2018, we launched our consumer-initiated testing offering that permits consumers to request their own lab tests, to allow consumers to take control of, and to better understand, their own health through access to personal diagnostic information.
In an evolving healthcare environment, consumers are increasingly engaged in their health care and want control, a dynamic experience and convenience.
−Removed: We believe that by building on the foundation of our strong consumer focus we can capture growing opportunities in consumer-initiated testing.
−Removed: In 2021, we continued the strong growth in QuestDirect ® and launched our comprehensive consumer health profile, which offers consumers a picture of their own health through a battery of tests and biometric measurements that provides a personalized health quotient score that can be used to track health progress over time.
−Removed: We also are extensively engaged with telehealth providers, supporting their offerings as a diagnostic information services provider.
+Added: Our QuestHealth TM offering reflects our belief that by building on the foundation of our strong consumer focus we can capture growing opportunities in consumer-initiated testing and demand for expanded access to basic health care services.
+Added: In 2022, we continued to invest in our offering, launching an enhanced digital platform with a more powerful and consumer-friendly user experience designed to better acquire, convert and retain more customers.
+Added: We collaborated with Walmart, to make consumer-initiated testing available through Walmart.com, and with eMed TM , to launch a COVID-19 rapid antigen test with observed collection, helping individuals meet travel and other observed collection and test report requirements.
We are focusing on consumer interest to experience health care in a different way
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Consumer-Initiated Testing (Table 5)
−Removed: Consumer-initiated testing • Consumers can choose from approximately 50 different test packages focused on consumer interests, such as general health, men's and women's health, digestive health, heart health, infectious disease, sexually transmitted disease, COVID-19 and Lyme disease.
−Removed: In 2021, we expanded our offerings to include Insure ® ONE TM for colorectal cancer screening.
−Removed: Self-collection technology • In 2021, we expanded our proprietary, consumer-friendly self-collection technology offered to consumers at home.
−Removed: Convenient access • Access to services in our patient service centers and in select Walmart stores
−Removed: Convenient payment • Introduced flexible payment options in 2021
+Added: Consumer-initiated testing • Consumers can choose from approximately 60 different test purchase options focused on consumer interests, such as general health, men's and women's health, digestive health, heart health, infectious disease, sexually transmitted infection, COVID-19, and Lyme disease.
+Added: Expanded offerings • In 2022, we expanded our offerings to include, among others, new respiratory, thyroid, kidney and fitness tests.
+Added: Basic healthcare services • Comprehensive consumer health profile available, through tests and biometric measurements that provide a personalized health quotient score that can be used to track health progress over time.
+Added: Self-collection technology • Proprietary, consumer-friendly self-collection technology offered to consumers at home.
+Added: Convenient online access • In addition to access through QuestHealth.com, access to services through Walmart.com.
+Added: Convenient physical access • Access to services in our patient service centers and in select Walmart stores.
Drive operational excellence
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Major Themes to Drive Operational Excellence (Table 6)
−Removed: Reduce denials and patient concessions Standardize and automate
−Removed: Digitize the customer experience Optimize
+Added: Reduce denials and patient concessions Standardize, automate and optimize
+Added: Digitize the customer experience Select and retain talent
Improving our operations will yield many benefits, including:
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During 2022, we made strong progress on our improvement initiatives.
−Removed: We completed the consolidation and integration of Northeast U.S.
−Removed: regional operations into our new 250,000 square foot, highly automated, flagship laboratory in Clifton, New Jersey.
−Removed: We also commenced consolidation of our urinalysis testing onto a new highly automated platform that we expect will generate substantial savings once implemented.
−Removed: We are taking advantage of robotic process automation technologies.
−Removed: In addition, we also increased patient use of appointment scheduling, reduced payor denials and improved patient collection at the time of service.
−Removed: We also are seeing increased patient and physician acceptance of the digitization of our service offerings, with more self-service options and a greater percentage of our volume moving to digital, paperless transactions.
+Added: We are working to further enhance end-to-end specimen tracking.
+Added: We concluded consolidation of our urinalysis testing onto a new highly automated platform.
+Added: We implemented new semi-automated technology in parasitology and are expanding use of a highly automated microbiology platform that makes use of artificial intelligence to assist with sample analysis.
+Added: We also made significant progress transferring immunoassay tests to a more automated platform, and expect to finish this project in 2023.
+Added: We increased customer adoption of our digital self-service channels, reducing demand in our call centers.
+Added: We implemented several initiatives to improve talent retention, including capability-building programs, and launched plans for a new daily management system for our frontline employees.
+Added: In addition, we continue to drive to take advantage of robotic process automation and artificial intelligence technologies to drive productivity gains.
Our cost excellence program, Invigorate, includes structured plans to drive savings and improve productivity across the value chain, including in such areas as revenue services, information technology and procurement.
We currently aim annually to achieve savings and productivity improvements of 3% of our costs.
−Removed: In 2021, we exceeded our goal.
+Added: In 2022, we approached our goal.
OUR STRENGTHS
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Our goal is to provide every patient with services and products of superior quality.
−Removed: We strive to accomplish that through commitment, leadership, and establishing rigorous processes which we measure and continually seek to improve, and by using the Quest Management System, which provides best-in-class business performance tools to create and implement effective and sustainable quality processes.
−Removed: The Quest Diagnostics Quality Program includes policies and procedures to document, measure and monitor the effectiveness of our laboratory operations in providing and improving quality and meeting applicable regulatory requirements.
+Added: We strive to accomplish that through commitment, leadership, and establishing rigorous processes that we measure and continually seek to improve, and by using the Quest Management System, which provides best-in-class business performance tools to create and implement effective and sustainable quality processes.
+Added: Our Quality Program includes policies and procedures to document, measure and monitor the effectiveness of our laboratory operations in providing and improving quality and meeting applicable regulatory requirements.
The Quality Program is designed so that the quality of laboratory services is monitored objectively and evaluated systematically to deliver superior quality care, identify opportunities to improve patient care and resolve identified problems.
−Removed: To help achieve our goal of becoming recognized as the undisputed quality leader in the diagnostics information services industry, we have implemented our Quality System Framework, which serves as a reference
−Removed: guide for our employees and describes our Quality System Elements, which provide the structure for each laboratory to achieve and maintain quality processes.
+Added: To help achieve our goal of becoming recognized as the undisputed quality leader in the diagnostics information services industry, we have implemented our Quality System Framework, which serves as a reference guide for our employees and describes our Quality System Elements, which provide the structure for each laboratory to achieve and maintain quality processes.
We also have a robust Supplier Quality Program designed to ensure we have a high-quality supplier network and to raise the bar of quality expectations across that network.
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• Align for Growth, Execution and Efficiency .
−Removed: Our organization is designed to align around future growth opportunities, coordinate business units for seamless execution and leverage our company-wide infrastructure to gain more capability, value and efficiency.
+Added: Our organization is designed to align around growth opportunities, coordinate business units for seamless execution and leverage our company-wide infrastructure to gain more capability, value and efficiency.
We relied on this organizational design to allow us to develop a coordinated and sustained strategy to respond to the unprecedented challenges we face responding to the COVID-19 pandemic.
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We maintain a sharp focus on providing diagnostic information services.
−Removed: During 2021, we sold to IQVIA Holdings Inc.
−Removed: our 40% minority stake in Q 2 Solutions, ® our clinical trials central laboratory services joint venture, and in connection with the sale we entered a multi-year agreement to continue to support Q 2 Solutions as its strategic preferred laboratory partner.
Deliver disciplined capital deployment.
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Consistent with that expectation, in February 2023 we announced that we increased our quarterly common stock cash dividend by approximately 7.6%, from $0.66 per common share to $0.71 per common share.
−Removed: This represents our eleventh increase in the dividend since 2011.
+Added: This represents our twelfth increase in the dividend since 2011.
For many years, we have maintained a common stock repurchase program.
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We screen potential acquisitions using guidelines that assess strategic fit and financial considerations, including value creation, return on invested capital and impact on our earnings.
−Removed: In 2021, we consummated the acquisition of the outreach laboratory services business of Mercy, one of the most highly-integrated, multi-state health care systems, with operations serving providers and patients in Arkansas, Kansas, Missouri and Oklahoma.
−Removed: We also acquired assets of Labtech Diagnostics LLC, an independent clinical laboratory serving physicians and patients primarily in South Carolina, North Carolina, Georgia and Florida, and a couple of other small independent regional labs.
+Added: In 2022, we consummated the acquisition of Pack Health, a patient engagement company that helps individuals adopt healthier behaviors to improve outcomes, and the outreach testing business of Summa Health, a large integrated healthcare system in Northeastern Ohio.
+Added: We also agreed to acquire select assets of the outreach testing business of Northern Light Health, a large integrated healthcare system in Maine.
Our significant acquisitions in each of the last three years are further discussed in Note 6 to the audited consolidated financial statements (Part II, Item 8 of this Report).
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Our near-term investments in growth are likely to focus on the approaches to accelerate growth set forth in table 2 above.
−Removed: Our near-term investments to drive operational excellence are likely to focus on improving the customer experience and gaining efficiency, systems standardization, digital enablement of our processes and footprint optimization.
+Added: Our near-term investments to drive operational excellence are likely to focus on improving the customer experience and gaining efficiency, systems standardization, and digital enablement of our processes.
Assets and capabilities to deliver value
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Assets and Capabilities (Table 8)
−Removed: Connectivity ● Provide healthcare connectivity solutions to >445,000 clinician and IDN accounts and interface with >800 electronic health records systems
+Added: Connectivity ● Provide healthcare connectivity solutions to >475,000 clinician and IDN accounts and interface with nearly 850 electronic health records systems
Data ● The largest private database of de-identifiable laboratory test results:
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● One of the largest medical and scientific staffs in the industry to provide interpretive consultation
−Removed: • >650 M.D.s and Ph.D.s, many of whom are recognized leaders in their field
+Added: • Approximately 600 M.D.s and Ph.D.s, many of whom are recognized leaders in their field
• Genetic counselors
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Consumer Access
−Removed: ● >7,100 patient access points, including phlebotomists in physician offices and the most extensive patient service center network in the U.S.
−Removed: with >2,100 locations
+Added: ● Approximately 7,300 patient access points, including phlebotomists in physician offices and the most extensive patient service center network in the U.S.
+Added: with approximately 2,100 locations
Health Plan Participation
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Processing Volume
−Removed: ● Processed approximately 218 million test requisitions in 2021
+Added: ● Processed approximately 208 million test requisitions in 2022, including approximately 15 million COVID-19 molecular test requisitions
Range of Testing
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Cardiovascular, Metabolic and Endocrinology Cancer Diagnostics
−Removed: General Health and Wellness Drug Monitoring and Toxicology
−Removed: Infectious Diseases and Immunology Sports Science and Human Performance
+Added: Infectious Diseases and Immunology Drug Monitoring and Toxicology
Neurology Women’s and Reproductive Health
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In addition, we aim to develop holistic solutions responsive to challenges that healthcare providers and patients face, by developing solutions of tests, information and services focused on specific clinical challenges, and taking advantage of the latest healthcare data capabilities.
−Removed: We also look for innovations and solutions that are less invasive than currently available options, and to increase the choices that healthcare providers and patients have for the collection of diagnostic samples.
+Added: We also look for innovations and solutions that are less invasive than currently available options, and to increase the choices that healthcare providers and patients have for the collection of diagnostic specimens.
We seek innovation in the ways we bring solutions to customers, and in the customer experience, including enhanced services and end-to-end solutions for convenience and support.
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We plan to expand our innovative solutions through research and development, as well as partnerships with academic institutions, other technology and healthcare leaders and public health agencies.
−Removed: Since the beginning of the COVID-19 pandemic, we have secured an Emergency Use Authorization from the FDA for pooled specimen testing in connection with molecular diagnostic COVID-19 testing.
−Removed: With government and private sector partners, we developed and built "pop-up" COVID-19 testing sites that offered a new, efficient model for consumer access to testing at a critical time.
−Removed: During 2021, we introduced a new COVID-19 semi-quantitative serology test service that aids in providing insight into an individual's immune response as a result of a recent or prior infection with SARS-CoV-2, including assessing blood levels of antibodies.
−Removed: In addition, we licensed the patented ceramide-analysis technology of Zora Biosciences Oy and announced plans to develop, and offer through our Cardiometabolic Center of Excellence at Cleveland Heartlab, a test service as an aid in identifying patients at risk for cardiovascular-related disease and death.
+Added: During the COVID-19 pandemic, we secured numerous Emergency Use Authorizations from the FDA related to molecular diagnostic COVID-19 testing and, with government and private sector partners, developed and built "pop-up" COVID-19 testing sites that offered a new, efficient model for consumer access to testing.
+Added: In 2022, we innovated with the CDC Increasing Community Access to Testing for COVID-19 program to increase access to $0 out-of-pocket COVID-19 testing in underserved communities using a combination of our capabilities including our strong COVID-19 molecular testing, our on-line capabilities and our patient service centers.
+Added: We secured the first Emergency Use Authorization from the FDA during the Mpox (formerly known as Monkeypox) public emergency for an LDT to aid in the detection of Mpox.
+Added: We also launched a new obstetrics test panel that included hepatitis C screening.
These initiatives, along with other developments highlighted below under the headings "Collaboration," "Medical and Scientific Expertise," and "Healthcare Information Technology Solutions and Information Assets," demonstrate our agility and strength in innovation.
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We plan to continue to pursue strategic relationships to help accelerate growth and drive operational excellence.
−Removed: In 2021, we announced our collaboration with Paige to unlock the potential of artificial intelligence to improve and speed the diagnosis of cancer and other diseases that rely on pathologic assessment.
−Removed: We also collaborated with CIC Health, Ginko Bioworks and Battelle Memorial Institute to develop solutions to make testing easy, fast and affordable for school systems and other group settings ( e.g ., the travel and entertainment industry) across the country.
+Added: In 2022, we collaborated with IRIS (Intelligent Retinal Imaging Systems) to offer diabetic retinopathy screening services in our patient service centers, with Walmart to make consumer-initiated testing available through Walmart.com, and with eMed TM to launch a COVID-19 rapid antigen test with observed collection, to help individuals meet travel and other observed collection and test report requirements.
Medical and Scientific Expertise
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The Company also publishes Quest Diagnostics Health Trends, ® a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy.
−Removed: Our role at the forefront of the response to the COVID-19 pandemic demonstrated this strength.
−Removed: We have secured over 20 Emergency Use Authorizations from the FDA for innovations in connection with COVID-19 testing and specimen collection, including regarding unobserved nasal specimen self-collection, combined COVID-19 and respiratory virus tests, COVID-19 at-home specimen collection by consumers, and methods to increase testing capacity and expand the testing supply base.
−Removed: In addition to a Health Trends ® report on children in the U.S.
−Removed: with detectable levels of lead in their blood, we published numerous Health Trends ® reports on COVID-19, including during 2021 additional reports addressing the "hidden pandemic":
−Removed: signs of addiction missed during the pandemic;
−Removed: the sharp decline in cancer diagnoses during the first year of the pandemic;
−Removed: decreases in hepatitis C testing and treatment during the first months of the pandemic;
−Removed: and Blacks and Hispanic/Latinx less confident in their ability to access COVID-19 vaccines, treatment and healthcare than white Americans.
−Removed: We also expanded our engagement with the Centers for Disease Control and Prevention to provide genomic sequencing of emerging COVID-19 variants, to aid public health response to COVID-19.
+Added: Our role at the forefront of the response to the COVID-19 pandemic demonstrated this strength, as we secured numerous Emergency Use Authorizations from the FDA for innovations in connection with COVID-19 testing and specimen collection ( e.g.
+Added: , unobserved nasal specimen self-collection;
+Added: combined COVID-19 and influenza virus tests;
+Added: COVID-19 at-home specimen collection by consumers).
+Added: In 2022, we published more Health Trends ® reports on consequences of COVID-19, along with other reports on, for example, screening pregnant women for hepatitis C, and hepatitis B and tuberculosis co-infection.
+Added: We also published studies regarding diabetes cost reductions achieved for participants in employer-sponsored health programs, perspectives on the future of Alzheimer's Disease treatment and the potential importance of employee health to addressing the "Great Resignation." In addition, we employed our comprehensive menu of COVID-19 test and data analytics to support CDC population health research, helping to identify SAR-COV-2 seroprevalence on a multistate basis.
Health Information Technology Solutions and Information Assets
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We were the first national diagnostic information services provider to offer online patient appointment scheduling and a patient connectivity solution.
−Removed: Our MyQuest ® patient healthcare portal, with 21.5 million registered users at year-end 2021, enables patients to manage healthcare and medical information for themselves and a circle of others and, among other things, use their smartphone or computer to order a test, find a Quest Diagnostics location, schedule appointments, receive appointment reminders, and receive and archive their test resul ts.
−Removed: During the COVID-19 pandemic, we collaborated with CLEAR to integrate CLEAR's safe and secure "Health Pass" technology with the Company's advanced COVID-19 testing capabilities to foster safer public environments and help reduce public health risk.
−Removed: We also are a founding member of the Synaptic Healthcare Alliance, which is working to create a platform, powered by blockchain technology, that enables a culture of innovation, removes friction and solves shared challenges impacting constituents across healthcare today.
+Added: Our MyQuest ® patient healthcare portal, with more than 27.5 million registered users at year-end 2022, enables patients to manage healthcare and medical information for themselves and a circle of others and, among other things, use their smartphone or computer to order a test, find a Quest Diagnostics location, schedule appointments, receive appointment reminders, assess whether their health plan is in-network and receive and archive their test results.
+Added: We are expanding our use of digital and other technology tools to improve our customer experience for patients and providers.
+Added: We also were a founding member of the Synaptic Healthcare Alliance, which is working to create a platform, powered by blockchain technology, that enables a culture of innovation, removes friction and solves shared challenges impacting constituents across healthcare today.
We also have significant information assets and offer a robust portfolio of powerful analytics that inspire action and deliver value to an array of customers.
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Commonly ordered routine tests include blood chemistries, urinalysis, allergy tests and complete blood cell counts.
−Removed: Non-routine tests may require professional “hands-on” attention from highly-skilled technical personnel, generally require more sophisticated data analysis, technology, equipment or materials, may be performed less frequently than routine tests and may be reimbursed at higher levels than routine tests.
−Removed: It may not be practical, from a cost-effectiveness or infrastructure perspective, for many IDNs, ACOs, DCEs, commercial laboratories or physician office laboratories to develop and perform a broad menu of non-routine tests, or to perform low-volume non-routine testing in-house.
+Added: Non-routine tests may
+Added: require professional “hands-on” attention from highly-skilled technical personnel, generally require more sophisticated data analysis, technology, equipment or materials, may be performed less frequently than routine tests and may be reimbursed at higher levels than routine tests.
+Added: It may not be practical, from a cost-effectiveness or infrastructure perspective, for many IDNs, ACOs, commercial laboratories or physician office laboratories to develop and perform a broad menu of non-routine tests, or to perform low-volume non-routine testing in-house.
Such tests generally are outsourced to a clinical testing laboratory which can perform these non-routine tests.
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We are the world's leading provider of diagnostic information services.
−Removed: We provide information and insights based on the industry-leading menu of routine, non-routine and advanced clinical testing and anatomic pathology testing, and other diagnostic information services.
+Added: We provide information and insights based on an industry-leading menu of routine, non-routine and advanced clinical testing and anatomic pathology testing, and other diagnostic information services.
We have strong testing capabilities, including services for the predisposition, diagnosis, treatment and monitoring of cancers and other diseases, and offer advanced tests in many fields, including endocrinology, immunology, neurology and oncology.
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We offer the broadest access in the United States to clinical testing.
−Removed: We maintain a nationwide network of laboratories, including advanced laboratories (such as our world-renowned Quest Diagnostics Nichols Institute ® ) as well as rapid response laboratories (smaller facilities where we can quickly perform an abbreviated menu of routine tests for customers that require rapid turnaround times).
+Added: We maintain a nationwide network of laboratories, including advanced laboratories as well as rapid response laboratories (smaller facilities where we can quickly perform an abbreviated menu of routine tests for customers that require rapid turnaround times).
We operate 24 hours a day, 365 days a year.
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We strive to be the first to provide diagnostic solutions for emerging infectious diseases ( e.g ., our offerings for Zika, West Nile Virus, SARS and Influenza A H1N1).
−Removed: We have leading positions in drug monitoring and toxicology, in neurology diagnostics, in advanced cardiovascular diagnostic information services ( e.g ., our CardioIQ ® and Cleveland HeartLab ® offerings through our Cardiometabolic Center of Excellence TM ), and in cancer diagnostics ( e.g ., our QuestVantage ® and Med Fusion TM offerings).
−Removed: We are a leader in providing testing for the detection of employee use of drugs of abuse, offering a full range of solutions, including urine, hair, blood and oral fluid tests.
−Removed: We are the largest workplace drug testing provider certified by the U.S.
−Removed: Department of Health and Human Services to perform drug testing using electronic custody and control forms for federally-mandated, safety-sensitive workers.
+Added: We have leading positions in drug monitoring and toxicology, in neurology diagnostics, in advanced cardiovascular diagnostic information services ( e.g ., our CardioIQ ® and Cleveland HeartLab ® offerings through our Cardiometabolic Center of Excellence TM ), and in cancer diagnostics ( e.g ., our QuestVantage ® offerings).
+Added: We are the largest workplace drug testing provider, testing urine, hair, and oral fluid specimens, and are certified by HHS to perform drug testing using electronic custody and control forms for federally-mandated, safety-sensitive workers.
We are a leading provider of employer population health services, including biometric screenings, flu shots and related preventative services that leverage clinical data to improve population health outcomes and reduce healthcare spend.
Our solutions enable employers to leverage screening insights to identify chronic disease risks, connect employees to needed in-network care, and empower better health.
−Removed: Our offerings include connecting participants to the right care at the right time, such as (i) a program designed to prevent diabetes and other chronic conditions, (ii) a program that enables participants to engage with a board-certified physician about their results and to be guided about actions based on those results and (iii) a mental health assessment program that links participants to virtual support.
−Removed: We also collaborate with Catapult Health, the leading national provider of employer-sponsored preventative checkups, to help organizations facilitate virtual telehealth access to clinical services for their employees and adult dependents, with emphasis on reducing risks related to preventable chronic diseases.
−Removed: These services are sold directly to employers and through reseller partnerships with health plans.
−Removed: In response to the COVID-19 pandemic, we developed and offered COVID-19 return to work services, to assist organizations as they developed plans for safer workplaces.
+Added: Our offerings include connecting participants to the right care at the right time, such as (i) a program designed to prevent diabetes and other chronic conditions, (ii) a program that enables participants to engage with a board-certified physician about their results and to be guided about actions based on those results, (iii) a mental health assessment program that links participants to virtual support and (iv) a program to facilitate virtual telehealth access to clinical services for participants and adult dependents, with emphasis on reducing risks related to preventable chronic diseases.
+Added: These services are sold directly to employers and by health plan resellers.
+Added: In response to the COVID-19 pandemic, we developed and offered COVID-19 return to work services, to assist organizations developing plans for safer workplaces.
We offer Quanum ® health information technology solutions, including our products and national healthcare provider network, to help healthcare organizations and clinicians empower better health by leveraging the power of our significant information assets, including many years of test result data, and our technology prowess, including our history of providing leading information technology for diagnostic information services.
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They can enter, share and access clinical information without costly information technology implementation or significant workflow disruption.
−Removed: We offer an array of population health solutions to clinicians, health plans, and IDNs.
+Added: We offer population health solutions to clinicians, health plans, and IDNs.
Our services build on the power of our information assets and data capabilities and help our customers deliver better care to their patient populations by identifying gaps in care in a population, providing clinical solutions to close the gaps and fostering consumer engagement with a solution.
−Removed: For example, Quest Lab Stewardship TM employs machine learning to help optimize medically-appropriate laboratory test utilization.
−Removed: Our extended care services, including home-based health risk assessments and related services, help deliver better care to their patient populations by identifying and filling gaps in care for their patient populations and by enabling them to deliver the most effective healthcare to the right populations and individuals.
−Removed: These services leverage the power of our assets ( e.g ., our extensive clinical data and data analytics services) and capabilities ( e.g ., call centers, patient service centers and mobile workforce, including professionals) and focus on extending the reach of clinician offices beyond their traditional four walls to assess the health of their populations, and doing so when and where it is convenient for consumers.
−Removed: Once gaps are identified, we engage patients in our retail sites, in home or by telephone, including through our call centers and our mobile base capabilities, including highly-trained healthcare professionals.
−Removed: We also offer services such as diabetic retinopathy and bone density examinations.
−Removed: We offer services to pharmaceutical companies, including clinical trials testing.
−Removed: We have expertise in developing laboratory tests for FDA submission as companion diagnostics and laboratory developed tests for complementary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
−Removed: For example, in 2021, we introduced Ki-67 IHC MIB-1 pharmDx, the first companion diagnostic for Eli Lilly and Company's Verzenio ® (abemaciclib), a CDK4/6 inhibitor for certain people with HR+HER2- High Risk early breast cancer.
+Added: For example, Quest Lab Stewardship TM employs machine learning to help clinicians optimize medically-appropriate laboratory test utilization.
+Added: Our extended care services ( e.g ., bone density examinations;
+Added: home collection kits for lab testing) help deliver better care to patient populations by identifying and filling gaps in care for patient populations and by enabling delivery of the most effective healthcare to the right populations and individuals.
+Added: These services leverage the power of our assets ( e.g.
+Added: , our extensive clinical data and data analytics services) and capabilities ( e.g ., call centers, patient service centers, mobile workforce) and focus on extending the reach of clinician offices beyond their traditional four walls to assess the health of their populations, and doing so when it is convenient for consumers.
+Added: Once gaps are identified, we engage patients in our retail sites, in home or by telephone, including through our call centers and our mobile capabilities, including highly trained healthcare professionals.
+Added: In 2022, we enhanced our extended care offering by acquiring Pack Health, which offers patient engagement services that help individuals adopt healthier behaviors to improve outcomes.
+Added: We also enhanced our diabetic retinopathy screening offering, collaborating with IRIS (Intelligent Retinal Imaging Systems) to offer retinal imaging services in our patient service centers.
+Added: We offer services to pharmaceutical companies.
+Added: We offer clinical trials testing and have expertise in developing laboratory tests for FDA submission as companion diagnostics and laboratory developed tests for complementary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
We also offer Quest Clinical Trials Connect TM to help accelerate clinical trials (and thus the speed of drugs to market) through better patient recruitment, involvement and management, and improved physician outreach.
−Removed: We also offer sports teams, including at the professional and collegiate levels, our BluePrint for Athletes ® performance tools, based on biomarker testing, designed to optimize high-level athletic performance through actionable insights.
+Added: In 2022, we also began to offer Pack Health's patient engagement services to our pharma clients.
+Added: We also offer sports teams, including at the professional and collegiate levels, performance tools, based on biomarker testing, designed to optimize high-level athletic performance through actionable insights.
This service provides the context for athletes to consider performance variables holistically, including nutritional education and intervention, maximum fitness, injury assessment and training load monitoring as well as sophisticated biometric analysis.
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Our risk assessment services comprise underwriting support services, including data gathering, paramedical examinations and clinical laboratory testing and analytics, designed to assist life insurance companies objectively to evaluate the mortality risks of applicants.
−Removed: Most specimen collections and paramedical examinations are performed by our network of paramedical examiners at the applicant's home or workplace, but they also are offered at hundreds of Company patient service centers and hundreds of additional North American locations.
+Added: Most specimen collections and paramedical examinations are performed by our network of paramedical examiners at the applicant's home or workplace, but they also are offered at hundreds of Company patient service centers and many additional locations.
Healthcare Information Technology.
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Our healthcare information technology offerings, including Quanum ® Practice Solutions, our Electronic Health Record, Practice Management and Revenue Cycle Management Solutions for healthcare providers, and our award-winning Quanum ® Enterprise Content Solutions for IDNs, connect data to decision-making and help clinicians advance clinical and operational strategies.
−Removed: Healthcare organizations use Quanum ® Enterprise Content Solutions at over 375 sites in North America.
+Added: Healthcare organizations use Quanum ® Enterprise Content Solutions at approximately 675 sites in North America.
Our Quanum ® Electronic Health Record is a cloud-based, mobile-accessible offering that enables clinicians to generate a complete record of a clinical patient encounter, automates and streamlines the clinician's workflow, provides clinical decision support tools, captures patient encounter notes and lab and radiology results and enables secure communication with patients and other clinicians.
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The healthcare system in the United States is evolving.
−Removed: significant change is taking place in the system.
We expect that the evolution of the healthcare industry, including impacts of the COVID-19 pandemic, which include the increased adoption of telemedicine, will continue, and that industry change is likely to be extensive.
−Removed: There are a number of key trends that are having, and that we expect will continue to have, a significant impact on the diagnostic information services business in the United States and on our business.
+Added: There are a number of key trends that we expect will continue to have a significant impact on the diagnostic information services business in the United States and on our business.
These trends, discussed in the table below, present both opportunities and risks.
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First, we believe that PAMA-driven reimbursement pressure is a catalyst for structural change in the market.
−Removed: Second, we believe that health plans increasingly are focusing on driving better value in laboratory testing services.
+Added: Second, we believe that there is an increased focus among our customers, including health plans, ACOs and government programs, on driving value in connection with laboratory testing services.
Third, we believe that ongoing consumerization in healthcare, with increased cost being borne by consumers, is changing consumption of healthcare services.
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PAMA's next data collection and reporting period have been delayed, most recently by federal legislation adopted in December 2022, which further delayed the reimbursement rate reductions and reporting requirements until January 1, 2024.
−Removed: The American Clinical Laboratory Association, of which the Company is a member, initiated a lawsuit charging that in implementing PAMA, CMS failed to follow a Congressional directive to implement a market-based laboratory payment system.
−Removed: The lawsuit is pending.
Health plans driving value in lab spending IDNs, which provide outreach testing and may encourage clinicians to send their outreach testing volume to the IDN's laboratory, historically were able to negotiate higher reimbursement rates with health plans than commercial clinical laboratories for comparable services.
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Health plans increasingly are taking steps to encourage the movement of testing volume to high value, lower cost providers like our Company, including by identifying preferred provider partners, plan design changes ( e.g ., zero-dollar out-of-pocket costs for members using preferred providers) and better aligning reimbursement rates for IDN-based providers and independent commercial laboratories.
−Removed: The UnitedHealthcare Preferred Lab Network, which chose us to participate, is a recent example of a health plan taking these steps.
+Added: The UnitedHealthcare Preferred Lab Network, which chose us to participate, is an example of a health plan taking these steps.
Health plans also are increasingly adopting policies, practices and procedures based on requirements imposed by government payers such as Medicare and Medicaid in order to influence the utilization and reimbursement of testing services.
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Increasingly, consumers are engaged and interested in, and empowered to manage and take direct responsibility for, their own healthcare.
−Removed: As a result, they are more sophisticated in their understanding of their healthcare needs and their expectations of healthcare providers.
+Added: As a result, they are becoming more sophisticated in their understanding of their healthcare needs and their expectations of healthcare providers.
Some consumers are interested in selecting their own diagnostics tests, rather than relying upon a healthcare professional to select the tests.
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In our experience, consumers are more focused on transparency, ease of doing business and understanding diagnostics information services than they have been in the past.
−Removed: Consumers increasingly are demanding convenience;
−Removed: a superior and personalized experience relevant to their needs;
−Removed: and to be empowered to make their own healthcare decisions.
−Removed: During the COVID-19 pandemic, we are seeing consumers increase their use of telemedicine capabilities, increase their responsibility for their own healthcare ( e.g.
+Added: Consumers increasingly are demanding convenience and a superior and personalized experience relevant to their needs.
+Added: During the COVID-19 pandemic, we saw consumers increase their use of telemedicine capabilities, increase their responsibility for their own healthcare ( e.g.
, increased consumer-initiated testing;
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Increasingly, consumers are motivated to find high quality service providers with strong digital experience delivery engines, accessible customer service and lower prices, like our Company.
+Added: Our consumer-initiated testing offering is part of our response to this trend.
Prevention and wellness We believe that the value of detection, prevention, wellness and personalized care is well recognized.
−Removed: Government agencies and other customers discussed in table 13 increasingly focus on helping the healthy stay healthy, detecting symptoms among those at risk and providing preventive insight and care that helps avoid disease.
−Removed: Medical innovation Medical advances allow for more accurate and earlier diagnosis and treatment of diseases.
−Removed: Continuing advances in genomics and proteomics are expected to yield new, more sophisticated and specialized diagnostic tests.
+Added: Government agencies and other customers discussed in table 13 increasingly focus on helping the healthy stay healthy, detecting symptoms among those at risk and providing preventive insight and care that helps avoid or reduce the negative impacts of a disease.
+Added: Medical innovation Medical developments are creating new opportunities and new challenges and disrupting the healthcare environment.
+Added: For example, during the COVID-19 pandemic, telemedicine practices became more commonly used and digital pathology is an emerging technology that may change the practice of pathology.
+Added: Information technology that includes self-learning or "artificial intelligence" features is growing and impacting healthcare.
+Added: Continuing advances in genomics and proteomics are expected to give rise to new, more sophisticated and specialized diagnostic tests.
These advances also are spurring interest in and demand for precision medicine, which relies on diagnostic and prognostic testing and in which data information services and strategies are used to deliver the most effective healthcare to the right populations and individuals.
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Innovation also includes making healthcare services, including laboratory testing services, more convenient for populations and consumers to access, including at home ( e.g ., telehealth) or in retail settings.
−Removed: There is increasing focus on access to patient data and data-driven insights.
−Removed: Healthcare industry evolution Customers discussed in table 13 and other healthcare system participants have been consolidating, converging and diversifying.
+Added: Healthcare industry evolution;
+Added: focus on value Customers discussed in table 13 and other healthcare system participants have been consolidating, converging and diversifying.
For example, a number of IDNs are considering establishing or have established health insurance plans, and health insurance providers are considering providing or are providing healthcare services.
−Removed: In recent years, a leading provider of retail medical clinics and pharmacy benefits management services has acquired a leading health insurance provider, a leading health insurance provider has acquired a leading pharmacy benefits manager, and the corporate parent of a leading health insurance company provides a wide array of healthcare services through its non-insurance company subsidiaries.
+Added: In recent years, a leading provider of retail medical clinics and pharmacy benefits management services has acquired a leading health insurance provider, a leading health insurance provider has acquired a leading pharmacy benefits manager, leading providers of retail pharmacy services have acquired, or agreed to acquire, significant ownership stakes in physician practices, and the corporate parent of a leading health insurance company provides a wide array of healthcare services through its non-insurance company subsidiaries and is collaborating with the nation's largest retailer.
Health plans are entering agreements with other providers of healthcare services, including laboratory testing services providers, to partner on value-based approaches to delivering healthcare to populations.
Consolidation is increasing pricing transparency and bargaining power, and may encourage internalization of clinical testing.
−Removed: Physicians frequently now are employed by IDNs, ACOs, DCEs or large group practices integrated with IDNs, instead of organizing physician-owned practices, which is impacting the dynamics for whether clinical testing is performed in or outside of an IDN.
−Removed: Physicians and other clinicians also increasingly are being employed by health plans or their affiliates.
−Removed: Value-based reimbursement is contributing to changes in the healthcare system.
−Removed: ACOs, DCEs and patient-centered medical homes have grown as a means to deliver patient care.
+Added: Physicians frequently now are employed by IDNs, ACOs or large group practices integrated with IDNs, instead of organizing physician-owned practices, which is impacting the dynamics for whether clinical testing is performed in or outside of an IDN.
+Added: Physicians and other clinicians also increasingly are being employed by health plans, large retailers or their affiliates.
+Added: Value-based reimbursement and demand for convenience and greater availability are contributing to changes in the healthcare system.
+Added: ACOs and patient-centered medical homes have grown as a means to deliver patient care.
+Added: CMS has refreshed its strategy to reinvigorate the national push toward value-based care for Medicare and Medicaid beneficiaries, and set goals for value-based reimbursement to be achieved.
+Added: CMS has stated that the Medicare Sharing Savings Program for ACOs is a critical component of CMS' vision to advance health equity, drive high-quality, person-centered care and promote affordability and sustainability of the Medicare program.
+Added: CMS sponsors two additional programs for ACOs, has stated that its goal is for all people in traditional Medicare to be in an ACO by 2030, and is adopting policies to drive growth in ACO participation.
+Added: Changes also are taking place in the way that some healthcare services are purchased and delivered in the United States.
+Added: IDNs are under significant pressure, and IDNs and large retailers are evolving.
Healthcare services increasingly are being provided by non-traditional providers ( e.g.
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, telemedicine, digital pathology).
−Removed: Changes are taking place in the way that some healthcare services are purchased and delivered in the United States.
−Removed: IDNs are under significant pressure, and are evolving.
Pricing transparency There has been a trend toward greater pricing transparency in healthcare, including in the laboratory testing marketplace.
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For example, Massachusetts launched a website to help consumers understand the wide variation in healthcare costs.
−Removed: Federal laws effective January 1, 2022 require health care providers to provide good faith estimates of costs to self-pay patients, and provide rights and protections for consumers against surprise billing or balance billing.
−Removed: In addition, the federal government requires providers of COVID-19 testing to post on their websites information regarding test pricing, and has adopted new legislation and issued new regulations designed to increase transparency regarding pricing and quality in healthcare, including requiring providers, group health plans and insurers to disclose cost information to consumers in advance of care being provided.
+Added: Federal laws require health care providers to provide good faith estimates of costs to self-pay patients, and provide rights and protections for consumers against surprise billing or balance billing.
+Added: In addition, the federal government has adopted new legislation and issued new regulations designed to increase transparency regarding pricing and quality in healthcare, including requiring providers, group health plans and insurers to disclose cost information to consumers in advance of care being provided.
Increased price transparency, combined with increased patient financial responsibility for medical care, is enhancing purchasing sophistication and fostering changes in behavior in the healthcare marketplace.
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Healthcare market participants, including governments, are focused on controlling costs.
−Removed: Examples of cost control approaches include reducing reimbursement for healthcare services, changing reimbursement for healthcare services ( e.g ., shift from fee for service to capitation), changing medical coverage policies ( e.g ., healthcare benefits design), denying coverage for services, requiring preauthorization of laboratory testing, requiring co-pays, introducing laboratory spend management utilities and payment and patient care innovations such as ACOs, DCEs and patient-centered medical homes.
−Removed: CMS has set goals for value-based reimbursement to be achieved in Medicare.
+Added: Examples of cost control approaches include reducing reimbursement for healthcare services, changing reimbursement methodology for healthcare services ( e.g ., shift from fee for service to capitation), changing medical coverage policies ( e.g ., healthcare benefits design), denying coverage for services, requiring preauthorization of laboratory testing, requiring co-pays, introducing laboratory spend management utilities and payment and patient care innovations such as ACOs and patient-centered medical homes.
There is increased market activity regarding alternative payment models, including bundled payment models.
−Removed: The Health Transformation Alliance, a group of over 50 major U.S.
+Added: The Health Transformation Alliance, initially a group of over 50 major U.S.
companies, was formed to improve and reform the healthcare system in the United States.
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healthcare payment reform and cost transparency are significant issues.
−Removed: Legislation introduced in Congress would enable the FDA to regulate LDTs, in vitro diagnostics, software and other items used in the diagnosis of disease.
−Removed: If the legislation becomes law, the FDA could regulate diagnostic tests and components and platforms used as part of these tests.
−Removed: The FDA and HHS also have expressed views regarding the regulation of LDTs.
−Removed: Either new law or a revised approach to regulation of LDTs could have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating avenues of opportunity and competition regarding clinical laboratory testing.
+Added: The FDA and HHS have expressed views regarding the regulation of LDTs.
+Added: Legislation introduced in recent sessions of Congress that would authorize the FDA to regulate LDTs has not become law.
+Added: If legislation that authorizes the FDA to regulate LDTs were to become law, it could have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating avenues of opportunity and competition regarding clinical laboratory testing.
New competitors may enter the industry, and competition may come in new forms.
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These developments are creating new opportunities and new challenges and disrupting the healthcare environment.
−Removed: For example, during the COVID-19 pandemic, telemedicine practices became more commonly used;
−Removed: digital pathology is an emerging technology that may change the practice of pathology.
−Removed: Information technology that includes self-learning or "artificial intelligence" features is growing and may impact the healthcare industry.
+Added: For example, during the COVID-19 pandemic, telemedicine practices became more commonly used and digital pathology is an emerging technology that may change the practice of pathology.
+Added: Information technology that includes self-learning or "artificial intelligence" features is growing and impacting the healthcare industry.
Healthcare market participants, including many of our customers discussed in table 13, are striving to leverage interoperability and healthcare data analysis to positively influence the health of patient populations while maintaining patient privacy.
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Healthcare services delivery Healthcare delivery is moving out of hospitals, clinician offices and other traditional locations in which it had been provided.
−Removed: Care is increasingly being provided in new settings, such as outpatient, consumer-focused and home settings.
+Added: Care is increasingly being provided in new settings, such as outpatient, retail, consumer-focused and home settings.
In response to the COVID-19 pandemic, telemedicine practices became more commonly used.
−Removed: In addition, see the discussion of Emerging Retail Healthcare Providers in table 13.
This dynamic offers new opportunities and challenges for healthcare providers and reflects not only efforts to take advantage of new technologies, but also the trends of consumerization and affordability, each of which are discussed above in this table.
The Value of Diagnostic Information Services
−Removed: There is an increased focus on the affordability of healthcare and on a disease-oriented approach to diagnostics, treatment and management.
−Removed: Healthcare providers, consumers and payers increasingly recognize the value of diagnostic information services as a means to improve health and reduce the overall cost of healthcare through early detection, prevention and treatment.
−Removed: Healthcare providers increasingly rely on diagnostic information services to help identify risk for a disease, to detect the symptoms of disease earlier, to aid in the choice of therapeutic regimen, to monitor patient compliance and to evaluate treatment results.
−Removed: Table 12 highlights how diagnostic information services contribute to improving care and reducing healthcare costs.
−Removed: Reducing Healthcare Costs and Improving Care (Table 12)
−Removed: • Identifying patients at risk for disease before they require urgent care, hospital treatment or expensive therapies
−Removed: • Helping clinicians to target the right medicines for the right patients at the right time
+Added: In view of the key trends discussed in table 11, healthcare providers, consumers and payers increasingly recognize the value of diagnostic information services as a means to help achieve the triple aim of healthcare:
+Added: improving medical quality and the patient experience while reducing the cost of care.
+Added: The CDC states that 70% of today's medical decisions depend on laboratory test results.
+Added: Table 12 highlights how diagnostic information services contribute to improving medical quality and the patient experience while reducing healthcare costs.
+Added: Helping to Achieve the Triple Aim of Healthcare (Table 12)
+Added: • Detect the symptoms of disease earlier (by identifying patients at risk for disease before they require urgent care, hospital treatment or expensive therapies)
+Added: • Aid in the choice of therapeutic regimen (by helping clinicians to target the right medicines for the right patients at the right time)
• Identifying treatment-related side effects
−Removed: • Assessing early the efficacy of a therapy, enabling changes or discontinuation of ineffective therapies
+Added: • Monitor patient compliance
+Added: • Evaluate treatment results ( e.g ., assessing early the efficacy of a therapy, enabling changes or discontinuation of ineffective therapies)
• Enabling population health management by identifying gaps in care and delivery of targeted solutions to individuals who need care
−Removed: • Identifying and proactively managing individuals at risk for chronic diseases, to decrease progression and associated costs and morbidity
−Removed: • Providing telemedicine services along with laboratory testing to help individuals interpret and obtain appropriate advice and referrals into needed care
+Added: • Identifying and proactively managing individuals at risk for diseases, to decrease progression and associated costs and morbidity
+Added: • Help individuals obtain and interpret appropriate advice and referrals into needed care
We provide diagnostic information services to a broad range of customers, including those discussed in table 13.
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Increasingly, patients are bearing greater responsibility for some portion of the payment for the services we provide to them, even if a third party is primarily responsible for payment.
−Removed: In addition, consumers are more frequently taking advantage of offerings like the Company's QuestDirect ® offering, and requesting and paying for tests themselves.
+Added: In addition, consumers are more frequently taking advantage of offerings like the Company's QuestHealth TM offering, and requesting and paying for tests themselves.
Customers (Table 13)
+Added: Clinicians Clinicians ( e.g ., primary care physicians, specialists and physician assistants) requiring diagnostic information services for patients are the primary referral source for our services when patients choose their diagnostic information services provider.
+Added: In recent years, there has been a marked increase in the number of physician practices owned by IDNs.
+Added: There also has been a notable increase in some branches of medicine of the establishment of very large "rolled-up" physician practice groups.
+Added: IDNs that own physician practices may encourage or require the practices to refer outreach testing to the IDN's affiliated laboratory.
+Added: Large specialty physician groups may encourage their members to refer testing to other members of the group or to a lab owned by the large physician group.
+Added: In each case, referrals to independent diagnostic services providers may be reduced.
+Added: Clinicians determine which laboratory to recommend or use based on a variety of factors, including those set forth in table 14.
Health plans including managed care organizations and other health insurance providers These customers typically reimburse us as a contracted (or out-of-network) provider for services rendered to their members.
−Removed: In certain locations, health plans may delegate to IPAs or other alternative delivery systems ( e.g ., physician IDN organizations, ACOs, DCEs, patient-centered medical homes) the ability to negotiate for diagnostic information services on behalf of certain members.
+Added: In certain locations, health plans may delegate to IPAs or other alternative delivery systems ( e.g ., physician IDN organizations, ACOs, patient-centered medical homes) the ability to negotiate for diagnostic information services on behalf of certain members.
+Added: Increasingly, these customers are interested in value-based arrangements.
Health plans and IPAs often require that diagnostic information services providers accept discounted fee structures or assume all or a portion of the financial risk associated with providing such services through capitated payment arrangements.
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We offer to health plans services and programs that leverage our Company's expertise and resources, including our superior patient access, extensive test menu, medical staff, data, information technology solutions, and wellness and population health management capabilities.
−Removed: Since the beginning of 2019, the Company has had access to a very high percentage of the insured lives in the U.S., including very strong access in key high-population states.
+Added: For the last few years, our Company has had access to a very high percentage of the insured lives in the U.S., including very strong access in key high-population states.
We believe that this strong access increases our attractiveness to other customer groups, including clinicians, patients and employers.
−Removed: Clinicians Clinicians, including primary care physicians, specialists and physician assistants, requiring diagnostic information services for patients are the primary referral source for our services when patients choose their diagnostic information services provider.
−Removed: In recent years, there has been a marked increase in the number of physician practices owned by IDNs.
−Removed: There also has been a notable increase in some branches of medicine of the establishment of very large "rolled-up" specialty physician practice groups.
−Removed: IDNs that own physician practices may encourage or require the practices to refer outreach testing to the IDN's affiliated laboratory.
−Removed: Large specialty physician groups may encourage their members to refer testing to other members of the group.
−Removed: In each case, referrals to independent diagnostic services providers may be reduced.
−Removed: Clinicians determine which laboratory to recommend or use based on a variety of factors, including those set forth in table 14.
IDNs We believe that we are an industry leader in servicing hospitals.
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Fee schedules for IDN reference testing services often are negotiated on behalf of IDNs by group purchasing organizations.
−Removed: We also have joint venture arrangements with leading IDNs in several metropolitan areas.
+Added: We also have joint venture arrangements with leading IDNs.
These joint venture arrangements, which provide diagnostic information services for affiliated IDNs as well as for unaffiliated clinicians and other local healthcare providers, serve as our principal facilities in their service areas.
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We believe that our combination of services positions us to be an attractive partner for IDNs, offering a full range of strategic relationships.
−Removed: ACOs and DCEs An ACO is a network of providers and facilities that share financial risk in providing or arranging for the provision of healthcare.
−Removed: A DCE is a healthcare provider that is contracted directly with Medicare and agrees to assume some level of financial risk for providing Medicare services.
−Removed: ACOs and DCEs have increased in number;
−Removed: their impact on the provision of healthcare services to date has varied.
−Removed: ACOs and DCEs may exercise operational and financial control over providers across the continuum of care, and may function as a payer.
−Removed: Thus, they may be able to manage the health of a population group within a defined geography, and also may be able to influence the cost and quality of healthcare delivery.
−Removed: They may be encouraged to consider exclusive arrangements with healthcare providers, or to limit service providers.
−Removed: We are actively engaging with ACOs and DCEs to demonstrate the value of our services.
−Removed: Employers Employers use tests for drugs of abuse to determine an individual's employability and his or her “fitness for duty.” Companies with high levels of employee hiring, safety conscious environments or regulatory testing requirements provide the highest volumes of testing.
−Removed: Factors such as the general economy, the job market and changes in the legal environment ( e.g ., marijuana decriminalization) can impact the utilization of drugs-of-abuse testing.
+Added: ACOs An ACO is a network of providers and facilities that share financial risk in providing or arranging for the provision of healthcare.
+Added: ACO members collaborate to provide coordinated, high-quality care to their patients;
+Added: ACOs may manage the health of a population group, exercise operational and financial control over providers across the continuum of care, and function as a payer.
+Added: Increasingly, ACOs are focusing on driving improvement in healthcare through value-based services arrangements, and to influence reimbursement for healthcare delivery.
+Added: For example, ACOs may be encouraged to consider exclusive arrangements with healthcare providers, or to limit service providers.
+Added: The Medicare Sharing Savings Program for ACOs is a critical component of CMS' vision to advance health equity, drive high-quality, person-centered care and promote affordability and sustainability of the Medicare program.
+Added: CMS sponsors two additional programs for ACOs, has stated that its goal is for all people in traditional Medicare to be in an ACO by 2030, and is adopting policies to drive growth in ACO participation.
+Added: We believe that our experience with value-based arrangements with other payers positions us as a strong partner for ACOs.
+Added: In addition, we believe that our extended care experience and population health capabilities are attractive to ACOs, and that our Quest for Health Equity initiative underscores our commitment to health equity important to ACOs.
+Added: Employers Employers use tests for drugs of abuse to determine an individual's employability and “fitness for duty.” Companies with high levels of employee hiring, safety conscious environments or regulatory testing requirements provide the highest volumes of testing.
+Added: Factors such as the general economy, the job market and changes in the legal environment ( e.g ., marijuana legalization or decriminalization) can impact the utilization of drugs-of-abuse testing.
Some employers retain third party administrators to handle such testing and related services;
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These services help employers, employees and others manage healthcare costs, capitalize on trends in personalized health and improve health outcomes.
−Removed: In response to the COVID-19 pandemic, we expanded our offerings to employers to assist their pandemic response to create safer workplaces (discussed above at page 13).
We seek to grow our employer business through offering new and innovative programs to help them with their goals of (1) maintaining a safe and productive workplace, (2) improving healthcare for employees and (3) lowering healthcare costs for employees and employers.
−Removed: Consumers We are well positioned to provide information and insights to patients to help them take actions to improve their healthcare.
−Removed: The changing expectations of patients about their healthcare and their healthcare transactions are influencing our services and the way we provide them.
+Added: Consumers We are well positioned to provide information and insights to individual consumers to help empower them take actions to improve their healthcare.
+Added: The changing expectations of individual consumers about their healthcare and their healthcare transactions are influencing our services and the way we provide them.
See the discussions of our consumer strategy at page 5 and consumerization above in table 11.
−Removed: FQHCs Federally Qualified Health Centers offer a broad array of healthcare services, including to historically underserved populations.
−Removed: We strive to offer an attractive array of services to FQHCs to demonstrate the value of our services.
−Removed: Emerging Retail Healthcare Providers In recent years, as the healthcare sector changes, retail providers of healthcare services have emerged and are growing.
+Added: FQHCs FQHCs are non-profit, community-directed organizations that offer care to medically underserved patients;
+Added: FQHCs are the largest primary care system in the United States today.
+Added: Their patients are mostly low income, members of racial and ethnic minority groups, and are uninsured or publicly insured.
+Added: We offer an array of services that we believe are attractive to FQHCs as they pursue better outcomes for their patients and maintain financial stability for their organizations.
+Added: Our services include our financial assistance programs, customized billing solutions that help to assist patients who struggle to afford testing, home-based collection options and our extensive patient service center network.
+Added: We offer solutions for optimizing test utilization, simplifying lab-related tasks, and reducing inefficiencies and duplicative efforts can help FQHCs keep costs in line, and technology solutions that can help them to meet quality reporting requirements and achieve quality measures through benchmarking and identifying areas for improvement.
+Added: We also offer a tiered, flexible approach to gaps-in-care programs that helps complement FQHC efforts to emphasize preventive care.
+Added: Our Quest for Health Equity initiative also demonstrates our commitment to FQHCs and the people they serve;
+Added: many of these initiatives support FQHCs, including by providing free lab testing services.
+Added: Emerging Retail Healthcare Providers In recent years, retail providers of healthcare services have emerged and are growing as customers.
These providers include "big-box" retailers, pharmacy chains, supermarkets, urgent care centers and Internet-based service providers.
−Removed: We are taking advantage of opportunities to work with these providers, not only to offer new access partners (e.g., CVS retail locations) and new access points for our services ( e.g ., our collaboration with Safeway), but also to grow our business by expanding our service offerings ( e.g ., our joint venture with Walmart).
+Added: We are taking advantage of opportunities to work with these providers, not only to offer new access partners ( e.g ., CVS and Rite-Aid retail locations) and new access points for our services ( e.g ., our collaboration with Safeway), but also to grow our business by expanding our service offerings ( e.g ., our collaboration with Walmart).
See the discussion of our consumer strategy at page 5
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States also have mandated that Medicaid beneficiaries enroll in private managed care arrangements.
−Removed: During the COVID-19 pandemic, we provided additional services to and in conjunction with government agencies across the United States in connection with the COVID-19 pandemic.
−Removed: Pharmaceutical companies We have expertise with laboratory developed tests for companion and complementary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
−Removed: We also offer Quest Clinical Trials Connect, TM to help accelerate clinical trials (and thus the speed of drugs to market) through better patient recruitment, involvement and management, and improved physician outreach.
+Added: We provide additional services to and in conjunction with government agencies across the United States in connection with the COVID-19 pandemic ( see , e.g ., the discussion at page 10 above regarding our collaboration with CDC).
+Added: Pharmaceutical companies We offer clinical trials testing and have expertise with laboratory developed tests for companion and complem entary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
+Added: We also offer data services solutions, leveraging our data, analytics and expertise, to help therapy developers understand markets and patient and disease journeys, and plan commercial activity.
+Added: In addition, we offer Quest Clinical Trials Connect TM to help accelerate clinical trials (and thus the speed of drugs to market) through better patient recruitment, involvement and management, and improved physician outreach.
+Added: We also offer Pack Health's patient engagement services.
Other Laboratories We provide services on a fee-for-service basis to other commercial clinical laboratories.
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In anatomic pathology, we compete with anatomic pathology practices, including those in academic institutions and large physician group practices, and providers of emerging digital pathology solutions.
−Removed: There also has been a trend among specialty physician practices to establish their own histology laboratory capabilities and/or bring pathologists into their practices, thereby reducing referrals from these practices and increasing the competitive position of these practices.
+Added: There also has been a trend among physician practices to establish their own histology laboratory capabilities and/or bring pathologists into their practices, thereby reducing referrals from these practices and increasing the competitive position of these practices.
Healthcare providers consider a number of factors when selecting a diagnostic information services provider.
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• Real time payment determination • Capabilities to support population health initiatives 0
−Removed: We believe that providing the most attractive service offering in the industry, including the most comprehensive test menu, innovative test offerings, a positive customer experience, a staff including medical and scientific experts, strong quality, unparalleled access and distribution, and data-powered integrated information technology solutions provide us with a competitive advantage.
+Added: We believe that providing the most attractive service offering in the industry, including the most comprehensive test menu, innovative test offerings, a positive customer experience, a staff including medical and scientific experts, strong quality, leading access and distribution, and data-powered integrated information technology solutions provide us with a competitive advantage.
We believe that large diagnostic information services providers have a competitive advantage due to their large networks and lower cost structures.
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As a result, we compete against IDN-affiliated laboratories primarily on the basis of service capability, quality and pricing.
−Removed: In addition, market activity may increase the competitive environment.
+Added: In addition, market activity may increase the
+Added: competitive environment.
For example, IDN ownership of physician practices may enhance the ties of the clinicians to IDN-affiliated laboratories, enhancing the competitive position of IDN-affiliated laboratories.
−Removed: ACOs and DCEs and their approach to contracts with healthcare providers also may impact competition to provide diagnostic information services.
The diagnostic information services industry is faced with changing technology, new product introductions and new service offerings.
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We compete in the risk assessment business by seeking to provide a wider array of quality, integrated services than our competitors, faster services completion and a superior applicant experience.
−Removed: We compete in the healthcare information technology industry by offering solutions that foster better patient care and improve performance for healthcare providers, including smaller and medium sized physician practices.
+Added: We compete in the healthcare information technology industry by offering solutions that foster better patient care and improve performance for healthcare providers, particularly smaller and medium sized physician practices.
Human Capital Management.
Creating an inspiring workplace is one of our three corporate goals, and this goal drives our approach to human capital management.
−Removed: Effectively managing our human capital resources is a priority with key components that include culture, safety and well-being programs, employee engagement, and training, development and succession planning.
+Added: Effectively managing our human capital resources is a priority with key components that include culture, safety and well-being programs, employee engagement, and attracting, training, development and succession planning.
Our Board of Directors actively engages in oversight of our human capital management, including by receiving management reports on key areas, strategies and initiatives.
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During the COVID-19 pandemic, our cross-functional Safely Working Together Steering Committee designed and implemented tactics, techniques and procedures to enable our colleagues to continue to work safely.
−Removed: As part of our comprehensive and competitive compensation and benefits program, we also offer innovative initiatives to support the well-being of our employees and their
−Removed: families through our HealthyQuest program.
+Added: As part of our comprehensive and competitive compensation and benefits program, we also offer innovative initiatives to support the well-being of our employees and their families through our HealthyQuest program.
The cornerstone of HealthyQuest is our Blueprint for Wellness program, which empowers our employees and their dependents with health insights based on lab and biometric data and invites them each year to take the initiative to improve their physical and mental health.
We also offer other programs designed to engage employees in managing their health, including access to medical expertise and support programs tailored to their individual needs, helping them to adopt healthier behaviors and access better care at lower costs.
−Removed: These include customized programs for conditions such as type 2 diabetes management, chronic kidney disease, cardiovascular disease, zero-cost lab testing and specialty drugs, and special support for orthopedic surgery and for cancer and other serious diagnoses.
−Removed: For 2022, we enhanced our mental health offering for employees.
+Added: These include customized programs for conditions such as type 2 diabetes management, chronic kidney disease, cardiovascular disease, specialty drugs, and zero-cost lab testing, and
+Added: special support for orthopedic surgery and for cancer and other serious diagnoses.
+Added: In 2022, we enhanced our mental health offering for employees.
Inclusion and Diversity .
−Removed: We understand the need to create an environment where employees can bring their whole selves to work.
+Added: We understand the need to create an environment where employees can bring their whole selves to work, and our Everyday Equity philosophy embodies our commitment to promote inclusion and embrace diversity by consistently inviting new perspectives and exploring new experiences.
We aim to harness the unique mix of capabilities, talents, cultures, beliefs and experience of our employees and create a workforce that is demographically diverse at all levels of the organization.
Through our CTC Framework (focusing on Culture, Talent and Community), we prioritize diversity across the entire talent lifecycle, with the goals of supporting employees throughout their careers at Quest, ensuring transparency and identifying opportunities for action.
−Removed: In 2021, we continued to focus on inclusion and diversity issues through additional training for leaders and other employees.
+Added: In 2022, we continued to focus on inclusion and diversity through additional training for leaders and other employees.
We also continued, with the Quest Diagnostics Foundation, Quest for Health Equity, our initiative to help reduce health disparities in underserved communities.
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Employee engagement has been a metric in the annual incentive plan for our executive officers since 2013.
−Removed: In 2020, we launched a new strategy for gathering employee feedback that utilizes more frequent employee surveys.
+Added: Since 2020, our strategy for gathering employee feedback utilizes more frequent employee surveys.
This approach is designed to build an agile culture, based on continuous feedback that fuels ongoing conversations about priorities, performance, opportunities and growth, to result in a higher performing organization and committed employees.
−Removed: In addition, throughout the COVID-19 pandemic, we have held weekly or bi-weekly meetings among hundreds of company leaders to foster increased communication across the company regarding topics of concern to employees.
−Removed: Training, Development and Succession Planning .
+Added: In addition, we hold regular meetings among hundreds of company leaders to foster increased communication across the company regarding topics of concern to employees.
+Added: Attracting, Training, Development and Succession Planning .
+Added: We have a strong program designed to attract a diverse, qualified work force that will assist us to achieve our business goals.
+Added: For example, we are partnering with universities to help build our pipeline of expertise in medical technology, cytology and histology, and we have teamed up with a third-party phlebotomy training program to train and certify phlebotomist candidates who can join our ranks upon graduation.
We provide training on a wide array of topics to our employees through live and online formats, including opportunities that can be accessed through their mobile devices.
−Removed: We also offer a number of development opportunities for our employees, such as mentoring and education programs, including a higher education tuition reimbursement or assistance program.
+Added: We also offer a number of development opportunities for our employees, such as mentoring and education programs, including a higher education tuition assistance program.
In addition, we provide leadership training opportunities for employees at all levels, including a manager essentials curriculum, our Leading Quest Supervisor and Manager Core Program, coaching programs and trainings to strengthen critical leadership skills.
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We also maintain distinct sales and marketing organizations for our offerings in Diagnostic Solutions and our employer drugs-of-abuse testing services.
−Removed: In 2021, we launched a new marketing campaign designed to remind customers of the value that we bring to healthcare.
−Removed: Our "Powering Affordable Care" campaign speaks about our leadership in clinical innovation, our ability to enable better clinical outcomes, our improved patient experience and our ability to reduce the cost of care.
Information Technology.
−Removed: We use information systems extensively in virtually all aspects of our business, including clinical testing, test ordering and reporting, billing, customer service, logistics and management of medical data.
+Added: We use information systems extensively in virtually all aspects of our business, including clinical testing, test ordering and reporting, billing, customer service, logistics and management of data.
We endeavor to establish systems that create value and efficiencies for our Company and customers.
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We have made significant progress implementing common systems in our regional laboratories, and we continue to standardize laboratory information and billing systems across our operations.
−Removed: We expect that our standardization efforts will
−Removed: take several more years to complete, and will result in significantly more centralized systems, improved operating efficiency, more positive customer experiences and enhanced control over our operational environment.
+Added: We expect that our standardization efforts will take several more years to complete, and will result in significantly more centralized systems, improved operating efficiency, more positive customer experiences and enhanced control over our operational environment.
Even after we complete our efforts to standardize our legacy systems, we will need to focus on standardizing systems in connection with future business acquisitions.
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Employing root cause analysis, process improvements and rigorous tracking and measuring, we continuously seek to enhance quality, reduce defects, further increase the efficacy and efficiency of our operations and processes, eliminate waste and help standardize operations across our Company.
−Removed: In our laboratory operations, our quality assurance efforts focus on pre-analytic, analytic and post-analytic processes, including positive patient identification of specimens, appropriate specimen transport, analysis and report accuracy, reference interval establishment and review, statistical process control and personnel training for all of our laboratories and patient service centers.
+Added: In our laboratory operations, our quality assurance efforts focus on pre-analytic, analytic and post-analytic processes, including positive patient identification of specimens, appropriate specimen transport, analysis and report accuracy, reference interval establishment and review, statistical process control and personnel training for our laboratories and patient service centers.
As part of our quality assurance program, we utilize internal proficiency testing, comprehensive quality control and rigorous process audits.
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In the aggregate, our intellectual property assets and licenses are of material importance to our business.
−Removed: We believe, however, that no single patent, technology, trademark, intellectual property asset or license is material to our business as a whole.
+Added: We believe, however, that no single intellectual property asset is material to our business as a whole.
Our approach is to manage our intellectual property assets, to safeguard them and to maximize their value to our enterprise.
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We maintain an enterprise risk management program designed to promote a culture of risk awareness throughout the Company's key business, operations and support functions.
−Removed: Our program, which is
−Removed: integrated with the Company’s governance, performance management and internal control frameworks, entails a formal continuous process that identifies, assesses, mitigates and manages the risks from both internal and external conditions that could significantly impact the Company and influence its business strategy and performance.
−Removed: The program is based on the most recent framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, which focuses on the following risk types:
+Added: Our program, which is integrated with the Company’s governance, performance management and internal control frameworks, entails a formal continuous process that identifies, assesses, mitigates and manages the risks from both internal and external conditions that could significantly impact the Company and influence its business strategy and performance, including environmental, social and governance issues.
+Added: The program is designed based on the most recent framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, and we benchmark it against best practices.
+Added: We focus on the following risk types:
• Operational risk - risks arising from systems, processes, people and external events that affect the Company’s operational objectives or fundamental reason for its existence, including:
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supply chain and business disruption;
−Removed: and other risks, including human capital and reputation.
+Added: and other risks, including human capital, reputation and environmental.
• Financial risk - risks arising from the Company’s ability to meet its financial obligations pursuant to its strategic and operational objectives, including exposure to broad market and more specific industry risk that could impact liquidity, interest rate, credit, pricing and reimbursement, and also to internal and external financial reporting.
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PAMA's next data collection and reporting period have been delayed, most recently by federal legislation adopted in December 2022, which further delayed the reimbursement rate reductions and reporting requirements until January 1, 2024.
−Removed: Our net revenues reimbursed under Medicare and Medicaid in 2021 were lower as a percentage of our consolidated net revenues than in recent years (excluding 2020, when we also experienced significant COVID-19 testing).
+Added: Our net revenues reimbursed under Medicare and Medicaid in 2022 were lower as a percentage of our consolidated net revenues than in recent years (excluding 2021 and 2020, when we also experienced significant COVID-19 testing).
Excluding revenues attributable to COVID-19 testing, approximately 12% of our net revenues were reimbursed under Medicare and Medicaid in 2022, compared to approximately 15% in 2019.
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It has been used by the FDA, in part, to assert authority over the annotation software aspects of pharmacogenetic testing services.
−Removed: Legislation introduced in Congress would enable the FDA to regulate LDTs, in vitro diagnostics, software and other items used in the diagnosis of disease.
−Removed: The FDA and the U.
−Removed: Department of Health and Human Services also have expressed views regarding the regulation of LDTs.
−Removed: Either new law or a revised approach to regulation of LDTs could have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating avenues of opportunity and competition regarding clinical laboratory testing.
+Added: The FDA and HHS have expressed views regarding the regulation of LDTs.
+Added: Legislation introduced in recent sessions of Congress that would authorize the FDA to regulate LDTs has not become law.
+Added: If legislation that authorizes the FDA to regulate LDTs were to become law, it could have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating avenues of opportunity and competition regarding clinical laboratory testing.
New competitors may enter the industry, and competition may come in new forms.
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Physicians Our pathologists are required to hold a valid license to practice medicine in the jurisdiction in which they practice.
−Removed: Several jurisdictions in which our businesses are located prohibit business corporations from engaging in the practice of medicine.
−Removed: In certain jurisdictions, business corporations are prohibited from employing licensed healthcare professionals to provide services on behalf of the corporation;
−Removed: these laws vary.
−Removed: In some jurisdictions, anatomic pathology services are delivered through physician-owned entities that employ the practicing pathologists.
The manner in which licensed physicians can be organized to perform medical services may be governed by the laws of the jurisdictions in which medical services are provided and by the medical boards or other entities authorized by these jurisdictions to oversee the practice of medicine.
+Added: Several jurisdictions in which our businesses are located prohibit business corporations from engaging in the practice of medicine.
+Added: In these jurisdictions, anatomic pathology services are delivered through physician-owned entities that employ the practicing pathologists.
Privacy and Security of Health and Personal Information We are subject to laws and regulations regarding protecting the security and privacy of certain healthcare and personal information, including:
(a) the federal Health Insurance Portability and Accountability Act and the regulations thereunder, which establish (i) a complex regulatory framework including requirements for safeguarding protected health information and (ii) comprehensive federal standards regarding the uses and disclosures of protected health information;
−Removed: (b) state laws, including the California Consumer Privacy Act and similar laws in other states ;
−Removed: and (c) laws outside the U.S., including the European Union's General Data Protection Regulation.
−Removed: A healthcare provider may be subject to penalties for non-compliance and may be required to notify individuals or state, federal or county governments if the provider discovers certain breaches of personal information or protected health information.
+Added: (b) state laws ( e.g ., California) and similar laws in other states;
+Added: and (c) laws outside the U.S., including the European Union's General Data Protection Regulation and similar laws in other jurisdictions.
+Added: We may be subject to penalties for non-compliance and may be required to notify individuals or state, federal or county governments if we discover certain breaches of personal information or protected health information.
Drug Testing;
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We conduct annual training of our employees on these compliance policies and procedures.
−Removed: As an integral part of our billing compliance program, we investigate reported or suspected failures to comply with federal and state healthcare reimbursement requirements.
−Removed: Any Medicare or Medicaid overpayments resulting from non-compliance are refunded by us.
+Added: As an integral part of our billing compliance program, we investigate reported or suspected failures to comply with Medicare or Medicaid reimbursement requirements.
As a result of these efforts, we have periodically identified and reported overpayments, refunded the payers for overpayments and taken appropriate corrective action.
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Name, Age, Title Background
−Removed: Rusckowski (64)
−Removed: Chairman of the Board, Chief Executive Officer and President Mr.
−Removed: Rusckowski joined the Company in May 2012 as Chief Executive Officer and President and became Chairman of the Board on January 1, 2017.
−Removed: From October 2006 until he joined the Company, he was Chief Executive Officer of Philips Healthcare, the largest unit of Royal Philips Electronics, and a member of the Board of Management of Royal Philips Electronics and its Executive Committee.
−Removed: Previously, he was CEO of the Imaging Systems business of Royal Phillips Electronics.
−Removed: On February 3, 2022, the Company announced that, as part of its ongoing leadership succession planning, effective November 1, 2022, Mr.
−Removed: Rusckowski would step down as Chief Executive Officer and President, and become Executive Chairman and continue to serve on the Company's Board of Directors through March 2023.
−Removed: Before joining Philips in 2001, Mr.
−Removed: Rusckowski held numerous management positions with the healthcare division of Hewlett-Packard/Agilent Technologies.
−Removed: Rusckowski has been a director of the Company since May 2012.
−Removed: He was a director of Xerox Corporation from February 2015 to 2018, and a director of Covidien plc from December 2013 to January 2015.
−Removed: Rusckowski served as Chairman of the American Clinical Laboratory Association from 2014 to 2017.
−Removed: Executive Vice President, General Diagnostics;
−Removed: Chief Executive Officer - Elect In January 2017, he became Executive Vice President, General Diagnostics;
+Added: Chief Executive Officer and President On November 1, 2022, Mr.
+Added: Davis became Chief Executive Officer and President, having served as CEO-Elect since February 3, 2022.
+Added: In January 2017, he became Executive Vice President, General Diagnostics;
previously Mr.
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Davis joined Quest Diagnostics in April 2013 as Senior Vice President, Diagnostics Solutions, with responsibility for the healthcare information technology, risk assessment, clinical trials, diagnostic products and employer solutions businesses.
−Removed: On February 3, 2022, the Company announced that Mr.
−Removed: Davis was appointed Chief Executive Officer - Elect, effective immediately, and that he would become Chief Executive Officer effective November 1, 2022.
Prior to joining Quest Diagnostics, from March 2012 to April 2013, Mr.
4 unchanged sentences
Davis held leadership positions in GE’s aviation business and led the development of strategic and operational improvement initiatives for clients of McKinsey & Company, Inc.
−Removed: Senior Vice President and Group Executive - Clinical Franchise Solutions and Marketing Since January 2013, Ms.
−Removed: Doherty has been responsible for overseeing the development of clinical franchise solutions in the areas of general health and wellness, cardiovascular, metabolic and endocrinology, infectious disease and immunology, and prescription drug monitoring and toxicology, as well as enterprise-wide marketing.
−Removed: Doherty is also responsible for the employer solutions and risk assessment businesses, and since February 2020, our sports diagnostics franchise.
−Removed: Additionally, in October 2018, QuestDirect ® , our consumer initiated testing platform was launched under her leadership.
+Added: Senior Vice President and Chief Commercial Officer Mr.
+Added: Delaney joined the Company in March 2022 and is responsible for all sales operations.
+Added: From 2017 until Hill-Rom Holdings Inc.
+Added: was acquired by Baxter Healthcare in 2021, Mr.
+Added: Delaney served as Vice President of Sales and Marketing at Hill-Rom, a manufacturer and provider of medical technologies and related services for the healthcare industry;
+Added: after the acquisition by Baxter Mr.
+Added: Delaney became Vice President and General Manager at Baxter until he joined Quest Diagnostics.
+Added: Previously, Mr.
+Added: Delaney served in a number of senior sales and marketing leadership roles at General Electric's healthcare business, most recently as Senior Vice President and Zone Manager, where he had regional responsibility for sales of imaging, patient monitoring, information technology and services.
+Added: Senior Vice President, Regional Businesses Since March 2022, Ms.
+Added: Doherty has been responsible for the general management of the Company's regional Diagnostic Information Services business, the commercial organization, marketing and consumer-initiated testing.
+Added: She also is responsible for driving operational excellence, including the Company's quality and efficiency initiatives.
+Added: Doherty is the Executive Sponsor of the Company's Women in Leadership Employee Business Network.
+Added: From January 2013 to March 2022, Ms.
+Added: Doherty was Senior Vice President and Group Executive - Clinical Franchise Solutions and Marketing.
+Added: In this role, she was responsible for overseeing the development of clinical franchise solutions in the areas of general health and wellness, cardiovascular, metabolic and endocrinology, infectious disease and immunology, and prescription drug monitoring and toxicology, as well as enterprise-wide marketing, consumer-initiated testing, the employer solutions and risk assessment businesses, and beginning in February 2020, our sports diagnostics franchise.
She also was responsible for clinical franchise solutions in the areas of neurology and women's health from January 2013 to January 2017 and for the healthcare information technology business from February 2014 to January 2017.
6 unchanged sentences
and Chief Accounting Officer.
−Removed: Carrie Eglinton Manner (47)
−Removed: Senior Vice President, Advanced Diagnostics Ms.
−Removed: Eglinton Manner joined the Company in January 2017.
−Removed: She is responsible for the Company's advanced testing activities, including overseeing the development of clinical franchise solutions in the areas of neurology, oncology, pathology and women's health, as well as the Company's global business and pharmaceutical/diagnostic development services.
−Removed: Eglinton Manner has served as a director of Repligen Corporation since June 2020.
−Removed: Previously, Ms.
−Removed: Eglinton Manner spent over 20 years in various leadership roles in healthcare businesses at General Electric.
−Removed: From 2015 to 2016, she served as President and CEO of the Detection and Guidance Solutions business, delivering advanced x-ray technologies spanning the continuum of healthcare.
−Removed: From 2013 to 2015, Ms.
−Removed: Eglinton Manner served as President and CEO of OEC Surgical Mobile C-arm systems.
−Removed: She was President and CEO of General Electric's diagnostic pathology laboratory services business from 2012 to 2013, and President of the Maternal Infant Care Business from 2009 to 2012.
−Removed: Executive Vice President and Chief Financial Officer
−Removed: Guinan joined the Company in July 2013.
−Removed: From 2010 until joining Quest Diagnostics in 2013, he served as Chief Financial Officer for Hill-Rom Holdings Inc., a manufacturer and provider of medical technologies and related services for the healthcare industry.
−Removed: Guinan has served as a director of Myovant Sciences, Ltd.
−Removed: since July 2018.
−Removed: On February 3, 2022, the Company announced that Mr.
−Removed: Guinan would retire in 2022.
−Removed: Previously, he had served in a number of finance and operations roles in a long career at Johnson & Johnson including 2009 to 2010 as Vice President, Chief Procurement Officer, and 2005 to 2009 as Vice President, Group Finance Pharmaceuticals.
−Removed: Before joining Johnson & Johnson in 1997, he held a number of financial roles at Procter & Gamble.
+Added: Gardner (57), Senior Vice President, Molecular Genomics and Oncology Mr.
+Added: Gardner joined the Company in October 2022 in his current role.
+Added: He is responsible for oncology, pathology, specialty genetics, and research and development.
+Added: Gardner joined Quest from Corza Medical, a provider of surgical technologies and tools, where he served since 2019 as Executive Partner, Senior Vice President and General manager of European Commercial Operations and Biosurgery Products.
+Added: Prior to that, Mr.Gardner served as Chief Executive Officer of OmniSeq Corporation, a molecular diagnostics company, from 2016 to 2019 and in Vice President and General Manager positions at Thermo Fisher Scientific Inc.
+Added: from 2003 to 2016, including roles with Life Technologies and Invitrogen.
+Added: He began his career as a consultant with McKinsey and Company, Inc.
+Added: Karthik Kuppusamy (53)
+Added: Senior Vice President, Clinical Solutions Mr.
+Added: Kuppusamy assumed his current role in August 2022.
+Added: He is responsible for the Company's clinical franchises other than oncology, as well as the Company's pharmaceutical services, genomic services, medical affairs, medical quality and global markets activities.
+Added: Kuppusamy serves as co-chair of the Company's Inclusion and Diversity Council.
+Added: Previously, Mr.
+Added: Kuppusamy was Vice President and General Manager of the Company's Diagnostics Information Services business in its North Region since from 2018 and General Manager of the Neurology Franchise and Consumer Genetics from 2014 to 2017.
+Added: He joined the Company in 2014 from General Electric's healthcare business where he held general manager roles in product development, research and development, sales and marketing in the Diagnostics Imaging Division.
+Added: Patrick Plewman (56)
+Added: Senior Vice President, Diagnostics Services Mr.
+Added: Plewman assumed his current role in April 2022.
+Added: He is responsible for a portfolio of data driven analytics and services offerings, including Employer Population Health, Healthcare Analytic Solutions, Pack Health, Risk Assessment (ExamOne) and Employer Solutions.
+Added: Since joining the Company in 2013, Mr.
+Added: Plewman was Vice President and General Manager of the Company's Diagnostic Information Services Business in its West Region since 2018 and previously served as General Manager of the Company's Cardiovascular, Metabolic and Endocrinology Franchise, General Manager of the Company's Infectious Disease and Immunology Franchise and General Manager of the General Health and Wellness franchise.
+Added: Prior to joining the Company, Mr.
+Added: Plewman served as Co-Founder, President and Chief Executive Officer of diaDexus, Inc.
+Added: Previously, Mr.
+Added: Plewman held various positions of increasing responsibility at SmithKline Beecham Inc.
Prevoznik (61)
2 unchanged sentences
In 2003, he assumed responsibility for governmental affairs.
+Added: Prevoznik also is the Executive Co-Sponsor of the Company's Quest For Health Equity Initiative.
From 1999 until April 2009, Mr.
3 unchanged sentences
Prevoznik served in positions of increasing responsibility within the compliance organization at SmithKline Beecham, most recently as Vice President, Compliance, with responsibility for coordinating all SmithKline Beecham compliance activities worldwide.
+Added: Executive Vice President and Chief Financial Officer Mr.
+Added: Samad joined the Company in his current role in July 2022.
+Added: He is responsible for the Company's finance, accounting, investor relations, internal audit and treasury activities.
+Added: Prior to joining the Company, Mr.
+Added: Samad served as Chief Financial Officer of Illumina, Inc., a global leader in DNA sequencing and array-based technologies, since 2017.
+Added: Prior to joining Illumina, Mr.
+Added: Samad held several senior leadership positions at Cardinal Health, including Senior Vice President and Treasurer, with operational and financial responsibility for Cardinal Health's China business, and before that in sales and finance roles at Eli Lilly and Company, both domestically and internationally.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.