Direct-to-Consumer Telemedicine

Direct-to-Consumer Telemedicine

Clinical Commentary Review Direct-to-Consumer Telemedicine Tania Elliott, MD, and Margot C. Yopes, MD New York, NY INFORMATION FOR CATEGORY 1 CME CR...

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Clinical Commentary Review

Direct-to-Consumer Telemedicine Tania Elliott, MD, and Margot C. Yopes, MD New York, NY

INFORMATION FOR CATEGORY 1 CME CREDIT Credit can now be obtained, free for a limited time, by reading the review articles in this issue. Please note the following instructions. Method of Physician Participation in Learning Process: The core material for these activities can be read in this issue of the Journal or online at the JACI: In Practice Web site: www.jaci-inpractice.org/. The accompanying tests may only be submitted online at www.jaciinpractice.org/. Fax or other copies will not be accepted. Date of Original Release: November 1, 2019. Credit may be obtained for these courses until October 31, 2020. Copyright Statement: Copyright Ó 2019-2021. All rights reserved. Overall Purpose/Goal: To provide excellent reviews on key aspects of allergic disease to those who research, treat, or manage allergic disease. Target Audience: Physicians and researchers within the field of allergic disease. Accreditation/Provider Statements and Credit Designation: The American Academy of Allergy, Asthma & Immunology (AAAAI) is accredited by the Accreditation Council for Continuing Medical

The telemedicine industry and adoption of services have grown exponentially in the last 5 years, and the market is expected to reach more than $130 billion by 2025. Most US health institutions and hospital systems are currently using some form of telehealth, and more than 90% of health care executives surveyed across the United States have virtual care on their roadmap for growth. Telemedicine has been proposed as a way to expand the reach of allergy services and allow more patients to manage their disease with an allergy specialist. Technology can help address fragmentation of allergy care, which is currently provided in multiple clinical settings beyond the allergist’s office including in primary care, pulmonary, dermatology, ear, nose, and throat, urgent care, and the emergency room. Remote monitoring, specialist second opinions, and synchronous and asynchronous encounters offer opportunities to streamline routine care, especially as smart hardware such as digital inhalers

NYU Langone Health, Columbia University Irving Medical Center, New York, NY Conflicts of interest: T. Elliott is a shareholder in Doctor On Demand, Inc, and an employee of Aetna. M. C. Yopes declares no relevant conflicts of interest. Received for publication April 4, 2019; revised June 11, 2019; accepted for publication June 21, 2019. Corresponding author: Tania Elliott, MD, NYU Langone Health, 462 1st Avenue, New York, NY 10016. E-mail: [email protected]. 2213-2198 Ó 2019 Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology https://doi.org/10.1016/j.jaip.2019.06.027

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Education (ACCME) to provide continuing medical education for physicians. The AAAAI designates this journal-based CME activity for 1.00 AMA PRA Category 1 CreditÔ. Physicians should claim only the credit commensurate with the extent of their participation in the activity. List of Design Committee Members: Tania Elliott, MD, and Margot C. Yopes, MD (authors); Michael Schatz, MD, MS (editor) Learning objectives: 1. To understand the current direct-to-consumer (DTC) telemedicine landscape. 2. To appreciate the limitations of DTC telemedicine. 3. To recognize future implications of DTC medicine on the practice of allergy/immunology. Recognition of Commercial Support: This CME has not received external commercial support. Disclosure of Relevant Financial Relationships with Commercial Interests: T. Elliott is a shareholder in Doctor On Demand, Inc, and an employee of Aetna. M. C. Yopes declares no relevant conflicts of interest. M. Schatz declares no relevant conflicts of interest.

hit the market and reimbursement for telehealth services evolve. To date, allergy care has been a significant area of interest for direct-to-consumer telemedicine solutions, although the care has mainly been offered by nonallergists. Quality assurance and adherence to evidence-based standards, particularly in the selfpay direct-to-consumer space, warrant attention. Ó 2019 Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology (J Allergy Clin Immunol Pract 2019;7:2546-52) Key words: Telemedicine; Direct to consumer; Virtual care; Video visit; Asynchronous; Synchronous; E-consults; mHealth; Direct pay; Teledermatology; Virtual urgent care; Telehealth

DEFINING DIRECT-TO-CONSUMER TELEMEDICINE The term “direct to consumer” (DTC) in the health care industry has historically referred to marketing strategies deployed by pharmaceutical companies to advertise directly to patients. More recently, it has been used to define health care products and services that are marketed directly to and initiated by a patient as opposed to access that is made available only through a provider. Examples include access to 24/7 physician services via talk, phone, and text, interactive mobile health applications, home laboratory testing kits, and online physician selection and appointment scheduling. Many DTC offerings aim to address common pain points experienced in traditional health care delivery settings.1

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Abbreviations used ARI- acute respiratory infection DTC- direct to consumer EMR- electronic medical record PCP- primary care provider

A key differentiator of DTC telemedicine, in contrast to other forms of telemedicine, is the patient initiation of care, with no intermediary clinician or facilitator present. Telemedicine encounters can be between patients and their own providers, backup providers at the same institution or practice, or providers with whom they have no preestablished relationship.2,3 The latter type of telemedicine has seen recent growth with companies such as American Well, Teladoc, MDLive, and Doctor On Demand providing 24/7 telemedicine services targeting cold and flu, allergies, rashes, and other nonurgent medical conditions. These companies account for millions of visits per year.4,5 Two large telemedicine solutions, American Well and Teladoc, also white-label their software. This enables health plans and hospital systems to offer a DTC telemedicine solution of their own. Health systems can use the technology to put their own providers on the platform, with “backup” physician coverage provided by the vendor. However, unless there is a costly electronic medical record (EMR) integration, there is no bidirectional flow of information between the telemedicine medical record and that of the institution. Some institutions have built telemedicine technology into their native EMR to develop a virtual front door for their patients.6 Now that Epic enables video visits, there is likely to be larger scale adoption of a DTC telemedicine approach by health systems using their own providers. There is an additional subset of DTC telemedicine that is outside of health plan and employer coverage, where patients pay directly out of pocket. Many of the newer asynchronous telemedicine solutions are self-pay.

DTC TELEMEDICINE MODALITIES There are 2 types of DTC telemedicine: synchronous and asynchronous (Table I). Synchronous telemedicine involves realtime 2-way video conferencing, chat rooms, or audio-only encounters, whereas asynchronous telemedicine, also referred to as “store and forward,” involves information transferred between patient and provider over hours or days. This can be achieved via secure text messaging or email and may include audio, images, or other multimedia files. If indicated, prescriptions may be provided in either type of encounter. A typical DTC telemedical encounter starts with the creation of an online account, completion of a health questionnaire, and a description of current symptoms. Telephonic registration may also be available. In the case of synchronous encounters, history can be obtained, documented, and verified live; in asynchronous visits, logic-based questioning and clinical decision support tools are used more often to aid in history-taking.7 Physicians review the information provided by the patient and determine appropriate next steps before replying. For example, Lemonaid uses computerassisted algorithms to diagnose and treat common conditions, including acid reflux, urinary tract infections, and oral contraception, and a physician does not review the case unless there is a

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deviation from the algorithm.8 The most popular type of DTC telemedicine use for allergic conditions is a synchronous video visit, with most telemedicine companies touting the treatment of allergies on their website. Plushcare.com also offers allergy laboratory testing through quest and labcorp, with a follow-up physician visit, although the type of test is not specified.

CURRENT DTC TELEMEDICINE USE TRENDS IN AMERICA Overall, telemedicine use is growing rapidly. Among privately insured and Medicare Advantage enrollees in a large, private US health plan, telemedicine use grew at a compound annual growth rate of 52% from 2005 to 2017.9 In the same population, primary care telemedicine grew at an annual compound rate of 36% and increased sharply in 2016, when access to DTC telemedicine increased.9-11 Teladoc alone reported that its visits increased 53% from 2016 to 2017, for a total of more than 1.46 million visits in 2017, and increased another 80% to 2.6 million visits in 2018.12,13 Cleveland Clinic partnered with American Wells’ Online Care Group in 2015 and saw an increase in visits of more than 200% over 1 year.14 Use of DTC telemedicine in a pediatric population within a national commercial health plan grew at a compound annual growth rate of more than 200% from 2011 to 2016.15 Despite this rapid growth, telemedicine still accounts for only an estimated 0.7% of all health care encounters, and is poised for additional expansion.9 THE DTC TELEMEDICINE LANDSCAPE: HIGH-GROWTH AREAS The most well-known DTC telemedicine market is dominated by for-profit companies, which are often venture capitalefunded or publicly exchanged. Synchronous video visits continue to grow exponentially year over year. Coverage for these services is often offered through health plans or an employer, with anywhere from a $0 to standard co-pay, although self-payper-visit options are also available at an average of $79.3,16 In addition, up to 75% of providers and health systems now offer some telemedicine services or plan to offer in the future.17 Patient acquisition is typically through digital marketing and direct mail marketing campaigns, based on demographic information, claims data, and, in some cases, consumer behavior data available through large marketing organizations.18 A common concern regarding DTC telemedicine is the provision of services by DTC companies that do not interface with existing EMRs.19 This problem is solved when health systems build telemedicine capabilities into their native EMR, or when the telemedicine vendor includes an interface between their database and the client’s EMR.6,20 Despite the lack of integration of health records, most traditional DTC telemedicine services have a way to provide visit information to the patient’s primary care provider (PCP), either by making visit summaries and notes directly available to patients or through traditional secure faxing. Asynchronous telemedicine growth In addition to established players, many new DTC telemedicine companies offering lifestyle medications have entered the market, mainly through asynchronous modalities and a self-pay, subscription-based model. These companies use logic or artificial

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TABLE I. Synchronous vs asynchronous telemedicine Feature

Synchronous

Asynchronous

Interaction Provider involvement Modalities

Real-time Yes Live chat, phone, video

Popular applications

Urgent care, tele-ICU, telepsychiatry

Technology Staffing and support

Use of artificial intelligence

Requires real-time video connection Requires more complicated staffing and technology support to provide patients with real-time access to providers Increasingly used for history-taking

Patient satisfaction Prescriptions Quality assurance oversight Reimbursement Multistate licensure required

High Provided if appropriate Yes Yes, but slow to adoption Yes

Delayed Yes/no Secure messaging—may include audio files and/or photos Teledermatology, remote monitoring (eg, blood sugar and blood pressure), lifestyle medication prescriptions, e-consults Does not require video Requires less complicated staffing models because responses are not real-time Increasingly used for history-taking and decisionmaking algorithms High Provided if appropriate Minimal Mostly direct pay No

ICU, Intensive care unit.

intelligenceebased intake forms, which are reviewed by a physician who then approves a prescription. Some companies elevate the intake form to a physician only when there is a deviation from the algorithm that would make a patient ineligible for a prescription. These companies are quickly dominating the market, with men’s health company Hims providing erectile dysfunction and hair loss treatment reaching a valuation of $1 billion and recently launching Hers, which provides birth control and medication for decreased female sexual desire.21-23 Roman, another company focused exclusively on men’s health, provides treatment for smoking cessation, herpes simplex virus, and erectile dysfunction via computer-assisted algorithms. Keeps and Nurx are similar point solutions. All these companies own or work with a private pharmacy to ship the medication, white-labeled, directly to the patient’s home.24-26 In the mental health space, companies such as Talkspace, Breakthrough, and Ginger.io offer DTC text-based therapy services; in addition, companies such as Genoa Health provide prescription refill services directly to psychiatry patients.27-30 However, it is important to note that the American Psychiatric Association specifically supports the use of video-based telemental health services, and so more research is needed to determine efficacy in the asynchronous space.31 There are currently no end-toend DTC allergy solutions in the marketplace. Teledermatology services overlap with allergy care. Dermatologist On Call and SkyMD, 2 of the largest players, are widely available across the United States and advertise treating the most common skin conditions, including contact and atopic dermatitis as well as urticaria.32,33 Teladoc and Amwell also provide teledermatology services. Apostrophe is a subscription-based player that provides treatment for hair loss, wrinkles, and eyelash growth and ships white-labeled medications to the home.34

E-consults The specialist second opinions space is also another area of growth. 2nd.MD and Grand Rounds are platforms through which patients can contact experts via video, email, or text for second

opinions on new or complex diagnoses. They tout access to worldclass specialists.35,36 Second Opinions, a similar company, allows members to access radiology and medical second opinions.37 Best Doctors, another second opinions solution, was acquired by Teladoc in 2017.38 Most data on e-consults to allergists are in the hospital setting from provider to provider, with a focus on immunodeficiency and drug allergy.39 E-consults in the outpatient setting, also provider to provider, include interpretation of allergy testing results and recommendations for treatment of allergic skin diseases, including urticaria. However, little is known about the DTC use of e-consults for allergic conditions.

Special patient populations Quicker access to care, more convenient appointment times, and the elimination of travel time are key benefits of DTC telemedicine for certain populations. In the United States, Medicare and Medicaid patients currently wait an average of 32 days for a new patient dermatology appointment, and more than half of US and Canadian adults report that they are unable to schedule a same- or next-day appointment with theirprimary care physician.40,41 Average travel time to appointments totals 37 minutes, with an additional 64 minutes spent in clinic not seeing a physician.42 DTC telemedicine offers opportunities for patients to increase access to specialists and same-day primary care appointments, eliminate travel time, and wait in the comfort of their home or office instead of a brick-and-mortar waiting room. Rural populations In rural populations, DTC telemedicine may offer an alternative to nonurgent emergency department visits. In rural North Carolina, a recent study of a “Discharge to Medical Home” model, where nonurgent emergency department visits are diverted to a hospital-adjacent primary care clinic with expanded hours, found that 36% of emergency department visits were considered appropriate for diversion.43 These divertible visits may represent the potential market size for rural DTC virtual urgent care services. In addition, in areas where specialists are

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scarce, DTC telemedicine eliminates the need for long transit times.

Populations impacted by natural disasters Natural and man-made disasters including hurricanes, floods, communicable disease outbreaks, earthquakes, toxic exposure, and fires are likely to result in interruptions to health care. If telecommunications infrastructure is available, DTC telemedicine may offer a stopgap modality for providing care for acute conditions or for chronic disease management if physical access to patients is impossible. A recent study of virtual visits after hurricanes Harvey and Irma found that acute respiratory infections (ARIs) and skin problems were among the most common complaints, but that physicians also saw patients for chronic conditions, musculoskeletal complaints, general medical advice, and prescription refills.44 Other proposed uses of DTC telemedicine in disaster response include supporting bystander response and providing behavioral health services during the recovery phase.45 PATIENT SATISFACTION Overall, patients report high levels of satisfaction with DTC telemedicine encounters. For synchronous encounters through Online Care Group with providers with whom patients had no previous relationship, a recent study found that 85% of patients were satisfied with the provider.14 Prescription receipt and coupon use were associated with the highest odds of patient satisfaction, highlighting convenience and cost as drivers.46,47 In a pilot study of synchronous versus in-person encounters in an urgent care setting, patients were equally satisfied with either service.48 A large health plan recently provided access to a customized teledermatology portal to more than 40,000 of its members for a 6-month period, with 243 teledermatology consults completed and a patient satisfaction score of 4.38/5.49 Despite these levels of satisfaction, a survey of a random sample of the US adult population shows preference for telemedicine care delivery by their own physicians. Fifty percent of respondents were willing to see their own PCP via telemedicine, whereas only 17% reported willingness to see a provider from an unaffiliated health care organization.3 QUALITY ASSURANCE To practice telemedicine, a physician is required to be licensed in the state where the patient is located.50 The Interstate Medical Licensure Compact has made it easier for physicians to get medical licenses outside of their state of primary licensure; however, multistate licensure requirements still remain a major barrier to adoption.51 Guidelines for clinical telemedicine encounters have been proposed by the American Telemedicine Association. It recommends that several quality review metrics be routinely assessed, including equipment or connectivity failures, number of attempted and completed visits, patient and provider satisfaction and complaints, measures of whether the visit was appropriate for a virtual encounter, and adherence to established standards of care, such as Healthcare Effectiveness and Data Information Set measures, for antibiotic prescribing.52 Antibiotic use in ARIs and acute bronchitis has been most studied. Early studies of Teladoc encounters found that antibiotics were prescribed for patients with ARI at the same rate for telemedicine versus in-person physician visits, but that antibiotics were overprescribed in both settings and Teladoc providers tended to use more broad-spectrum antibiotics.53 Additional

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analysis of Teladoc encounters found that Teladoc had higher rates of antibiotic prescribing for acute bronchitis.54 Newer research with a larger sample size, however, has found that rates of antibiotic use, broad-spectrum antibiotic use, and guidelineconcordant antibiotic management for ARI are within 1 to 2 percentage points for DTC telemedicine visits and PCP visits.55 For acute sinusitis, rates of concordance with established guidelines for antibiotic use were similar across DTC telemedicine, urgent care, and emergency room visits.56 Rates of follow-up and further testing offer additional quality assurance metrics. After DTC telemedicine visits for ARIs, rates of follow-up visits within 2 to 21 days were significantly higher for patients seen in telemedicine encounters versus urgent care and emergency room encounters, with more than 40% of the follow-up visits to PCPs.55 That said, there may be a difference between a follow-up visit in 2 to 7 days versus 14 to 21 days. A 2- to 7-day follow-up visit is likely related to disease progression or inaccurate diagnosis, whereas a later appointment could be to establish care with a PCP. More research is needed in this area. Telemedicine may also offer an opportunity to reduce unnecessary diagnostic testing, which can be costly to the health system. Notably, 67% of patients seen in PCP visits and 78% of those seen in urgent care visits receive diagnostic testing for pharyngitis evaluation, despite the recommendations of the Infectious Disease Society of America to refrain from testing in patients with clinical features of viral illness.55,57 For low back pain, rates of imaging were similar across all visit types.54 DTC teledermatology has faced concern in the past related to automated history-taking practices and the use of international dermatologists not licensed to practice in the United States.58,59 One analysis of 4 popular teledermatology apps found that 3 of the 4 apps demonstrated diagnostic concordance with an inperson dermatologist.59 Another study using simulated patients and asynchronous teledermatology apps found very poor diagnostic performance for conditions that required medical history follow-up questioning to accurately diagnose.60 In addition, treatment recommendations sometimes contradicted established guidelines and prescriptions were frequently written without discussion of side effects or guidelines for use in pregnant patients.60 However, the simulated cases were not evaluated in-person, limiting the study’s ability to compare DTC teledermatology to traditional dermatology care. Across the asynchronous space, ease of use and access to care need to be properly balanced with implementation of highquality care measures to avoid lax prescribing practices. The asynchronous industry is less regulated and licensure requirements are less stringent. Information is not typically required to be shared with a patient’s PCP, and formal verification of patient history and previous results is somewhat lax. Theoretically, a patient could create an account with erroneous information to receive medications. That said, this could also occur in a brick-and-mortar environment, although the barriers to such behaviors are much higher. In addition, the American Urological Association recommends a physical examination and evaluation of underlying causes for erectile dysfunction before treating the symptom, raising concerns around quality of care for DTC asynchronous telemedicine companies in the men’s health space. Convenience should not replace adherence to guidelinesbased practice. Finally, point solutions that focus only on a single problem prevent a holistic view of the patient, the complete opposite of a patient-centered medical home. We may see

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over time that these services continue to fragment health care delivery in this country. The challenge of medical record keeping will continue to plague our ability to coordinate care, and will inevitably need to be the full responsibility of the patient in a DTC health care world.

BARRIERS TO ADOPTION Barriers to adoption of DTC telemedicine include issues related to technology, reimbursement, licensure, training, and quality (Table II).7 Technology limitations are a key barrier to adoption for patients, providers, and hospital systems. Patients may lack the technology or infrastructure to use telemedicine, or may simply be in the habit of seeing a provider in person. Patients also cite a preference to see their own provider who may not have telemedicine capabilities.48 For providers, there are concerns that telemedicine technology will increase the already-substantial burden of documentation, or lack seamless integration with existing platforms and disrupt workflows. At the institutional level, implementation of telemedicine requires a coordinated approach and buy-in across multiple disciplines including IT, operations, marketing, legal, and clinical teams. In addition, with the pace of technological innovation increasing, administrators may fear making a large investment in a technology that becomes quickly obsolete.61 Lack of standardized training and awareness of the need for the development of certain skill sets to effectively practice telemedicine has also limited adoption. Finally, many providers may lack awareness of the advances in this rapidly growing space. Reimbursement and licensure requirements remain complex issues. With policies varying by state and payer, uncertainty regarding economic feasibility is a barrier to adoption for providers and health systems, paving the way for DTC self-pay telemedicine solutions to disrupt the current system.

ALLERGIST ROLE IN DTC TELEMEDICINE The allergy specialty is prime for telemedicine because patients are generally healthy, frequently visit their provider, and have a range of conditions that lend themselves through treatment via video or asynchronous modalities (ie, store and forward images). For example, assessment of environmental triggers is made feasible via telemedicine as is the ability to evaluate a reaction in real time. The latter is of increasing importance as sublingal immunotherapy gains popularity in the United States. The use of peripheral devices expands this scope even further. Tytocare, for example, is a virtual stethoscope, otoscope, and thermometer that is currently available for purchase online and in stores. Telemedicine also offers the opportunity to increase access to allergists, of which there is a shortage, particularly in rural areas.62 Finally, it will be critical to incorporate a telemedicine modality into the workflow for the use of mHealth and remote monitoring devices in direct patient care. Allergists interested in the DTC telemedicine space have opportunities to join existing telemedicine companies to provide virtual urgent care, much of which is centered on allergic conditions, support startups looking to disrupt the allergy market, and get involved in quality assurance and regulatory measures to ensure that the highest levels of care are met.

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TABLE II. Facilitators and barriers to adoption Facilitators

Cost Access Ease of use Efficiency Convenience Peripheral devices mHealth

Barriers

Technology infrastructure Patient and provider training Lack of integration with EMRs Implementation Reimbursement Licensure requirements Paucity of outcomes research

FUTURE DIRECTION/TRENDS As telemedicine becomes more mainstream and is adopted by hospital systems and provider groups, and as reimbursement models evolve, it will be interesting to see where DTC telemedicine solutions live. On one hand, the technology exists to enable providers and hospital systems to address gaps in care in a way that integrates with the existing health care ecosystem. On the other hand, if the selfpay DTC telemedicine industry continues to see tailwinds and billion-dollar valuations, health care delivery can be highly disrupted much more quickly than payers and providers can evolve. Patient acquisition tactics for privately owned DTC companies are very different from traditional health care marketing services, and make seeing a doctor or getting a prescription as easy as placing an online grocery delivery order. This can be very enticing to patients, particularly those who regularly use social media and web searches. Eighty-five percent of people use the internet to look up health- or medical-related information at least a few times per year, and 65% of US adults aged 50 to 65 years and 41% of US adults 65 years and older are currently using Facebook. This implies that digital marketing tactics and oneclick virtual care can reach a very broad population.63,64 In addition, as more individuals are cost conscious because of high-deductible health plans, they will look for alternatives that are more convenient and cost-saving, and there is the risk that they will be drawn to point solutions that address a single issue versus interacting with a PCP who may send them for additional tests and workups, which could lead to costly out-of-pocket expenses. Although the self-pay DTC approach can be attractive and engaging for patients, there is an ethical responsibility to ensure that care is adherent to guidelines-based practice and held to the same standards of clinical quality. It is important for companies to be proactive about setting themselves to the highest standards of care and involving medical experts in the design of their products, services, and quality assurance metrics. The field of allergy and immunology, already plagued by fragmentation and a shortage of physicians, is prime for disruption. Allergies, rashes, upper respiratory infections, and bronchitis are consistently within the top 5 diagnoses treated via telemedicine.7 It is important for allergists to understand the DTC space as well as opportunities to get involved to shape guidelines and policy and become advocates of reimbursement. There is opportunity for allergists, particularly in the specialist second opinions space, to leverage DTC care for new patient acquisition as well as appropriate usage of referral services. The field is fast-moving and will inevitably be a part of the future of health care delivery.

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