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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Chicago Conference Attracts a Sizeable Crowd of Enthusiastic Hospital and Health System Clinical Laboratory Outreach Leaders

Sessions at this annual medical laboratory conference demonstrated that lab outreach continues to be a productive clinical and business line at numerous hospitals and IDNs

Sept. 26-Chicago: During the past 24 months, there have been multiple news stories announcing that different hospitals or integrated delivery networks (IDNs) had signed agreements to sell their clinical laboratory outreach businesses to one of the two multi-billion-dollar commercial lab corporations. Some Wall Street analysts have taken these lab outreach acquisitions as a sign that hospitals are struggling to compete in the outreach laboratory marketplace. They predict that the big commercial labs will continue to scoop up hospital laboratory outreach businesses at a brisk pace.

However, this may be an example of popular wisdom not reflecting the true state of the outpatient/outreach market for clinical laboratory testing services. Evidence of the contrary view—that many hospitals and IDNs have flourishing lab outreach programs—was in plain view last week here in the Windy City.

Last Tuesday and Wednesday, Mayo Clinic Laboratories presented its 33rd annual “Leveraging the Laboratory: Dimensions of Outreach” conference at the Intercontinental Hotel on Chicago’s Magnificent Mile. It was a sold-out event with about 150 attendees. Organizers said this was the largest attendance at this lab outreach meeting in the past 10 years.

Group at outreach conference

During last week’s “Leveraging the Laboratory” outreach conference in Chicago, produced by Mayo Clinic Laboratories, the individuals pictured above each presented different aspects of success in operating an effective hospital clinical laboratory outreach program. Front row top to bottom they are Henry Givray, Leadership’s Calling; Brianne Newton, Mayo Clinic Laboratories; Nilesh Kachalia, Yuma Medical Center; Trudie Milner, PhD, Yuma Regional Medical Center. And rear row top to bottom: Robert Michel, The Dark Report; Tony Bull, Medical University of South Carolina; Nicholas Rambow, Corewell Health; Jane Hermansen, Mayo Clinic Laboratories; Ellen Dijkman Dulkes, Mayo Clinic Laboratories. (Photo copyright: The Dark Report.)

Optimism was High at Mayo’s Lab Outreach Conference

Throughout the two days of the conference, there was enthusiasm for the viability of hospital laboratory outreach programs. There was also optimism that these local and regional outreach businesses will continue to be profitable and can support better patient care. Had any of the Wall Street analysts been in attendance, they would have heard the other side of the coin about the profitability and viability of hospital laboratory outreach programs—a story documented by the presentations of different hospital and IDNs that operate flourishing lab outreach programs.

“What makes this meeting unique is that it is the longest-running and biggest conference devoted to best practices in hospital and health system laboratory outreach programs,” said Jane Hermansen, Manager, Outreach and Network Development at Mayo Clinic Laboratories. “There are signs that increased integration within multi-hospital health systems requires a common lab test menu with consistent methodologies and reference ranges.

“During the conference, we heard many participants describe one part of their lab testing services to office-based physicians as ‘inreach’ when it involves employed providers of the parent health system,” she continued. “This is evidence that health system administration recognizes the value of a full longitudinal lab test record for their patients—whether from inpatient, inreach, or outreach testing.

“As well, this year’s exceptionally large attendance shows that hospital-based labs across the United States are forging ahead with their lab outreach services in ways that generate many benefits,” Hermansen noted. “The most important is to help physicians deliver better care to patients. At the same time, the added test volumes from a productive hospital laboratory outreach program improves the productivity of the laboratory while generating much needed income that helps that lab’s parent organization.”

Day one of this two-day event featured presentations about successful hospital laboratory outreach programs. Speakers included:

Day two was organized around hands-on workshops that addressed the management, operational, financial, and sales/marketing elements that make up a growing, dynamic hospital laboratory outreach business. Attendees were fully engaged in these sessions as they learned best practices. Innovations and clever approaches to increasing physician and patient satisfaction were shared during peer-to-peer exchanges.

Local Clinical Laboratories Serving their Communities

Hospital laboratories are uniquely positioned to deliver value to the physicians and other providers in the towns and regions they served. The obvious benefit is that the lab, its employees, and its clinical pathologists all live in the community. They have professional relationships that may go back decades with the physicians who order medical laboratory tests for their patients.

These local hospital labs can report many test results on the same day that they get the specimens from the doctors’ offices. Another benefit for those physicians and patients is that when a hospital lab performs all the tests originated in inpatient, outreach, and outpatient settings, it has a full longitudinal record of a patient’s lab test results, which often covers years of testing. This is important when patients show up in specialists’ offices or hospital emergency departments. Physicians in these settings can see all of the patient’s lab test history, and the tests are performed with the same methodology and have the same reference ranges.

Ways to Differentiate Hospital Laboratory Outreach Services

Hospital and health system laboratory outreach programs have multiple ways to differentiate their lab testing services. During his presentation, Tony Bull, System Administrative Officer, Pathology and Laboratory Medicine, Medical University of South Carolina, Charleston, South Carolina, provided the following list of different benefits that a lab outreach program can offer to local physicians, patients, and consumers:

  • Ease of access
  • Patient experience
  • Couriers
  • Pricing
  • Payer contracts
  • Customer service
  • Marketing and sales
  • Physician perception

One point of competitive advantage the speakers emphasized was the outreach laboratory’s access to lab test data. When lab data is combined with patient demographics and other sets of data, an outreach laboratory can develop clinically actionable intelligence that helps physicians and health insurers improve patient care, while lowering the total cost of care. When packaged correctly, these enriched data offerings can generate a new source of revenue for lab outreach programs.

Given the tough finances experienced by health systems and hospitals across the United States in recent years, it’s notable that the attendees at Mayo Clinic Laboratories’ “Leveraging the Laboratory” conference reported positive growth and profitable results from their laboratory outreach programs.

That’s solid evidence that there continues to be an opportunity for pathologists and clinical laboratory leaders of IDNs to ramp up their laboratory outreach businesses to win new client-physicians and produce additional cash flow for their labs.  

—Michael McBride

Related Information:

Mayo Clinic Laboratories’ “Leveraging the Laboratory: Dimensions of Outreach” Conference Will Be Held Sept. 26–27, 2023, in Chicago

Hospital Laboratory Outreach: Benefits and Planning

Leveraging the Laboratory: A Community Focus

Dimensions of Lab Outreach

Mayo Clinic Laboratories’ 33rd Outreach Conference

Video Podcast: Leveraging the Laboratory, Mayo Clinic Laboratories

Understanding Gen Z’s Approach to Healthcare Helps Clinical Laboratories Learn How to Better Meet Their Needs

Healthcare providers of all types will benefit from acknowledging Gen Z’s preference for digital interactions, self-testing, and over-the-counter medications

Each generation has its own unique connection to how it manages its health, and the latest studies into the healthcare habits of Generation Z (aka, Gen Z or Zoomers) are providing valuable insight that savvy clinical laboratory managers and pathologists—in fact all healthcare providers—can use to better serve their Gen Z patients.

According to McKinsey and Company, Gen Z’s “identity has been shaped by the digital age, climate anxiety, a shifting financial landscape, and COVID-19.” And Pew Research states that Zoomers “are also digital natives who have little or no memory of the world as it existed before smartphones.”

As the largest demographic, “Gen Z stands 2.6 billion members strong. … Globally, they hold purchasing power of more than $500 billion and mobile buying power of $143 billion,” wrote Stacy Rapacon, Managing Editor at Senior Executive Media, in an article she penned for HP’s The Garage.

Meeting Gen Zers’ healthcare needs on their terms would seem to be a judicious choice.

Bernhard Schroeder

“Gen-Z’s buying power may exceed $3 trillion,” wrote Bernhard Schroeder (above), a clinical lecturer on integrated/online marketing at San Diego State University, in Forbes. “Their spending ability exceeds the gross domestic product of all but about 25 of the world’s countries.” Thus, it behooves healthcare leaders, including clinical laboratory managers and pathologists, to consider how best to approach treating Gen Z patients. (Photo copyright: San Diego State University.)

Gen Z Leads in Digital Healthcare Use, Self-testing, OTC Drugs

“Gen Z engages in every type of digital healthcare activity more than other generations,” a recent study by PYMNTS noted. A total of 2,735 consumers were surveyed, and though all reported using digital healthcare to some degree, Gen Z stood out.

Patient portal access was the highest digital method accessed by Zoomers (62%), followed by telemedicine appointment usage (55%), the PYMNTS report found.

Knowing the direction Gen Z is trending may lead clinical laboratory leaders to expect self-testing to be on the rise, and that hunch would be correct. “There are two converging trends; the rise of women’s health technology and increased use of at-home sample collection for diagnosis tests,” Clinical Lab Products reported.

“Ongoing innovation in these areas could significantly improve the accessibility of women’s health testing. It will also have repercussions for labs, potentially changing the way samples are received and processed, and the way results are distributed. The quantity and quality of samples may be impacted, too. It’s important for labs to be aware of likely developments so they can prepare, and potentially collaborate with the health technology companies driving change,” CLP noted.

Another area feeling the impact of Gen Z’s healthcare spending is the over-the-counter (OTC) drug market.

“Since the pandemic began, more Americans are paying closer attention to their symptoms and looking for easily accessible information about over-the-counter medications, especially for allergies, coughs, and headaches,” said Kim Castro, Editor and Chief Content Officer for US News and World Report, in a press release.

Zoomers Want Healthcare on Their Own Terms

Gen Z grew up with the internet, Amazon, Netflix, Google, and social media since birth.

“The ‘norm’ they experienced as children was a world that operated at speed, scale, and scope. They developed an early facility with powerful digital tools that allowed them to be self-reliant as well as collaborative,” anthropologist Roberta Katz, PhD, a senior research scholar at Stanford’s Center for Advanced Study in the Behavioral Sciences (CASBS) told Stanford News.

As digital natives, Gen Z can be more science and data driven and yet still expect to find health advice on YouTube or TikTok. According to an article published by Harvard Pilgrim Healthcare, “Gen Z is the first generation to grow up surrounded by digital devices, and they expect their health benefits to be digital, too. From choosing a benefits package to finding a provider, Gen Z wants to take care of their health on their own terms. And that may just include video chatting with a doctor from the back of an Uber.”

In its 2022 US Digital Health Survey, research firm Insider Intelligence found that “Half of Gen Z adults turn to social media platforms for health-related purposes, either all the time or often.”

“Gen-Z will make up 31% of the world’s population by 2021 and they have deeply formed perceptions and beliefs … This has led to an amazing change in the way Gen-Z is disrupting several industries simultaneously,” wrote Bernhard Schroeder (above), a clinical lecturer on integrated/online marketing at San Diego State University, in Forbes.

What Can Clinical Laboratories Learn from These Findings

Gen Z seeks accuracy and trustworthy information. “Gen-Zers’ natural penchant for skepticism and frugality—coupled with low levels of confidence in the US healthcare system—makes them less likely to trust providers, more likely to research prices before seeking care, and more apt to worry that their health insurance won’t cover their treatment,” Insider Intelligence noted.

According to Contract Pharma, “Gen Z is concerned with holistic health and self-care, rather than a one size fits all pharmaceutical approach. They share a hesitancy for traditional healthcare models but with very interesting differences. By understanding these differences, the consumer healthcare industry can focus on agile and distinctive brands to harness Gen Z’s tremendous purchasing power.”

Savvy clinical laboratory leaders can better serve their Gen-Z client physicians and patients by better understanding why Zoomers are more inclined to order their own lab tests (without a physician), collect their own specimens to send into labs, and/or collect their own specimens to do home testing (think COVID-19 self-test kits). Zoomers may need an entirely new business model from their healthcare providers, including clinical laboratories.

Kristin Althea O’Connor

Related Information:

What is Gen Z?

On the Cusp of Adulthood and Facing an Uncertain Future: What We Know about Gen Z So Far

How Gen Z is Redefining Their World through Technology

Gen Z Is ‘Generation Digital Health’ as 62% Use Digital Patient Portals

What Self-Sampling for Women’s Health Testing Means for Labs

US News Top Recommended Over-the-Counter Health Products

Gen Z Are Not ‘Coddled.’ They Are Highly Collaborative, Self-Reliant and Pragmatic, According to New Stanford-Affiliated Research

Who is Gen Z and How Are They Shaping the Future of Health Benefits?

Generation Z: Transforming Consumer Healthcare

Gen Z’s Take on Healthcare

US Generation Z Healthcare Behaviors

Retail Pharmacies Are Working with Pharmaceutical Companies to Recruit and Enroll Patients in Decentralized Clinical Trials

This trend, which began during the COVID-19 pandemic, may bypass those clinical laboratories and pathology groups that recruit patients for clinical trials, but increase the diversity of the pool of study participants

National retail pharmacy chains are seeking new lines of business in the healthcare market and their efforts could cost clinical laboratories and pathology groups revenue. Their strategy is to identify patients who are candidates for specific clinical trials and connect them with clinical trial managers for enrollment, according to CNET.

This comes on the back of the US Food and Drug Administration’s (FDA) move to decentralize clinical trials, which got started during the COVID-19 pandemic, and support clinical trials that covered a wider swath of the American population.

Dark Daily first covered this trend in “Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research.” We reported how Walgreens was launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giant’s growing menu of healthcare services.  

Traditionally, there are clinical laboratories and anatomic pathology groups that actively work to connect their patients with appropriate clinical trials (and earn revenue for both the enrollment and doing necessary testing of the patient in support of the trial). Now, following the FDA’s lead, pharmacy companies seem to be working to capture some of that revenue.

“COVID-19 was definitely the impetus for reevaluating how we did clinical trials,” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. The interest of retail pharmacies in the business of identifying their patients as candidates for clinical trials is a development that clinical lab managers and pathologists may want to monitor. (Photo copyright: Walgreens.)

Customer Demand for Convenience a Factor

Clinical trials are imperative to the drug approval process required by the FDA’s Center for Drug Evaluation and Research (CDER). The COVID-19 pandemic fueled the FDA’s move to decentralize clinical trials to help pharmaceutical companies recruit subjects for drug testing.

Retail pharmacy chains apparently saw that as the latest opportunity to position retail pharmacies as intermediaries between drug manufacturers and patients.

In response to growing demand for convenient healthcare locations, Walgreens, CVS, Rite Aid, and Walmart have all installed primary care clinics into their retail pharmacies and added vaccinations. Further, after COVID-19 caused retail pharmacy chains to sell over-the-counter SARS-CoV-2 home test kits, pharmacies sought to offer more diagnostic test options to their customers, which would further direct such tests away from clinical laboratories.

Over the last two years, Walgreens, Walmart, CVS, and Kroger have also added clinical trials divisions to their corporate holdings. Among the companies’ stated goals is to make clinical trials more accessible and convenient for their customers, as well as to recruit more trial participants from underrepresented populations. 

According to an article published in the Journal of Medical Internet Research (JMIR), “around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.” This shortfall may delay the creation of useful drugs, medical devices, and other essential treatments. 

“If you see the trial is at an academic institution that’s 30, 40 miles away, you’re going to say, ‘Forget it. It’s too far,’” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. “But if you can go to a Walgreens that’s maybe five miles away, you’re more likely to participate and complete the trial.”

Creating a More Diverse Group of Clinical Trial Participants

CNET reported that “Pfizer, Gilead, and other biopharmaceutical companies are eager to diversify their patient pool.”

According to the FDA’s 2022 Drug Trials Snapshot, “Whites comprised the majority of patients enrolled in most of the pivotal trials supporting approval of all 37 novel therapies, followed by Asians and Blacks.”

Walgreens, which operates 8,698 pharmacies in 53 states and territories, has installed special clinical trial centers at 15 pharmacies and has approximately one dozen clinical trials in various stages. Tandon said more than two million Walgreens customers have already been contacted about participating in clinical trials.

In January, grocery giant Kroger announced its first clinical trial partnership with Persephone Biosciences to locate subjects for a study on gut health and its influence on colorectal cancer. Data collected from this trial will help develop personalized medicines and discover cancer-specific indicators that may be beneficial in guiding treatments and preventative measures. 

Kroger Health operates nearly 2,200 pharmacies across the US, including 11 specialty pharmacies and 225 clinics.

In October of last year, Walmart announced the creation of the Walmart Healthcare Research Institute (WHRI), which will focus on innovative interventions and medications to help communities that are unrepresented in clinical trials, such as older adults, rural residents, women and minority populations.

Walmart operates over 3,000 pharmacies in 49 states. Ninety percent of Americans live within ten miles of a Walmart, which translates to the retailer being able to reach a large number of candidates for clinical trials.

Study findings published by marketing research company Precedence Research illustrate how the business of clinical trials generated more than $48 billion last year and is projected to reach over $83 billion by 2032. (Graphic copyright: Precedence Research.)

CVS Discontinues Decentralized Clinical Trial Business

CVS Health was the first pharmacy to launch a clinical trials program back in May 2021. However, in May of this year, the company announced it was shuttering that portion of its business.

CVS Health expects to fully phase out its clinical trials unit by the end of 2024, citing “the need to align existing businesses with its larger corporate strategy,” according to BioSpace.

“Fully decentralized models preclude a huge swath of possible research because of safety and regulatory concerns,” Steve Wimmer, Vice President of Partnerships at decentralized clinical trial recruiter 1nHealth, told BioSpace. “It’s difficult to conduct such trials in a standardized manner. I think [CVS] may have imagined that a clinical study visit wouldn’t be that different from the primary care visits they already do. But for interventional, go-to-study trials, it’s not the same as a primary care visit.”

According to the US National Library of Medicine, more than 38,000 registered clinical studies occurred in 2022. As of August 24 of this year, 26,237 clinical studies have been registered on clinicaltrials.gov

There are clinical laboratories and anatomic pathology groups that actively work to connect their patients with those clinical trials. Though pharmacy companies’ clinical trial recruitment programs may reduce revenue for those labs and pathologists, the increased participation in such trials by greater numbers and more diverse populations of people could advance the development of new lifesaving treatments and therapies, which is good for everyone.  

—JP Schlingman

Related Information:

Clinical Trials Are Now at Your Local Drugstore. What That Means for You

Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research

FDA: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

FDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

US National Library of Medicine: Trends, Charts, and Maps

Healthcare Clinical Trials Market

Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis

FDA: Drug Trials Snapshots Summary Report 2022

Kroger Health Establishes Clinical Trial Site Network to Increase Reach and Access to Research Studies

Walmart’s Healthcare Research Institute Launches with Mission to Improve Care for Underserved Communities Through Research

CVS Health Winding Down Clinical Trial Business  

Calgary’s Long Clinical Laboratory Waits at Patient Service Centers Prompt Alberta Health Services to Add Extra Appointments, Temporary Locations

As patients and staff suffer with lengthening wait times, critics claim proposed solutions won’t remedy the ailing system of collecting medical laboratory specimens

With a backlog of lab appointments and a plethora of long wait times for phlebotomy services in the Canadian Province of Alberta, Alberta Health Services (AHS) is feeling the heat. As a result, Alberta Precision Laboratories is making efforts to improve services by adding 400 appointments in Calgary, CBC News reported.

The government-owned clinical laboratory lab company added these appointments at Peter Lougheed Centre and South Health Campus, both in Calgary, with 175 additional appointments coming down the line at the Foothills Medical Centre, also in Calgary, the CBC reported.

AHS is targeting “areas of high demand” and the efforts to bolster services include adding weekend appointments and “temporary new locations” the Calgary Herald reported.

The ripple effect from such delays in Canada’s public healthcare system are widespread and ruffling the feathers of patients, staff, and critics alike. Clinical laboratories in the United States may learn from watching how the Canadian health system resolves these issues.

“As of today, there were waits of upwards of 90 minutes for an appointment that’s already scheduled. That’s unacceptable,” Adriana LaGrange, Alberta’s Minister of Health, told CBC News. (Photo copyright: CBC News.)

Short- and Long-Term Efforts

Densely-populated Calgary and its surround areas have been experiencing increasingly long waits in the last few months. The Calgary Herald reported that their efforts to schedule a new lab appointment brought about only a handful of appointment times a few weeks out, with the majority of open times being five weeks out.

“I’ve heard some really distressing stories on how long it’s taken to get necessary lab work back,” Adriana LaGrange, Alberta’s Minister of Health, told CBC News. “This impedes the ability for physicians to make diagnoses, and we just can’t have that,” she added.

The 400 new appointments are “part of an arrangement worked out between Alberta Precision Labs and DynaLIFE, the private clinical laboratory provider that handles the bulk of community lab appointments in Alberta,” CBC News reported.

DynaLIFE, formerly Dynacare Kasper Medical Laboratories (DKML), is partly owned by Labcorp.

Alberta Precision Laboratories is “working on extending hours, hiring other third-party providers, and opening or expanding satellite centers [patient service centers] in and around Calgary to add 7,500 appointments per week, which would represent a 25% increase in the area,” LaGrange told CBC News.

“In the short term, we will provide the necessary appointments that are needed by Albertans, particularly in Calgary and the south area. In the long-term, we’ll work towards something where there’s more stability in the system,” she added.

Lengthy Waits to Receive Medical Laboratory Test Results

Patients and doctors in Calgary “say wait times for blood work and quality of services remain a concern under DynaLIFE Medical Labs who took operation over community labs last year,” the Calgary Herald reported.

“One Calgary doctor who asked to stay anonymous for fear of professional reprimand said she’s hearing from patients who have travelled out of the city to labs as far as Canmore or Didsbury to get testing done. She added her colleagues have complained about lengthy waits to receive lab results and said sometimes results aren’t sent at all or are directed to the wrong clinic,” the Calgary Herald reported.

At one DynaLIFE location, one patient waited two hours and 20 minutes for her previously-scheduled lab work even though online the wait time showed just 11 minutes, the Calgary Herald reported. “I don’t understand how anyone can get lab work done and work or look after their kids,” she said.

It is not clear why DynaLIFE is missing its published benchmarks.

AHS No Stranger to Controversy

Government health programs in many countries lack the necessary capital to train and employ adequate numbers of doctors, nurses, and other medical professionals, or to expand clinics/hospitals, clinical laboratories, or radiology services. Thus, demand generally exceeds supply and so government health systems ration care using wait times.

This is one factor in the Alberta story.

In Alberta, since the 1990s, various attempts by the AHS to expand clinical laboratory testing volumes/capabilities in advance of need have seesawed as liberal/conservative governments came and went—each with their own agenda on how healthcare should be organized.

Dark Daily’s sister publication The Dark Report covered that trend in “Alberta Health to Build New Lab to Serve Edmonton, Province.” We reported how following years of controversy associated with different plans to build a large new laboratory facility to serve Edmonton and the surrounding region, Alberta Health Services ended up financing and building the new lab with its own resources.

This was preceded by an announcement that the Alberta government would develop a new central laboratory to process 80% of the clinical laboratory tests in the Edmonton region and become the central lab for a new system from Alberta Health Services to process lab tests in the province.

At that time, Alberta had six different organizations providing clinical laboratory services. Having so many organizations involved in clinical laboratory testing services, according to then Alberta Health Minister Sarah Hoffman, resulted in a “needlessly complex and fragmented system.”

All of this explains why Calgary is experiencing wait times for phlebotomy that are frustrating patients. It’s a cautionary tale that clinical laboratory managers in this country may want to study.

—Kristin Althea O’Connor

Related Information:

Alberta Expands Medical Lab Test to Reduce Long Waits, Particularly in Calgary

Long Community Lab Wait Times Continue Under DynaLIFE for Calgary Patients

Alberta Health to Build New Lab to Serve Edmonton, Province

Amazon Expands Its Virtual Primary Care Service, including Clinical Laboratory Testing, to All 50 States along with More Locations for One Medical Clinics

Consumer demand for telehealth services and convenient healthcare locations fuels Amazon’s quest to ‘reinvent’ healthcare

Amazon’s stated goal of disrupting traditional healthcare processes and workflow continues. During the COVID-19 pandemic, Amazon built several large clinical laboratories to do its own SARS-CoV-2 testing. Then, last February, Amazon acquired One Medical, a San Francisco-based primary care provider that offers telehealth services, for $3.9 billion. Now, Amazon is opening new One Medical locations and expanding its primary care service nationwide.  

Dark Daily covered Amazon’s 2022 announcement to purchase One Medical in “Amazon Signs Agreement to Purchase One Medical for $3.9 Billion, Aims to ‘Reinvent’ Healthcare.” We reported how, for years, Amazon has tried to develop medical services that disrupt the US healthcare industry in the same way its digital book business upended traditional book publishing.

Acquiring One Medical gave Amazon dozens of existing physical healthcare locations. There are currently more than 125 One Medical clinics offering clinical laboratory testing and primary care services—including telehealth and live chat consulting—in several large metropolitan areas around the country.

For an annual fee of $199, patients who utilize One Medical receive access to year around 24/7 on-demand, virtual care. Other services, such as in-office doctor visits and clinical laboratory testing, can be billed to most major insurance health plans.

The trend of shifting clinical services from in-person, medical-office visits to other approaches, such as virtual care, continues to expand throughout the healthcare industry driven by consumer demand.

Amazon now offers virtual healthcare services in all 50 states and the District of Columbia. The company appears committed to delivering what it believes are better alternatives to existing primary care, clinical laboratory, and retail pharmacies.

“We’re on a mission to make it dramatically easier for people to find, choose, afford, and engage with the services, products, and professionals they need to get and stay healthy, and coming together with One Medical is a big step on that journey,” said Neil Lindsay, Senior Vice President of Amazon Health Services in a press release. Clinical laboratories in areas where One Medical operates may want to investigate opportunities to collaborate with Amazon. (Photo copyright: Advertising Age/Daniel Berman.)

Does One Medical Represent the Future of Healthcare?

In August, Amazon announced the opening of new One Medical offices in Connecticut and San Francisco. A new facility will also be opened in Milwaukee in the fall with more new locations planned for 2024. 

“If you fast forward 10 years from now, people are not going to believe how primary care was administered. For decades, you called your doctor, made an appointment three or four weeks out, drove 15-20 minutes to the doctor, parked your car, signed in and waited several minutes in reception, eventually [you] were placed in an exam room, where you waited another 10-15 minutes before the doctor came in, saw you for five to ten minutes and prescribed medicine, and then you drove 20 minutes to the pharmacy to pick it up—and that’s if you didn’t have to then go see a specialist for additional evaluation, where the process repeated and could take even longer for an appointment,” said Amazon CEO Andy Jassy in a One Medical news release.

“Customers want and deserve better, and that’s what One Medical has been working and innovating on for more than a decade. Together, we believe we can make the healthcare experience easier, faster, more personal, and more convenient for everyone,” he added.

These are some of One Medical’s offerings according to the news release:

  • Around-the-clock access through the One Medical app.
  • On-demand virtual care services, like 24/7 video chats and easy in-app messaging, included in membership at no extra cost.
  • Same and next-day in-office or remote visits.
  • Walk-in availability for on-site clinical laboratory services.
  • Clinical and digital integrations with leading hospital networks across the US.
  • Easy access to vaccine and medical records, prescription renewals, specialty referrals, and lab results in the One Medical app.

“One Medical has set the bar for what a quality, convenient, and affordable primary care experience should be like,” said Neil Lindsay, Senior Vice President of Amazon Health Services in the news release. “We’re inspired by their human-centered, technology-forward approach and excited to help them continue to grow and serve more patients.”

Not Amazon’s First Attempt at Delivering Healthcare

This latest venture is not Amazon’s first dive into the healthcare market. The company initially began offering medical services through its Amazon Clinic in limited locations starting last November. 

According to its website, Amazon Clinic can quickly treat common health issues via 24/7 video visits with a clinician. No appointments are needed, and health insurance is not a requirement.

Other Amazon ventures into healthcare have not been successful. In 2020, their Haven Healthcare project failed less than three years after its launch. Despite partnering with Berkshire Hathaway and JPMorgan Chase, Haven Healthcare faltered mostly due to insufficient market power, unacceptable incentives, and poor timing because of the COVID-19 pandemic, according to Harvard Business Review.

Amazon also shuttered Amazon Care, a pilot program for their employees that blended telehealth and primary healthcare services, at the end of last year. 

With an increase in the number of companies moving into the healthcare market, patients may have access to better options, more reasonable pricing, and faster and more convenient access to services in the future, including clinical laboratory testing.

“At the end of the day, all patients, all customers, all people want to be healthy,” said Nworah Ayogu, MD, Amazon Clinic General Manager and founding Medical Director for CityBlock Health, during a CNBC Healthy Returns Summit virtual event earlier this year. “The reason why they’re not healthy is because the health system has all these barriers, so whether that is cost, confusion … some are societal, some within the healthcare system, so that’s really on us to remove those barriers and think through how we do that.”

Clinical laboratories operating in areas serviced by Amazon’s One Medical clinics may find an opportunity to help support Amazon’s goal of providing affordable healthcare in convenient locations. At the same time, pathologists and lab executives may find it timely to recognize how primary care is poised to be transformed by disruptors, such as Amazon and those national retail pharmacy chains now building primary clinics in their stores.

—JP Schlingman

Related Information:

Amazon Clinic Expands Doctor Visit Marketplace to 50 States

Amazon-owned One Medical Begins Opening New Locations Across US

Amazon-Owned One Medical Celebrates Grand Opening in Darien

Primary Care Designed Around You

One Medical Joins Amazon to Make It Easier for People to Get and Stay Healthier

Amazon Clinic Dr. Nworah Ayogu at CNBC Healthy Returns Summit 2023

Why Haven Healthcare Failed

Amazon, Berkshire Hathaway, and JPMorgan Chase Close Haven Healthcare After Only Three Years in Operation

California’s Statute Restricting Use of Moniker ‘Doctor’ to Only Physicians and Surgeons Challenged by Nurse Practitioners in Court Case

Plaintiffs claim state is criminalizing speaking the truth about their earned advanced degrees

Doctorate of Nursing Practice (DNP) is the highest degree that can be acquired by a nurse practitioner (NP). But can NPs who achieve this degrees call themselves doctors? What about others who hold doctorates, such as PhDs in clinical laboratories?

According to the State of California—which has enacted a law restricting the use of the word “doctor” or the prefix “Dr.” in titles, online, or in business communications solely to physicians and surgeons—the answer is no.

Predictably, implementation of the law brought a lawsuit. In June, three California nurse practitioners with DNP degrees sued the California attorney general and leaders of the Medical Board of California and California Board of Registered Nursing.

They are seeking to block enforcement of the law, according to The Washington Post.

“The word ‘doctor’ doesn’t belong to physicians,” Jacqueline Palmer, DNP, one of the three NPs suing over California’s law restricting non-physician medical providers from using that word, told The Washington Post. Palmer argues that NPs should be able to use the word “doctor” or the prefix “Dr.” when describing themselves much like PhDs and other non-physicians do who hold doctorates. (Photo copyright: Jacqueline Palmer, DNP.)

Plaintiffs Claim Criminalization of the Truth

The statute in question is the California Business and Professions Code Section 2054 which is part of California’s Medical Practice Act originally written in 1931.

Section 2054 of the statute states, “Any person who uses in any sign, business card, or letterhead, or, in an advertisement, the words doctor or physician, the letters or prefix Dr., the initials M.D., or any other terms or letters indicating or implying that he or she is a physician and surgeon, physician, surgeon, or practitioner under the terms of this or any other law, or that he or she is entitled to practice hereunder, or who represents or holds himself or herself out as a physician and surgeon, physician, surgeon, or practitioner under the terms of this or any other law, without having at the time of so doing a valid, unrevoked, and unsuspended certificate as a physician and surgeon under this chapter, is guilty of a misdemeanor.”

In their complaint, the three lawsuit plaintiffs state, “Defendants are California state officials charged with enforcing a law that criminalizes the truthful use of the title ‘Dr.’ by any healthcare professional who is not a licensed physician or surgeon. That means veterinarians, dentists, pharmacists, physical therapists, and nurse practitioners are subject to severe penalties if they truthfully refer to themselves as ‘doctor.’ This is true even where the doctor specifies the specific profession in which he or she has obtained his or her doctorate degree. The statute that mandates this regime goes far beyond patient protection and violates the First Amendment rights of doctors to truthfully describe themselves and their credentials.”

The three plaintiffs in the case are:

California is not the only state that restricts the use of the word “doctor” or “Dr.” but it is the strictest, according to Donna Matias, JD, Pacific Legal Foundation, the attorney representing the three plaintiffs.

“If you read the law literally, it appears to prohibit even PhDs and university professors from using the title,” she told the Post.

Previous Case Led to Stiff Penalties for Nurse Practitioner

In November of 2022, California Nurse Practitioner Sarah Erny, DNP, was fined a total of $22,500 by both the State of California and the State Medical Association for describing herself as a doctor on several professional online platforms without also including that she was a nurse, not a physician.

“While in most instances Ms. Erny indicated that she was a nurse practitioner, she failed to advise the public that she was not a medical doctor and failed to identify her supervising physician. Adding to the lack of clarity caused by referring to herself as ‘Dr. Sarah,’ online search results would list ‘Dr. Sarah Erny,’ without any mention of Ms. Erny’s nurse status,” wrote County of San Luis Obispo District Attorney Dan Dow, JD, in a statement.

Dow went on to say, “All forms of professional medical services advertising, including websites and social media accounts, must be free of deceptive or misleading information and must clearly identify the professional license held by the advertiser. Providing patients upfront with the proper title of our healthcare professionals aids consumers in making a more informed decision about their healthcare.”

Along with the financial penalties, Erny was ordered to “refrain from referring to herself as ‘doctor’ in her role of providing medical treatment to the public. [The judgement] also requires Ms. Erny to identify and make reasonable efforts to correct information on internet sites referring to her as ‘doctor’ or ‘Dr.’” the statement noted.

Speaking Truthfully about Advanced Degrees

Palmer spent 14 years in school pursuing her degrees. She feels her patients are smart enough to know the difference between her and a physician. “It’s not an ego trip; it’s not a power trip,” Palmer told the Post, “It’s just validation that I worked hard to get where I am today.”

The Pacific Legal Foundation argues in favor of the nurses by virtue of their advanced and in-depth training: “[After] years earning their advanced degrees and qualifications … they should be able to speak truthfully about them in their workplaces, on their business cards, the internet, and social media, so long as they clarify that they are nurse practitioners.”

Until the dust settles, NPs in California are taking precautions. Palmer said she has asked her patients to stop calling her “doctor” out of fear of being fined like Erny, a move she also claimed her patients protested against. “They all have said that they know that I worked hard for it,” she told the Post.

Clinical laboratory PhDs and others with advanced degrees may want to investigate their state’s requirements as to how they can legally refer to themselves.

—Ashley Croce

Related Information:

Should Nurses with Doctorates Be Called Doctor? Lawsuit Targets California Rule

Nurse Practitioners Sue State Over Right to Use ‘Doctor’ Title

Nurse Practitioners Sue California over Restricted Use of ‘Doctor’

Complaint for Declaratory and Injunctive Relief: United States District Court Central District of California

California Medical Practice Act

DNPs Can Face Heavy Fines If They Call Themselves Doctors. Some Are Fighting Back Against the Laws

Nurses with a Doctorate in Nursing Practice (DNP) Should Not Call Themselves “Doctor” in a Clinical Setting

California Business and Professions Code Section 2054

Nurse Practitioner (DNP) Fined $19K for Calling Self “Doctor Sarah”

District Attorney Dan Dow Announces Settlement with Arroyo Grande Nurse for Unlawfully Advertising Herself as “Doctor”

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