WSJ reporter affirms that the pathologist was his “first and most important source” in confirming the problems at the now-defunct medical lab testing company
During the federal fraud trial of Theranos Founder and former-CEO Elizabeth Holmes, no one has spent more days on the witness stand than ex-Theranos Laboratory Director Adam Rosendorff, MD, the pathologist who testified for the prosecution that he repeatedly warned Holmes about problems with Theranos’ flawed Edison blood-testing device.
Dark Daily’s previous ebrief on the ongoing Holmes’ fraud trial reported that Rosendorff, who is board certified in clinical pathology, had testified, “I told her that the potassium was unreliable, the sodium was unreliable, the glucose was unreliable, [and] explained why. She was very nervous. She was not her usual composed self. She was trembling a bit, her knee was tapping, her voice was breaking up. She was clearly upset.”
It should come as no surprise that in response Holmes’ lawyers attempted to paint Rosendorff as an “incompetent” lab director with a resume littered with failures at other biotech companies. According to court documents, Holmes faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for allegedly misleading investors, clinical laboratories, patients, and healthcare providers about Theranos’ proprietary blood-testing technology.
But the many clinical laboratory professionals closely watching the Holmes trial will be equally interested to learn that outside of the courtroom former Wall Street Journal (WSJ) reporter John Carreyrou confirmed on Twitter that Rosendorff was the main source for his 2015 investigative reporting—which first called into question Theranos’ claim that it could run more than 200 blood tests using a finger-prick of blood—as well as for his subsequent book, “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”
Carreyrou Declares Ex-Theranos Lab Director Adam Rosendorff a Hero
“So, I’ve been fielding queries from reporters asking me to confirm that former Theranos lab director Adam Rosendorff, who is currently testifying at Elizabeth Holmes’ trial, was my source. I can now confirm it. Alan Beam = Adam Rosendorff,” Carreyrou tweeted.
“I’ll add this: Adam was my first and most important source. Without him, I wouldn’t have been able to break the Theranos story. Hats off to his courage and integrity. He’s one of the real heroes of this story,” Carreyrou added in a subsequent Tweet.
Inside the San Jose, Calif., courtroom, pathologist Rosendorff took centerstage, completing six days on the witness stand as Holmes’ defense attorney Lance Wade, JD, sought to undermine Rosendorff’s earlier testimony for the prosecution and question his competence as a laboratory leader.
Former Wall Street Journal reporter John Carreyrou (above) has revealed via Twitter that ex-Theranos laboratory director Adam Rosendorff, MD, was the “first and most important source” for his 2015 investigative reporting on Theranos. “Hats off to his courage and integrity,” Carreyrou tweeted. “He’s one of the real heroes of this story,” (Photo copyright: Penguin Random House Speakers Bureau.)
Rosendorff Testifies About Another CMS Investigation at Lab Where He is Medical Director
Rosendorff acknowledged during cross examination that he risked losing his license as a lab director after the CMS inspectors uncovered testing deficiencies at PerkinElmer’s Valencia (California) Branch Laboratory as well, where Rosendorff currently serves as Laboratory and Medical Director.
According to the WSJ, Rosendorff testified that most of the CMS inspection involved reviewing documents. During cross examination, it was revealed that the same CMS inspectors who investigated Theranos also conducted the PerkinElmer lab investigation.
Defense attorneys also had hoped to question Rosendorff about his previous work at uBiome Inc., a startup that was the target of a 2019 federal probe into its lab test billing practices, CNBC reported.
The Mercury News reported that during an October 5 hearing to determine the extent to which Holmes’ legal team could cross examine Rosendorff about his past employment, Wade told US District Judge Edward Davila that Rosendorff had a failed record as a lab leader. The Holmes defense lawyer alleged a link between “unreliable test results” at the biotechnology company Rosendorff went to after leaving Theranos and claimed that Rosendorff’s work at PerkinElmer resulted in the CMS notice of “serious deficiencies” at the lab.
“[Rosendorff] pointed the finger at many other people, including my client,” Wade told Davila. “He appears to almost never have competently done his job. He was incompetent at Theranos, too, and that is the reason many of the failures happened. He’s the person who’s ultimately responsible in the laboratory,” he added.
Nevertheless, Judge Davila prohibited questions regarding Rosendorff’s employment at uBiome and limited the scope of questions about his current role at PerkinElmer.
The graphic above depicts Holmes’ defense attorney Lance Wade, JD, cross examining former Theranos CLIA laboratory director Adam Rosendorff, MD. During his testimony, Rosendorff claimed he warned Holmes about the unreliability of Theranos’ Edison blood-testing device. Pathologists and clinical laboratory leaders will recall that Walgreens had contracted with Theranos to place testing devices in its in-store pharmacies. (Graphic copyright: The Wall Street Journal/Vicki Behringer.)
Holmes’ Attorneys Challenge Rosendorff’s Testimony During Cross Examination
After leaving Theranos, Rosendorff’s LinkedIn profile shows he served as Laboratory Director at San Francisco-based Invitae from December 2014 to September 2017 before moving to Millennium Health in San Diego as Medical Director from December 2017 to January 2021. He joined PerkinElmer in January.
The WSJ reported that Rosendorff’s ties to uBiome showed up in Theranos court records.
The WSJ also noted that during the multiday cross examination of Rosendorff, the Holmes defense team scored points by “pointing to contradictions in his testimony and challenging his assertions that he wanted to expose Theranos’ testing practices to the government.”
In making his point, Wade read aloud from a deposition Rosendorff gave during a separate case in which he claimed that Theranos did not have a greater number of anomalous test results than other labs where he had previously worked.
“And that’s 180 degrees from what you answered in your direct testimony,” Wade said to Rosendorff during cross examination.
“Yes, it seems to be different,” Rosendorff replied, but also noted that Theranos should have fewer errors than a lab with a much higher volume of tests.
Wade also introduced a November 2014 email in which Rosendorff told a colleague he knew of only one time when Theranos provided to a patient an obviously incorrect test result. Rosendorff had previously testified that he alerted Holmes on numerous occasions about his concerns with ongoing testing errors.
Wade also questioned whether Rosendorff had a financial motive for considering a whistleblower lawsuit against Theranos, pointing out that Rosendorff would be entitled to a portion of any damages recovered. Rosendorff responded that he did not have a profit motive in mind when he forwarded more than 150 Theranos emails to his personal account.
Former WSJ Reporter Carreyrou May Be Called to Testify
Clinical laboratory managers and pathologists will be fascinated with another twist that surfaced as this trial continued. Former WSJ reporter Carreyrou became personally intertwined with the Holmes’ trial after it came to light that the investigative reporter—whose podcast “Bad Blood: The Final Chapter” spotlights the ongoing fraud trial—is on Holmes’ potential witness list.
The motion, The Mercury News reported, states that “Placing Carreyrou on the witness list was done in bad faith and was designed to harass him,” and calls his placement on the list “a cynical ruse” that violates Carreyrou’s First Amendment rights.
CNN reported that Carreyrou’s attorneys are asking that the exclusion order (which prevents some witnesses from being inside the courtroom during other witness testimonies) or the gag order (which allows witnesses to discuss their testimonies only with their attorneys) not be applied to Carreyrou.
For clinical laboratory scientists awaiting the next installment in the now six-week-old trial, former Safeway CEO Steven Burd (now founder and CEO of Burd Health) will continue his testimony on the failed partnership between the grocery store chain and Theranos.
The Theranos agreement with Safeway is not as well-known as the Theranos-Walgreens deal. This was another news story written by Carreyrou and published by the WSJ on Nov. 10, 2015, titled, “Safeway, Theranos Split after $350 Million Deal Fizzles.”
As part of that agreement, Safeway spent $350 million to remodel 800 of its grocery stores to have a patient service center (PCS) and laboratory space where the unproven Edison device would be used to perform the clinical laboratory tests.
The testimony in this next phase of trial about the Safeway agreement with Theranos, and Holmes’ role in convincing the Safeway executive team to invest a third of a billion dollars to build 800 PSCs and lab spaces in 800 stores, should be as interesting as the witness testimony given earlier in this trial.
Faulkner was surpassed on Forbes’ list only by roofing material magnate Diane Hendricks, co-founder of ABC Supply Co., whose net worth of $11 billion puts her squarely in the top spot.
Richest Self-Made Women in Healthcare
Becker’s Hospital Review highlighted the seven richest “self-made” women who ran healthcare-related companies. They include:
Judith Faulkner, founder and CEO of Epic, ranked 2nd, net worth $6.5 billion.
Alice Schwartz, co-founder of Bio-Rad Laboratories, ranked 10th, net worth $2.9 billion.
Heather Hasson and Trina Spear, co-founders and co-CEOs of FIGS (direct-to-consumer healthcare apparel and scrubs), ranked 50th and 52nd, net worth $625 million and $600 million respectively.
Also listed by Forbes was Anne Wojcicki, CEO and founder of 23andMe, a personal genomics and biotechnology company. Wojcicki’s net worth of $1.1 billion puts her in the 25th position, according to Forbes.
In “Genetic Test Company 23andMe Completes Merger with Richard Branson’s VG Acquisition Corp., Stock Now Trades on NASDAQ,” Dark Daily noted that since the Sunnyvale, Calif. direct-to-consumer (DTC) genetic testing company will now be filing quarterly earnings reports, pathologists and clinical laboratory managers will have the opportunity to learn more about how 23andMe serves the consumer market for genetic types and how it is generating revenue from its huge database containing the genetic sequences from millions of people.
Judith Faulkner (left), founder and CEO of Epic Systems Corp., and Alice Schwartz (right), co-founder of Bio-Rad Laboratories, ranked 2nd and 10th respectively in Forbes’ list of the top 100 richest self-made women. In healthcare, Faulkner ranks 1st and Schwartz 2nd. Clinical laboratory personnel will likely be familiar with Epic Beaker, which, according to Healthcare IT Leaders, “is Epic’s laboratory information system (LIS) for hospitals, clinics, patient service centers, and reference labs. The software supports common workflows for clinical pathology (CP) labs as well as anatomic pathology (AP) labs.” (Photo copyrights: HIT Consultant/Science History Institute.)
“I always liked making things out of clay. And the computer was clay of the mind. Instead of physical, it was mental,” Faulkner, who is 77, told Forbes.
Company milestones noted by Forbes include:
Inking a deal in 2004 with Kaiser Permanente for a three-year, $400-million project.
Moving in 2005 to a corporate campus in southern Wisconsin—an “adult Disney World” with the largest underground auditoriums and more “fantastical” buildings.
More recently, AdventHealth of Altamonte Springs, Fla., contracted with Epic for a $650 million remote build and installation.
“Epic’s system has tentacles that go out through amazing networks. You can actually help a person get the care they need wherever they need to get it,” AdventHealth’s CEO Terry Shaw told Forbes.
“I think that what will happen is that a few of them will do very well. And the majority of them won’t. “It’s not us as much as the health systems who have to respond to the patient saying, ‘Send my data here,’ or ‘Send my data there,’” Faulkner told Forbes.
Bio-Rad’s Alice Schwartz an IVD ‘Pioneer’
As Faulkner rose to prominence in healthcare IT, Alice Schwartz of Bio-Rad Laboratories found massive success in the in vitro diagnostics industry.
She and her late husband, David, started Bio-Rad with $720 in 1952 in Berkeley, Calif. They were intent on offering life science products and services aimed at identifying, separating, purifying, and analyzing chemical and biological materials, notes the company’s website.
“They were at the right place and at the right time as they became pioneers in the industry,” International Business Times (IBT) stated.
Bio-Rad Laboratories (NYSE:BIO and BIOb) of Hercules, Calif., offers life science research and clinical diagnostic products. The company’s second quarter (Q2) 2021 net sales were $715.9 million, an increase of about 33% compared to $536.9 million in Q2 2020, according to a news release. Its Clinical Diagnostics segment Q2 sales were $380 million, an increase of 34% compared to 2020.
Norman Schwartz, the founders’ son, is Bio-Rad’s Chairman of the Board,
President, and CEO. However, at age 94, Alice Schwartz, the oldest person on Forbes’ richest self-made women list, “has no sign of stopping soon,” IBT reported.
Lists are fun. Medical laboratory and diagnostics professionals may admire such foresight and perseverance. Judith Faulkner and Alice Schwartz are extraordinary examples of innovative thinkers in healthcare. There are others—many in clinical laboratories and pathology groups.
As consumer demand increases for medical laboratory testing services that bypass the supervision of primary care doctors, clinical laboratories may be affected
Direct-to-consumer (DTC) genetic testing organizations and telecommunications companies in South Korea are collaborating to help consumers stay informed of their health status by sending lab test results directly to their mobile devices without requiring physician involvement. What can labs in the West learn from these developments?
Founded in 2015, NGeneBio provides smartphone-based healthcare services for individuals who solicit genetic testing. Through the partnership, KT plans to combine its knowledge of artificial intelligence (AI) and cloud computing with NGeneBio’s genetic decoding expertise to “provide services such as tailored health management (diet and exercise therapy) services, and storage and management of personal genome analysis information.”
No Doctors Involved?
Outside of genealogy, the general intent of DTC genetic testing is to equip consumers with certain genetic data that may help them manage their healthcare without requiring visits to their healthcare provider. The healthcare information provided through the NGeneBio venture will include data delivered directly to customers’ smartphones on the status of their:
skin,
hair,
nutrition, and
muscular strength.
According to an article in Korean business news publication Pulse, “Genetic test services in Korea are restricted to some 70 categories, such as the analysis of the risk of hair loss, high blood pressure, and obesity.”
Last September, Pulse reported, Korean mobile carrier SK Telecom Co. announced a similar partnership with Macrogen Inc. to introduce a mobile app-based DNA testing service called “Care8 DNA.” To utilize this service, consumers order a DNA test kit, take a saliva sample via mouth swab, and then send the kit to a clinical laboratory for analysis. Users typically receive their test results on the Care8 DNA app (available from both Google Play and Apple’s App Store) within a few weeks.
The service costs ₩8,250 South Korean won ($7.36 US) per month. A one-year subscription to the service costs ₩99,000 won or $88.36 US. The Care8 DNA app features 29 testing services, including:
skin aging,
possibility of hair loss,
resistance to nicotine,
the body’s recovery speed after exercise,
and more.
Along with those results, consumers can receive personalized health coaching guidance from professionals like nutritionists and exercise physiologists to improve their overall wellbeing, Pulse noted.
KoreaTechToday reports that the Macrogen/SK Telcom Care8 DNA app (above) “links the consumer immediately to a gene testing company instead of going through a medical institute first. BIS Research [a marketing research and intelligence company located in Freemont, Calif.] estimates the global direct-to-consumer (DTC) gene test market would increase to ₩7.6 trillion won in 2028.” That is more than $6.7 billion US dollars. Such a shift toward DTC home testing would likely have a huge financial impact on clinical laboratories that process genetic tests as well as the healthcare providers who order them. (Photo copyright: SK Telecom Co.)
In February 2019, Macrogen became the first company in South Korea to take advantage of the government’s relaxed regulations on DTC genetic testing, Korea Biomedical Review reported. In addition to the basic services offered through the Care8 DNA app, Macrogen’s DTC tests also can cover 13 diseases, including:
Other Korean Genetic Testing Companies Adding DTC Services
“Industry officials think DTC genetic tests should include testing for diseases,” an industry official told Korea Biomedical Review in April. “There will be more companies who make these attempts.”
“A DTC genetic test is a contactless healthcare service suitable for the COVID-19 era. The expansion of detailed test items allows users to comprehensively check nutrients, obesity, skin, hair, eating habits, and exercise characteristics at one time,” an official at Theragen Bio told Korea Biomedical Review. “We expect that our service will attract more attention from consumers.”
What Can Be Learned?
Countries in Asia—particularly South Korea, Japan, and Taiwan—are among the fastest adopters of new technology in the world. Thus, it can be instructive to see how their consumers use healthcare differently than in the West, and how those users embrace new technologies to help them manage their health.
It is not certain how all this will impact clinical laboratories and genetic doctors in the western nations. Direct-to-consumer genetic testing has had its ups and downs, as Dark Daily reported in multiple e-briefings.
Nevertheless, these developments are worth watching. Worldwide consumer demand for genetic home testing, price transparency, and easy access to test results on mobile devices is increasing rapidly.
With the majority of Americans living just a few miles from a Walmart, how might independent clinical laboratories compete?
Retail giant Walmart (NYSE:WMT) plans to install 4,000 primary care “supercenters” in stores by 2029 that will include clinical laboratory testing services. This is on top of the dozens of Walmart Health locations already in operation in Georgia, Florida, Arkansas, Illinois, and Texas.
Clinical laboratories already have growing competition in the healthcare marketplace from pharmacy chains CVS (NYSE:CVS), Walgreens (NASDAQ:WBA), and Rite Aid (NYSE:RAD) which have installed in-store healthcare clinics in their retail locations—many of which offer limited, but common, medical laboratory services—as well as from existing Walmart Health locations.
Now, Walmart is poised to become a much bigger healthcare player. According to MedCity News, Walmart is “looking beyond traditional retail clinics as it seeks to create ‘supercenters’ with comprehensive healthcare services.”
Presumably, this includes an expanded menu of clinical laboratory testing services—along with the EKGs, vision care, dental care, and more—that Walmart Health locations currently provide for children and adults.
And though Becker’s Hospital Review reported in March that Walmart’s “plan is in flux,” the major national retailer continues to disrupt healthcare in significant ways.
We reported that Walmart Health’s list of services included:
Primary care,
Dental,
Counseling,
Clinical laboratory testing,
X-rays,
Health screening,
Optometry,
Hearing,
Fitness and nutrition, and
Health insurance education and enrollment.
However, the new Walmart Healthcare supercenters differ from Walmart Health clinics and the clinics operated by Walmart’s retail competitors Target, CVS, Walgreens, and Rite Aid.
Those clinics are designed to draw customers into existing retail setting. Walmart has a different goal with its healthcare supercenter concept.
“There’s a big difference between offering healthcare services to drive more people to your store and offering healthcare services because you’re in the healthcare business,” said former President of Health and Wellness for Walmart, Sean Slovenski, during a panel hosted by the American Telemedicine Association. “We’re in healthcare,” he continued, “We’re not in retail healthcare. We’re recruiting physicians in all of these areas and bringing them in.”
Providing Transparency with Clear, Consistent Pricing
In response to consumer demand for transparency, Walmart is taking a different approach to charging patients for healthcare services. The cost of an appointment for primary care is $40 for an adult and $20 for a child. The patient can choose to bill insurance or not, and people without insurance can pay out-of-pocket.
Prices for individual services are equally transparent. Explaining why Walmart is becoming a player in the healthcare industry, Marcus Osborne, Senior Vice President Walmart Health, told Fierce Healthcare, “It’s issues of affordability. That people can’t afford the care they need for themselves and their families. It’s issues of access … That really is the business that we’ve been in. Walmart’s business has been about helping people afford the things they need, getting them in a more accessible, convenient way, and doing it in ways that are simple. Healthcare’s no different in that regard.”
According to STAT, some 35 million Americans were uninsured in 2020. Thus, the idea of transparent pricing and walk-in affordable care should appeal to a sizable market. Walmart is banking on that. Considering that 90% of Americans live within 10 miles of a Walmart, the potential success of the healthcare supercenters becomes clear, Becker’s Hospital Review noted.
Walmart’s Other Healthcare Moves
In addition to opening 20 Walmart Health Centers, and its plans for 4,000 healthcare supercenters, Walmart has made other moves that indicate its intention to disrupt the healthcare industry.
Walmart Insurance Services, for example, partnered with eight payers during the open enrollment period in 2020 to sell its Medicare products. Through a partnership with Clover Health, a Preferred Provider Organization (PPO), and a Health Maintenance Organization (HMO) with a Medicare contract, Walmart made its insurance plans available to 500,000 people in Georgia, Becker’s Hospital Review reported.
“We’re going to have a consumer revolution in retail for point of care,” John Sculley, former Apple CEO and current chairman at RxAdvance (now called nirvanaHealth), told CNBC. “Why? Because if the Walmart tests are successful, and I suspect they will be, people will be able to go in and get these kinds of health services at a lower cost than if they had health insurance.”
“A lot of the opportunity is just about bringing what we’re doing to more people. I think about Walmart Health and what we launched a little over a year ago in Georgia and the impact we’ve seen in the communities where it launched. I think one of the biggest things to do is how do we continue to find ways to make that model work so we can reach more people with it in more communities,” Marcus Osborne (above), Senior Vice President Walmart Health, told Fierce Healthcare. Walmart certainly has experience in disruption. The retailer upended the grocery industry from the moment it entered the market, and it was the first to offer $4 prescriptions, which disrupted long-standing retail relationships consumers had with their pharmacies. Clinical laboratories should realize that Walmart will likely make similar waves in the healthcare sector. (Photo copyright: Consumer Goods Forum.)
How Will Clinical Laboratories Compete?
Change is constant. Clinical laboratories that cannot adapt to changing market forces are ill-equipped to withstand the coming “consumer revolution.” However, labs that have already begun to plan for more direct-to-consumer interactions will be better positioned to adjust as changes come.
“My goal is that we have done the work on Walmart Health as a model, to really get it to work from a consumer perspective and get it to work in a way that it scales effectively, that we are able to reach more people,” Osborne told Fierce Healthcare.
Clinical laboratory leaders should understand that this trend is being driven by consumer demand for convenience, lower costs, and price transparency. Labs that don’t prepare to address those forces will be left behind as Walmart provides what consumers want.
Clinical laboratory information would be part of a “massive” transfer of data that may affect medical decision-making ‘to the detriment of consumers and healthcare providers’ the AHA stated in a letter to the DOJ
In yet another example of healthcare market concentration and consolidation where the big get bigger—sometimes at the expense of patients, physicians, and clinical laboratories—UnitedHealth Group (NYSE:UNH) announced in January the agreement that would enable it to acquire and merge Change Healthcare (NASDAQ:CHNG) with UnitedHealth Group’s (UHG’s) subsidiary OptumInsight. Many medical laboratories and anatomic pathology groups are clients of Change Healthcare.
Healthcare Finance reported that Nashville-based Change Healthcare “will join with OptumInsight to provide software and data analytics, technology-enabled services and research, advisory and revenue cycle management offerings, according to Optum parent company UnitedHealth Group.”
Change Healthcare says its Pathology Practice Revenue Cycle Management (RCM) services are used by more than 600 pathology and laboratory clients representing about 3,800 doctors. Perhaps this is why the American Hospital Association (AHA) has registered opposition to the proposed acquisition with the federal Department of Justice (DOJ).
In a letter to Richard Powers, JD, Acting Assistant Attorney General of the Antitrust Division at the DOJ, the AHA asked the DOJ to “conduct a thorough investigation of the proposed transaction because it threatens to reduce competition for the sale of healthcare information technology (HIT) services to hospitals and other healthcare providers, which could negatively impact consumers and healthcare providers.”
‘Substantial Antitrust Concerns’ Notes the AHA about the Merger
Optum, based in Eden Prairie, Minn., has approximately 5,000 hospitals and 300 health plans in its portfolio, according to Healthcare Finance. The health information technology and services firm offers data analytics, pharmacy care services, population health management, and more and is UHG’s fastest growing subsidiary, Modern Healthcare reported. UHG also owns UnitedHealthcare, the largest US health insurer.
When the AHA became troubled by UHG’s Optum/Change Healthcare plans, the national healthcare industry trade group asked the Antitrust Division of the DOJ to investigate the merger, noting in its letter to Powers that the merger “presents substantial antitrust concerns because the transaction agreement provides that the Parties will divest assets that generate hundreds of millions of dollars in revenue in order to obtain DOJ approval.”
Merger Could Affect Provider Reimbursement and Create Opportunity for Misuse of Patient Data
In its March 17 letter to DOJ’s Richard Powers, the AHA urged review of the proposed merger for these overarching reasons:
Possible loss of competition for services such as RCM and health IT services.
Likely repercussions from combining “massive” Optum and Change Healthcare data sets, which could be misused.
The marriage of Optum’s and Change Healthcare’s private patient data, the AHA portends, could possibly lead to altered decisions on patient care and claims processing and denials, Healthcare Finance reported.
Analysts told Healthcare Dive the merger would “consolidate Optum’s dominance in the data analytics space.”
In the AHA letter to the DOJ, Melinda Reid Hatton, JD, AHA Vice President and General Counsel, wrote, “The proposed acquisition would produce a massive consolidation of competitively sensitive healthcare data and shift such data from Change Healthcare, a neutral third party, to Optum.”
She continued, “Post-merger, Optum will have strong financial incentives to use competitive payers’ data to inform its reimbursement rates and set its competitive clinical strategy, which will reduce competition among payers and harm hospitals and other providers.
“Optum’s proposed acquisition of Change Healthcare will reduce the competition between two similarly scaled competitors,” Hatton concluded.
In the letter the AHA sent to Richard Powers, JD, Acting Assistant Attorney General of the Antitrust Division at the DOJ, Melinda Reid Hatton, JD (above), AHA Vice President and General Counsel, wrote, “Because Optum’s parent, UHG, also owns the largest health insurance company—UnitedHealthcare—the combination of the Parties’ data sets would impact and likely distort decisions about patient care and claims processing and denials to the detriment of consumers and healthcare providers.” Much of this data would come from the clinical laboratories and pathology groups in those two company’s databases. (Photo copyright: American Hospital Association.)
Optum, Change Healthcare Say Their Goal is Better Outcomes
For their part, according to a UHG news release announcing the merger in January, Optum and Change Healthcare are intent on combining their technology and service companies for the purpose of improving “core clinical, administrative, and payment processes.”
“Optum and Change Healthcare share a vision for better health outcomes and experiences for everyone at lower cost,” an Optum spokesperson told Becker’s Hospital Review.
A UHG spokesperson told Healthcare Dive a separation of UnitedHealthcare and Optum businesses is in place.
The AHA’s letter acknowledged Optum’s inclusion of an “informational firewall,” but noted that it is not enough. “UHG has never demonstrated that firewalls are sufficiently robust to prevent sensitive and strategic information-sharing,” Hatton wrote.
The deal, which was originally expected to close in the second quarter of 2021, has a $13 billion valuation, Healthcare Dive reported.
How Might This Affect Clinical Laboratories?
For clinical laboratories and pathology groups, the proposed merger could introduce questions about UnitedHealthcare’s access to information about how labs bill different payers other than UnitedHealthcare.
Change Healthcare each year processes more than 87 million pathology and clinical laboratory procedures, for which it charges $4.4 billion, according to the company’s website. The services it provides are aimed at increasing clinical laboratory cash flow, patient revenue and billing, coding efficiency, and compliance, according to Change Healthcare.
Therefore, Change Healthcare—in serving labs and pathology groups—already has data about agreements on charges for tests and other prices labs have with different insurers, noted Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“It’s only reasonable for lab leaders to be concerned—if this deal is made—about lab pricing and other information,” Michel said. “Could it be reviewed and possibly used by UnitedHealthcare to establish its own terms in its network contracts with clinical labs and pathology groups?”
Clinical laboratory leaders will want to monitor these events as DOJ receives more information and further examines the UHG Optum/Change Healthcare proposed merger. It will be interesting to see if opposition to the merger arises from other healthcare associations and professional groups.
Consolidation of hospitals and health systems means consolidated medical laboratory services as well, and that impacts laboratory revenue and staff
Though COVID-19 shifted many healthcare systems’ priorities in 2020—including quite dramatically altering the priorities of the nation’s clinical laboratories—the SARS-CoV-2 pandemic does not appear to have slowed the pace of healthcare mergers and acquisitions. Many such deals are kept secret until closed by Dec. 31. They are then then announced after Jan. 1, so we may see additional big and surprising healthcare acquisitions announced in coming weeks.
Leaving aside the shock waves brought about by COVID-19, transformational changes to the healthcare community have been underway for a while.
In his article on HealthManagement.org, healthcare consultant Paul D. Vitale, MPA, FACHE, noted that for the past several years, health systems have set records in the mergers and acquisitions space. In 2017, he noted, there were more than 115 deals, and by 2019, there was a series of “mega” mergers, each worth more than $10 billion. The pattern continued in 2020, even with economic concerns brought about by the pandemic.
“According to many health systems, acquiring another organization, or merging with it, holds the key to future success. Faced with intense pressure to cut back on costs, mergers and acquisitions can leverage the economies of scale,” he wrote.
Below are several “deals” that closed in 2020 or are expected to close in 2021.
Pre-merger, Atrium Health’s network included 41 hospitals and 900 care locations, while the Wake Forest Baptist Health system was comprised of 42 hospitals and 1,500 care locations. Plans are underway to build a second campus for the school of medicine, where 3,500 students will be trained in more than 100 specialized programs.
“The impact of the strategic combination will be far-reaching, elevating North Carolina as a clear destination of choice to receive medical care for people all across the nation,” Julie Ann Freischlag, MD (above), CEO of Wake Forest Baptist Health and Dean of Wake Forest School of Medicine, told Healthcare Finance News. “Through our combined, nationally recognized clinical centers of excellence in multiple specialties, we will be able to expand our research in signature areas, such as cancer, cardiovascular, regenerative medicine and aging, and target bringing research breakthroughs to the community in less than half the time of the national average.” Freischlag will serve as Atrium Health’s Chief Academic Officer as well. (Photo copyright: Triad Business Journal.)
Doctors Acquire a Controlling Stake of Steward Health Care
In June, physicians in Dallas purchased a controlling stake of Steward Health Care through a structured recapitalization transaction. Though not strictly a merger and acquisition, the deal represents a similar transformational change of a health system. The change makes Steward the largest physician-owned-and-operated health system in the country, noted a news release.
Ralph de la Torre, MD (above), CEO and founder of Steward, says the industry is in the midst of a transformational moment. “The COVID-19 global pandemic has exposed serious deficiencies in the world’s healthcare systems, with a disproportionate impact on underserved communities and populations,” he stated in the news release. “We believe that future healthcare management must completely integrate long-term clinical needs with investments. As physicians first, we will focus on creating structures and timelines that meet the long-term clinical needs of our communities and the short-term needs of our patients.” (Photo copyright: The Boston Globe.)
Harrington Healthcare System and UMass Memorial Health Care
In January 2020, Harrington Healthcare of Massachusetts announced it was pursuing a corporate affiliation with UMass Memorial Health Care. The transaction was expected to be finalized by 2021.
“When we entered into our initial agreement with UMass Memorial in January, we had no idea what the next several months would bring,” said Ed Moore (above), President and CEO of Harrington Healthcare, in a news release. “Our team performed exceptionally well, and the community supported us every step of the way, but we could not have provided the outstanding care we did without the partnership and support of the clinical team at UMass Memorial. This experience redoubled our confidence that becoming part of the system would offer maximum benefit to our community at a time that requires flexibility, scale, and resources.” (Photo copyright: Worcester Telegram.)
Will More Announcements Come in 2021? Probably
For clinical laboratory managers and pathologists, the healthcare mergers and acquisitions of greatest interest are those that involve hospitals and health systems. When two big health systems merge—such as the transaction involving Atrium Health and Wake Forest Baptist Health—one of the first clinical services to undergo rationalization and consolidation is the clinical laboratory. One reason for this is because it is much easier to move more lab test specimens around the system than it is to move patients. So, many healthcare merger and acquisition deals directly affect the medical laboratory professionals employed by the institutions involved in the transaction.
Despite the pandemic—or because of the financial stresses created by it—there continue to be strong buyers and financially-weak sellers. For this reason alone, pathologists and clinical laboratory administrators should expect to see a regular flow of merger or acquisition announcements involving major healthcare organizations during 2021.
