Expanded genomic dataset includes a wider racial diversity which may lead to improved diagnostics and clinical laboratory tests
Human genomic research has taken another important step forward. The National Institutes of Health’s All of Us research program has reached a milestone of 250,000 collected whole genome sequences. This accomplishment could escalate research and development of new diagnostics and therapeutic biomarkers for clinical laboratory tests and prescription drugs.
The NIH’s All of Us program “has significantly expanded its data to now include nearly a quarter million whole genome sequences for broad research use. About 45% of the data was donated by people who self-identify with a racial or ethnic group that has been historically underrepresented in medical research,” the news release noted.
“For years, the lack of diversity in genomic datasets has limited our understanding of human health,” said Andrea Ramirez, MD, Chief Data Officer, All of Us Research Program, in the news release. Clinical laboratories performing genetic testing may look forward to new biomarkers and diagnostics due to the NIH’s newly expanded gene sequencing data set. (Photo copyright: Vanderbilt University.)
Diverse Genomic Data is NIH’s Goal
NIH launched the All of Us genomic sequencing program in 2018. Its aim is to involve more than one million people from across the country and reflect national diversity in its database.
So far, the program has grown to include 413,450 individuals, with 45% of participants self-identifying “with a racial or ethnic group that has been historically under-represented in medical research,” NIH said.
“By engaging participants from diverse backgrounds and sharing a more complete picture of their lives—through genomic, lifestyle, clinical, and social environmental data—All of Us enables researchers to begin to better pinpoint the drivers of disease,” said Andrea Ramirez, MD, Chief Data Officer of the All of Us research program, in the news release.
More than 5,000 researchers are currently registered to use NIH’s All of Us genomic database. The vast resource contains the following data:
245,350 whole genome sequences, which includes “variation at more than one billion locations, about one-third of the entire human genome.”
1,000 long-read genome sequences to enable “a more complete understanding of the human genome.”
“Through a partnership with participants, researchers, and diverse communities across the country, we are seeing incredible progress towards powering scientific discoveries that can lead to a healthier future for all of us,” said Josh Denny, MD, Chief Executive Officer, All of Us Research Program, in the news release.
“[Researchers] can get access to the tools and the data they need to conduct a project with our resources in as little as two hours once their institutional data use agreement is signed,” said Fornessa Randal, Executive Director, Center for Asian Health Equity, University of Chicago, in a YouTube video about Researcher Workbench.
Medical laboratories and anatomic pathologists may need to squeeze into narrow networks to be paid under value-based schemes, especially where Medicare Advantage is concerned
Pathologists have likely heard the arguments in favor of value-based payment versus fee-for-service (FFS) reimbursement models: FFS encourages providers to order medically unnecessary procedures and lab tests. FFS removes incentives for providers to order patient services more carefully. Fraudsters can generate huge volumes of FFS claims that take payers months/years to recognize and stop.
Studies that favor value-based payment schemes support these claims. But do hospitals and other healthcare providers also accept them? And how is value-based reimbursement really doing?
To find out, Chicago-based thought leadership and advisory company 4Sight Health culled data from various organizations’ reports that suggest value-based reimbursement shows signs of growth as well as signs of stagnation.
“Physician compensation continues to emphasize volume more than value.
“Availability and use of data-driven tools to support physicians in practicing value-based care continue to lag.
“Existing care models do not support value-based care.”
Deloitte analysts wrote, “Physicians increasingly recognize their role in improving the affordability of care. We repeated a question we asked six years ago and saw a large increase in the proportion of physicians who say they have a prominent role in limiting the use of unnecessary treatments and tests: 76% in 2020 vs. 57% in 2014.
“Physicians also recognize that today’s care models are not geared toward value,” Deloitte continued. “They see many untapped opportunities for improving quality and efficiency. They estimate that even today, sizable portions of their work can be performed by nonphysicians (30%) in nontraditional settings (30%) and/or can be automated (18%), creating opportunities for multidisciplinary care teams and clinicians to work at the top of their license.”
Hospital CFOs Also See Opportunities for Value-based Care
This could be problematic for clinical laboratories, according to Robert Michel, Editor-in-Chief of Dark Daily and our sister publication The Dark Report. According to Guidehouse, “Nearly 60% of health systems plan to advance into risk-based Medicare Advantage models in 2022.”
Medicare Advantage (MA) enrollments have escalated over 10 years: 26.4 million people of the 62.7 million eligible for Medicare chose MA in 2021, noted a Kaiser Family Foundation brief that also noted MA enrollment in 2021 was up by 2.4 million beneficiaries or 10% over 2020.
“The shift from Medicare Part B—where any lab can bill Medicare on behalf of patients for doctor visits and outpatient care, including lab tests—to Medicare Advantage is a serious financial threat for smaller and regional labs that do a lot of Medicare Part B testing. The Medicare Advantage plans often have networks that exclude all but a handful of clinical laboratories as contracted providers,” Michel cautioned. “Moving into the future, it’s incumbent on regional and smaller clinical laboratories to develop value-added services that solve health plans’ pain points and encourage insurers to include local labs in their networks.”
Medical laboratories and anatomic pathology groups need to be aware of this trend. Michel says value-based care programs call on clinical laboratories to collaborate with healthcare partners toward goals of closing care gaps.
“Physicians and hospitals in a value-based environment need a different level of service and professional consultation from the lab and pathology group because they are being incented to detect disease earlier and be active in managing patients with chronic conditions to keep them healthy and out of the hospital,” he added.
Value-based reimbursement may eventually replace fee-for-service contracts. The change, however, is slow and clinical laboratories should monitor for opportunities and potential pitfalls the new payment arrangements might bring.
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.
“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.
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.
“Any one of these breakdowns could cause harmful results,” the report states. “Occurring together and over an extended period of time, the consequences were devastating, tragic, and deadly.”
The OIG report’s findings on how hospital and laboratory administrators dealt with Levy over the years of his employment at the Fayetteville VA Medical Center demonstrate why clinical and pathology lab leaders need to be constantly vigilant in how various quality and compliance procedures are administered in their laboratories. When people and processes are not meeting acceptable standards, it is patients who are at risk of being harmed.
In January, the federal court in Arkansas sentenced Levy to “240 months in federal prison, followed by three years of supervised release and ordered [him] to pay $497,745.70 in restitution for one count each of mail fraud and involuntary manslaughter,” according to court documents.
VA Pathologist ReceivedMultiple Suspensions, then Termination
Following his removal in April 2018, the OIG assembled a team of pathologists to review nearly 34,000 cases interpreted by Levy since he began working at the VA hospital. They identified more than 3,000 errors, of which 589 were classified as “major diagnostic discrepancies” potentially having a negative impact on patient care.
Of the 589, 34 were deemed serious enough to require institutional disclosures, defined as a discussion with the patient or the patient’s representative revealing “that an adverse event has occurred during the patient’s care that resulted in or is reasonably expected to result in death or serious injury.”
The OIG report cited at least two deaths likely resulting from misdiagnoses.
Levy’s hospital privileges were initially suspended in March 2016 following a blood alcohol test indicating he was legally intoxicated while at work. He was reinstated about six months later after completing a treatment program and agreeing to submit to random drug testing.
His privileges were suspended again in October 2017 after he showed signs of impairment during a hospital committee meeting. He was terminated in April 2018 after he was arrested for allegedly driving while intoxicated (DWI) during work hours.
Federal Court Indicts Levy on Multiple Counts
Shortly after the OIG team began reviewing Levy’s cases, a separate OIG group launched a criminal investigation. Levy admitted to investigators that he had been an alcoholic for 30 years, the report stated, and that he had “purchased a substance, 2-methyl-2-butanol (2M2B), online that could be ingested, was similar to alcohol but more potent, and was not detectable using routine drug and alcohol testing methods.”
Citing the federal indictment, the OIG report noted that Levy passed 42 drug and alcohol tests following his reinstatement at the hospital in 2016.
In August 2019, federal authorities charged Levy with three counts of involuntary manslaughter along with multiple counts of wire fraud, mail fraud, and making false statements. The wire and mail fraud charges were related to his 2M2B purchases.
Levy pleaded guilty in June 2020 and was sentenced on January 22, 2021. In addition to the 20-year prison term, he was ordered to pay approximately $498,000 in restitution to VA. The OIG report noted that Levy has appealed the sentence.
And in “Arkansas Pathologist Faces Three Manslaughter Charges,” Dark Daily’s sister publication, The Dark Report, noted that “The outcome of [the Levy] case could be a precedent that gives other prosecutors the confidence that they can file criminal charges in cases where evidence shows that a pathologist’s actions contributed to diagnostic errors that directly contributed to the death of one or more patients.”
OIG Finds Numerous ‘Deficiencies in Quality Management’
In its report, OIG found deficiencies in quality management going back to Levy’s original appointment as Pathology and Laboratory Medical Services Chief.
He was initially hired in September 2005 as a locum tenens (temporary) provider and appointed as full-time service chief a month later. This was despite a DWI conviction from 1996 and a stay of only eight months with his previous employer.
Neither would have barred the doctor as a potential candidate; however, the OIG report states, “the OIG is concerned that a rigorous process was not in place to better evaluate his clinical competency at the time he was hired.”
And that was just the beginning.
In his role as service chief, Levy was responsible for the Path and Lab quality management program with assistance from a subordinate staff pathologist, “which made the process susceptible to subversion,” the report states.
The VHA requires a second pathologist to review certain findings, such as diagnosis of a new cancer malignancy. But in some cases, “it was determined that Dr. Levy was entering concurrence statements into some patients’ electronic health records (EHR) when a second pathologist had not agreed with the interpretation or diagnosis,” the OIG report states.
In addition, second reads sometimes “were communicated by sticky notes, which provided Dr. Levy the opportunity to alter or ignore the results,” the OIG reported.
Inherent Conflict of Interest, Fear of Reprisals, and OIG Recommendations
The periodic privileging process, which grants ongoing hospital privileges, was based in part on a “10% peer review” conducted by the staff pathologist. “The involvement of a subordinate in the peer review process of a supervisor creates an inherent conflict of interest,” the OIG report stated. And in some cases, appraisals of the doctor’s competence came from non-pathologists.
The OIG report suggested that the Veteran’s Health Administration (VHA) re-examine its guidance on the peer review, which requires cases to be randomly selected. Instead, the report suggests that targeting specific kinds of cases, such as those with higher risk of interpretation error, could be more effective in analyzing a pathologist’s performance.
The OIG report also noted failures in dealing with the doctor’s impairment and fostering a “culture of accountability.” Hospital staff, apparently, reported signs of impairment as early as 2014, including incidents when the doctor smelled of alcohol and displayed hand tremors. But hospital leadership failed to “vigorously address allegations of impairment,” the OIG report states. And in interviews with the OIG, some staffers expressed fear of reprisal if they reported what they saw.
The OIG report offers 10 recommendations to the VA, including practices related to hiring processes, the 10% peer review, and alcohol and drug testing. It makes two additional recommendations to the director of the Ozarks VA health system: one related to the credentialing processes and the other aimed at ensuring staff and patients can report concerns without fear of reprisal.
Clinical laboratory managers and hospital pathologists may want to review these recommendations and consider the value of applying them in their own practices.
Patients in health systems that use the Cerner EHR can now track and share specific health metrics with their healthcare providers
In what may be first steps toward becoming a full-service digital healthcare platform, Health information technology (HIT) developer Cerner (NASDAQ:CERN) is partnering with Amazon (NASDAQ:AMZN) to bring cloud-based health tracking services to its EHR customers. People who use Amazon’s Halo service—which includes a wristband device and smartphone app to monitor specific health metrics—can now import that data directly into Cerner electronic health record (EHR) systems for sharing with healthcare providers.
This may turn out to be a pioneering effort by one of the nation’s major providers of EHR systems to pull in useful health data from a variety of non-traditional sources and incorporate them into a patient’s electronic health record. Cerner has a major market share of EHR systems (exceeded only by Epic) and has a laboratory information system (LIS) that is used by many clinical laboratories.
For this fact alone, strategic planners at medical laboratories and anatomic pathology groups should follow this development. That is particularly true of those labs operated by hospitals and health systems that decide to add this new feature to their existing Cerner EHR. If data is flowing into the EHR from patients’ Amazon Halo service, for example, it is not a big leap to imagine that clinical lab test data from the patients’ EHRs might later flow back to the Halo service where it would be instantly accessible to those patients.
This collaboration, according to a Cerner press release, “allows consumers to easily connect vital health and well-being information with their broader healthcare teams. … Historically this type of data has been siloed or difficult to obtain. Wearable technology, such as the Amazon Halo, can help achieve greater interoperability across healthcare when integrated directly into a patient’s electronic health record (EHR).”
Using Artificial Intelligence to Empower Healthcare Consumers
The Halo wristband, along with its accompanying smartphone app, “combines a suite of AI-powered health features that provide actionable insights into overall wellness … [and] uses multiple advanced sensors to provide the highly accurate information necessary to power Halo,” an Amazon press release states.
Data collected by Amazon Halo that are now importable into Cerner EHRs, according to the press release, include:
Activity: Informed by American Heart Association physical activity guidelines and the latest medical research, Amazon Halo awards points based on the intensity and duration of movement, not just the number of steps taken.
Sleep: Amazon Halo uses motion, heart rate, and temperature to measure time asleep and time awake; time spent in the various phases of sleep including deep, light, and REM; and skin temperature while sleeping.
Body: Amazon Halo lets customers measure their body fat percentage from the comfort and privacy of their own home, making this important information easily accessible.
Tone: This feature uses machine learning to analyze energy and positivity in a customer’s voice so they can better understand how they may sound to others, helping improve their communication and relationships.
Labs: Amazon Halo Labs are science-backed challenges, experiments, and workouts that allow customers to discover what works best for them specifically, so they can build healthier habits.
Leveraging Patient Generated Health Data
In the Cerner press release, David Bradshaw, Senior Vice President of Consumer and Employer Solutions at Cerner, said, “The healthcare industry is undergoing a digital revolution, where physicians are increasingly looking to leverage patient-generated health data to help keep them healthier and out of the doctor’s office.
“Our work with Amazon Halo,” he continued, “highlights the importance of using artificial intelligence and other leading-edge technologies to accelerate healthcare innovation and improve health outcomes. Cerner is focused on continuing to lead a wave of breakthrough innovation, and this integration with Amazon Halo is a step toward this goal.”
The first healthcare provider to offer the Amazon Halo service to its Cerner EHR users is Sharp HealthCare of San Diego. Some Sharp Health Plan members will participate in wellness programs and eventually have the option to link their Sharp and Halo data directly into the healthcare system’s Cerner EHR.
Sharp HealthCare includes 2,600 physicians, four acute care facilities, and three specialty hospitals.
“Technology is revolutionizing the way we care for patients and how consumers care for themselves, and at Sharp we strive to embrace innovative ways to leverage leading technology to engage consumers in managing their health,” said Michael Reagin, SVP and Chief Information and Innovation Officer at Sharp HealthCare, in the Cerner press release.
“With more relevant information at their fingertips, our populations will be empowered to make more informed decisions about the health and well-being of themselves and the communities they serve,” he added. “We are pleased to work with Cerner and Amazon Halo to offer our members, patients, and clinicians an opportunity to have a more connected health record.”
Cerner Expanding to Include Population Health and Precision Medicine
Cerner may be evolving toward a cloud-based platform that pulls in data from hospital and doctors’ office EHRs—as well as data gather by wearable devices—and uses that information for population health and precision medicine analysis to guide healthcare providers.
Last year, Cerner announced a collaboration with the Amazon Web Services (AWS) cloud platform, reportedly in an effort to pivot beyond its traditional health records business.
“Moving forward, I think Cerner will look more like a health platform company and less like an EHR company,” Dan Devers, SVP, Cloud Strategy, and Chief IP Officer at Cerner, told Fierce Healthcare. “As you play out the trend in healthcare, I see Cerner very much operating at the health network level—so beyond the enterprise of a single health system. Given the power of the cloud and the work we’re doing, I see Cerner having much more relevance into broader networks and providing nationwide capabilities.”
Cerner is aiming to provide consumers with more power regarding their own healthcare by equipping them with easy, fast, and efficient methods to access their personal information and provide healthcare professionals with useful data about individual patients.
Given the value and importance of clinical laboratory data, innovative lab managers should strive to be aware of collaborations like the one between Cerner and Amazon Halo. Remaining alert for opportunities to participate in these types of arrangements could provide labs with added revenue streams and inventive ways to offer customers value-added services.