Dec 24, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Direct-to-consumer testing companies’ privacy policies leave many consumers unaware their genetic information may be shared with third parties
Clinical laboratories and anatomic pathologists that perform genetics testing know they are responsible for protecting their patients’ privacy and securing the test results data. However, when it comes to direct-to-consumer (DTC) testing companies, patient privacy is not so clearly defined. This leave some patients vulnerable when their health data gets loose on the Internet.
One example involves a Bloomberg reporter who attempted to erase her genetic footprint online and found it to be very difficult to accomplish completely. She published her results in “Deleting Your Online DNA Data Is Brutally Difficult.”
The Bloomberg report provides medical laboratory managers and owners with another example of the importance of staying current with federal and state laws governing the privacy of patients’ protected health information (PHI).
Erasing Genetic Data Footprint ‘Not So Easy,’ Notes Bloomberg Reporter
In her article, Bloomberg health reporter Kristen V. Brown detailed her attempt to delete her genetic information from the websites and databanks of nearly a dozen genetic testing companies where she had shared her genetic information, while writing articles for various publications. They included:
- Ancestry;
- 23andMe; and,
- Helix.
In an article for Bloomberg, Future of Health reporter Kristen V. Brown (above) said, “Recently, I started feeling uneasy about how freely my DNA data flowed. So, I decided to try to erase my DNA data footprint from all the websites and databases and laboratories in which it was stored. It turns out that isn’t so easy.” (Photo copyright: Cayce Clifford/Bloomberg.)
Privacy Policies of DTC Genetics Companies ‘Well Short of Ideal’
Interest in direct-to-consumer genetic testing is booming, with dozens of companies offering tests ranging from helping consumers understand their genetic information and ancestral background to receiving wine recommendations tailored to taste preferences and DNA data. Healthcare market research firm Kalorama Information estimates the market for such testing will reach $310 million by 2022.
DTC customers sign agreements allowing genetics testing companies to use their DNA data for selected services. However, “informed consent” must be given for companies to use consumer data for third-party research projects, whether academic or commercial. These consent agreements typically also address the risk of data becoming public as the result of a security breach.
However, for research published in Cornell Journal of Law and Public Policy, James Hazel, PhD, JD, a Post-Doctoral Fellow at Vanderbilt University Medical Center, and Christopher Slobogin, Milton Underwood Professor of Law at Vanderbilt University, surveyed the privacy policies of 90 U.S. direct-to-consumer genetic-testing companies. They concluded most of the privacy policies “fall well short of ideal.”
“The language in their policies permits selling or sharing information with third parties in many cases. That could be, in theory, anyone,” Hazel told Bloomberg.
Hazel explained that because DNA information gets shared anonymously with third parties, it typically is not possible to purge information from all the secondary companies or research institutions that have received the data.
“They’ve already bundled it with other users’ data and stripped it of your name and aggregated it, and either sold it or shared it with other third parties,” he told Bloomberg.
CLIA Requirements and Stored DNA Data
Brown discovered that not only was deleting her data difficult, having her samples destroyed was next to impossible because she had consented for her information to be shared with other companies.
She was able to delete her Ancestry.com information with just a click, but a required phone call to have her sample destroyed ended in the request still being “in process” a week later. Because she had agreed to share information from the DNA sample she provided to 23andMe, the company told Brown they were unable to fully delete her data due to federal and state regulations.
“The federal Clinical Laboratory Improvement Amendments (CLIA) of 1988 and California laboratory regulations require the lab store your de-identified genotyping test results and to keep a minimal amount of test result or analysis information,” 23andMe stated. “Our laboratory will retain your genetic information and a randomized identifier on their secure servers for a limited period of time—10 years pursuant to CLIA regulations.”
Of the companies Brown contacted, only one told her it could delete her information entirely, leaving Brown to conclude that once DTC customers share their DNA information, it no longer belongs to just them.
“When you delete your DNA information, you are mainly hiding your information from yourself,” she wrote in Bloomberg.
Lawmakers Get Involved
Dark Daily has covered issues related to DTC genetic testing and clinical laboratories in many e-briefings. Now, lawmakers are responding to growing pressure from consumers demanding DTC genealogy and genetic testing companies identify and resolve privacy and security issues.
“Much more often than not, Congress acts after the horse is out of the barn,” U.S. Rep. Dave Loebsack of Iowa told STAT. “I want to try to partner with genetic testing services to address any potential challenges before there are actually breaches of trust.”
And last year, U.S. Senator Charles Schumer of New York called on the Federal Trade Commission to investigate genetic testing companies’ privacy policies and standards for sharing consumer DNA information.
“When it comes to protecting consumers’ privacy from at-home DNA test kit services, the federal government is behind,” Schumer said in a statement. “Besides, putting your most personal genetic information in the hands of third parties for their exclusive use raises a lot of concerns, from the potential for discrimination by employers all the way to health insurance.”
As the spotlight increases on DTC genetic testing companies’ use of their customers’ DNA data, medical laboratories and anatomic pathology practices should prepare to answer patients’ requests for information on policies that protect their privacy and data, and the state and federal regulations restricting sharing of information.
—Andrea Downing Peck
Related Information:
Deleting Your Online DNA Data Is Brutally Difficult
Who Knows What, and When?: A Survey of the Privacy Policies Proffered by U.S. Direct-to-Consumer Genetic Testing Companies
Lawmakers Press Genetic Testing Companies for Details on their Privacy Policies
The Golden State Killer Case Was Cracked with a Genealogy Website. What Does that Mean for Genetic Privacy?
Charles Schumer: Popular at Home DNA Test Kits Are Putting Consumer Privacy at Great Risk
Dec 17, 2018 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Cloud-based platform—IDseq—shows potential to track the causes and spread of infectious diseases worldwide using metagenomic data
Here’s the latest example of how
big data and related technologies can give physicians—as well as
microbiologists and
clinical pathologists—a new tool for understanding infectious disease and tracking outbreaks anywhere in the world. This project is being funded and organized by well-known Silicon Valley entrepreneurs.
The project is known as
IDseq. It was announced recently in a
press release issued by
Chan Zuckerberg Biohub (CZ Biohub),
Chan Zuckerberg Initiative (CZI), and the
Bill and Melinda Gates Foundation. IDseq is a platform designed to support global disease surveillance and prevention. It will make use of gene sequencing and analysis of
metagenomic data. This data will be made accessible to the global medical community.
The system leverages the power of
cloud computing to streamline the process of transmitting and analyzing metagenomic data, as well as sharing results with other platform users.
“That will be incredibly valuable. Information sharing is one of the most powerful public-health interventions in an outbreak,”
Jennifer Gardy, PhD, an epidemiologist at the
University of British Columbia, told
The Atlantic.
Designed by Engineers to Be Easily Used by Healthcare Providers and Medical Laboratory Technicians
Coverage in
The Atlantic notes that IDseq isn’t the first tool to offer similar features.
Joseph DeRisi, PhD, a biochemist at the
University of California San Francisco and co-president of
CZ Biohub, states, however, that IDseq is one of the first designed by a large team of engineers, security experts, and other tech and medical researchers.
Many tools see their origins in academic research and are less friendly to those without advanced academic expertise. The research team’s goal, according to DeRisi, is for IDseq “To enable people in under-resourced areas to do what we’ve been trying to do in San Francisco.”
“It’s easy for us to sit in our labs dreaming up tools and platforms,” Jennifer Gardy, PhD (above), an epidemiologist at the University of British Columbia, told The Atlantic. “But we need to make sure we’re designing them in a way that makes sense to the doctors, nurses, lab techs, and epidemiologists out there in an outbreak.” (Photo copyright: Michelle Thorpe/University of British Columbia.)
While the software is already available for free as a collection of open source tools, the IDseq platform is now in a “soft launch” phase. The Bill and Melinda Gates Foundation is funding training for clinicians at CZ Biohub’s labs in San Francisco through its
Grand Challenges Explorations Initiative.
However, the platform has already achieved success in two noted scenarios—one at
Dhaka Shishu Hospital in Dhaka, Bangladesh, and another in
Tororo District Hospital in Uganda. Both used the system to analyze the samples of children admitted for fevers for which they found no known cause.
In the Dhaka cases,
Senjuti Saha, PhD, a microbiologist from
Child Health Research Foundation, used the platform to trace unexplained cases of meningitis to an earlier
chikungunya virus outbreak. Saha explained to
The Atlantic that her colleagues previously thought chikungunya could not cause meningitis. The platform found otherwise, allowing her to analyze a further 478 samples and detect an additional 17 cases of potential chikungunya-related meningitis.
In the Uganda cases, the researchers used
metagenomic next-generation sequencing (mNGS) data and the IDseq platform to investigate unknown causes of fever in children.
“As progress is made toward elimination of malaria in sub-Saharan Africa, it will be increasingly important to understand the landscape of pathogens that account for the remaining burden of morbidity and mortality,” researchers state in their study, currently in early access at
bioRxiv. “The use of mNGS can contribute importantly to this understanding, offering unbiased identification of infecting pathogens.”
Wide-Spread Use of IDseq Not Without Challenges
While an article in
Medium by
Charles de Bourcy, PhD, Software Engineer at Chan Zuckerberg Initiative, outlines how the IDseq platform can process up to 480GB in approximately 10 minutes, it doesn’t account for the initial data input, which can be daunting.
For areas with weak infrastructure and/or slow connection speeds, this could add significant delays as medical laboratories and healthcare workers at remote sites attempt to transfer data to the nearest IDseq-enabled location. Saha told
The Atlantic, “If the transfer is too slow or the data too large, we just [ship] hard drives.”
Sequencing requirements create additional concerns. Bulky equipment and the skills required to run sequencers could limit the ability to use the IDseq platform to analyze and share results. Clinicians might also face difficulties in sourcing sequencing reagents due to customs and supply chain concerns.
Finally, the platform still requires an expert to interpret findings. “IDseq is an excellent tool, but it needs to be paired with people who have substantive knowledge to guide its use,” Saha told
The Atlantic.
Regardless of these issues, Saha believes IDseq can help remote/resource-challenged medical labs chase diseases. “It doesn’t solve all the problems, but it means that groups like ours don’t have to spend time to build up [sequencing] capacity. And anything is better than nothing.”
IDseq might offer an excellent opportunity for microbiology laboratories, clinical laboratories, and medical researchers around the world to share data surrounding outbreaks, track disease on global and community level, and better determine the strains and probable sources of infectious diseases.
—Jon Stone
Related Information:
Chan, Zuckerberg and the Gates Foundation Unveil Open-Source Global Infectious Disease Tracker
IDseq: An Open Source Platform for Infectious Disease Detectives
Chan Zuckerberg Biohub and Chan Zuckerberg Initiative Announce First-of-Its-Kind “IDseq” Platform and Service to Enable Real-Time Global Disease Surveillance and Prevention
A Simpler Way to Get to the Bottom of Mysterious Illnesses in Poor Countries
Etiology of Fever in Ugandan Children: Identification of Microbial Pathogens Using Metagenomic Next-Generation Sequencing and IDseq, a Platform for Unbiased Metagenomic Analysis
Dec 14, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Though they mostly receive medical laboratory services from their parent health networks, microhospitals may, nevertheless, need services from independent clinical laboratories as well
For years, independent clinical laboratories and anatomic pathology groups have been adapting to healthcare networks undergoing changes based on increased demand for convenient, affordable medical services. One such innovation is the growing trend and popularity of microhospitals, which Dark Daily has reported on in multiple e-briefings.
These scaled-down healthcare facilities offer most critical medical services in smaller settings. They fill gaps between traditional hospitals and urgent-care facilities, are intended to be easier for patients to get to, and usually cost less than a typical community hospital of several hundred beds.
Although these microhospitals are typically owned by existing health networks and receive lab services from their parent health networks, for independent clinical laboratories, microhospitals could represent another potential customer in need of rapid test TATs in support of the facility’s emergency department and limited inpatient beds.
One-Stop Shops for Primary and Secondary Care
Microhospitals are typically between 20,000 and 60,000 square feet in size and offer a small number of inpatient short-stay beds—usually less than 15. They are licensed as hospitals and are usually low-trauma (levels 4/5) facilities that tend to focus on low-acuity patients.
Services at microhospitals vary from location to location, but generally include:
- emergency departments;
- imaging and diagnostic services;
- surgery and procedure centers;
- inpatient nursing facilities; and,
- medical offices.
They are open 24-hours/day, seven days/week, and commonly located in small, underserved areas where there is not sufficient demand for healthcare to support a full-size hospital.
Microhospitals operate as comprehensive, one-stop shops, with both primary and secondary care available. Many microhospitals also have certified and accredited medical laboratories onsite that can provide immediate testing results.
Population Health and Precision Medicine Benefit from Microhospitals
Microhospitals have been in existence for more than 10 years and are growing in popularity among consumers as well as providers. Rising healthcare demands, lower costs, convenient locations, and more personalized care make them popular for patients.
From a business perspective, microhospitals have much lower construction and overhead costs when compared to large hospitals, making them an affordable market-growth opportunity for providers. The savings are passed on to the patients as services are offered at a lower rate than conventional hospitals.
Another advantage of microhospitals is that the services offered can be designed specifically for the demographics of their neighborhood. A guiding goal of both population health and precision medicine initiatives.
“That’s the beauty of it,” Robert Garcia, Vice President of Healthcare Advisory Services at Transwestern, told U.S. News and World Report (U.S. News). “You can tailor the hospital to the needs of the community, so if it’s an older community it may be more catheterization lab, and if it’s a younger community it may have more orthopedic procedures.”
Nineteen states now have at least one microhospital in operation with more in the works. They often offer more convenient, quicker access to healthcare than traditional full-size hospitals can deliver. Larger facilities tend to have longer wait times and typically cannot provide the same personalized care as microhospitals, due to a higher number of patients and many diverse problems.
“Our neighborhood [microhospitals] will bring to communities an innovative, patient-centered model that provides the best possible experience and outcomes for those requiring emergency care, short hospital stays, and other outpatient services,” Cynthia Hundorfean, Allegheny Health President and CEO, told Becker’s Hospital Review. Pittsburgh-based Allegheny Health is scheduled to open four new microhospitals in 2019, all located in the metropolitan Pittsburgh area. These facilities will each offer 10 inpatient beds and emergency and diagnostic services. (Photo copyright: Allegheny Health.)
Phoenix-based Abrazo Community Health Network, plans to open a microhospital in Mesa, AZ, in the spring of 2019. This facility will include an emergency department, an operating room, eight inpatient rooms, and will focus on lower acuity inpatient procedures.
“Medical care continues to evolve with a consumer focus, and this is a new model for bringing healthcare services into the community,” Frank Molinaro, CEO of Abrazo’s Phoenix Market, told Commercial Executive Magazine. “The Mesa microhospital will offer a patient-friendly design with emergency and acute care services in an efficient, convenient location. It’s designed to provide close integration with our other facilities for patients who may require more complex care.”
Emerus, a microhospital developer, operates more than 20 microhospitals nationwide. According to their website, the company has 24 additional microhospitals under development.
“Emerus picks locations that have a need for additional emergency room beds,” Richard Bonnin, Senior Public Relations Consultant at Emerus, told U.S. News. “Increasing access to high-quality emergency care and focusing on the patient-physician relationship has provided a strong foundation for our growth.”
Not a Replacement for Traditional Hospitals
While microhospitals are equipped to handle a large range of healthcare issues, they are not able to deal with all medical situations. There are cases where patients may have to be referred to a larger facility.
“Not every [microhospital] is a Level 1 trauma center or cardiac center of excellence. It’s up to the smaller hospitals to diagnose, stabilize, and transfer patients as appropriate,” noted Bonnin in the U.S. News article. “They will send patients to the best trauma center, the best heart hospital, the best stroke center without a lengthy emergency room wait, depending on what the most immediate needs may be.”
Although most microhospitals are owned by existing health networks and most likely receive their medical laboratory services through their parent organization, independent clinical laboratories might find themselves being contacted when faster TATs or closer proximities are required to ensure positive healthcare outcomes.
—JP Schlingman
Related Information:
What You Need to Know about Microhospitals
5 Common Questions about Microhospitals, Answered
Microhospitals Market: Global Industry Analysis 2012-2016 and Opportunity Assessment
Microhospitals Provide Health Care Closer to Home
Microhospitals Are on the Rise
2018 Trends: Microhospitals to Gain Popularity
Allegheny Health Network to Open Four Microhospitals in 2019
Abrazo Entering East Valley with New Microhospital in Mesa
Telemedicine and Microhospitals Could Make Up for Reducing Numbers of Primary Care Physicians in US Urban and Metro Suburban Areas
‘Thinking Small’ May Be Next Big Innovation in Healthcare Delivery as Microhospitals Spring Up in Metropolitan Areas Across Multiple States
Dec 12, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
By negotiating directly with healthcare systems employers garner cost savings, while creating opportunities for clinical laboratories willing to be flexible about claims and reimbursement
It’s a healthcare trend called “direct contracting” and it is the latest method that self-insuring employers are using to better manage the cost of their health benefits plan, while maintaining access and quality for their employees. The interesting thing about direct contracting is that it might be a strategy that could work for innovative regional clinical laboratories to negotiate a place for themselves in that employer’s provider network.
Healthcare costs continue to skyrocket in the United States, and in response, many large companies are providing healthcare services to their employees by working directly with health networks and other organizations, instead of using third-party administrators (TPAs) of insurance plans to create healthcare benefits packages for their employees.
This can provide clinical laboratories and anatomic pathology groups with opportunities to create revenue and further outreach into their communities. Astute lab leaders may want to consider meeting with the decision-makers at large companies in their areas and develop strategies for working together directly. Human resources managers may be interested in the benefits of working directly with medical laboratories.
Employers Already Engaged with Health Networks for Provider Services
Self-insuring is not a new concept. In a direct contracting relationship, the employer skips the TPA in hopes of achieving cost savings. Sometimes the direct contract is for specific services that employees need most often, or they can be designed to cover the entire spectrum of services available to employees.
Many companies have already engaged in direct contracting for healthcare services. Among them are: Cisco Systems, Boeing, Intel, Walmart, and Whole Foods. Amazon, JP Morgan Chase, and Berkshire Hathaway also have announced a joint agreement to self-insure their employees, which Dark Daily reported in June. (See, “Six New Jersey Hospitals and Several Major Corporations to Self-Insure Their Million+ Employees; Trend Could Impact How Local Clinical Laboratories Get Paid,” June 11, 2018.)
Cisco has negotiated a direct healthcare agreement with Stanford Health System. Stanford operates a clinic at the Cisco campus, so that the primary care doctor is a member of the community within the company.
“I’m in their space. I’m actually where they work. I’m a bit of a village doc,” Larry Kwan, MD (above), a doctor of internal medicine with Stanford Health Care, told Reuters about his role in the Stanford clinic at the Cisco campus. About 1,000 Cisco employees are enrolled in the Stanford plan. Katelyn Johnson, Integrated Health Manager at Cisco Systems, says it’s a program that requires a more active approach from companies than traditional health benefits plans. (Photo copyrights: Stanford Health Care.)
Boeing, too, has explored direct contracting in a program where the company negotiated directly with hospitals in four different states. The direct contracts have resulted in cost savings and cover some 15,000 employees plus their families. Some of those cost savings have come from things like getting doctors to prescribe generic drugs.
Intel also has a similar program, covering around 38,000 employees and their families. They have found success in managing chronic conditions like diabetes. Technology, such as video-conferencing, also has helped lower costs and improve retention.
Even health networks are getting into the game. One recent example is the Healthcare Transformation Consortium (HTC), a six-hospital healthcare systems in New Jersey that formed to self-insure and provide direct healthcare coverage for their employees.
Companies may gain some cost savings from directly negotiating, but there are gains for the health systems as well. In a deal with Whole Foods in 2016, Adventist Health System gained a new set of skills that they plan to use in negotiating similar deals with other employers.
“We have a little bit more flexibility as a health system to design around what Whole Foods defines as quality, or what Whole Foods defines as patient satisfaction, which is sometimes different than the traditional definitions,” Arby Nahapetian, MD, regional chief medical officer and SVP at Adventist-Southern California told Modern Healthcare.
Signs Point to Trend Continuing
The Healthcare Transformation Consortium in New Jersey, along with the joint agreement between Amazon, JP Morgan Chase, and Berkshire Hathaway, are examples of what the future is likely to hold. The more these kinds of collaborations and direct contracts result in both cost savings and patient satisfaction, the more companies will likely consider direct healthcare contracts.
Hospital-based and independent laboratories may want to consider meeting with the larger employers in their service regions and explain to the HR benefits managers how better utilization of selected lab tests could improve patient outcomes and contribute to better managing costs.
After all, employers tell health insurance companies what they want to cover with their health benefits plans. So, educating the employers’ HR teams about the true value of clinical laboratory tests could be a winning strategy for labs willing to take the time to do this.
—Dava Stewart
Related Information:
Fed Up with Rising Costs, Big US Firms Dig into Healthcare
Left Out of the Game: Health Systems Offer Direct-To-Employer Contracting to Eliminate Insurers
Six New Jersey Hospitals and Several Major Corporations to Self-Insure Their Million-plus Employees; Trend Could Impact How Local Clinical Laboratories Get Paid
Dec 10, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, Uncategorized
Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.
The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.
Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”
Value of Precision Medicine and Coordination of Care to Clinical Labs
“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.
The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.
CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.
“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)
The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.
How Does it Work?
The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.
It includes three programs, including the:
- Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
- Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
- Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.
CMS and Maryland officials also identified these six high-priority areas for population health improvement:
- Substance-use disorder;
- Diabetes;
- Hypertension;
- Obesity;
- Smoking; and
- Asthma.
“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.
OneCare in Vermont, Different Approach to One Payer
Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.
Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.
Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.
—Donna Marie Pocius
Related Information:
Maryland’s Total Cost of Care Model
Maryland All-Payer Model Expands to Include Outpatient Services
Gov. Hogan Sees Maryland Model as Example for U.S. Healthcare
The Maryland Model
Gov. Larry Hogan, Federal Government Sign Maryland Model All-Payer Contract
CMS Expands Maryland’s All-Payer Program to Outpatient Services
Vermont’s Bold Experiment in Community Driven Healthcare Reform
Dec 3, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
As personalized medicine becomes more popular, clinical laboratories, and anatomic pathologists are uniquely positioned to use next-generation sequencing to advance their scope among regulators, insurers, providers and patients, while adding clinical value and generating a new revenue source
By now, most clinical pathologists and medical laboratory scientists recognize that genetics, genetic testing, and gene sequencing will be a major transformative force in this country’s healthcare system. Genetics is the future of modern medicine.
At the same time, most independent labs and health network labs still lack the key resources needed for them to provide accurate and state-of-the-art genetic testing and gene sequencing services in support of clinical care.
The good news is that it is not yet prime time for genetic testing—meaning few genetic tests have become part of routine care, particularly in primary care settings. Today’s limited use of genetic tests creates the opportunity for any medical laboratory and anatomic pathology group to use this time to develop its genetic testing strategy. It also has time to incrementally put in place the resources it will need to offer genetic testing and gene sequencing services to its client physicians.
“Every clinical lab that wants to be a provider of genetic tests needs three basic resources,” stated Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily. “First, the lab must have information technology in place that can handle genetic and molecular data. The second thing needed are pathologists, PhDs, and clinical laboratory scientists trained in genetic and molecular diagnostics. Of course, the third resource is to have the lab analyzers, instruments, and automation needed to extract, amplify, and sequence specimens.”
Experts agree that adoption of genetic testing will happen at a rapid pace. “Next-generation sequencing (NGS) is an incredibly powerful, positive force in medical care. We were in the Dark Ages before this. It is the tsunami on our shores, and it’s going to take over all of medicine. It’s not a trend. It’s the future of medicine. There’s no question about it,” predicts Maurie Markman, MD, an oncologist and President of Medicine and Science at Cancer Treatment Centers of America, in an article he penned for Health Connect South.
“As knowledge of genomic medicine has increased, its cost has plummeted,” notes Maurie Markman, MD (above), President of the Cancer Treatment Centers of America, in his Health Connect South article. “Sequencing a human genome [in 2015] costs less than $10,000, compared to more than $100 million in 2001. Not only are the tests more available to patients, but more oncologists are trying their hand at tumor testing and building on the base of knowledge.” (Photo copyright: Cancer Treatment Centers of America.)
“This can be done by either adding the needed functions to the existing laboratory information system (LIS) or supplementing that LIS with appropriate middleware solutions,” he continued. “This is true even if a lab plans to outsource both the gene sequencing and the annotation and interpretation of the resulting gene sequences. It will need in-house informatics capabilities to store and report that genetic information.”
NGS, Gene Sequencing, Precision Medicine, and Clinical Laboratories
Purchasing, implementing, and operating NGS technologies can be a costly venture, so it is critical that labs know and understand the needs of their referring clients.
“Knowing who your lab’s customers are and what you do for them today should guide you as a laboratory,” notes Brian Keefe, Vice President of Sales and Customer Innovation at Psyche Systems, a laboratory solutions developer for the medical industry based in Boston. “For example, your pathology group knows it should be offering NGS testing, and the justification for needing to go in this direction is because 90% of your clients are oncologists.”
Using NGS technology and marketing it to clients will be a valuable benefit for clinical laboratories. It will enable labs to participate in personalized medicine and allow them to become the “go to” facility for specific genetic tests.
“If you’re a laboratory that has figured out how to map the genome for nightmare bacteria, it doesn’t matter whether you’re three miles or 3,000 miles away, physicians will send their samples to your lab regardless of the distance,” Keefe notes. “If your lab is first to market, you establish powerful brand recognition and attract positive attention, which justifies your lab’s cost to set up and offer that testing in the first place.”
Learn More by Requesting the Dark Daily NGS White Paper
To help medical laboratories and anatomic pathology groups learn more about the growing role of NGS in clinical care, and how NGS can benefit clinical and molecular laboratories, Dark Daily and The Dark Report have produced a white paper titled, “How Next-Generation Sequencing Helps Molecular Laboratories Deliver Personalized Medicine Services to their Client Physicians.”
Medical laboratory leaders who want to learn how labs can establish NGS services and implement the IT/Informatics needed to be successful in using NGS should request a copy of this important white paper. It reviews how pathologists can help providers select targeted therapies and touches on marketing strategies to use NGS to procure new customers and retain existing customers.
The NGS white paper can be downloaded at no cost by clicking here or placing https://www.darkdaily.com/how-next-generation-sequencing-helps-molecular-laboratories-deliver-personalized-medicine-services-to-their-client-physicians-601/ into your browser.
—JP Schlingman
Related Information:
How Next-Generation Sequencing Helps Molecular Laboratories Deliver Personalized Medicine Services to their Client Physicians
Genomic Medicine: The Future of Cancer Treatment Is Now
Clinical Pathology Labs Are on Track to Get New Genetic Test That Screens for 448 Rare Childhood Diseases
Is Whole-genome Sequencing Reaching a Tipping Point for Clinical Pathology Laboratories?
