Independent clinical laboratories may continue to see their customer numbers drop as more consumers choose healthcare delivered in non-traditional locations
More clinical laboratory companies are offering testing in non-traditional locations with non-traditional delivery systems to serve busy healthcare consumers and ambulatory patients. One such company is eTrueNorth, a pharmacy‐based clinical laboratory services network.
This is yet another example of a company responding to the
public’s demand for convenient healthcare delivery, including clinical
laboratory testing.
Pharmacists as Care Givers
eTrueNorth has quietly built a 5,500-location network of independent CLIA-waived laboratories in retail pharmacies. By bringing point-of-care testing to community pharmacies, the company says it can close gaps in healthcare.
“By empowering local pharmacists to administer preventative
healthcare screenings and close gaps in care, eTrueNorth is working in
partnership with retail pharmacies, self-funded employers, third-party payors
and pharmaceutical manufacturers to identify undiagnosed conditions and better
manage chronic diseases,” the company’s website states. “By leveraging the
accessibility of retail pharmacies, eTrueNorth expands the scope of services
provided to consumers to be more effective, of higher quality and, at the same
time, enhance the pharmacy’s value as a key participant in a multidisciplinary
healthcare delivery model.”
The website states that eTrueNorth’s ePOCT software suite “simplifies administrative processes for CLIA-waived labs that conduct point-of-care testing.” It provides the infrastructure for CLIA-waived laboratories to meet all applicable federal, state, and local regulations. In addition, the company provides documentation to medical professionals as they track compliance with quality-control efforts for diagnostic devices.
In an exclusive interview with Dark Daily, Coral May, eTrueNorth’s CEO, President, and co-founder, said the company’s growth will continue to accelerate.
“In the next few months, we will be adding quite a few more [eLabNetwork
locations] because we will be bringing on a couple of other major brands,” May
said in a telephone interview.
May explained that all eLabNetwork pharmacies have standing orders for their limited test menu. This means consumers do not need a physician’s order to receive clinical laboratory services. As a result, however, consumers currently cannot submit a claim for the eLabNetwork service to their insurer. This is about to change.
Health Plans May Soon Partner with eLabNetwork Pharmacies
May announced that in the second quarter of 2020 eTrueNorth will
launch “within several different health plans” the ability “to provide and
submit claims for tests that will close quality measures, gaps in care.”
Though May could not yet announce which health plans will be
partnering with eTrueNorth, she stated that participating insurers would be
communicating with their members directly to steer them to eLabNetwork pharmacies
where they can receive CLIA-waived testing.
May previously pointed out that health plans benefit from eTrueNorth engaging plan members at the pharmacy counter and addressing gaps in care ranging from diabetes testing to hypertension control and medication adherence. She cited as example an insurance plan member with diabetes who has not yet had an A1C test for diabetes or needs an microalbumin [urine] test.
“Our goal is to make it easier for individuals to have
affordable and increased access to additional healthcare from the convenience
of their local pharmacy,” she stated in a news
release.
Another of eTrueNorth’s stated objectives is to increase the
number of participants in the Center for Disease Control and Prevention (CDC) National Diabetes
Prevention Program (National DPP), which was created in 2010 to increase
evidence-based, cost-effective interventions that help prevent Type 2 diabetes.
In order for Medicare Advantage-eligible patients to participate in the program, they must have a fasting blood glucose test. eTrueNorth believes increasing access to point-of-care blood testing could boost participation in the DPP.
“The eTrueNorth Voucher Solution is designed to maximize participation in wellness-screening events by providing convenient access to screenings,” May said in a news release. “Local pharmacists are trusted medical providers to the community. The eTrueNorth Voucher Solution allows individuals to obtain the same high-quality, accurate testing at retail pharmacies as they would from their primary-care office.”
How the Voucher Solution Works
The company’s voucher program enables employees who miss onsite wellness screenings, or who work remotely, to visit a local pharmacy to obtain point-of-care testing and on-the-spot counseling.
Through eLabNetwork’s website, an employee can confirm
eligibility, choose a pharmacy based on zip code, schedule an appointment and
create a voucher. In addition, the eLabNetwork transmits results to the
wellness plan and/or patient’s physician, invoices wellness plan vendors, and
sends payments to participating pharmacies for:
Full lipid panel;
Glucose;
Hemoglobin A1C testing (for individuals already
diagnosed with diabetes); and
“With 95% of the US population living within five miles of a
retail pharmacy, eTrueNorth envisions a future where consumers can access healthcare,”
May said in a company
statement. “This expanding list of retail pharmacies has the potential to
make a significant impact on how healthcare is delivered.”
Will independent clinical laboratories be affected by these
events? Almost certainly. Dark
Daily has reported often on the public’s increasing demand to receive
healthcare in convenient, nearby locations, such as shopping malls and retail
pharmacies. This is just another example of that expanding trend.
Lab leaders will want to keep a close eye on it and plan
accordingly. It’s a trend that could potentially threaten clinical
laboratories’ bottom lines.
Powerful forces are reshaping the clinical laboratory industry, making 2020 a critical year as hospitals determine whether retaining the laboratory in-house or selling it is the better path.
Mergers, acquisitions, and joint ventures, along with the development of new testing technologies are but a few of the factors that have changed the profile of the medical laboratory footprint across the U.S. And now, downward reimbursement reform combined with impending integration of clinical care, promise to again challenge the traditional laboratory service model in significant ways beyond 2020.
As a clinical laboratory leader, it is important for you to understand why selling the laboratory will not solve core problems like overutilization, low-value testing, inappropriate use of high-cost testing, and provider confusion over best test choice which can lead to irrelevant results and the need for a repeat study. Rather, when you take action to build value within your lab, the result is to sell significant change to the organization in the form of a reinvented, reinvigorated, test-optimized lab.
To assist clinical labs and their leaders in rationalizing the laboratory’s value and relevance in ways that support lab value plus appropriate and high-quality patient care, fiscal strength, and program integrity for payers, DARK Daily is pleased to offer this FREE White Paper—“Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence”—the first publication of a three-part White Paper series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare.
Providing rich industry perspective, commentary, and insights on the use and value of decision support in building an effective laboratory stewardship program, the paper also highlights case-study proof points developed in collaboration with Mayo Clinic from early-adopter hospital laboratories—points that have successfully implemented third-party decision support to their value advantage.
This White Paper provides a concise discussion regarding:
Why establishing the relevance of the clinical laboratory is more important than ever before, especially with the integration of care delivery and the shift away from fee-for-service payments
How retaining the clinical lab and committing to effective stewardship through better laboratory test utilization can positively impact not only clinical outcomes and financial performance, but also the viability of the organization as a whole
Learn the three evidence-based categories of good stewardship—and the three critical stewardship functions you should integrate into your lab operations plan
Address clinical laboratory waste through stewardship: four core test utilization patterns to monitor in order to identify gaps in care, and to develop your own specific strategies to manage overall test utilization
Gain insights into stewardship strategies that have worked for other laboratories, and how they have been able to reduce per-patient per-day tests, manage inappropriate test ordering, more effectively utilize and redirect lab staff, and much more!
Table of Contents
INTRODUCTION
Chapter 1: Industry Update: Commoditization of Common Tests Puts Clinical Laboratories Under Pressure to Validate Value
Chapter 2: Critical Factors That Make Stewardship Work Toward Clinical Laboratory Value and Value-Based Initiatives
Chapter 3: Addressing Clinical Laboratory Waste Through Stewardship: 4 Core Categories and Early Results
CONCLUSION
Increasing the clinical laboratory’s value to a hospital organization does not begin by reducing or selling the lab. Armed with the knowledge within this White Paper, you’ll learn how you can effectively transform your lab into a strategic unit that drives clinical and financial value for itself and for the organization it serves.
Learn more by downloading your FREE copy of “Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence” now.
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Researchers are discovering it’s possible to determine a person’s age based on the amount of protein in the blood, but the technology isn’t always correct
Mass spectrometry is increasingly finding its way into clinical laboratories and with it—proteomics—the study of proteins in the human body. And like the human genome, scientists are discovering that protein plays an integral part in the aging process.
This is a most interesting research finding. Might medical laboratories someday use proteomic biomarkers to help physicians gauge the aging progression in patients? Might this diagnostic capability give pathologists and laboratory leaders a new product line for direct-to-consumer testing that would be a cash-paying, fast-growing, profitable clinical laboratory testing service? If so, proteomics could be a boon to clinical laboratories worldwide.
When research into genomics was brand-new, virtually no one imagined that someday the direct-to-consumer lab testing model would offer genetic testing to the public and create a huge stream of revenue for clinical laboratories that process genetic tests. Now, research into protein and aging might point to a similar possibility for proteomics.
For example, through proteomics, researchers led by Benoit Lehallier, PhD, Biostatistician, Instructor of Neurology and Neurological Sciences, and senior author Tony Wyss-Coray, PhD, Professor of Neurology and Neurological Sciences and co-director of the Stanford Alzheimer’s Disease Research Center at Stanford University in California, gained an understanding of aging that suggest intriguing possibilities for clinical laboratories.
In their study, published in Nature, titled, “Undulating Changes in Human Plasma Proteome Profiles Across the Lifespan,” the scientists stated that aging doesn’t happen in a consistent process over time, reported Science Alert.
The Stanford researchers also found that they can accurately
determine a person’s age based on the levels of certain proteins in his or her
blood.
Additionally, the study of proteomics may finally explain why blood from young people can have a rejuvenating effect on elderly people’s brains, noted Scientific American.
Each of these findings is important on its own, but taken
together, they may have interesting implications for pathologists who follow
the research. And medical laboratory leaders may find opportunities in mass
spectrometry in the near future, rather than decades from now.
Three Distinct Stages in Aging and Other Findings
The Stanford study found that aging appears to happen at
three distinct points in a person’s life—around the ages 34, 60, and 78—rather
than being a slow, steady process.
The researchers measured and compared levels of nearly 3,000
specific proteins in blood plasma taken from healthy people between the ages of
18 and 95 years. In the published study, the authors wrote, “This new approach
to the study of aging led to the identification of unexpected signatures and
pathways that might offer potential targets for age-related diseases.”
Along with the findings regarding the timeline for aging, the researchers found that about two-thirds of the proteins that change with age differ significantly between men and women. “This supports the idea that men and women age differently and highlights the need to include both sexes in clinical studies for a wide range of diseases,” noted a National Institutes of Health (NIH) report.
“We’ve known for a long time that measuring certain proteins in the blood can give you information about a person’s health status—lipoproteins for cardiovascular health, for example,” stated Wyss-Coray in the NIH report. “But it hasn’t been appreciated that so many different proteins’ levels—roughly a third of all the ones we looked at—change markedly with advancing age.”
Differentiating Aging from Disease
Previous research studies also found it is indeed possible
to measure a person’s age from his or her “proteomic signature.”
The researchers published their findings in Aging Cell, a peer-reviewed open-access journal of the Anatomical Society in the UK, titled, “Plasma Proteomic Signature of Age in Healthy Humans.” In it, the authors wrote, “Our results suggest that there are stereotypical biological changes that occur with aging that are reflected by circulating proteins.”
The fact that chronological age can be determined through a
person’s proteomic signature suggests researchers could separate aging from
various diseases. “Older age is the main risk factor for a myriad of chronic
diseases, and it is invariably associated with progressive loss of function in
multiple physiological systems,” wrote the researchers, adding, “A challenge in
the field is the need to differentiate between aging and diseases.”
Can Proteins Cause Aging?
Additionally, the Stanford study found that changes in protein levels might not simply be a characteristic of aging, but may actually cause it, a Stanford Medicine news article notes.
“Changes in the levels of numerous proteins that migrate
from the body’s tissues into circulating blood not only characterize, but quite
possibly cause, the phenomenon of aging,” Wyss-Coray said.
Can Proteins Accurately Predict Age? Not Always
There were, however, some instances where the protein levels inaccurately predicted a person’s age. Some of the samples the Stanford researchers used were from the LonGenity research study conducted by the Albert Einstein College of Medicine, which investigated “why some people enjoy extremely long life spans, with physical health and brain function far better than expected in the 9th and 10th decades of life,” the study’s website notes.
That study included a group of exceptionally long-lived Ashkenazi Jews, who have a “genetic proclivity toward exceptionally good health in what for most of us is advanced old age,” according to the Stanford Medicine news article.
“We had data on hand-grip strength and cognitive function
for that group of people. Those with stronger hand grips and better measured
cognition were estimated by our plasma-protein clock to be younger than they
actually were,” said Wyss-Coray. So, physical condition is a factor in
proteomics’ ability to accurately prediction age.
Although understanding the connections between protein in
the blood, aging, and disease is in early stages, it is clear additional
research is warranted. Not too long ago the idea of consumers having their DNA
sequenced from a home kit for fun seemed like fantasy.
However, after multiple FDA approvals, and the success of
companies like Ancestry, 23andMe, and the clinical laboratories that serve them,
the possibility that proteomics might go the same route does not seem so
far-fetched.
Experts say Amazon could be planning a roll-out of healthcare services to its Prime members and others
Clinical laboratory leaders will want to note that the Telehealth and home healthcare industries have expanded with the launch of Amazon Care, a virtual medical clinic and home care services program from global retailer Amazon.com, Inc. (NASDAQ:AMZN).
Amazon is piloting Amazon Care as a benefit for its 53,000
Seattle-area employees and their families, according to published reports. Could
this indicate the world’s largest online retailer is moving into the primary
care space? If so, clinical laboratory leaders will want to follow this
development closely, because the program will need clinical laboratory support.
Amazon has successfully disrupted multiple industries in its
corporate life and some experts speculate Amazon may be using its own employees
to design a new medical delivery model for national roll-out.
The S&P report goes on to state, “In as little as five years, the Seattle-based e-commerce company could interlink its system of capabilities and assets to launch various healthcare products, insurance plans, virtual care services, and digital health monitoring to a broader population. The rollout would be part of a larger plan by Amazon to deliver convenient, cost-effective access to care and medications across the U.S., likely tied to Amazon’s Prime membership program, according to experts.”
Modern Healthcare reported that Amazon Care services include telemedicine and home visits to employees enrolled in an Amazon health insurance plan.
Experts contacted by S&P Global Market Intelligence
suggest Amazon:
Plans a “suite of customized health plans and
services for businesses and consumers;”
May offer health services to its five million
seller business and more than 100 million Amazon Prime members; and
Sees healthcare as a growing market and wants
greater involvement in it.
How Amazon Care Works
Amazon Care offers online, virtual care through a
downloadable mobile device application (app) as well as in-person home care for
certain medical needs, such as:
Colds, allergies, infections, and minor injury;
Preventative consults, vaccines, and lab tests;
Sexual health services; and
General health inquiries.
Becker’s Hospital Review reported that once a participant downloads the Amazon Care app to a smartphone or tablet and signs up for the program, he or she can:
Communicate with healthcare providers via text
or video;
Plan personal visits if needed;
Set payment methods in their user profile; and
Receive a “potential diagnosis” and treatment
plan.
“The service eliminates travel and wait time, connecting employees and their family members to a physician or nurse practitioner through live chat or voice,” an Amazon spokesperson told CNBC, “with the option for in-person follow-up services from a registered nurse ranging from immunizations to instant strep throat detection.”
The “mobile health nurse” may also collect clinical laboratory
specimens, the Verge
reported.
Amazon has partnered with Oasis Medical Group, a family primary care practice in Seattle, to provide healthcare services for Amazon Care patients.
Paving the Way to Amazon Care
The Healthcare Financial Management Association (HFMA) compares Amazon’s piloting of Amazon Care to similar healthcare projects that studied population health by first involving employee health plans.
HFMA’s analysis noted that Amazon Care is similar to Haven, a patient advocate organization based in Boston and New York that was created in 2018 by Amazon, JPMorgan Chase, and Berkshire Hathaway to lower healthcare costs and improve outcomes for participating companies.
Tech Crunch reported that in 2018 Amazon also purchased PillPack for nearly $1 billion and integrated its prescription delivery services into Amazon Care.
More recently, Amazon acquired Health Navigator and plans to bring those offerings to Amazon Care as well, CNBC reported. Founded in 2014, Health Navigator provides caregivers with symptom-checking tools that enable remote diagnoses.
Should Telemedicine Firms Be Nervous?
Dark Daily recently reported on Doctor on Demand’s launch of its own virtual healthcare telehealth platform called Synapse. The e-briefing also covered Doctor on Demand’s partnership with Humana (NYSE:HUM) to provide virtual primary care services to the insurer’s health plan members, including online doctor visits at no charge and standard medical laboratory tests for a $5 copayment.
So, should telemedicine firms be concerned about Amazon competing in their marketplace? Business Insider predicts Amazon will need time to beef up its medical resources to serve people online and in-person through Amazon Care.
But that’s the point of Amazon’s pilot, isn’t it? What comes
from it will be interesting to watch.
“Meanwhile, telemedicine firms can ink strategic
partnerships and strengthen their existing payer relationships to safeguard
against Amazon’s surge into the space,” Business Insider advised.
It remains to be seen how medical laboratory testing and reports
would fit into an expanded Amazon Care health network. Or, how clinical laboratories
will get “in-network” with Amazon Care, as it grows to serve customers beyond
Amazon’s employees.
As Dark Daily recently advised, medical laboratory leaders will want to ensure their lab’s inclusion in virtual care networks, which someday may include Amazon Care.
In a federal lawsuit, seven healthcare organizations and hospitals systems allege HHS exceeded its statutory authority and clinical laboratories will want to watch how this court case unfolds
There is quite a brouhaha over the final new federal rule requiring hospitals to allow patients and the public to see the prices they charge for services—including clinical laboratory and anatomic pathology prices. Some very influential hospital associations and healthcare systems are opposing implementation of this rule.
For more than a decade, Dark Daily has
reported on the federal government’s efforts to enact pricing transparency in
healthcare. In many e-briefings, we advised pathologists
and medical
laboratory leaders that the outcome of those efforts will likely affect
clinical laboratory workflows and bottom lines, and that many clinical laboratories
are not prepared to negotiate directly with customers over the price of their
services.
Now, the federal Centers for Medicare and Medicaid Services
(CMS) has passed a final
rule (CMS-1717-F2) that expands on an earlier rule mandating pricing
transparency for hospital procedures—including medical
laboratory and anatomic
pathology services. This new rule requires hospitals to disclose not only
their chargemaster
prices, but also prices negotiated with payers.
Hospital leaders are not pleased by this, and though the
final rule does not go into effect until January 1, 2021, they are already
pushing back through representative organizations such as the American Hospital Association (AHA), which has
brought a lawsuit to federal court that seeks to overturn the new rule.
New Transparency Rules Include Rates Negotiated with Health
Insurers
Beginning Jan. 1, 2019, CMS required hospitals to disclose chargemaster prices to customers. These are essentially the “list prices” for hospital procedures. However, as Dark Daily reported in “California Healthline Report Finds Hospital Chargemaster Prices Fluctuate Dramatically Even Among Hospitals Located Near Each Other,” June 12, 2019, there were problems. Chargemaster prices typically do not reflect the actual fees charged to patients or payers. Thus, consumers still found it problematic to price shop before committing to healthcare.
In an effort to remedy this, the
new 2020 final rule expands the pricing information hospitals are required to
provide and includes several categories of prices negotiated with health insurers.
Simultaneous to this final rule, CMS also announced a
proposed rule (CMS-9915-P) titled, “Transparency
in Coverage,” that if passed, will require health insurers to disclose
pricing for healthcare services as well.
In a federal Department of Health and Human Services (HHS) press
release, the Trump Administration stated that both rules will “increase
price transparency to empower patients and increase competition among all
hospitals, group health plans, and health insurance issuers in the individual
and group markets.”
“Under the status quo, healthcare prices are about as clear
as mud to patients,” said CMS Administrator Seema Verma in the HHS press
release. “This final rule and the proposed rule will bring forward the
transparency we need to finally begin reducing the overall healthcare costs.”
AHA Sues HHS in Federal Court
In response, four hospital organizations and three health
systems filed a
lawsuit in federal court against the HHS. The suit alleges the final rule
“exceeds the agency’s statutory authority,” and violates the First Amendment by
requiring public disclosure of prices negotiated with payers. This information,
they say, is “highly confidential and commercially sensitive.”
In court
documents, the plaintiffs argue that “the Final Rule is arbitrary and
capricious and lacks any rational basis. The agency’s explanation for the Final
Rule runs counter to both logic and evidence. In fact, it is belied by the
agency’s own research regarding what patients care about most when selecting a
hospital: their own out-of-pocket costs. The agency’s justification for the
Final Rule therefore does not stand up to even the barest of scrutiny. That is
the epitome of arbitrary and capricious agency action.”
A brief
filed by the plaintiffs contends that patients’ actual out-of-pocket costs
are determined by a complex set of factors and aren’t reflected in negotiated
rates. In addition, the brief states, “the sheer burden of compliance with the
rule is staggering, and way out of line with any projected benefits associated
with the rule.”
Details of the Final Rule on Hospital Price Transparency
If it goes forward, starting Jan. 1, 2021, the final rule
requires hospitals to disclose five types of standard charges, according to the
HHS and AHA press releases:
The chargemaster rate, also known as the gross
charge;
The discounted cash price, which CMS defines as
the amount the hospital will accept from self-paying patients;
The payer-specific negotiated charge, defined as
“the charge that the hospital has negotiated with a third-party payer for an
item or service.” This would be the charge that applies if a patient uses an
in-network provider;
The maximum charge negotiated with payers; and
The minimum charge negotiated with payers.
Hospitals must list these charges for all billable “items
and services,” including medical laboratory and pathology services, in a
machine-readable format, such as a CSV file that
can be opened in a spreadsheet program.
In addition, they must provide a “consumer-friendly” list of charges for at least 300 “shoppable services,” defined as services that consumers can schedule in advance. Each list would include 70 services specified by CMS and an additional 230 services selected by the hospital.
The CMS-specified shoppable services include 14 laboratory
and pathology tests. They include:
Basic metabolic panel
Blood test, comprehensive group of blood
chemicals
Obstetric blood test panel
Blood test, lipids (cholesterol and triglycerides)
Kidney function panel test
Liver function blood test panel
Manual urinalysis test with examination using
microscope
Automated urinalysis test
PSA (prostate specific antigen)
Blood test, thyroid stimulating hormone (TSH)
Complete blood cell count, with differential
white blood cells, automated
Complete blood count, automated
Blood test, clotting time
Coagulation assessment blood test
Blood Brother Clinical Laboratories Also Affected by
Price Transparency
Price transparency is also at the center of two federal
lawsuits involving Laboratory Corporation of America (LabCorp) and Quest
Diagnostics. The Dark Report, Dark Daily’s sister publication, reported
on these suits in “Lawsuits
Alleging Overcharges to Proceed in Two Courts in 2020,” December 16, 2019.
The plaintiffs in those cases are uninsured or underinsured
customers who claim they were charged far more for medical laboratory tests
than customers covered by insurance. In both cases, customers were charged at
the chargemaster rates. The plaintiffs contend that the medical laboratories
should have disclosed their rates in advance.
Whichever way this all goes, clinical laboratories will need
to monitor the multiple efforts by the states and the federal government to
make it easy for patients to see the prices of hospital, physician, and other
medical services in advance of treatment. This has the potential to be a disruptive
trend, particularly for hospitals.