UPS’ program on
WakeMed Hospital’s Raleigh campus in N.C. is first drone delivery service
cleared by FAA for commercial purposes
UPS (NYSE:UPS) Chairman and CEO David Abney emphasizes patients, not packages, in the company’s new drive toward drone technology in medical laboratory specimen transport and logistics.
“Healthcare is a strategic imperative for us,” Abney said.
“We deliver a lot of important things, but lab [shipments] are critical, and
they’re very much a part of patient care.”
UPS entered the healthcare sector in 2000 with its acquisition of Livingston HealthCare. In 2016, the company acquired Marken, a move that Abney said, “sent a clear message to our customers that we were taking healthcare and clinical trials very seriously.”
UPS Chairman and CEO David Abney (above) explained the company’s new drive toward drone technology in medical laboratory specimen transport and logistics. Abney closed Day 1 sessions at the 24th Annual Executive War College on Lab and Pathology Management. (Photo copyright: DARK Daily.)
Clinical Laboratory
Specimens Delivered by Drone
With healthcare deliveries already a big part of UPS’ ground
business, the company now moves lab specimens by drone on WakeMed’s hospital campus in
Raleigh, N.C. The effort marks the first commercial daily drone service to be
cleared by the Federal Aviation Administration (FAA) for lab specimen
transport, and it is made possible through UPS’s new partnership with Menlo
Park, Calif.-based Matternet.
Matternet Founder and CEO Andreas Raptopoulos described how the new technology is impacting turnaround time, specimen stability, and viability. The “Future of Lab Logistics” session at EWC, featuring Raptopoulos and Shannon DeMar, Senior Marketing Manager Healthcare Strategy at UPS in Atlanta, Ga., brought questions about FAA regulations, risk mitigation, and more. Laboratory leaders are looking at how to take their logistics to the next level.
On-Demand/Same-Day
Delivery of Medical Lab Samples
The UPS/Matternet program represents a major milestone for
unmanned aviation in the United States, according to UPS, in a recent release.
Currently, the majority of medical samples and specimens are transported across
WakeMed’s expanding health system by courier cars. The addition of drone
transport provides an option for on-demand and same-day delivery, the ability
to avoid roadway delays, increase medical delivery efficiency, lower costs, and
improve the patient experience.
How drones, sensors, and new technologies are poised to
increase the quality and accuracy of specimen transport and logistics
represented just a slice of the first full day of sessions at Executive War
College. UPS is an official partner and sponsor.
Also speaking at the 24th Annual Executive War College on
Lab and Pathology Management:
Evolving market trends are creating both concern and
opportunities for the clinical laboratory industry. New sources of revenue are essential
at a time when fee-for-service prices for lab tests are decreasing.
Early registration is already open for 2020 Executive War College, happening April 28-29, in New Orleans.
With Medicare taking a critical look at clinical laboratory test bills and labs contending with the onerous new federal EKRA law and the newly-implemented NCCI guidelines, there is a need for lab leaders to get accurate and timely recommendations on how their labs can respond and be compliant.
Confronting the market and regulatory challenges of managing clinical labs and anatomic pathology groups has sparked record attendance at the 24th Annual Executive War College on Laboratory and Pathology Management, which opens today in New Orleans.
This week, experts from some of the largest medical laboratories, health insurers, and in-vitro diagnostics manufacturers in the U.S. will present on the state of the clinical laboratory industry—from legal and business angles to the latest in informatics, highly-specialized lab operations, and automated workflows.
Robert L. Michel, Editor-in-Chief of The Dark Report, a keynote speaker and
founder of Executive War College and
other industry-leading events, such as Lab Quality Confab and the Precision
Medicine Institute Symposium (also this week), said the event supports the
success of clinical laboratories and anatomic pathology groups at a critical
time in the ongoing transformation of the American healthcare system.
“This year, all labs must deal with
dramatic reductions in revenue and budgets, while needing to comply with tough
new federal regulations,” Michel says, adding that this clinical lab management
conference puts attendees face-to-face with the most innovative and successful
clinical lab organizations that are ready to share how they are responding to
such market forces as narrowing payer networks, Medicare lab test price cuts,
and unwelcome prior-authorization requirements for lab test claims.
Among the lineup of master classes, breakout
sessions, roundtables, and workshops, attendees will learn ways to sensibly
transition to value over volume; important updates to changing federal and
state laws, regulations, and reimbursement policies; perspectives from C-suite
financial executives; and current opportunities in genetic testing and
precision medicine.
“In
the midst of these powerful negative forces in the clinical laboratory
marketplace, this Executive War College delivers
plenty of good news,” emphasized Michel said. “One example is the progress some
labs are having at adding value with lab testing services, consistent with the
Clinical Lab 2.0 paradigm.
Attendees will learn how this handful of
pioneering labs are being paid by health insurers for providing actionable
clinical intelligence to both physicians and payers. These new sources of
revenue are essential at a time when fee-for-service prices for lab tests are
decreasing.
Fine-tuned to the needs of medical labs
to comply with the PAMA private payer market price reporting rule, as well as
to define their lab-specific value along the healthcare continuum, Executive War College offers two
daylong, post-conference workshops geared to each objective.
Khosrow R. Shotorbani, MBA, MT(ASCP),
Executive Director of the Project Santa Fe Foundation and CEO of Lab 2.0
Strategic Services, based in Salt Lake City, Utah, will be among those featured
during the event.
“We are preparing for almost 900
attendees at this conference,” stated Michel. “This record level of support by
senior lab administrators, executives, and pathologists shows how important it
is for leaders in all types of medical laboratories to understand the negative
economics reshaping how labs operate, along with learning what strategies
successful labs are using to stay clinically relevant and financially stable.”
Also speaking at the 24th Annual Executive War College on Laboratory and
Pathology Management: Julie Khani, President of the American Clinical
Laboratory Association; Curt Hanson, MD, Chief Medical Officer of Mayo Clinic
Laboratories; Philip M. Oravetz, MD, of New Orleans-based Ochsner Health
System; Philip Chen, MD, PhD, Chief Strategy Officer for Sonic Healthcare USA;
Anil Asnani, Senior Vice President of Laboratory Corporation of America
Holdings (LabCorp), and Sonny Varadan, MBA, Chief Information Officer for Sonora
Quest Laboratories.
Researchers at UC Berkley developed new ways to use CRISPR as a genetic “search engine” in addition to a cut and paste tool
Clinical pathology laboratory professionals have long been aware of the potential diagnostic properties related to CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology. Now, new tests using the gene-editing tool show that potential is being realized.
One example involves using CRISPR to detect diseases in Nigeria, where a Lassa fever epidemic has already led to the death of 69 people this year alone. According the journal Nature, this diagnostic test “relies on CRISPR’s ability to hunt down genetic snippets—in this case, RNA from the Lassa virus—that it has been programmed to find. If the approach is successful, it could help to catch a wide range of viral infections early, so that treatments can be more effective and health workers can curb the spread of infection.”
Researchers in Honduras and California are working on similar projects to develop diagnostic tests for dengue fever, Zika, and the strains of human papillomavirus (HPV) that lead to cancer. There’s also a CRISPR-based Ebola test pending in the Democratic Republic of Congo.
These new genetic tests, which may be as simple as at-home
pregnancy tests to use, could save many lives throughout the world. They will
give medical laboratories new tools for diagnosing disease and guiding
therapeutic decisions.
Shift in How
Researchers View CRISPR
“We really think of CRISPR fundamentally as a kind of search engine for biology—like Google for biology—rather than [a kind of] word processing tool, although it’s really good at that too,” Trevor Martin, PhD, co-founder and CEO of Mammoth Biosciences, told CRISPR Cuts, a Synthego CRISPR podcast.
Professor of Biochemistry and Molecular Biology, and Li Ka
Shing Chancellor’s Professor in Biomedical and Health.
Martin’s statement represents a shift in how researchers are thinking about CRISPR. At first, CRISPR was seen as a tool for cutting and pasting genetic material. Scientists could tell it to find a target DNA sequence, make a cut, and paste in something different. However, by thinking of the tool as a search engine, CRISPR’s tremendous diagnostic potential becomes apparent.
“This is a very exciting direction for the CRISPR field to
go in,” Doudna told Nature.
Martin told CRISPR
Cuts that diagnostics is “fundamentally a search problem,” adding, “Now you
can program [CRISPR] to find something, and then tell you that result.”
Doudna notes in Technology Networks that, “Mammoth’s technology exemplifies some of the most urgent, impactful, and untapped potential in the CRISPR space.”
Fehintola Ajogbasile (above), a graduate student at the African Centre of Excellence for Genomics of Infectious Diseases in Nigeria, uses a CRISPR diagnostic test to look for Lassa virus in a blood sample. Similar clinical pathology laboratory tests are becoming available in the US as well. (Photo and caption copyright: Nature/Amy Maxmen.)
Investors See
Economic Benefits of CRISPR
The potential financial and economic impact of simple-to-use CRISPR-based diagnostic tools is considerable. Technology Networks notes that the diagnostics market is estimated at $45 billion, and that venture capital firms Mayfield, First Trust Mid Cap Core AlphaDEX Fund (NASDAQ:FNX), and 8VC have all invested in Mammoth Biosciences.
Although the diagnostics market is huge, a critical aspect
of the Lassa fever diagnostic test the Nigerian researchers are developing is
that it will be as accurate as conventional clinical laboratory testing
methods, but much simpler and less expensive.
Dhamari Naidoo, a technical officer at the World Health Organization (WHO) told Nature that researchers often fail to think about the fact that new technology must be affordable for use in low-income countries.
About a dozen diagnostic tests for Ebola have been
developed, according to Naidoo, but only two have been used recently in the
Democratic Republic of Congo, where the virus is resurging, due to economic
concerns. To be useful, medical laboratory tests in low-income countries must
be affordable to license and distribute, and critically, the manufacturers must
identify a market large enough to motivate them to make and distribute such
diagnostic tests.
Future Directions for
CRISPR and Clinical Pathology
Researchers first discovered what would come to be known as CRISPR in the early 1990s. However, it wasn’t until 2012 – 2013 that scientists used CRISPR and Cas9 for genome editing, a Broad Institute CRISPR timeline notes.
Now, researchers around the world are finding innovative
ways to employ the technology of CRISPR to detect disease in some of the most
remote, challenging areas where diseases such as Lassa fever, Zika, and dengue
fever among others, have devastated the populations, as Dark Daily has previously reported.
What’s next for clinical and pathology laboratories and
CRISPR? We’ll let you know.
As drug recalls increased over the past 12 months, questions regarding FDA oversight of drug manufacturing are triggering questions involving IVD oversight by the federal agency and potential implications for clinical laboratories
Pathologists and clinical laboratory managers are following the recent recalls of popular blood pressure medications in the past six months. These issues once again placed the spotlight on failures in the US Food and Drug Administration’s (FDA’s) drug safety oversight processes.
With the global supply chain—and a large amount of secrecy—involved with manufacturing modern pharmaceuticals, maintaining standards and enforcing safety requirements appears to be challenging the FDA’s monitoring capacity. In November 2018, Scott Gottlieb, MD, then commissioner of the FDA and current resident fellow at the American Enterprise Institute, told USA Today, “We put out very big guidance on this—it’s a known risk. It’s a place where there’s been a significant increase in focus in recent years.”
Despite the increase in focus, Kaiser Health News(KHN)recently highlighted potential concerns not shown in the headlines of mainstream media outlets—both for the public and for medical laboratories that rely on FDA oversight in other areas, such as in vitro diagnostics (IVD).
“Since the start of 2013, pharmaceutical companies based in
the US or abroad have recalled about 8,000 medicines, comprising billions of
tablets, bottles, and vials that have entered the US drug supply and made their
way to patients ….” KHN reported. “Over
the same period, 65 drug-making facilities recalled nearly 300 products within
12 months of passing [an FDA] inspection ….”
Data published by Stericycle Expert Solutions, a global B2B services company, offers deeper insight into forces driving recalls in Q3 of 2018. “Pharmaceutical recalls increased 19% to 92—the second highest quarter since Q3 2013,” they note. “Failed specifications were the top reason based on recalls for the ninth consecutive quarter.”
Current Good Manufacturing Practices (CGMPs) ranked second, accounting for 23.9% of recalls in their study. The same data shows medical device recalls also increased across 2018 compared to the prior year.
In an e-mail to Kaiser Health News, FDA spokesman Jeremy Kahn said, “While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs.” He continued, noting that inspectors “may not uncover all issues or practices that may eventually result in a problem leading to a recall” and that “not all recalls are the result of poor manufacturing practice.” (Graphic and caption copyright: Kaiser Health News.)
Issues now presented as “shortcomings” with pharmaceutical oversight could one day present serious concerns for pathology groups, clinical laboratories, and other service providers using IVDs.
In a field requiring precision, quality, and accuracy to provide
reliable results for an ever-growing portion of modern healthcare’s questions, quality
control of testing materials and devices is critical—particularly when dealing
with the increasingly smaller samples and sensitive reagents used today.
Enforcing Standards
Around the World
Despite today’s CGMPs and myriad regulations designed to ensure
pharmaceuticals are safe, KHN notes
that the FDA struggles to stay ahead of manufacturers and suppliers who might
violate regulations. Even when FDA inspectors discover issues, they have little
means of enforcing standards and encouraging change.
“A KHN review of
thousands of FDA documents—inspection records, recalls, warning letters and
lawsuits—offers insight into the ways poorly manufactured or contaminated drugs
reach consumers,” KHN notes. “Inspectors
miss serious hazards. Drug makers fail to meet standards even after the FDA has
taken enforcement action. Hundreds of plants haven’t been inspected for years,
if ever.”
However, no amount of protective regulations or standards can
make a significant impact without proper enforcement. In October 2017, the FDA
announced they would recognize the European drug regulatory authorities of
eight countries to help reduce duplicative inspection. “By partnering with
these countries,” said Gottlieb, “we can create greater efficiencies and better
fulfill our public health goals, relying on the expertise of our colleagues and
refocusing our resources on inspections in higher risk countries.”
Nonetheless, statistics indicate that the FDA’s ability to support
global inspections is still stretched thin. More than 2,500 foreign and
domestic facilities have not received a drug-quality inspection in more than
five years, according to KHN. Additionally,
1,200 domestic facilities and 400 foreign facilities were found to have no
drug-quality inspection records dating back 10 years, KHN reported.
While Gottlieb hopes to “clear the backlog” by the end of
September 2019, the fact that such a backlog exists at all is cause enough for
concern—particularly in light of Gottlieb’s
April 2019 resignation, KHN
noted.
Lack of Effective IVD
Manufacturing Oversight Affects Medical Laboratories
Even with an effective inspection system, the FDA’s options
for bringing manufacturers into compliance are limited. KHN points out that over the past decade, 70 plants in their data
sets received citations for the same violation four or more times. The FDA
cannot issue mandatory
recalls, and while it can seize drug products, it has only exercised that
right 23 times in the past decade. This shows how few options the FDA has for
ensuring contaminated or otherwise defective medications do not reach patients,
hospitals, and other part of the healthcare industry.
For anatomic
pathologists, clinical laboratories, and other diagnosticians relying on the
FDA to be the gatekeeper of quality and safety—as well as ensuring IVDs provide
accurate, reproducible results—these trends in pharmaceutical oversight should be
cause for concern.
Worse still, the lack of effective enforcement options
available to inspectors and oversight committees—alongside the sheer scale of a
global manufacturing chain—offer few easy answers for reversing the trends
making headlines today.
Vague language and last-minute additions to the federal SUPPORT Act of 2018 with its included EKRA provisions mean big changes to how clinical laboratories can legally compensate sales professionals for referrals
Labs that compensate their sales staff for referrals to recovery homes (aka, sober living houses) and clinical treatment facilities are particularly vulnerable and should carefully examine the wording in the legislation, legal experts warn.
“For sales-driven laboratories who have evolved practices to
comply with Anti-Kickback
Statute (AKS) requirements, what are now best practices might soon create
major concerns regarding laboratory
compliance with EKRA [H.R. 6878],”
Marty
Barrack, Senior Vice President and
General Counsel at XIFIN told Dark Daily.
Stiff Penalties Threaten
Clinical Laboratories and Pathology Groups
With fines of up to $200,000, 10 years in jail, or both, the
new EKRA/SUPPORT Act regulations—passed in October 2018—apply separately from existing federal anti-kickback
statute (AKS) regulations. Compliance violations can expose both the
laboratory, pathologists, and other individuals to federal prosecution.
“Because this is a criminal statute, some laboratories
overlook the fact that felony convictions mean zero payments. This is more than
worrying about federal prosecution, it can have a lasting impact on a
laboratory’s financials and its reputation,” noted Barrack. “The provisions
regarding invoicing will raise concerns with how clinical laboratories bill and
write-off co-payments and deductibles in areas previously untouched by AKS
requirements.”
Charles
Dunham, Health Law Attorney, Corporate and Regulatory Practice, Epstein Becker and Green, P.C., outlined
potential payment arrangement concerns at Health Law Advisor, saying, “… one
statutory exemption provides that compensation paid to both W-2 employees and
1099 contractors would not violate EKRA if the payment is not determined by or
does not vary by:
“the number of individuals referred;
“the number of tests or procedures performed; or,
“the amount billed or received.”
The National Law Review warns that “With
the passage of EKRA, laboratories, clinical treatment facilities, and recovery
homes should immediately consider reviewing all financial arrangements with
healthcare providers, contractors, and
employees who are in a position to generate referrals—including marketing
personnel and sales reps.”
They further note, “… Previously compliant payment
methodologies structured under the Anti-Kickback Statute’s employment safe
harbor (such as paying W-2 employees a volume or value-based commission) are now at risk of violating EKRA.”
Vague Wording in Law
Creates Confusion
As covered in the December 3, 2018, issue of The Dark Report, the American Clinical Laboratory Association (ACLA)
questions whether—under the new law—laboratories can continue providing
phlebotomists or specimen collection devices to physicians’ offices under EKRA.
While both scenarios are currently permissible under existing federal AKS
regulations, the SUPPORT Act and EKRA do not include language that covers such
scenarios.
“Primarily, this language was designed to address potential
bad actors working in recovery homes and addiction treatment facilities,” Sharon L. West, Vice
President of the ACLA, told The Dark
Report. “But then language was added to the bill extending that far beyond
treatment facilities to include clinical labs. Now, the new law extends to all
payers and all laboratory testing services provided to patients.”
While revisions to or amendment of existing legislation is possible,
the terms defined in the existing regulations should concern any medical
laboratory offering compensation for the referral
of patients for testing.
“The lab industry has some influence to help drive revisions
of existing statues. The payer industry also has representation,” Barrack
notes. “However, revisions may not proceed as quickly or bring the results some
labs expect.”
Understand EKRA and
Stay Out of Jail!
It’s critical that all clinical laboratories understand the
impact EKRA will have on existing payment agreements, billing practices, and workflows.
Non- or incorrect compliance could bring hefty fines—and even jail time!
Lab administrators, directors, and compliance managers; and,
Laboratory legal representatives.
Barrack and Dunham’s presentation will offer a concise look
at:
Essential elements required to understand the
impact of this new legislation;
How to best prepare your laboratory to minimize
risk; and,
Methods to avoid whistleblowers looking for
rewards.
A following Q/A session also offers lab professionals an
opportunity to speak directly with Barrack and Dunham, ask questions, and gain
clarification on pressing concerns regarding laboratory compliance programs and
operations.
(To register for this
critical April 24th webinar, click here (or, copy and paste this URL into your browser:
https://www.darkdaily.com/product/are-you-ready-for-ekra-what-your-lab-needs-to-know-now-about-how-this-new-legislation-affects-your-lab/).
That’s the premise behind a population health informatics program from Sonic Healthcare called iMorpheus. The program—in conjunction with Sonic Healthcare USA (SHUSA) laboratories throughout the US—provides physicians with “real-time clinical decision support and advanced healthcare informatics capabilities utilizing an agile pattern recognition software.”
This program is also a noteworthy example that demonstrates
two characteristics vital to the future success of the clinical laboratory industry.
First, the program is an early example of how clinical laboratories and
anatomic pathology groups can use lab test data to collaborate with physicians
in ways that add value in patient care. Second, this program also shows that
providers and others are ready to pay labs for that added value.
Sonic Healthcare is a global company serving the laboratory
medicine/pathology, radiology/diagnostic imaging, and primary care industries.
“If we have the laboratory data to identify people, what we
can do is help bring them in and get taken care of before a catastrophic event
happens. That is what our program is all about—how we use laboratory data to
identify people with chronic disease who are not being managed according to clinical
guidelines,” Philip
Chen, MD, PhD, a board-certified pathologist and the Chief Strategy Officer
at Sonic Healthcare USA, told Dark Daily.
Dr. Chen will be speaking on “How Labs Can Support Precision
Medicine and Shared Saving Initiatives” during a General Session at the 24th Annual Executive War College
April 30-May 1 in New Orleans.
Medicare Shared
Savings Program and Sonic’s iMorpheus Program
Data provided by Sonic Healthcare suggest its program—along
with services provided by clinical laboratories and physicians—can reduce
healthcare costs while helping providers earn rewards for their initiatives. “Laboratory
data are very strong. And a lab needs to have a basic knowledge of the
population. So, labs should look at their database, find out what they have,
and reach out to physician partners and find out what they have,” he added.
Sonic Healthcare aims to use iMorpheus to identify care gaps
and leverage clinical laboratory data to identify and help people manage their
chronic conditions, such as diabetes and other
chronic diseases.
As clinical laboratory leaders know, diabetics need to
obtain a hemoglobin
A1c (HbA1c) test every three to six months to gauge blood glucose levels
over a period of time. When Sonic Healthcare and ACO physicians roll out an
iMorpheus program, practice partners deploy Sonic’s automated technology to
share voice alerts with patients informing them that it’s time to follow-up
with their physicians. Patients also can connect to a scheduling center to set
an appointment.
The iMorpheus alerts encourage diabetics to get their lab
tests done in advance of the physician office visit, thereby saving the time
and expense of a second office visit.
“There are a lot more details to executing this. But what
the technology does is identify high-risk patients and bring them in before
they run into trouble,” Chen said.
The cost of treating diabetes in the US has risen to $327 billion in 2017, up from $245 billion in 2012, according the American Diabetes Association (ADA). The ADA study also indicated hospital inpatient care is 30% of cost, while physician office visits make up 13% of medical expenditures.
“This is not just a Sonic company program. It is a legitimate practice for legitimate value for the entire clinical laboratory and pathology profession. It’s what we can bring to the table, and we can become recognized for the value of the medical laboratory,” noted Philip Chen, MD, PhD, board-certified pathologist and Chief Strategy Officer at Sonic Healthcare USA. Chen will be speaking at the 24th Annual Executive War College in New Orleans April 30-May 1. (Photo copyright: Sonic Healthcare.)
iMorpheus Gets People
to Medical Labs, Physicians’ Offices
Sonic Healthcare studied the effectiveness of automated
patient engagements and pre-visits for lab services. They surveyed 39 primary
care practices with 207,248 patients, 14,438 of which are diabetics. According
the data, through the iMorpheus program:
The average days between visits for a diabetic
fell from 278 days to 218 days;
44% of patients returned to the clinic and had care
gaps and lab test needs fulfilled;
Half of the patients returning to outpatient
clinics had lab tests done within 24 hours;
35% to 45% of patients did not return to the physician’s
office (largely due to wrong phone numbers or new home addresses); and,
7% of patients chose to opt out of the automated
engagement service.
Clinical Laboratories
as Agents of Change
Sonic Healthcare’s program also contributed to lowering
Medicare costs, while enabling providers to share in the savings, according to case
study data shared by Chen. “With our program, the Shared Savings went from $12.8
million in the first year to $26 million in the second year of the program—with
payouts to laboratories,” Chen said.
Chen wants the clinical laboratory profession to be widely
recognized for its strategic use of big data. “This is one of those transformational
practices that labs can provide to fill a significant gap in the healthcare
ecosystem,” he said.
He describes the key takeaway: “We have been talking for
years about the medical laboratory being 3% of the healthcare spend, while it
influences 70% of healthcare decisions. We need to show that value and tie
things together.”
