Clinical laboratory leaders interested in positioning their labs to be paid for added-value services will get knowledge, insights, and more at upcoming third annual Clinical Lab 2.0 Workshop in November
It’s a critical time for medical laboratories. Healthcare is transitioning from a fee-for-service payment system to new value-based payment models, creating disruption and instability in the clinical lab test market. In addition, payers are cutting reimbursement for many lab tests.
These are among the market factors leading some pathologists
and clinical lab leaders to seek new or alternative sources of revenue to keep
the lights on and the machines running in their laboratories. Some might say,
it’s a dark time for the lab industry.
“This is not the time to be shy or timid,” he declared. “The
quantitative value of medical laboratory domain is significant and will be lost
if not exploited or leveraged.”
Shotorbani has reason to be positive. In recent years the Project Santa Fe Foundation (PSFF) has emerged to advocate for, and teach, the Clinical Lab 2.0 model. Clinical Lab 2.0 is an approach which focuses on longitudinal clinical laboratory data to augment population health in new payment arrangements.
Earlier this year, PSFF filed for 501(c) status, according to a news release. It is now positioned as a nonprofit organization, guided by a board of directors whose mission is “to create a disruptive value paradigm and alternative payment model that defines placement of diagnostic services in healthcare.”
Progressing Toward Clinical Lab 2.0
At the 24th Annual Executive War College on Lab and Pathology Management held in New Orleans last May, the nation’s first ever Clinical Lab 2.0 “Shark Tank” competition was won by Aspenti Health, a full-service diagnostic laboratory specializing in toxicology screening.
“This project, as well as all of the other cases that were presented, were quite strong and all were aligned with the mission of the Clinical Lab 2.0 movement,” said Shotorbani, in a news release. “This movement transforms the analytic results from a laboratory into actionable intelligence at the patient visit in partnership with front-liners and clinicians—allowing for identification of patient risks—and arming providers with insights to guide therapeutic interventions.
“Further, it reduces the administrative burden on providers by collecting SDH [social determinants of health] predictors in advance and tying them to outcomes of interest,” he continued. “By bringing SDH predictors to the office visit, it enables providers to engage in SDH without relying on their own data collection—a current care gap in many practices. The lab becomes a catalyst helping to manage the population we serve.”
Aspenti Health’s Shark Tank entry, “Integration of the Clinical Laboratory and Social Determinants of Health in the Management of Substance Use,” focused on the social factors tied to the co-use of opioids and benzodiazepines, a combination that puts patients at higher risk of drug-related overdose or death.
The project revealed that the top-two predictors of co-use
were the prescribing provider practice and the patient’s age.
“They did an interesting thing—what clinical laboratories
alone cannot do—the predictive value of lab test data mapped by zip code for
patients admitted in partnership with social determinants of health. This helps
to create delivery models to potentially help prevent opioid overdose,” said
Shotorbani, who sees economic implications for chronic conditions.
“If clinical laboratories have that ability to do that in
acute conditions such as opioid overdose, what is our opportunity to use lab test
data in chronic conditions, such as diabetes? The cost of healthcare is in
chronic conditions, and that is where clinical lab data has an essential role—to
support early detection and early prevention,” he added.
Clinical Laboratory Data is Health Business Data
One clinical laboratory working toward that opportunity is TriCore Reference Laboratories in Albuquerque, N.M. It recently launched Diagnostic Optimization with the goal of improving the health of their communities.
“TriCore turned to this business model,” Shotorbani
explained. “It is actively pursuing the strategy of intervention, prevention,
and cost avoidance. TriCore is in conversation with health plans on how its lab
test data and other data sets can be combined and analyzed to risk-stratify a
population and to identify care gaps and assist in closing gaps.
“Further, TriCore is identifying high-risk patients early
before they are admitted to hospitals and ERs—the whole notion of facilitating
intervention between the healthcare provider and the potential person who may
get sick,” he added. “These are no longer theoretical goals. They are
realizations. Now the challenge is for Project Santa Fe to help other lab
organizations develop similar value-added collaborations in their communities.”
Renee Ennis, TriCore’s Chief Financial Officer, told American Healthcare Leader, “Women go in (to an ER) for some condition, and the lab finds out they are pregnant before anyone else,” she said, adding that TriCore reaches out to insurers who can offer care coordinators for prenatal services.
“There is definitely a movement within the industry in this
direction [of Clinical Lab 2.0],” she added. “But others might not be moving as
quickly as we are. As a leader in this transition, I think a lot of eyes are on
what we are doing and how we are doing it.”
Why Don’t More Lab Leaders Move Their Labs to Clinical
Lab 2.0?
So, what holds labs back from pursing Clinical Lab 2.0?
Shotorbani pointed to a couple of possibilities:
A lab’s traditional focus on volume while not
developing partnerships (such as with pharmacy colleagues) inside the
organization; and
Limited longitudinal data due to a provider’s
sale of lab outreach services or outsourcing the lab.
“The whole notion of Clinical Lab 2.0 is basically connecting the longitudinal data—the Holy Grail of lab medicine. That is the business model. Without the longitudinal view, the ability to become a Clinical Lab 2.0 is extremely limited,” added Shotorbani.
New Clinical Lab 2.0 Workshop Focuses on Critical ‘Pillars’
Project Santa Fe Foundation will host the Third Annual Clinical Lab. 2.0 Workshop in Chicago on November 3-5. New this year are sessions aligned with Clinical Lab 2.0 “pillars” of leadership, standards, and evidence. The conference will feature panels addressing:
C-suite Drivers: moderated by Mark Dixon, President of The Mark Dixon Group;
Drug companies claim HHS rule violates their first amendment rights, but added web links to drug prices in their TV ads anyway
Will American consumers ever see the prices of their
prescription drugs? That almost happened this summer, when a Trump
administration healthcare transparency initiative would have required
pharmaceutical companies to include prices in drug advertisements. But that
requirement was halted by a federal judge one day before it was scheduled to take
effect.
The measure, which passed in May, was intended to provide
healthcare consumers with price transparency for some prescription medications
and help lower prescription costs. However, a federal judge placed the new law
on hold citing government over-reach.
This is a significant development for clinical
laboratory managers, pathologists,
and others watching efforts that will enable patients to see the cost of their
medical care in advance of service. Also, few were surprised to learn that this
court case was filed by pharmaceutical companies with the goal of preventing
prescription drug prices from being disclosed in these advertisements.
HHS Tells Big Pharma to ‘Level with People’ About Drug
Costs
Reducing prescription drug prices is a critical issue for
healthcare consumers. Therefore, any policy that helps lower costs should
provide benefits for both patients as well as the healthcare industry overall.
That’s why President Trump signed the initiative that required pharmaceutical
companies to include drug prices in television advertisements.
The controversial proposal, which would have applied to all prescription
drugs that cost more than $35 for a one-month supply, was scheduled to go into
effect over the summer until it was blocked by Federal Judge Amit Mehta of
the US District Court for the District of Columbia.
Judge Mehta ruled that HHS does not have the regulatory
power to force pharmaceutical companies to include the prices of prescription
drugs in their TV ads and that the agency had violated laws passed by Congress.
“That policy very well could be an effective tool in halting
the rising cost of prescription drugs. But no matter how vexing the problem of
spiraling drug costs may be, HHS cannot do more than what Congress has
authorized,” Mehta wrote in his decision, NPR
reported.
Drug companies Amgen
(NASDAQ:AMGN), Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) along with the Association of National Advertisers (ANA) filed
lawsuits over the regulation stating it was a violation of their free speech
rights. They won the reprieve on July 8, just one day before the regulation would
have gone into effect.
Mehta stated in his opinion
that the Social
Security Act, which HHS used as its basis for the regulation, does not
“empower HHS to issue a rule that compels drug manufacturers to disclose list
prices,” Fierce
Pharma reported.
In August, the Trump administration filed an appeal after the
federal judge struck down the regulation. The exact basis for that appeal has
not been disclosed.
Drug Companies Decry New Law as Unconstitutional
Many drug makers are not happy with the rule. Drug industry
trade group Pharmaceutical Research and
Manufacturers of America (PhRMA) believes that mandating drug companies to
disclose pricing in TV commercials is a violation of their First Amendment
rights, STAT reported.
Nevertheless, PhRMA proposed that pharmaceutical companies
provide a web link in their TV advertisements that directs consumers to pricing
information online. And some companies also are experimenting with going a step
further and voluntarily complying with the original regulation.
In a news
release, PhRMA states, “To help patients make more informed healthcare
decisions, [PhRMA] member companies today announced their commitment to
providing more transparency about medicine costs. PhRMA member companies’
direct-to-consumer (DTC) television advertisements will soon direct patients to
information about medicine costs, including the list price of the medicine,
out-of-pocket costs, or other context about the potential cost of the medicine
and available financial assistance. The biopharmaceutical industry will also
launch a new platform that will provide patients, caregivers, and providers
with cost and financial assistance information for brand-name medicines, as
well as other patient support resources.”
However, Azar said that action is not in compliance with the
rule. “They put $4 billion a year into television advertising because the
television ad is where people are getting their information, and to point them
to the internet would be the equivalent of saying that they should simply be
putting their ads on the internet and not running them on TV,” he told the
press, STAT reported.
Opponents of the rule noted that actual drug costs for
consumers can vary widely depending on coverage and that patients might forgo
their medications if they are concerned about the costs, reported Politico
following passage of the measure in May.
Critics also claimed that that there were no enforcement
mechanisms outlined for companies that did not comply with the ruling, and that
it relied on the pharmaceutical industry to police itself. If a particular
company failed to include the required information in its TV ads, competitors
could file suit against it under the deceptive and unfair trade practice
provisions of the Lanham Act,
Politico noted.
Solutions to the public’s demand for price transparency in
healthcare may be forthcoming. However, at press time, no further information
concerning the status of this HHS regulation was available. Dark Daily
will continue to monitor the situation and inform readers of any developments.
Meanwhile executives and pathologists at the nation’s
clinical laboratories should continue to develop strategies to serve patients
who want to know the prices of their medical laboratory tests before they arrive
to have their specimens collected.
This summer, several pharma companies may have succeeded in
getting a federal court to stop this particular rule to disclose prescription
drug prices. But the trend toward price transparency has deep roots and will
continue forward.
Another push for price transparency steps up pressure on medical laboratories and anatomic pathology groups to develop compliance strategies
Clinical
laboratories and anatomic
pathology groups are under increasing pressure to develop strategies for
making their test prices more accessible to patients. Those pressures are
likely to grow due to newly proposed federal regulations that aim to allow
patients to compare prices for healthcare services on their smartphones.
This new proposed rule comes less than a year after a rule
involving hospital prices was implemented. As of January 1, 2019, the federal
Centers for Medicare and Medicaid Services (CMS) required
US hospitals to post their prices online. Dark
Daily reported last year about the risks and opportunities posed by
that move.
Giving Patients Access to Their Health Information
In May, officials with those agencies discussed the
regulations in prepared remarks for a hearing of the HELP committee.
“A central purpose of the proposed [ONC] rule is to
facilitate patient access to their EHI on their smartphone, growing a nascent
patient- and provider-facing app economy,” he said, noting that this access is
impeded by a lack of interoperability between health information systems, as
well as restrictions on information exchange imposed by health IT developers.
The proposed rule will mandate use of common software
standards so that app developers can access health information systems from
different vendors. As a result, patients could choose their own apps to view
their data regardless of which electronic
health records (EHR) system their provider uses. The rule also includes
provisions for dealing with so-called “information blocking”
by vendors, Rucker noted.
If the proposed rule is implemented as currently written,
there would be a need for clinical laboratories and pathology groups to ensure
that their laboratory
information systems (LIS) meet the specifications of the new rule. This may
mean that, along with enabling two-way digital interfaces with physicians’
EHRs, labs also would need to be able to pass data to the apps and mobile
devices used by patients that are covered by the proposed new rule.
“ONC’s proposed rule primarily focuses on clinical data,” he
said. “However, advances in computer science and the maturity of data standards
are accelerating the convergence of medical data with billing and price data.
As such, the rule proposes to include such information as part of a patient’s
EHI that should be available for access, exchange, and use.”
Enabling cost comparisons will allow patients to make
more-informed decisions about their healthcare, Rucker added. But he
acknowledged that implementing this vision won’t be easy.
“Unfortunately, the complex and decentralized nature of how
payment information for healthcare services is currently created, structured,
and stored presents many challenges to achieving price transparency,” he said.
“This entire information chain is geared to retrospective payments rather than
prices.”
Rucker told the HELP committee that the [ONC] will be
seeking public input about how to capture price information and enable price
transparency. Once the rule is finalized and published, providers will have two
years to comply.
Medical Laboratories Need a Strategy for Providing Access
to Patient Records
The proposed CMS rule imposes requirements on payers to
provide electronic access to health claims and other information for their
enrollees.
In her prepared remarks
for the Senate HELP hearing, Kate Goodrich,
MD, Director of the Center for Clinical Standards and Quality (CCSQ) and
CMS Chief Medical Officer, said, “A core policy principle underlying our
proposals is that every American should be able, without special effort or
advanced technical skills, to see, obtain, and use all electronically available
information that is relevant to their health, care, and choices—of plans,
providers, and specific treatment options.”
That’s all well and good, however, as Fred Schulte, a senior
correspondent for Kaiser
Health News, wrote in his coverage of the two proposed rules, “Meeting
these goals could prove to be a tall order.”
He continued, “For well over a decade, federal officials
have struggled to set up a digital records network capable of widespread
sharing of medical data and patient records.” Not to mention the billions of
dollars already spent by the CMS and ONC incentivizing providers to implement
truly interoperable health
information exchange (HIE) systems nationwide.
Nevertheless, pressure for greater consumer data access and
price transparency will likely continue to build across the healthcare
industry, including on medical laboratories. Price transparency as a trend is
making steady forward progress, despite resistance by hospitals, physicians,
medical associations, and others.
All clinical laboratories should have a strategy to make lab
test prices readily available to patients. It is something that will become
common at some future point.
Study suggests AI-enabled technology can help clinical laboratories and hospital blood banks save thousands of dollars annually on expensive blood products
Artificial intelligence may prove to be a useful tool in helping hospitals better manage utilization of blood products. That’s one conclusion from a newly-published study done at New York’s Icahn School of Medicine at Mount Sinai. If so, this is a technology improvement that would be welcomed by blood bankers and clinical laboratory managers who must manage the cost and utilization of blood products.
There’s no way around it—blood is expensive. A typical 400- to 600-bed hospital likely budgets upwards of one million dollars annually just for blood products. Almost universally, in hospitals the medical laboratory manages the blood bank. This is where medical technologists trained in blood banking test patients and test blood to ensure whole blood units, or other blood products such as platelets, match and will not trigger a negative reaction when administered to the patient.
When left unmanaged, the cost and utilization of blood bank
products can put the budgets of hospital medical laboratories in the red. Hospitals
also invest a great deal of money training surgeons to accurately assess the
procedure and order the correct amount of blood components prior to surgery.
Therefore, new artificial intelligence (AI) technology that helps pinpoint patients’ blood loss during childbirth will be of interest to blood bankers and hospital laboratory administrators.
Can AI Help Clinical Labs Improve Utilization of Blood Products
in Hospitals?
Physicians at the Icahn School of Medicine at Mount Sinai recently investigated whether “Quantifying blood loss” would improve the use of blood during human childbirth. They published the results of their study in the International Journal of Obstetric Anesthesia.
Their research into 7,618 deliveries (vaginal and cesarean) involved “An observational study comparing blood loss, management, and outcomes between two historical cohorts (August 2016 to January 2017 and August 2017 to January 2018) at an academic tertiary care center. Patients in the intervention group (second period) had blood loss quantified compared with visual estimation for controls,” the research paper notes.
The researchers concluded that “Quantifying blood loss may
result in increased vigilance for vaginal and cesarean delivery. We identified
an association between quantifying blood loss and improved identification of
postpartum hemorrhage, patient management steps, and cost savings.”
The researchers, according to a press release, employed the Triton AI-enabled platform from Gauss Surgical, a silicon valley-based health technology company, to “monitor blood loss in all deliveries (vaginal and cesarean, n=3807) at Mount Sinai Hospital from August 2017 through January 2018 to support the institution’s stage-based hemorrhage protocol.”
The researchers found that use of a monitoring system was
associated with earlier postpartum hemorrhage
intervention and annual cost savings of $172,614 in lab costs and $36,614 in blood
bank costs.
Measuring Blood Loss: The Eye versus AI
Gauss has secured Food and Drug Administration (FDA) clearance for Triton and more than 50 US hospitals are using it. Triton provides, in real-time, images of blood-saturated surgical sponges and canisters and uses computer vision and machine learning to pinpoint blood loss, reported MD+DI.
Traditionally, physicians visually estimate blood loss
during procedures. When they are off in their estimates of postpartum
hemorrhage, harmful postpartum health complications and deaths can occur, the
Mount Sinai researchers explained in their paper.
And although other vital signs—heart rate, rhythm, blood
pressure, oxygen level, etc.— are monitored with equipment in the surgical
suite, blood usage is not.
“Blood loss in surgery has been an enigma for decades since the dawn of medicine,” Siddarth Satish, Founder and Chief Executive Officer of Gauss, told MD+DI. “We monitor many other vital signs in surgery, but ultimately there hasn’t been any direct indicator of a patient’s hemoglobin loss.”
Bleeding Better Recognized, Less Blood Transfusions
After the Mount Sinai researchers used the Triton system to
monitor blood loss during 3,807 vaginal and cesarean deliveries from August
2017 to January 2018 at Mount Sinai Hospital, they compared their findings to
3,811 deliveries from August 2016 to January 2017, during which doctors relied
solely on visual estimation of blood loss.
The study found the following, according to the news
release:
Improved hemorrhage recognition in vaginal deliveries of 2.2% and cesarean sections of 12.6% compared to .5% and 6.4%, respectively;
Less blood transfusions needed (vaginal patients): 47% with Triton compared to 71%;
Reduced blood transfusion dose (cesarean section): 1.90 units with Triton compared to 2.52 units;
Cost savings: $209,228 a year (the total of aforementioned lab and blood bank costs).
“What we like about [Gauss] is that it somewhat embodies precision medicine in the sense that you’re using more precise tools of measurement in their first use case,” Garrett Vygantas, MD, MBA, Managing Director for OSF Ventures, the financing arm of OSF Healthcare, who also serves on Gauss Surgical’s board, told MD+DI.
Possible New Resource for Hospital Medical Laboratories
So, will AI quickly become an omnipresent overseer in surgical suites? Hardly. However, AI is in the early stages of finding places in healthcare where it can be useful. “A lot of people are predicting that AI will play a huge role in healthcare … I think it’ll be ever-present. There will be a little bit of AI in everything you’re doing, but I think the actual practice of medicine in its truest form is going to carry forward,” Satish told Fierce Healthcare.
Hospital medical laboratories and blood blanks looking for
new tools to manage blood use may want to look into AI-enabled systems like
Triton. Saving money is not the only benefit. Less transfused blood is better
for patient care as well.
Use of synthetic genetics to replicate an infectious disease agent is a scientific accomplishment that many microbiologists and clinical laboratory managers expected would happen
Microbiologists and infectious disease doctors are quite familiar with Escherichia coli (E. coli). The bacterium has caused much human sickness and even death around the globe, and its antibiotic resistant strains are becoming increasingly difficult to eradicate.
Now, scientists in England have created a synthetic “recoded” version of E. coli bacteria that is being used in a positive way—to fight disease. Their discovery is being heralded as an important breakthrough in the quest to custom-alter DNA to create synthetic forms of life that one day could be designed to fight specific infections, create new drugs, or produce tools to diagnose or treat disease.
Scientists worldwide working in the field of synthetic genomics are looking for ways to modify genomes in order to produce new weapons against infection and disease. This research could eventually produce methods for doctors—after diagnosing a patient’s specific strain of bacteria—to then use custom-altered DNA as an effective weapon against that patient’s specific bacterial infection.
This latest milestone is the result of a five-year quest by researchers at the Medical Research Council Laboratory of Molecular Biology (MRC-LMB) in Cambridge, England, to create a man-made version of the intestinal bacteria by redesigning its four-million-base-pair genetic code.
The MRC-LMB lab’s success marks the first time a living
organism has been created with a compressed genetic code.
The researchers published their findings in the journal Nature.
“This is a landmark in the emerging field of synthetic
genomics and finally applies the technology to the laboratory’s workhorse
bacterium,” they wrote. “Synthetic genomics offers a new way of life, while at
the same time moving synthetic biology towards a future in which genomes can be
written to design.”
All known forms of life on Earth contain 64 codons—a specific sequence of three consecutive nucleotides that corresponds with a specific amino acid or stop signal during protein synthesis. Jason Chin, PhD, Program Lead at MRC-LMB, said biologists long have questioned why there are 20 amino acids encoded by 64 codons.
“Is there any function to having more than one codon to encode each amino acid?” Chin asked during an interview with the Cambridge Independent. “What would happen if you made an organism that used a reduced set of codons?”
The MRC-LMB research team took an important step toward
answering that question. Their synthetic E. coli strain, dubbed Syn61,
was recoded through “genome-wide substitution of target codons by defined
synonyms.” To do so, researchers mastered a new piece-by-piece technique that
enabled them to recode 18,214 codons to create an organism with a 61-codon
genome that functions without a previously essential transfer RNA.
“Our synthetic genome implements a defined recoding and refactoring scheme–with simple corrections at just seven positions–to replace every known occurrence of two sense codons and a stop codon in the genome,” lead author Julius Fredens, PhD, a post-doctoral research associate at MRC, and colleagues, wrote in their paper.
Joshua Atkinson, PhD, a postdoctoral research associate at Rice University in Houston, labeled the breakthrough a “tour de force” in the field of synthetic genomics. “This achievement sets a new world record in synthetic genomics by yielding a genome that is four times larger than the pioneering synthesis of the one-million-base-pair Mycoplasma mycoides genome,” he stated in Synthetic Biology.
“Synthetic genomics is enabling the simplification of
recoded organisms; the previous study minimized the total number of genes and
this new study simplified the way those genes are encoded.”
Manmade Bacteria That are Immune to Infections
Researchers from the J.
Craig Venter Institute in Rockville, Maryland, created the first synthetic
genome in 2010. According to an article in Nature,
the Venter Institute successfully synthesized the Mycoplasma mycoides genome
and used it “reboot” a cell from a different species of bacterium.
The MRC-LMB team’s success may prove more significant.
“This new synthetic E. coli should not be able to decode DNA from any other organism and therefore it should not be possible to infect it with a virus,” the MRC-LMB stated in a news release heralding the lab’s breakthrough. “With E. coli already being an important workhorse of biotechnology and biological research, this study is the first time any commonly used model organism has had its genome designed and fully synthesized and this synthetic version could become an important resource for future development of new types of molecules.”
Because the MRC-LMB team was able to remove transfer RNA and
release factors that decode three codons from the E. coli bacteria,
their achievement may be the springboard to designing manmade bacteria that are
immune to infections or could be turned into new drugs.
“This may enable these codons to be cleanly reassigned and
facilitate the incorporation of multiple non-canonical amino acids. This
greatly expands the scope of using non-canonical amino acids as unique tools
for biological research,” the MRC-LMB news release added.
Though synthetic genomics impact on clinical laboratory diagnostics is yet to be known, medical laboratory leaders should be mindful of the potential for rapid innovation in this field as proof-of-concept laboratory innovations are translated into real-world applications.