Sale of respected laboratory information system company may be an early sign that investors believe clinical laboratories and pathology groups are ready to upgrade their LISs and add needed capabilities
In the past 10 years there has been little disruption to the
laboratory
information systems (LIS) market that clinical
laboratories and anatomic
pathology groups use. Yet, over that same 10-year period, almost every
hospital and physician group practice adopted an electronic
health system (EHR), primarily because of federal financial incentives that
encouraged such adoption.
For medical
laboratories and pathology groups, this widespread—nearly
universal—adoption of EHRs by the nation’s hospitals and physicians was
disruptive. Labs were required to expend resources building digital interfaces
to the EHRs of their parent hospitals and client physicians to support
electronic test ordering and test reporting.
However, because that wave of EHR adoption is now over,
clinical labs and pathology groups have an opportunity to assess the current
state of the health
information technology (HIT) that they use daily, primarily in the form of
the classic laboratory information system that handles nearly all the primary
functions needed to support testing and other operational needs.
This opportunity to help medical laboratories enhance and/or
upgrade the capabilities of their laboratory information systems may be one
motivation behind the recent sale of a well-known LIS company.
Private Equity Firm Buys Orchard Software
On Oct. 7, 2019, Orchard Software Corporation of Carmel,
Ind., announced its acquisition by Franciscan Partners, a private equity firm
based in San Francisco.
Orchard Software, founded in 1993, has grown steadily over
the past 20 years, primarily by serving physician office laboratories,
community hospital labs, and independent clinical laboratory companies. With each
stage of growth, Orchard added functionality to its LIS and related software
offerings and moved up-market to serve larger hospitals and larger labs.
The purchase price and the terms of the sale were not
announced. Orchard’s Founder, President and CEO, Rob Bush, will retire. The new
CEO is Billie Whitehurst, who came to Orchard from Netsmart Technologies, where she was Senior
Vice President. The remainder of Orchard’s management team will be kept in
place.
Is the LIS Market Heating Up?
What makes the purchase of Orchard by a multi-billion-dollar
private equity company noteworthy is the fact that it is the first significant
transaction in the LIS sector probably since the mid-2000s, which saw several
significant mergers and acquisitions.
Other acquisitions or investments involving LIS companies
need to happen before it would be appropriate to say that investor interest in
the LIS sector is heating up. However, it is accurate to say that many
professional investors will be watching to see whether Franciscan Partners
succeeds with its investment in Orchard Software. If Orchard’s revenue and
operating profits increase substantially in the next few years, that may
encourage other investors to look for LIS companies and products that they can
buy.
If this were to happen, that would be a positive development
for both clinical laboratories and anatomic pathology groups, because these
investors would have a motive to add new functions and capabilities to their
LIS products. It would also wake up a sector of lab information technology that
has been relatively quiet for several years.
As hospitals are forced to innovate, anatomic pathologists and medical laboratories will need to adapt to new healthcare delivery locations and billing systems
As new challenges threaten the survival of many hospitals worldwide, medical laboratories may be compelled to adapt to the needs of those transforming organizations. Those challenges confronting hospitals are spelled out in a recent report from management consulting firm McKinsey and Company with the provocative title, “The Hospital Is Dead, Long Live the Hospital!”
A team of analysts led by McKinsey senior partner Penny
Dash, MB BS, MSc, looked at nine trends affecting hospitals in North America,
Europe, Asia, and other regions. These trends, the authors contend, will force
hospitals to adopt innovations in how they are structured and how they deliver
healthcare.
Here are nine challenges hospitals face that have
implications for medical laboratories:
1. Aging Patient Populations
“Patient populations are getting older, and their needs are becoming more complex,” McKinsey reports, and this is imposing higher cost burdens. The US Census Bureau projects that by 2030 approximately 20% of the US population will be 65 or older compared with about 15% in 2016.
The federal Centers for Medicare and Medicaid Services (CMS) reports that this age group accounts for a disproportionate share of healthcare costs. In 2014, CMS states, per-capita healthcare spending was $19,098 for people 65 or older compared with $7,153 for younger adults.
2. Patients Are Behaving More Like Consumers
“Patients—along with their families and caregivers—expect to
receive more information about their conditions and care, access to the newest
treatments, and better amenities,” McKinsey reports.
Clinical advances are increasing the range of treatments that can be performed in outpatient settings, McKinsey reports. The authors point to multiple studies suggesting that patients can receive better outcomes when more care is delivered outside the hospital. Dark Daily has often reported on the impact of this trend, which has reduced demand for in-hospital laboratory testing while increasing opportunities for outpatient services.
4. Move Toward High-Volume Specialist Providers
Compared with general hospitals, specialized, high-volume “centers
of excellence” can deliver better and more cost-effective care in many
specialties, McKinsey suggests. As evidence, the report points to research
published over the past 12 years in specialist journals.
Some US employers are steering patients to top-ranked providers as part of their efforts to reduce healthcare costs. For example, Walmart (NYSE:WMT) pays travel costs for patients to undergo evaluation and treatment at out-of-state hospitals recognized as centers of excellence, which Dark Daily reported on in July.
UnitedHealthcare’s new preferred lab network also appears to be a nod toward this trend. As The Dark Report revealed in April, the insurer has designated seven laboratories to be part of this network. These labs will offer shorter wait times, lower costs, and higher quality of care compared with UnitedHealthcare’s larger network of legacy labs, the insurer says.
5. Impact of Clinical Advances
Better treatments and greater understanding of disease
causes have led to significantly lower mortality rates for many conditions,
McKinsey reports. But the authors add that high costs for new therapies are
forcing payers to contend with questions about whether to fund them.
As Dark Daily has often reported, new genetic therapies often require companion tests to determine whether patients can benefit from the treatments. And these also face scrutiny from payers. For example, in January 2018, Dark Daily reported that some insurers have refused to cover tests associated with larotrectinib (LOXO-101), a new cancer treatment.
6. Impact of Disruptive Digital Technologies
The McKinsey report identifies five ways in which digital
technologies are having an impact on hospitals:
Automation of manual tasks;
More patient interaction with providers;
Real-time management of resources, such as use of hospital beds;
Real-time clinical decision support to enable more consistency and timeliness of care; and
Use of telemedicine applications to enable care for patients in remote locations.
All have potential consequences for medical laboratories, as Dark Daily has reported. For example, telepathology offers opportunities for pathologists to provide remote interpretation of blood tests from a distance.
7. Workforce Challenges
Many countries are contending with shortages of physicians,
nurses, and allied health professionals, McKinsey reports. The authors add that
the situation is likely to get worse in the coming decades because much of the current
healthcare workforce consists of baby boomers.
An investigation published in JAMA in May indicated that, in the US, the number of active pathologists decreased from 15,568 to 12,839 between 2007 and 2017. In January, Dark Daily reported that clinical laboratories are also dealing with a generational shift involving medical technologists and lab managers, as experienced baby boomers who work in clinical laboratories are retiring.
8. Financial Challenges
In the United States and other countries, growth in
healthcare spending will outpace the gross domestic product, the McKinsey
report states, placing pressure on hospitals to operate more efficiently.
9. More Reliance on Quality Metrics
McKinsey cites regulations in Canada, Scandinavia, and the UK that require hospitals to publish quality measurements such as mortality, readmittance, and infection rates. These metrics are sometimes linked to pay-for-performance programs, the report states. In the United States, Medicare regularly uses quality-of-care metrics to determine reimbursement, and as Dark Daily reported in July, a new Humana program for oncology care includes measurements for medical laboratories and anatomic pathology groups.
The McKinsey report reveals that several trends in
healthcare are forcing healthcare leaders to adopt new strategies for success.
The report’s authors state that their “results show that contemporary
healthcare providers around the world are facing several urgent imperatives: to
strengthen clinical quality; increase the delivery of personalized,
patient-centered care; improve the patient experience; and enhance their
efficiency and productivity.”
These pressures on hospitals typically also require
appropriate responses from clinical laboratories and anatomic pathology groups
as well.
Kaiser
Health News (KHN) recently
reported on investigations by the OIG into hospitals allegedly offering
unusually high salaries and other perks to specialists because they attract highly
profitable business.
Wheeling, KHN reported, paid one anesthesiologist $1.2
million per year, which, Rau notes, is higher than the salaries of 90% of the
pain management specialists around the country. Rau went on to describe how
Wheeling also paid one obstetrician-gynecologist $1.3 million per year, and a
cardiothoracic surgeon $770,000 per year along with 12 weeks of vacation time.
In each of those cases, the whistleblower who prompted the qui tam investigation reported
that the specialists’ various departments were frequently in the red, reported KHN.
“The problem, according to the government, is that the
efforts run counter to federal self-referral bans and anti-kickback laws that
are designed to prevent financial considerations from warping physicians’
clinical decisions,” wrote Rau.
Wheeling not only contests the lawsuits brought against it,
but also has filed a countersuit against the whistleblower. KHN said the
hospital claims “its generous salaries were not kickbacks but the only way it
could provide specialized care to local residents who otherwise would have to
travel to other cities for services such as labor and delivery that are best
provided near home.”
OIG’s Fraud and Abuse Laws: A Roadmap for Physicians
The KHN article mentions
five laws the OIG lists on
its website that are particularly important for physicians to be aware of. They
include the:
False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims.
Anti-Kickback Statute: states that paying for referrals is illegal, that physicians can’t provide free or discounted services to uninsured people, and that money and gifts from drug and device makers to physicians are prohibited.
Stark Law(physician self-referral): says that referrals to entities with whom the physician has a familial or financial relationship are off-limits.
Exclusion Statue: describes who cannot participate in federal programs, such as Medicare.
Civil Monetary Penalties Law: authorizes the Secretary of Health and Human Services, which operates the OIG, to impose penalties in cases of fraud and abuse that involve Medicare or Medicaid.
“Together, these rules are intended to remove financial
incentives that can lead doctors to order up extraneous tests and treatments
that increase costs to Medicare and other insurers and expose patients to
unnecessary risks,” KHN said.
Other Hospitals Under Investigation
Wheeling Hospital is not the only healthcare institution
facing investigation. The Dallas
Morning News (DMN) reported on a case involving Forest
Park Medical Center (FPMC) in Dallas that resulted in the conviction of
seven defendants, including four doctors. Prosecutors outlined the scheme in
court, saying that FPMC illegally paid for surgeries.
“Prosecutors said the surgeons agreed to refer patients to
the Dallas hospital in exchange for money to market their practices,” DMN
reported, adding “Patients were a valuable commodity sold to the highest
bidder, according to the government.”
One of the convicted physicians, Michael Rimlawi, MD,
told DMN, “I’m in disbelief. I thought we had a good system, a fair
system.” His statement may indicate the level to which some healthcare
providers at FPMC did not clearly understand how anti-kickback laws work.
“The verdict in the Forest Park case is a reminder to
healthcare practitioners across the district that patients—not payments—should
guide decisions about how and where doctors administer treatment,” US Attorney Erin Nealy Cox told DMN.
Know What Is and Is Not a Kickback
Both the Wheeling Hospital investigation and the Forest Park
Medical Center case make it clear that kickbacks don’t always look like
kickbacks. Becker’s Hospital Review
published an article titled “Four
Biggest Anti-Kickback Settlements Involving Hospitals in 2018” that details
cases in which hospitals chose to settle.
These four incidents involved hospitals in Tennessee,
Montana, Pennsylvania, and New York. This demonstrates that kickback schemes
take place nationwide. And they show that violations of the Stark Law, the
False Claims Act, and the Anti-Kickback Statute can happen in numerous ways.
Whether in a clinical laboratory or an enterprisewide health
network, violating laws written to prevent money—rather than appropriate
patient care—from being the primary motivator in hiring decisions, may result
in investigation, charges, fines, and even conviction.
“If we’re going to solve the healthcare pricing problem,
these kinds of practices are going to have to go away,” Vikas Saini, MD, President
of the Lown Institute, a Massachusetts
nonprofit that advocates for affordable care, told KHN.
Though these recent OIG investigations target hospitals,
clinical laboratory leaders know from past experience that they also must be
vigilant and ensure their hiring practices do not run afoul of anti-kickback
legislation.
Clinical laboratories may soon find opportunities to assist retail pharmacists who are doing genetic test counseling, as employers’ support of genetic testing advances
In another market example of acceptance of genetic tests by major employers, a new pilot program is underway by Kroger Prescription Plans that offers GeneSight by Myriad Genetics as a benefit. GeneSight is an LDT, a laboratory-developed pharmacogenomic test, used to treat psychiatric disorders, such as depression.
As part of the agreement with Myriad Genetics, Inc. (NASDAQ:MYGN), pharmacists at more than 2,300 Kroger stores will offer counseling about GeneSight to eligible employees and coordinate the testing with referring healthcare providers, according to a news release.
Clinical laboratory leaders and clinical pathologists will want to observe these early steps by Kroger to offer genetic tests and genetic test counseling in a retail pharmacy setting. If the GeneSight benefit option and in-store pharmacy interventions prove popular, Kroger Prescription Plans may soon offer other genetic tests, as well.
Kroger Not the Only Pharmacy to Offer Genetic Tests and
Counseling
Headquartered in Cincinnati, Ohio, Kroger (NYSE:KR) is the largest supermarket chain in the US and the country’s fourth-largest employer. Kroger Prescription Plans—a pharmacy benefit manager (PBM)—provides pharmacy management services and clinical programs to employers, including Kroger, in 32 states. But it’s not the only pharmacy company to offer genetic tests and genetic counseling.
Last year Albertsons Companies and Genomind, a personalized medicine platform, launched Genecept Assay (now known as Professional PGx)—a genetic test designed to help doctors make informed treatment decisions for their mental health patients—as well as pharmacy-based genetic counseling at select Albertsons and its subsidiaries, according to Supermarket News.
Participating locations include:
21 Sav-On pharmacies at Albertsons in Boise,
Idaho;
Five Jewel-Osco pharmacies in the Chicago area;
and
Two Sav-On pharmacies at Acme supermarkets in
the Philadelphia area.
The Albertsons-Genomind partnership is aimed at patients who
may be struggling with a medication for depression, anxiety,
obsessive-compulsive disorder, or other mental illnesses. Patients can receive
counseling from “specially trained pharmacists” who work with referring
clinicians to offer [Professional PGx], noted Supermarket News.
Pharmacists as Genetic Test Counselors?
Pathologists and medical laboratory leaders may be intrigued
by the concept of putting pharmacists into the role of a genetic test
counselor. However, pharmacists may need to increase their knowledge of
pharmacogenomics, reported Drug
Topics.
“The science advances in the field are just making it more
critical that pharmacists have a really strong understanding of how to blend [pharmacogenomics]
into their training,” Kathleen Jaeger,
National Association of Chain Drug Stores
(NACDS) Senior Vice President of Pharmacy Care and Patient Advocacy, told Drug
Topics.
However, some see pharmacists as the natural experts in the space. “In my opinions, [pharmacists] should be the people who own pharmacogenetics. It’s a relatively new field, and who better than pharmacists to optimize drug therapy?” Daniel Dowd, PharmD, Vice President of Medical Affairs at Genomind, told Drug Topics.
Pharmacists will need to be proactive in working with companies that provide genetic testing, according to a Managed Health Care Connect Pharmacy Learning Network analysis, which also indicated billing for pharmacists’ informational services would need to be addressed.
“These opinions about this type of role for pharmacists will not be what pathologists want to hear,” stated Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “Pathologists have had the role of the ‘doctor’s doctor’ for decades. Pathologists are trained in how to recognize disease, how to determine which medical laboratory tests are appropriate for the symptoms displayed by a patient, and how to interpret the results to select the best therapies.
“Additionally, pathologists are trained to understand the
technical performance of clinical laboratory tests, such as whether the sample
was of acceptable quality to produce a reliable result, whether the analyzer
that produced a result was performing within specifications, and what factors
should be considered in tandem with the lab test results when making a
diagnosis,” he explained. “It is easy to see why the pathology profession would
argue that pharmacists lack this depth of knowledge and experience when
ordering and interpreting medical laboratory tests. How the pathology
profession will respond to these developments involving pharmacists,
interpretation of genetic test results, and counseling patients is not yet
clear.”
Opportunities for Clinical Laboratories to Assist
Pharmacies
Additionally, we suggested, clinical laboratory leaders and
pathologists could find opportunities helping others understand the results of
the genetic tests.
The recent partnerships between genetic test companies and
corporate retail pharmacies suggest that clinical laboratories could benefit
from reaching out to pharmacists who are now at a point-of-care and who may be
looking to improve their knowledge of pharmacogenomics.
As physicians continue to re-evaluate their career strategies, clinical laboratories must closely monitor changes to test ordering from formerly self-employed doctors
For the first time, more doctors are employed by health networks than are in private practice. That’s according to a recent report from the American Medical Association (AMA). In a press release, the AMA describes the event as “the continuation of a long-term trend that has slowly shifted the distribution of physicians away from ownership of private practices.”
This trend impacts independent clinical
laboratories and anatomic
pathology groups because hospital-based physicians have reasons to order
tests from in-house medical
laboratories. Thus, a reduction in independent self-employed doctors could also
mean reductions in test orders from those physicians.
To make its conclusions, the AMA drew on six years’ worth of
Physician
Practice Benchmark Survey data, gathered from 2012-2018. In its published Policy
Research Perspectives report, the AMA describes the findings as “one of the
more dramatic changes over this six-year span.”
Independence versus Employment
According to the new release, employed physicians made up
47.4% of all patient care doctors in 2018—an increase of 6% since 2012. Meanwhile,
self-employed doctors represented 45.9% of physicians in patient care—down 7% (from
53.2%) since 2012.
“Due to this swing, for the first time in 2018, there were
fewer physician owners than employed physicians,” the AMA researchers wrote in their
report.
The AMA has conducted its benchmark surveys every other year
since 2012. They are nationally representative surveys of doctors to record
employment status, practice size, specialties, and ownership.
Who Employs Doctors?
Physicians can be employed by other doctors in
physician-owned practices, by hospitals directly, and by hospital-owned medical
practices.
Most, however, work for other doctors, reported Fierce Healthcare. In a summary of
the latest AMA survey data, Fierce noted that:
54% of doctors are owners, employees, or contractors
in practices owned by physicians—compared to 60% in 2012;
8% of doctors work directly for a hospital—up
from 5.6% in 2012;
26.7% of doctors are employed by hospital-owned
practices—up from 23.4% in 2012; and
34.7% of doctors work for a hospital or a
practice partly owned by a hospital in 2018—up from 29% in 2012.
The AMA partly attributed the increase in employed physicians
to age: 70% of doctors under the age of 40 reported as employees in 2018,
compared to 38.2% of doctors 55 and over who reported as employed.
Family Practice Physicians
Most Likely to Become Employed by Hospitals
Other intriguing data points include the percentages of practice
ownership among medical specialties.
Pathology was not broken out. However, the AMA’s report did state
that, “surgical subspecialties had the highest share of owners (64.5%) followed
by obstetrics/gynecology (53.8%) and internal medicine subspecialties (51.7%).
“Emergency medicine had the lowest share of owners (26.2%)
and the highest share of independent contractors (27.3%). Family practice was
the specialty with the highest share of employed physicians (57.4%),” the
report concluded.
The AMA
researchers also noted that the number of doctors seeking employment in
healthcare networks may be decreasing. “The trend away from physician-owned
practices and toward working directly for a hospital or for a hospital-owned
practice appears to be slowing—more than half of that shift occurred in the first
two years of [the benchmark survey] period [2012 to 2018].”
The AMA also noted that the success or failure of accountable
care organizations (ACOs) could have an effect on hospital acquisition of
private practices. “Should evolving models of care not deliver on their theoretical
savings or improvements, that might put a break on consolidation,” the researchers
wrote.
It’s critical that clinical laboratories continue to improve
the quality and efficiency of outreach services to retain and grow medical
laboratory testing business that increasingly may come from health networks
versus physician-owned private medical practices.
With a now-estimated price tag of $16.1 billion, federal regulators and government representatives question the VA’s replacement for their VistA medical records system
Originally estimated to cost $10 billion, a contract to
replace the federal Department of Veterans
Affairs (VA) electronic
health record (EHR) system will now cost $16.1 billion, according to new
estimates, and this has drawn increased scrutiny from regulators and the media.
ProPublica reports that the initial
deal signed in May 2018 between the VA and Cerner,
one of the nation’s largest vendors of laboratory
information systems (LIS) and anatomic pathology information systems,
included a $10-billion ‘no-bid’ contract to replace the VA’s aging VistA medical records system
over 10 years. Since then, that estimate has ballooned to $16 billion, and with
this latest increase, is now at $16.1 billion.
One ongoing challenge facing clinical
laboratories and anatomic
pathology groups is maintaining interfaces to the plethora of disparate EHR
systems implemented in healthcare networks across the country. It’s a costly
undertaking that has nearly bankrupted many healthcare providers.
Thus, these developments could impact how medical
laboratories and pathology groups work and communicate with the VA in the
future and are worth paying attention to.
In response, John Windom,
Executive Director of the federal government’s Office of Electronic Health Record Modernization (OEHRM), told the House Committee that the VA’s
original estimate failed to include roughly $35 million/year for VA government employee
costs over the decade-long Cerner contract.
“We have to have highly qualified subject matter experts to
grade the implementation efforts of Cerner. Those people in the industry cost
money,” noted Windom, Health Data Management reported.
This review hearing came just after ProPublica reported on a progress report where Cerner had assigned
an alert rating of “yellow trending toward red” to the VA’s EHR implementation efforts.
Deploying a new EHR in a system as large as the VA is a
highly complex operation. Adding in government oversight—and coordinating
development and deployment between all the parties involved—further complicates
the VA and Cerner’s efforts.
One complication not receiving much coverage is the fact
that EHR systems designed primarily for insurance billing purposes may be
incompatible with the needs of the VA and other federal agencies that do not
bill insurance companies.
“VA is different. The focus of the VA’s electronic medical
record is never about clinical documentation to support billing. It’s about
giving the information to the provider at the right time to inform the best
care. There are true risks to patients if they don’t do this right,” Heather
Woodward-Hagg, PhD, former National Program Director (Acting), Veterans
Engineering Resource Centers (VERC) and Founding Director, Veterans Affairs
Center for Applied System Engineering (VA-CASE), told ProPublica.
Nevertheless, according to coverage of the Review Committee
hearing by MeriTalk, Windom remains hopeful
that the project’s financials will improve. “There are going to be efficiencies
gained we can’t forecast at this point,” he told the Committee members.
According to MeriTalk, the original deal between
the DoD, Cerner, and Leidos in 2015 was estimated
at $4.3 billion. However, in July 2018, the DoD increased the project budget by
$1.2 billion—bringing the total estimate to $5.5 billion.
Still, this falls far short of the VA estimate of $16.1
billion leaving regulators and media outlets questioning the health and
oversight of the Cerner/VA project.
The VA estimate also is well above the cost of other notable
EHR implementations—such as the development and deployment of Kaiser
Permanente’s HealthConnect EHR.
Speaking with InfoWorld in 2013, Philip Fasano, then CIO
of Kaiser Permanente, noted
that it cost roughly $4 billion to build a system alongside Epic to serve their
9-million members. When asked what it would take to implement a similar system
nationally, he estimated costs in the “tens of billions.”
The Hidden Costs of
EHR Implementation
Speaking with Becker’s Hospital Review in 2016, Eric Helsher, Vice
President of Client Success at Epic, highlighted
how difficult it is to budget for such upgrades. “It’s misleading to say, ‘A
hospital is undergoing a $X million Epic
implementation,’ because the install includes far more than simply the Epic
software,” he said. “An EHR from any vendor requires technology like servers
and storage to house the software—be it on-premise
or in the Cloud—and laptops and mobile devices to access it. That would be like
if you go buy a fully loaded laptop and attribute that full cost to Microsoft
Word. You needed the computer to get Word.”
Whether the VA and Cerner can determine ways to bring the
contract in line with budgets remains to be seen. However, while healthcare
reform highlights EHR implementation and interoperability as major concerns in
the modern US healthcare landscape, the VA’s latest attempts at replacing their
VistA medical records system serves as a reminder of the complexity and hidden
costs facing healthcare providers working to meet healthcare reform
requirements and offer a more personalized care experience.
This, of course, applies equally well to clinical
laboratories.