Medical laboratories that develop appropriate clinical strategies may find opportunities to leverage several new technologies expected to have a big impact on providers
Industry experts often speculate how developing technologies will impact healthcare. However, clinical laboratory leaders may be surprised by how much blockchain, medical malls, and Uber Health are expected to alter healthcare delivery in the next decade.
An article in FierceHealthcare states that “Healthcare is on the cusp of a technology revolution. Technology is primed to disrupt healthcare more explosively than it has any other industry.”
Medical advancements certainly impact clinical laboratories
and anatomic pathology groups, and any acceleration in these developing
technologies applied to healthcare will certainly be of interest to lab leaders
who want to ensure their labs are ready.
Blockchain Provides Healthcare Security, Privacy, and
Interoperability
Authored by Sloan Gaon, CEO, PulsePoint, the FierceHealthcare article predicts that blockchain will be an important feature in the future of healthcare. It will allow patients to have an online, accurate health record that is accessible only to necessary parties in real time. Consumers will be able to maintain, control, and share their data as they wish while increasing the security, privacy, and interoperability of their health information.
“A primary care physician could access a complete medical history of the member, while the radiologist could be limited to only the specifics he or she needs to perform the task at hand. For each, it’s about accessing the right data at the right time, and the blockchain technology could enable this type of specific ‘need-to-know’ medical history access,” wrote Bruce Broussard, President and CEO of Humana in a LinkedIn article.
The blockchain records can be shared among a network of
computers and kept secure via cryptography. And the
technology allows for easy transferability among different networks, improving
performance and outcomes for patients. Broussard also stated that blockchain
technology will provide more efficient payment for insurance claims.
“With transparency and automation, greater efficiencies will
lead to lower administration costs, faster claims, and less money wasted.
Blockchain enables claims to be paid without an intermediary, since health plan
members are connecting directly with their providers. These consumers can also
access their permanent electronic health records in a secure fashion, enabling
them to have a real-time understanding of their health,” he wrote.
Should blockchain achieve widespread adoption as a platform
for patient health information, the clinical laboratory industry will need to
address the problem of different test methodologies and different reference
ranges for test results. If blockchain makes it feasible to bring all pieces of
a single patient’s cumulative health data into a single record, then clinical
labs will need to address that problem in an effective way.
Medical Malls a Win-Win for Healthcare Providers and
Retail Locations
With big shopping malls dying due to economic recessions and the emergence of online retail destinations, property owners are seeking new tenants. In the summer of 2017, there were still about 1,100 malls remaining in the US, however, a quarter of them were at a risk of closing within five years, Time noted that year.
As healthcare organizations expand, there is an overwhelming
need for suitable space that is accessible for consumers at a reasonable price.
Fading shopping malls with their convenient locations, sturdy foundations, and
large parking lots could fill that gap.
In February of 2017, Avita Health System opened a boutique hospital in a space once occupied by an anchor store in a mall located in Ontario, Ohio. The healthcare provider purchased a 185,000 square-foot space that was formerly a Lazarus department store.
Mansfield News Journal reported that when the hospital opened, it included a walk-in clinic, an emergency room, surgical suites, pre-operative and post-operative areas, an onsite pharmacy, imaging services, a clinical laboratory, and 30 acute care beds.
Other services, including a Level II Cath lab, a maternity center, and the installation of a 3T Magnetic Resonance Imaging (3T MRI) machine, have been added since the facility opened. And there’s room for more expansion at the site.
Vanderbilt Medical Group (VMG) now occupies the entire second level of One Hundred Oaks Mall, in Nashville, Tenn. Their services at the once-struggling retail shopping center include 22 specialty clinics in 450,000 square feet of space designed by architecture firm Gresham Smith.
Patients can pick up a pager at the VMG facility and then
shop on the lower level while waiting to be paged to see a healthcare
professional or receive test results.
“More important than the significant increase in our available clinical space is the overall concept and design which is focused on providing our patients, faculty, and staff with a new paradigm for health and wellness. The convenience, accessibility, and innovative ways of providing care for our patients are a true transformation of both the architecture and the way our patients experience healthcare,” said Cyril Stewart, former Director of Facility Planning for Vanderbilt University Medical Center (VUMC) in a testimonial on the Gresham Smith website.
Non-Emergency Medical Transportation and Uber Health
Kaiser Family Foundation (KFF) reported in 2016 that “Medicaid’s non-emergency medical transportation (NEMT) benefit facilitates access to care for low income beneficiaries who otherwise may not have a reliable affordable means of getting to healthcare appointments. NEMT also assists people with disabilities who have frequent appointments and people who have limited public transit options and long travel times to healthcare providers, such as those in rural areas.”
The Hospital and Healthsystem Association of Pennsylvania (HAP) reported that an average of 3.6 million Americans miss their healthcare appointments annually due to lack of or unreliable transportation. These missed appointments can cause an avalanche of future problems, including increased visits to emergency rooms, extended hospital stays, and higher costs for providers.
“If there are people who are missing their appointments because they’re using an unreliable bus service to get to and from their healthcare provider, this is a great solution for them,” Christopher Weber, General Manager and Senior Project Manager at Uber Health, told The Verge. “The types of individuals this is valuable for really is limitless.”
Uber health’s mobile device application (app) enables patients and healthcare providers to schedule non-emergency medical transportation for medical appointments within a few hours or up to a 30-day notice. It is also available both as an online dashboard and as an application-programming interface (API) for software developers to integrate the service into their proprietary healthcare tools.
An Uber
(NYSE:UBER) account is not required, as notifications about rides can be sent
to patients via text messages.
Clinical laboratory leaders may want to develop strategies
around these three predictions to increase business and maximize profits. Since
more healthcare organizations will soon be linked via blockchain, and an
increased number of consumers could start using non-emergency medical
transportation, such as Uber Health, to get to medical appointments, becoming
familiar with these technologies could prove to be beneficial to labs.
In addition, medical facilities cropping up in former mall
spaces will require medical laboratories to be onsite to support care and
provide lab test results within an acceptable turnaround time.
Medical laboratory leaders need to take opportunities to stay abreast of government and payer activity, particularly as payer audits become tougher, say legal experts
Even compliant clinical laboratories and anatomic pathology groups are reporting tougher audits and closer scrutiny of the medical lab test claims they submit for payment. This is an unwelcome development at a time when falling lab test prices, narrowing networks, and more prior-authorization requirements are already making it tough for labs to get paid for the tests they perform.
Clinical laboratory leaders can expect continued scrutiny of
their labs’ operations and financials as government and commercial payers move
forward with invasive programs and policies designed to ferret out fraud and
bad actors.
Federal officials are focusing their investigations on healthcare providers who mismanage or inappropriately use Medicare and Medicaid programs, while commercial payers are closely scrutinizing areas such as genetic testing prior authorization, say healthcare attorneys with Cleveland Ohio-based McDonald Hopkins, LLC.
“The government is looking at fraud, waste, and abuse, and all the different ways they come into play,” said Elizabeth Sullivan, Esq., a Member and Co-Chair of the firm’s Healthcare Practice Group, in an exclusive interview with Dark Daily. “We anticipate there will be more enforcement [of fraud and abuse laws] centered around different issues—anything that can be a false claim.”
Specifically, government officials will key in on violations of the Stark Law, EKRA (the Eliminating Kickback in Recovery Act of 2018), and other anti-kickback statutes and laws, Sullivan said.
“And clinical laboratories, by virtue of the type of
services and service arrangements they offer, will continue to be a target,” she
added.
Medical laboratory leaders also must prepare for aggressive tactics by insurance companies. “On the commercial side, payers are getting more aggressive and more willing to take things to ligation if they don’t get what they want and don’t see a settlement that satisfies their concerns over issues,” said Courtney Tito, Esq., also a Member with McDonald Hopkins, in the Dark Daily interview.
Current Investigations Likely to Impact Clinical
Laboratories
Sullivan and Tito advise clinical labs to be aware of the
following issues being fast-tracked by government and private payers:
EKRA (Eliminating Kickback in Recovery Act of 2018).
The TPE audits program, according to CMS, is focused on providers with high claim error rates or unusual billing practices. During a TPE, a Medicare administrative contractor (MAC) works with a provider to identify and correct errors.
“The TPE audits are real hot right now. We are seeing a lot
of clients go through this,” Tito said.
Feds Crack Down on Genetic Testing Fraud Schemes
Genetic testing is another “hot button” issue for
enforcement by government and private payers, Sullivan and Tito state.
CMS is taking action against testing companies and
practitioners who submitted more than $1.7 billion in claims to Medicare, the
statement added.
The scheme involved medical laboratories conducting the genetic tests, McDonald Hopkins noted in an Alert about the DOJ investigation. The alert described how the scam operated:
Scam recruiters approached Medicare
beneficiaries at health fairs;
In exchange for a DNA sample (in the form of a
cheek swab) and a copy of the victim’s driver’s license, the “representative”
offered a free genetic test;
Representatives allegedly asked the seniors’
doctors to sign-off on test orders. If the seniors’ physicians refused, the
scammers offered kickbacks to doctors already in their group;
Clinical laboratories that performed the tests
were reimbursed from Medicare and, allegedly, shared the proceeds with the scammers.
“Although these opportunities may seem appealing as an
additional revenue source for providers, it is always important to review the
regulatory requirements as well as the potential anti-kickback statute and
Stark implications for any new arrangement,” Sullivan and Tito wrote in the McDonald
Hopkins Alert article.
Criminal Behavior in CMS Programs
Effective Nov. 4, 2019, CMS issued a final rule intended to stop fraud before it happens by keeping “unscrupulous providers” out of the federal healthcare programs in the first place, states a CMS news release.
Additionally, EKRA establishes “criminal penalties for unlawful payments for referrals to recovery homes and clinical treatment facilities,” Dark Daily recently reported. However, as the e-briefing points out, it is unclear whether EKRA applies to clinical laboratories.
Nevertheless, Sullivan points out that, “Even without EKRA,
the anti-kickback statute applies to any arrangement between individuals. And,
it is good to have an attorney look at those arrangements. What your sales reps
are doing in the field, how they are communicating, and their practices warrant
oversight. EKRA just makes it all the more important.”
Clinical Laboratories Need Compliance Plan, Focus on
Payers
With so many legal requirements and payer programs, Sullivan
advises medical labs and pathology group practices to work with resources they
trust and to have a compliance plan at the ready. “Have resources in place,
including but not limited to a compliance officer, a committee, and someone who
is spending time on these issues. Monitoring government enforcement and payer
activity is the most critical,” she said.
To assist labs in remaining fully informed on these critical
compliance topics, and the federal government’s latest legislation to combat
fraud, Dark Daily is offering a webinar on November 20th at 1pm Eastern
time. Sullivan and Tito will offer their insights and advice on how labs should
prepare for CMS’ battle to reign in fraud and commercial payers’ increased
scrutiny into prior authorizations.
Clinical laboratory leaders, compliance officers, and
finance staff will benefit greatly from this crucial resource.
This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices
It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg).
In September, Bloomberg reported that 17 former Orig3n employees said the company’s Deoxyribonucleic acid (DNA) tests sometimes failed to deliver the intended results or were often contaminated or inaccurate. The individuals had been employed by the company as managers, lab technicians, software engineers, marketers, and salespeople between 2015 and 2018.
The former employees claimed that Orig3n “habitually cut
corners, tampered with or fabricated results, and failed to meet basic
scientific standards,” Bloomberg reported. The individuals also stated
that advice intended to be personalized to individual consumers’ genetic
profiles was often just generic information or advice that had no scientific
basis.
According to Bloomberg, the individuals also alleged
that Orig3n’s lab was careless in its handling of genetic samples in several
ways, including:
Multiple samples being labeled with the same
barcode;
DNA and blood samples for stem cell bank
misplaced or mixed up;
No controls to ensure accuracy;
Handling methods that could lead to
contamination; and
Fabricating results when a test outcome was
unclear.
The former employees also stated that “Orig3n ran tests without proper authorization in its lab at the 49ers’ stadium, and that managers regularly compelled them to write positive reviews of Orig3n’s tests on Amazon.com and Google to offset waves of negative feedback,” Bloomberg reported.
“Accurate science didn’t seem to be a priority. Marketing
was the priority,” said a former lab technician who spoke with Bloomberg
on the condition of anonymity. Orig3n denied the accusations in a statement,
describing them as “grossly inaccurate,” and claimed the former employees were
simply disgruntled.
“In some cases, former employees are former employees for a reason,” Orig3n Chief Executive Officer Robin Smith told Bloomberg. “We’ve found after employees are gone that they have not done things appropriately.”
Is it Dog or Human DNA?
In 2018, NBC Chicago(NBC) conducted an investigation into various consumer DNA testing kits. NBC sent DNA samples to several different testing companies. This included non-human samples, which NBC’s investigators had obtained from a female Labrador Retriever.
With the exception of Orig3n, all of companies identified
the DNA as non-human and did not process the kits. Orig3n did, however, process
the canine DNA. It then returned a seven-page analysis that suggested the
subject of the sample “would probably be great for quick movements like boxing
and basketball, and that she has the cardiac output for long endurance bike
rides or runs,” NBC reported.
This would be funny if it weren’t so concerning.
Following reports that it had processed dog DNA, Orig3n stated
it had made changes and improvements to the company’s testing methodologies. Smith
also stated Orig3n’s lab protocols had been improved as well.
“Sometimes we look at the accuracy of things and go, ‘Man,
that’s not working,’” Smith told Bloomberg. “Our approach and our
philosophy is [sic] to constantly improve the products.”
Serious Accusations of Clinical Laboratory Malfeasance
Founded in 2014 with the intent of creating the world’s largest stem cell bank, by 2016, Boston-based Orig3n had refocused its attention on the burgeoning field of direct-to-consumer DNA testing. On its website, Orig3n sells several DNA-testing kits with varying costs.
Orig3n’s attempt to offer free genetic tests to large numbers of people at a professional sporting event in the fall of 2017 may be what caught the attention of federal investigators and led to a deeper investigation. Dark Daily previously covered this controversy, which centered around Orig3n’s plan to distribute free genetic testing kits to fans at a Baltimore Ravens football game.
In that situation, state and federal healthcare regulators blocked the giveaway over concerns about protected health information (PHI). Now, Orig3n is being accused of questionable business practices by 17 of its former employees.
The former employees’ statements that the company’s genetic
testing lab did not follow appropriate test protocols—and that it allegedly
mishandled specimens and even reported false test results—are serious
allegation of malfeasance and warrants an investigation.
Pathologists and clinical laboratory managers know that patient
harm can potentially result from inaccurate genetic test results if used for
clinical purposes. Dark Daily will continue to follow the investigation
into Orig3n.
Some companies save so much in healthcare cost they pay their employees to participate in medical tourism programs
Medical tourism is not new, but it’s changing, and clinical laboratories have a role to play in the models employers use to save money on their employees’ health coverage costs.
Employers that manage the entire process—from securing
passports for their employees, to ensuring they have access to high-quality care
outside the country’s borders—report saving money as well as simplifying the
process for their employees. An apparent win-win.
However, questions linger about:
Availability of diagnostic testing and clinical
laboratories;
If patients treated outside the US receive
adequate protections; and
Whether the quality of care is equal to that in
the US.
One recent example of a company helping employers and employees receive high quality care outside of the US is NASH—the North American Specialty Hospital. NASH was featured in a Kaiser Health News (KHN) article that described one patient’s experience traveling to Cancún for a surgical procedure.
Location, Pre-Existing Conditions, Length of Stay, Etc.,
Affect Final Bill in US
One of NASH’s corporate clients is Ashley Furniture Industries. Headquartered
in Arcadia, Wis., the American home furnishings manufacturer and retailer employs
approximately 17,000 people, including Terry Ferguson. Terry’s wife, Donna, is
the patient highlighted in the KHN story.
One of the healthcare providers NASH partners with is Galenia Hospital, a 55-bed general services hospital in Cancún, Mexico. NASH leases the entire third floor of the hospital. Galenia is next door to a Four Points Sheraton Hotel, making lodging a simple matter for medical tourists.
Currently, NASH focuses on orthopedic surgeries such as total
knee replacements, the medical procedure Donna Ferguson underwent.
A 2015 BlueCross
BlueShield study showed that costs for total-knee-replacement surgery in
the US averaged about $31,000. However, depending on where the surgery takes
place, it can cost as low as $11,317 (Alabama) and as high as $69,654 (New York
City). Pre-existing conditions, length of time in the operating room, number of
days in the hospital, and numerous other factors contribute to the final bill.
NASH, however, sets the final price is up front.
Some Companies Pay Their Employees to Use Medical Tourism
With the average cost for the surgery coming in at around
$12,000, the cost savings to employers is so great some companies actually pay employees
who are willing to travel for procedures, KHN reported. Donna Ferguson paid
no co-pays for her surgery, paid nothing out of pocket for travel or lodging
while in Cancún, and the Ferguson’s received a $5,000 check from Ashley
Furniture.
Ferguson told KHN, “It’s been a great experience.
Even if I had to pay, I would come back here because it’s just a different
level of care—they treat you like family.”
That’s important for hospitals, clinical laboratories, and
all healthcare providers in America to consider. In the minds of patients,
quality of care starts with their experience at the hands of the provider.
Clinical Laboratory Tests in US, Surgery in Mexico
Prior to traveling outside the US for surgery, Ferguson
underwent a physical exam, X-rays, and other diagnostic testing to ensure the
treatment approach was the best for her. Once that was confirmed, IndusHealth, Ashely’s medical travel
plan administrator, “coordinated [Donna’s] medical care and made travel
arrangements, including obtaining passports, airline tickets, hotel and meals,”
for both Donna and Terry Ferguson, KHN reported.
It seems reasonable to assume that NASH has agreements with
multiple clinical pathology laboratories and healthcare facilities throughout
the US for patients to get the tests they need prior to surgery. Partnerships
with medical tourism companies may well represent an avenue for pathology
laboratories to pursue.
Protections for Patients
So, why hasn’t medical tourism become the healthcare juggernaut some experts predicted? Managed Care suggests one reason is that Americans tend to be skeptical of the quality of care they will receive in a foreign facility.
“Building a familiar culture in a foreign destination may be appealing to some American consumers, but I do not see it as a sustainable business,” Health consultant Irving Stackpole, PhD, MEd, Psychology, told KHN. “It’s not unusual for people thinking about this to have doctors, family, and friends who will see this as a high-risk undertaking.”
Several factors helped Ferguson feel better about her
decision to travel to Mexico for surgery. One is that Galenia is credentialed.
Managed Care notes, “A number of organizations credential international facilities. The American Medical Association guidelines for medical tourism recommend that foreign medical providers have accreditation from the Joint Commission International or a similar organization.”
In addition to a credentialed facility and a highly trained
surgeon, NASH also provides US malpractice insurance coverage, giving patients
recourse in the event something goes wrong. Ferguson and American patients like
her would be able to sue in the US if care under this arrangement was not
successful.
Medical Tourism Pays Surgeon’s Full Fee
One fascinating twist in this story is that an American physician was flown to Cancun to perform this operation and was paid his full fee. The surgeon scheduled to perform Ferguson’s operation, Thomas Parisi, MD, JD, trained at the Mayo Clinic. He traveled from Wisconsin to Cancún to perform the procedure. “Dr. Parisi trained at Mayo, and you can’t do any better than that,” Ferguson told KHN.
KHN reported that Parisi spent less than 24 hours in
Cancun and was paid $2,700 for this surgery. That fee is three times of the
amount Medicare pays for this procedure. Further, Parisi’s fee was
significantly above what many managed care plans would negotiate for this type
of surgery.
American-trained physicians are common at many of the
facilities credentialed by the Joint Commission International. “Many overseas
hospitals are staffed in part by physicians and other health professionals who
were trained in US hospitals. One hospital in India has 200 US-trained
board-certified surgeons,” wrote James E. Dalen, MD,
MPH, ScD, and Joseph S. Alpert,
MD, in “Medical Tourists: Incoming and Outgoing,” published in The American
Journal of Medicine (AMJMED).
“In the past, medical tourism has been mostly a blind leap to a country far away, to unknown hospitals and unknown doctors with unknown supplies, to a place without US medical malpractice insurance. We are making the experience completely different and removing as much uncertainty as we can,” James Polsfut, CEO and Chairman, North American Specialty Hospital (NASH), told KHN.
Clinical laboratories in America may find opportunities
providing testing services to medical tourism organizations like NASH. It’s
worth investigating.
Medical laboratories may find opportunities guiding hospital telehealth service physicians in how clinical lab tests are ordered and how the test results are used to select the best therapies
Telehealth is usually thought of as a way for patients in remote settings to access physicians and other caregivers. But now comes a pair of studies that indicate use of telehealth in inpatient settings is outpacing the growth of telehealth for outpatient services.
This is an unexpected development that could give clinical laboratories new opportunities to help improve how physicians in telehealth services use medical laboratory tests to diagnose their patients and select appropriate therapies.
Dual Surveys Compare Inpatient and Outpatient Telehealth
Service Use
Definitive Healthcare (DH) of Framingham, Mass., is an analytics company that provides data on hospitals, physicians, and other healthcare providers, according to the company’s website. A survey conducted by DH found that use of telehealth solutions—such as two-way video webcams and SMS (short message service) text—has increased by inpatient providers from 54% in 2014 to 85% in 2019, a news release stated.
Meanwhile, a second Definitive Healthcare survey suggests
use of telehealth in outpatient physician office settings remained essentially
flat at 44% from 2018 to 2019, according to another news
release.
For the inpatient report, Definitive Healthcare polled 175 c-suite
providers and health
information technology (HIT) directors in hospitals and healthcare systems.
For the outpatient survey, the firm surveyed 270 physicians and outpatient
facilities administrators.
DH’s research was aimed at learning the status of telehealth
adoption, identifying the type of telehealth technology used, and predicting possible
further investments in telehealth technologies.
Most Popular Inpatient Telehealth Technologies
On the inpatient side, 65% of survey respondents said the most used telehealth mode is hub-and-spoke teleconferencing (audio/video communication between sites), Healthcare Dive reported. Also popular:
Fierce
Healthcarereports that the telehealth technologies showing the largest
increase by hospitals and health networks since 2016 are:
Two-way video/webcam between physician and
patient (70%, up from 47%);
Population health management tools, such as SMS
text (19%, up from 12%);
Remote patient monitoring using clinical-grade
devices (14%, up from 8%);
Mobile apps for concierge services (23%, up from
17%).
“Organizations are finding new and creative ways through telehealth to fill gaps in patient care, increase care access, and provide additional services to patient populations outside the walls of their hospital,” Kate Shamsuddin, Definitive Healthcare’s Senior Vice President of Strategy, told Managed Healthcare Executive.
DH believes investments in telehealth will increase at
hospitals as well as physician practices. In fact, 90% of respondents planning
to adopt more telehealth technology indicated they would likely start in the
next 18 months, the news releases state.
Most Popular Outpatient Telehealth Technologies
In the outpatient telehealth survey, 56% of physician
practice respondents indicated patient portals as the
leading telehealth technology, MedCity
News reported. That was followed by:
Hub-and-spoke teleconferencing (42%);
Concierge services (42%);
Clinical- and consumer-grade remote patient
monitoring products (21% and 12%).
While adoption of telehealth technology was flat over the
past year, 68% of physician practices did use two-way video/webcam technology
between physician and patient, which is up from 45% in 2018, Fierce
Healthcare reported.
MedCity News reports that other telehealth technologies in
use at physician practices include:
Mobile apps for concierge service (33%);
Two-way video between physicians (25%);
SMS population management tools (20%).
Telehealth Reimbursement and Interoperability Uncertain
Why do outpatient providers appear slower to adopt
telehealth, even though they generally have more patient encounters than
inpatient facilities and need to reach out further and more often?
Definitive Healthcare reports that 20% of physician practice
respondents are “satisfied with the practice’s current solutions and services,”
and though telehealth reimbursement is improving, 13% are unsure they will be
reimbursed for telehealth services.
The Centers
for Medicare and Medicaid Services (CMS) states that Medicare
Part B covers “certain telehealth services,” and that patients may be
responsible for paying 20% of the Medicare approved amount. CMS also states
that, effective in 2020, Medicare
Advantage plans may “offer more telehealth benefits,” as compared to
traditional Medicare.
The increase in telehealth use at hospitals—as well as its
increased adoption by physician offices—may provide clinical laboratories with opportunities
to assist telehealth doctors with lab test use and ordering. By engaging in telehealth
technology, such as two-way video between physicians, pathologists also may be
able to help with the accuracy of diagnoses and timely and effective patient
care.
Could local and federal prosecutors ask clinical laboratories to disclose information on their client physicians’ test-ordering activities when investigating medical errors?
Are physicians facing greater risk of criminal indictments when one of their patients dies, and investigators find that physician impairment or inappropriate medical treatments contributed to the patient’s death? Could clinical laboratories be drawn into federal investigations of their client physicians?
The healthcare industry is responding to often highly-publicized
accusations of alleged wrongful care with extensive investigations of the
doctors involved. And following suit, local and federal prosecutors increasingly
seem willing to bring criminal charges against those physicians.
Thus, it behooves clinical laboratories to be aware of client physicians who may be over-ordering lab tests or regularly ordering inappropriate tests for their patients. At what point might criminal investigators hold medical laboratories accountable for not notifying authorities about lab test utilization patterns by physicians who could be reasonably understood to be putting their patients at risk of harm?
Doctors Charged in Three Cases Involving Deaths of
Patients
In two separate reports, Fierce Healthcare covered three pending cases in which doctors are being charged in the deaths of their patients: article one covers a case is in Ohio; and article two covers cases in Arkansas and California. Charges were filed against:
William Husel, DO, an Ohio critical care specialist who was indicted for 25 counts of murder for allegedly intentionally ordering fatal drug overdoses, according to a statement by the Franklin County Prosecuting Attorney. He pleaded not guilty, the Associated Press reported.
Robert Levy, MD, an Arkansas pathologist who was indicted by a federal grand jury on “three counts of involuntary manslaughter” in the deaths of three patients, according to a statement by the US Attorney’s Office for the Western District of Arkansas. Levy pleaded not guilty at an arraignment in August, the Washington Post reported.
Thomas Keller, MD, a California neurosurgeon who was indicted in the deaths of five patients, which allegedly resulted from his overprescribing opioids and narcotics, according to a statement from the State of California Department of Justice. Keller pleaded not guilty to second-degree murder charges in Sonoma County Court, according to the Press Democrat.
Dark Daily’s sister publication The Dark Report (TDR) covered the year-long investigation of Arkansas Pathologist Robert Levy, MD, by the US Attorney’s Office for the Western District of Arkansas. (See TDR, “Arkansas Pathologist Faces Three Manslaughter Charges,” September 30, 2019.)
Levy served as the Chief of Pathology and Laboratory Medical Services for the Veterans Health Care System of the Ozarks in Fayetteville, Ark., from 2005 through 2018.
In a statement, the US Attorney’s Office Western District of
Arkansas said, “A federal grand jury … indicted Levy on twelve counts of wire
fraud, twelve counts of mail fraud, four counts of making false statements in
certain matters, and three counts of involuntary manslaughter.”
A fact-finding panel interviewed Levy in 2015 after reports
that he was under the influence of alcohol while on duty, stated the US
Attorney Arkansas, adding that Levy denied the allegations.
In addition to other charges, the US Attorney Arkansas
statement said, “The indictment charges Levy with three counts of involuntary manslaughter
for causing the death of three patients through entering incorrect and
misleading diagnoses and, on two occasions, by falsifying entries in the
patients’ medical records to state that a second pathologist concurred with the
diagnosis Levy had made. The indictment alleges that the incorrect and
misleading diagnoses rendered by Levy caused the deaths of three veterans.”
In a news conference covered by the Washington Post, Duane Kees, US Attorney for the Western District of Arkansas, Department of Justice (DOJ), said, “I don’t think anyone would ever have imagined that a pathologist would use his knowledge and expertise to do something like this.”
Clinical laboratory leaders know how important it is to have
quality processes to prevent misdiagnosis, mistakes, and inappropriate test
utilization. Now, lab leaders may want to be aware of the activities of their
client physicians as well.
During investigations involving harm to patients allegedly
at the hands of healthcare providers, information kept by medical laboratories
about the lab test ordering practices of their client physicians may become an
important resource to officials conducting inquiries.